Regulatory Affairs Industry Overview

The global regulatory affairs market size was valued at USD 11.8 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 8.4% from 2021 to 2028. 

This growth can be attributed to the increasing demand for the faster approval process, changing regulatory landscape, growth in emerging fields such as specialty therapies, orphan drugs, personalized medicines, and companion diagnostics. The market for regulatory affairs is also driven by the emergence of new diseases triggering the need for effective vaccines and therapies.

Gather more insights about the market drivers, restrains and growth of the Global Regulatory Affairs Market

The growing pace of innovation in digital health and the rapid technological advancements in data collection, analysis, and management is anticipated to create a need for digital transformation in one or more regulatory processes in order to improve the access and analysis of the continuously growing volume of information due to connected health products and programs. Furthermore, even several pharma/biotech companies are anticipated to upgrade their existing technologies to meet the growing healthcare needs. For instance, according to the 2018 Steve Gens Report, nearly 58% of survey pharma companies planned to enhance their Regulatory Intelligence (RI) capability while another study mentioned that 20 out of 22 participating companies considered leveraging AI for RI data processing activities. 

Presently, the healthcare industry is focused not only on the development of blockbuster therapies for the treatment of various diseases but also on targeted gene therapies, specialty drugs, and precision medicine that help treat specific diseases and disorders. Furthermore, some of these products are also being combined with medical devices to enhance the quality of drug delivery, dose, and patient monitoring or adherence, thus increasing the complexity of defining the regulatory strategy and pathway to market.

Furthermore, launched or soon to be launched therapies, such as AbbVie’s JAK1 inhibitor, Alexion’s Ultomiris, Novartis/Avexis’ Zolgensma, Boehringer Ingelheim/AbbVie’s Skyrizi, Aimmune’s Palforzia, and bluebird bio’s Zynteglo, are expected to be blockbusters products by 2023, indicating huge opportunities in areas of intellectual property rights, commercialization strategies, and post-marketing strategies. 

Browse through Grand View Research's Medical Devices Industry Research Reports.

• Regulatory Affairs Outsourcing Market – The global regulatory affairs outsourcing market size was estimated at USD 6.5 billion in 2021 and is anticipated to expand at a compound annual growth rate (CAGR) of 8.9% from 2022 to 2030. The outsourcing of regulatory affairs has become an increasingly important practice in the healthcare industry. An increase in geographical expansion activities by companies that aim for speedy approvals in local markets is expected to contribute to the adoption of outsourcing models for regulatory services. 
• U.S. Medical Device Outsourcing Market – The U.S. medical device outsourcing market size was valued at USD 23.3 billion in 2021 and is anticipated to exhibit a compound annual growth rate (CAGR) of 11.2% over the forecast period. The COVID-19 pandemic in 2020 had delayed medical procedures; thereby, creating a challenging environment for the manufacturers. Many companies had temporarily ceased their research & development activities due to complete lockdowns.

Regulatory Affairs Market Segmentation

Grand View Research has segmented the global regulatory affairs market report on the basis of service, service provider, categories, product stage, company size, end use, indication, and region:

1. Regulatory consulting
2. Legal representation
3. Regulatory writing & publishing
4. Product registration & clinical trial applications
5. Other services 

1. Drugs
   • Innovator
     • Preclinical
     • Clinical
     • Post market
   • Generic
     • Preclinical
     • Clinical
     • Post market
2. Biologics
   1. Biotech
      • Preclinical
      • Clinical
      • Post market
   2. ATMP
      • Preclinical
      • Clinical
      • Post market
   3. Biosimilars
      • Preclinical
      • Clinical
      • Post market
3. Medical devices
   1. Diagnostics
      • Preclinical
      • Clinical
      • Post market
   2. Therapeutics
      • Preclinical
      • Clinical
      • Post market 

• Oncology
• Neurology
• Cardiology
• Immunology
• Others

• Preclinical
• Clinical
• PMA

• Medical Device Companies
• Biotechnology Companies
• Pharmaceutical Companies 

• In-house
• Outsourced 

• Small
• Medium
• Large 

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa (MEA)

Market Share Insights

Key Companies profiled:

Some of the prominent players in the regulatory affairs market include:

• Accell Clinical Research, LLC.
• GenPact Ltd.
• Criterium, Inc.
• PRA Health Sciences
• Promedica International
• WuXi AppTec, Inc.
• Medpace
• Pharmaceutical Product Development, LLC (PPD)
• Charles River Laboratories International, Inc.
• ICON plc
• Covance
• Parexel International Corporation, Inc.
• Freyr 

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About Grand View Research

Grand View Research, U.S.-based market research and consulting company, provides syndicated as well as customized research reports and consulting services. Registered in California and headquartered in San Francisco, the company comprises over 425 analysts and consultants, adding more than 1200 market research reports to its vast database each year. These reports offer in-depth analysis on 46 industries across 25 major countries worldwide. With the help of an interactive market intelligence platform, Grand View Research Helps Fortune 500 companies and renowned academic institutes understand the global and regional business environment and gauge the opportunities that lie ahead.

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