Global Regulatory Affairs Market to Reach USD 165.73 Billion by 2032 with a CAGR of 13.6%, Driven by Increasing Regulatory Demands and Drug Approvals

The global Regulatory Affairs Market was valued at USD 53.6 billion in 2022 and is projected to achieve a rapid revenue CAGR of 13.6% during the forecast period. The growth is mainly fueled by increasing regulatory compliance demands and complexity, rising number of drug approvals, and implementation of new regulations by regulatory bodies.

The pharmaceutical, biotechnology, and medical device sectors rely on regulatory affairs services to guarantee their products comply with national and international regulations. In addition, the complexity of regulatory standards in various regions is a driving factor, with new and stricter regulations being implemented by regulatory bodies such as the European Union and the FDA.

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Key players in the Regulatory Affairs Market -

• IQVIA
• PPD, Inc.
• Parexel International Corporation
• Charles River Laboratories International, Inc.
• PRA Health Sciences, Inc.
• Medpace Holdings, Inc.
• ICON plc
• Covance Inc.
• Syneos Health, Inc.
• SGS S.A.

As a result, businesses are increasingly seeking regulatory affairs specialists for guidance on navigating the regulatory environment and ensuring compliance. The demand for regulatory affairs services is also rising due to a surge in drug approvals and the introduction of new regulations by regulatory bodies. However, high compliance costs could be a limiting factor for market growth, particularly for small and medium-sized businesses.

Segments Covered in the Report -

The regulatory affairs market offers a range of products and services catering to various end-users. The market can be segmented based on product type and end-use outlook.

In terms of product type, the regulatory affairs market can be categorized into clinical trial application, regulatory consultancy, regulatory writing and publishing, product registration, and legal representation. Clinical trial application involves regulatory submissions for clinical trials, including data on efficacy and safety of the product. Regulatory consultancy includes regulatory strategy development, pre-market regulatory evaluations, and compliance assessments. Regulatory writing and publishing involves the preparation and submission of regulatory documents, such as clinical study reports and Common Technical Document (CTD). Product registration includes registration submissions to regulatory agencies, such as New Drug Application (NDA) or Marketing Authorization Application (MAA). Legal representation involves regulatory support in legal proceedings.

In terms of end-use outlook, the regulatory affairs market can be segmented into pharmaceutical and biotechnology firms, producers of medical equipment, contract research firms, and others. Pharmaceutical and biotechnology firms are the largest end-users of regulatory affairs services, as they require regulatory support for drug approvals and post-approval compliance. Producers of medical equipment also rely on regulatory affairs services, as they require regulatory clearance for marketing their devices. Contract research firms require regulatory support for clinical trial conduct and data submissions. Other end-users include academic and government research institutions, contract manufacturing organizations, and non-profit organizations.

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In summary, the regulatory affairs market offers various products and services to cater to the regulatory needs of different end-users. The market can be segmented based on product type and end-use outlook, with pharmaceutical and biotechnology firms being the largest end-users of regulatory affairs services.

Strategic development:

Medable, a top cloud platform for decentralized clinical trials, was acquired by IQVIA on November 22, 2021. The acquisition was intended to increase IQVIA's digital capabilities and enable the company to provide complete support for decentralized clinical trials, including patient engagement, protocol design, and data management.

On January 3, 2021, PPD, Inc. announced the acquisition of ScienceMedia, a leading provider of digital learning and training solutions for clinical trial sites. PPD acquired ScienceMedia to enhance its digital capabilities and offer innovative training solutions that support clinical trials.

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