Global Healthcare Regulatory Affairs Outsourcing Market to reach a Valuation of US$ 4,052.30 million by 2034, FMI projection

The global healthcare regulatory affairs outsourcing market had an estimated valuation of US$ 1,985.60 million in 2023 and is expected to reach a size of US$ 4,052.30 million by 2034, increasing at a CAGR of 6.70% between 2024 and 2034. By 2024, the market for healthcare regulatory affairs outsourcing is poised to reach a valuation of US$ 2,118.60 million.

Companies in the healthcare sector deal with various kinds of tasks on a daily basis. It becomes challenging for them to focus on non-core functions like regulatory affairs and take required actions. This trend indicates a shift of various healthcare companies toward outsourcing their regulatory affairs tasks. This outsourcing not only reduces their workload but also cuts costs and helps them focus more on other core activities.

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Regulatory affairs are also an important stage in drug development and drug approval. A company may need complete knowledge and expertise about that specific drug and its compositions. This indicates a shift of the pharmaceutical companies towards various outsourcing companies to gain knowledge and help them.

Key Takeaways from the Market Analysis:

  • The global healthcare regulatory affairs outsourcing market was valued at US$ 1,123.80 million in 2018.
  • From 2018 to 2023, the healthcare regulatory affairs outsourcing market experienced a CAGR of 12.10%.
  • The United States healthcare regulatory affairs outsourcing industry is anticipated to develop with a 6.70% CAGR from 2024 to 2034.
  • With a 33.60% market share in 2023, the regulatory writing and publishing services segment is anticipated to expand in the global healthcare regulatory affairs outsourcing market.
  • With a 29.20% market share in 2023, mid-sized pharmaceutical companies will probably be the dominant end users of healthcare regulatory affairs outsourcing.

“Healthcare regulations are becoming stricter and more complex globally every day. The demand for healthcare regulatory affairs outsourcing is becoming essential to overcome these regulatory challenges with specialized expertise. Various companies opt for partnerships to help them navigate the various frameworks and legal implications,” says an FMI analyst.

Competitive Landscape:

Market players in the global healthcare regulatory affairs outsourcing market aim to provide pharmaceutical, biotechnology, and medical device sectors with specialized regulatory services, accelerated product approvals, compliance assurance, and process simplification.

They provide proficiency in managing intricate regulatory environments, optimizing effectiveness, and maintaining quality benchmarks in developing and promoting healthcare products.

Startups in this market are addressing regulatory obstacles for biotech, pharmaceuticals, and medical devices with customized solutions. Their primary areas of expertise include effective regulatory strategies, pharmacovigilance services, compliance monitoring, and submission preparation.

While maintaining compliance with evolving regulations, these companies want to reduce regulatory burdens, improve product development deadlines, and improve market access for advanced healthcare solutions.

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Key Developments:

  • In 2024, Wheeler Bio, Inc. and Charles River Laboratories International, Inc. announced a strategic partnership. Customers may now use Wheeler’s innovative Portable CMC® (Chemistry, Manufacturing, and Controls) platform as a result of this partnership.
  • This partnership provides early-stage biotech companies a unique route for rapidly moving from preclinical to early human clinical trial phases.

Key Companies Profiled:

  • Accell Clinical Research, LLC
  • Charles River Laboratories
  • Syneos Health
  • Laboratory Corporation of America Holdings
  • ICON PLc.
  • Medpace, Inc.
  • PAREXEL International Corporation
  • Thermo Fisher Scientific Inc. (PPD)
  • Promedica International
  • WuXi App Tec

Key Segments Profiled in the Healthcare Regulatory Affairs Outsourcing Market:

By Services:

  • Regulatory Writing and Publishing
  • Regulatory Submissions
  • Clinical Trial Applications
  • Product Registrations
  • Regulatory Consulting
  • Legal Representation

By End User:

  • Pharmaceutical Companies
  • Biotechnology Companies
  • Medical Devices Manufacturer
  • Food and Beverage Companies

By Region:

  • North America
  • Latin America
  • Western Europe
  • Eastern Europe
  • South Asia and Pacific
  • East Asia
  • Middle East & Africa

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About Future Market Insights (FMI)

Future Market Insights, Inc. (ESOMAR certified, recipient of the Stevie Award, and a member of the Greater New York Chamber of Commerce) offers profound insights into the driving factors that are boosting demand in the market. FMI stands as the leading global provider of market intelligence, advisory services, consulting, and events for the Packaging, Food and Beverage, Consumer Technology, Healthcare, Industrial, and Chemicals markets. With a vast team of over 400 analysts worldwide, FMI provides global, regional, and local expertise on diverse domains and industry trends across more than 110 countries.

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