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Biot e c h n o l o g y
Biotechnology 2008




  B i ot e c h n o l o g y
  December 2008




www.ibef.org
Bi ot e c h n o l o g y
 December 2008




Market overview
• indian biotech industry contributes to two per cent        Share of companies involved
                                                             in each biotech segment 2006-2007
  of the global biotech industry.
• the sector grew at a healthy 20 per cent in                                        5%

  2007-2008.                                                                14%


• the industry in 2007-2008 clocked US$ 2.5 billion
  registering a 30.98 per cent growth                                                                   40%
                                                                      19%

• growth has been mainly fuelled by rise in domestic
  business, exports, M&A and, new product innovations.                                 21%



                                                             n Bio-pharma         n Bio-services
                                                             n Bio-agri           n Bioinformatics   n Bio-industrial

                                                             Sourc: Biospectrum June ‘07




                                                                                                                       www.ibef.org
Bi ot e c h n o l o g y
 December 2008




Market overview
• the sector employs approximately 20,000 scientists,          Biotech industry Revenues
  and over 325 companies drive it towards further                  Segment        Revenue       Contribution
                                                                                (US$ million)    (per cent)
  growth                                                       Bio-pharma           1683             67
                                                               Bio-services         383              15
• india is among top 12 biotech markets globally.              Bio-agri             293              12
                                                               Bio-industrial       100              4
• india ranks third in the Asia-Pacific, after Japan and       Bioinformatics        46              2
  Korea.
• indian market is expected to touch US$ 5 billion by
  2010 and US$ 25 billion by 2015.




                                                                                                              www.ibef.org
Bi ot e c h n o l o g y
  December 2008




Biotech industry 2002-2007
Biotech industry 2002-2007 (US$ million)
  2007-08                                                                     293 100 46
                                       1683                      383


  2006-07                              1457                       269         226 96 35


  2005-06                              1148                        176        146    91 29


  2004-05                              871                              104    80 78 24


  2003-04                              671                                67 32 58 20


  2002-03                              437                          33 27           57   18



n Biopharma n Bio-Services n Bioagri n Bioindustrial n Bioinformatics
Source: Biospectrum 2007-2008




                                                                                                 www.ibef.org
Bi ot e c h n o l o g y
 December 2008




exports
• Biotech exports alone generated                               Biotechnology Sector exports from india
                                                                2007-2008 (US$ million)
  US$ 1.2 billion, i.e., 58 per cent of total
                                                                      Segment                     Revenue
  biotech revenues
                                                                 Bio-pharma                         1683
• Bio-pharma exports accounted for over 70 per cent              Bio-services                       383
  of the total industry, while bio-services sector had 26        Bio-agri                           293

  per cent share in exports*.                                    Bio-industrial                     100
                                                                 Bioinformatics                         46



                                                                Biotech industry: exports vs domestic sales 2007-2008 **

                                                                   Biopharma          975                                                 707

                                                                  Bio-Services        336               17

                                                                       Bioagri        12          280

                                                                  Bioindustrial       7     93

                                                                Bioinfoematics        37    10


                                                                                  0         200     400      600   800   1000     1200   1400   1600   1800

                                                                                                                    US$ million
                                                                                  n exports                              n Domestic

* ABLE-Biospectrum Survey 2007-2008                             **Numbers may appear inconsistent because of rounding off.



                                                                                                                                                             www.ibef.org
Bi ot e c h n o l o g y
 December 2008




Share of different segments in export and domestic sales 2007-2008


Percentage share in export sales                          Percentage share in domestic sales

                                                                             2%1%
                  2%
              1%1%                                                     8%




      26%                                                                                     64%
                                                                25%
                                   70%




n Biopharma      n Bio-Services                           n Biopharma        n Bioagri
n Bioagri        n Bioindustrial   n Bioinformatics       n Bioindustrial    n Bio-Services
                                                          n Bioinformatics
                                                          Source: Biospectrum 2007-2008




                                                                                                   www.ibef.org
Bi ot e c h n o l o g y
 December 2008




Biotech clusters in india
india’s main bio-clusters are located in Bangalore,                                                         • Department of Biotechnology
                                                                                                            • Center for Biotechnology
hyderabad, Pune-Mumbai and Ahmedabad-Vadodara                                                               • The National Institute of Immunology
                                                              • Food biotech park (proposed)
                                                                                                            • Institute of Genomics  Interative
                                                                                                              Biology
                                                                                                            • National Brain Research Centre
                                                                                        Panjab
                                                                                                            • National Centre for Plant Genome
                                                                                                 Haryana
                                                              • Food biotech park                             Research
                                                              (proposed)
Western Region                                                                            New Delhi
                                                                                                      Lucknow
• comprises the Pune-Mumbai and Ahmedabad-                                  Vadodhara                       • Food biotech park (proposed)
                                                              • Savli biotech Park
                                                                                                            • Central Drug Research Institute
  Vadodara clusters                                           (proposed)
                                                                                                                Kolkata
                                                                                                                          • India Institute of
                                                              • Tata Institute of  Mumbai
• Accounted for 48 per cent of india’s biotech business                                                                     Chemical Biology
                                                              Fundamental Research

                                                              • National Chemical
  with revenues of US$ 998 million                                                                    Hyderabad
                                                                Laboratory           Pune
                                                                                                                  • Center for Cellular  Molecular
                                                              • National Center
                                                                                                                    Biology
                                                                for Cell Sciences

• 44 per cent of companies are involved in bio-pharma;                                                            • Center for DNA Fingerprinting
                                                              • Hinjewadi Biotech Park
                                                                                                                     Diagnostics
                                                              • National Center for
                                                                                          Bengaluru               • Indian Institute of Chemical
  31 per cent involved in bio-agri sectors                      Biological Seiences
                                                                                                                    Technology
                                                              • Jawaharlal Nehru Center for
                                                                                                                  • National Institute of Nutrition
                                                                Advanced Scientific Research
                                                                                                                  • Shapoorji Pallonji Biotech Park
                                                              • India Institute of Science
                                                                                                                  • ICIC Knowledge Parke
                                                              • Institute of Bioinformatics and
                                                                                                                  • Ticel Biotech Park
                                                                Applied Biotechnology




                                                                                                                                                     www.ibef.org
Bi ot e c h n o l o g y
 December 2008




Biotech clusters in india
Southern Region                                           Biotechnology Revenues by Regions
                                                                   Region         2006-07                  Share
• comprises of the Bangalore and hyderabad clusters                             (US$million)
                                                           North                     249                       12%
• Karnataka generated revenues of US$ 488 million,         South                     831                       40%

  showing with a 35 per cent growth                        West                      998                       48%
                                                           Total                    2,078                  100%
• hyderabad’s genome Valley comprises of the              Number may appear inconsistent because of rounding
  Shapoorji Pallonji Biotech Park and icici               Source: Biospectrum, July ‘07

  Knowledge Park




                                                                                                                    www.ibef.org
Bi ot e c h n o l o g y
 December 2008




Bio-pharmaceuticals
• top five players accounted for 45 per cent of the           top 5 Bio-pharma companies 2006
  biopharma market.                                                Company               Revenue            Per cent change
                                                                                     (US$ million 2006)       from 2005

• of the top 10 biopharma companies, seven were                Serum Institute of             231                   35.27
                                                               India

  vaccine players.                                             Biocon                         177                   20.73
                                                               Panacea Biotec                 146                   37.04
• largest contributor to the biotech industry revenues.        Novonordisk                    54                    26.86
                                                               Venkateshwara                  46                    N/A
• Recorded sales in excess of US$ 1.72 billion in 2007-        Hatcheries

  2008.                                                       Number may appear inconsistent because of rounding
                                                              Source: Biospectrum, July ‘07
• Accounted for 67 per cent of the total industry
  revenues, registering 16 per cent growth.                   Bio-pharma Sector-wise Revenues
                                                                   Sector            2006       2005       Change      Share in
                                                                                    (US$ m)    (US$ m)                  2006
                                                               Vaccines               743           570    30.41%           51%
                                                               Diagnostics            231           220    4.97%            16%
                                                               Therapeutics           176           156    13.28%           12%
                                                               Others                 303           200    51.46%           21%
                                                               Total                 1,453         1,146   26.87%           100%
                                                               Bio-pharma
                                                               Revenues

                                                              Number may appear inconsistent because of rounding
                                                              Source: Biospectrum, July ‘07




                                                                                                                                  www.ibef.org
Bi ot e c h n o l o g y
  December 2008




indian Biotech industry: current and future state


total revenue for indian biotech industry                                                2%
                                                                                 4%
total biotech revenues for Fy 2007-08 stood at US$
                                                                           12%
2493 million.
                                                                                                            67%
                                                                          15%

Forecast for indian biotech industry 2015

   Biopharma                                            6,030

  Bio-Services              1,374
                                                                      n Biopharma         n Bio-Services
       Bioagri                                                        n Bioagri           n Bioindustrial
                           1,050
                                                                      n Bioinformatics
 Bioindustrial       358

Bioinformatics       166


                 0   1,000 2,000 3,000 4,000 5,000 6,000 7,000
                                    US$ billion




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Bi ot e c h n o l o g y
 December 2008




Bio-pharma:Vaccines
• Vaccines account for 51 per cent of the bio-pharma             top 5 Vaccine companies 2006
  market with revenues of US$ 743 million                                          Company                       Revenue
                                                                                                             (US$ million 2006)
                                                                  Serum Institute of India                            231
• Serum institute is india’s leading vaccine company              Panacea Biotec                                      146
  with revenues of US$ 231 million                                Venkateshwara Hatcheries                            46
                                                                  Indian Immunologicals                               38
• india is one of the largest producers of traditional            GlaxoSmithKline                                     29
  vaccines, considered the “vaccine capital” of the world         Total Vaccines Market                               743

• hepatitis B vaccine market continues to exhibit                Number may appear inconsistent because of rounding
                                                                 Source: Biospectrum, July ‘07
  robust growth
• indian companies have also been focussing on
  under-served markets like hiV, and Japanese
  encephalitis and high-value combination vaccines




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Bi ot e c h n o l o g y
 December 2008




Bio-pharma: Diagnostics
• Diagnostics account for 16 per cent of the bio-               top 5 Diagnostics companies 2006-07
  pharma market with revenues of US$ 221 million                               Company                          Revenue
                                                                                                          (US$ million 2006-07)

• tulip is the leading diagnostics company in india with         Tulip                                              40
                                                                 TransAsia Biomedical                               37
  revenues of US$ 38 million                                     Bayer                                              18
                                                                 Span Diagnostics                                   13
• there are over 50 diagnostics companies in india               Becon Diagnostics                                   5
  including Mncs                                                 Others                                             118

• top companies have consolidated their market                   Total Revenues                                     231


  presence and are growing at 15 per cent to                    Number may appear inconsistent because of rounding off
                                                                Source : Biospectrum, July ‘07
  20 per cent
• Many diagnostics products in india are imported,
  but increase in local activity has made the market
  more competitive




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Bi ot e c h n o l o g y
 December 2008




Bio-pharma: therapeutics
• therapeutics generated revenues of US$ 176 million
  showing a growth of 13 per cent
• therapeutics remain the thrust in indian RD,
  with human insulin being the most common area
  of research
• huge biosimilars opportunity opening up for indian
  companies with regulatory approval pathways in
  europe and the US becoming clearer




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Bi ot e c h n o l o g y
 December 2008




Bio-pharma: therapeutics
Human Insulin
• largest contributor to the therapeutics market with
  revenues of US$ 88 million
• large opportunity for insulin manufacturers
• over 37.5 million people suffer from diabetes in india,
  thereby creating a huge prospect
• Mncs such as novo nordisk, eli lilly and Aventis
  Pasteur currently dominate the market
• novo nordisk is the market leader with revenues
  of US$ 54 million




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Bi ot e c h n o l o g y
 December 2008




Bio-pharma: therapeutics
Plasma Proteins
• Plasma proteins is an emerging market in india
• over 100,000 people in india suffer from haemophilia
  (25 per cent of the world’s haemophiliac population)
• india has been sourcing plasma proteins from Mncs
  such as Baxter
• there is Market potential for manufacturing plasma
  proteins locally and indigenously
• Reliance life Sciences is the first company to tap into
  the plasma protein market




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Bi ot e c h n o l o g y
 December 2008




Bio-pharma: therapeutics
Monoclonal Antibodies (mAbs)
• mAbs is a fast-growing market-especially in oncology
  and auto-immune diseases
• india has 3 million cancer patients and 700,000 new
  cases every year
• Biocon has an international collaboration on anti-
  egFR mAbs for head and neck cancer
• Serum institute has tied up with US-based Akorn for
  development and exclusive distribution rights for a
  rabies mAbs




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Bi ot e c h n o l o g y
 December 2008




Bio-services
• Bio-Services is the second largest contributor to the          top five Bio-services companies 2006-07
  industry with 15 per cent share of the industry.                              Company                         Revenue
                                                                                                          (US$ million 2006-07)

• it accounts for 26 per cent share of the total exports.         Syngene                                             38.0
                                                                  Quintiles                                           36.0

• Syngene is a leading company with revenues of                   Lambda                                              15.0
                                                                  Vimta Labs                                          13.9
  US$ 38 million and an impressive growth of
                                                                  Veeda                                               13.8
  71 per cent.                                                    Others                                              152.0

• More than 70 companies in india are involved in                 Total Revenues                                      268.0


  bio-services.                                                  Number may appear inconsistent because of rounding
                                                                 Source: Biospectrum, July ‘07
• global companies find india as the imperative
  destination for outsourcing services.
• india offers a US$ 1 billion opportunity in clinical
  trials alone.




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Bi ot e c h n o l o g y
 December 2008




Bio-services
GVK Biosciences  Drug Development Solutions
Drug Development Solutions (UK-based) has signed a
long-term agreement with gVK Bio for providing clinical
data management services for clinical trials


Bristol-Myers Squibb  Syngene
A research collaboration agreement has been signed
to enhance capabilities and service offering.




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Bi ot e c h n o l o g y
 December 2008




Bio-services
GlaxoSmithKline  Tata Consultancy Services
gSK signed a multi-million dollar contract with tcS
to establish an RD support center in Mumbai


Acunova Life Sciences  Kiecana Clinical
Research
KcR (Poland-based) formed a strategic regional alliance
with Acunova life Sciences for leveraging operations in
South Asia, europe and latin America.




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Bi ot e c h n o l o g y
 December 2008




Bio-agri
• Bio-agri generated revenues of US$ 280 million, and         top five Bio-agri companies 2006-07
  grew at the rate of 30 per cent.                                            Company                        Revenue
                                                                                                       (US$ million 2006-07)

• top three companies (Rasi Seeds, nuziveedu Seeds             Rasi Seeds                                          81
                                                               Nuziveedu Seeds                                     55
  and Mahyco) account for 72 per cent of the segment’s         Mahyco                                              27
  total revenues                                               Ankur Seeds                                         17
                                                               Biotech International                                6
• Bio-agri is driven primarily by Bt cotton seeds;             Others                                              39
  Bt cotton seeds market alone was estimated to                Total Revenues                                      225

  be worth US$ 203 million                                    Number may appear inconsistent because of rounding

                                                              Source: Biospectrum, July ‘07




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Bi ot e c h n o l o g y
 December 2008




Bio-agri
• india overtook china in total area under Bt cotton
  cultivation, i.e, 3.8 million hectares as opposed to
  china’s 3.5 million hectares in 2006-07
• 62 Bt cotton hybrids were approved for planting in
  2006 and 111 Bt cotton hybrids were approved for
  commercial cultivation by May 2007
• About 15 gM crop products are under development
  by both the public and private sectors




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Bi ot e c h n o l o g y
 December 2008




Bio-agri
Bio-diesel
• Bio-fuels in india are still in their infancy - about 66
  million gallons of ethanol is utilised in 10 indian states
• Domestic and foreign collaborations are expected to
  boost india’s bio-diesel production to 1 million tons
  per year in the next 2-3 years
• india has developed high-yielding varieties of
  jatropha seeds
• government has been testing bio-diesel in public
  transport locomotives and buses
• commercial bio-diesel production units have been set
  up by Southern online Biotechnologies and naturol
  Bioenergy ltd.
• Bio-diesel companies have collaborations with
  companies in the US and europe



                                                                  www.ibef.org
Bi ot e c h n o l o g y
 December 2008




Bio-agri
Bio-pesticides  Bio-fertilizers
• Bio-pesticides and bio-fertilizers estimated to have a
  combined market value of US$ 19.5 million in india
• Phosphate-solubilising micro-organisms market
  witnessed the most growth among biofertilizers
• leading players include Biotech international, excel,
  and Multiplex
• Many research universities and institutes pursuing
  research in bio-fertilizers, eg. University of hyderabad,
  national Research center for Plant Biotechnology etc.




                                                                 www.ibef.org
Bi ot e c h n o l o g y
 December 2008




Bioinformatics
• Bioinformatics is a US$ 35 million opportunity in india
  and is rapidly growing
• increasing number of investors are funding
  bioinformatics in india, eg. Kotak Mahindra Bank,
  international Financial corporation (iFc) etc.
• Department of Biotechnology (DBt) has taken
  initiatives to link 63 bioinformatics centers in india
  to promote networking of information resources




                                                               www.ibef.org
Bi ot e c h n o l o g y
 December 2008




Bioinformatics
Going Global
• international client base for indian bioinformatics
  companies has expanded rapidly
• indian companies cater to the national institute of
  health (nih), national institute for cellular Biology
  (Dublin), David eisenberg’s research lab at Doe
  institute for genomics and Proteomics, UclA etc.
• Pure play bioinformatics companies in india include
  players such as Strand life Sciences, ocimum
  Biosolutions, Molecular connections, Mascon life
  Sciences, etc.
• three main areas of opportunity are: integrated
  research application service providers, providers of
  database services and discovery software providers,
  and the software requirements of the biotech industry




                                                             www.ibef.org
Bi ot e c h n o l o g y
 December 2008




Bioinformatics
DNA Chips
• DnA chips market is valued at US$ one million,
  and will grow by 50 per cent by 2008.
• leading companies include Agilent technologies,
  Affymetrix and ocimum Biosolutions




                                                       www.ibef.org
Bi ot e c h n o l o g y
 December 2008




Bio-industrial
• Bioindustrial segment touched almost US$ 97 million        top five Bio-industrial companies 2006-07
  in 2007-2008 witnessing a growth of four per cent.                            Company                     Revenue
                                                                                                      (US$ million 2006-07)

• About 15 companies in india are involved in the             Novozymes                                           24
                                                              Biocon                                              23
  enzymes business                                            Advanced Enzymes                                    17
                                                              Rossari Biotech                                     16
• top five bio-industrial companies contributed
                                                              Zytex                                               4
  87 per cent of the segment’s market value                   Others                                              12

• novozymes is the segment leader with revenues               Total Revenues                                      96


  of US$ 24 million                                          Number may appear inconsistent because of rounding
                                                             Source: Biospectrum, July ‘07




                                                                                                                            www.ibef.org
Bi ot e c h n o l o g y
 December 2008




Bio-industrial
• novozymes and Biocon together make up 50 per cent
  of the bio-industrial revenues
• companies are focussing on new areas of application:
  such as food processing, agriculture, animal nutrition,
  dairy, aquaculture, marine etc.
• Many opportunities exist in india for manufacturing
  industrial for export purposes




                                                               www.ibef.org
Bi ot e c h n o l o g y
 December 2008




Key growth Drivers  trends
Pharmacos focus on biotechnology
• Major pharmacos are diversifying into biotech, eg.
  Ranbaxy, cadila healthcare, lupin, Wockhardt,
  Dr. Reddy’s(DRl) and intas
• DRl plans to establish recombinant proteins
  technology platform
• cadila healthcare plans to enter market by building a
  string pipeline of biopharmaceuticals in oncology and
  blood disorders




                                                             www.ibef.org
Bi ot e c h n o l o g y
 December 2008




Key growth Drivers  trends
Indian players expand their capacities to global
standards
• companies are putting efforts into upgrading facilities
  and capabilities to global standards for better access
  to partnerships
• Biocon plans to set up a new plant worth
  US$ 116 million in Visakhapatnam, Andhra Pradesh
• Reliance life Sciences (RlS) plans to invest
  US$ 219 million into four new facilities for
  home-grown clinical and generic products
• RlS also plans to set up a world-class clinical data
  Management center(cDM) in Bengaluru




                                                            0   www.ibef.org
Bi ot e c h n o l o g y
 December 2008




Key growth Drivers  trends
Direct investments from international
biotech firms
• Foreign companies increasingly making direct
  investments into indian biotech
• Avesthagen managed to raise around US$ 36 million
  from europe’s groupe Danone, groupe limagrain
  and two other strategic investors
• Shantha Bioetchnics ltd. will receive close to
  US$ 10 million from its majority French partner
  Merieux Alliance
• Amgen has opened a wholly-owned subsidiary, Amgen
  technology, in Mumbai




                                                      1   www.ibef.org
Bi ot e c h n o l o g y
 December 2008




Key growth Drivers  trends
Collaborations and alliances
• there is an unprecedented surge in partnering
  activity as a means to enter new markets and expand
  competencies and capacities
• RlS plans to acquire a 74 per cent stake in UK-based
  biotech company geneMedix for about
  US$ 31 million in 2007
• Syngene plans to enter into a research partnership
  with international pharma player Bristol-Myers Squibb
• DBt signed MoU with national Research council
  (nRc) in canada
• Panacea Biotec acquired a 10 per cent stake in
  UK-based cambridge Biostability limited (cBl) for
  over US$ 3.8 million




                                                             www.ibef.org
Bi ot e c h n o l o g y
 December 2008




Key growth Drivers  trends
Increasing government support for
biotechnology
• governments initiating various proactive reforms
  for the industry
• central government will provide biotechnology, all
  benefits and advantages that it industry currently has
• government is implementing a national
  Biotechnology Development Strategy (nBDS) and
  establishing a national Biotechnology Regulatory
  Authority (nBRA)
• DBt plans to invest US$52.5 million in
  RD in 2007-08
• increasing number of biotech parks




                                                              www.ibef.org
Bi ot e c h n o l o g y
 December 2008




Key growth Drivers  trends
Strengthening confidentiality and IP protection
• Roche india was first life sciences company in india
  to be granted a product patent for its drug Pegasys
• efforts to increase presence of judicial courts that
  deal with iP issues
• Patent applications can be submitted in four locations
  in india
• Strengthening iP has attracted international players
  to invest in the domestic market




                                                              www.ibef.org
Bi ot e c h n o l o g y
 December 2008




Key growth Drivers  trends
Increased biotech funding for the Indian market
• Various global and domestic financial institutions have
  shown interest in investing in biotech
• expected investments of US$ 730 million to
  US$ 850 million are expected over the next
  two years
• Reliance industries ltd. is partaking in the
  US$ 27 billion venture financing space in
  india through RlS
• international Finance corporation committed




                                                               www.ibef.org
Bi ot e c h n o l o g y
 December 2008




Key growth Drivers  trends
  equity of up to US$ 4 million to the APiDc
  Biotechnology Fund
Emerging areas: stem cells and nanotecnology
• Significant investments have been made in
  stem cell research
• the center for cellular and Molecular Biology
  (ccMB) has collaborations with Deccan Medical
  college (DMc) and Japan-based nichi-in center
• DBt is setting up a center for Stem cells; has been
  approved by the indian council to conduct india’s first
  ever multi-centric clinical trials with stem cells
• Dabur Pharma developed the country’s first
  indigenously developed nanotech-based chemotherapy
  agent; the first of its kind outside of USA




                                                               www.ibef.org
Bi ot e c h n o l o g y
 December 2008




Policy
Regulatory framework                                                                Government
                                                                                      of India

• government has established a multi-regulatory                     Department of                 Ministry of
  structure for gM crops and human health products                  Biotechnology                 Environment


• Key body under the Ministry of Science and                                                            Genetic
                                                                              Regulatory
                                                           Recombinant
                                                                                                        Engineering
                                                                              Committee On
                                                           DNA Appraisal
  technology is Department of Biotechnology (DBt)                                                       Approval
                                                                              Genetic Manipulation
                                                           Committee (RDAC)
                                                                                                        Committee (GEAC)
                                                                              (RCGM)


                                                                                Institutional Safety
                                                                                Committee (ISC)

                                                          Source: ABLE




                                                                                                                         www.ibef.org
Bi ot e c h n o l o g y
 December 2008




Policy
Natural Biotechnology Development Strategy                     Key features - Natural Biotechnology Development Strategy (NBDS)
                                                               A National Task Force to establish model academic curricula
(NBDS)                                                         Scaling up of proven technologies like diagnostics and vaccines; scaling up infrastructure for RD

• Developed by the government to ensure further                Establishing a Single Window Clearance
                                                               Financial support through incubator funds and incentives for RD
  industry growth; goal is an industry worth                   Small Business Innovation Research Initiative (SBIRI)

  US$ 5 billion by 2010                                        National Biotechnology Regulatory Authority (NBRA)
                                                               Biotechnology Parks




Budget 00-0
• no service tax for clinical services and RD of drugs
• Five-year extension on incentive for RD spend and
  150 per cent weighted average tax deduction
• no excise duty for life saving vaccines
• excise duty and sales tax exemption for bio-diesel
• tax benefits to Vcs investing in biotech




                                                                                                                                                                  www.ibef.org
Bi ot e c h n o l o g y
 December 2008




Key Players: india’s top biotech players
• top five companies contributed 35 per cent of the          top 10 companies 2006-07
  total industry revenues and all were home grown                      Company                  Revenue      Percentage
                                                                                              (US$million)    2005-06
• Mncs such as novo nordisk, Mahyco Monsanto                                                   2006-2007


  and gSK are among the top 10 biotech companies              Serum Institute of India Ltd.      231.4         35.27%
                                                              Biocon                             200.2         19.62%
• top three companies are involved in bio-pharma;             Panacea Biotec                     145.9         37.04%
                                                              Rasi Seeds                          81.1         7.70%
  fourth and fifth ranked companies are into bio-agri         Nuziveedu Seeds                     55.1        262.16%

• 16 of the top 20 companies had revenues over                Novo Nordisk                        54.0         26.86%
                                                              Venkateshwara Hatcheries            46.4          N/A
  US$ 24 million                                              Indian Immunologicals               38.4         54.50%
                                                              Mahyco Monsanto Biotech             36.6        - 61.58%
                                                              GlaxoSmithKline                     29.2         27.66%

                                                             Source: Compiled from industry sources, EY research




                                                                                                                        www.ibef.org
Bi ot e c h n o l o g y
 December 2008




Key players: india’s top biotech players
• top 30 home grown companies contributed
  US$ 1.05 billion in revenues (over 50 per cent
  of total revenues)
• Serum institute, Biocon and Panacea crossed the
  US$ 120 million mark in revenues
• Serum institute is the leading biotech player with
  revenues of over US$ 231 million and growth
  of 35 per cent




                                                       0   www.ibef.org
Bi ot e c h n o l o g y
 December 2008




Select foreign players
Novo Nordisk, India
• Present in india since 1990
• Bio-pharma company
• Diabetes care products, human growth hormone
  and haemostasis management
• launched levemir, a basal insulin analogue, in
  May 2006
• exclusive agreement with torrent Pharma
  for manufacturing insulin
• Distributorship alliance with Abbot india
• Agreement with tcS for offshore clinical
  operations service




                                                   1   www.ibef.org
Bi ot e c h n o l o g y
 December 2008




Select foreign players
GlaxoSmithKline, India
• Present in india since 2001
• Bio-pharma company
• Revenues: US$ 29 million
• Revenues: US$ 411.12 million (December 2007)
• one of the leaders in the indian vaccine market
• Set up vaccines facility in nasik
• About to launch a cardiovascular drug
• in discussions with Japanese and American companies
  for launching of other products
• identified 6 oncology centers for conducting
  clinical trials




                                                           www.ibef.org
Bi ot e c h n o l o g y
 December 2008




Select foreign players
Quintiles Spectral, India
• Present in india since 1997
• Bio-services company
• Second largest provider of bio-services in india
• conducting studies in various therapeutic areas
• offers a full portfolio of services for Phase i-iV
  clinical studies
• has clinical research collaborations with Manipal
  group Alliance




                                                          www.ibef.org
Bi ot e c h n o l o g y
 December 2008




Select foreign flayers
Novozymes South Asia
• Present in india since 2000
• Bio-industrial company
• Sells more than 600 products in 130 countries
• Building new laboratory/office space in india
• establishing RD operations in india soon
• novozyme’s enzymes play a significant role in food,
  textile, cleaning and wastewater treatment




                                                           www.ibef.org
Bi ot e c h n o l o g y
 December 2008




Select domestic players
Serum Institute
• established in 1966
• Bio-pharma company
• launched hiB vaccine
• involved with global organisation in conducting
  clinical trials for meningitis vaccine
• Bought stake in UK-based lipoxen
• entered into agreement US-based Akorn
• growth of 39 per cent in 2007-2008
• top bio-agri company in india in 2007-2008 beating
  last year’s winner Rasi Seeds.
• Sales of US$ 246 million in 2007-2008




                                                          www.ibef.org
Bi ot e c h n o l o g y
 December 2008




Select domestic players
Biocon
• established in 1978
• Diversified biotech company
• Wide range of products across key therapeutic
  segments: diabetology, cardiology and oncology
• Syngene entered into research partnership with
  Bristol-Myers Squibb
• Developing nasulin with Bentley Pharmaceuticals
• Signed an MoU with Abu Dhabi’s nMc group
• launched BioMAb-egFR for head/neck tumors
• launched a comprehensive portfolio of renal therapy
  products
• Recorded revenues of US$ 228 million in 2007-2008




                                                           www.ibef.org
Bi ot e c h n o l o g y
 December 2008




Select domestic players
Panacea Biotec
• established in 1984
• Bio-pharma company
• Received first supply order from Who in 2007
• entered into collaboration with netherlands Vaccines
  institute for iPV vaccine in 2006
• entered into collaboration with Pt. Bio Farma,
  indonesia for measles vaccine in 2006
• Acquired a 10 per cent stake in cambridge Biostability
• Planned joint venture with novartis Vaccines
• Planning launch of Polprotec in india and overseas
• Revenue of US$ 169 million in 2007-2008




                                                              www.ibef.org
Bi ot e c h n o l o g y
 December 2008




Select domestic players
Rasi Seeds
• established in 1973
• Bio-agri company
• company provides seeds of various crops
• Undertaken field trials and large scale trials
  of Bt cotton
• top notch marketing network all over india and two
  production centers
• entered contract farming with an elS cotton hybrid
• generated sales of US$ 73.5 million in 2007-2008.




                                                          www.ibef.org
Bi ot e c h n o l o g y
 December 2008




Select domestic players
Nuziveedu Seeds
• established in 1973
• Bio-agri company
• commercially released two Bt hybrid varieties
• Working on indigenous transgene to combat
  bollworms
• has 15 cotton hybrids in pipeline
• Signed an MoU with tamil nadu industrial
  Development corporation (tiDco) to establish
  a biotech/it SeZ near chennai
• generated sales of US$ 75.75 million in 2007-2008.




                                                          www.ibef.org
Bi ot e c h n o l o g y
 December 2008




highlights of 2008
Collaborations and acquisitions
• Biocon acquired 70 per cent stake in german
  pharmaceutical company, Axicorp for approximately
  US$ 43.5 million.
• Albany Molecular Research inc. (AMRi) bought
  FineKem laboratories, a manufacturing facility located
  in Aurangabad.
• ocimum Biosolutions announced an equity
  investment of up to US$ 17 million for the acquisition
  of the genomics division of gene logic.




                                                           0   www.ibef.org
Bi ot e c h n o l o g y
 December 2008




highlights of 2008
Union budget 00-00
• Reduction of cenvat to 8.24 per cent
• 12.5 per cent weighted deduction to outsourced
  research
• Reduction in customs duty on raw materials for eliSA
  kits to 18.72 per cent, select vaccines, and select bio-
  therapeutics to 9.36 per cent.
• Allocation of US$ 242 million for the national AiDS
  programme.
• excise duty rate reduced to eight per cent.




                                                             1   www.ibef.org
Bi ot e c h n o l o g y
 December 2008




Advantage india
Low cost Operations                                              Some Bioscience related indian institutions
                                                                          Institution Name                     Area of focus
• RD costs in india significantly lower; outsourcing             National Center for Biological        Biochemistry, Bioinformatics 
  to india can save up to US$ 200 million                         Sciences                              Genetics
                                                                  Jawaharlal Nehru Institute for        Molecular and Chemical

• cost of clinical trials 50 per cent lower in Phase              advanced Scientific Research          Biology  Genetics
                                                                  National Institute of Immunology      Immunology
  i and 60 per cent lower in Phase ii compared to                 Institute of Genomics  Integrative   Genomics, Genome
  global markets                                                  Biology                               Informatics and Proteomics
                                                                  International Centre for Genetic      Molecular Biology 

• clinical trials take significantly lesser time in india         Engineering and Biotechnology         Biotechnology
                                                                  Centre for Cellular  Molecular       Bioinformatic  Genetics
                                                                  Biology
                                                                  Centre for DNA Fingerprinting        Computational Biology and
                                                                  Diagnostics                           Bioinformatics
                                                                  Central Drug Research Institute       Drug Discovery  Regulatory
                                                                                                        studies




                                                                                                                                       www.ibef.org
Bi ot e c h n o l o g y
 December 2008




Advantage india
Large Human Resource Pool
• higher education in the sciences is india’s forte.
• 5000 PhDs and 1000 post-docs in biosciences-related
  fields
• numerous top-notch life science education and
  research institutes


Favorable IP Climate
• Adherence to the tRiPS agreement with regard to
  the Patent Protection Act implemented in 2005 has
  increased the confidence of innovator companies
  in india




                                                           www.ibef.org
Bi ot e c h n o l o g y
 December 2008




                                                   DiSclAiMeR
this publication has been prepared by india Brand                 this publication is for information purposes only. While
equity Foundation (“iBeF”).                                       due care has been taken during the compilation of this
                                                                  publication to ensure that the information is accurate
All rights reserved. All copyright in this publication and
                                                                  to the best of knowledge and belief of iBeF, the content
related works are owned by iBeF.
                                                                  is not to be construed in any manner whatsoever as a
the same may not be reproduced, wholly or in part in              substitute for professional advice.
any material form (including photocopying or storing
                                                                  iBeF neither recommends nor endorses any specific
it in any medium by electronic means and whether or
                                                                  products or services that may have been mentioned in
not transiently or incidentally to some other use of this
                                                                  this publication and nor does it assume any liability or
publication), modified or in any manner communicated
                                                                  responsibility for the outcome of decisions taken as a
to any third party except with the written approval of
                                                                  result of any reliance placed on this publication.
iBeF.
                                                                  iBeF shall in no way, be liable for any direct or indirect
                                                                  damages that may arise due to any act or omission
                                                                  on the part of the user due to any reliance placed or
                                                                  guidance taken from any portion of this publication.



www.ibef.org

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Indian Biotech Industry Presentation 010709

  • 1. Biot e c h n o l o g y Biotechnology 2008 B i ot e c h n o l o g y December 2008 www.ibef.org
  • 2. Bi ot e c h n o l o g y December 2008 Market overview • indian biotech industry contributes to two per cent Share of companies involved in each biotech segment 2006-2007 of the global biotech industry. • the sector grew at a healthy 20 per cent in 5% 2007-2008. 14% • the industry in 2007-2008 clocked US$ 2.5 billion registering a 30.98 per cent growth 40% 19% • growth has been mainly fuelled by rise in domestic business, exports, M&A and, new product innovations. 21% n Bio-pharma n Bio-services n Bio-agri n Bioinformatics n Bio-industrial Sourc: Biospectrum June ‘07 www.ibef.org
  • 3. Bi ot e c h n o l o g y December 2008 Market overview • the sector employs approximately 20,000 scientists, Biotech industry Revenues and over 325 companies drive it towards further Segment Revenue Contribution (US$ million) (per cent) growth Bio-pharma 1683 67 Bio-services 383 15 • india is among top 12 biotech markets globally. Bio-agri 293 12 Bio-industrial 100 4 • india ranks third in the Asia-Pacific, after Japan and Bioinformatics 46 2 Korea. • indian market is expected to touch US$ 5 billion by 2010 and US$ 25 billion by 2015. www.ibef.org
  • 4. Bi ot e c h n o l o g y December 2008 Biotech industry 2002-2007 Biotech industry 2002-2007 (US$ million) 2007-08 293 100 46 1683 383 2006-07 1457 269 226 96 35 2005-06 1148 176 146 91 29 2004-05 871 104 80 78 24 2003-04 671 67 32 58 20 2002-03 437 33 27 57 18 n Biopharma n Bio-Services n Bioagri n Bioindustrial n Bioinformatics Source: Biospectrum 2007-2008 www.ibef.org
  • 5. Bi ot e c h n o l o g y December 2008 exports • Biotech exports alone generated Biotechnology Sector exports from india 2007-2008 (US$ million) US$ 1.2 billion, i.e., 58 per cent of total Segment Revenue biotech revenues Bio-pharma 1683 • Bio-pharma exports accounted for over 70 per cent Bio-services 383 of the total industry, while bio-services sector had 26 Bio-agri 293 per cent share in exports*. Bio-industrial 100 Bioinformatics 46 Biotech industry: exports vs domestic sales 2007-2008 ** Biopharma 975 707 Bio-Services 336 17 Bioagri 12 280 Bioindustrial 7 93 Bioinfoematics 37 10 0 200 400 600 800 1000 1200 1400 1600 1800 US$ million n exports n Domestic * ABLE-Biospectrum Survey 2007-2008 **Numbers may appear inconsistent because of rounding off. www.ibef.org
  • 6. Bi ot e c h n o l o g y December 2008 Share of different segments in export and domestic sales 2007-2008 Percentage share in export sales Percentage share in domestic sales 2%1% 2% 1%1% 8% 26% 64% 25% 70% n Biopharma n Bio-Services n Biopharma n Bioagri n Bioagri n Bioindustrial n Bioinformatics n Bioindustrial n Bio-Services n Bioinformatics Source: Biospectrum 2007-2008 www.ibef.org
  • 7. Bi ot e c h n o l o g y December 2008 Biotech clusters in india india’s main bio-clusters are located in Bangalore, • Department of Biotechnology • Center for Biotechnology hyderabad, Pune-Mumbai and Ahmedabad-Vadodara • The National Institute of Immunology • Food biotech park (proposed) • Institute of Genomics Interative Biology • National Brain Research Centre Panjab • National Centre for Plant Genome Haryana • Food biotech park Research (proposed) Western Region New Delhi Lucknow • comprises the Pune-Mumbai and Ahmedabad- Vadodhara • Food biotech park (proposed) • Savli biotech Park • Central Drug Research Institute Vadodara clusters (proposed) Kolkata • India Institute of • Tata Institute of Mumbai • Accounted for 48 per cent of india’s biotech business Chemical Biology Fundamental Research • National Chemical with revenues of US$ 998 million Hyderabad Laboratory Pune • Center for Cellular Molecular • National Center Biology for Cell Sciences • 44 per cent of companies are involved in bio-pharma; • Center for DNA Fingerprinting • Hinjewadi Biotech Park Diagnostics • National Center for Bengaluru • Indian Institute of Chemical 31 per cent involved in bio-agri sectors Biological Seiences Technology • Jawaharlal Nehru Center for • National Institute of Nutrition Advanced Scientific Research • Shapoorji Pallonji Biotech Park • India Institute of Science • ICIC Knowledge Parke • Institute of Bioinformatics and • Ticel Biotech Park Applied Biotechnology www.ibef.org
  • 8. Bi ot e c h n o l o g y December 2008 Biotech clusters in india Southern Region Biotechnology Revenues by Regions Region 2006-07 Share • comprises of the Bangalore and hyderabad clusters (US$million) North 249 12% • Karnataka generated revenues of US$ 488 million, South 831 40% showing with a 35 per cent growth West 998 48% Total 2,078 100% • hyderabad’s genome Valley comprises of the Number may appear inconsistent because of rounding Shapoorji Pallonji Biotech Park and icici Source: Biospectrum, July ‘07 Knowledge Park www.ibef.org
  • 9. Bi ot e c h n o l o g y December 2008 Bio-pharmaceuticals • top five players accounted for 45 per cent of the top 5 Bio-pharma companies 2006 biopharma market. Company Revenue Per cent change (US$ million 2006) from 2005 • of the top 10 biopharma companies, seven were Serum Institute of 231 35.27 India vaccine players. Biocon 177 20.73 Panacea Biotec 146 37.04 • largest contributor to the biotech industry revenues. Novonordisk 54 26.86 Venkateshwara 46 N/A • Recorded sales in excess of US$ 1.72 billion in 2007- Hatcheries 2008. Number may appear inconsistent because of rounding Source: Biospectrum, July ‘07 • Accounted for 67 per cent of the total industry revenues, registering 16 per cent growth. Bio-pharma Sector-wise Revenues Sector 2006 2005 Change Share in (US$ m) (US$ m) 2006 Vaccines 743 570 30.41% 51% Diagnostics 231 220 4.97% 16% Therapeutics 176 156 13.28% 12% Others 303 200 51.46% 21% Total 1,453 1,146 26.87% 100% Bio-pharma Revenues Number may appear inconsistent because of rounding Source: Biospectrum, July ‘07 www.ibef.org
  • 10. Bi ot e c h n o l o g y December 2008 indian Biotech industry: current and future state total revenue for indian biotech industry 2% 4% total biotech revenues for Fy 2007-08 stood at US$ 12% 2493 million. 67% 15% Forecast for indian biotech industry 2015 Biopharma 6,030 Bio-Services 1,374 n Biopharma n Bio-Services Bioagri n Bioagri n Bioindustrial 1,050 n Bioinformatics Bioindustrial 358 Bioinformatics 166 0 1,000 2,000 3,000 4,000 5,000 6,000 7,000 US$ billion 10 www.ibef.org
  • 11. Bi ot e c h n o l o g y December 2008 Bio-pharma:Vaccines • Vaccines account for 51 per cent of the bio-pharma top 5 Vaccine companies 2006 market with revenues of US$ 743 million Company Revenue (US$ million 2006) Serum Institute of India 231 • Serum institute is india’s leading vaccine company Panacea Biotec 146 with revenues of US$ 231 million Venkateshwara Hatcheries 46 Indian Immunologicals 38 • india is one of the largest producers of traditional GlaxoSmithKline 29 vaccines, considered the “vaccine capital” of the world Total Vaccines Market 743 • hepatitis B vaccine market continues to exhibit Number may appear inconsistent because of rounding Source: Biospectrum, July ‘07 robust growth • indian companies have also been focussing on under-served markets like hiV, and Japanese encephalitis and high-value combination vaccines 11 www.ibef.org
  • 12. Bi ot e c h n o l o g y December 2008 Bio-pharma: Diagnostics • Diagnostics account for 16 per cent of the bio- top 5 Diagnostics companies 2006-07 pharma market with revenues of US$ 221 million Company Revenue (US$ million 2006-07) • tulip is the leading diagnostics company in india with Tulip 40 TransAsia Biomedical 37 revenues of US$ 38 million Bayer 18 Span Diagnostics 13 • there are over 50 diagnostics companies in india Becon Diagnostics 5 including Mncs Others 118 • top companies have consolidated their market Total Revenues 231 presence and are growing at 15 per cent to Number may appear inconsistent because of rounding off Source : Biospectrum, July ‘07 20 per cent • Many diagnostics products in india are imported, but increase in local activity has made the market more competitive 1 www.ibef.org
  • 13. Bi ot e c h n o l o g y December 2008 Bio-pharma: therapeutics • therapeutics generated revenues of US$ 176 million showing a growth of 13 per cent • therapeutics remain the thrust in indian RD, with human insulin being the most common area of research • huge biosimilars opportunity opening up for indian companies with regulatory approval pathways in europe and the US becoming clearer 1 www.ibef.org
  • 14. Bi ot e c h n o l o g y December 2008 Bio-pharma: therapeutics Human Insulin • largest contributor to the therapeutics market with revenues of US$ 88 million • large opportunity for insulin manufacturers • over 37.5 million people suffer from diabetes in india, thereby creating a huge prospect • Mncs such as novo nordisk, eli lilly and Aventis Pasteur currently dominate the market • novo nordisk is the market leader with revenues of US$ 54 million 1 www.ibef.org
  • 15. Bi ot e c h n o l o g y December 2008 Bio-pharma: therapeutics Plasma Proteins • Plasma proteins is an emerging market in india • over 100,000 people in india suffer from haemophilia (25 per cent of the world’s haemophiliac population) • india has been sourcing plasma proteins from Mncs such as Baxter • there is Market potential for manufacturing plasma proteins locally and indigenously • Reliance life Sciences is the first company to tap into the plasma protein market 1 www.ibef.org
  • 16. Bi ot e c h n o l o g y December 2008 Bio-pharma: therapeutics Monoclonal Antibodies (mAbs) • mAbs is a fast-growing market-especially in oncology and auto-immune diseases • india has 3 million cancer patients and 700,000 new cases every year • Biocon has an international collaboration on anti- egFR mAbs for head and neck cancer • Serum institute has tied up with US-based Akorn for development and exclusive distribution rights for a rabies mAbs 1 www.ibef.org
  • 17. Bi ot e c h n o l o g y December 2008 Bio-services • Bio-Services is the second largest contributor to the top five Bio-services companies 2006-07 industry with 15 per cent share of the industry. Company Revenue (US$ million 2006-07) • it accounts for 26 per cent share of the total exports. Syngene 38.0 Quintiles 36.0 • Syngene is a leading company with revenues of Lambda 15.0 Vimta Labs 13.9 US$ 38 million and an impressive growth of Veeda 13.8 71 per cent. Others 152.0 • More than 70 companies in india are involved in Total Revenues 268.0 bio-services. Number may appear inconsistent because of rounding Source: Biospectrum, July ‘07 • global companies find india as the imperative destination for outsourcing services. • india offers a US$ 1 billion opportunity in clinical trials alone. 1 www.ibef.org
  • 18. Bi ot e c h n o l o g y December 2008 Bio-services GVK Biosciences Drug Development Solutions Drug Development Solutions (UK-based) has signed a long-term agreement with gVK Bio for providing clinical data management services for clinical trials Bristol-Myers Squibb Syngene A research collaboration agreement has been signed to enhance capabilities and service offering. 1 www.ibef.org
  • 19. Bi ot e c h n o l o g y December 2008 Bio-services GlaxoSmithKline Tata Consultancy Services gSK signed a multi-million dollar contract with tcS to establish an RD support center in Mumbai Acunova Life Sciences Kiecana Clinical Research KcR (Poland-based) formed a strategic regional alliance with Acunova life Sciences for leveraging operations in South Asia, europe and latin America. 1 www.ibef.org
  • 20. Bi ot e c h n o l o g y December 2008 Bio-agri • Bio-agri generated revenues of US$ 280 million, and top five Bio-agri companies 2006-07 grew at the rate of 30 per cent. Company Revenue (US$ million 2006-07) • top three companies (Rasi Seeds, nuziveedu Seeds Rasi Seeds 81 Nuziveedu Seeds 55 and Mahyco) account for 72 per cent of the segment’s Mahyco 27 total revenues Ankur Seeds 17 Biotech International 6 • Bio-agri is driven primarily by Bt cotton seeds; Others 39 Bt cotton seeds market alone was estimated to Total Revenues 225 be worth US$ 203 million Number may appear inconsistent because of rounding Source: Biospectrum, July ‘07 0 www.ibef.org
  • 21. Bi ot e c h n o l o g y December 2008 Bio-agri • india overtook china in total area under Bt cotton cultivation, i.e, 3.8 million hectares as opposed to china’s 3.5 million hectares in 2006-07 • 62 Bt cotton hybrids were approved for planting in 2006 and 111 Bt cotton hybrids were approved for commercial cultivation by May 2007 • About 15 gM crop products are under development by both the public and private sectors 1 www.ibef.org
  • 22. Bi ot e c h n o l o g y December 2008 Bio-agri Bio-diesel • Bio-fuels in india are still in their infancy - about 66 million gallons of ethanol is utilised in 10 indian states • Domestic and foreign collaborations are expected to boost india’s bio-diesel production to 1 million tons per year in the next 2-3 years • india has developed high-yielding varieties of jatropha seeds • government has been testing bio-diesel in public transport locomotives and buses • commercial bio-diesel production units have been set up by Southern online Biotechnologies and naturol Bioenergy ltd. • Bio-diesel companies have collaborations with companies in the US and europe www.ibef.org
  • 23. Bi ot e c h n o l o g y December 2008 Bio-agri Bio-pesticides Bio-fertilizers • Bio-pesticides and bio-fertilizers estimated to have a combined market value of US$ 19.5 million in india • Phosphate-solubilising micro-organisms market witnessed the most growth among biofertilizers • leading players include Biotech international, excel, and Multiplex • Many research universities and institutes pursuing research in bio-fertilizers, eg. University of hyderabad, national Research center for Plant Biotechnology etc. www.ibef.org
  • 24. Bi ot e c h n o l o g y December 2008 Bioinformatics • Bioinformatics is a US$ 35 million opportunity in india and is rapidly growing • increasing number of investors are funding bioinformatics in india, eg. Kotak Mahindra Bank, international Financial corporation (iFc) etc. • Department of Biotechnology (DBt) has taken initiatives to link 63 bioinformatics centers in india to promote networking of information resources www.ibef.org
  • 25. Bi ot e c h n o l o g y December 2008 Bioinformatics Going Global • international client base for indian bioinformatics companies has expanded rapidly • indian companies cater to the national institute of health (nih), national institute for cellular Biology (Dublin), David eisenberg’s research lab at Doe institute for genomics and Proteomics, UclA etc. • Pure play bioinformatics companies in india include players such as Strand life Sciences, ocimum Biosolutions, Molecular connections, Mascon life Sciences, etc. • three main areas of opportunity are: integrated research application service providers, providers of database services and discovery software providers, and the software requirements of the biotech industry www.ibef.org
  • 26. Bi ot e c h n o l o g y December 2008 Bioinformatics DNA Chips • DnA chips market is valued at US$ one million, and will grow by 50 per cent by 2008. • leading companies include Agilent technologies, Affymetrix and ocimum Biosolutions www.ibef.org
  • 27. Bi ot e c h n o l o g y December 2008 Bio-industrial • Bioindustrial segment touched almost US$ 97 million top five Bio-industrial companies 2006-07 in 2007-2008 witnessing a growth of four per cent. Company Revenue (US$ million 2006-07) • About 15 companies in india are involved in the Novozymes 24 Biocon 23 enzymes business Advanced Enzymes 17 Rossari Biotech 16 • top five bio-industrial companies contributed Zytex 4 87 per cent of the segment’s market value Others 12 • novozymes is the segment leader with revenues Total Revenues 96 of US$ 24 million Number may appear inconsistent because of rounding Source: Biospectrum, July ‘07 www.ibef.org
  • 28. Bi ot e c h n o l o g y December 2008 Bio-industrial • novozymes and Biocon together make up 50 per cent of the bio-industrial revenues • companies are focussing on new areas of application: such as food processing, agriculture, animal nutrition, dairy, aquaculture, marine etc. • Many opportunities exist in india for manufacturing industrial for export purposes www.ibef.org
  • 29. Bi ot e c h n o l o g y December 2008 Key growth Drivers trends Pharmacos focus on biotechnology • Major pharmacos are diversifying into biotech, eg. Ranbaxy, cadila healthcare, lupin, Wockhardt, Dr. Reddy’s(DRl) and intas • DRl plans to establish recombinant proteins technology platform • cadila healthcare plans to enter market by building a string pipeline of biopharmaceuticals in oncology and blood disorders www.ibef.org
  • 30. Bi ot e c h n o l o g y December 2008 Key growth Drivers trends Indian players expand their capacities to global standards • companies are putting efforts into upgrading facilities and capabilities to global standards for better access to partnerships • Biocon plans to set up a new plant worth US$ 116 million in Visakhapatnam, Andhra Pradesh • Reliance life Sciences (RlS) plans to invest US$ 219 million into four new facilities for home-grown clinical and generic products • RlS also plans to set up a world-class clinical data Management center(cDM) in Bengaluru 0 www.ibef.org
  • 31. Bi ot e c h n o l o g y December 2008 Key growth Drivers trends Direct investments from international biotech firms • Foreign companies increasingly making direct investments into indian biotech • Avesthagen managed to raise around US$ 36 million from europe’s groupe Danone, groupe limagrain and two other strategic investors • Shantha Bioetchnics ltd. will receive close to US$ 10 million from its majority French partner Merieux Alliance • Amgen has opened a wholly-owned subsidiary, Amgen technology, in Mumbai 1 www.ibef.org
  • 32. Bi ot e c h n o l o g y December 2008 Key growth Drivers trends Collaborations and alliances • there is an unprecedented surge in partnering activity as a means to enter new markets and expand competencies and capacities • RlS plans to acquire a 74 per cent stake in UK-based biotech company geneMedix for about US$ 31 million in 2007 • Syngene plans to enter into a research partnership with international pharma player Bristol-Myers Squibb • DBt signed MoU with national Research council (nRc) in canada • Panacea Biotec acquired a 10 per cent stake in UK-based cambridge Biostability limited (cBl) for over US$ 3.8 million www.ibef.org
  • 33. Bi ot e c h n o l o g y December 2008 Key growth Drivers trends Increasing government support for biotechnology • governments initiating various proactive reforms for the industry • central government will provide biotechnology, all benefits and advantages that it industry currently has • government is implementing a national Biotechnology Development Strategy (nBDS) and establishing a national Biotechnology Regulatory Authority (nBRA) • DBt plans to invest US$52.5 million in RD in 2007-08 • increasing number of biotech parks www.ibef.org
  • 34. Bi ot e c h n o l o g y December 2008 Key growth Drivers trends Strengthening confidentiality and IP protection • Roche india was first life sciences company in india to be granted a product patent for its drug Pegasys • efforts to increase presence of judicial courts that deal with iP issues • Patent applications can be submitted in four locations in india • Strengthening iP has attracted international players to invest in the domestic market www.ibef.org
  • 35. Bi ot e c h n o l o g y December 2008 Key growth Drivers trends Increased biotech funding for the Indian market • Various global and domestic financial institutions have shown interest in investing in biotech • expected investments of US$ 730 million to US$ 850 million are expected over the next two years • Reliance industries ltd. is partaking in the US$ 27 billion venture financing space in india through RlS • international Finance corporation committed www.ibef.org
  • 36. Bi ot e c h n o l o g y December 2008 Key growth Drivers trends equity of up to US$ 4 million to the APiDc Biotechnology Fund Emerging areas: stem cells and nanotecnology • Significant investments have been made in stem cell research • the center for cellular and Molecular Biology (ccMB) has collaborations with Deccan Medical college (DMc) and Japan-based nichi-in center • DBt is setting up a center for Stem cells; has been approved by the indian council to conduct india’s first ever multi-centric clinical trials with stem cells • Dabur Pharma developed the country’s first indigenously developed nanotech-based chemotherapy agent; the first of its kind outside of USA www.ibef.org
  • 37. Bi ot e c h n o l o g y December 2008 Policy Regulatory framework Government of India • government has established a multi-regulatory Department of Ministry of structure for gM crops and human health products Biotechnology Environment • Key body under the Ministry of Science and Genetic Regulatory Recombinant Engineering Committee On DNA Appraisal technology is Department of Biotechnology (DBt) Approval Genetic Manipulation Committee (RDAC) Committee (GEAC) (RCGM) Institutional Safety Committee (ISC) Source: ABLE www.ibef.org
  • 38. Bi ot e c h n o l o g y December 2008 Policy Natural Biotechnology Development Strategy Key features - Natural Biotechnology Development Strategy (NBDS) A National Task Force to establish model academic curricula (NBDS) Scaling up of proven technologies like diagnostics and vaccines; scaling up infrastructure for RD • Developed by the government to ensure further Establishing a Single Window Clearance Financial support through incubator funds and incentives for RD industry growth; goal is an industry worth Small Business Innovation Research Initiative (SBIRI) US$ 5 billion by 2010 National Biotechnology Regulatory Authority (NBRA) Biotechnology Parks Budget 00-0 • no service tax for clinical services and RD of drugs • Five-year extension on incentive for RD spend and 150 per cent weighted average tax deduction • no excise duty for life saving vaccines • excise duty and sales tax exemption for bio-diesel • tax benefits to Vcs investing in biotech www.ibef.org
  • 39. Bi ot e c h n o l o g y December 2008 Key Players: india’s top biotech players • top five companies contributed 35 per cent of the top 10 companies 2006-07 total industry revenues and all were home grown Company Revenue Percentage (US$million) 2005-06 • Mncs such as novo nordisk, Mahyco Monsanto 2006-2007 and gSK are among the top 10 biotech companies Serum Institute of India Ltd. 231.4 35.27% Biocon 200.2 19.62% • top three companies are involved in bio-pharma; Panacea Biotec 145.9 37.04% Rasi Seeds 81.1 7.70% fourth and fifth ranked companies are into bio-agri Nuziveedu Seeds 55.1 262.16% • 16 of the top 20 companies had revenues over Novo Nordisk 54.0 26.86% Venkateshwara Hatcheries 46.4 N/A US$ 24 million Indian Immunologicals 38.4 54.50% Mahyco Monsanto Biotech 36.6 - 61.58% GlaxoSmithKline 29.2 27.66% Source: Compiled from industry sources, EY research www.ibef.org
  • 40. Bi ot e c h n o l o g y December 2008 Key players: india’s top biotech players • top 30 home grown companies contributed US$ 1.05 billion in revenues (over 50 per cent of total revenues) • Serum institute, Biocon and Panacea crossed the US$ 120 million mark in revenues • Serum institute is the leading biotech player with revenues of over US$ 231 million and growth of 35 per cent 0 www.ibef.org
  • 41. Bi ot e c h n o l o g y December 2008 Select foreign players Novo Nordisk, India • Present in india since 1990 • Bio-pharma company • Diabetes care products, human growth hormone and haemostasis management • launched levemir, a basal insulin analogue, in May 2006 • exclusive agreement with torrent Pharma for manufacturing insulin • Distributorship alliance with Abbot india • Agreement with tcS for offshore clinical operations service 1 www.ibef.org
  • 42. Bi ot e c h n o l o g y December 2008 Select foreign players GlaxoSmithKline, India • Present in india since 2001 • Bio-pharma company • Revenues: US$ 29 million • Revenues: US$ 411.12 million (December 2007) • one of the leaders in the indian vaccine market • Set up vaccines facility in nasik • About to launch a cardiovascular drug • in discussions with Japanese and American companies for launching of other products • identified 6 oncology centers for conducting clinical trials www.ibef.org
  • 43. Bi ot e c h n o l o g y December 2008 Select foreign players Quintiles Spectral, India • Present in india since 1997 • Bio-services company • Second largest provider of bio-services in india • conducting studies in various therapeutic areas • offers a full portfolio of services for Phase i-iV clinical studies • has clinical research collaborations with Manipal group Alliance www.ibef.org
  • 44. Bi ot e c h n o l o g y December 2008 Select foreign flayers Novozymes South Asia • Present in india since 2000 • Bio-industrial company • Sells more than 600 products in 130 countries • Building new laboratory/office space in india • establishing RD operations in india soon • novozyme’s enzymes play a significant role in food, textile, cleaning and wastewater treatment www.ibef.org
  • 45. Bi ot e c h n o l o g y December 2008 Select domestic players Serum Institute • established in 1966 • Bio-pharma company • launched hiB vaccine • involved with global organisation in conducting clinical trials for meningitis vaccine • Bought stake in UK-based lipoxen • entered into agreement US-based Akorn • growth of 39 per cent in 2007-2008 • top bio-agri company in india in 2007-2008 beating last year’s winner Rasi Seeds. • Sales of US$ 246 million in 2007-2008 www.ibef.org
  • 46. Bi ot e c h n o l o g y December 2008 Select domestic players Biocon • established in 1978 • Diversified biotech company • Wide range of products across key therapeutic segments: diabetology, cardiology and oncology • Syngene entered into research partnership with Bristol-Myers Squibb • Developing nasulin with Bentley Pharmaceuticals • Signed an MoU with Abu Dhabi’s nMc group • launched BioMAb-egFR for head/neck tumors • launched a comprehensive portfolio of renal therapy products • Recorded revenues of US$ 228 million in 2007-2008 www.ibef.org
  • 47. Bi ot e c h n o l o g y December 2008 Select domestic players Panacea Biotec • established in 1984 • Bio-pharma company • Received first supply order from Who in 2007 • entered into collaboration with netherlands Vaccines institute for iPV vaccine in 2006 • entered into collaboration with Pt. Bio Farma, indonesia for measles vaccine in 2006 • Acquired a 10 per cent stake in cambridge Biostability • Planned joint venture with novartis Vaccines • Planning launch of Polprotec in india and overseas • Revenue of US$ 169 million in 2007-2008 www.ibef.org
  • 48. Bi ot e c h n o l o g y December 2008 Select domestic players Rasi Seeds • established in 1973 • Bio-agri company • company provides seeds of various crops • Undertaken field trials and large scale trials of Bt cotton • top notch marketing network all over india and two production centers • entered contract farming with an elS cotton hybrid • generated sales of US$ 73.5 million in 2007-2008. www.ibef.org
  • 49. Bi ot e c h n o l o g y December 2008 Select domestic players Nuziveedu Seeds • established in 1973 • Bio-agri company • commercially released two Bt hybrid varieties • Working on indigenous transgene to combat bollworms • has 15 cotton hybrids in pipeline • Signed an MoU with tamil nadu industrial Development corporation (tiDco) to establish a biotech/it SeZ near chennai • generated sales of US$ 75.75 million in 2007-2008. www.ibef.org
  • 50. Bi ot e c h n o l o g y December 2008 highlights of 2008 Collaborations and acquisitions • Biocon acquired 70 per cent stake in german pharmaceutical company, Axicorp for approximately US$ 43.5 million. • Albany Molecular Research inc. (AMRi) bought FineKem laboratories, a manufacturing facility located in Aurangabad. • ocimum Biosolutions announced an equity investment of up to US$ 17 million for the acquisition of the genomics division of gene logic. 0 www.ibef.org
  • 51. Bi ot e c h n o l o g y December 2008 highlights of 2008 Union budget 00-00 • Reduction of cenvat to 8.24 per cent • 12.5 per cent weighted deduction to outsourced research • Reduction in customs duty on raw materials for eliSA kits to 18.72 per cent, select vaccines, and select bio- therapeutics to 9.36 per cent. • Allocation of US$ 242 million for the national AiDS programme. • excise duty rate reduced to eight per cent. 1 www.ibef.org
  • 52. Bi ot e c h n o l o g y December 2008 Advantage india Low cost Operations Some Bioscience related indian institutions Institution Name Area of focus • RD costs in india significantly lower; outsourcing National Center for Biological Biochemistry, Bioinformatics to india can save up to US$ 200 million Sciences Genetics Jawaharlal Nehru Institute for Molecular and Chemical • cost of clinical trials 50 per cent lower in Phase advanced Scientific Research Biology Genetics National Institute of Immunology Immunology i and 60 per cent lower in Phase ii compared to Institute of Genomics Integrative Genomics, Genome global markets Biology Informatics and Proteomics International Centre for Genetic Molecular Biology • clinical trials take significantly lesser time in india Engineering and Biotechnology Biotechnology Centre for Cellular Molecular Bioinformatic Genetics Biology Centre for DNA Fingerprinting Computational Biology and Diagnostics Bioinformatics Central Drug Research Institute Drug Discovery Regulatory studies www.ibef.org
  • 53. Bi ot e c h n o l o g y December 2008 Advantage india Large Human Resource Pool • higher education in the sciences is india’s forte. • 5000 PhDs and 1000 post-docs in biosciences-related fields • numerous top-notch life science education and research institutes Favorable IP Climate • Adherence to the tRiPS agreement with regard to the Patent Protection Act implemented in 2005 has increased the confidence of innovator companies in india www.ibef.org
  • 54. Bi ot e c h n o l o g y December 2008 DiSclAiMeR this publication has been prepared by india Brand this publication is for information purposes only. While equity Foundation (“iBeF”). due care has been taken during the compilation of this publication to ensure that the information is accurate All rights reserved. All copyright in this publication and to the best of knowledge and belief of iBeF, the content related works are owned by iBeF. is not to be construed in any manner whatsoever as a the same may not be reproduced, wholly or in part in substitute for professional advice. any material form (including photocopying or storing iBeF neither recommends nor endorses any specific it in any medium by electronic means and whether or products or services that may have been mentioned in not transiently or incidentally to some other use of this this publication and nor does it assume any liability or publication), modified or in any manner communicated responsibility for the outcome of decisions taken as a to any third party except with the written approval of result of any reliance placed on this publication. iBeF. iBeF shall in no way, be liable for any direct or indirect damages that may arise due to any act or omission on the part of the user due to any reliance placed or guidance taken from any portion of this publication. www.ibef.org