The regulatory affair outsourcing companies are responsible for keeping track about the regulatory requirements specific to regions, in order to ensure that the company have successfully launches and commercializes pharmaceutical products, medical devices, biologics, and functional foods. If the product does not meet the regulatory guidelines, it can be recalled resulting in huge loss. Regulatory affairs outsourcing activities to the contract research organization (CROs) offers cost efficiency, reduced regulatory submission time, and quality control in all over manufacturing process.
Regulatory Affairs Outsourcing Market - Drivers
Increasing research and development expenditure is a major factor driving the regulatory affairs outsourcing market growth during the forecast period. For instance, according to Pharmaceutical Research and Manufacturers of America, in 2016, the biopharmaceutical industry invested an estimated $90 billion in research and development in the U.S.
Increase in demand for various services offered by contract research organization (CRO) to pharmaceutical industry is expected to drive the regulatory affairs outsourcing market growth during the forecast period. CRO offers a variety of drug development services including clinical trial management, medical and safety monitoring, data management, and medical writing.
Regulatory Affairs Outsourcing Market-Restraints
Price fluctuation and hidden cost of regulatory affairs outsourcing services are major factors restraining the regulatory affairs outsourcing market growth. The prices of the services are not stated clearly in the healthcare regulatory affairs outsourcing sources and the fluctuations differs with the extra costs are involved in the services with the increasing use of technological platforms such as software for the clinical data management, content management, data base and document management.
Regulatory Affairs Outsourcing Market-Regional Analysis
North America is expected to hold dominant position in the regulatory affairs outsourcing market during the forecast period, owing to increased stringent government regulations and automation in regulatory affairs. For instance, according to the U.S. department of health and human service (HHS), implement the drug price ceiling and civil monetary penalties for manufactures under the 340B Drug Pricing Program in 2018. Moreover, in January 2019, Health Resource and Service Administration (HRSA) enforced the rule for creating an environment of uncertainty for life science industry in the U.S.
Asia pacific is expected to witness significant growth over the forecast period, owing to increasing number of biopharmaceutical companies and healthcare expenditure in India.
Regulatory Affairs Outsourcing Market-Competitive Landscape
Key players operating in the regulatory affairs outsourcing market include Criterium, Inc., Covance, Inc., Clinilabs, Inc., Charles River Laboratories International, Inc., and Accell Clinical Research, LLC.
Regulatory Affairs Outsourcing Market- Taxonomy
The Regulatory Affairs Outsourcing Market is segmented on the basis of Service type and region.
By Service Type
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