Global Healthcare Regulatory Affairs Outsourcing Market will achieve a valuation of USD 4,052.30 Million by 2034

Healthcare Regulatory Affairs Outsourcing Market
Healthcare Regulatory Affairs Outsourcing Market

The global healthcare regulatory affairs outsourcing market is on a trajectory of substantial growth, with an estimated valuation of USD 1,985.60 million in 2023 and projected to reach USD 4,052.30 million by 2034, reflecting a robust CAGR of 6.70% between 2024 and 2034. By the end of 2024, the market is expected to reach USD 2,118.60 million.

As healthcare firms increasingly turn to outsourcing to streamline operations and bolster efficiency, market players are offering specialized services to meet these demands. Outsourcing companies are providing healthcare firms with dedicated teams including clinical research associates (CRAs), coordinators, senior monitors, and project managers on a contract basis. This approach allows healthcare companies to augment their internal resources without the need for expanding their clinical teams.

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“These outsourcing services are designed to offer comprehensive support to healthcare companies,” said Future Market Insights. “By providing dedicated clinical experts and project management tailored to the client’s needs, we ensure seamless integration and efficient project execution.”

Key features of these outsourcing solutions include FTE-based budgets with predictable and fixed pricing, ensuring financial transparency and control for healthcare companies. Moreover, outsourcing firms act as a single point of contact, managing all staffing requirements and providing operational and financial oversight throughout the project lifecycle.

The growth of the healthcare regulatory affairs outsourcing market underscores its pivotal role in enabling healthcare firms to navigate regulatory complexities while optimizing resource allocation and accelerating time-to-market for new therapies and medical products.

Key Takeaways from the Market Analysis:

  • The global healthcare regulatory affairs outsourcing market was valued at USD 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.

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.
  • IQVIA
  • 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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About the Author

Nikhil Kaitwade

Associate Vice President at Future Market Insights, Inc. has over a decade of experience in market research and business consulting. He has successfully delivered 1500+ client assignments, predominantly in Automotive, Chemicals, Industrial Equipment, Oil & Gas, and Service industries.
His core competency circles around developing research methodology, creating a unique analysis framework, statistical data models for pricing analysis, competition mapping, and market feasibility analysis. His expertise also extends wide and beyond analysis, advising clients on identifying growth potential in established and niche market segments, investment/divestment decisions, and market entry decision-making.
Nikhil holds an MBA degree in Marketing and IT and a Graduate in Mechanical Engineering. Nikhil has authored several publications and quoted in journals like EMS Now, EPR Magazine, and EE Times.

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