Regulatory Affairs Outsourcing Market To Reach $11.31 Billion By 2030

Regulatory Affairs Outsourcing Market Growth & Trends

The global regulatory affairs outsourcing market size is expected to reach USD 11.31 billion by 2030, registering a CAGR of 8.3% over the forecast period, according to a new report by Grand View Research, Inc. Significant increase in the fixed costs of in-house resources for regulatory affairs & operation activities like training, technology, specialized knowledge, and facilities are driving outsourcing of regulatory affair functions. Addressing local regulatory challenges and constant changes in the regulations of the major markets, such as the U.S., Europe, and Asia, is creating demand for these services. Compliance with the current regulations has become an immense chore, leave alone trying to stay up to date with developments around the world. Amendments to current regulations are likely to simplify the regulatory pathway for the industry but in turn, complicate the operation for healthcare product manufacturing companies. Thus, leading to the regulatory affairs outsourcing to service providers.

The market witnessed a significant decline in 2020 due to the outbreak of the COVID-19 pandemic, as there was a halt in clinical trial activities including regulatory updates. Disruption in the supply chain and closure of R&D sites resulted in a significant loss of revenues in 2020 across the industry. However, due to the pandemic, various healthcare companies are opting for more regulatory advice, as companies push to speed up the product development & approvals in therapies, vaccines, & devices for COVID-19. Owing to the urgent need for medical devices and therapies for COVID-19, regulatory authorities are providing emergency use authorization for the majority of products. Such actions have further promoted the demand for these services post 2022 and the positive rebound of sales across the industry can be witnessed from 2023.

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Regulatory Affairs Outsourcing Market Report Highlights

• The product registration and clinical trial applications segment dominated the market and accounted for the largest revenue share of over 26.0% of the global revenue. The increasing number of clinical trials across the globe, stringent regulations in developed markets, and legal/regulatory reforms in emerging markets such as Asia Pacific are driving the outsourcing trend for clinical trial applications.

• The large companies segment is projected to register a significant growth rate of 7.7% over the forecast period. The availability of a wide variety of services and the presence of these providers in various geographies are the key factors driving the segment’s growth.

• The clinical studies stage segment accounted for the largest market share of 46.8% in 2023 due to the increasing demand for clinical trials in developing countries.

• The pharmaceutical companies by end-use segment is anticipated to witness the fastest growth rate of 8.2% over the forecast period due to evolving areas, such as orphan drugs and personalized therapies.

• Drugs segment dominated the market and accounted for the largest share of 39.7% in 2023. The segment is currently leading the regulatory affairs outsourcing market due to the increasing demand for regulatory support services in the pharmaceutical industry.

• Asia Pacific held the maximum revenue share of 39.9% in 2023, owing to higher off shoring of such services into regions of economic benefits and the expansion of life sciences companies in countries, such as India & China

Regulatory Affairs Outsourcing Market Segmentation

Grand View Research has segmented the global regulatory affairs outsourcing market based on category, company size, indication, product stage, service, end-use and region:

Regulatory Affairs Outsourcing Service Outlook (Revenue, USD Million, 2018 - 2030)

• Regulatory Consulting

  • Strategy & Development Planning

  • QA Consulting

  • Others

• Legal Representation

• Regulatory Writing & Publishing

• Product Registration & Clinical Trial Applications

• Regulatory Submission

• Regulatory Operations

• Other Services

Regulatory Affairs Outsourcing Company Size Outlook (Revenue, USD Million, 2018 - 2030)

• Small

• Medium

• Large

Regulatory Affairs Outsourcing Category Outlook (Revenue, USD Million, 2018 - 2030)

• Pharmaceuticals

  • Regulatory Consulting

    • Strategy & Development Planning

    • QA consulting

    • Others

  • Legal Representation

  • Regulatory Writing & Publishing

  • Product Registration & Clinical Trial Applications

  • Regulatory Submissions

  • Regulatory Operations

  • Other Services

• Medical Device

  • Regulatory Consulting

    • Strategy & Development Planning

    • QA Consulting

    • Others

  • Legal Representation

  • Regulatory Writing & Publishing

  • Product Registration & Clinical Trial Applications

  • Regulatory Submissions

  • Regulatory Operations

  • Other Services

Regulatory Affairs Outsourcing Indication Outlook (Revenue, USD Million, 2018 - 2030)

• Oncology

• Neurology

• Cardiology

• Immunology

• Others

Regulatory Affairs Outsourcing Product Stage Outlook (Revenue, USD Million, 2018 - 2030)

• Preclinical

• Clinical

• PMA (Post Market Authorization)

Regulatory Affairs Outsourcing End-use Outlook (Revenue, USD Million, 2018 - 2030)

• Medical Device Companies

• Pharmaceutical Companies

• Biotechnology Companies

Regulatory Affairs Outsourcing Regional Outlook (Revenue, USD Million, 2018 - 2030)

• North America

  • U.S.                    

  • Canada

• Europe

  • U.K.

  • Germany

  • France

  • Italy

  • Spain

  • Russia

  • Turkey

  • Netherlands

  • Switzerland

  • Sweden

  • Europe CIS Countries

• Asia Pacific

  • Japan

  • China

  • India

  • Australia

  • South Korea

  • Indonesia

  • Malaysia

  • Singapore

  • Thailand

  • Taiwan

  • CIS Countries

• Latin America

  • Brazil

  • Mexico

  • Argentina

  • Colombia

  • Chile

• Middle East & Africa

  • South Africa

  • Saudi Arabia

  • UAE

  • Egypt

  • Israel

  • Kuwait

List of Key Players of Regulatory Affairs Outsourcing Market

• Accell Clinical Research, LLC

• Genpact

• CRITERIUM, INC

• Promedica International

• WuXi AppTec

• Medpace

• Charles River Laboratories

• ICON plc

• Labcorp Drug Development

• Parexel International Corporation

• Freyr

• PHARMALEX GMBH

• NDA Group AB

• Pharmexon

• Qvigilance

• BlueReg

• Cambridge Regulatory Services

• APCER Life Sciences, Inc.

• Real Regulatory Ltd

• VCLS

• PrimeVigilance

• ProPharma Group MIS Limited

• Regulatory Pharma Net srl

• ZEINCRO

• BioMapas

• REGENOLD GMBH