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Personalized Products Expanding

The personalized medicine business has been steadily growing over the past several years, as evidenced by a 57 percent increase in the number of personalized drugs, treatments, and diagnostics, according to a new Personalized Medicine Coalition report.

PMC says that way back in the genesis period of personalized medicine in 2006, there were 13 examples of such personalized products on the market, and today there are 113 such drugs and tests available.

The recent expansion represents a first wave of personalized products, and more are on the way, PMC says. The group points out that 30 percent of all treatments that are in late clinical development rely on biomarker data, 50 percent of all those in early clinical development use biomarkers, and 60 percent of all treatments in preclinical development do.

The advocacy group says 30 percent of biopharma companies it surveyed require all their developing compounds to have a biomarker, and that 50 percent of all clinical trials collect DNA from patients for use in biomarker development. Today, 137 FDA-approved drugs have pharmacogenomic information in their labeling, and 155 total pharmacogenomic biomarkers are included on FDA-approved drug labels.

This push to personalize also has caught the eyes of investors, PMC says, as there was a 75 percent increase in investments in this area between 2006 and 2011.

Another indicator PMC points to is its own membership, which has jumped from 20 partners when it launched in 2004 to 230 members today.

The report, The Case for Personalized Medicine, lists some of the many ways that personalized drugs and diagnostics can affect healthcare, by detecting diseases earlier, avoiding adverse drug reactions, guiding and stratifying treatments, and by enabling people to make personalized decisions to prevent or avoid diseases.

The report also delves into the regulatory landscape into which personalized medicine has arrived, and offers PMC's proposals for overseeing lab-developed tests, avoiding duplicative or conflicting regulations, setting standards for clinical validity, and taking a risk-based approach to regulating, and it addresses coverage and reimbursement strategies.