Rising demand for regulatory affairs outsourcing services in the healthcare industry is one of the key drivers for market growth
The global healthcare regulatory affairs outsourcing market size is expected to reach USD 16.67 billion in 2028 and register a revenue CAGR of 12.5% over the forecast period, according to the latest report by Reports and Data. Market revenue growth is significantly driven by increasing R&D activities across the pharmaceutical and biotechnology sectors, rising volumes of clinical trial applications, and growing need for timely product registration and approvals. Healthcare regulatory affairs outsourcing services predominantly include regulatory writing & publishing, regulatory submissions, clinical trial application, product registration, and regulatory consulting and legal services offered by highly experienced medical writers, publishers, and quality control (QC) auditors. These services are mostly utilized by large and mid-sized pharmaceutical companies, biotechnology companies, and medical device manufacturing companies. Regulatory affairs outsourcing ensures that these companies strictly comply with the product quality and safety standards and policies set by regulatory authorities.
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The global Healthcare Regulatory Affairs Outsourcing market is expected to reach. This can be attributed to factors such as rising prevalence of chronic diseases, infections, rapidly growing healthcare and medical sectors, improving healthcare infrastructure and research centers, and increasing adoption of latest equipment and medical devices in medium to large scale hospitals, clinics and ambulatory care centers. In addition, high adoption of latest treatment facilities across several healthcare sectors, government initiatives to create awareness about diseases, increasing funds by public and private sectors, and growing demand for home care devices and point of care diagnosis are expected to fuel global market revenue growth going ahead.
Competitive Landscape:
The report also covers the competitive landscape with extensive profiling of the key competitors. It covers recent product developments, joint ventures, product launches, technological advancements, mergers and acquisitions, collaborations, and partnerships. Some of the key players operating in the global market are Covance Group Ltd., Parexel International Corporation, Accell Clinical Research LLC, Clinilabs Inc., Pharmaceutical Product Development, Medelis Inc., Freyr Solutions, Quintiles Transnational Holdings, Inc., Charles River Laboratories International, Inc., KAI Research, Inc., Medpace Inc., Criterium Inc., Cardinal Health, IQVIA, and ICON Plc.
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Market segment analysis:
By Region:
· North America
o U.S.
o Canada
o Mexico
· Europe
o Germany
o U.K.
o Italy
o France
o BENELUX
o Rest of Europe
· Asia Pacific
o China
o India
o Japan
o South Korea
o Rest of APAC
· Latin America
o Brazil
o Rest of LATAM
· Middle East & Africa
o Saudi Arabia
o U.A.E.
o South Africa
o Rest of MEA
By Type:
Service Type Outlook (Revenue, USD Billion; 2018-2028)
- Regulatory writing & publishing
- Regulatory submissions
- Clinical Trial Applications
- Product Registrations
- Regulatory Consulting and Legal Representation
- Others
Stage Outlook (Revenue, USD Billion; 2018-2028)
- Clinical
- Preclinical
- PMA (Post Market Authorization)
Category Outlook (Revenue, USD Billion; 2018-2028)
- Drugs
- Generics
- Innovators
- Biologics
- Biotech
- ATMPs
- Biosimilars
- Medical devices
- Therapeutic
- Diagnostic
End-use Outlook (Revenue, USD Billion; 2018-2028)
- Pharmaceutical Companies
- Biotechnology Companies
- Medical Device Companies
Some Key Highlights from the Report:
· Based on service type, the regulatory writing & publishing segment accounted for the highest revenue share of around 40% in 2020. Increasing need for high-quality, comprehensive and convincing regulatory filing documents and rising demand for regulatory writing & publishing services among healthcare companies including medical device and biopharmaceutical companies are key factors supporting the growth of this segment.
· The clinical stage segment held the largest revenue share in 2020 and is expected to register the highest revenue CAGR over the forecast period. Growing number of clinical trial registrations and increasing development of biologics and personalized orphan drugs the major factors expected to fuel this segment’s growth.
· Based on end-use, the pharmaceutical companies segment is projected to register the highest CAGR during the forecast period. Factors majorly contributing to this segment’s growth are growing need for development of advanced pharmaceutical products, increasing number of clinical trials, and surging need for regulatory affairs outsourcing services.
· Among regional markets, the North America market was the most dominant in terms of revenue share contribution in 2020. Increasing life sciences research & development programs, rise in drug discovery & development activities, growing number of clinical trials, and presence of leading pharmaceutical and biotechnology companies in the region are the most important factors accounting for the North America market growth.
· Some of the most noted companies in the global healthcare regulatory affairs outsourcing market include Covance Group Ltd., Parexel International Corporation, Accell Clinical Research LLC, Clinilabs Inc., Pharmaceutical Product Development, Medelis Inc., Freyr Solutions, Quintiles Transnational Holdings, Inc., Charles River Laboratories International, Inc., KAI Research, Inc., Medpace Inc., Criterium Inc., Cardinal Health, IQVIA, and ICON Plc.
· In July 2020, Covance Group Ltd. completed the acquisition of GlobalCare, a leading provider of patient-centric decentralized clinical trials (DCTs) solutions. Through this development, Covance looks to cater to the escalating demand for DCT solutions and support ongoing clinical trials in various therapeutic areas including personalized medicine and genomics.
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