Global Demand and Utilization of Mammalian Cell Culture Manufacturing Capacity

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1 Global Demand and Utilization of Mammalian Cell Culture Manufacturing Capacity Howard L. Levine, Ph.D. Eighth Annual BioProcess International Europe 2012 Apr Prague, Czech Republic BioProcess Technology Consultants

2 Increasing Sales of Biopharmaceutical Products

3 US Approval of Monoclonal Antibody Products by Year 6 5 No. Products Approved Similar approval rates for the UK and Europe

4 Monoclonal Antibodies Drive Biopharmaceutical Revenue Average Revenue, US$ million Ref: Datamonitor, company related information

5 Top Ten Selling Biopharmaceutical Products US Product Name Company 2010 Sales (Billions USD) Remicade J&J/Merck Enbrel Amgen/Pfizer Humira Abbott Avastin Roche Sales of almost $50 billion 8 out of 10 are produced in mammalian cell culture 7 out of 10 are monoclonal antibody related products CAGR for monoclonal antibodyrelated products from was >40% Rituxan Roche Lantus Sanofi Aventis Herceptin Roche Neulasta Amgen Novolog Novo Nordisk Lucentis Roche/Novartis 2.899

6 Product Demand Greatest for Monoclonal Antibodies Demand for existing commercial antibody products will nearly double by 2016 ~8.3 metric ton ~13.4 metric tons (2010) (2016) Product Demand for Commercial Antibody Products 2010 requirements for each of the top five monoclonal antibody products ranged from metric ton All others (27) 26% Remicade 17% 2010 demand for all other monoclonal antibody products combined was approximately 2.5 metric tons Anticipated demand for new monoclonal antibody products approved between now and 2016 is expected to be <5 metric tons per year per monoclonal antibody product Herceptin 12% Enbrel 13% Rituxan 16% Avastin 16%

7 Demand for Biomanufacturing Capacity Growing Driven by growing market for approved products, large number of products in clinical development, and growing interest in biosimilars Volumetric requirements will almost double by 2016, leaving companies and markets without capacity scrambling for resources

8 Distribution of Mammalian Cell Culture Capacity Greatest increase in number of companies with clinical capacity

9 Geographic Distribution of Cell Culture Capacity Region North America Volume in 000s L 1,661 2,181 UK/Ireland Europe 712 1,125 Korea Japan China <1 37 India Singapore/ Malaysia Perfusion capacity adjusted to equivalent fed batch capacity where appropriate Australia <1 3

10 Balance of Supply and Demand Assumes no increase in current titers Capacity utilization to increase from 43% to 64% in next five years Perfusion capacity adjusted to equivalent fed batch capacity where appropriate

11 Product Companies Control ~70% of Capacity 4,500 3,600 Installed Capacity 2,700 1, CMO XS Product Co. Perfusion capacity adjusted to equivalent fed batch capacity where appropriate

12 Capacity Distribution by Bioreactor Scale

13 Ten Companies Control >75% of Capacity 2010 Rank 2016 Rank Company 2010 Volume (1,000s L) 2016 Volume (1,000s L) 1 1 Roche J&J Boehringer Ingelheim Amgen Lonza Pfizer Sanofi Aventis Novartis Lilly Biogen Idec Celltrion 140 All Others 614 1,070 TOTAL 2,558 3,431 Perfusion capacity adjusted to equivalent fed batch capacity where appropriate

14 Utilization at Top 5 Product Companies ~50% Includes Roche, J&J, Amgen, Pfizer, Sanofi Aventis Perfusion capacity adjusted to equivalent fed batch capacity where appropriate

15 Utilization Pushes 75% for the Rest of the Industry 45% 45% 45% 45% 45% 45% Perfusion capacity adjusted to equivalent fed batch capacity where appropriate

16 Biomanufacturing Capacity Adequate but Tightening Increase in number of products and expanding markets will increase demand by ~1 million liters by 2016 Current and anticipated supply of capacity is sufficient to meet the market needs for the foreseeable future Existing capacity may not be available or appropriate Product companies control >70% of total capacity Utilization rates for the majority of the industry will reach almost 75% by 2016 Companies without manufacturing capacity or secure manufacturing contracts may experience difficulties in accessing capacity in the coming years

17 Trends Influencing Future Capacity Requirements Higher yielding processes Biosimilars New Product Types Today s bioreactors will produce more product per batch Existing markets spread capacity demand among more players New markets potential increase in demand Shift away from full length, naked monoclonal antibodies to other scaffolds or more potent products may alter demand

18 Effect of Titer on Volume Over Time

19 Modern, State-of-the art Processes Cell culture titers of titer >5 g/l imply smaller bioreactors producing similar quantities to today s six pack facilities Multi product capabilities and flexibility will become increasingly important Disposable technologies will become increasingly prevalent Continuous processing, PAT and other modern manufacturing methods will be incorporated into bioprocessing Photos courtesy of Pall Life Sciences and Sartorius Stedim

20 Biologic Products Current and Future New MAbs, F c fusion proteins, F ab, Antibody Drug Conjugates, alternate scaffolds Smaller niche markets that current products Biosimilar products currently approved in Europe Many Mabs will be off patent in next few years Some already available in India and China Adapted from Stout, J. BPI Conference 2011

21 Biosimilars Are Reality and Growing Today relatively simple proteins tomorrow, more complex proteins Biosimilar products currently approved in Europe Product Name Active Substance Company Abseamed Medice Arzneimittel Pütter Binocrit Epoetin alfa Sandoz Epoetin alfa Hexal Hexal Biograstim CT Arzneimittel Filgrastim Hexal Hexal Filgrastim Ratiopharm Ratiopharm Nivestim Filgrastim Hospira Ratiograstim Ratiopharm Tevagrastim Teva Generics Zarzio Sandoz Omnitrope Sandoz Somatropin Valtropin BioPartners Retacrit Hospira Epoetin zeta Silapo Stada Ref: General/Biosimilars approved in Europe From Clone to Clinic

22 Adoption Rates of Biosimilars in Europe Country Biosimilar Share of Innovator Product Sales (March 2011) Somatropin (1) Erythropoietin (5) Filgrastim (6) Austria 6% 50% 52% France 20% 11% 42% Germany 12% 65% 45% Italy 12% 7% 18% Poland 7% 62% 38% Romania 34% 58% 77% Spain 15% 16% 24% Sweden 21% 63% 45% UK 4% 9% 80% EU Total 13% 18% 38% 22 From Clone to Clinic

23 Monoclonal Antibodies Will Be The Next Wave Many blockbuster MAbs will be off patent in the next few years Biosimilar MAbs already available in India and China Monoclonal antibody products soon to be off patent: Product Name Active Substance Company Avastin Bevacizumab Roche/Genentech Enbrel Etanercept Amgen Erbitux Cetuximab Eli Lilly Herceptin Trastuzumab Roche/Genentech Humira Adalimumab Abbott Lucentis Ranibizumab Roche/Genentech Remicade Infliximab Johnson & Johnson Rituxan Rituximab Roche/Genentech Ref: 25 biotechdrugs the next biosimilars targets From Clone to Clinic

24 Interest in Antibody-Drug Conjugates is Growing Are more ADCs entering and moving through the pipeline compared to 5 years ago? How important a class of compounds do you expect ADCs to become? biopulse

25 Enter to win The State of Mammalian Cell Culture Biomanufacturing Comprehensive in depth analysis of the biopharmaceutical market and the impact of current trends on the supply and demand for mammalian cell culture manufacturing capacity through 2016 Drop your business card in the bowl at the registration desk to enter the drawing

26 Thank You! Howard L. Levine, Ph.D BioProcess Technology Consultants, Inc. 12 Gill Street, Suite 5450 Woburn, MA 01801