During the forecast period, the healthcare regulatory affairs outsourcing market is expected to develop at a CAGR of 11.3%. As of 2023, the market is worth $2 billion, and by 2033, it is predicted to be worth $5.8 billion.

Drug and other medical equipment approval is a costly, time-consuming, and documentation-intensive procedure that puts companies under a lot of strain. Such circumstances are driving an increase in the use of healthcare regulatory affairs outsourcing.

Regulatory affairs activities are difficult, and a surge in demand to acquire permission for new products and maintain compliance is likely to increase market share.

With a growing emphasis on novel medication development in the healthcare sector, several corporations are collaborating with outsourcing organisations to expedite documentation and approvals.

Aside from that, healthcare companies who are expanding globally are searching for quick approvals in local markets. During the projection period, this could increase demand for healthcare regulatory affairs outsourcing.

Competitive Landscape:

The leading participants in the healthcare regulatory affairs outsourcing market are concentrating on the best strategy to improving access to Real World Data from Electronic Medical Records and medical insurance claims, as well as technologies such as wearables and sensors. Parexel, for example, has a dedicated team to examine and understand clinical data, as well as digital services that employ proper statistical approaches. This would undoubtedly enable the organisation to hire the appropriate experts based on the type of data.

Key Companies Profiled

  • PAREXEL International Corporation
  • Quintiles IMS Holdings Inc.
  • Clinilabs, Inc.
  • Accell Clinical Research, LLC
  • Freyr Solutions

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Market Segmentation

Services

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

End Users

  • Mid-Size Pharmaceutical
  • Companies
  • Large Pharmaceutical Companies
  • Biotechnology Companies
  • Medical Devices Manufacturer
  • Food & Beverage Companies