Beyond Borders: Global biotechnology report 2010

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FDA product approvals, 1996–2009 Number of approvals New molecular entity Biologic license application 60 50 40 30 20 10 0 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Source: Ernst & Young, FDA Chart shows product approvals by the FDA’s Center for Drug Evaluation and Research. Europe Pipeline strength: continued growth The total number of drugs in clinical development in Europe climbed to 1,199 in 2009, a 16% annual increase that is relatively on par with the growth seen over the last several years. Phase II programs led the growth with an increase of 120 products (22%) over 2008. There were also increases in late- and early-stage development, with a 12% increase in Phase III and 7% increase in Phase I products. UK-based companies continue to lead the European pipeline, accounting for 20% of products in clinical development, on par with their share in 2008. The majority of clinical programs in development (71%) for British companies are in Phase II or later. Germany and Denmark were in second and third place in 2009, with their companies accounting for 12% and 11% of the European clinical pipeline. France and Switzerland round out the top five countries, with each representing about 10% of developmental programs. The relative positions of the top five are unchanged from 2008. Swiss companies’ contribution to the overall European pipeline had declined in the past couple of years because of the acquisitions of prominent Swiss biotech players, including Speedel (acquired by Novartis in 2008) and Serono (acquired by Merck KGaA in 2007). In 2009 — in the absence of any such large Swiss acquisitions — the aggregate pipelines of Swiss companies 88 Beyond borders Global biotechnology report 2010 increased by a healthy 20%. Israeli companies also had a big year in stoking their clinical pipelines, as they increased their clinical development portfolio by 26% and overtook Italy to reach the number seven spot. As in previous years, cancer therapeutics led the European drug pipeline with 22% of Phase III candidates in development. The oncology segment has declined somewhat from levels seen in 2007, when oncology made up 28% of the late-stage pipeline. The “metabolic and endocrine” and “autoimmune” indications rounded out the top three late-stage development therapeutic categories, representing 13% and 12%, respectively.
United Kingdom Germany Denmark France Switzerland Sweden Isreal Italy Netherlands Ireland Spain Belgium Norway Austria Finland European clinical pipeline by country, 2009 Phase I Phase II Phase III 0 50 100 150 200 250 Source: Ernst & Young, MedTRACK and company websites Number of product candidates 89
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Beyond borders Global biotechnology
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Contents The new normal: the global
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The new normal
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Global introduction The new normal
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Of course, this is not a novel deve
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“Since by definition, increasing
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In both of these models, investors
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“For most of the history of the b
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A closer look Reforming US health c
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Perspectives for the new normal Foc
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Perspectives for the new normal Suc
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John Maraganore of Alnylam Pharmace
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Perspectives for the new normal The
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Using FIPNet to supercharge the inn
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New opportunities 24 Beyond borders
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Conversation on emerging markets Ne
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“The biggest challenge for Wester
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China year in review Accelerating r
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addition, the Government committed
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In 2009, overseas-listed Chinese bi
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India year in review Preparing for
Page 44 and 45: acquired US-based hybrid sorghum se
Page 46 and 47: Japanese biotech IPOs, 2009 Company
Page 48 and 49: drug application for Lurasidone to
Page 50 and 51: The year saw some examples of globa
Page 52 and 53: of today’s increasingly pragmatic
Page 54 and 55: Biotech will provide the technology
Page 56 and 57: Malaysia year in review A strategic
Page 58 and 59: A transformational year 52 Beyond b
Page 60 and 61: Financial performance A transformat
Page 62 and 63: explained by developments at a few
Page 64 and 65: Selected 2009 US biotechnology publ
Page 66 and 67: Growth rate Canada Behind the numbe
Page 68 and 69: Australian biotechnology at a glanc
Page 70 and 71: Financing A higher bar After a dism
Page 72 and 73: the pharmaceutical industry, as pha
Page 74 and 75: The final 2009 IPO to close in the
Page 76 and 77: The IPO market in Europe remains la
Page 78 and 79: Capital raised by Canadian province
Page 80 and 81: developed countries — and whether
Page 82 and 83: Deals A new landscape Given the rea
Page 84 and 85: companies will not make any large u
Page 86 and 87: with Elan (the judge agreed) the pa
Page 88 and 89: Without Roche-Genentech, the value
Page 90 and 91: total potential value of these tran
Page 92 and 93: Products and pipeline Steady growth
Page 96 and 97: European Phase III pipeline by indi
Page 98 and 99: A closer look Uncertain by design:
Page 100 and 101: oral anti-diabetes medications Janu
Page 102 and 103: Perspectives on personalized medici
Page 104 and 105: Moderated by: Gil Forer Ernst & You
Page 106 and 107: “I’m starting to see non-tradit
Page 108 and 109: from infrastructure funds, but they
Page 110 and 111: Data exhibit index 2 The not-quite-
Page 112 and 113: Global biotechnology contacts Globa
Page 114: Ernst & Young thought leadership Wa
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