- Industry organizer CPhI is predicting increased growth in U.S. contract manufacturing markets, as regulatory oversight weighs on Indian and Chinese pharmaceutical production, according to a new report cited by Outsourcing-Pharma.
- As the U.S. biosimilar market begins to heat up, specialist manufacturing in the U.S. appears more attractive.
- Overall, the report sees the US CMO market as likely to grow substantially, perhaps faster than the pharma industry as a whole.
Together, India and China produce roughly 80% of the active pharmaceutical ingredients in the world's drugs. As concerns over quality have mounted, the FDA has increased its regulatory scrutiny of both Indian and Chinese pharmaceutical suppliers.
In 2015, nearly a third of the warning letters issued by the FDA's Center for Drug Evaluation and Research (CDER) were tied to violations of safe manufacturing practices in India-based facilities. CDER sent a total of 12 such letters last year, and has sent two so far this year.
This increased regulatory pressure could make U.S. based contract manufacturing more attractive, particularly as the U.S. biosimilar market heats up. Biologics are often more complicated and difficult to manufacture than small-molecule pharmaceuticals.
An FDA advisory panel recently recommended Celltrion and Pfizer's Remicade copycat, setting up a future approval—which would be only the 2nd biosimilar approved in the U.S.
The CPhI report claims international companies with a developmental base in the U.S. coupled with generic facilities abroad are particularly well-positioned to take advantage of CMO growth.