Press release
Global Healthcare Regulatory Affairs Outsourcing Industry Poised for Strong Growth, Projected to Reach USD 4,052.30 Million by 2034
Healthcare Regulatory Affairs Outsourcing Industry
As the healthcare industry continues to evolve, outsourcing has become an increasingly popular strategy for companies looking to streamline operations, reduce costs, and improve efficiency. In response, outsourcing firms are offering specialized services designed to address the growing and diverse needs of healthcare organizations. These services include providing dedicated teams of clinical research associates (CRAs), coordinators, senior monitors, and project managers on a contract basis, enabling healthcare companies to augment their internal resources without the need for extensive team expansions.
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"These outsourcing services are designed to offer comprehensive support to healthcare companies," said a representative from 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, allowing healthcare firms to focus on core activities while meeting regulatory requirements."
Key features of these outsourcing solutions include full-time equivalent (FTE)-based budgets with fixed and predictable pricing, ensuring financial transparency and control for healthcare companies. Additionally, outsourcing firms act as a single point of contact, managing staffing requirements while providing operational and financial oversight throughout the entire project lifecycle.
This growth trajectory highlights the crucial role the healthcare regulatory affairs outsourcing industry plays in helping healthcare companies navigate the complexities of regulatory compliance. It allows firms to optimize resource allocation, reduce costs, and accelerate the 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 industry 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 industry.
● With a 29.20% market share in 2023, mid-sized pharmaceutical companies will probably be the dominant end users of healthcare regulatory affairs outsourcing.
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Competitive Landscape:
Market players in the global healthcare regulatory affairs outsourcing industry 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.
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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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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