Towards Healthcare

Regulatory Affairs Companies and Development Strategy

Date : 03 October 2025

Top Companies in the Regulatory Affairs Market

Regulatory Affairs Market Companies

Market Growth

The global regulatory affairs market size is calculated at US$ 16 billion in 2024, grew to US$ 17.37 billion in 2025, and is projected to reach around US$ 36.33 billion by 2034. The market is expanding at a CAGR of 8.55% between 2025 and 2034.

What are the Major Drifts in the Regulatory Affairs Market?

Diverse pharmaceutical and biopharmaceutical companies are focusing on R&D enhancements, expansion of their facilities is fueling the respective market growth.

  • In June 2025, the Association for Accessible Medicines invested $1 billion to boost its domestic manufacturing and research and development through Hikma Pharmaceuticals USA.
  • In May 2025, Sanofi opened $130m corporate hub in New Jersey as part of $20b U.S. investment push.
  • In May 2025, Recipharm, a global contract development and manufacturing organization (CDMO), and ProductLife Group (PLG), a global provider of product development and regulatory affairs services, collaborated to support (bio)pharmaceutical companies in escalating time to clinical trials and market approval.

Latest Announcements by Industry Leaders

In January 2025, Medical Regulation Gate (MRG) and the Regulatory Affairs Professionals Society (RAPS) announced a new collaboration to address the growing and emerging regulatory training requirements of Saudi Arabia and the broader Middle East region. Mohsen Al Muslimani, Chief Executive Officer of Medical Regulation Gate (MRG), stated that this accelerates the growth of the largest global organization of professionals involved in regulatory and quality assurance for healthcare products, enhancing offerings and support for this vital community of professionals.

What are the Ongoing Developments in the Regulatory Affairs Market?

  • In August 2025, Abbott, the global healthcare company, received regulatory approval for the first denosumab biosimilar in Thailand, escalating access to advanced therapies for osteoporosis and cancer-related bone loss. 
  • In June 2025, ByteBrain LLC, an emerging AI research and consulting firm, unveiled MEDRAIL, an intelligent platform created to support pharmaceutical companies run faster, safer, and more adaptive clinical trials.
  • In May 2025, Lonza, one of the world’s largest contract development and manufacturing organizations (CDMOs), launched its new Design2Optimize platform to accelerate process development and manufacturing of small molecule APIs.

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