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.
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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).
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The Contract research organization players are involved in acquisition to expand the geographical presence of the CROs. For instance, in April 2018, Frontage Laboratories, Inc. an early-stage contract research organization located in China and the U.S. acquired Concord Biosciences, a preclinical organization based in Cleveland, OH aiming the company’s goal to build a global CRO with integrated services. Furthermore, in May 2018, RxCelerate acquired Total Scientific, a CRO focused in bioanalysis, protein assays and gene-phenotype association.
Key players operating in the global contract research organization services market include IQVIA, LabCorp, PAREXEL, ICON plc, PPD, PRA Health Sciences, Syneos Health, Charles River, Wuxi PharmaTech, Medpace Holdings, SGS, Envigo, and MPI Research.
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