Market Trends of Global Healthcare Regulatory Affairs Outsourcing Industry
Product Registration & Clinical Trial Application Segment is Expected to Hold Significant Market Share Over the Forecast Period
Product Registration refers to the application for regulatory approval granted by the applicable authority in a given country or territory to allow a product to be marketed, distributed, sold, or imported into the country or region. The Clinical Trial Application refers to submission to the competent national regulatory authorities for getting authorization to conduct a clinical trial in the country. The clinical trial application contains detailed information about the investigational medicinal product and planned trial, allowing regulatory authorities to assess the study's feasibility.
The increase in outsourcing of clinical trial applications and product registrations in both developed and developing countries is driving the product registration and clinical trial application segment over the forecast period. Due to the complexity of the product registration process, lack of professionals in the industry, and lack of internal capability, most pharmaceutical and medical device companies outsource their product registration activities to third-party service providers. Furthermore, constant changes and updation in regulatory affairs also drive the outsourcing of such services. For instance, on 31 January 2022, the European Medicines Agency announced the regulatory harmonization of clinical trials in the EU. It also launched a new Clinical Trials Information System (CTIS). This is anticipated to propel the segment growth over the forecast period.
Thus, all factors mentioned above are expected to boost segment growth over the forecast period.
North America is Expected to Hold Major Market Share Over the Forecast Period
Pricing pressure due to the changing reimbursement scenario and generic competition is causing major pharmaceutical firms to outsource regulatory affairs activities expected to drive the growth of healthcare regulatory outsourcing services in North America. Additionally, growing research and development activity and rising clinical trials are anticipated to drive regional market growth. For instance, according to the Global Observatory on Health R&D, the United States registered 10,870 clinical trials in 2021, accounting for 18.1% of the total. According to the same source, Canada registered 2,099 clinical trials in 2021, accounting for 3.5% of the total. Thus, many clinical trials in the region are likely to drive the regulatory affairs outsourcing market.
Moreover, the presence of key regional players and strategic collaborations in the industry are driving the market's growth. For instance, in April 2021, Parexel and Veeva Systems announced a strategic partnership to speed up clinical trials by leveraging technology and process innovation. Both businesses will benefit from each other's regulatory consulting services.
Thus, all factors above are expected to boost the market growth in the North America region over the forecast period.
