What is the global market size of Regulatory Affairs Market?

Regulatory Affairs Market size was valued at USD 12.84 billion in 2021 and is poised to grow from USD 14 billion in 2022 to USD 27.30 billion by 2030, growing at a CAGR of 9% in the forecast period (2023-2030).

Regulatory Affairs Market Size, Share, Growth Analysis, By Services(Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Writing), By Category(Drugs, Innovator, Preclinical, Clinical), By Company Size(Small, Medium, Large), By Region - Industry Forecast 2025-2032

Report ID: SQMIG35A2460 | Region: Global | Published Date: March, 2024
Pages: 219 | Tables: 120 | Figures: 76

Regulatory Affairs Market News

On March 8, 2023, The US Food and Drug Administration (FDA) issued a new guidance on the use of artificial intelligence (AI) in medical devices.

On February 14, 2023, The European Medicines Agency (EMA) published a new guideline on the development and evaluation of gene therapy medicinal products.

On January 20, 2023, The World Health Organization (WHO) released a new report on the global regulatory landscape for medical products.

Regulatory Affairs Market Report Snapshots

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Regulatory Affairs Market size was valued at USD 15.26 Billion in 2023 and is poised to grow from USD 16.63 Billion in 2024 to USD 33.15 Billion by 2032, growing at a CAGR of 9% during the forecast period (2025-2032).

The competitive landscape of the global regulatory affairs market is characterized by a dynamic interplay of established industry leaders and innovative emerging players. Key players like IQVIA Holdings Inc., PAREXEL International Corporation, and ICON plc hold prominent positions owing to their extensive experience, global reach, and diverse service portfolios. These industry giants leverage their deep regulatory expertise, technological capabilities, and strong client relationships to offer comprehensive regulatory solutions. 'Parexel International Corporation', 'QuintilesIMS (Now IQVIA)', 'ICON plc', 'PRA Health Sciences', 'Covance Inc. (a subsidiary of LabCorp)', 'Wuxi AppTec', 'Charles River Laboratories', 'Medpace Holdings, Inc.', 'Syneos Health', 'Certara', 'Intertek Group plc', 'Premier Research', 'DIA (Drug Information Association)', 'NSF International', 'Freyr Solutions', 'RAPS (Regulatory Affairs Professionals Society)', 'PharmaLex', 'ProPharma Group', 'ERA Consulting Group', 'Regulatory Compliance Associates Inc.'

The expansion of biopharmaceutical companies into emerging markets, especially in Asia Pacific, Latin America, and the Middle East, demands comprehensive regulatory strategies to address diverse regional requirements.

Accelerated Approval Programs: Regulatory authorities are implementing expedited approval pathways for critical drugs, such as orphan drugs and breakthrough therapies, to address unmet medical needs.

The Asia Pacific region asserted its dominance within the market, capturing the foremost share of revenue, surpassing 37.5% in 2022. Expected to exhibit the swiftest Compound Annual Growth Rate (CAGR) from 2023 to 2030, the region's expansion is driven by several factors including enhancements in the regulatory landscape, cost-efficiency gains, a burgeoning volume of clinical trials conducted within the area, and an increasing influx of biopharmaceutical companies venturing into this territory. Additionally, the presence of a skilled workforce in the region at a more economical rate compared to the United States is poised to further propel market growth. The escalating demand for biosimilars and medical devices also contributes to the burgeoning biopharmaceutical and medical devices market in the region. A prime example is Biocon, a renowned Indian biopharmaceutical firm, actively engaged in developing diverse novel treatments slated for market launch over the forecast period, consequently driving the demand for regulatory support.

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Regulatory Affairs Market Size, Share, Growth Analysis, By Services(Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Writing), By Category(Drugs, Innovator, Preclinical, Clinical), By Company Size(Small, Medium, Large), By Region - Industry Forecast 2025-2032

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