Market elements of the biopharmaceutical market and single-use technologies

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Relevant marketing elements and intelligence for the understanding of the biopharmaceutical and single-use technology.

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Market elements of the biopharmaceutical market and single-use technologies

  1. 1. Single Use Technology in the Pharmaceutical industry Paris, February 2014
  2. 2. The single-use technology (SUT) market is estimated to more than quadruple in the coming years, which will pull the need for compatible bioreactors of volume lower than 2000L Evolution of Biotechnology & Equipments Markets – 2011 to 2016, est., $ Billions - 2011 2016 est. 300,0 12,5 +107% +136% 145,0 5,3 2,8 0,6 Biotherapeutics overall Upstream (bioproduction) +367% Total SUT market 0,5 1,3 +160% R&D-support single-use systems Disposables and related market estimates; the good manufacturing practice (GmP) market for single-use technology (SUT) today is estimated at us $150 million (for plastic tubing, manifolds, and connectors used with stainless steel systems). For bioreactors, the market is almost equally divided between SIP and SUT. Most of the bioreactors in place have a volume inferior than 2000L. “There’s been a shift from blockbuster drugs produced in massive quantities to niche-busters, so we’re moving toward smaller volumes at the same time that titers in bioreactors are getting higher”. Sources : contractpharma.com 2
  3. 3. Disposable Bioreactors have seen a peak of interest in late 2011, as well as a few months ago Disposable bioreactors online queries – 2004-2013, % of maximum search volume - Sources : Google Trends 3
  4. 4. The SUT still have many limitations which limit their implementation in the pharmaceutical industries Manufacturing disposable equipment having high-quality/high-tech control systems at the same time is a big challenge, since these manufacturing processes need different core competencies. Single-use sensors still have a lack of performance and, therefore, sometimes do not meet the needs for highperformance process control. Also finding materials free from leachables/extractables is still a challenge. Manufacture single-use bioreactors that encompass microbial culture with, for example, high oxygen demand or a larger pH range is a challenge. The limits here are clearly the higher requirements for material stability and higher performance sensors, similar to nondisposable solutions. Customers need to be open to redeveloping and optimizing their processes to the technology, which will result in an increased overall yield. Single-use bioreactors are relatively expensive and have to be handled correctly to avoid damage. Construction of the bags requires mechanical welding of the seams and this needs to be of the highest quality in order to ensure that welds do not come apart and result in lost sterility and consequently loss of the entire run. The complete lack of standardization renders the implementation of SUT, or any change in the production process more complex than necessary. Customers are asking for more detailed characterization of films, raw materials, and other plastic components with the goal of better assessing the patient risk associated with production single-use bioreactors. Sources : genengnews.com 4
  5. 5. Substituting products are rare, however new competitors could emerge Risks for GPC activity: “Virtual R&D”. Mutualization of R&D by CMOs growing larger. Integration of bioreactor design and production in pharmaceutial companies / CMOs. Low required investment to enter the market 5
  6. 6. The pharmaceutical market undergoes a financial transition which renders the development of new therapeutics even riskier than in the past „The cost of developing an asset has remained relatively static while the likely revenues have declined. The cost of developing an aset, from discovery to launch, has increades slightly by four per cent from $1,089 milion to $1,137 in 2012. Average inflow per asset is forcast to decline by 14% relative to 2010 to reach a figure of $2,166 million in 2012.“ Sources : Deloitte Life Science innovation Report 6
  7. 7. Only 5 out of the 12 biggest pharmaceutical companies have enough molecules in the pipeline to stay financially healthy in 2017 Drug pipeline & associated estimated revenues– 2012-2017est, # of drugs, Bn€ Number of drugs in development Incremental revenues from new pipeline 2012-2017 EU companies EU companies EU comp. 7,5 Bn€ 7,3 Bn€ 12,0 Bn€ 7,4 Bn€ 6,5 Bn€ 5,3 Bn€ 4,1 Bn€ 8 21 Johnson Novo & Nordisk Johnson 3,2 Bn€ 53 56 65 3,0 Bn€ 28 35 37 3,0 Bn€ Bayer Novartis Merk Eli Lilly Sources : Businessweek 60 Astra- Bristolzeneca Meyers 67 80 90 5,3 Bn€ 3,0 Bn€ Pfizer Sanofi Roche GlaxoSmithKline 7
  8. 8. The number of clinical trials is still growing, but might reach a peak despite efforts made by goverments to facilitate drug devlopment Evolution of number of clinical trials – Thousands of clinical trials, 2000-2012 Registered studies (thousands) Y-to-Y Growth 138,8 +52% 119,4 101,3 +30% +27% +19% +19% +16% +26% 83,5 66,4 +15% +18% +21% +15% +14% 2011 2012 49,3 35,9 25,0 5,6 7,0 8,6 10,3 12,1 2000 2001 2002 2003 2004 Sources : clinicaltrials.gov 2005 2006 2007 2008 2009 2010 8
  9. 9. The market share of biopharmaceuticals is growing but is controlled by only a few key companies Evolution of the Pharmaceutical Market – Billion USD, 2001-2011 - Biopharmaceutical Global Production Capacity – Share of production capacity, 2011 - Biopharmaceuticals Rest of Pharma 855 812 770 727 684 641 489 38 (8%) 451 523 46 (9%) 477 560 51 (9%) 509 599 59 (10%) 69 (11%) 82 (12%) 95 (13%) 106 (14%) 117 (14%) 128 (15%) 889 139 (16%) Others Roche 21% 25% Novartis 5% 540 572 602 632 664 695 727 750 Eli Lilly 5% Sanofi 9% Johnson & Johnson 6% 9% 6% Pfizer 7% Lonza 8% Boehringer Ingelheim Amgen 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 Sources : GiResearch 9
  10. 10. The top CMOs are based in Germany, Switzerland and the USA, and have made a growth of 9,9 % between 2011 and 2012 Top 10 CMO ranking– Million USD, # of Employees, 2012- 10
  11. 11. Of the top 27 european companies by R&D investment, 6 are Pharmaceutical companies, and account for 23% of the total investment in 2010. Top 27 European Investors in R&D– Billion Euros, 2011 Volkswagen Nokia Daimler Sanofi-Aventis GlaxoSmithKline Siemens Robert Bosch Bayer AstraZeneca EADS Ericsson BMW Alcatel-Lucent Boehringer Ingelheim Peugeot (PSA) Finmeccanica Fiat Volvo SAP Renault Philips Electronics STMicroelectronics Continental BASF Merck DE Banco Santander Novo Nordisk 3,21 3,20 3,08 3,02 2,77 2,56 2,45 2,40 1,97 1,94 1,80 1,73 1,73 1,70 1,63 1,53 1,41 1,40 1,34 1,27 4,94 4,85 4,39 4,38 4,24 3,82 Sources : The 2011 EU Industrial R&D Investment Scoreboard 6,26 In the pharmaceutical sector, the top 3 countries investing in R&D are : United Kingdom France Germany 11
  12. 12. Although the number of approvals is similar in Europe and in the U.S.A., France is less and less involved in new drug development The Food and Drug Administration (FDA) approved the same number of new drugs in 2010 and 2011 as the Medecines Agency (EMA), +/-1. However, France is less and less chosen by the EMA as reviewer in centralized procedures. Also, only 7% of AMM filing belonged to France in 2010 vs. 14% in 2009. Sources : LEEM 12
  13. 13. There is a cyclical tendency that might reflect the intensive financial needs of the pharmaceutical industry Filings of NME/NBE and approvals by the FDA– # of filings & approals, 1993-2012 NME/NBE filings NME/NBE approvals by the FDA 53 50 45 41 43 39 36 35 28 29 25 26 36 30 21 35 24 30 26 22 26 21 17 36 34 32 30 26 27 39 38 20 24 22 26 22 21 18 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 Sources : FDA Filling and approval file Allyprime 13

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