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Has Genomics Failed to Deliver?
Decision Resources, Inc, June 2006
Following its conception more than a decade ago, the field of genomics excited the research community with the possibility of a faster, surer route to drug discovery, but this optimism has quickly faded and the industry is reassessing its prospects. To date, no genomics-derived product has successfully completed Phase III trials, and it will be another two to four years before a significant number of the genomics compounds now in early-stage development reach this critical juncture. In the meantime, genomics companies face the continuing challenge of supporting the cost of clinical development. In this report, we examine the success that the biotechnology industry, in contrast to the genomics industry, has had with drug discovery; profile today’s genomics companies and their pipelines; provide a SWOT analysis of the strengths (S), weaknesses (W), opportunities (O), and threats (T) facing the genomics industry; describe the various strategies that companies are using to improve their financial situation and get products to market; and discuss the outlook for the genomics industry, including the development of personalized medicine and genomics-derived diagnostics.
Business Implications
In 2005, biotechnology companies, overall, reached unprecedented levels of fund raising and product sales, based on the continued success of protein-based products. In contrast, genomics companies, which aimed to mimic that success, continue to struggle to bring their first products to market. Genomics has uncovered many novel targets, but as suspected, they are not all good for drug discovery. To date, this field has experienced many key drug failures, of which a number occurred in Phase II or III. This problem highlights the need for thorough target validation. A second wave of genomics products is in early-stage development. Getting these products through Phase III trials successfully will be the real proving ground for these companies. The year 2005 was a turning point for many genomics companies. Frustration over the lack of products on the market, the continued high cost of clinical development, and the rate of cash-burn have caused several high-profile companies to refocus their efforts and modify their business strategies. Celera Genomics, for example, has turned its business focus to molecular diagnostics, while Incyte is now entirely dependent on non-genomics-based drugs. Other genomics companies may be acquisition targets. Human Genome Sciences and Exelixis are leaders in terms of number of small-molecule, antibody, or protein drugs under clinical development. In addition to these products, genomics has spawned a large number of new technologies and tools that can be used to better understand the disease state and validate targets for further development. Genomics will likely also be critical in the field of pharmacogenomics and personalized medicine, for which clinical trials and drugs can be tailored to those patients most likely to benefit from them. Leaders in this arena include deCode Genetics, Millennium, and Celera.
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