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Healthcare Regulatory Affairs Outsourcing Market Trends

  • Report ID: GMI8287
  • Published Date: Feb 2024
  • Report Format: PDF

Healthcare Regulatory Affairs Outsourcing Market Trends

The global healthcare landscape is witnessing an unprecedented surge in clinical trials, reflecting a dynamic era of intensified research and innovation across diverse therapeutic domains.

  • The surge in the number of clinical trials is accompanied by an increase in the complexity of regulations governing these trials. For instance, according to ClinicalTrials.gov data, as of February 2024, there were nearly 483,793 clinical studies registered globally. This surge in clinical research activities necessitates effective regulatory affairs management. Outsourcing regulatory affairs enables companies to navigate the complexities of diverse trials, ensuring compliance, timely submissions, and efficient interactions with regulatory authorities, ultimately driving the growth of the healthcare regulatory affairs outsourcing market.
  • The globalization of clinical trials, with studies conducted across multiple countries, introduces a diverse set of regulatory frameworks. Outsourcing regulatory affairs aids companies in understanding and aligning with the regulatory requirements of each region, facilitating the smooth conduct of global clinical trials.
  • Moreover, the growing emphasis on transparency and accountability in clinical trial reporting necessitates comprehensive and meticulous documentation. Outsourcing regulatory affairs ensures that companies can manage the increasingly stringent reporting requirements, including the preparation of regulatory submissions, safety reports, and compliance documentation.
Authors: Mariam Faizullabhoy, Gauri Wani

Frequently Asked Questions (FAQ) :

The market size of healthcare regulatory affairs outsourcing reached USD 7.1 billion in 2023 and is set to cross USD 14.8 billion by 2032, attributed to the growing need to comply with regulatory requirements, and surging demand for faster approval processes for breakthrough drugs and devices.

The product registration & clinical trial segment is anticipated to witness a CAGR of 8.5% through 2032, owing to its role in guiding companies through the complexities of gaining regulatory approvals for new medical products.

North America market accounted for USD 2.8 billion revenue in 2023, driven by well-established medical infrastructure and stringent regulatory environment governing healthcare product.

Accell Clinical Research, LLC, Charles River Laboratories, Clinilabs, Inc., Freyr, Genpact, ICON plc, Labcorp Drug Development, PAREXEL International Corporation, ProPharma Group, Proventa International are some of the major industry contenders.

Healthcare Regulatory Affairs Outsourcing Market Scope

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Premium Report Details

  • Base Year: 2023
  • Companies covered: 11
  • Tables & Figures: 307
  • Countries covered: 22
  • Pages: 180
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