CONTRACT RESEARCH ORGANIZATION SERVICES MARKET ANALYSIS

Market Challenges And Opportunities

Contract Research Organization Services Market Dynamics

Increasing number of Food and Drug administration (FDA) approvals are supporting the growth of biopharma industry, which in turn is fuelling growth of the CROs market. According to article published in Nature, the U.S. FDA approved 46 novel drugs for various indication by the agency’s Center for Drug Evaluation and Research (CDER) in 2017 and 22 drugs in 2016. As the drug companies and few research institutes face challenges in marketing their product due to limited resources and huge capital investment, which decreases the affordability of errors in research work. Therefore CROs play an important role in reducing the cost of research and help in successful clinical development program, which is the most important step of drug development process. As developing a safe and efficacious biological product for human is demonstrated through clinical trials.

Furthermore, stringent regulatory policies for drug development make process more complex, as it required more resources to develop new drugs, devices, and biologics. These process requires expertise in broad scientific disciplines of preclinical, clinical, ancillary clinical in chemistry, packaging, manufacturing, project management, and regulatory affairs which are provided by the CRO’s, considered as a major reason for drug companies to outsource clinical trials to CROs. Besides, the pharmaceuticals & biopharmaceutical companies are collaborating to undergo clinical trials with CROs to undergo the drug development process.

For instance, in May 2018, Ritter Pharmaceuticals, Inc. a developer of novel therapeutic products signed an agreement with the clinical research organization (CRO) Medpace to conduct the first of two pivotal Phase 3 clinical trials for RP-G28 in patients with lactose intolerance (LI).