New Revolution in Regulatory Affairs Outsourcing Market Size & Share to 2022-2032

The global regulatory affairs outsourcing market is anticipated to secure a market value of US$ 15.11 Bn by 2032 while expanding at a CAGR of 8% during the forecast period from 2022 to 2032. The rising number of product registrations and the growing clinical trial applications are key factors propelling the market growth.

In addition, the rapid development of the biotechnology and pharmaceutical industry is projected to hold significant opportunities for market expansion in the forthcoming period.
The growing pressure on personal pockets and the initiatives taken by various governments in the concerned field are likely to provide thrust to the industry’s growth. Also, the growing demand to reduce costs in the life-science sector is likely to create a significant demand for third-party services for regulatory affairs. In addition, the increasing application of efficacious software to keep a record of regulatory affairs is expected to augment the market size during the forecast period.

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The outbreak of the COVID-19 pandemic posed a major challenge across the globe which resulted in emergency usage of various equipment approved by FDA and EU, which boosted the market significantly during the lockdown period. Moreover, development of critical vaccines and drugs to counter the coronavirus threat has further widened prospects for the market.

Key Takeaways from the Market Study
• The global regulatory affairs outsourcing market to value US$ 7 Bn in 2022
• From 2015-2021, regulatory affairs outsourcing demand flourished at a 6.5% CAGR
• APAC to garner a market share of 37% in 2022 with respect to regulatory affairs outsourcing
• Clinical studies segment procured the largest market share of 46% in 2021.
• Based on end-user segment, the pharmaceutical companies segment to secure the largest market share of 38% in 2022.
“The advent of smart technology in the healthcare sector is likely to transform the sector in the coming time, benefitting the market considerably. “- says an analyst at Fact. MR.

Competitive Landscape

Key players of the global regulatory affairs outsourcing market take various initiatives to strengthen their influence across the globe and secure the forefront position in the market.

Some recent developments among key players:
• In July 2021, PRA Health Sciences, a CRO, was acquired by ICON. The company aims to bring together 38,000 employees across 47 countries and create the most advanced healthcare infrastructure and clinical research organization.
• In August 2021, ProPharma Group, disclosed its acquisition of iSafety, which is an Indian pharmacovigilance outsourcing service provider.

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More Valuable Insights

Fact.MR, in its new offering, presents an unbiased analysis of the global regulatory affairs outsourcing market, presenting historical market data (2015-2021) and forecast statistics for the period of 2022-2032.

The study reveals essential insights based on services (product registration & clinical trial applications, legal representation, regulatory consulting, regulatory writing & publishing and other services), category (biologics, drugs and medical devices), company size (small sized companies, medium sized companies and large sized companies), indication (immunology, neurology, cardiology, oncology and others), stage (pre-clinical, clinical and PMA (post market authorization)) and end use (medical device companies, pharmaceutical companies and biotechnology companies) across five major regions (North America, MEA, Latin America, Europe and Asia Pacific).

Fact.MR’s Domain Knowledge in Healthcare
Our healthcare consulting team guides organizations at each step of their business strategy by helping you understand how the latest influencers account for operational and strategic transformation in the healthcare sector. Our expertise in recognizing the challenges and trends impacting the global healthcare industry provides indispensable insights and support - encasing a strategic perspective that helps you identify critical issues and devise appropriate solutions.

Key Market Segments Covered in the Global Regulatory Affairs Outsourcing Market
• By Services
o Regulatory Consulting Outsourcing
o Legal Representation Outsourcing
o Regulatory Writing & Publishing Outsourcing
o Other Regulatory Affairs Outsourcing Services
• By Company Size
o Regulatory Affairs Outsourcing for Small Sized Companies
o Regulatory Affairs Outsourcing for Medium Sized Companies
o Regulatory Affairs Outsourcing for Large Sized Companies
• By Category
o Regulatory Affairs Outsourcing for Drugs
 Generics
 Innovators
o Regulatory Affairs Outsourcing for Biologics
 Biotech
 ATMPs
 Biosimilars
o Regulatory Affairs Outsourcing for Medical Devices
 Therapeutic
 Diagnostic
• By Indication
o Regulatory Affairs Outsourcing for Oncology
o Regulatory Affairs Outsourcing for Neurology
o Regulatory Affairs Outsourcing for Radiology
o Regulatory Affairs Outsourcing for Immunology
o Regulatory Affairs Outsourcing for Other Indications
• By Stage
o Pre-Clinical Regulatory Affairs Outsourcing
o Clinical Regulatory Affairs Outsourcing
o Post Market Authorization Regulatory Affairs Outsourcing
• By End Use
o Regulatory Affairs Outsourcing for Medical Device Companies
o Regulatory Affairs Outsourcing for Pharmaceutical Companies
o Regulatory Affairs Outsourcing for Biotechnology Companies
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