Newark, NJ, Sept. 15, 2020 (GLOBE NEWSWIRE) -- As per the report published by Fior Markets, the global healthcare regulatory affairs outsourcing market is expected to grow from USD 6.55 billion in 2019 and to reach USD 16.57 billion by 2027, growing at a CAGR of 12.3% during the forecast period 2020-2027.
The healthcare regulatory affairs outsourcing market is witnessing significant growth from the past years. This growth is attributed to increasing cost efficiencies, extensive documentation during drug manufacturing, and increasing research and development activities. The strict government regulations imposed by the regulatory authorities to hire skilled regulatory professionals capable of handling evaluation, registration, and compilation of regulatory compliant documentation will propel the market growth. Rising demand for speedy product approval, increasing investments in the regulatory information system to automate activities like regulatory publishing and operations is expected to influence market growth.
Healthcare regulatory affairs outsourcing is the regulatory policies that are implemented to ensure that companies comply with certain functioning standards in relation to their businesses. These policies are aimed at safeguarding the public health and welfare by ensuring the safety of healthcare and pharmaceutical products. The healthcare regulatory affairs outsourcing includes medical writing and publishing the regulatory documentation offered by quality control, experienced medical writers, and publishers that play an important role in developing high-quality documents for clinical research projects. Other outsourcing services include regulatory consulting, clinical trial applications, legal representations, and quality assurance and compliance. Moreover, ascertaining the advent of an increasing number of drugs in the clinical development process, regulatory affairs outsourcing is shifting more towards the healthcare sector. Healthcare regulatory affairs outsourcing services are in demand from mid-size pharma companies, large pharma companies, and various others.
Global healthcare regulatory affairs outsourcing market is expected to witness significant growth, owing to the increasing number of healthcare institutes and pharmaceutical companies that are outsourcing regulatory affairs to capitalize on the expertise and save cost available with the contract research organizations. Other factors influencing the market growth include increasing R&D activities, rising investments in the healthcare sector in developed and developing countries, and increasing collaborations between regulatory outsourcing and drug developers. The factors restraining the market growth are the risk associated with data security, system access, and loss of control and technological advances leading to pricing fluctuations.
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Key players operating in global healthcare regulatory affairs outsourcing market are Parexel International Corporation, Covance Group Ltd., Quintiles Transnational Holdings, Inc., ICON Plc., Pharmaceutical Product Development, Charles River Laboratories International, Inc., Medpace, Inc., KAI Research, Inc., and Medelis, Inc. To gain a significant market share in the global healthcare regulatory affairs outsourcing market, the key players are now focusing on adopting strategies such as product innovations, mergers & acquisitions, recent developments, joint venture, collaborations, and partnership. ICON Plc. and Covance Group Ltd are some of the leading players of the healthcare regulatory affairs outsourcing market.
- For instance, in March 2018, PAREXEL’s medical writing was introduced by Parexel International corporation to offer regulatory services.
- In April 2019, Citoxlab, a non-clinical contract research organization, was acquired by Charles River Laboratories International Inc. This acquisition was made to expand the product portfolio and strengthen its market position.
Regulatory Writing and Publishing segment dominated the market and held the largest share of 36.4% in the year 2019
On the basis of services, the global healthcare regulatory affairs outsourcing is segmented into legal representation, regulatory consulting, regulatory writing and publishing, and product registration and clinical trial application. Regulatory writing and publishing segment dominated the market and held the largest share of 36.4% in the year 2019. This growth is attributed to increasing demand for regulatory writing and publishing services, and increasing need for high-quality documents to support timely drug approval.
Pharmaceutical segment dominated the market and held the largest share of 28.09% in the year 2019
On the basis of end-user, the global healthcare regulatory affairs outsourcing is segmented into pharmaceutical, medical devices, food and beverages, and biotechnology. Pharmaceutical segment dominated the market and held the largest share of 28.09% in the year 2019. This growth is attributed to the rising need for efficient manufacturing and development of pharmaceutical products, adoption of full-time regulatory affairs outsourcing, and rising demand from small and mid-size companies.
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Regional Segment of Healthcare Regulatory Affairs Outsourcing Market
- North America (U.S., Canada, Mexico)
- Europe (Germany, France, U.K., Italy, Spain, Rest of Europe)
- Asia-Pacific (China, Japan India, Rest of APAC)
- South America (Brazil and Rest of South America)
- Middle East and Africa (UAE, South Africa, Rest of MEA)
On the basis of geography, the global healthcare regulatory affairs outsourcing market is classified into North America, Europe, Asia-Pacific, Middle East & Africa, and South America. North America region held a major share of 32.19% in the year 2019. This growth is attributed to increased focus on reducing investment cost and capitalize on the availability of cheap labor, rising concentration on the optimum utilization of resources, and changing regulatory scenarios across the region. The market in the Asia-Pacific region is expected to witness significant growth, owing to the availability of a large number of skilled labor at an affordable price, rapid expansion of healthcare companies, and increasing number of pharmaceutical companies.
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About the report:
The global healthcare regulatory affairs outsourcing market is analysed on the basis of value (USD billion). All the segments have been analysed on global, regional and country basis. The study includes the analysis of more than 30 countries for each segment. The report offers in-depth analysis of driving factors, opportunities, restraints, and challenges for gaining the key insights of the market. The study includes porter’s five forces model, attractiveness analysis, raw material analysis, and competitors’ position grid analysis.
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