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Report Finds Speedy Drug Approval Process Boosts Biologics Market


Pharmaceutical Executive

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:

  • Monoclonal antibodies (mAbs) are the largest segment of the biologics market, followed by therapeutic proteins and vaccines. All three segments are growing at over 9% year-on-year.

  • The global biologics market is fairly concentrated, with ten biologics companies accounting for over 80% of sales. The US's Johnson & Johnson is in the lead, closely followed by Swiss company Hoffman-La Roche. Bristol-Myers Squibb, Glaxo Smith-Kline and AbbVie Inc. are other key players.

  • Therapeutic areas where the largest number of biologics are being developed are cancer, rare diseases, neurological disorders, autoimmune disorders, heart disease and stroke, diabetes, mental health disorders and Alzheimer's, in that order.

  • Consolidation, rationalization, and development-driven M&A are taking place, particularly in the vaccine segment. 

Read the full report here.


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