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The Trend Toward Personalized Medicine
Decision Resources, Inc, Dec 2005, Pages: 14
In vitro diagnostics (IVD) and molecular diagnostics are multibillion-dollar industries. Together, they play critical roles in the trend toward personalized medicine. Pharmaceutical and biotechnology companies are turning to personalized medicine to help improve the drug development process and speed the approval of new drugs.
In this report, we discuss the role of IVD and molecular diagnostics in personalized medicine, profile companies in the field, discuss key trends and issues, and ponder the future of personalized medicine.
Business Implications
- Personalized medicine is a component of the molecular diagnostics market, which is the fastest-growing segment of the in vitro diagnostics (IVD) market. According to S.G. Cowen & Co., the IVD industry was a $26 billion industry in 2004. Within this industry, the molecular diagnostics market segment is expected to show the most robust growth, increasing from $1.8 billion in 2004 to $3.6 billion in 2009, representing an annual growth rate of 15%.
- Personalized medicine will require more emphasis on IVD and greater cooperation between diagnostic and therapeutic companies in the development of new technologies and products; it will result in improved health care and business growth for both diagnostic and therapeutic companies. The beginnings of this increased cooperation are already evident in several diagnostic products and services directly guiding therapeutic decisions, notably in the areas of cancer and infectious disease.
- Diagnostic assays that test the genetic basis for the metabolism of drugs, including toxicity, and define eligibility for targeted oncological therapies are already on the market. We anticipate that the FDA will require the development of companion diagnostic tests before it approves some of the targeted therapeutic products in development.
- Business models for diagnostic companies engaged in personalized medicine include major IVD manufacturers such as Roche (with a significant existing molecular diagnostics business), technology platform companies such as Affymetrix (with stand-alone products as well as partnering relationships with IVD manufacturers), and small specialized diagnostic companies such as DakoCytomation, which partners with pharmaceutical companies to develop and produce specific companion diagnostics.
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