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New Report Projects 11 Percent Annual Growth in Genomically Guided Personalized Medicine

NEW YORK (GenomeWeb News) – A new report by PricewaterhouseCoopers estimates the $232 billion personalized medicine market will grow 11 percent annually.

According to the professional services firm, the trend toward tailoring drugs based on clinical factors and genomic variation will create opportunities and challenges for the pharmaceutical and biotech industries. As far as the opportunities, however, the market for "a more personalized approach to health and wellness will grow to as much as $452 billion by 2015," PricewaterhouseCooper gauges.

The estimates in the report, titled "The Science of Personalized Medicine: Translating the Promise into Practice", factor in market opportunities beyond drugs and devices to included demand for data storage, data sharing, as well as increased consumer demand to know their own health risks.

Based on these considerations, PricewaterhouseCoopers expects the $24 billion drug and diagnostic market will grow by 10 percent annually, reaching $42 billion by 2015. "The personalized medical care portion of the market – including telemedicine, health information technology and disease management services offered by traditional health and technology companies – is estimated at $4 billion to $12 billion and could grow tenfold to over $100 billion by 2015 if telemedicine takes off," the report notes.

The report sees direct-to-consumer genomics firms, such as the services offered by 23andMe and Navigenics, adding to the growth of the personalized medicine market by empowering individuals with real-time information regarding medical risks.

"Market research analysts estimate the current size of the global market for genetic testing at $730 million, with a 20 percent annual growth rate. Though a relatively small portion of this market, DTC testing is expected to grow rapidly in response to consumer demands and declining prices," the report notes.

The economic downturn has hit many DTC genomics firms hard. 23andMe recently laid off some employees and raised the price of its genomic risk scans [see GenomeWeb Daily News sister publication PGx Reporter 11-04-2009]. Although many industry observers have often doubted whether the information offered by DTC gene testing firms is worth the price, other experts have recognized that the consumer-driven research model is one that empowers individuals and may catch on as people get more comfortable learning about genetic risk.

"Medical science and technological advancement have converged with the growing emphasis on health, wellness and prevention sweeping the country to push personalized medicine to a tipping point," said David Levy, global healthcare leader at PricewaterhouseCoopers, in a statement. "We are now seeing a blurring of the lines between traditional healthcare offerings and consumer-oriented wellness products and services. The market potential is enormous for any company that learns to leverage the science, target individuals and develop products and services that promote health."

One thing all healthcare stakeholders agree on is that the trend toward personalized medicine will be disruptive to the traditional way of doing things. Personalized medicine has begun to shift Big Pharma's drug development focus from one-size-fits-all to looking at what works in subpopulations. And although drug companies are still eyeing the largest possible market for their drugs, most heads of research and development at large drug companies have admitted that the blockbuster model is dying [see PGx Reporter 12-02-2009].

"We need to replace our current focus on treating disease with a better approach that is personalized, preventive, predictive and participatory, the basic tenants of personalized medicine," Gerald McDougall, principal in charge of personalized medicine and health sciences at PricewaterhouseCoopers, said in a statement. "Greater collaboration around personalized medicine should be a key strategy for health reform."

Things do appear to be moving in this direction. Within industry, 2009 was a year of Rx/Dx collaborations with several major drug firms including Pfizer, GSK, Bristol-Myers Squibb, Amgen, and AstraZeneca all inking collaborations with diagnostics firms to personalize investigational treatments, mainly for the individualization of cancer treatments using genomic markers.

In the regulatory arena, the US Food and Drug Administration updated the labels for the anticoagulant Plavix with gene-response data and affected a class labeling change for EGFR-inhibiting monoclonal antibodies in the treatment of colorectal cancer (ie. Erbitux and Vectibix).In updating the label for Erbitux and Vectibix the FDA considered retrospective clinical trial data from the sponsors, which offers alternative study models to the long and costly prospective, randomized-controlled study designs for companies looking to get develop personalized drugs [see PGx Reporter 10-07-2009].

The report also discusses how this projected growth in the personalized medicine market will impact technology companies. Tech firms "some with little or no health expertise, are capitalizing on emerging opportunities to manage vast quantities of genetic and other health data and build IT infrastructure and connectivity solutions," the report notes.

When it comes to genomically guided personalized care, physician education is mandatory, the report notes. "Universities will have to update their programs," it said.

"Primary care providers may have to build new service lines around prevention and wellness in order to replace revenues lost from traditional medical procedures," according to the report. "When they do, they can expect to face low-cost competition from non-healthcare companies skilled in consumer marketing and consumers armed with knowledge of their options."

Payors will also need to change their reimbursement schemes. Insurance premiums are currently calculated with the general population in mind, but "personalized medicine targets small populations which are far less stable and predictable from an actuarial standpoint," the report notes.

"How payors approach personalized medicine will be critical, as their reimbursement schemes will influence the business models of pharma and diagnostics companies as well as providers who depend on third-party payment," according to the report. "Payors that want to embrace the new science will have to rethink how they define coverage."

A more detailed version of this article will appear in this week's issue of Pharmacogenomics Reporter.

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