美国生物制药行业发展概况(英文原版)

Biotechnology Overview Biotechnology OverviewLeading biotechs continue to outpace pharmaceutical company growthAmgen, the worlds largest biotech as measured by ethical drug sales, has completed its transition into a globally integrated drug company and is competing effectively with the leading pharmaceutical companies. Ranked 14th by revenues amongst global pharmaceutical companies in 2004, Amgen is on course to break into the top 10 by 2008 (source: Wood Mackenzie’s Productview TM). The other members of the elite group of top biotechs are also developing rapidly, although none approach the sheer scale realised by Amgen. The key to their growth is a broadening of their product portfolios by in-licensing and M&A activity, as well as in-house drug discovery and development. Genentech is the leader in terms of revenue growth, estimated by Wood Mackenzie to be 22% over the next 5 years, driven by a series of approvals of anti-cancer biotherapeutics including Avastin, Tarceva and Herceptin.Wood Mackenzie predicts that, despite the challenges presented by today’s regulatory environment and pricing constraints, the leading biotechnology companies will continue to leverage their innovative drug discovery capabilities to yield double digit revenue growth (averaging 13.5%) over the next 5 years, well in excess of that experienced by the global pharmaceutical market (averaging 7.6% over the same period), as illustrated in Figure 1 (source: Wood Mackenzie’s Productview TM).Figure 1 - Ethical drug sales & CAGR’s of leading Biotechnology Companies, 2004 and 2009Source: Wood Mackenzie’s Productview TMInward investment to biotech was strong in 2004Unlike the leading biotechs, the much larger group of emerging biotech companies characteristically lack a portfolio of existing products and are typically some years away from marketing their own products. They are therefore vulnerable due to their dependence on external financing. In that respect, 2004 was a positive year for biotech, as the sector enjoyed a cash influx of $20.8bn, of which 23.5% flowed into private companies. The IPO window that opened in late 2003 remained available throughout 2004, during which time 28 companies in the US, and another 9 internationally, went public. This made 2004 second only to the genomics-inspired IPO peak of 2000, in which $37.2bn was invested in the industry and 91 companies went public.WOOD MACKENZIE Executive’s Guide 2005 9Biotechnology OverviewThe companies that went public in 2004 had a strong clinical focus, with 33 of the 38 (87%) having candidates in clinical development or products already on the market. This is in stark contrast to 2000, when only 26 of the 91 (28%) companies achieving IPO had clinical stage candidates. Three of the IPOs in 2004 exceeded $100m; Eyetech Pharmaceuticals, Cytokinetics, and Theravance.Although 2004 was a successful year for raising finance, overall biotech stock performance for the year was more disappointing. Moreover, a series of events including drug safety concerns (Tysabri) and high profile clinical trials failures (e.g. Targretin, Canvax) in early 2005 has led to a dramatic slowdown in biotech investment and a distinct narrowing of the IPO window.Biotech continues to be a key forum for strategic activity by pharmaceutical companiesIn a challenging investment environment, the biotech industry as a whole traditionally looks to strategic alliances to provide operating capital. However, Wood Mackenzie’s analysis of the licensing activity of the Top 25 pharmaceutical companies shows that the total number of licensing deals (pharma-to-pharma as well as pharma-to-biotech) has declined from a high of 66 in 1998 to 44 in 2004 (see Figure2). Licensing activity between biotechnology companies has increased in importance in recent years and currently represents around 50% of licensing deals affected each year. However, in line with deal-making within the industry as a whole, the number of deals struck within the biotech sector has fallen slightly from a high in 2001. Furthermore, Wood Mackenzie’s analysis of the top 25 pharmaceutical companies suggests that while the total number of alliance deals has been falling, the value (or cost) of individual deals has increased. This is particularly true of deals involving late stage candidates, which are highly competitive and command a financial premium.Figure 2 - Licensing deals (by development stage) of the top 25 Pharmaceutical Companies 1989 - 2004Source: Wood Mackenzie’s LicensingInsight04TMNonetheless the pharmaceutical industry remains hungry for innovative drugs to fill dwindling pipelines, and the larger biotechnology companies are also looking beyond organic growth to fuel their development. Both are natural partners for the wider biotech industry and have large cash reserves, boosted in 2004/05 by new tax breaks in the US. These are potentially worth tens of billions of dollars to the leading pharmaceutical companies, revenue that must be re-invested in the US.Taken together these trends indicate that for the leading pharmaceutical companies, outright acquisitions or broad strategic alliances (e.g. the Cambridge Antibody Technology/AstraZeneca alliance of 2004) with biotech companies possessing promising pipelines or cutting edge technologies may be more attractive, and in the long run more cost effective, than discrete alliance deals involving late stage compounds. Thus far in 2005, Pfizer has acquired Angiosyn Inc., a young biotech with a novel ophthalmic candidate in preclinical development, and Idun Pharmaceuticals, which have an apoptosis-based technology platform and a candidate in Phase II trials. GlaxoSmithKline has acquired Corixa Corp., a move that provides GSK with rights to a key vaccine adjuvant and a pipeline of novel, early stage vaccine candidates.10WOOD MACKENZIE Executive’s Guide 2005Biotechnology OverviewInnovation is driving growth of the biotechnology industryInnovative drug discovery is the life blood of the biotech sector and remains its key strength. Wood Mackenzie’s analysis of the market indicates that in 2004, 15 of 92 blockbusters (16.5%) were biologics, compared to 5 of 43 (11.5%) in 2000. Several other biotech products, including Avastin and Synagis, are forecast to attain blockbuster status in 2005 (source: Wood Mackenzie’s Productview TM).Although the total number of novel drugs approved by the US FDA in recent years has exhibited a general decline (see Figure 3), drugs discovered within biotechnology companies represent an increasingly large proportion of the total. In 2004, biotech company-derived drugs constituted 9 out of 24 approvals (37.5%), compared to 7 of 29 approvals (24%) in 2000. Wood Mackenzie expects this trend to continue in the future. Figure 3 - Novel Small Molecule Drugs and Biological Therapeutics Approved in the US, 1995 – 2004Source: Tufts Center for the Study of Drug DevelopmentOf the nine biotech-derived novel drug approvals in 2004, five (Avastin, Erbitux, Clolar, Tarceva, and Sensipar) have applications in oncology. In fact all but one of the novel drugs approved for oncology indications in 2004 were biotech-derived, the exception being Eli Lilly’s Alimta. To further emphasise the innovative role that the biotech industry plays in oncology, one biological therapy, the monoclonal antibody Avastin, has recently shown a survival benefit in colorectal, breast and lung cancer. Avastin is widely expected to become the gold standard of therapy in these (and possibly other) cancers in the next few years. Wood Mackenzie’s analysis indicates that Avastin will generate $4.4bn in total revenues for partners Genentech and Hoffmann-La Roche by 2009 (source; Wood Mackenzie’s Productview TM).Regulatory and pricing issues and patent expiries are the biggest threats to biotechIn the wake of the high profile COX-2 and Tysabri drug safety withdrawals, political pressure in all major markets makes regulatory reform inevitable. Although the precise nature of these changes will vary from region to region, the expectation is that requirements for drug approval will be made more stringent, increasing both the cost and the time required to bring a drug to market. Given their dependence on external financing, this has significant implications for emerging biotech companies working to bring their first product to market.Pressure is growing from drug pricing and reimbursement authorities around the world to rein in spiralling healthcare costs by cutting ethical drug expenditure. Such an environment is likely to favour cheaper generic drugs or new drugs with clear therapeutic benefits in areas of unmet need. The biotech industry has a history of delivering innovative drugs to the market, but is also entering an era of patent expiries on early biologic drugs, such as human growth hormone, interferon alpha and insulin, that renders it vulnerable to the development of biogenerics.The US and European regulatory frameworks surrounding biogenerics (or biosimilars in Europe) are still evolving and the potential impact on sales of branded drugs remains unknown. However it is probable that some level of price erosion will follow their introduction, although this is likely to be less than that seen with small molecules due to the inherently high manufacturing costs for biologics. Furthermore, we expect the first biogenerics to be marketed as branded biogenerics (not AB rated). Due to their specialty indications, we anticipate that they will require some level of sales and marketing effort, further reducing the scope for significantly lower prices. Wood Mackenzie expects Europe to be the first major market to approve biogenerics.WOOD MACKENZIE Executive’s Guide 2005 11Biotechnology OverviewPharmacogenomics and stem cell technologies present exciting opportunitiesThe FDA has issued guidelines on the submission of pharmacogenomic data to support drug approvals, both to stimulate the development of personalised medicines and to enhance drug safety. Biotechnology has already generated several targeted therapies, notably Genentech and Hoffmann-La Roche’s Herceptin. We expect the industry to continue to capitalise on the opportunity to develop new targeted drugs and the diagnostic tests required to make them practicable.The emerging field of stem cell technology is largely being pioneered in Europe and Asia, while the US is engaged in a debate over moral and religious issues. Stem cell therapies could potentially revolutionise approaches for treating many deadly and debilitating diseases. Early-stage biotech companies, with their technical excellence, strategic flexibility, and tolerance of risk are well placed to be at the forefront of the development and application of this ground-breaking technology.ConclusionFor the biotechnology industry, 2004 was a solid year in which the leading biotech companies, led by Amgen, continued to cement their position amongst leading pharmaceutical companies. The distinctions between the larger biotechnology companies and pharmaceutical companies are becoming more and more blurred, with the former increasingly adding small chemical entities to their drug pipelines and the latter increasingly adopting biologics. The elite biotechs are also employing in-licensing, alliances and M&A activity as a means of supplementing, their in-house drug discovery capabilities, but with rather more success than the pharmaceutical industry, enabling them to maintain twofold higher growth rates. The leading biotechs have achieved their success by focussing largely on specialist markets and increasingly adapting a pharmacogenomic approach. In doing so, they are demonstrating that alternatives to the “blockbuster model” beloved of the larger pharmaceutical industry are financially viable.12WOOD MACKENZIE Executive’s Guide 2005。