Pharmaceutical Regulatory Affairs Market To Reach $14.34 Billion By 2030

Pharmaceutical Regulatory Affairs Market Growth & Trends

The global pharmaceutical regulatory affairs market size is expected to reach USD 14.34 billion by 2030, according to a new report by Grand View Research, Inc. The market is projected to grow at a CAGR of 7.16% from 2024 to 2030. The key factors driving the market growth are the changing regulatory landscape and growth in emerging areas such as personalized medicine, biosimilars, and orphan drugs. There have been significant changes to the FDA’s drug approval processes. Recently, the 21^st Century Cures bill was passed, which is expected to speed up the approval process of the FDA for certain types of drugs.

The FDA has launched four programs-Accelerated Approval, Priority Review, Fast Track, and Breakthrough Therapy-to expedite drug reviews for serious and life-threatening diseases. The medicines under these programs are approved faster by regulatory agencies. In addition, in the UK, the launch of The Accelerated Access Collaborative, a government initiative to fast-track patient access to potential breakthrough medicines, is anticipated to boost the availability and accessibility of novel therapies in the country. These changes in approval processes are expected to drive innovation and increase the demand for regulatory service providers who are well-acquainted with recent changes in approval processes globally.

The demand for regulatory specialization in these fields is anticipated to increase with the growth of the markets for biosimilar, orphan medications, personalized medicines, companion diagnostics, adaptive trial designs, and other products. Demand for specialized service providers with expertise in regulatory affairs is increasing as companies expand into different industries and face a growing burden of regulatory compliance. Government financing has considerably accelerated the development of orphan medications, particularly in industrialized economies.

Several companies are involved in collaborations, acquisitions, and new product development to gain a position in the market. For instance, in October 2022, Freyr partnered with an orthopedic implant manufacturing company in Korea, and as per the agreement, provided it with regulatory device registration and legal representation services. Moreover, in January 2022, Parexel International Corporation formed a Regulatory & Access Consulting Organization. This organization was established to provide regulatory support to clinical studies from the early stages.

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Pharmaceutical Regulatory Affairs Market Report Highlights

• In terms of category, the drug segment held the largest revenue share of over 55.36% in 2023. The growing population, increasing urbanization, and rising demand for quality healthcare in the country have created a significant potential for pharmaceutical companies that develop and manufacture innovative drugs

• Based on category, the biologics segment is anticipated to register the fastest CAGR of 9.07% over the forecast period owing to the prevalence of diseases such as malaria, HIV/AIDS, and non-communicable diseases

• In terms of indication, the immunology segment is projected to grow at the fastest CAGR of 10.34% over the forecast period. The robust immunology pipeline of pharmaceutical and biopharmaceutical companies is anticipated to further boost segment growth

• The oncology segment dominated the market in 2023 with the largest revenue share of 32.98%. This can be attributed to the high prevalence of cancer, which is boosting the need for safe and effective treatment options

• In terms of product stage, the clinical studies segment held the largest market share of 44.14% % in 2023. This can be attributed to the increasing number of clinical trial registrations, which is expected to drive the segment growth

• The preclinical segment is projected to grow at the fastest CAGR of 8.40% during the forecast period. Increasing prevalence of existing diseases such as cancer, CVDs, & neurological diseases are factors driving the market growth

• In terms of service providers, the outsourced regulatory affairs segment held the largest market share in 2023 at 58.16% % and is anticipated to witness the fastest CAGR of 8.76% over the forecast period. The increasing popularity of these services can be attributed to the fact that outsourcing enables healthcare companies to reduce costs, which is a major contributing factor to market growth

Pharmaceutical Regulatory Affairs Market Segmentation

Grand View Research has segmented the global pharmaceutical regulatory affairs market report based on service provider, service, category, indication, development stage, company size, and region.

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

• In-house

• Outsourcing

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

• Regulatory Consulting

• Legal Representation

• Regulatory Writing & Publishing

  • Writing

  • Publishing

• Product Registration & Clinical Trial Applications

• Other Services

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

• Drugs

  • Innovator

    • Preclinical

    • Clinical

    • Post Market Approval (PMA)

  • Generics

    • Preclinical

    • Clinical

    • Post Market Approval (PMA)

• Biologics

  • Biotech

    • Preclinical

    • Clinical

    • Post Market Approval (PMA)

  • ATMP

    • Preclinical

    • Clinical

    • Post Market Approval (PMA)

  • Biosimilars

    • Preclinical

    • Clinical

    • Post Market Approval (PMA)

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

• Oncology

• Neurology

• Cardiology

• Immunology

• Others

Pharmaceutical Regulatory Affairs Development Stage Outlook (Revenue, USD Million, 2018 - 2030)

• Preclinical

• Clinical

• Post Market Approval (PMA)

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

• Small

• Medium

• Large

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

• North America

  • U.S.

  • Canada

  • Mexico

• Europe

  • UK

  • Germany

  • France

  • Italy

  • Spain

  • Denmark

  • Norway

  • The Netherlands

  • Switzerland

  • Sweden

• Asia Pacific

  • Japan

  • China

  • India

  • Australia

  • South Korea

  • Indonesia

  • Malaysia

  • Singapore

  • Thailand

  • Taiwan

• Latin America

  • Brazil

  • Argentina

  • Colombia

  • Chile

• Middle East

  • Saudi Arabia

  • UAE

  • Kuwait

  • Egypt

  • Israel

• Africa

  • South Africa

  • Botswana

  • Namibia

  • Zimbabwe

  • Zambia

  • Tanzania

  • Rwanda

  • Ghana

  • Nigeria

  • Uganda

  • Mauritius

  • Kenya

List of Key Players of Pharmaceutical Regulatory Affairs Market

• Freyr

• IQVIA Inc

• ICON plc

• WuXi AppTec (WAI)

• Charles River Laboratories International, Inc.

• Labcorp Drug Development

• Parexel International Corporation

• Pharmalex GmbH

• Pharmexon

• Genpact