Regulatory Affairs Outsourcing Market Growth & Trends

The global regulatory affairs outsourcing market size is expected to reach USD 15.6 billion by 2027, expanding at a CAGR of 11.9%, according to a new report by Grand View Research, Inc. The entry of life sciences companies in global markets and the evolution of new areas such as orphan drugs, biosimilar, and personalized medicine are propelling the market growth.

A significant increase in the fixed costs of in-house resources for regulatory affairs and operation activities like training, technology, specialized knowledge, and facilities are driving life science firms to outsource these functions. Also, the rising number of clinical trials is expected to boost the demand for regulatory affairs services such as clinical trial applications and product registration in these regions.

Product-specific clinical advice & strategy along with administrative compliance at the early stages of product development can be critical to product approval. Failure to address administrative compliance in the early development stage often leads to delay in the approval process owing to inappropriately designed studies, manufacturing oversights, omitted studies, and other failures to meet the administrative requirements.

Addressing local regulatory challenges and constant changes in the regulations of the major markets such as the U.S., Europe, and Asia is creating demand for the services. Compliance with the current regulations has become an immense chore, leave alone trying to stay current with developments around the world. Amendments to current regulations are likely to complicate the regulatory pathway for the industry. Thus, the demand for regulatory affairs outsourcing is increasing. In addition, the presence of major players in the regions contributed to market growth.

Regulatory Affairs Outsourcing Market Report Highlights

  • The regulatory writing and publishing services dominated the market in 2019 with a share of around 35.6% as they are offered from early stages of development to post-marketing authorization phase and is vital for the success of a product
  • The large companies segment accounted for the highest revenue share in 2019 and is anticipated to maintain its dominance over the forecast period due to increasing demand for outsourcing services provided by the large companies to various pharma industries
  • The drugs segment was the largest in 2019 in terms of both revenue and market share due to increasing prevalence of various chronic diseases and increasing expenditure on drug R&D activities
  • The oncology segment holds the largest revenue share as of 2019 due to the increasing prevalence of cancer cases globally
  • The clinical segment accounted for the largest revenue share of 45.0% in 2019 due to increasing demand for clinical trials in developing countries
  • Based on end-use, the pharmaceutical companies segment was the largest in 2019 due to growth in evolving areas such as orphan drugs and adaptive trial designs
  • Asia Pacific dominated the market and accounted for 43.0% of the revenue share in 2019. This can be attributed to the relatively lower cost for outsourcing, skilled workforce with technical expertise, and expansion of life sciences companies in countries such as India and China
  • In the U.S., the market is expected to witness the fastest growth over the forecast period owing to the growing adoption of large molecule therapeutics as an alternative for small molecules.