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Building Bridges to
Innovation
Decoding the Big Slowdown;
Assessing Progress on Innovation
Shanghai, October 20-21 2015
CONFIDENTIAL AND PROPRIETARY
Any use of this material without specific permission of McKinsey & Company is strictly prohibited
McKinsey & Company 2|
Decoding the big
slowdown
Contents
2015 in the mirror
Assessing progress
on innovation
McKinsey & Company 3|
2015 in the mirror
McKinsey & Company 4|
Last year we introduced the concept of China’s
potential “Bridges to Innovation”
Broken bridgeNarrow bridgeBroad bridge1 2 3
▪ Mature drugs have lasting
staying power and continue to
grow beyond 2020
▪ China delivers meaningful and
broad step-up to reward of
innovation
▪ Mature drugs have staying
power, but come under
stronger pressure and plateau
beyond 2020
▪ China delivers meaningful but
narrow reward for innovation,
closely aligned with disease
priorities
▪ Window for mature drugs
starts closing rapidly by 2020,
earlier for some drug
categories
▪ Innovation remains heavily
constrained
▪ Self-pay market becomes
main viable segment
e-Health
▪ Each potential scenario has profound implications on market outlook and
attractiveness for participants
▪ It will take some time before we know for sure which bridge we are walking on
McKinsey & Company 5|
As of today, we would argue that we are on a Narrow bridge scenario
Narrow bridgeBroad bridge Broken bridge
Slowdown in Rx market
(still growing though)
CFDA reform
13th Five Year Plan
CDI expansion
Delay in NRDL update
Pricing reform
McKinsey & Company 6|
2015 in the mirror – 8 key trends worth understanding
Deals
7
Anti-corruption drive
2
Economic slow-
down
1
China manufacturing
2025
CFDA reform
5
Cost containment
6
e-Health
8
China innovation
43
McKinsey & Company 7|
Slowdown of the economy is impacting many sectors, some
more dramatically than others
Construction Automobile Retail
Electricity consumption Luxury goods
1
SOURCE: McKinsey
McKinsey & Company 8|
Large, low-
cost, lower-
skilled labor
supply $300
150m
Monthly
salary
Migrant
workers
Old
Lower-value,
low-productivity export business model
with FDI
20% Annual export growth
Old
Cost-conscious
with lower
sophistication
(supply-driven
offerings)
50% Household
saving rate
Old
4x Debt in
2014 vs.
2007
Debt-financed
property and
infrastructure
investment
Old
50% Urban
population
(1978:
18%)
Inflow into cities
with pollution,
real estate
inflation, etc.
Old
China’s new normal – China is transitioning to a new growth
model with less rapid but higher quality growth (1/2)
SOURCE: McKinsey
Previous
growth
engine
1
Labor
5
Investment/
debt
4
Urbani-
zation
2
Consum
-ption
3 Business
model
Model not sustainable
1
McKinsey & Company 9|
More emphasis on soft than
hard infrastructure
and deleveraging
More experienced, higher-
wage work force, and more
entrepreneurship and job
creation
Sustainable and equitable
growth in smarter cities
Consumption-driven growth
with digitally informed and
demanding customers
Higher-value adding
activities (service and manufacturing)
and mass innovation
China’s new normal – China is transitioning to a new growth
model with less rapid but higher quality growth (2/2)
SOURCE: McKinsey
Previous
growth
engine
1
Labor
5
Investment/
debt
4
Urbani-
zation
2
Consum
-ption
3 Business
model
The success of companies in China will depend on how quickly they adapt to
the new normal
1
McKinsey & Company 10|
"China Manufacturing 2025" to promote Biomedicine
and high-performance medical apparatus
SOURCE: State Council announcement; lit search; McKinsey analysis
▪ China Manufacturing 2025 released in May,
2015 by State Council (similar to Germany
industry 4.0)
– First step of the bigger plan to upgrade
manufacturing industry
▪ Aim to transform the nation from a big
manufacturer to a strong manufacturer
– Move up the global value chain from low value
added manufacturing
– Accelerate development in 10 priority areas
including biopharmaceutical and medical
products
▪ Focus on the innovation and integration of
information technology in manufacturing
– Enhance the adoption of Internet, cloud service
and big data in traditional manufacturing
▪ Information technology
▪ High-end numerical machinery
and automation
▪ Aerospace and aviation
equipment
▪ Maritime engineer equipment
and high-tech vessel
▪ Rail equipment
▪ Electrical equipment
▪ Energy saving vehicles
▪ New material
▪ Biomedicine and high-
performance medical
apparatus
▪ Agriculture equipment
4
Overview 10 industrial sectors
McKinsey & Company 11|
Deals – Another year of heavy activity
+++
7
McKinsey & Company 12|
“Internet+” aims to further fuel economic growth by
integrating Internet with traditional industries
Policy description Implication to healthcare stakeholders
▪ Encourage online healthcare service
– Develop internet based healthcare services
and information exchange centers across
hospitals (e.g., EMR and imaging records)
– Promote online registration, result checking,
drug distribution and BMI payment
– Improve treatment outcome by adopting
precision treatment and disease prevention
▪ Promote digital elderly care
– Set up digital community centers and
enhance chronic disease management
– Adopt innovative products such as wearable
devices and remote monitoring devices to
monitor and track physical conditions
▪ Enhance e-commerce in healthcare
– Improve operational efficiency and
procurement process via e-commerce
platform
▪ Released in July 2015
▪ Mapped out development targets in 11 key
sectors incl. healthcare, manufacturing,
agriculture, energy, finance, logistics etc. by
integrating mobile Internet, cloud
computing, and big data technologies
▪ Aims to build a new economic model and an
important driving force for social innovation
by 2025
SOURCE: Lit-search; Government website; McKinsey analysis
8
McKinsey & Company 13|
Many players – both small and large – are actively ridding
the e-Health wave
Example of players Digital giants Healthcare ITEntrepreneurs
Delivery
Personal
care
Accessibility
Distribution
Community
8
McKinsey & Company 14|
In this complex context, we aimed to tackle two key themes
▪ Survey of 50
hospital directors
▪ CPA market data up
to July 2015
▪ China Drug
Innovation Index –
survey of
innovation leaders
(BayHelix)
▪ Interviews with
industry leaders
“Decoding the big
slowdown”
▪ What is really happening?
▪ What should we expect next?
▪ What are the implications?
“Assessing
progress on China
innovation”
▪ Are measures for real?
▪ Who will pay for innovation?
▪ What are the implications?
1
2
McKinsey & Company 15|
Decoding the big slowdown
McKinsey & Company 16|
Decoding the big slowdown – How we went about it
Sources of insights
Latest NHFPC
statistics on
patient flow
across hospital
segments
Hospital level
prescriptions
data from China
Pharmaceutical
Association
(CPA) up to
June 2015
Multiple
discussions with
senior
executives in the
pharma industry
Results from a
survey of 50
hospital
directors across
city tiers
McKinsey market
perspectives
McKinsey & Company 17|
China pharma market has experienced a marked slowdown in 2015
YoY sales growth of CPA sampled Class III/ II hospitals1, 2012-15 Q2
Percent
SOURCE: China Pharmaceutical Association (CPA); NHFPC
1 679 sampled hospitals, including 468 Class III hospitals, 211 Class II hospitals
2 2015 April and May data
6.3%
2015Q114 2015Q213
9.6%
12.4%
16.4%
2012
12.0%
9.8%Outpatient
YOY growth
Percent
8.2% 5.6% 3.9% 1.8%2
McKinsey & Company 18|
Majority of TAs and top MNC brands are affected by
the slowdown
Growth comparison by TA (ranked by 2014 TA size)
CPA sampled hospitals1
Growth comparison by Top MNC Brands (ranked by
2014 sales)
RDPAC reported sales
CV
CNS
Blood
Alimentary Tract and Metabolism
AI
Antineoplastic and
Immunomodulating
12%
7%
8%
7%
9%
6%
9%
Sensory Organs
3%
Genito-Urinary System And
Sex Hormones
Dermatologicals
19%
2%
Systemic Hormones 4%
Musculo-Skeletal 8%
Respiratory
8%
LIPITOR
GLUCOBAY
14%
18%
PLAVIX
8%
BETALOC
27%
7%
12%
22%
15%
24%
DIOVAN
NEXIUM
HERCEPTIN
LANTUS
CRESTOR
SULPERAZON
NORVASC
ADALAT
BARACLUDE
-7%
3%
PULMICORT
16%
BAYASPIRIN 8%
43%
16%
5%
15%
15%
18%
19%
15%
13%
14%
19%
12%
15%
39%
18%
14%
23%
19%
36%
35%
22%
15%
28%
12%
13%
32%
27%
78%
2011-14 CAGR
2014H1-15H1 growth
1 679 sampled hospitals, including 468 Class III hospitals, 213 Class II hospitals
SOURCE: China Pharmaceutical Association (CPA); RDPAC
McKinsey & Company 19|
Mature brands drive 78% of growth compared with 71% last year,
suggesting an aging portfolio
SOURCE: Industry association; McKinsey analysis
1 By year of registration
2013-14 growth breakdown by brands launch year1
RMB billions, %
2015H1 sales contribution of top 3 brands
%
75%
96%
85%
60%
53%
78%
100%
19%
14%
19%
50%
11%
20%
1%
11%
MNC 4
MNC 7 0%
MNC 6
0%
MNC 5 -3%
MNC 3
0%
MNC 1
3%MNC 2
6%
78%
< 5 years>10 years 5-10 years
63
42
57
42
50
62
44
51%2012-13 growth contribution from brands
>10 years was 71%, suggesting an aging
portfolio
McKinsey & Company 20|
4
8
10
7
12
4
6
3
4
17
8
7
15
24
10%
25%
20%
15%
5%
0
6
6
1310 1411
17
6
1208 09
10
2006
10
9
07 2015
Apr-May
2
2015
Q1
Not just a price effect – growth rate of patient flow has declined to its
lowest point in 10 years
SOURCE: NHFPC
1 Include hospitals and grassroots facilities
Patient flow1-YOY growth
Percent
InpatientOutpatient
McKinsey & Company 21|
Many MNCs and locals feel the pain; some leaders continue to grow at
double digits
SOURCE: China Pharmaceutical Association (CPA); company financial reports; investor calls; literature search
2015 H1
perfor-
mance vs.
2014 H1, %
2015 H1
perfor-
mance vs.
2014 H1, %
Pharma
players
Pharma
playersQuotes from Q2 releases
+1MNC
pharmaco
2
Sales of mature products
were impacted by
competition
+3MNC
pharmaco
3
A combination of
government cost control on
reimbursement, strict anti-
graft campaigns, the rise of
local player with cheaper
products and the slowdown
in distribution resulted in our
slowdown
+6Local
pharmaco
1
Industry continues to
slow … lowest in 10 years
-5Local
pharmaco
2
Due to price control,
increased production cost,
and tender policy the whole
industry is facing severe
challenges
Quotes from Q2 releases
-5.4MNC
pharmaco
1
Chinese government is
putting a lot of pressure on
off-patent originators. This
will be a big challenge for us
in the short term
+25Local
pharmaco
3
Despite the negative
impact from the government,
we have achieved rapid
growth by adapting the
strategy of innovation and
internationalization
+19MNC
pharmaco
4
Pricing pressure will be
tight in China and we are
trying to achieve significant
volume reflex as a remedy
for the price drop
+16Local
pharmaco
4
Despite the slowdown
of the overall
pharmaceutical industry in
China, the strategy of lean
manufacturing and internet
marketing has lead to
success in 2015 1H
+11Local
pharmaco
5
Facing a challenging
environment, we have
maintained moderately rapid
growth through innovative
marketing method, industrial
resource consolidation, etc.
McKinsey & Company 22|
Decoding the slowdown: Five key questions
Where have patients gone?
How low could
prices go?
¥
What does this
all mean for
pharmacos?
What are the
bright spots?
Who’s capturing
the volume?
McKinsey & Company 23|
Growth of public hospital patient flow has experienced marked
slowdown this year
Public hospital patient flow (January to May
of each year)
YoY growth, %
SOURCE: NHFPC; interviews
WHERE HAVE THE PATIENTS GONE?
4.7%
9.5%
8.5%
12.0%
4.9%
8.5%
2012-
2013
2013-
2014
2014-
2015
2012-
2013
2013-
2014
2014-
2015
Outpatient Inpatient
Budget control
policies limiting
hospital ability to
treat patients Anti-graft
campaign reducing
unnecessary visitsMore patients
going to retail
pharmacy for self-
medication
Reduced
income for
healthcare due to
stock market crash
Hospitals
reaching saturation
Migrant workers
returning to rural areas
due to economic
slowdown
Pharma executives hypotheses
Public hospital patient flow growth
significantly slower than previous years
Patients
getting medical
advice through
mobile apps
Fewer patients
due to a warm
winter
McKinsey & Company 24|
Effects of hospital related policies and constraints are seen as
the primary driver to patient flow slowdown
How does YoY growth in outpatient flow
compare between 2015 H1 and 2014 H1?
100% = 48 respondents
22%
Patients are less inclined to go to hospitals
due to reduced disposable income
44%
Reduction of unnecessary return visits
of patients
33%
Fewer people getting sick
Patients choose to self-medicate more
by going to retail
Hospital capacity reaches saturation
and has limited room to accommodate
patient growth
Hospitals less focused on increasing scale and
patient volume due to public hospital reform
61%
89%
44%
What is driving reduced patient flow growth?
% of top 3 drivers among respondents seeing slower growth
WHERE HAVE THE PATIENTS GONE?
SOURCE: 2015 McKinsey hospital director survey; McKinsey analysis
Hospital related drivers most impactful to patient
flow slowdown, suggesting no fundamental shift in
underlying demand
50%
25%
21%
29%
46%
29%
Slower
Faster
Same
100%
Tier 3 and
below/ county
(N=24)
Tier 1/2 city
(N=24)
100%
McKinsey & Company 25|
Shift in hospital focus driven by BMI budget control and greater
emphasis on service quality
Due to the BMI budget control policies, we are
simply not able to treat more patients
– Deputy hospital director, Class III hospital in
Kunming
▪ BMI budget control measures continue to
expand both in breadth and depth
– Most provinces have set targets for BMI
control since 2012
– Jiangsu plans to implement BMI budget
control to all cities/counties
– Coverage of budget control in Shanxi
exceeds 80% among all Class II and III
hospitals
▪ Hospital management focus switches
from capacity expansion to service
improvement
– Multiple government announcements to
prevent “unnecessary” capacity
expansion
– Hospitals make service quality
improvement a top priority
[2014] Document No.32 by NHFPC
[2015] Document No.45 by State Council
Hospital expansion was very common in the past
while recently central government no longer
encourage large hospitals to continue to expand
– Government official in healthcare reform
We have no plans to add more beds in the next
few years. Top priority is to enhance quality and
service of selected departments and make them
national leaders
– Director of BMI affairs, Class III hospital in Shanghai
[2015] Document No.38 by State Council
SOURCE: Government website; expert Interview; McKinsey Analysis
WHERE HAVE THE PATIENTS GONE?
McKinsey & Company 26|
Respondents from lower tier cities are more optimistic on future
outlook for patient flow growth
WHERE HAVE THE PATIENTS GONE?
How would you predict patient flow growth in 2016 H1 vs 2015 H1?
100% = 48 respondents
SOURCE: 2015 McKinsey hospital director survey; McKinsey analysis
67%
29%
29%
42%
29%
Same
Slower
Faster
Tier 3 and
below/ county
(N=24)
4%
100% 100%
Tier 1/2 city
(N=24)
Future increase in hospital level patient
flow will be driven by capacity expansion.
When you look at the big picture, we expect a
relatively stable growth
– Deputy hospital director, Class III, Weifang
Growth of patient flow will continue to
slow down in 2016. Class III hospitals today
focus more on improving service quality,
rather than just attracting more patients
– Head of Reimbursement. Class III, Shanghai
McKinsey & Company 27|
2015 has been a busy year on the pricing front
National
pricing
Reimburse-
ment
Provincial
tendering
Secondary price
negotiation
Increasingleveloffragmentation
2015 highlights
▪ National retail price cap removed for most drugs
▪ NDRC retains price monitoring and investigation authority
▪ Price for patented drugs to be set through “multi-party negotiation
mechanism”
▪ Reimbursement based pricing piloted
▪ Price point collection initiated for international price referencing
▪ Highly transparent price reference across the country
▪ Provinces demanding aggressive tender price cuts
▪ Independent price category for off-patent originators at risk
▪ Hospital/group level price negotiation pilots ongoing
▪ Expanding scale of pilots in 100+ cities
▪ Lack of volume guarantee
HOW LOW COULD PRICES GO?
¥
McKinsey & Company 28|
Most provinces expected to initiate tender the near term, many early
movers demanding aggressive price cuts
SOURCE: Literature research; GBI; McKinsey analysis
Tender in progress1Tender hasn’t started Finished 2015 tender2
Anhui
▪ “Double envelope” process
▪ City level “price-volume”
negotiation after provincial
tendering
▪ Severe price cut across cities,
e.g. average 17% price cut in
Bengbu
Hunan
▪ Two rounds of negotiation before
another two rounds of bidding
▪ Less than 50% of drugs
accepted negotiation
▪ Average price cut 10%-20%1 Includes provinces that have published tendering policies
2 Guangdong has finished 2015 tender for reimbursed drugs, while tendering for non-reimbursed drugs is in progress
3 No.7 document refers to <Guiding Opinion for Public Hospital Centralized Drug Procurement> issued by State council in Feb. 2015; No. 70 refers to
<Opinion of Public Hospital Centralized Drug Procurement> issued by NHFPC in June 2015
▪ Request 10-20% price cut as
pre-requisite for participation
▪ Reference national lowest price
▪ Separate groups for off-patent
originators and Gx
Zhejiang
Guangdong
▪ Third party online platform
▪ Monthly tendering
▪ 2 quality layers and set the 5
lowest average price as the cap
▪ Average price cut 5-10%
▪ First province to tender after
Document No.7 and No.703 were
published
▪ Introduced transparent purchasing
(price negotiation)
▪ Reference national lowest price
Beijing
HOW LOW COULD PRICES GO?
Jiangsu
▪ Draft version for tendering
published in Sep. 2015
▪ Off-patent originators may
potentially be in same category
with first-to-market Gx
¥
McKinsey & Company 29|
Downward tender price pressure likely to continue
SOURCE: GBI
HOW LOW COULD PRICES GO?
2012-15 Indexed average provincial tendering price
2012 price = 100
80
85
90
95
100
105
110
142012 13 2015
2015 average
price
2012 price = 100
2015 lowest
price
2012 price = 100
9999
9696
9297
8892
8795
9090
8790
8383
EXAMPLES
¥
▪ Price trends vary across brands – selected brands chose to drop out of tender requesting fierce
price drop, in the process sacrificing some volume
▪ Greater downward price pressure expected in 2016 due to
– Increasing transparency in tender price reference system
– More provinces expected to initiate tender
McKinsey & Company 30|
Secondary price negotiation continue to expand, adding further price
pressure on manufacturers
100
Hospital
purchase
price
85-95
Secondary
price
negotia-
tion
0-15
Retail
price
Provincial
tender
price
5-15
Hospital
markup
100-115
Zero-markup hospitals no
longer enjoy15% margin
on drug sales
Secondary price
negotiation provides
some margin relief
SOURCE: NHFPC; literature search; McKinsey analysis
Latest development
▪ 3 archetypes of secondary price negotiations
emerging
– City level volume based price negotiation for
all public hospitals, e.g. Anhui, Liaoning, 21
cities in Sichuan
– Hospital group purchasing organization,
e.g., Ningbo, Shaoxing
– Individual hospital negotiations, e.g.,
Tianjin, Shanxi, Hubei
▪ Zhejiang province took the lead to pilot profit
attribution scheme, savings from price
negotiation collected by local Bureau of Finance
(BoF), and allocated to local hospitals
Indexed price waterfall (tender price = 100)
Context
HOW LOW COULD PRICES GO?
¥
McKinsey & Company 31|
Several reimbursement pricing models being piloted
SOURCE: Literature search; McKinsey analysis
HOW LOW COULD PRICES GO?
Policy Overview Latest development in 2015
▪ Sanming Model
– Set the lowest Gx price as price for
reimbursement (piloted for select drugs)
– The rest is out-of-pocket expense for
patients
▪ Chongqing Model
– Use average tendering price to set
reimbursement price
– Select top 300 drugs (based on 2014
trading volume) in the pilot
▪ Shaoxing Model
– Use tendering price for each brand to
set reimbursement price
– Anhui and Zhejiang provinces adopt
similar model in 2015
▪ Pricing Bureau Chief conference on
October 27, 2014 suggested
reimbursement-based pricing be
implemented in 2015
▪ No official national guideline published
to date
▪ Pilots start to emerge in different
provinces with different
¥
Reimbursement pricing expected to promote usage of Gx given greater discrepancy in
out-of-pocket expense for patients using originators vs Gx
McKinsey & Company 32|
Volume growth has not been holding up for many top molecules
-5
0
5
10
15
20
Q215
Q1
Q4Q3Q2Q413
Q1
Q22012
Q1
Q3 Q4 Q3Q2 14
Q1
-5
0
5
10
15
20
25
30
35
40
45
50
15
Q1
Q4Q3Q214
Q1
Q22012
Q1
Q3Q2Q3Q2 13
Q1
Q4 Q4
Price
Volume
YoY growth by quarter of volume and price for
Acarbose, 2012 Q1-2015 Q2
Growth rate by quarter, %
YoY growth by quarter of volume and price for
Atorvastatin, 2012 Q1-2015 Q2
Growth rate by quarter, %
CPA sampled Class III/Class II hospitals1
SOURCE: China Pharmaceutical Association (CPA); McKinsey analysis
WHO IS CAPTURING THE VOLUME?
Drop in volume rather than price is partly caused by pharmacos’ decision to “walk away” from
provinces with too aggressive pricing conditions
1 679 sampled hospitals, including 468 Class III hospitals, 211 Class II hospitals
McKinsey & Company 33|
In the battle for share, both MNCs and locals are able to win
WHO IS CAPTURING THE VOLUME?
9%
Local
14
10%
90%
12%
91%
2015
1H
8%
100
MNC
92%
100 100
1312
100
88%
2011
15%
85%
100100
59%
41%
48%
52% 47%
100
2011 12 13
100
53%
39%
MNC
Local
61%
2015
1H
14
100
39%
61%
100
Locals gaining volume share
# of Gx
Top 3 Gx
Companies
15
▪ Shandong Qilu
▪ Jiangsu Haosoh
▪ Shanghai Chemo Wanbang
41%
14%
CAGR
2011-14
%
MNC gaining volume share
77
▪ CR Saike
▪ Yangtze River
▪ Dawnrays Pharma
5%
25%
CAGR
2011-14
%
# of Gx
Top 3 Gx
Companies
Amlodipine volume
%
Pemetrexed volume
%
SOURCE: China Pharmaceutical Association (CPA); McKinsey analysis
CPA sampled Class III/Class II hospitals1
1 679 sampled hospitals, including 468 Class III hospitals, 211 Class II hospitals
McKinsey & Company 34|
WHO IS CAPTURING THE VOLUME?
17%
81%
81%
31%
6%
69%
15%
Importance for preferred prescription
% of hospital directors list as top 3 reasons, N = 48
Product attributes and organizational capabilities are key to capturing
volume
Good quality
Convincing clinical data
Low price/good reimbursment
coverage policies
Original drug with good
brand image
Strong support on drug/TA
information
Innovative communication
New drug with patent
SOURCE: 2015 McKinsey hospital director survey; McKinsey analysis
Product related attributes
Deep understanding of prescriber
mindset and emotions
Unique channel access, e.g., retail,
digital
Extensive external collaborations,
e.g., distributor, government,
ecosystem partners
Effective coverage and competitive
share of voice
Market shaping capability
Organizational capabilities
Holistic offering key
to volume capture
McKinsey & Company 35|
Despite slowing growth, there are still bright spots in market
WHAT ARE THE BRIGHT SPOTS?
E-health initiatives
▪ Strong government
endorsement on e-health
e.g., Internet+ plan
▪ Digital provide new
models to broaden
accessibility, improve
healthcare delivery
quality, and strengthen
physician and patient
connections
High potential online
channel
▪ Online OTC sales only
USD 60 million in 2014
but regulation on online
Rx sales would unlock
significant upside
▪ County hospital, fastest
growing segment in hospital
sector, achieved 28% CAGR
2011-2013
▪ CHC market achieved 30%
CAGR 2011-2013
▪ Brick-and-mortar
retail channel
kept ~9% growth
in H1 2015,
on par with H1 2014
▪ Retail pharmacies becoming an increasingly important
channel given access hurdles to hospitals
S
Growth potential
beyond large
hospitals
Rising importance
of retail channel
New product
launches
Digital-health
frenzy, beginning of
a new S-curve
S
▪ 20+ innovative drugs launched since
2013. Many with potential to change
treatment paradigm and become future
drivers of the market
▪ CFDA reform underway – “tsunami of
launches” coming
McKinsey & Company 36|
County hospital market experiencing strong growth momentum
7%
66%
Urban
393
County
144
27%
25%
5.5%
70%
County
89
Urban
271
County
52
Urban
171
CHC
Hospital
4.5%
23%72%
2008 2011 2013
17%
22%
Hospital western medicine expense, 2008-2013 (latest available data)
Billion RMB
SOURCE: MOH database; NHPFC yearbook
16%
19%
28%
CAGR CAGR
19%
28%
32%
Urban
hospital
County
hospital
CHC
WHAT ARE THE BRIGHT SPOTS?
Accelerated growth in
county hospitals
further driven by
government financial
and policy support (e.g.,
MoF allocated $900+M
to support county
hospital reforms)
CHCs fast growth from
a small base, important
to target cities with
concentrated market
potential
McKinsey & Company 37|
Retail pharmacies becoming an increasingly important channel given
access challenges
SOURCE: MOHRSS; MOC; expert interviews
WHAT ARE THE BRIGHT SPOTS?
Initial
prescri-
ption in
hospitals
Two
prescri-
ption
fulfillment
channels
Patient self-
pick up from
pharmacies
Cold-chain
delivery to home/
hospital
Case example: Victoza effectively leverages
pharmacy channel to drive growth
Retail channel has been growing significantly
in the past few years
39322521
+11% p.a.
20112009 20132007
Revenue (at retail price) of retail pharmacies
in China
Billion USD
Pharmacy reimbursement coverage
‘000s of pharmacies
284 288 272 265
168152136115
424 424
12112010
399
+3% p.a.
433
2013
# of pharmacies
w/o reimbursement
# of pharmacies
w/ reimbursement
10%
CAGR,
2010-13
-2%
McKinsey & Company 38|
Another breakthrough year for E-health in 2015
SOURCE: Lit research; McKinsey analysis
WHAT ARE THE BRIGHT SPOTS?
NOT EXHAUSTIVE
▪ Healthcare information service provider authorization moved to provincial gvt
▪ State council issued Internet Plus plan in July 2015
▪ Moving one step further in lifting the ban on online sale of Rx drugs
▪ Linking remote healthcare to tiered treatment
▪ Fosun Pharma cooperates with Guahao.com on O2O strategy
▪ Pfizer teams up with Yuwell Medical on chronic disease
management through online platform
▪ Shanghai Pharma partners with Wonders and JD.com for pharma
e-commerce
▪ Sanofi cooperates with Google life science to treat diabetics
▪ PingAn insurance enters into E-health with PingAn Good Doctor
▪ Guahao.com USD 394mn in series D financing
▪ 111.com RMB 450mn in series C financing
▪ Haodf.com RMB 370mn in series C financing
▪ Huakang RMB 200mn in series B financing
▪ Baidu leverages big data capability, introduces robot assistant “Duer”, “Baidu Brain”
▪ Ali Cloud Hospital went online; cooperates with Carestream on setting up online
imaging platform; partners with CPIC for online health insurance service
▪ Tencent releases intelligent blood glucose meter; publishes smart pharmacy plan to
build one-stop online healthcare service platform through WeChat
E-health
Policy and
Regulation
Business
Model
Investment
BAT on the
move
McKinsey & Company 39|
Recently launched products and new launches should be
an engine of growth
SOURCE: RDPAC; CFDA
WHAT ARE THE BRIGHT SPOTS?
Examples of recently
approved drugs
2011-2015 new launch products by RDPAC companies
Mn RMB
NOT EXCLUSIVE
Examples
2,425
1,360
725
1405
122011 13 2015E14
All products
launched since
2011 expected to
account for only
~2% of MNC Rx
sales in 2015
# of new
launches
3 4 19 1
▪ New approvals post
MRCT rules
interpretation
▪ Does not include
several indication
expansions, e.g.
Xarelto (SPAF),
Avastin (lung cancer)
McKinsey & Company 40|
Our perspectives on the big slowdown
WHAT DOES THIS ALL MEAN FOR PHARMACOS?
While price pressure and slowing volume growth both contribute to recent market slow
down, the latter seems to have played a bigger role in 2015
Slowing patient flow growth is not a result of changing underlying demand, but more likely
reflects shifting policies/ incentives and constraints at hospital level
Slowdown will likely continue in the near term as more provincial tenders are
announced and volume growth will take time to recover
Attractive areas still exist (e.g., lower tier markets, retail channel, digital health,
regulatory); those able to capture new opportunities will have a clear competitive
advantage
Changing market context has become a catalyst for organizational changes, e.g.,
dynamics between local and HQ, greater emphasis on resource efficiency and productivity
Future winners will be those who can evolve their capabilities and strengths to fit the new
market norm
McKinsey & Company 41|
Eight commercial imperatives for pharmacos
Through cycle mentality
with “topline corridor”
Resource
flexibility in face
of uncertainties
Dynamic pricing
model to cope
with pricing
pressure
E-health
initiatives to
drive growth from
new channels
1
2
5
3
6
7
8
Rigorous SFE
fundamentals to
drive productivity
gain
External
collaboration to
shape regulatory
framework
Granular mining
of data for better
insights and decisions
WHAT DOES THIS ALL MEAN FOR PHARMACOS?
4
Innovations to
shape treatment
paradigm and the
market
McKinsey & Company 42|
Assessing progress on innovation
McKinsey & Company 43|
China Drug Innovation Index (CDII) is the first holistic assessment
of China’s innovation ecosystem, to be tracked annually
Assess 5 key dimensions of China
innovation ecosystem
▪ Policy, Funding, Capability, Local
innovation output, Level of integration
into global
Calibrated against current U.S. levels
(2014 US = 8 out of 10 points)
Aim to update annually to track progress
Approach
Sources of insights
Survey of ~70
members
10 quantitative metrics comparing
U.S. and China on reported innovation
indicators
Holistic view of
China innovation
ecosystem relative
to that of the U.S.
Output
McKinsey & Company 44|SOURCE: Source
Text
Where does China stand on drug innovation?
McKinsey & Company 45|
Jan 2015 March 2015 March 2015 June 2015
Epidaza, a global first
selective HDAC
inhibitor, launched in
China by Chipscreen
AZ and Wuxi AppTec
JV filed clinical trials
application for MEDI-
5117
Innovent and Lilly
entered into a 10-year,
~$450M collaboration
on biologics
J&J Innovation and
WuXi AppTec formed
partnership to fund/
incubate high quality
start-ups
July 2015
Beigene compound
BGB-283 received
CFDA IND approval,
and CTA approval
Mar-Aug 2015
Zai Lab secured 4
assets from deals with
3 MNCs – BMS, Sanofi,
UCB
Sept 2015
Hengrui out-licensed
ex-China rights of
SHR-1210 to Incyte for
up to ~$800M
Oct 2015
Innovent and Lilly
deepened relationship
with up to $1bn deal to
develop 3 preclinical
anti-PD-1-based
antibodies
Momentum of China innovation accelerating over the last 12 months
SOURCE: Press search
McKinsey & Company 46|
Our inaugural China Drug Innovation Index (CDII) survey
confirms such positive trend
Momentum of drug innovation in China over the past year compared to previous year
N = 69
SOURCE: 2015 CDII Survey
3%
Significantly
slowed down
5%
Slightly
accelerated
Status quo 3%
Slightly
slowed down
Significantly
accelerated
39%
50%
~90% of R&D leaders surveyed believe China drug innovation accelerated last year
McKinsey & Company 47|
So where does China stand today across
5 key dimensions of innovation ecosystem?
SOURCE: 2015 CDII Survey
Min Max
0 10Survey
score
Ave. China
Score = 4.2
Key insightsCDII scores
Access to funding less of an issue
Novelty of innovation is lacking.
On the bright side, # of Class 1.1
drug applications has increased at
CAGR 18% since 2010
Local
innovation
4
Min
0 4.7
Max
10
Integration with global seen as a
weak link in China’s innovation
ecosystem
Integration
with global
5
Min
0 3.6
Max
10
Regulatory environment faces
challenges but CFDA is planning
unprecedented reforms
Lack of reimbursement
continues to be a key challenge
Min
0 3.1
Max
108.0
Overall infrastructure perceived
to be weaker than talentCapabilities3
Min
0 5.4
Max
108.0
8.0
8.0
Min
0
Max
108.04.0
Funding2
Policy1
McKinsey & Company 48|
Approval time for IND Approval time for NDA
Drug review and approval process very lengthy and seen as a
weak link for China
14.6
11.6
9.6
11.6
1.01.01.01.0
>10X
201413122011
USChina
22.021.0
19.018.0
6.5
11.010.09.6
>3X
201413122011
USChinaMonths Months
Min Max
0 103.1 8
Ave. China Score = 4.2
Effectiveness of
drug review/
approval process
SOURCE: 2015 CDII Survey; DXY Insight 2014; CDER 2014 update
R&D leaders view regulatory process as a major barrier in current innovation ecosystem
POLICY
1
McKinsey & Company 49|
Recently announced CFDA reform could potentially accelerate
approval timeline and boost innovation
SOURCE: State Council; CFDA; Industry expert interviews; McKinsey analysis
Industry experts expect significant progress to be made in the next 2-3 years
Application
timeline
▪ Dedicated innovative
drugs review channel
▪ MRCT data will be
accepted to support
filing
▪ Pilot MAH scheme
▪ Bio-equivalent testing
changed from
application to
notification
▪ Potentially unified
application process
▪ Enforce originator as
reference
Eliminate
review
backlog
Improve
quality of
generics
Encourage
innovation
Improve
quality of
review and
approval
process
Increase
transparency
of review and
approval
process
Reduce non-
qualified
applications
▪ Self-audit by
applicants
▪ CROs
inspection
5 pillars of Reform Review and Approval
System for Drugs and Medical Devices
国务院关于改革药品医疗器械
审评审批制度的意见
国发〔2015〕44号
Targeted
results
Generics application
Innovative drug
application process/
requirement
▪ Eliminate all
backlog by
2016
▪ Achieve
review time
target set out
in regulation
by 2018
2 3 41 5
POLICY
1
McKinsey & Company 50|
Pricing and reimbursement policy remains a major barrier
in the China innovation ecosystem
Examples of MNC and
local drugs not on NRDL
Non-
NRDL
50
0
50
NRDL
It is very challenging for
pharmacos to recoup R&D
investment if innovative drugs
cannot be listed on RDL. One
of our cancer drugs is still not
listed on NRDL 8 years after
launch
– SVP of a leading
local pharmaco
Min Max
0 103.1 8
Ave. China Score = 4.2
Pricing
and
reimbursement
China
new drug
launch
reimbur-
sement
status
(2011-
2014)
SOURCE: 2015 CDII Survey; GBI; expert interview
▪ NRDL has not been updated since 2009, and no drug launched since is covered yet
▪ Going forward, pharmacos need to consider pricing/coverage tradeoffs, as
government will not cover everything at any price
POLICY
1
McKinsey & Company 51|
Access to funding not perceived as a major hurdle
for pharmacos
Start-up’s access to funding
Min Max
0 1085.9
Min Max
0 1086.6
Mature-co’s1 access to funding
Private
capital
Min Max
0 1085.1
Min Max
0 1086.1
Govern-
ment
funds
Debt
financing
Min Max
0 1082.9
Min Max
0 1085.6
Ave. China Score = 4.2 Ave. China Score = 4.2
SOURCE: 2015 CDII Survey
1 Established company with commercial presence
Types of funding options for Chinese companies are limited, whereas in U.S. companies
have access to broad ecosystem of angel investors, VCs etc., … with creative funding
options
FUNDING
2
McKinsey & Company 52|
Total R&D funding has been rapidly growing, although still
at 1/8th of US investment level
+27% p.a.
2014
8.9
13
6.5 7.5
2010 11 12
4.83.4
2014
68
13
+1% p.a.
65
12
63
11
62
2010
66
NSF Pharma R&DVC
Funding for R&D
$Bn
Funding for R&D
$Bn VCNIH Pharma R&D
5% 8% 10% 12% 13%
% of US level
1 McKinsey Global Institute projection
SOURCE: 2015 CDII Survey; McKinsey Global Institute; China Investment 2015 – ChinaBio, STS.org; NSF annual report;
NIH report; PWC Moneytree life science report; 2015 PhRMA industry profile
China R&D funding has grown at 27% CAGR in the past five years,
and is expected to reach ~$25-30 Bn by 20251
FUNDING
2
McKinsey & Company 53|SOURCE: Press search
Funding raised by Chinese innovation companies has been growing in
past 12 months; first wave of IPOs also coming up
FUNDING
2
Jan, 2015
Dec, 2014
Dec, 2014
Dec, 2014
Jan, 2015
May, 2015
Oct, 2015
Sep, 2015
Aug, 2015
May, 2015
$100M
$75M
$8M
$10M
$25M
$97M
$100M
$35M
$16M
$45M
Growing fund raising in innovation Recent IPOs from China Pharmacos
Oct, 2015
Jun, 2015
Oct, 2015
McKinsey & Company 54|
Capabilities and infrastructure still lagging US benchmarks,
but with some promising potential
SOURCE: 2015 CDII Survey
Discovery
Clinical
develop-
ment
How would
you rate China’s overall
infrastructure for drug
innovation today
Chemistry,
Manu-
facturing,
Controls
How would you rate
the quality of R&D
talent available in
China today?
Min Max
0 1084.9
Min Max
0 1084.6
Min Max
0 1085.0
Min Max
0 108
Ave. China Score = 4.2
CAPABILITIES
4.6
3
McKinsey & Company 55|
Capabilities in basic research has gap to U.S.,
particularly in quality
Publications
in inter-
national
journals
(‘000s)
+20% p.a.
2014
73
13
66
12
52
11
42
2010
35
269
+3% p.a.
201413
275
12
268
11
250
2010
242
Average
citations (#)
SOURCE: Thomson Reuters; InCite; Using Essential science indicators category (Immunology, Microbiology, Neuroscience
& Behavior, Clinical medicine, molecular biology & genetics, Biology & biochemistry, Pharmacology & toxicology)
0.8 1.4
▪ China’s quantity of research is rapidly gaining momentum
▪ However, to improve quality, the academic community needs to clean up
practices of mediocre/me-too publications and enhance data integrity
CAPABILITIES
3
China US
McKinsey & Company 56|SOURCE: Company website; annual report; news release; expert interviews
Chinese firms are building technology platforms to enable
innovation – BGI and genomics / DNA sequencing example
CAPABILITIES
Unique scale in genomics
#1 in NGS field in China
16 Years in business
15 state of the art genetic
sequencing machines
Large database specific for
Chinese patients
#1
16
150
Ranked by Nature in 2014 as:
5th of Top institutions in
Nature and Science
15th of Top institutions
5th
15th
Sequencing Platform
Mass Spectrometry platform
Computing platform3
9
OrganizationsPlatforms
3
Managing director Wang Jun recently
founded a startup ShenZhen Tanyuan
Technology Ltd. focusing on healthcare
big data
McKinsey & Company 57|
Chinese firms also actively contributing to improving global
drug innovation model – Wuxi AppTec example
SOURCE: Expert interview; company website
CAPABILITIES
Large scale enabling 2,000
collaborators globally
Start-up
companies with
great ideas
Equipment
Key analytical
equipment of over
50 percent
measured by 24x7
utilization
Innovative
companies with
capacity
constraints
Capability
augmentation
Facility
5 millions sq ft of
R&D and
manufacturing
Space 21 sites
Traditional Gx
companies trying
to innovate
Virtual labInnovative engine
Man power
10,000 employees
globally
4,000 synthetic,
medicinal and
process chemists
#1 CRO in Asia
CMC platform inspected by
FDA
1st
cGMP biologics manufacturing
facility compliant with US, EU
and Chinese regulatory
standards
1st
GLP preclinical laboratory
double certified with an OECD
country and CFDA
1st
GLP/GCP bio-analytical lab
that passed FDA, OECD, and
CFDA inspections
1st
CLIA-certified clinical
genomics lab
1st
#1
3
1st in China:
McKinsey & Company 58|
4 Novelty and quality of innovation still lagging
SOURCE: 2015 CDII Survey; expert interview
LOCAL INNOVATION
Min Max
0 1083.8
Min Max
0 108
Min Max
0 1084.2
Ave. China Score = 4.2
4.3Quality of R&D
Novelty
of innovative
pipeline
Discovery
research
Clinical
develop-
ment
Today majority of Chinese companies are focusing on “me-too” and “me-better”
targets in drug R&D with few exceptions, such phenomenon is probably driven by
the fact that pharmacos need to establish credibility and demonstrate progress on
innovation. Going forward I hope these companies will also invest in new MOAs and
first-in-class as they build up R&D scale and capabilities
– China-based investor
McKinsey & Company 59|
Local PCT and IND applications are rapidly growing
PCT
patents
filed1
(#)
1 PCT: Patent Cooperation Treaty
2 Class 1 applications in China; Commercial IND applications in the US
SOURCE: 2015 CDII Survey; PatentScope; GBI; FDA
IND
applica-
tions2
(#)
China’s levels of PCT patent and IND applications still a fraction of that of U.S. (17% and 22%
in 2014, respectively), however growth trajectory of both metrics has been strong
LOCAL INNOVATION
974
504
+18% p.a.
17356
+33% p.a.
20142010
5,821
5,272
+3% p.a.
782
601
+7% p.a.
2010 2014
4
McKinsey & Company 60|
While cross-border collaboration is increasing, participation in
global trials has been limited due to recent regulatory hurdles
SOURCE: 2015 CDII Survey; China Investment 2015 – ChinaBio; Thomson Reuters
# of global trials (#)
Cross-border deals
on drug R&D (#)
Min Max
0 103.6 8
Ave. China Score = 4.2
Contribution
to global
innovation
Co-authorship with
overseas
researchers (‘000s)
China contribution by the numbers
INTEGRATION WITH GLOBAL
5
47
71
2014
-10% p.a.
2010
26
13
+19% p.a.
76
27
+30% p.a.
McKinsey & Company 61|
Overall, survey participants believe that the outlook for
China innovation is promising
What role will China play in global
drug innovation by 2025?
% of surveyed, N = 69
Majority of R&D leaders believe China could become a top-3 contributor
or a solid 2nd tier player in global drug innovation by 2025
9%62%29%
Top 3 global
contributor
Solid 2nd
tier player
Struggling,
focused on
incremental
innovation
What are China’s biggest advantages in
drug innovation?
Strong government support, evidenced by
recently announced changes to accelerate
drug registration and approval
Sizable Chinese market attracts R&D
investments from both MNCs and locals
Proximity to leading drug R&D service
providers in China including CROs, CMOs
etc.
Highly motivated Chinese companies
eager to learn and play in global marketReference countries
McKinsey & Company 62|
¥
Opportunities for key ecosystem participantsKey hurdles / challenges
Making the leap – what it could take
Pharma-coGov PE/VC
▪ Challenging regulatory
environment
▪ Lack of mechanisms to
reward innovation
Consider trade-off between pricing and reimbursement
Incorporate value evidence in clinical development plans
▪ Limited types of funding
options for start-ups
Allocate a proportion of government pension fund or
sovereign wealth fund to VCs focusing on life science
Partner with promising startups in early stages
▪ Large talent pool with
mixed level of capabilities
Encourage academic-private collaboration; urge
academic to train “industry-ready” graduates
Attract and develop high-quality R&D talent
▪ Pipeline novelty and
quality of R&D can be
enhanced Invest in innovative solutions that address China-
prevalent disease areas (e.g., Lung cancer, liver cancer)
▪ Inclusion in global trials
has declined
Leverage new CFDA reforms to integrate China early on
into global development planning
Incentivize high-quality basic research (especially in
Biology) to build cutting-edge expertise in select areas
¥
McKinsey & Company 63|
Finding the funds for innovation
McKinsey & Company 64|
“Finding the funds for innovation” becoming increasingly relevant
“Who will pay for innovation” becomes an increasingly relevant question for pharma
industry, payors, policy makers and ultimately patients
Research & development Registration
Market access &
commercialization
▪ Growth of mature drugs slowing down further
exacerbates importance of innovative drugs
▪ Wave of new drugs expected to reach China
– MNCs launching waves of new drugs with high
expectations on uptake
– China innovation ecosystem has been improving,
leading locals begun to develop and launch new
drugs
– CFDA reform expected to accelerate review and
approval of new drugs in coming years
▪ Patients increasingly demand access to new
drugs as affordability and awareness of options
improve
▪ Market rewards for innovative
drugs remain limited
– Fragmented and inefficient
listing & tendering processes
– Infrequent RDL/PRDL
updates with narrow
coverage
▪ Government spending on
healthcare remains
constrained and focuses on
providing basic coverage
▪ Private health insurance still at
nascent stage
McKinsey & Company 65|
Large number of innovative drugs expected to hit the market in
coming years
SOURCE: GBI; lit search
Strong innovative pipeline …
129
284
70
83
34
IND1
367
NDA2
104
131
Pre-
clinical1
2
1 Class 1.1 Chemical drugs and Class 1 biologics in CFDA
2 Drugs in NDA review and drugs approved for NDA but not marketed (Jan 1st, 2011-Oct 13th, 2015), including drugs in category chem-1.1, chem-3.1,
and innovative biologics
… with multiple planned new launches (examples)
Cadrofloxacin
Hemporfin
Nolatrexed
LocalMNC
Brand / product Company
NDA approved In NDA review
McKinsey & Company 66|
China faces clear constraints when considering rewards for innovation
SOURCE: WHO; World Bank
Per capita health
expenditure
USD
US
Japan
UK
China
3,965
9,150
3,600
370
Total health expenditure
Bn,USD
230
2,870
510
505
▪ Despite strong growth in past decade, China per capita healthcare spend still
significantly lagging behind developed countries
▪ Reward for innovation will be selective – government unlikely to support all innovative
treatments equally
17.1%
10.3%
9.1%
5.6%
Healthcare
expenditure
as % of GDP
McKinsey & Company 67|
A set of levers could be considered to bridge the funding gap and
reward innovation
SOURCE: NHFPC Yearbook; McKinsey Analysis
China healthcare spend by
funding source
$ Bn, percentage
40
34
35
36
25
30
515209
2008
Social
Patient
Out-of-
pocket
Govern-
ment
2013 2020
?
~1,000
?
?
On-going levers
Future possibilities?
Direct increased public
spend on innovation
5
Redeployment of savings
from price cuts of mature
drugs
6
Government
reimbursement
 NRDL and CDI1
 Selected local
reimbursement
4 Self-pay market
3 Patient Assistance
Programs (PAPs)
Outcome/value-based
negotiation
7Development of private
health insurance (PHI)
2
1 NRDL: national reimbursement drug list; CDI: critical disease insurance
1
McKinsey & Company 68|
Local governments have provided reimbursement scheme
to a subset of innovative drugs – select examples
1
SOURCE: GBI; literature research; McKinsey analysis
1 Chronic myelogenous leukemia 2 Gastrointestinal Stromal Tumor
# of provinces
with PRDLDisease area
Locally negotiated
reimbursement scheme
2Non-small cell
lung cancer
 Qingdao
4Non-small cell
lung cancer
 Zhejiang
 3 cities (Qingdao, Zhuhai and Shenzhen
2Breast cancer  3 provinces (Zhejiang, Inner Mongolia,
and Jiangxi)
 8 cities
11Rheumatoid
arthritis
 Zhejiang
 Qingdao
12Non-small cell
lung cancer
 2 provinces (Jiangxi and Zhejiang)
 Zhuhai
While more cities and provinces are starting to cover innovative drugs through PRDL
or local negotiations, overall scale and scope of coverage remain limited
McKinsey & Company 69|
Acceleration of roll-out of Critical Disease Insurance program
SOURCE: Government official website; lit research; McKinsey analysis
Policy evolution Impact to date
2007
2012
2014
▪ Piloted in all 31 provinces,
covering ~700 million
population as of April.2015
▪ Actual reimbursement rate no
less than 50% for OOP, and
increases with OOP expense
▪ ESRD example: NRCMS cover
the first 70% of expenses, then
CDI covers 50% of remaining
expenses
▪ CDI is now operated by private
insurers in most regions
▪ “Guidance and
Definition of
Critical Disease
Insurance” issued
by CIRC1 to set
up a model policy
of critical disease
insurance
 “Opinions on Implementing
Critical Disease Insurance
for Urban and Rural
Residents” jointly issued by
MOH, MoLSS2, CIRC, etc. to
encourage cooperation
between government and
PHIs
▪ “Accelerate Development
of CDI for Urban & Rural
Resident” issued by the
State Council, which
encourage PHI to provide
CDI services and establish
evaluation and supervision
system for expanding PHI
coverage
▪ “Guideline on Full Implementation of
CDI for Urban and Rural Residents”
released by the State Council in Aug.
– CDI should benefit all urban and rural
residents covered in the nation's basic
health insurance by the end of 2015
– A relatively sound system for CDI will
be established by 2017
▪ CDI expected to be
fully roll-out soon and
may cover UEBMI
participants as well
(Pilots in some regions
already)
▪ The reimbursement
rate will increase
gradually in future
Future outlook
2015
1 China Insurance Regulatory Commission
2 Ministry of Labor and Social Security
CDI programs should expand
to the whole country by the end of
2015 to help financially challenged
residents
– Premier Li, Keqiang
1
McKinsey & Company 70|
Growth of China PHI market
USD, bn
Private health insurance (PHI) is rapidly growing, providing
supplementary funding source
SOURCE: CIRC; State Council; literature research; McKinsey analysis
13
18.2
13.7
2012
20.1
2015 H114
25.8
+37%
Private payors actively expanding presence
Private payors are exploring new ways to
enhance access to data and improve risk
assessment
▪ Collaborate with providers
▪ Invest in mHealth
▪ Invest in hospitals to become integrated
managed care systems
▪ Manage BMI for local government
▪ Growth driven by favorable policies, e.g.,
– Increasing social capital
– Tax benefits
▪ PHI uptake still limited by
– Access to patient data
– Demand generation of target population
– Lack of bargaining power over providers
– Capability and talent
+
++
+
2% 2% 5% 7%
xx% PHI as % of total HC spend
2
Nanjing Gulou hospital
McKinsey & Company 71|SOURCE: China Charity Federation; literature search; McKinsey analysis
Patient Assistance Programs (PAPs) could help expand accessible
patient pool
NexavarGleevec Iressa
▪ Donation to poorest
RCC and HCC
patients
▪ Donation to poorest 10%
of CML & GIST patients
▪ Setup medical centers &
disease consulting
hotline
▪ Provide medical
assessment to patients
▪ Iressa Pan Asian
Study (IPASS)
clinical trials in 11
cities in China
Charity
donation and
clinical trials
▪ 3-month cap, after
which drugs are free
for life with proven
efficacy
▪ Free for patients with
basic living allowences
▪ 3/6-month cap, after
which free for rest of
year
▪ 5-month cap for
NSCLC patients,
after which drugs are
free for life
Program
3
% of relevant patient pool coveredxx
▪ 20K patients▪ 25K patients
Impact
(by 2014)
▪ 39K patients
~10% <5% <10%
While beneficial to patients enrolled, PAPs only cover a subset of diseases and
fraction of patients in need of innovative therapies; scaling up poses challenges
McKinsey & Company 72|
Self-pay segment could be further activated, leveraging
learnings from other markets
Increasing
willingness
to pay
Increasing patient affordability & willingness to pay
Innovative ways to activate
self-pay segment
SOURCE: National Bureau of Statistics; MGI; McKinsey analysis
1 Affluent (>36K USD annual household income), Mainstream (17-36K USD annual household income), Mass (10-17K USD annual household income),
Poor (<10K USD annual household income)
2 Including all healthcare related spending across prevention, diagnosis, treatment and nutrition
Example
Learnings from other markets
▪ Partner with private banks and
consumer financing
companies to provide loans to
patients
▪ Short-term installments to help
patients manage cash flows
▪ Risk-sharing mechanisms to
mitigate patients’ perceived
risk (e.g. on product efficacy)
24%
7%
26%
16%
26%
Healthcare2
Transportation and
communication
Recreation, education
and culture
Others
Personal product
Consumption of New Mainstream by category, 2015
42.9
45.6
60.7
62.4
14.0 21.4
14.923.7
9.3
Poor
Affluent
New
Mainstream
Mass
2025E
6.2
1.3
2020E
4.2
1.7
2015
2.7
2.3
Increasing
affordiblity
Consumption of urban households – By annual income1
Percentage, 100% = trillion USD
In India, Enbrel can be paid
through installments of <$200
to minimize cash flow disruption
for RA patients
4
McKinsey & Company 73|
Going forward, additional set of levers can also be explored
SOURCE: McKinsey analysis
Rationale
Potential
impact
▪ Current healthcare spending accounts for 5.6%
of GDP, lower than many developed market
▪ Increasing healthcare spend on innovative
drugs by 0.5% of GDP in 2025 could
translate into ~$20 Bn opportunity for
pharma industry
Increase public
direct
spending on
innovative drugs
5 High
▪ Cost saving from reducing price of mature
drugs likely to be limited – estimated at $0.6-
1.5 Bn per year
Redeploy savings of
price cuts on
mature drugs
6 Low
▪ Adopt Health Technology Assessment
tools/framework, where drugs with compelling
clinical benefits could gain more commercial
upside
Value-based
negotiation between
payors and
pharmacos
7 Medium
McKinsey & Company 74|
A multi-pronged
approach
In summary, narrowing the “paying for innovation” gap requires a
multi-pronged effort
Better articulate the total economic and social
impact of rewarding innovation, including
addressing critical medical needs, creating a healthier
society and cultivate an innovative and strong industry
Tap into multiple funding sources, e.g.,
▪ Increase government HC spend on innovative drugs
▪ Unleash Private Health Insurance market
▪ Further activate self-pay segment
Not all innovation will be rewarded –
demonstrating the value of innovative drugs
will be critical
Creative cross-sector partnerships
should be explored (e.g., between
private payors and pharmacos)
McKinsey & Company 75|
Implications for pharmacos
Implications for pharmacos
Engage regulatory bodies as an industry to help formulate policies
that properly reward innovation
Invest in market shaping activities, including self-pay segment
Incorporate demonstrating value of innovative drugs into
clinical development and life cycle management plans
Explore creative partnerships (e.g., with private payors, local
government) to enhance patients’ access to innovative drugs
Double-down innovation efforts in disease areas highly relevant to
China and/or with strong government support
1
2
3
4
5
6
Explore price-volume trade-offs at launch time and regularly over
brand life-cycle
McKinsey & Company 76|
Closing thoughts
We are on a narrow bridge to innovation, with still
a high degree of uncertainty on outlook1
2 The going gets tougher; however there are
still tremendous opportunities to capture
3 The time to drive real change in business and
operating models is now
McKinsey & Company 77|
For more on China healthcare …
Our China healthcare leadership team (Partners and Associate Partners)
Industry insights Collaboration with CPA
▪ Data driven periodic reports
▪ TA specific deep-dive
(e.g., oncology, immunology)
iTunes Store –
“McKinsey on
China”
▪ How sick is China's
pharmaceutical market?
▪ Will market forces revolutionize
Chinese healthcare?
▪ What healthcare system can
China afford?
▪ Will the next medical equipment
champion come from China?
▪ Obesity – How big will
China get?
www.mckinseychina.com
2014
2013
2012
2015
1
2
3
4
5

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China Pharmaceuticals - Building Bridges to Innovation - 2015 McKinsey report

  • 1. Building Bridges to Innovation Decoding the Big Slowdown; Assessing Progress on Innovation Shanghai, October 20-21 2015 CONFIDENTIAL AND PROPRIETARY Any use of this material without specific permission of McKinsey & Company is strictly prohibited
  • 2. McKinsey & Company 2| Decoding the big slowdown Contents 2015 in the mirror Assessing progress on innovation
  • 3. McKinsey & Company 3| 2015 in the mirror
  • 4. McKinsey & Company 4| Last year we introduced the concept of China’s potential “Bridges to Innovation” Broken bridgeNarrow bridgeBroad bridge1 2 3 ▪ Mature drugs have lasting staying power and continue to grow beyond 2020 ▪ China delivers meaningful and broad step-up to reward of innovation ▪ Mature drugs have staying power, but come under stronger pressure and plateau beyond 2020 ▪ China delivers meaningful but narrow reward for innovation, closely aligned with disease priorities ▪ Window for mature drugs starts closing rapidly by 2020, earlier for some drug categories ▪ Innovation remains heavily constrained ▪ Self-pay market becomes main viable segment e-Health ▪ Each potential scenario has profound implications on market outlook and attractiveness for participants ▪ It will take some time before we know for sure which bridge we are walking on
  • 5. McKinsey & Company 5| As of today, we would argue that we are on a Narrow bridge scenario Narrow bridgeBroad bridge Broken bridge Slowdown in Rx market (still growing though) CFDA reform 13th Five Year Plan CDI expansion Delay in NRDL update Pricing reform
  • 6. McKinsey & Company 6| 2015 in the mirror – 8 key trends worth understanding Deals 7 Anti-corruption drive 2 Economic slow- down 1 China manufacturing 2025 CFDA reform 5 Cost containment 6 e-Health 8 China innovation 43
  • 7. McKinsey & Company 7| Slowdown of the economy is impacting many sectors, some more dramatically than others Construction Automobile Retail Electricity consumption Luxury goods 1 SOURCE: McKinsey
  • 8. McKinsey & Company 8| Large, low- cost, lower- skilled labor supply $300 150m Monthly salary Migrant workers Old Lower-value, low-productivity export business model with FDI 20% Annual export growth Old Cost-conscious with lower sophistication (supply-driven offerings) 50% Household saving rate Old 4x Debt in 2014 vs. 2007 Debt-financed property and infrastructure investment Old 50% Urban population (1978: 18%) Inflow into cities with pollution, real estate inflation, etc. Old China’s new normal – China is transitioning to a new growth model with less rapid but higher quality growth (1/2) SOURCE: McKinsey Previous growth engine 1 Labor 5 Investment/ debt 4 Urbani- zation 2 Consum -ption 3 Business model Model not sustainable 1
  • 9. McKinsey & Company 9| More emphasis on soft than hard infrastructure and deleveraging More experienced, higher- wage work force, and more entrepreneurship and job creation Sustainable and equitable growth in smarter cities Consumption-driven growth with digitally informed and demanding customers Higher-value adding activities (service and manufacturing) and mass innovation China’s new normal – China is transitioning to a new growth model with less rapid but higher quality growth (2/2) SOURCE: McKinsey Previous growth engine 1 Labor 5 Investment/ debt 4 Urbani- zation 2 Consum -ption 3 Business model The success of companies in China will depend on how quickly they adapt to the new normal 1
  • 10. McKinsey & Company 10| "China Manufacturing 2025" to promote Biomedicine and high-performance medical apparatus SOURCE: State Council announcement; lit search; McKinsey analysis ▪ China Manufacturing 2025 released in May, 2015 by State Council (similar to Germany industry 4.0) – First step of the bigger plan to upgrade manufacturing industry ▪ Aim to transform the nation from a big manufacturer to a strong manufacturer – Move up the global value chain from low value added manufacturing – Accelerate development in 10 priority areas including biopharmaceutical and medical products ▪ Focus on the innovation and integration of information technology in manufacturing – Enhance the adoption of Internet, cloud service and big data in traditional manufacturing ▪ Information technology ▪ High-end numerical machinery and automation ▪ Aerospace and aviation equipment ▪ Maritime engineer equipment and high-tech vessel ▪ Rail equipment ▪ Electrical equipment ▪ Energy saving vehicles ▪ New material ▪ Biomedicine and high- performance medical apparatus ▪ Agriculture equipment 4 Overview 10 industrial sectors
  • 11. McKinsey & Company 11| Deals – Another year of heavy activity +++ 7
  • 12. McKinsey & Company 12| “Internet+” aims to further fuel economic growth by integrating Internet with traditional industries Policy description Implication to healthcare stakeholders ▪ Encourage online healthcare service – Develop internet based healthcare services and information exchange centers across hospitals (e.g., EMR and imaging records) – Promote online registration, result checking, drug distribution and BMI payment – Improve treatment outcome by adopting precision treatment and disease prevention ▪ Promote digital elderly care – Set up digital community centers and enhance chronic disease management – Adopt innovative products such as wearable devices and remote monitoring devices to monitor and track physical conditions ▪ Enhance e-commerce in healthcare – Improve operational efficiency and procurement process via e-commerce platform ▪ Released in July 2015 ▪ Mapped out development targets in 11 key sectors incl. healthcare, manufacturing, agriculture, energy, finance, logistics etc. by integrating mobile Internet, cloud computing, and big data technologies ▪ Aims to build a new economic model and an important driving force for social innovation by 2025 SOURCE: Lit-search; Government website; McKinsey analysis 8
  • 13. McKinsey & Company 13| Many players – both small and large – are actively ridding the e-Health wave Example of players Digital giants Healthcare ITEntrepreneurs Delivery Personal care Accessibility Distribution Community 8
  • 14. McKinsey & Company 14| In this complex context, we aimed to tackle two key themes ▪ Survey of 50 hospital directors ▪ CPA market data up to July 2015 ▪ China Drug Innovation Index – survey of innovation leaders (BayHelix) ▪ Interviews with industry leaders “Decoding the big slowdown” ▪ What is really happening? ▪ What should we expect next? ▪ What are the implications? “Assessing progress on China innovation” ▪ Are measures for real? ▪ Who will pay for innovation? ▪ What are the implications? 1 2
  • 15. McKinsey & Company 15| Decoding the big slowdown
  • 16. McKinsey & Company 16| Decoding the big slowdown – How we went about it Sources of insights Latest NHFPC statistics on patient flow across hospital segments Hospital level prescriptions data from China Pharmaceutical Association (CPA) up to June 2015 Multiple discussions with senior executives in the pharma industry Results from a survey of 50 hospital directors across city tiers McKinsey market perspectives
  • 17. McKinsey & Company 17| China pharma market has experienced a marked slowdown in 2015 YoY sales growth of CPA sampled Class III/ II hospitals1, 2012-15 Q2 Percent SOURCE: China Pharmaceutical Association (CPA); NHFPC 1 679 sampled hospitals, including 468 Class III hospitals, 211 Class II hospitals 2 2015 April and May data 6.3% 2015Q114 2015Q213 9.6% 12.4% 16.4% 2012 12.0% 9.8%Outpatient YOY growth Percent 8.2% 5.6% 3.9% 1.8%2
  • 18. McKinsey & Company 18| Majority of TAs and top MNC brands are affected by the slowdown Growth comparison by TA (ranked by 2014 TA size) CPA sampled hospitals1 Growth comparison by Top MNC Brands (ranked by 2014 sales) RDPAC reported sales CV CNS Blood Alimentary Tract and Metabolism AI Antineoplastic and Immunomodulating 12% 7% 8% 7% 9% 6% 9% Sensory Organs 3% Genito-Urinary System And Sex Hormones Dermatologicals 19% 2% Systemic Hormones 4% Musculo-Skeletal 8% Respiratory 8% LIPITOR GLUCOBAY 14% 18% PLAVIX 8% BETALOC 27% 7% 12% 22% 15% 24% DIOVAN NEXIUM HERCEPTIN LANTUS CRESTOR SULPERAZON NORVASC ADALAT BARACLUDE -7% 3% PULMICORT 16% BAYASPIRIN 8% 43% 16% 5% 15% 15% 18% 19% 15% 13% 14% 19% 12% 15% 39% 18% 14% 23% 19% 36% 35% 22% 15% 28% 12% 13% 32% 27% 78% 2011-14 CAGR 2014H1-15H1 growth 1 679 sampled hospitals, including 468 Class III hospitals, 213 Class II hospitals SOURCE: China Pharmaceutical Association (CPA); RDPAC
  • 19. McKinsey & Company 19| Mature brands drive 78% of growth compared with 71% last year, suggesting an aging portfolio SOURCE: Industry association; McKinsey analysis 1 By year of registration 2013-14 growth breakdown by brands launch year1 RMB billions, % 2015H1 sales contribution of top 3 brands % 75% 96% 85% 60% 53% 78% 100% 19% 14% 19% 50% 11% 20% 1% 11% MNC 4 MNC 7 0% MNC 6 0% MNC 5 -3% MNC 3 0% MNC 1 3%MNC 2 6% 78% < 5 years>10 years 5-10 years 63 42 57 42 50 62 44 51%2012-13 growth contribution from brands >10 years was 71%, suggesting an aging portfolio
  • 20. McKinsey & Company 20| 4 8 10 7 12 4 6 3 4 17 8 7 15 24 10% 25% 20% 15% 5% 0 6 6 1310 1411 17 6 1208 09 10 2006 10 9 07 2015 Apr-May 2 2015 Q1 Not just a price effect – growth rate of patient flow has declined to its lowest point in 10 years SOURCE: NHFPC 1 Include hospitals and grassroots facilities Patient flow1-YOY growth Percent InpatientOutpatient
  • 21. McKinsey & Company 21| Many MNCs and locals feel the pain; some leaders continue to grow at double digits SOURCE: China Pharmaceutical Association (CPA); company financial reports; investor calls; literature search 2015 H1 perfor- mance vs. 2014 H1, % 2015 H1 perfor- mance vs. 2014 H1, % Pharma players Pharma playersQuotes from Q2 releases +1MNC pharmaco 2 Sales of mature products were impacted by competition +3MNC pharmaco 3 A combination of government cost control on reimbursement, strict anti- graft campaigns, the rise of local player with cheaper products and the slowdown in distribution resulted in our slowdown +6Local pharmaco 1 Industry continues to slow … lowest in 10 years -5Local pharmaco 2 Due to price control, increased production cost, and tender policy the whole industry is facing severe challenges Quotes from Q2 releases -5.4MNC pharmaco 1 Chinese government is putting a lot of pressure on off-patent originators. This will be a big challenge for us in the short term +25Local pharmaco 3 Despite the negative impact from the government, we have achieved rapid growth by adapting the strategy of innovation and internationalization +19MNC pharmaco 4 Pricing pressure will be tight in China and we are trying to achieve significant volume reflex as a remedy for the price drop +16Local pharmaco 4 Despite the slowdown of the overall pharmaceutical industry in China, the strategy of lean manufacturing and internet marketing has lead to success in 2015 1H +11Local pharmaco 5 Facing a challenging environment, we have maintained moderately rapid growth through innovative marketing method, industrial resource consolidation, etc.
  • 22. McKinsey & Company 22| Decoding the slowdown: Five key questions Where have patients gone? How low could prices go? ¥ What does this all mean for pharmacos? What are the bright spots? Who’s capturing the volume?
  • 23. McKinsey & Company 23| Growth of public hospital patient flow has experienced marked slowdown this year Public hospital patient flow (January to May of each year) YoY growth, % SOURCE: NHFPC; interviews WHERE HAVE THE PATIENTS GONE? 4.7% 9.5% 8.5% 12.0% 4.9% 8.5% 2012- 2013 2013- 2014 2014- 2015 2012- 2013 2013- 2014 2014- 2015 Outpatient Inpatient Budget control policies limiting hospital ability to treat patients Anti-graft campaign reducing unnecessary visitsMore patients going to retail pharmacy for self- medication Reduced income for healthcare due to stock market crash Hospitals reaching saturation Migrant workers returning to rural areas due to economic slowdown Pharma executives hypotheses Public hospital patient flow growth significantly slower than previous years Patients getting medical advice through mobile apps Fewer patients due to a warm winter
  • 24. McKinsey & Company 24| Effects of hospital related policies and constraints are seen as the primary driver to patient flow slowdown How does YoY growth in outpatient flow compare between 2015 H1 and 2014 H1? 100% = 48 respondents 22% Patients are less inclined to go to hospitals due to reduced disposable income 44% Reduction of unnecessary return visits of patients 33% Fewer people getting sick Patients choose to self-medicate more by going to retail Hospital capacity reaches saturation and has limited room to accommodate patient growth Hospitals less focused on increasing scale and patient volume due to public hospital reform 61% 89% 44% What is driving reduced patient flow growth? % of top 3 drivers among respondents seeing slower growth WHERE HAVE THE PATIENTS GONE? SOURCE: 2015 McKinsey hospital director survey; McKinsey analysis Hospital related drivers most impactful to patient flow slowdown, suggesting no fundamental shift in underlying demand 50% 25% 21% 29% 46% 29% Slower Faster Same 100% Tier 3 and below/ county (N=24) Tier 1/2 city (N=24) 100%
  • 25. McKinsey & Company 25| Shift in hospital focus driven by BMI budget control and greater emphasis on service quality Due to the BMI budget control policies, we are simply not able to treat more patients – Deputy hospital director, Class III hospital in Kunming ▪ BMI budget control measures continue to expand both in breadth and depth – Most provinces have set targets for BMI control since 2012 – Jiangsu plans to implement BMI budget control to all cities/counties – Coverage of budget control in Shanxi exceeds 80% among all Class II and III hospitals ▪ Hospital management focus switches from capacity expansion to service improvement – Multiple government announcements to prevent “unnecessary” capacity expansion – Hospitals make service quality improvement a top priority [2014] Document No.32 by NHFPC [2015] Document No.45 by State Council Hospital expansion was very common in the past while recently central government no longer encourage large hospitals to continue to expand – Government official in healthcare reform We have no plans to add more beds in the next few years. Top priority is to enhance quality and service of selected departments and make them national leaders – Director of BMI affairs, Class III hospital in Shanghai [2015] Document No.38 by State Council SOURCE: Government website; expert Interview; McKinsey Analysis WHERE HAVE THE PATIENTS GONE?
  • 26. McKinsey & Company 26| Respondents from lower tier cities are more optimistic on future outlook for patient flow growth WHERE HAVE THE PATIENTS GONE? How would you predict patient flow growth in 2016 H1 vs 2015 H1? 100% = 48 respondents SOURCE: 2015 McKinsey hospital director survey; McKinsey analysis 67% 29% 29% 42% 29% Same Slower Faster Tier 3 and below/ county (N=24) 4% 100% 100% Tier 1/2 city (N=24) Future increase in hospital level patient flow will be driven by capacity expansion. When you look at the big picture, we expect a relatively stable growth – Deputy hospital director, Class III, Weifang Growth of patient flow will continue to slow down in 2016. Class III hospitals today focus more on improving service quality, rather than just attracting more patients – Head of Reimbursement. Class III, Shanghai
  • 27. McKinsey & Company 27| 2015 has been a busy year on the pricing front National pricing Reimburse- ment Provincial tendering Secondary price negotiation Increasingleveloffragmentation 2015 highlights ▪ National retail price cap removed for most drugs ▪ NDRC retains price monitoring and investigation authority ▪ Price for patented drugs to be set through “multi-party negotiation mechanism” ▪ Reimbursement based pricing piloted ▪ Price point collection initiated for international price referencing ▪ Highly transparent price reference across the country ▪ Provinces demanding aggressive tender price cuts ▪ Independent price category for off-patent originators at risk ▪ Hospital/group level price negotiation pilots ongoing ▪ Expanding scale of pilots in 100+ cities ▪ Lack of volume guarantee HOW LOW COULD PRICES GO? ¥
  • 28. McKinsey & Company 28| Most provinces expected to initiate tender the near term, many early movers demanding aggressive price cuts SOURCE: Literature research; GBI; McKinsey analysis Tender in progress1Tender hasn’t started Finished 2015 tender2 Anhui ▪ “Double envelope” process ▪ City level “price-volume” negotiation after provincial tendering ▪ Severe price cut across cities, e.g. average 17% price cut in Bengbu Hunan ▪ Two rounds of negotiation before another two rounds of bidding ▪ Less than 50% of drugs accepted negotiation ▪ Average price cut 10%-20%1 Includes provinces that have published tendering policies 2 Guangdong has finished 2015 tender for reimbursed drugs, while tendering for non-reimbursed drugs is in progress 3 No.7 document refers to <Guiding Opinion for Public Hospital Centralized Drug Procurement> issued by State council in Feb. 2015; No. 70 refers to <Opinion of Public Hospital Centralized Drug Procurement> issued by NHFPC in June 2015 ▪ Request 10-20% price cut as pre-requisite for participation ▪ Reference national lowest price ▪ Separate groups for off-patent originators and Gx Zhejiang Guangdong ▪ Third party online platform ▪ Monthly tendering ▪ 2 quality layers and set the 5 lowest average price as the cap ▪ Average price cut 5-10% ▪ First province to tender after Document No.7 and No.703 were published ▪ Introduced transparent purchasing (price negotiation) ▪ Reference national lowest price Beijing HOW LOW COULD PRICES GO? Jiangsu ▪ Draft version for tendering published in Sep. 2015 ▪ Off-patent originators may potentially be in same category with first-to-market Gx ¥
  • 29. McKinsey & Company 29| Downward tender price pressure likely to continue SOURCE: GBI HOW LOW COULD PRICES GO? 2012-15 Indexed average provincial tendering price 2012 price = 100 80 85 90 95 100 105 110 142012 13 2015 2015 average price 2012 price = 100 2015 lowest price 2012 price = 100 9999 9696 9297 8892 8795 9090 8790 8383 EXAMPLES ¥ ▪ Price trends vary across brands – selected brands chose to drop out of tender requesting fierce price drop, in the process sacrificing some volume ▪ Greater downward price pressure expected in 2016 due to – Increasing transparency in tender price reference system – More provinces expected to initiate tender
  • 30. McKinsey & Company 30| Secondary price negotiation continue to expand, adding further price pressure on manufacturers 100 Hospital purchase price 85-95 Secondary price negotia- tion 0-15 Retail price Provincial tender price 5-15 Hospital markup 100-115 Zero-markup hospitals no longer enjoy15% margin on drug sales Secondary price negotiation provides some margin relief SOURCE: NHFPC; literature search; McKinsey analysis Latest development ▪ 3 archetypes of secondary price negotiations emerging – City level volume based price negotiation for all public hospitals, e.g. Anhui, Liaoning, 21 cities in Sichuan – Hospital group purchasing organization, e.g., Ningbo, Shaoxing – Individual hospital negotiations, e.g., Tianjin, Shanxi, Hubei ▪ Zhejiang province took the lead to pilot profit attribution scheme, savings from price negotiation collected by local Bureau of Finance (BoF), and allocated to local hospitals Indexed price waterfall (tender price = 100) Context HOW LOW COULD PRICES GO? ¥
  • 31. McKinsey & Company 31| Several reimbursement pricing models being piloted SOURCE: Literature search; McKinsey analysis HOW LOW COULD PRICES GO? Policy Overview Latest development in 2015 ▪ Sanming Model – Set the lowest Gx price as price for reimbursement (piloted for select drugs) – The rest is out-of-pocket expense for patients ▪ Chongqing Model – Use average tendering price to set reimbursement price – Select top 300 drugs (based on 2014 trading volume) in the pilot ▪ Shaoxing Model – Use tendering price for each brand to set reimbursement price – Anhui and Zhejiang provinces adopt similar model in 2015 ▪ Pricing Bureau Chief conference on October 27, 2014 suggested reimbursement-based pricing be implemented in 2015 ▪ No official national guideline published to date ▪ Pilots start to emerge in different provinces with different ¥ Reimbursement pricing expected to promote usage of Gx given greater discrepancy in out-of-pocket expense for patients using originators vs Gx
  • 32. McKinsey & Company 32| Volume growth has not been holding up for many top molecules -5 0 5 10 15 20 Q215 Q1 Q4Q3Q2Q413 Q1 Q22012 Q1 Q3 Q4 Q3Q2 14 Q1 -5 0 5 10 15 20 25 30 35 40 45 50 15 Q1 Q4Q3Q214 Q1 Q22012 Q1 Q3Q2Q3Q2 13 Q1 Q4 Q4 Price Volume YoY growth by quarter of volume and price for Acarbose, 2012 Q1-2015 Q2 Growth rate by quarter, % YoY growth by quarter of volume and price for Atorvastatin, 2012 Q1-2015 Q2 Growth rate by quarter, % CPA sampled Class III/Class II hospitals1 SOURCE: China Pharmaceutical Association (CPA); McKinsey analysis WHO IS CAPTURING THE VOLUME? Drop in volume rather than price is partly caused by pharmacos’ decision to “walk away” from provinces with too aggressive pricing conditions 1 679 sampled hospitals, including 468 Class III hospitals, 211 Class II hospitals
  • 33. McKinsey & Company 33| In the battle for share, both MNCs and locals are able to win WHO IS CAPTURING THE VOLUME? 9% Local 14 10% 90% 12% 91% 2015 1H 8% 100 MNC 92% 100 100 1312 100 88% 2011 15% 85% 100100 59% 41% 48% 52% 47% 100 2011 12 13 100 53% 39% MNC Local 61% 2015 1H 14 100 39% 61% 100 Locals gaining volume share # of Gx Top 3 Gx Companies 15 ▪ Shandong Qilu ▪ Jiangsu Haosoh ▪ Shanghai Chemo Wanbang 41% 14% CAGR 2011-14 % MNC gaining volume share 77 ▪ CR Saike ▪ Yangtze River ▪ Dawnrays Pharma 5% 25% CAGR 2011-14 % # of Gx Top 3 Gx Companies Amlodipine volume % Pemetrexed volume % SOURCE: China Pharmaceutical Association (CPA); McKinsey analysis CPA sampled Class III/Class II hospitals1 1 679 sampled hospitals, including 468 Class III hospitals, 211 Class II hospitals
  • 34. McKinsey & Company 34| WHO IS CAPTURING THE VOLUME? 17% 81% 81% 31% 6% 69% 15% Importance for preferred prescription % of hospital directors list as top 3 reasons, N = 48 Product attributes and organizational capabilities are key to capturing volume Good quality Convincing clinical data Low price/good reimbursment coverage policies Original drug with good brand image Strong support on drug/TA information Innovative communication New drug with patent SOURCE: 2015 McKinsey hospital director survey; McKinsey analysis Product related attributes Deep understanding of prescriber mindset and emotions Unique channel access, e.g., retail, digital Extensive external collaborations, e.g., distributor, government, ecosystem partners Effective coverage and competitive share of voice Market shaping capability Organizational capabilities Holistic offering key to volume capture
  • 35. McKinsey & Company 35| Despite slowing growth, there are still bright spots in market WHAT ARE THE BRIGHT SPOTS? E-health initiatives ▪ Strong government endorsement on e-health e.g., Internet+ plan ▪ Digital provide new models to broaden accessibility, improve healthcare delivery quality, and strengthen physician and patient connections High potential online channel ▪ Online OTC sales only USD 60 million in 2014 but regulation on online Rx sales would unlock significant upside ▪ County hospital, fastest growing segment in hospital sector, achieved 28% CAGR 2011-2013 ▪ CHC market achieved 30% CAGR 2011-2013 ▪ Brick-and-mortar retail channel kept ~9% growth in H1 2015, on par with H1 2014 ▪ Retail pharmacies becoming an increasingly important channel given access hurdles to hospitals S Growth potential beyond large hospitals Rising importance of retail channel New product launches Digital-health frenzy, beginning of a new S-curve S ▪ 20+ innovative drugs launched since 2013. Many with potential to change treatment paradigm and become future drivers of the market ▪ CFDA reform underway – “tsunami of launches” coming
  • 36. McKinsey & Company 36| County hospital market experiencing strong growth momentum 7% 66% Urban 393 County 144 27% 25% 5.5% 70% County 89 Urban 271 County 52 Urban 171 CHC Hospital 4.5% 23%72% 2008 2011 2013 17% 22% Hospital western medicine expense, 2008-2013 (latest available data) Billion RMB SOURCE: MOH database; NHPFC yearbook 16% 19% 28% CAGR CAGR 19% 28% 32% Urban hospital County hospital CHC WHAT ARE THE BRIGHT SPOTS? Accelerated growth in county hospitals further driven by government financial and policy support (e.g., MoF allocated $900+M to support county hospital reforms) CHCs fast growth from a small base, important to target cities with concentrated market potential
  • 37. McKinsey & Company 37| Retail pharmacies becoming an increasingly important channel given access challenges SOURCE: MOHRSS; MOC; expert interviews WHAT ARE THE BRIGHT SPOTS? Initial prescri- ption in hospitals Two prescri- ption fulfillment channels Patient self- pick up from pharmacies Cold-chain delivery to home/ hospital Case example: Victoza effectively leverages pharmacy channel to drive growth Retail channel has been growing significantly in the past few years 39322521 +11% p.a. 20112009 20132007 Revenue (at retail price) of retail pharmacies in China Billion USD Pharmacy reimbursement coverage ‘000s of pharmacies 284 288 272 265 168152136115 424 424 12112010 399 +3% p.a. 433 2013 # of pharmacies w/o reimbursement # of pharmacies w/ reimbursement 10% CAGR, 2010-13 -2%
  • 38. McKinsey & Company 38| Another breakthrough year for E-health in 2015 SOURCE: Lit research; McKinsey analysis WHAT ARE THE BRIGHT SPOTS? NOT EXHAUSTIVE ▪ Healthcare information service provider authorization moved to provincial gvt ▪ State council issued Internet Plus plan in July 2015 ▪ Moving one step further in lifting the ban on online sale of Rx drugs ▪ Linking remote healthcare to tiered treatment ▪ Fosun Pharma cooperates with Guahao.com on O2O strategy ▪ Pfizer teams up with Yuwell Medical on chronic disease management through online platform ▪ Shanghai Pharma partners with Wonders and JD.com for pharma e-commerce ▪ Sanofi cooperates with Google life science to treat diabetics ▪ PingAn insurance enters into E-health with PingAn Good Doctor ▪ Guahao.com USD 394mn in series D financing ▪ 111.com RMB 450mn in series C financing ▪ Haodf.com RMB 370mn in series C financing ▪ Huakang RMB 200mn in series B financing ▪ Baidu leverages big data capability, introduces robot assistant “Duer”, “Baidu Brain” ▪ Ali Cloud Hospital went online; cooperates with Carestream on setting up online imaging platform; partners with CPIC for online health insurance service ▪ Tencent releases intelligent blood glucose meter; publishes smart pharmacy plan to build one-stop online healthcare service platform through WeChat E-health Policy and Regulation Business Model Investment BAT on the move
  • 39. McKinsey & Company 39| Recently launched products and new launches should be an engine of growth SOURCE: RDPAC; CFDA WHAT ARE THE BRIGHT SPOTS? Examples of recently approved drugs 2011-2015 new launch products by RDPAC companies Mn RMB NOT EXCLUSIVE Examples 2,425 1,360 725 1405 122011 13 2015E14 All products launched since 2011 expected to account for only ~2% of MNC Rx sales in 2015 # of new launches 3 4 19 1 ▪ New approvals post MRCT rules interpretation ▪ Does not include several indication expansions, e.g. Xarelto (SPAF), Avastin (lung cancer)
  • 40. McKinsey & Company 40| Our perspectives on the big slowdown WHAT DOES THIS ALL MEAN FOR PHARMACOS? While price pressure and slowing volume growth both contribute to recent market slow down, the latter seems to have played a bigger role in 2015 Slowing patient flow growth is not a result of changing underlying demand, but more likely reflects shifting policies/ incentives and constraints at hospital level Slowdown will likely continue in the near term as more provincial tenders are announced and volume growth will take time to recover Attractive areas still exist (e.g., lower tier markets, retail channel, digital health, regulatory); those able to capture new opportunities will have a clear competitive advantage Changing market context has become a catalyst for organizational changes, e.g., dynamics between local and HQ, greater emphasis on resource efficiency and productivity Future winners will be those who can evolve their capabilities and strengths to fit the new market norm
  • 41. McKinsey & Company 41| Eight commercial imperatives for pharmacos Through cycle mentality with “topline corridor” Resource flexibility in face of uncertainties Dynamic pricing model to cope with pricing pressure E-health initiatives to drive growth from new channels 1 2 5 3 6 7 8 Rigorous SFE fundamentals to drive productivity gain External collaboration to shape regulatory framework Granular mining of data for better insights and decisions WHAT DOES THIS ALL MEAN FOR PHARMACOS? 4 Innovations to shape treatment paradigm and the market
  • 42. McKinsey & Company 42| Assessing progress on innovation
  • 43. McKinsey & Company 43| China Drug Innovation Index (CDII) is the first holistic assessment of China’s innovation ecosystem, to be tracked annually Assess 5 key dimensions of China innovation ecosystem ▪ Policy, Funding, Capability, Local innovation output, Level of integration into global Calibrated against current U.S. levels (2014 US = 8 out of 10 points) Aim to update annually to track progress Approach Sources of insights Survey of ~70 members 10 quantitative metrics comparing U.S. and China on reported innovation indicators Holistic view of China innovation ecosystem relative to that of the U.S. Output
  • 44. McKinsey & Company 44|SOURCE: Source Text Where does China stand on drug innovation?
  • 45. McKinsey & Company 45| Jan 2015 March 2015 March 2015 June 2015 Epidaza, a global first selective HDAC inhibitor, launched in China by Chipscreen AZ and Wuxi AppTec JV filed clinical trials application for MEDI- 5117 Innovent and Lilly entered into a 10-year, ~$450M collaboration on biologics J&J Innovation and WuXi AppTec formed partnership to fund/ incubate high quality start-ups July 2015 Beigene compound BGB-283 received CFDA IND approval, and CTA approval Mar-Aug 2015 Zai Lab secured 4 assets from deals with 3 MNCs – BMS, Sanofi, UCB Sept 2015 Hengrui out-licensed ex-China rights of SHR-1210 to Incyte for up to ~$800M Oct 2015 Innovent and Lilly deepened relationship with up to $1bn deal to develop 3 preclinical anti-PD-1-based antibodies Momentum of China innovation accelerating over the last 12 months SOURCE: Press search
  • 46. McKinsey & Company 46| Our inaugural China Drug Innovation Index (CDII) survey confirms such positive trend Momentum of drug innovation in China over the past year compared to previous year N = 69 SOURCE: 2015 CDII Survey 3% Significantly slowed down 5% Slightly accelerated Status quo 3% Slightly slowed down Significantly accelerated 39% 50% ~90% of R&D leaders surveyed believe China drug innovation accelerated last year
  • 47. McKinsey & Company 47| So where does China stand today across 5 key dimensions of innovation ecosystem? SOURCE: 2015 CDII Survey Min Max 0 10Survey score Ave. China Score = 4.2 Key insightsCDII scores Access to funding less of an issue Novelty of innovation is lacking. On the bright side, # of Class 1.1 drug applications has increased at CAGR 18% since 2010 Local innovation 4 Min 0 4.7 Max 10 Integration with global seen as a weak link in China’s innovation ecosystem Integration with global 5 Min 0 3.6 Max 10 Regulatory environment faces challenges but CFDA is planning unprecedented reforms Lack of reimbursement continues to be a key challenge Min 0 3.1 Max 108.0 Overall infrastructure perceived to be weaker than talentCapabilities3 Min 0 5.4 Max 108.0 8.0 8.0 Min 0 Max 108.04.0 Funding2 Policy1
  • 48. McKinsey & Company 48| Approval time for IND Approval time for NDA Drug review and approval process very lengthy and seen as a weak link for China 14.6 11.6 9.6 11.6 1.01.01.01.0 >10X 201413122011 USChina 22.021.0 19.018.0 6.5 11.010.09.6 >3X 201413122011 USChinaMonths Months Min Max 0 103.1 8 Ave. China Score = 4.2 Effectiveness of drug review/ approval process SOURCE: 2015 CDII Survey; DXY Insight 2014; CDER 2014 update R&D leaders view regulatory process as a major barrier in current innovation ecosystem POLICY 1
  • 49. McKinsey & Company 49| Recently announced CFDA reform could potentially accelerate approval timeline and boost innovation SOURCE: State Council; CFDA; Industry expert interviews; McKinsey analysis Industry experts expect significant progress to be made in the next 2-3 years Application timeline ▪ Dedicated innovative drugs review channel ▪ MRCT data will be accepted to support filing ▪ Pilot MAH scheme ▪ Bio-equivalent testing changed from application to notification ▪ Potentially unified application process ▪ Enforce originator as reference Eliminate review backlog Improve quality of generics Encourage innovation Improve quality of review and approval process Increase transparency of review and approval process Reduce non- qualified applications ▪ Self-audit by applicants ▪ CROs inspection 5 pillars of Reform Review and Approval System for Drugs and Medical Devices 国务院关于改革药品医疗器械 审评审批制度的意见 国发〔2015〕44号 Targeted results Generics application Innovative drug application process/ requirement ▪ Eliminate all backlog by 2016 ▪ Achieve review time target set out in regulation by 2018 2 3 41 5 POLICY 1
  • 50. McKinsey & Company 50| Pricing and reimbursement policy remains a major barrier in the China innovation ecosystem Examples of MNC and local drugs not on NRDL Non- NRDL 50 0 50 NRDL It is very challenging for pharmacos to recoup R&D investment if innovative drugs cannot be listed on RDL. One of our cancer drugs is still not listed on NRDL 8 years after launch – SVP of a leading local pharmaco Min Max 0 103.1 8 Ave. China Score = 4.2 Pricing and reimbursement China new drug launch reimbur- sement status (2011- 2014) SOURCE: 2015 CDII Survey; GBI; expert interview ▪ NRDL has not been updated since 2009, and no drug launched since is covered yet ▪ Going forward, pharmacos need to consider pricing/coverage tradeoffs, as government will not cover everything at any price POLICY 1
  • 51. McKinsey & Company 51| Access to funding not perceived as a major hurdle for pharmacos Start-up’s access to funding Min Max 0 1085.9 Min Max 0 1086.6 Mature-co’s1 access to funding Private capital Min Max 0 1085.1 Min Max 0 1086.1 Govern- ment funds Debt financing Min Max 0 1082.9 Min Max 0 1085.6 Ave. China Score = 4.2 Ave. China Score = 4.2 SOURCE: 2015 CDII Survey 1 Established company with commercial presence Types of funding options for Chinese companies are limited, whereas in U.S. companies have access to broad ecosystem of angel investors, VCs etc., … with creative funding options FUNDING 2
  • 52. McKinsey & Company 52| Total R&D funding has been rapidly growing, although still at 1/8th of US investment level +27% p.a. 2014 8.9 13 6.5 7.5 2010 11 12 4.83.4 2014 68 13 +1% p.a. 65 12 63 11 62 2010 66 NSF Pharma R&DVC Funding for R&D $Bn Funding for R&D $Bn VCNIH Pharma R&D 5% 8% 10% 12% 13% % of US level 1 McKinsey Global Institute projection SOURCE: 2015 CDII Survey; McKinsey Global Institute; China Investment 2015 – ChinaBio, STS.org; NSF annual report; NIH report; PWC Moneytree life science report; 2015 PhRMA industry profile China R&D funding has grown at 27% CAGR in the past five years, and is expected to reach ~$25-30 Bn by 20251 FUNDING 2
  • 53. McKinsey & Company 53|SOURCE: Press search Funding raised by Chinese innovation companies has been growing in past 12 months; first wave of IPOs also coming up FUNDING 2 Jan, 2015 Dec, 2014 Dec, 2014 Dec, 2014 Jan, 2015 May, 2015 Oct, 2015 Sep, 2015 Aug, 2015 May, 2015 $100M $75M $8M $10M $25M $97M $100M $35M $16M $45M Growing fund raising in innovation Recent IPOs from China Pharmacos Oct, 2015 Jun, 2015 Oct, 2015
  • 54. McKinsey & Company 54| Capabilities and infrastructure still lagging US benchmarks, but with some promising potential SOURCE: 2015 CDII Survey Discovery Clinical develop- ment How would you rate China’s overall infrastructure for drug innovation today Chemistry, Manu- facturing, Controls How would you rate the quality of R&D talent available in China today? Min Max 0 1084.9 Min Max 0 1084.6 Min Max 0 1085.0 Min Max 0 108 Ave. China Score = 4.2 CAPABILITIES 4.6 3
  • 55. McKinsey & Company 55| Capabilities in basic research has gap to U.S., particularly in quality Publications in inter- national journals (‘000s) +20% p.a. 2014 73 13 66 12 52 11 42 2010 35 269 +3% p.a. 201413 275 12 268 11 250 2010 242 Average citations (#) SOURCE: Thomson Reuters; InCite; Using Essential science indicators category (Immunology, Microbiology, Neuroscience & Behavior, Clinical medicine, molecular biology & genetics, Biology & biochemistry, Pharmacology & toxicology) 0.8 1.4 ▪ China’s quantity of research is rapidly gaining momentum ▪ However, to improve quality, the academic community needs to clean up practices of mediocre/me-too publications and enhance data integrity CAPABILITIES 3 China US
  • 56. McKinsey & Company 56|SOURCE: Company website; annual report; news release; expert interviews Chinese firms are building technology platforms to enable innovation – BGI and genomics / DNA sequencing example CAPABILITIES Unique scale in genomics #1 in NGS field in China 16 Years in business 15 state of the art genetic sequencing machines Large database specific for Chinese patients #1 16 150 Ranked by Nature in 2014 as: 5th of Top institutions in Nature and Science 15th of Top institutions 5th 15th Sequencing Platform Mass Spectrometry platform Computing platform3 9 OrganizationsPlatforms 3 Managing director Wang Jun recently founded a startup ShenZhen Tanyuan Technology Ltd. focusing on healthcare big data
  • 57. McKinsey & Company 57| Chinese firms also actively contributing to improving global drug innovation model – Wuxi AppTec example SOURCE: Expert interview; company website CAPABILITIES Large scale enabling 2,000 collaborators globally Start-up companies with great ideas Equipment Key analytical equipment of over 50 percent measured by 24x7 utilization Innovative companies with capacity constraints Capability augmentation Facility 5 millions sq ft of R&D and manufacturing Space 21 sites Traditional Gx companies trying to innovate Virtual labInnovative engine Man power 10,000 employees globally 4,000 synthetic, medicinal and process chemists #1 CRO in Asia CMC platform inspected by FDA 1st cGMP biologics manufacturing facility compliant with US, EU and Chinese regulatory standards 1st GLP preclinical laboratory double certified with an OECD country and CFDA 1st GLP/GCP bio-analytical lab that passed FDA, OECD, and CFDA inspections 1st CLIA-certified clinical genomics lab 1st #1 3 1st in China:
  • 58. McKinsey & Company 58| 4 Novelty and quality of innovation still lagging SOURCE: 2015 CDII Survey; expert interview LOCAL INNOVATION Min Max 0 1083.8 Min Max 0 108 Min Max 0 1084.2 Ave. China Score = 4.2 4.3Quality of R&D Novelty of innovative pipeline Discovery research Clinical develop- ment Today majority of Chinese companies are focusing on “me-too” and “me-better” targets in drug R&D with few exceptions, such phenomenon is probably driven by the fact that pharmacos need to establish credibility and demonstrate progress on innovation. Going forward I hope these companies will also invest in new MOAs and first-in-class as they build up R&D scale and capabilities – China-based investor
  • 59. McKinsey & Company 59| Local PCT and IND applications are rapidly growing PCT patents filed1 (#) 1 PCT: Patent Cooperation Treaty 2 Class 1 applications in China; Commercial IND applications in the US SOURCE: 2015 CDII Survey; PatentScope; GBI; FDA IND applica- tions2 (#) China’s levels of PCT patent and IND applications still a fraction of that of U.S. (17% and 22% in 2014, respectively), however growth trajectory of both metrics has been strong LOCAL INNOVATION 974 504 +18% p.a. 17356 +33% p.a. 20142010 5,821 5,272 +3% p.a. 782 601 +7% p.a. 2010 2014 4
  • 60. McKinsey & Company 60| While cross-border collaboration is increasing, participation in global trials has been limited due to recent regulatory hurdles SOURCE: 2015 CDII Survey; China Investment 2015 – ChinaBio; Thomson Reuters # of global trials (#) Cross-border deals on drug R&D (#) Min Max 0 103.6 8 Ave. China Score = 4.2 Contribution to global innovation Co-authorship with overseas researchers (‘000s) China contribution by the numbers INTEGRATION WITH GLOBAL 5 47 71 2014 -10% p.a. 2010 26 13 +19% p.a. 76 27 +30% p.a.
  • 61. McKinsey & Company 61| Overall, survey participants believe that the outlook for China innovation is promising What role will China play in global drug innovation by 2025? % of surveyed, N = 69 Majority of R&D leaders believe China could become a top-3 contributor or a solid 2nd tier player in global drug innovation by 2025 9%62%29% Top 3 global contributor Solid 2nd tier player Struggling, focused on incremental innovation What are China’s biggest advantages in drug innovation? Strong government support, evidenced by recently announced changes to accelerate drug registration and approval Sizable Chinese market attracts R&D investments from both MNCs and locals Proximity to leading drug R&D service providers in China including CROs, CMOs etc. Highly motivated Chinese companies eager to learn and play in global marketReference countries
  • 62. McKinsey & Company 62| ¥ Opportunities for key ecosystem participantsKey hurdles / challenges Making the leap – what it could take Pharma-coGov PE/VC ▪ Challenging regulatory environment ▪ Lack of mechanisms to reward innovation Consider trade-off between pricing and reimbursement Incorporate value evidence in clinical development plans ▪ Limited types of funding options for start-ups Allocate a proportion of government pension fund or sovereign wealth fund to VCs focusing on life science Partner with promising startups in early stages ▪ Large talent pool with mixed level of capabilities Encourage academic-private collaboration; urge academic to train “industry-ready” graduates Attract and develop high-quality R&D talent ▪ Pipeline novelty and quality of R&D can be enhanced Invest in innovative solutions that address China- prevalent disease areas (e.g., Lung cancer, liver cancer) ▪ Inclusion in global trials has declined Leverage new CFDA reforms to integrate China early on into global development planning Incentivize high-quality basic research (especially in Biology) to build cutting-edge expertise in select areas ¥
  • 63. McKinsey & Company 63| Finding the funds for innovation
  • 64. McKinsey & Company 64| “Finding the funds for innovation” becoming increasingly relevant “Who will pay for innovation” becomes an increasingly relevant question for pharma industry, payors, policy makers and ultimately patients Research & development Registration Market access & commercialization ▪ Growth of mature drugs slowing down further exacerbates importance of innovative drugs ▪ Wave of new drugs expected to reach China – MNCs launching waves of new drugs with high expectations on uptake – China innovation ecosystem has been improving, leading locals begun to develop and launch new drugs – CFDA reform expected to accelerate review and approval of new drugs in coming years ▪ Patients increasingly demand access to new drugs as affordability and awareness of options improve ▪ Market rewards for innovative drugs remain limited – Fragmented and inefficient listing & tendering processes – Infrequent RDL/PRDL updates with narrow coverage ▪ Government spending on healthcare remains constrained and focuses on providing basic coverage ▪ Private health insurance still at nascent stage
  • 65. McKinsey & Company 65| Large number of innovative drugs expected to hit the market in coming years SOURCE: GBI; lit search Strong innovative pipeline … 129 284 70 83 34 IND1 367 NDA2 104 131 Pre- clinical1 2 1 Class 1.1 Chemical drugs and Class 1 biologics in CFDA 2 Drugs in NDA review and drugs approved for NDA but not marketed (Jan 1st, 2011-Oct 13th, 2015), including drugs in category chem-1.1, chem-3.1, and innovative biologics … with multiple planned new launches (examples) Cadrofloxacin Hemporfin Nolatrexed LocalMNC Brand / product Company NDA approved In NDA review
  • 66. McKinsey & Company 66| China faces clear constraints when considering rewards for innovation SOURCE: WHO; World Bank Per capita health expenditure USD US Japan UK China 3,965 9,150 3,600 370 Total health expenditure Bn,USD 230 2,870 510 505 ▪ Despite strong growth in past decade, China per capita healthcare spend still significantly lagging behind developed countries ▪ Reward for innovation will be selective – government unlikely to support all innovative treatments equally 17.1% 10.3% 9.1% 5.6% Healthcare expenditure as % of GDP
  • 67. McKinsey & Company 67| A set of levers could be considered to bridge the funding gap and reward innovation SOURCE: NHFPC Yearbook; McKinsey Analysis China healthcare spend by funding source $ Bn, percentage 40 34 35 36 25 30 515209 2008 Social Patient Out-of- pocket Govern- ment 2013 2020 ? ~1,000 ? ? On-going levers Future possibilities? Direct increased public spend on innovation 5 Redeployment of savings from price cuts of mature drugs 6 Government reimbursement  NRDL and CDI1  Selected local reimbursement 4 Self-pay market 3 Patient Assistance Programs (PAPs) Outcome/value-based negotiation 7Development of private health insurance (PHI) 2 1 NRDL: national reimbursement drug list; CDI: critical disease insurance 1
  • 68. McKinsey & Company 68| Local governments have provided reimbursement scheme to a subset of innovative drugs – select examples 1 SOURCE: GBI; literature research; McKinsey analysis 1 Chronic myelogenous leukemia 2 Gastrointestinal Stromal Tumor # of provinces with PRDLDisease area Locally negotiated reimbursement scheme 2Non-small cell lung cancer  Qingdao 4Non-small cell lung cancer  Zhejiang  3 cities (Qingdao, Zhuhai and Shenzhen 2Breast cancer  3 provinces (Zhejiang, Inner Mongolia, and Jiangxi)  8 cities 11Rheumatoid arthritis  Zhejiang  Qingdao 12Non-small cell lung cancer  2 provinces (Jiangxi and Zhejiang)  Zhuhai While more cities and provinces are starting to cover innovative drugs through PRDL or local negotiations, overall scale and scope of coverage remain limited
  • 69. McKinsey & Company 69| Acceleration of roll-out of Critical Disease Insurance program SOURCE: Government official website; lit research; McKinsey analysis Policy evolution Impact to date 2007 2012 2014 ▪ Piloted in all 31 provinces, covering ~700 million population as of April.2015 ▪ Actual reimbursement rate no less than 50% for OOP, and increases with OOP expense ▪ ESRD example: NRCMS cover the first 70% of expenses, then CDI covers 50% of remaining expenses ▪ CDI is now operated by private insurers in most regions ▪ “Guidance and Definition of Critical Disease Insurance” issued by CIRC1 to set up a model policy of critical disease insurance  “Opinions on Implementing Critical Disease Insurance for Urban and Rural Residents” jointly issued by MOH, MoLSS2, CIRC, etc. to encourage cooperation between government and PHIs ▪ “Accelerate Development of CDI for Urban & Rural Resident” issued by the State Council, which encourage PHI to provide CDI services and establish evaluation and supervision system for expanding PHI coverage ▪ “Guideline on Full Implementation of CDI for Urban and Rural Residents” released by the State Council in Aug. – CDI should benefit all urban and rural residents covered in the nation's basic health insurance by the end of 2015 – A relatively sound system for CDI will be established by 2017 ▪ CDI expected to be fully roll-out soon and may cover UEBMI participants as well (Pilots in some regions already) ▪ The reimbursement rate will increase gradually in future Future outlook 2015 1 China Insurance Regulatory Commission 2 Ministry of Labor and Social Security CDI programs should expand to the whole country by the end of 2015 to help financially challenged residents – Premier Li, Keqiang 1
  • 70. McKinsey & Company 70| Growth of China PHI market USD, bn Private health insurance (PHI) is rapidly growing, providing supplementary funding source SOURCE: CIRC; State Council; literature research; McKinsey analysis 13 18.2 13.7 2012 20.1 2015 H114 25.8 +37% Private payors actively expanding presence Private payors are exploring new ways to enhance access to data and improve risk assessment ▪ Collaborate with providers ▪ Invest in mHealth ▪ Invest in hospitals to become integrated managed care systems ▪ Manage BMI for local government ▪ Growth driven by favorable policies, e.g., – Increasing social capital – Tax benefits ▪ PHI uptake still limited by – Access to patient data – Demand generation of target population – Lack of bargaining power over providers – Capability and talent + ++ + 2% 2% 5% 7% xx% PHI as % of total HC spend 2 Nanjing Gulou hospital
  • 71. McKinsey & Company 71|SOURCE: China Charity Federation; literature search; McKinsey analysis Patient Assistance Programs (PAPs) could help expand accessible patient pool NexavarGleevec Iressa ▪ Donation to poorest RCC and HCC patients ▪ Donation to poorest 10% of CML & GIST patients ▪ Setup medical centers & disease consulting hotline ▪ Provide medical assessment to patients ▪ Iressa Pan Asian Study (IPASS) clinical trials in 11 cities in China Charity donation and clinical trials ▪ 3-month cap, after which drugs are free for life with proven efficacy ▪ Free for patients with basic living allowences ▪ 3/6-month cap, after which free for rest of year ▪ 5-month cap for NSCLC patients, after which drugs are free for life Program 3 % of relevant patient pool coveredxx ▪ 20K patients▪ 25K patients Impact (by 2014) ▪ 39K patients ~10% <5% <10% While beneficial to patients enrolled, PAPs only cover a subset of diseases and fraction of patients in need of innovative therapies; scaling up poses challenges
  • 72. McKinsey & Company 72| Self-pay segment could be further activated, leveraging learnings from other markets Increasing willingness to pay Increasing patient affordability & willingness to pay Innovative ways to activate self-pay segment SOURCE: National Bureau of Statistics; MGI; McKinsey analysis 1 Affluent (>36K USD annual household income), Mainstream (17-36K USD annual household income), Mass (10-17K USD annual household income), Poor (<10K USD annual household income) 2 Including all healthcare related spending across prevention, diagnosis, treatment and nutrition Example Learnings from other markets ▪ Partner with private banks and consumer financing companies to provide loans to patients ▪ Short-term installments to help patients manage cash flows ▪ Risk-sharing mechanisms to mitigate patients’ perceived risk (e.g. on product efficacy) 24% 7% 26% 16% 26% Healthcare2 Transportation and communication Recreation, education and culture Others Personal product Consumption of New Mainstream by category, 2015 42.9 45.6 60.7 62.4 14.0 21.4 14.923.7 9.3 Poor Affluent New Mainstream Mass 2025E 6.2 1.3 2020E 4.2 1.7 2015 2.7 2.3 Increasing affordiblity Consumption of urban households – By annual income1 Percentage, 100% = trillion USD In India, Enbrel can be paid through installments of <$200 to minimize cash flow disruption for RA patients 4
  • 73. McKinsey & Company 73| Going forward, additional set of levers can also be explored SOURCE: McKinsey analysis Rationale Potential impact ▪ Current healthcare spending accounts for 5.6% of GDP, lower than many developed market ▪ Increasing healthcare spend on innovative drugs by 0.5% of GDP in 2025 could translate into ~$20 Bn opportunity for pharma industry Increase public direct spending on innovative drugs 5 High ▪ Cost saving from reducing price of mature drugs likely to be limited – estimated at $0.6- 1.5 Bn per year Redeploy savings of price cuts on mature drugs 6 Low ▪ Adopt Health Technology Assessment tools/framework, where drugs with compelling clinical benefits could gain more commercial upside Value-based negotiation between payors and pharmacos 7 Medium
  • 74. McKinsey & Company 74| A multi-pronged approach In summary, narrowing the “paying for innovation” gap requires a multi-pronged effort Better articulate the total economic and social impact of rewarding innovation, including addressing critical medical needs, creating a healthier society and cultivate an innovative and strong industry Tap into multiple funding sources, e.g., ▪ Increase government HC spend on innovative drugs ▪ Unleash Private Health Insurance market ▪ Further activate self-pay segment Not all innovation will be rewarded – demonstrating the value of innovative drugs will be critical Creative cross-sector partnerships should be explored (e.g., between private payors and pharmacos)
  • 75. McKinsey & Company 75| Implications for pharmacos Implications for pharmacos Engage regulatory bodies as an industry to help formulate policies that properly reward innovation Invest in market shaping activities, including self-pay segment Incorporate demonstrating value of innovative drugs into clinical development and life cycle management plans Explore creative partnerships (e.g., with private payors, local government) to enhance patients’ access to innovative drugs Double-down innovation efforts in disease areas highly relevant to China and/or with strong government support 1 2 3 4 5 6 Explore price-volume trade-offs at launch time and regularly over brand life-cycle
  • 76. McKinsey & Company 76| Closing thoughts We are on a narrow bridge to innovation, with still a high degree of uncertainty on outlook1 2 The going gets tougher; however there are still tremendous opportunities to capture 3 The time to drive real change in business and operating models is now
  • 77. McKinsey & Company 77| For more on China healthcare … Our China healthcare leadership team (Partners and Associate Partners) Industry insights Collaboration with CPA ▪ Data driven periodic reports ▪ TA specific deep-dive (e.g., oncology, immunology) iTunes Store – “McKinsey on China” ▪ How sick is China's pharmaceutical market? ▪ Will market forces revolutionize Chinese healthcare? ▪ What healthcare system can China afford? ▪ Will the next medical equipment champion come from China? ▪ Obesity – How big will China get? www.mckinseychina.com 2014 2013 2012 2015 1 2 3 4 5