Drug Development, Protocols

Protocols: CRO industry poised for steady growth as new work in China explodes (in a good way); Vectura dinged on PhIII Flutiform flop

Shares of the UK’s Vectura dropped early Tuesday after the company conceded that Flutiform had failed a Phase III study for COPD. The failed study, run by Mundipharm, is scuttling plans for a regulatory filing.”Whilst this result is disappointing, Flutiform continues to grow strongly based on the approved asthma indication, which continues to underpin our expectations for future growth of the product,” Chief Executive Officer James Ward-Lilley said.

As expected, Ariad Pharmaceuticals has completed its rolling submission for the NDA on its ALK inhibitor brigatinib. Ariad is shooting for a priority review that would cut the review process down to eight months. “We remain grateful to the FDA for granting brigatinib a breakthrough designation and the benefit of a rolling submission process, unique to the U.S. regulatory system,” said CEO Paris Panayiotopoulos.

Typically long on promises and short on performance, Inovio Pharmaceuticals has started another clinical trial for its zika vaccine. CEO Joseph Kim, who’s been criticized for leaping from pandemic to pandemic without actually seeing anything through to an approval, says the company will meet with regulators next year if the study proves promising.

The future looks good for the CRO industry. Not great or fantastic, but a lot better than it has been earlier in the decade. A new report out from KPMG notes that the industry appears headed for steady growth through 2019, with the largest organizations emerging from a major round of consolidation set to outperform the hundreds of smaller companies that still operate in biopharma. One of the big trends to look for here is a shift to China, where CRO work has been exploding. The CRO market was a modest $1.4 billion in 2007, but grew to $6.4 billion in ’14. That rapid growth rate underscores the growing role that emerging markets plays in this field, where costs can be considerably lower. The top 10 CROs dominate, with a global reach that leaves them with half of the market. The massive shakeout in the market over the past few years is also blurring the line between disciplines, a strategy that has helped drive growth in the CRO business.


Steady but tentative growth for CROs, from KPMG.


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