While the economic downturn took a toll on most markets, the U.S. contract research organization (CRO) market bucked the trend to post impressive growth rates of 8.5 percent in 2009. The slowdown in funding for early-stage projects has, no doubt, dampened the market's prospects for the next three years to four years, but this lack of funding has also restricted companies from investing in in-house clinical trials, creating opportunities for CROs.
New analysis from Frost & Sullivan's (pharma.frost.com) U.S. Contract Research Outsourcing Market: Trends, Challenges and Competition in the New Decade research finds that the market earned revenues of $11.43 billion in 2010 and estimates this to reach $20.09 billion in 2017.
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Market participants are optimistic about continued growth due to the interest shown by new sponsors, especially biotechnology and specialty pharmaceutical companies that are demanding full services–from the pre-clinical to post-commercialization stages. This spurt in demand and strategic partnerships with CROs could be mainly attributed to the sponsors' limited development infrastructure.
"The sponsor-CRO relationship has historically been heavily transaction-based," said a Frost & Sullivan senior research analyst. "However, in the past few years, companies have been making a gradual shift to strategic alliances that are built on a long-term view of outsourcing rather than transactions."
Earlier, start-up pharmaceutical and biotechnology companies would out-license their product after Phase I/II or acquisition, which raised a question mark over the future of projects. This trend is slowly phasing out as companies are increasingly retaining products within their pipeline and taking them closer to the market through CROs, thereby increasing the value of the products and the company. The enhanced profile of CROs, in recent times, is expected to significantly improve the market's penetrations rates.
"Despite the existence of CROs for more than two decades now, the penetration rate of outsourcing, as a percentage of the total R&D spending, is less than 25.0 percent," said the senior research analyst. "Hence, there is great potential for CROs to grow through just expansion."
Meanwhile, as trials continue to become increasingly complex and global, the competition for access to patients, new investigators, and fresh studies has started heating up. The gap between patient access and studies has been rising consistently over the past decade and could affect future studies. For studies that depend heavily on emerging markets, this patient access-study gap could lower productivity by lengthening the time for each trial.
There is also an underlying churn among existing investigators, which is causing this divide to widen further. CROs and sponsors are grappling with the situation and are exploring new ways to increase access to patients.
"CROs and service providers are looking to counter this challenge by partnering with patient recruitment firms," said the senior research analyst. "Service providers are also outsourcing large-scale global trials through the expanded reach of CRO partners, which enables access to an extensive patient pool."
U.S. Contract Research Outsourcing Market: Trends, Challenges and Competition in the New Decade is part of the Pharmaceuticals & Biotechnology Growth Partnership Services program, which also includes research in the following markets: U.S. Contract Research Organizations Markets, Global CRO Spending Trends, Global Biopharmaceutical Contract Manufacturing Market, and Strategic Analysis of Opportunities in the CRO Market. All research services included in subscriptions provide detailed market opportunities and industry trends evaluated following extensive interviews with market participants.
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U.S. Contract Research Outsourcing Market: Trends, Challenges and Competition in the New Decade / N8B7