In this week’s news, the CDMO sector set for growth but there will be challenges, US FDA sees lower contractor fees and more…

CDMOs should see growth in 2020, but there are risks

Upcoming US elections, uncertainties surrounding trade and efforts to control drug prices could impact growth of the pharmaceutical contract manufacturing sector says DCAT.

Last year was a big year for contractors according to the report, which states “Many CDMOs experienced double-digit growth, and the key indicators of opportunity for CDMOs, although down from the blowout levels of 2018, performed well.”

In general the authors predicted the growth would continue in 2020, citing robust industry pipelines and growing interest in innovative hard to make therapies as likely drivers.


However, they also identify some potential challenges.

“Risks to that outlook include events that are not specific to the biopharma industry, e.g., a stock-market correction, the upcoming US elections, or uncertainties surrounding trade. Efforts to control drug prices in the US could have a negative impact but are unlikely to have much impact near term.

The authors also suggest trends in the types of medicines being developed could impact outsourcing.

“Clinical and commercial setbacks to major classes of drugs like those experienced for treatments for non-alcoholic steatohepatitis (NASH), Alzheimer’s and infection, could hurt funding for some segments of the pipeline.”

See full report here.

CMO facility fees paid to US FDA fall for third year in a row

The number of CMO facilities approved to make drugs for the US market is falling according to US FDA data.

According to a post on the US Food and Drug Administration’s (FDA) site, user fees paid by contractors producing medicines for the US have fallen for the third year in a row.

Pharmacompass took a closer look at emerging trends.

Also in the news

Janet Woodcock director of the Center for Drug Evaluation and Research has said the FDA will focus on issues including opioid abuse, compounding and shortages in 2020. Read more at Inside Health Policy.

The Hill looked at the pharmaceutical industry’s efforts to influence drug and healthcare policy in the US.

Bioprocess International examined dynamics in cell and gene therapy production. The article focuses on viral vector capacity in the sector.

Regeneron shared details of its bispecific monoclonal antibody development programme at the JP Morgan Healthcare conference in the US last week.

Hackers are targeting biopharma according to a report in GEN. Experts quizzed by the publication suggest developers need to do more to protect themselves or risk manufacturing interruptions.

CDMO trends

Some developments of note in the contracting space.

Civica Rx has signed a long-term agreement with Thermo Fisher Scientific to develop and manufacture medications. See press release.

BridgeBio Pharma has reserved capacity at Catalent Paragon’s gene therapy facility in Harmans, Maryland. The deal will support production of BridgeBio’s candidates for congenital adrenal hyperplasia, BBP-631, and Canavan disease, BBP-812.

Apceth has started commercial manufacture of Blubird Bio’s Zynteglo thalassemia gene therapy at its facility in Germany. See press release.

Wuxi Biologics has announced plans to buy Bayer’s drug manufacturing facility in Leverkusen, Germany. The plant will serve as a back-up site for the manufacture of Bayer’s Kovaltry, product. See press release.