Global trends in molecular diagnostics was a key topic of discussion for an expert business panel at the recent “CHI Molecular Medicine Tri-Conference” in San Francisco.
The panel predicted that some of the approximately $50 billion of President Obama’s stimulus package will be allocated to electronic medical record (EMR) opportunities and will directly impact the diagnostics market. By expanding access to a patient’s records and making them portable, EMRs will foster the use of point-of-care diagnostic tests.
Harry Glorikian, a partner at Scientia Advisors, spoke of the growing recognition that diagnostics will be a significant enabler of reduced healthcare costs. He identified several major global drivers of an expanding market for in vitro and molecular diagnostics: an aging population; an increase in chronic diseases (as therapeutic regimens improve); the availability of high-value diagnostics; and growth in decentralized healthcare (e.g., China plans to establish about 60,000 healthcare clinics by 2012).
Glorikian described increasing scientific innovation in Eastern countries, where products can be made for a fraction of the cost in the U.S., with similar quality, and projected a shift in the flow of products from Asia to the West in the near future.
Diagnostics offers the potential for shorter timelines to market and profitability, noted a venture capital panel during a discussion entitled, “How Is Personalized Medicine Moving Forward?”
Although, historically, diagnostics were less heavily regulated than drugs, that equation appears to be changing for molecular diagnostics, at least within the U.S. FDA. The panelists advised that when a company develops a companion diagnostic it has to consider whether the product can reap a profit, but it also has to assess the cost/benefit for all concerned, including the patients (Will insurance cover it?), the physicians (Will they be reimbursed?), and the healthcare system (Will the test reduce the overall cost of care by enabling the use of targeted, more effective treatments or identifying early on therapies not likely to be effective?).