Healthcare Regulatory Affairs Outsourcing Market

Mid-size pharmaceutical companies and biotechnology companies may compete in the global healthcare regulatory affairs outsourcing market

The global healthcare regulatory affairs outsourcing market is at a surge with the increase in demand for various services it offers. It includes medical writing and publishing of the regulatory documentation offered by experienced medical writers, quality control (QC) auditors and publishers that plays an important role to develop high-quality documents for clinical research projects. Then there are regulatory submissions which refer to the submission of any documentation or information on a healthcare product to a regulatory agency in order to get it reviewed. There are also outsourcing services like clinical trial applications, and regulatory consulting and legal representations. All these services are in high demand from end users like mid-size pharma companies, large pharma companies, biotechnology companies, medical device manufacturers and food & beverage companies.

The analysis of global healthcare regulatory affairs outsourcing market depicts that, among various end users in the market, the mid-size pharmaceutical companies are expected to dominate with a market value of over US$ 700 Mn by the end of 2025, growing at a CAGR of 13.8% during the forecast period.  Biotechnology companies are expected to be a lucrative end user segment of the market with a significant demand expected during the forecast period of 2017-2025. The biotechnology companies segment is expected to grow at a CAGR of 13.2% during the forecast period, giving tough competition to mid-size pharmaceutical companies.

Increasing R&D activities and development of new products to boost the healthcare regulatory affairs outsourcing market

Various countries are gradually increasing their investments in the R&D departments. This has triggered development of new products in the industry. With the increasing strictness by the respective regulatory authorities worldwide, a growing collaboration between the drug developers and Clinical Research Organizations (CROs) and contract manufacturing organizations (CMOs) has been observed in order to mitigate risks. As CROs and CMOs help the companies in such risks, companies are able to focus on their core businesses. Therefore, increasing research and development activities along with patent expirations have been identified as the major factors fueling the growth of the regulatory affairs outsourcing market.

The rise in demand for services offered by healthcare regulatory affairs outsourcing market is also a result of increasing documentation during drug and device manufacturing. The mid or small size pharmaceutical companies, face problems like extensive documentation. The regulatory authorities, owing to their stringent policies, demand the need for trained and skilled regulatory professionals capable of efficiently handling registration, evaluation and compilation of scientific data. Subsequently, the pharmaceutical and biotechnology companies are seeking help of regulatory service providers, thereby driving the market’s growth.

Hidden costs and pricing fluctuations may discourage many end users from using services available in the healthcare regulatory affairs outsourcing market

There’s an increase in the instances where prices of the services are not stated clearly in the healthcare regulatory affairs outsourcing market. In addition, extra costs are said to be involved in the services with the increasing use of technological platforms such as software for the clinical data management, content management, database and document management. The use of such technologies results in hyped ultimate price for the services offered and this in turn would hamper the market’s growth. The technological advances no doubt improves the overall process but adds to the total costs as well. But makes the companies hesitant of spending high extra amounts. Many companies even confine themselves by outsourcing the regulatory activities to one destination country.