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The Business Research Company, a research publisher and consulting firm, published its Biologics Global Market Report 2018. The report covers biologics, healthcare services, pharmaceutical drugs, and medical equipment markets.
The FDA is aiming to cut the time-to-market and the development costs for new drugs. This will help drive growth in the biologics market, where over 1,000 drugs are currently under development, to 9.6% year-on-year from its recent rate of 5.4%.
The changes being implemented or considered by the FDA include allowing organ-on-chip trials to be substituted for animal trials in the early stages of the process, allowing the inclusion of non-trial data from patients, and changing the end-point benchmark from proving that the drug extends overall survival to showing that it prolongs the time a patient lives without the disease getting worse. These changes will increase the rate of approvals in the US biologics market.
Some key findings from the report include:
Read the full report here.