Europe And North America Are Expected To Account For 60% Of Global Regulatory Affairs Outsourcing Demand; States Fact.MR
07 Jul 2022
AntibodyGeneric DrugBiosimilarVaccineADC
Rapid Growth Of The Pharmaceutical And Biotechnology Sectors Is Likely To Offer Significant Growth Opportunities To The Regulatory Affairs Outsourcing Market.
Fact.MR, a market research and competitive intelligence provider: 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 rising demand to reduce costs in the life-sciences industry is enhancing the demand for third-party services for regulatory affairs.
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
The players of the global regulatory affairs outsourcing market focus on expanding their global influence. Some of the adopted strategies are partnerships, collaborations, and acquisitions. Recent key developments among key players are:
In August 2021, ProPharma Group, a portfolio company of Odyssey Investment Partners, announced the acquisition of iSafety Systems. iSafety is an Indian pharmacovigilance outsourcing service provider.
In July 2021, ICON plc acquired a CRO, called PRA Health Sciences. The objective of the acquisition was to increase the services portfolio of ICON plc. The company plans to continue its original name, ICON. It aims to bring together 38,000 employees across 47 countries and create the most developed clinical research organization and healthcare intelligence.
For Comprehensive Insights Ask An Analyst Here Key Market Segments Covered in the Global Regulatory Affairs Outsourcing Market
By Services
Regulatory Consulting Outsourcing
Legal Representation Outsourcing
Regulatory Writing & Publishing Outsourcing
Other Regulatory Affairs Outsourcing Services
By Company Size
Regulatory Affairs Outsourcing for Small Sized Companies
Regulatory Affairs Outsourcing for Medium Sized Companies
Regulatory Affairs Outsourcing for Large Sized Companies
By Category
Regulatory Affairs Outsourcing for Drugs
Generics
Innovators
Regulatory Affairs Outsourcing for Biologics
Biotech
ATMPs
Biosimilars
Regulatory Affairs Outsourcing for Medical Devices
Therapeutic
Diagnostic
By Indication
Regulatory Affairs Outsourcing for Oncology
Regulatory Affairs Outsourcing for Neurology
Regulatory Affairs Outsourcing for Radiology
Regulatory Affairs Outsourcing for Immunology
Regulatory Affairs Outsourcing for Other Indications
By Stage
Pre-Clinical Regulatory Affairs Outsourcing
Clinical Regulatory Affairs Outsourcing
Post Market Authorization Regulatory Affairs Outsourcing
By End Use
Regulatory Affairs Outsourcing for Medical Device Companies
Regulatory Affairs Outsourcing for Pharmaceutical Companies
Regulatory Affairs Outsourcing for Biotechnology Companies
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).
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About Healthcare Division at Fact.MR
Expert analysis, actionable insights, and strategic recommendations of the highly seasoned healthcare team at Fact.MR helps clients from across the globe with their unique business intelligence needs. With a repertoire of over thousand reports and 1 million-plus data points, the team has analyzed the healthcare industry across 50+ countries for over a decade. The team provides unmatched end-to-end research and consulting services.
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