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introduction to the pharmaceutical market and practice
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Presentation20190103 final
- 1. 藥品市場概論及實務 Introduction to the pharmaceutical market and practice 2019/1/3 魏景成 新藥研發流程與原理
- 2. 產業分析 INDUSTRY ANALYSIS 價值與價格 VALUE & PRICE 課 程 大 綱 ＡＧＥＮＤＡ 01 03 05 競爭策略 COMPETITIVE STRATEGY 行銷策略 MARKETING STRATEGY 02 04 2 產品生命週期 PRODUCT LIFE CYCLE
- 3. 魏景成 講師自介 製藥業職歷 生達化學製藥 國際事業部課長 國鼎生物科技 國際業務部副總經理 董事長特助 展旺生命科技 事業發展專員 語言：英文、日文、韓文 藥事法規：RAC國際醫藥醫材法規人才認證（Regulatory Affair Certificate- General Scope） 專案管理：PMP國際專案管理師（Project Management Professional） 產品上市：NPDP國際新產品開發管理師 （New Product Development Professional） 企業鑑價：企業評價師證照（經濟部工業局培訓，中華無 形資產暨企業評價協會認證） 科技管理：MMOT跨領域科技管理與智財運用國際人才培 訓計畫先修班結訓 智財管理：智慧財產人員能力認證(TIPA)：專利程式控管 類、專利檢索分析與加值運用類認證 日本醫藥：日本登錄販賣者試驗合格、日本藥學檢定一級 企業法務：日本企業法務（ビジネス法務）檢定二級 國際貿易：國貿大會考合格 3
- 5. Features of Pharmaceutical Market 医薬品マーケティング新戦略 高橋真人 5 Enormous cost and time are required for product developmen t. Influenced by pharmaceuti cal regulation. Price of the drug is determined by the drug pricing system. Complicated and exact information Promotion and advertiseme nt is regulated
- 6. Environment analysis Macro- environment Demographic Economy Technical environment Politics / regulation Society / culture Micro- environment External factors Internal factors Management HR & Organization Financial ability R&D ability Formulation Tech Production capacity Market entry Marketing power Product lineup Sales force Client Market Competition Supplier Environment analysis of Pharmaceutical Market 医薬品マーケティング新戦略 高橋真人 6
- 7. PEST analysis for pharmaceutical products Politics 1. Regulation relief 2. Healthcare system reform 3. Revision of Pharmaceutical Affairs Law 4. Strategies against intractable diseases Economics 1. GDP/ appreciation/ depreciation 2. Increasing drug expenses 3. Promotion of generic products Society 1. Aging 2. Increase of lifestyle diseases 3. Stressful society Technology 1. Development of regenerative medicine 2. Genomic medicine 3. New treatment method 医薬品マーケティング新戦略 高橋真人 7
- 8. Healthcare environmental analysis Epidemiology 1. Potential patients / diagnosed patients 2. Incidence 3. Average onset age · mean disease duration 4. Gender/ age composition ratio 5. Survival rate / mortality Etiology 1. Condition (pathogenic mechanism) 2. Pathological findings 3. Classification on pathology, pathology 4. Presence of inheritance Diagnosis / examination 1. Criteria 2. Main symptoms 3. Inspection method (insurance reimbursement?...) 4. Monitoring method (blood concentration…) 5. Criteria for determining severity Treatment 1. Non medication therapy 2. Medication therapy 3. Guidelines 4. Market size (amount, number of patients) 5. Competition situation (number of products / share) 医薬品マーケティング新戦略 高橋真人 8
- 9. Geriatric Population B00ming IMS Market Prognosis 2014-2018 9
- 10. Most countries will experience an increase in pharmaceutical spending per capita by 2018 Pharmaceutical Spending IMS Market Prognosis 2014-2018 10
- 11. Spending growth in the total market reaches $100 billion by 2018. Pharmaceutical Spending IMS Market Prognosis 2014-2018 11 (Rest of world)
- 12. U.S. spending growth on medicines will peak in 2014 and then moderates through 2018 Pharmaceutical Spending IMS Market Prognosis 2014-2018 12
- 13. Top 5 European markets spending growth will be flat through 2018Pharmaceutical Spending IMS Market Prognosis 2014-2018 13
- 14. Japan’s growth is expected to return to historic patterns through 2018 after atypical 2014 Pharmaceutical Spending IMS Market Prognosis 2014-2018 14
- 15. Pharmerging growth steady with greater access to medicines and economic improvement increases Pharmaceutical Spending IMS Market Prognosis 2014-2018 15
- 16. Pharmaceutical Spending Spending level increases are tied to recently expanded access, with 95% of the population now covered by public health insurance plans. IMS Market Prognosis 2014-2018 16
- 17. North America continues to contribute the largest proportion to growth, but Asia is gaining growth rapidly. Pharmaceutical Spending IMS Market Prognosis 2014-2018 17
- 18. Generics continue to drive growth globally IMS Market Prognosis 2014-2018 18
- 19. Pharmerging market growth is driven by generics and non-branded products Pharmaceutical Spending IMS Market Prognosis 2014-2018 19
- 20. Specialty therapies continue to be more significant in developed markets than in pharmerging IMS Market Prognosis 2014-2018 20
- 21. Therapeutic Area Igea Hub Pharmaceutical Club 21
- 22. Top 10 therapy areas in 2024, market share & sales growth World Preview 2018, Outlook to 2024, EvaluatePharma® 22
- 23. Ranking of top pharma 23
- 24. Ranking of best selling products 24
- 25. Ranking of most promising products EP Vantage 2018 Preview 25
- 26. R&D investment Igea Hub Pharmaceutical Club 26
- 27. R&D investment IMS Market Prognosis 2014-2018 27
- 28. Consistent high numbers of innovative and orphan medicines expected through 2018 NME launch IMS Market Prognosis 2014-2018 28
- 29. Biosimiliar in development by country 2018 Global life sciences outlook, Deloitte 29
- 31. Market environment and basic concept Diverse needs Narrow down market Segmented market Competition intensification Differentiated market Products differentiatio n Market change Product value change Product life cycle 医薬品マーケティング新戦略 高橋真人 31
- 32. Mega player (Almighty type) • Covering primary area and specialty area • Marketing powerfully in all directions Multiplayer (Diversified type) • Covering both original and generic drugs • Larger company size Niche player (Concentrated type) • Covering intensively the niche area • No.1 or first three in the target category Category players (Specialty type) • Covering mainly on specialty areas • No. 1 in target category Classifications of Originators 医薬品マーケティング新戦略 高橋真人 32 ① ② ③ ④
- 33. Leader Feature eager to M&A domination by size and resources brand Product blockbuster products first-in-class Competitive strategies in pharmaceutical industry Challenger Feature research intensive type differentiation alliance Product blockbuster products best-in-class Followers Feature conventional sales & marketing resist to merge Product medium market size product cloner & imitator Nicher Feature centralized type resist to merge high profit Product small to medium market size products less competition area医薬品マーケティング新戦略 高橋真人 33
- 34. 5 forces analysis for pharmaceutical products New entrants (from different industries) Competitive relationship within the industry (competitors) Replacement/ Substitution (new TX, generic product) Buyer (hospitals / patients/ payers) Seller (API manufacturers) 供應商的議 價力量 客戶的 議價力量 替代品/ 服務的威脅 新加入者的威脅 医薬品マーケティング新戦略 高橋真人 34
- 35. 3C analysis for pharmaceutical products Customer Company Competitor Where to compete? How to compete? What to compete? Patient trend patient pool size recognition rate acceptance rate Actual medical condition number of physicians diagnostic rate specialty Treatment status dosage rate, efficacy rate, satisfaction level guideline Organization sales system quantities of MRs marketing system Status of products characteristics of products market share Market entry product lineup relationship with customers Organization sales system quantities of MRs marketing system Status of products characteristics of products market share Market entry product lineup relationship with customers 医薬品マーケティング新戦略 高橋真人 35
- 36. Decide priority of product 3 new products business strategies Existing category competition New category entry New business development Market analysis Customer analysis Product analysis Competitive analysis Resource and inventory check Macro-environment analysis · Industry analysis Market analysis · customer analysis · competitive analysis Impact on market entry & investment outcome investigation 医薬品マーケティング新戦略 高橋真人 36
- 37. 8 Elements for product differentiation Price Dosage Chemical Formulation Usage ADME Mechanism Form Core function Efficacy Safety Indicatio n 医薬品マーケティング新戦略 高橋真人 37
- 38. Purpose of the Strategic Alliance Cost reduction type Time saving type Risk avoidance type Weakness complement type Synergy type 医薬品マーケティング新戦略 高橋真人 38
- 39. Alliance & outsourcing viewed from value chain Research Development Clinical Trial Marketing Promotion RD Alliance Co-promotion CSOCRO Vertical integration Horizontal integration 医薬品マーケティング新戦略 高橋真人 AllianceOutsourcingIntegration 39
- 42. 42 價值計算：①市場基礎法 亦稱市場比較法、相對評價法 在於在市場內，具相當營業項目、成長率、財務特性與規模的公司，應有類似 的表現及價值。應用非常廣泛，許多股市的研究報告即用此類方法。 因此某一公司的價值應可由其它類似公司的價值估算而得。 有兩個基本的構成要素，市場乘數(Market Multiple)及類似可做對照的公司。 常用的市場乘數： 本益比：每股價格/每股盈餘 股價淨值比：每股價格/每股帳面價值 本銷比：每股價格/每股營收 市價現金流量比：每股價格/每股現金流量
- 43. 43 價值計算：②收益基礎法 公司的價值主要來自於公司未來所能創造的現金流量的現值總和。 企業經營之目的在追求股東價值最大化，此法同時考量公司所處的經濟產業環 境、歷史經營績效、未來成長率、市場風險、資金結構和賦稅等因素，因此最 能反應企業實際面臨的情境，而其結果亦最能代表公司的實際價值。 缺點在於未來現金流量不易準確估計，且方法中使用大量變數需要估計，操作 較為複雜，過程中主觀判斷因素亦較多。 有股利折現法、盈餘折現法、經濟利潤折現法、 自由現金流量折現法等。
- 44. 44 價值計算：③資產基礎法 資產基礎法認為企業的價值，在於其擁有的資產價值，所以此方法的重點在於 如何評估企業所擁有的資產價值。 採用資產基礎法評價時，所有資產負債科目需視為個別單一的評價標的，並視 各個評價標的特性，選擇適當的方法進行評價，故其複雜繁瑣的程度並不下於 其他評價方法。 一般而言，資產基礎法應用時機多為企業進行清算時或企業併購進行購買價值 分攤（Purchase Price Allocation, PPA ）。
- 45. Pharma & biotech M&A transactions announced each quarter EP Vantage 2018 Preview 45
- 46. Licensing activity- total upfronts paid & deal volume EP Vantage 2018 Preview 46
- 47. VC investment EP Vantage 2018 Preview 47
- 49. Research Div. Development Div. Production Div. Distributio n Div. Sales Div. Physician Patient Payer Value chain in pharmaceutical companies Construction of value chain Unmet Medical Needs 医薬品マーケティング新戦略 高橋真人 49 Marketin g Div.
- 50. Target Focus Time perspective Sales Product Sales Short-term Marketin g Market Profit Medium / Long-Term Sales vs Marketing 医薬品マーケティング新戦略 高橋真人 50
- 51. Technology changes Existing product Improved product New product Market changes Mature market Growing market New market Marketing Marketing vs R&D: Who leads product development? 医薬品マーケティング新戦略 高橋真人 51 R&D
- 52. Innovator (dissemination) theory 医薬品マーケティング新戦略 高橋真人 52 Awareness Differentiation Loyalty Concentration
- 53. Attribute and behavior analysis Attribute analysis Geographic Demographics Age, Gender Psychological Lifestyle, personality, prescription rights Behavioral Frequency of use, Loyalty, Consultation Awareness of disease / treatment Awareness of disease, Adaption rate of treatment Specialty · clinical dept. GI · CV… Facility Attribute University Hospital · Clinic Behavior analysis Product selection Problem recognition, Problem solving, Product selection, Product purchasing, Product valuation 医薬品マーケティング新戦略 高橋真人 53
- 54. Model in calculation drugs consumption 50 100 100% 70% 60% 50% 30% 20% Potentialpatients Consultationrate Diagnosticrate Dosagerate Prescriptionrate Persistencerate LOSS 医薬品マーケティング新戦略 高橋真人 54
- 55. Market composition of medical products and example of patient flow Total p‘ts Conscious Consultation Diagnosis Prescription Our p’t share Average dose Persistency Daily avg. price Non-conscious Non-consultation Non-diagnosis Non prescription Competitor’s p’t share Average dose Persistency Daily avg. price Realize it is a disease? Been consulted at a hospital? Been diagnosed? Drugs are prescribed? What is the patient share? Average amount daily intake? How long will it be taken? Existing market Potential market 医薬品マーケティング新戦略 高橋真人 55
- 56. Examples of existing market and drug decision trees Patient Symptom(+) Symptom(-) Implemented Not-implemented Abnormalities Normality Exclusion Mild to Moderate Mild Moderate to Severe Mild Exclusion Exclusion 1. Effect A 2. Safety 1. Effect B 2. Safety 1. Effect A 2. Effect B 1. Effect B 2. Safety Drug A Drug C Drug B Drug C Drug A Drug B Drug B Drug C Consult Examination Diagnosi s Treatment goal Prescriptio n Implemented Not-implemented Abnormalities Normality 100 60 40 42 18 32 8 12 30 9 9 12 20 医薬品マーケティング新戦略 高橋真人 56
- 57. 4 Ps marketing mix Product Price Place Promotion Generic name Brand name Effect, feature Quality Dosage form Package design Product logo Warranty Drug price Transferred price Sales price Allowance Discount Credit conditions Channel Distribution coverage Product assortment Location Stock Transport Advertising Sales Force Sales Promotion Public Relations Internet 医薬品マーケティング新戦略 高橋真人 57
- 58. Target Product Profile (TPP) • Indication • Efficacy • Safety • Dosage & Administration • Sales Impact • Superiority • Time • Form Proof of Concept 医薬品マーケティング新戦略 高橋真人 58
- 59. TPP & strategy design in development stage TPP design Research design STP design 4P design PM assign Market research Competition survey PEST Analysis Needs Survey Fact Investigation SWOT Analysis 3C Analysis Segmentation Targeting Positioning Task extraction Promotion scenario Scenario investigation Branding Promotion strategy Price strategy Distribution strategy PMS design MR training MR promotion PMSNDAPhase IIIPhase IIbPhase IIaPhase I 医薬品マーケティング新戦略 高橋真人 Approval 59
- 60. Drug price setter Involvement of the authority Drug price of new drug Price reduction after launch Japan Government High Low High France Government Medium Medium Low England Free Medium Medium Low Germany Free Medium Medium Low US Free Low High NA Drug pricing system 医薬品マーケティング新戦略 高橋真人 60
- 61. Relationship between drug price and prescription share and profit 100% 50% 50 100 150 200 250 300 350 Patient share 1 day drug price Share Profit drug price*patient share* (1 - cost rate) Share at best price Best price 医薬品マーケティング新戦略 高橋真人 61 Profit/day
- 62. Marketing process & survey Segmentatio n & Targeting Positioning Branding Promotion Prescription share Amount share Fact Needs & insights Positioning & Message Branding Survey Scenario survey Mind share survey Dynamic survey Market share Treatment algorithm (decision tree) Patient flow Drug evaluation, treatment motivation Tx issues, dissatisfied or worried points, ideal status Major treatment goal, clinical benefit, product characteristics Visual, logo, tagline, signal Understanding and acceptance of promotional content Understanding, conviction, differentiation, prescription intention New patient share, Switching share, Additional share, Maintenance share, Total share IMS share 医薬品マーケティング新戦略 高橋真人 62
- 63. Strengths Weaknesses Sales force Effect is high Provide highly complex info Info exchange is possible High cost (continuous) Coverage is limited Latent effect Advertisement High coverage Messages can be transmitted quickly High impact High cost (depends on cost) Difficult to provide complex info Publicity Reliability is high Reasonable cost Difficult to control by company Negative information may be spread Promotion Fast Effect Synergy is expected (with sales force) Effect period is short High cost Word-of- mouth reviews Reliable and low cost Difficult to control by company Negative information may be spread Internet Internet can be seen anytime, anywhere No restriction in amount of info Comparation and exchange is possible Weak impact Strengths and weaknesses of promotion methods 医薬品マーケティング新戦略 高橋真人 63
- 64. Benefits • Finely responding • Provide advanced information • Information exchange • Prompt response and feedback Human Promotion Process Discover existing customers' needs Search for new customers Detail presentation Attention-drawing, Interest facilitation Occurrence of desire (counterargument, differentiation) Prescription occurrence Follow-up (confirmation of customer satisfaction) 医薬品マーケティング新戦略 高橋真人 64
- 65. Priority Top priority Monitor Watching Sensitivity analysis Impact on sales 医薬品マーケティング新戦略 高橋真人 65 Mild Huge High possibility/ frequency Low possibility/ frequency
- 66. Methods of Sales Forecasts Sales forecast New Products Introduction/ growing Short-term forecast (within 1 year) Medium- to long- term forecast (longer than 2 years) Existing Products maturity/ deline Short-term forecast (within 1 year) Medium- to long- term forecast (longer than 2 years) Market breakdown method Benchmark method Growth rate analysis method Survey analysis method · Product competitiveness Statistical prediction method Product life cycle analysis method subjective intensive method 医薬品マーケティング新戦略 高橋真人 66
- 68. Development of new products and time Marginratio Time Company Existing Category Priority Category Existing category Non-priority category New category 医薬品マーケティング新戦略 高橋真人 68
- 69. Stage Development Introduction Growth Mature Declining Strategic Issues Product design Market penetration Increase market share Maintaining revenue Maintaining profit Profit (revenue) minus + - increase max reduction Product lifecycle and profit Revenu e Cost Sales Profit Marketing cost Production cost Development cost ApprovalDiscovery Launch 医薬品マーケティング新戦略 高橋真人 69
- 70. Lifecycle management up to drug launch 5~9y 3~9y 1~3y Non- clinical Fundamen tal research Phase I Phase IIa Phase IIb Phase III Expert committee Pharmaceutical committee Pharmaceutical Affairs Post marketing surveyApplication for re- examination Clinical Trial Submission TPP Plan (indications, target countries) TPP Decision Sales scale, sales system, production system evalua Scale of trial, facilities, PI, etc. Response to deficits, launch plan and sales strategy Plan for post-marketing surveillance 医薬品マーケティング新戦略 高橋真人 70
- 71. The availability of new medicines varies by country and disease IMS Market Prognosis 2014-2018 71
- 72. Drug lag US JP Preparation period Clinical trial period Review Preparation period Clinical trial period Review Drug lag Launch Launch 医薬品マーケティング新戦略 高橋真人 72 Time
- 73. Patent period, development and sales period in pharmaceuticals Nonclinical Fundamental research Clinical trial Dossier submission 3~5y 2~3y 3~9y 1~3y R & D period Reexamination Revaluation period Patent application Originator sales period Generic sales period Patent period 医薬品マーケティング新戦略 高橋真人 73
- 74. Comparison of sales of originator and generic sales between US & JP US JP Originator sales Generic sales 医薬品マーケティング新戦略 高橋真人 74patent expiration time revenue in US
- 75. Rank of lifecycle value-growth to mature #2 Humira Launched on 2002 115.9B USD #9 Herceptin Launched on 1998 79.2B USD #12 Nexium Launched on 2001 65.3B USD #3 Remicade Launched on 1998 105.1B USD 史上最畅销的21个药，你认识几个？ 药事纵横 75
- 76. Rank of lifecycle value-mature to decline #13 Abilify Launched on 2005 63.5B USD #19 Gleevec Launched on 2001 56.2B USD #20 Losec Launched on 1992 52.0B USD #1 Lipitor Launched on 1998 152.0B USD 史上最畅销的21个药，你认识几个？ 药事纵横 76
- 77. Goal of post market lifecycle management Development Introduction Growth Mature Declining Revenue Launch Years of post marketing 医薬品マーケティング新戦略 高橋真人 77
- 78. 78 Case study: Quick death of Aliskiren
- 79. Small molecule patent expiries will moderate through 2018 after a peak in 2012 IMS Market Prognosis 2014-2018 79
- 80. • Launch next generation products • New indication • New dosage form • Change Composition • Maximize brand loyalty • Strategic pricing • Switch to OTC • Release of generics by our company • Liquidation/ license out the product Strategy against Patent Expiration Strategy against Patent Expiration 医薬品マーケティング新戦略 高橋真人 80
Notas del editor
- •• Growth in the U.S. market will remain strong, disproportionate to its population growth; this is driven by fewer patent expiries than in previous years, innovative product launches and rising prices. •• Despite high growth in pharmerging countries, there remains a large difference in pharmaceutical spending per capita versus developed markets. •• Only France and Spain will see a contraction of pharmaceutical spend per capita in 2018, due to policies intended to control spending growth. •• Highest growth is anticipated in China, where per capita spending is anticipated to grow by over 70% in the next five years. •• As the second largest market in the world, China’s spend is expected to be just 9% per capita of that in the U.S.
- •• Spending on oncology medicines globally is expected to grow by over 50% to exceed $100Bn in 2018 driven by increases in cancer incidence of up to 31% by 2020, and rising rates of melanoma and kidney cancers.1 •• Absolute growth is expected to be $25-45Bn, compared to $17Bn in the prior five years. •• High numbers of global drug approvals and launches in 2012 and 2013 and a strong pipeline will drive higher growth in developed markets in the forecast period. •• Greater use of multi-targeted, or “stacked,” treatments that demonstrate greater survival benefit will also increase spending levels in developed markets. •• Biosimilars will play a greater role in cancer treatment in pharmerging markets but are expected to have limited impact in developed countries over the next five years.
- •• The U.S. market will see dramatic growth in 2014, due to the launch of innovative products, lower impact from patent expirations and price increases that are partially offset by rebates and discounts and are not reflected in the forecasts. •• The implementation of the Affordable Care Act will have a positive impact on demand for medicines during the first half of the forecast period due to expanded enrollment in state Medicaid programs and increased use of tax credits to purchase private health insurance. •• However, expanded coverage will increase budgetary pressure on payers, with drug spending being a popular target for cost containment. •• Biosimilars will target a limited number of originator molecules during the forecast period, and contribute to lower medicine spending for those medicines, while biologics’ spending will continue to grow faster than medicines overall, driven by innovation.
- ＊德國、英國、法國、西班牙、荷蘭 •• Europe has emerged from recession, but recovery across the region has been uneven, with high unemployment and large debt burdens yet to be addressed. •• Healthcare budgets across much of the region remain under pressure from austerity measures. •• The highest growth will be in Germany and the U.K., boosted by a reduction in mandatory discounts in Germany and National Health Service (NHS) budget easing in the U.K. •• France and Spain will see zero to negative growth, due to price cuts and increased generic utilization in France, and changes to the reference pricing system in Spain.
- •• In 2014, scheduled average price cuts of 5-6% were offset by simultaneous value-added tax (VAT) increases of nearly 3%, and market growth was boosted by stockpiling prior to the VAT implementation resulting in growth higher than a typical price-cut year. •• Innovative medicines will be a key driver of growth as manufacturers are insulated from biennial price cuts in return for new drug development as part of reforms implemented in 2010. •• Steep reductions in branded drug pricing post expiry and intensifying pressure on generic prices are also intended to reduce spend. •• Generic utilization remains low by international standards, but is slowly increasing due to policies and financial incentives aimed at doubling generic usage by 2018. •• Price cuts will deliver substantial cost reduction but the market will still grow 1-4%. •• While the population as a whole will decline, the number of retirees —already accounting for a quarter of all patients in Japan —continues to increase and is expected to drive up demand for medicines.
- •• Spending level increases are tied to recently expanded access, with 95% of the population now covered by public health insurance plans. •• Improvements to the healthcare infrastructure and community health services are expected under the current Five-Year Plan (2011-2015) and will further grow the market through 2018. •• Reform of the hospital sector will continue to impact prescribing, as cost-containment measures limit drug budgets to a fixed percentage of total budget and reduce profits obtained by hospitals for dispensing medicines. •• Policy changes in 2014 will bring more drugs under the remit of the National Development and Reform Commission, including those to treat serious diseases, exposing them to price ceilings and in-market price cuts that will continue to exert downward pressure on prices. •• While public institutions remain the main providers of hospital care, the growing numberof private hospitals is expected to drive demand, providing shorter waiting times and better conditions: the number of private hospitals increased 15.9% in 2012 and policy aims are to double private capacity to 20% of national volume by 2015.
- •• Strong economic recovery in the U.S. and recent healthcare reform have already had a positive impact on the use of medicines and will grow the market through the first half of the forecast period. •• Drug spending in Europe will remain limited by a weak economic recovery, low population growth and continued efforts to reduce public debt, including healthcare and drug spend. •• Asian export economies, including South Korea and India, will grow along with global recovery, increasing demand for medicines in Asia. •• Southeast and East Asia will grow at twice the global average, driven by population growth, rising incomes and improved access to healthcare. •• Political tensions in Russia, Ukraine, Thailand and Hong Kong pose a threat to economic stability and negative price pressure from government cost-control initiatives may also limit growth. •• Unrest in the Middle East and North Africa will further weaken Africa and the Middle East (AFME) economies and investment, although medicine spending growth is expected to continue with rising incomes in Africa and continued immigration to the Gulf region.
- •• Latin America has the highest proportion of growth from generics of any region; generics are the largest driver everywhere but North America. •• Increases in low-cost generics will continue to be seen in Asia, including India and Pakistan, as efforts to broaden access to basic health insurance is pursued. •• Locally manufactured generics will be the main beneficiaries of rising demand in Latin America, with local manufacturers increasing their share of the market. •• Innovative launches and price increases in North America keep generic growth more tempered than in other regions by offsetting genericization. •• Locally manufactured generics are a key source of affordable drugs in African markets, where domestic manufacturers often enjoy preferential treatment to encourage domestic production. •• Demand for generics has outpaced overall market growth rates in both Australia and New Zealand, while the sector has also benefited from a succession of major patent expiries.
- •• Growth in pharmerging markets is comprised of 83% non-brand medicine growth, driven mostly by growth in generics. •• China demonstrates 75% total growth in the next five years, driven by both brands (70% growth) and non-brands (75% growth). •• While some pharmerging markets have robust domestic generic industries, other typically smaller countries rely more on the import of medicines and tend to have higher branded medicine spending as a share of their total spend. •• As a percentage of total growth in pharmerging markets, brand growth remains steady at 30% growth while non-brand growth sharply increases at 61%. •• Brand growth comprises 23% of total growth for Tier 3 pharmerging markets primarily due to significant importation of medicines and pricing policies that promote competition. •• Government pricing policies are typically restrictive, including price controls, driving brand prices to competitive levels and limiting price growth.
- •• The emergence of new therapies for hepatitis C have brought that therapy area into the top 20 for both developed and pharmerging countries. •• Oncology continues to be the largest category in developed countries, and the largest specialty area in pharmerging countries. •• Leading classes in pharmerging markets are dominated by pain, antibiotics and hypertension, while in developed markets specialty categories such as oncology and autoimmune diseases are more prominent. •• Six of the top 20 classes in developed markets will face patent expiration in the next five years and therefore declining growth.
- •• Through October 2014, there have been 31 NMEs approved globally and 26 launched, six of which are classified as orphans in either the U.S. or E.U., and 18 are specialty products. •• In 2014 there have already been 12 drugs approved in the U.S. that have FDA Breakthrough Therapy Designation, including the first biologic (meningococcal group B vaccine). •• Increasing numbers of orphan and breakthrough designation applications and steady approval rates are expected through the forecast period.
- •• The countries with the highest availability of all NMEs launched 2008-12 continue to be high income countries, including the U.S., Germany, the U.K., Canada and Italy. •• Pharmerging markets have a lower percentage of possible NMEs across all medicine classes. •• Approximately 32% of NMEs launched in at least one country are not available in the U.S. •• Compared to a similar analysis of the availability in 2012 of the 2007-11 cohort of NMEs, pharmerging countries all achieved increases in availability.1 •• In developed markets, the U.K. had the biggest increase (9%) and Spain the biggest decrease (-14%) in availability over the 2012 analysis.
- •• In the last five years, the value of small molecule products facing loss of exclusivity in developed markets totaled $154Bn. •• The patent cliff peaked in 2011-12 when Lipitor, Plavix, Singulair and Seroquel faced generic competition in the U.S. for the first time. •• Global brands such as Nexium, Celebrex, Symbicort, Abilify, Gleevec, Crestor, Zytiga and Cialis face patent expiry in the next five years. •• While a further $48Bn of spending for biologic medicines will lose exclusivity in the next five years, gradual evolution of biosimilar regulations and competition will result in less impact on brands than is typically seen with small molecules.1