In-vivo contract research organizations (CROs) are those institutions engaged in biopharmaceutical research on a contractual basis. With the growing popularity of biologics over small molecule drugs, the popularity of in-vivo CROs are gaining traction. Given high competition in development of mABs the CROs are increasing focus on development of biosimilars. Pipeline focus is shifting from development of standard format mABs to development of bispecifics or, biosimilars. With increasing demand for clinical scale manufacturing of active pharmaceutical ingredients, integrated contract research, development, and manufacturing organizations (CDMOs) are gaining wider revenue footprint across all regions. Key trends making the CRO marketplace increasingly competitive include frequent mergers and partnerships for smaller companies by larger companies in order to emerge as an “One-Stop- Shop” and simultaneously enhance international geographical footprint. Few others are focusing on catering niche sectors through execution of functional service provider (FSP) contracts. These contracts allow clients to outsource individual services instead of entire studies or projects. Increasing demand for CRO services is fostering the growth of employment in new clinical research jobs and hence clinical recruitment agencies in major hubs throughout Europe, the USA, and emerging markets in Asia Pacific countries.
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It is important to understand the long and complex drug development process in the U.S. before analyzing the role of CROs. As the advancement of technology for in- vivo CROs present in various regions, increase in healthcare spending by government and availability of grants and funding from government organizations. Asia Pacific are expected to record robust growth due to growing health care industry, economic development and huge patient base affects the growth of in- vivo CRO market.
Revenue drivers for the market include high R&D cost for development of biologic drugs. Market estimates in this regard note that development of biologics cost US$ 22 per day as compared to US$ 1 per day, for development of small molecule drugs in oral solid dosage formulations. Challenges for the in-vivo CROs include growing product complexity, poor stability of drugs, and easy product-associated contamination. Purification of biologics is known to be a capital-intensive process and there is limited skill base needed for seamless execution of such processes. There is increased demand for bulk development of mABs, chemical conjugation services, which requires extensive process and product knowledge.
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Some of the major market players in In-vivo contract research organization globally include American Preclinical Services, LLC., BTS Research, Charles River Laboratories International, Inc., Chiltern International Ltd., Covance Inc., ICON Plc., INC Research, inVentiv Health, PAREXEL International Corporation, Pharmaceutical Product Development, LLC., PRA Health Sciences, Quintiles Inc. and WuXi AppTec, Inc.
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