Biologics Regulatory Affairs Outsourcing Market To Reach $3.69 Billion By 2030

Biologics Regulatory Affairs Outsourcing Market Growth & Trends

The global biologics regulatory affairs outsourcing market size is expected to reach USD 3.69 billion by 2030, registering a CAGR of 8.87% from 2024 to 2030, according to a new report by Grand View Research, Inc. Globalization of biopharmaceutical companies is one of the major growth drivers boosting overall market demand. Emerging markets of Asia Pacific, Latin America, and MEA regions offer low product development & manufacturing costs, tax benefits, and availability of skilled labor at relatively low costs with supportive regulations. The abovementioned factors have made the regional markets attractive prospects in terms of outsourcing and expansion for biopharmaceutical companies, thereby stimulating the demand for regulatory services. Furthermore, the presence of EMA- and/or FDA-approved facilities in emerging economies is anticipated to increase foreign investments in the country and the demand for regulatory services, such as legal representation and regulatory consulting services.

A significant increase has been witnessed in the number of clinical trials conducted in emerging economies. This can be attributed to the availability of skilled labor, advanced technologies, and infrastructure facilities at relatively lower costs than developed economies such as the U.S., which is expected to stimulate the demand for regulatory services such as clinical trial applications & product registrations in these regions. Emerging economies contribute to more than 30.0% of total clinical trial applications submitted across the globe, and the share is expected to increase over the coming years, contributing to market growth.

Several biopharmaceutical companies are focusing on their core competencies and outsourcing noncore functions to increase their productivity & operational efficiency. These companies face several challenges with regard to complying with global regulations, which can be a lengthy and tedious process. Thus, the race to launch a novel molecule in the market in a feasible timeline and at a reasonable cost will likely propel the demand for service providers. Furthermore, many small- and medium-scale biopharma companies lacking in-house capabilities are inclined towards outsourcing regulatory affairs, which is estimated to positively influence the industry's progression.

Growth in markets for biosimilars, orphan drugs, personalized medicines, adaptive trial designs, and others is projected to boost the demand for regulatory specialization in these areas. As several companies expand into new avenues, the increasing need for skilled service providers with experience in regulations leads to the necessity to comply with regulations. Government support, especially in developed economies, has significantly increased the development of orphan drugs. Patent expiration of biologics, such as Simulect, Vectibix, Mircera, and Kineret, is increasing the demand and development of biosimilars, thereby contributing to the demand for regulatory services in this segment.

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Biologics Regulatory Affairs Outsourcing Market Report Highlights

• The regulatory writing & publishing segment held the largest market share in 2023. The high segment growth is owing to the increasing complexity of biologics requiring precise and comprehensive documentation, stringent global regulatory requirements demanding thorough submissions, and the need for specialized expertise to ensure compliance. The rapid pace of innovation in biologics, such as gene therapies and biosimilars, necessitates up-to-date knowledge of evolving regulations is anticipated overall market growth

• The pharmaceutical companies segment accounted for the largest revenue share of over 76.23% in 2023. The segmental growth is owing to a high number of clinical trials for biologics, a growing product pipeline for ATMPs, stringent regulatory guidelines for advanced therapeutics, and growing outsourcing trends for non-core activities such as clinical trials, data management, regulatory compliance etc., are few factors further boosting segment growth

• The monoclonal antibodies (mAbs) segment accounted for the largest revenue share in 2023. The segmental growth is owing to rapid advancements in mAb technology, including novel delivery methods and therapeutic targets, which require updated and precise regulatory strategies leading to overall market growth potential

• North America dominated the market with a share of 30.54% in 2023. The regional market growth is owing to high R&D activities and government initiatives for clinical trials. Moreover, the strong presence of biopharmaceutical companies and outsourcing service providers is another major factor expected to propel market growth. For instance, in October 2021, the U.S. FDA approved 11 novel clinical trial research, resulting in over USD 25 million in funding over the next four years to support the development of innovative drugs to treat rare diseases

Biologics Regulatory Affairs Outsourcing Market Segmentation

Grand View Research has segmented the global biologics regulatory affairs outsourcing market based on service, phase, modality, phase by service, phase by modality, modality by service, and region:

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

• Regulatory Consulting

  • Strategy & Development Planning

  • QA Consulting

  • Agent Services

  • Others

• Legal Representation

• Regulatory Writing & Publishing

• Product Registration & Clinical Trial Applications

• Regulatory Submissions

• Regulatory Operations

• Other Services

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

• Preclinical

• Clinical

  • Phase I

  • Phase II

  • Phase III

  • Phase IV

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

• Monoclonal Antibodies (mAbs)

• Recombinant Proteins

• Vaccines

• Cell & Gene Therapies

• Biosimilars

• Others

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

• Preclinical

  • Regulatory Consulting

  • Legal Representation

  • Regulatory Writing & Publishing

  • Product Registration & Clinical Trial Applications

  • Regulatory Submissions

  • Regulatory Operations

  • Other Services

• Clinical

  • Regulatory Consulting

  • Legal Representation

  • Regulatory Writing & Publishing

  • Product Registration & Clinical Trial Applications

  • Regulatory Submissions

  • Regulatory Operations

  • Other Services

Biologics Regulatory Affairs Outsourcing Phase by Modality Outlook (Revenue, USD Million, 2018 - 2030)

• Preclinical

  • Monoclonal Antibodies (mAbs)

  • Recombinant Proteins

  • Vaccines

  • Cell & Gene Therapies

  • Biosimilars

  • Others

• Clinical

  • Monoclonal Antibodies (mAbs)

  • Recombinant Proteins

  • Vaccines

  • Cell & Gene Therapies

  • Biosimilars

  • Others

Biologics Regulatory Affairs Outsourcing Modality by Phase Outlook (Revenue, USD Million, 2018 - 2030)

• Monoclonal Antibodies (mAbs)

  • Regulatory Consulting

  • Legal Representation

  • Regulatory Writing & Publishing

  • Product Registration & Clinical Trial Applications

  • Regulatory Submissions

  • Regulatory Operations

  • Other Services

• Recombinant Proteins

  • Regulatory Consulting

  • Legal Representation

  • Regulatory Writing & Publishing

  • Product Registration & Clinical Trial Applications

  • Regulatory Submissions

  • Regulatory Operations

  • Other Services

• Vaccines

  • Regulatory Consulting

  • Legal Representation

  • Regulatory Writing & Publishing

  • Product Registration & Clinical Trial Applications

  • Regulatory Submissions

  • Regulatory Operations

  • Other Services

• Cell & Gene Therapies

  • Regulatory Consulting

  • Legal Representation

  • Regulatory Writing & Publishing

  • Product Registration & Clinical Trial Applications

  • Regulatory Submissions

  • Regulatory Operations

  • Other Services

• Biosimilars

  • Regulatory Consulting

  • Legal Representation

  • Regulatory Writing & Publishing

  • Product Registration & Clinical Trial Applications

  • Regulatory Submissions

  • Regulatory Operations

  • Other Services

• Others

  • Regulatory Consulting

  • Legal Representation

  • Regulatory Writing & Publishing

  • Product Registration & Clinical Trial Applications

  • Regulatory Submissions

  • Regulatory Operations

  • Other Services

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

• North America

  • U.S.

  • Canada

  • Mexico

• Europe

  • UK

  • Germany

  • France

  • Italy

  • Spain

  • Denmark

  • Sweden

  • Norway

• Asia Pacific

  • China

  • Japan

  • India

  • Australia

  • South Korea

  • Thailand

• Latin America

  • Brazil

  • Argentina

• Middle East and Africa (MEA)

  • South Africa

  • Saudi Arabia

  • UAE

  • Kuwait

List of Key Players in the Biologics Regulatory Affairs Outsourcing Market

• Lonza AG

• Wuxi AppTec Inc.

• Thermo Fisher Scientific Inc.

• Eurofins Scientific SE

• Freyr solutions

• Catalent Inc.

• Piramal Group

• AGC Biologics

• ICON Plc.

• Charles River Laboratories International, Inc.

• Labcorp

• Parexel International

• Medpace Holdings, Inc.

• IQVIA

• Syneos Health

• SGS SA (SGS)