According to our new market research study on “Healthcare Regulatory Affairs Outsourcing Market to 2028 – Global Analysis and Forecast – by service type, and end user,” the market is expected to reach US$ 14,996.35 million by 2028 from US$ 7,274.73 million in 2021; it is expected to grow at a CAGR of 10.9% from 2021 to 2028. The report highlights trends, drivers, and hindrances pertaining to the market growth.
Factors such as increasing regulatory pressure on healthcare companies and escalating demand for speedy approval of new products boost the growth of the healthcare regulatory affairs outsourcing market. However, dearth of skilled professionals hamper the market growth.
Regulatory affairs outsourcing is the services offered to the pharmaceutical, biotech, and medical devices manufacturing industries. Regulatory affair outsourcing services help to achieve fast regulatory approvals. Regulatory affairs outsourcing industries are helping to get approval for new products, preparing protocols for conducting a clinical trial, publishing reports etc. An increase in demand for various services like regulatory consultation, medical writing and publishing of the regulatory documentation, clinical trial applications, and regulatory consulting and legal representations, patent application, product registration, and clinical trial applications has resulted in a surge in the adoption of healthcare regulatory affairs outsourcing business.
Market leaders operating in the market have undertaken various organic growth strategies in the behavioral rehabilitation market. The behavioral rehabilitation market majorly consists of the players KLIFO, ProPharma Group, Arriello Ireland Ltd., DRA CONSULTING OY, Asphalion S.L, Parexel International Corporation, IQVIA Inc., Pharmalex Gmbh, ProductLife Group, Voisin Consulting Life Sciences (VCLS) and Azierta Contract Science Support Consulting. The companies have been implementing various strategies that have helped the growth of the company and in turn have brought about various changes in the market. The companies have utilized organic strategies such as launches, expansion, and product approvals. Moreover, the companies have utilized inorganic strategies including mergers & acquisitions, partnership, and collaborations.
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IQVIA Feb-2019
Product Launch IQVIA has launched IQVIA RIM Smart, the first fully integrated, cloud-based, end-to-end regulatory information management solution for life sciences. RIM Smart can automate high-volume tasks, efficiently boosting accuracy, improving data quality, and reducing costs.
ProductLife Group Sep-2021
Mergers and Acquisitions ProductLife Group (PLG) has acquired US regulatory drug development consultancy DS INPHARMATICS (DSI) with this acquisition ProductLife Group has expanded its operations in United States.
ProPharma Group Aug-21
Mergers and Acquisitions The company announced the acquisition of India based iSafety Systems. This acquisition pursue to strengthen ProPharma Group’s position as the prime global provider of regulatory and compliance consulting, pharmacovigilance, clinical research services, and medical information.
ProPharma Group May-21
Mergers and Acquisitions Propharma Group announced that the company has entered into a definitive agreement to merge with "The Planet Group". The merger will accelerate growth opportunities as well as support ProPharma Group’s higher purpose of enhancing patient health and safety and Planet’s mission.
Asphalion Feb-20
Mergers and Acquisitions
Asphalion S.L announced that the company has entered into a new collaboration with Maria Molist for the providing pharmacovigilance/regulatory services in the UK.
Based on service type, the healthcare regulatory affairs outsourcing market is segmented into Regulatory & Scientific Strategy Development, Medical & Scientific Writing, eCTD & e-Submissions, Data Management Services, Life Cycle Management Services, Pharmacovigilance, Chemistry Manufacturing & Controls (CMC) Services, Regulatory Labelling, Regulatory Artwork Services. The Medical & Scientific Writing segment is expected to hold a larger market share in 2021, and Pharmacovigilance segment is further anticipated to register a higher CAGR during the forecast period. Based on end user, the healthcare regulatory affairs outsourcing market is segmented into pharmaceutical companies, biotechnology companies, medical devices companies. The pharmaceutical companies segment would account for a larger market share in 2021. The market for the pharmaceutical companies segment is estimated to grow at a higher CAGR from 2021 to 2028.
By Geography
- North America
- US
- Canada
- Mexico
- Europe
- France
- Germany
- UK
- Spain
- Italy
- Rest of Europe
- Asia Pacific (APAC)
- China
- India
- Japan
- Australia
- South Korea
- Rest of APAC
- Middle East and Africa (MEA)
- Saudi Arabia
- UAE
- South Africa
- Rest of MEA
- South and Central America (SCAM)
- Brazil
- Argentina
- Rest of SCAM
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