The TechSci Research report, “Regulatory Affairs Outsourcing Market – Global Industry Size, Share, Trends, Opportunity, and Forecast, 2018-2028F”, projects a strong growth rate for the global regulatory affairs outsourcing market from 2024 to 2028. The main factors driving this growth are the need for life sciences companies to reduce costs, the increasing use and demand of generic drugs and low-priced drugs & medical devices, and the uneven economic growth and cost-containment policies of various governments. Moreover, the rising number of new drug applications and the growing complexity of regulatory requirements are leading pharmaceutical companies to outsource their regulatory affairs to specialized service providers.
However, the global regulatory affairs outsourcing market faces some challenges, such as the difficulty of navigating different languages, cultures, and legal systems, the lack of standardization in regulatory affairs services, and the risk of errors and omissions due to outsourcing. These challenges may limit the growth of the market in the forecast period.
The Global Regulatory Affairs Outsourcing Market can be classified by service, category, company size, indication, products stage, end use, and region. The service segment includes regulatory consulting, legal representation, regulatory writing & publishing, product registration & clinical trial applications, regulatory submissions, regulatory operations, and other services. The market was dominated by the Legal Representation segment in 2022 and is projected to maintain its lead throughout the forecast period. This is due to the rising demand for legal representatives worldwide as medical devices and pharmaceutical companies expand globally. Moreover, the need for local experts for legal representation to obtain regulatory approvals and custom clearance is expected to drive the market growth during the forecast period.
The end user segment comprises medical device companies, pharmaceutical companies, and biotechnology companies. The Pharmaceuticals & Biotechnology Companies segment is anticipated to dominate the market during the forecast period because of the growth in emerging areas, such as biosimilar, orphan drugs, and personalized medicines, which create more demand for regulatory services and increased demand for biopharmaceuticals, vaccines, advanced medical devices, and other products.
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Major companies operating in the global Regulatory Affairs Outsourcing market are:
· Accell Clinical Research, LLC.
· Genpact Ltd.
· CRITERIUM, INC.
· Promedica International.
· WuXi AppTec Co Ltd.
· Medpace Inc.
· Charles River Laboratories.
· ICON plc.
· Covance, Inc.
· Parexel International Corporation.
· Freyr AS.
· PHARMALEX GMBH
· NDA Group AB
· Pharmexon Consulting.
· Qvigilance
· BlueReg Group.
In July 2021, ICON plc acquired a CRO involved in providing drug development and regulatory consulting services – PRA Health Sciences. This acquisition was aimed at enhancing the services portfolio of ICON plc.
In August 2021, ProPharma Group acquired iSafety Systems., an Indian pharmacovigilance service provider, for strengthening its market position in pharmacovigilance.
In April 2019, Charles River Laborateries International, Inc. purchased Citoxlab, a non-clinical contract research business. This purchase was undertaken to broaden the company’s product range and boost the market position.
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“North America is expected to dominate in the Global Regulatory Affairs Outsourcing Market on account due to growing research and development activity rising in the number of clinical trials along with presence of key players in the region and strategic collaborations by these companies. Similarly, the availability of a skilled workforce in the region at lower costs compared to the U.S. is another factor is expected to create lucrative growth in the market during the forecast period. Also, the presence of key pharmaceutical and medical device companies and the rise in R&D spending in the region is expected to drive the growth of the market during the forecast period. Furthermore, owing to the presence of two major international regulatory agencies, the European Medicines Agency (EMA) and the U.S. FDA, which regulate more than half of the medical devices worldwide will further be expected to create lucrative opportunities for market growth” said Mr. Karan Chechi, Research Director with TechSci Research, a research-based global management consulting firm.
“Regulatory Affairs Outsourcing Market – Global Industry Size, Share, Trends, Opportunity, and Forecast, 2018-2028F” Segmented By Service (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product registration & clinical trial applications, Regulatory Submissions, Regulatory Operations, Other services), By Category (Pharmaceutical, Medical Device), By Company Size (Small Companies, Medium Companies, Large Companies), By Indication (Oncology, Neurology, Cardiology, Immunology, Other Indications), By Product Stage (Preclinical, Clinical, Premarket Approval), By End Use (Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies), By Region and By Competition”, has evaluated the future growth potential of global Regulatory Affairs Outsourcing market and provides statistics & information on market size, structure, and future market growth. The report intends to provide cutting-edge market intelligence and help decision-makers take sound investment decisions. Besides, the report also identifies and analyzes the emerging trends along with essential drivers, challenges, and opportunities in the Global Regulatory Affairs Outsourcing market.
Table Of Content –
1. Product Overview
1.1. Market Definition
1.2. Scope of the Market
1.2.1. Markets Covered
1.2.2. Years Considered for Study
1.2.3. Key Market Segmentations
2. Research Methodology
2.1. Objective of the Study
2.2. Baseline Methodology
2.3. Key Industry Partners
2.4. Major Association and Secondary Sources
2.5. Forecasting Methodology
2.6. Data Triangulation & Validation
2.7. Assumptions and Limitations
3. Executive Summary
3.1. Overview of the Market
3.2. Overview of Key Market Segmentations
3.3. Overview of Key Market Players
3.4. Overview of Key Regions/Countries
3.5. Overview of Market Drivers, Challenges, Trends
4. Voice of Customer
5. Global Regulatory Affairs Outsourcing Market Outlook
5.1. Market Size & Forecast
5.1.1. By Value
5.2. Market Share & Forecast
5.2.1. By Service (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product registration & clinical trial applications, Regulatory Submissions, Regulatory Operations, Other services)
5.2.2. By Category (Pharmaceutical, Medical Device)
5.2.3. By Company Size (Small Companies, Medium Companies, Large Companies)
5.2.4. By Indication (Oncology, Neurology, Cardiology, Immunology, Other Indications)
5.2.5. By Product Stage (Preclinical, Clinical, Premarket Approval)
5.2.6. By End Use (Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies)
5.2.7. By Region (North America, Europe, Asia Pacific, South America, Middle East & Africa)
5.2.8. By Company (2022)
5.3. Market Map
5.3.1 By Service
5.3.2 By Category
5.3.3 By Company Size
5.3.4 By Indication
5.3.5 By Product Stage
5.3.6 By End Use
……………….
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