Healthcare Regulatory Affairs Outsourcing Market Size, Share, Growth Report 2032

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With the rising demand for various services, the market for healthcare regulatory affairs outsourcing is at upsurge. It includes writing and publishing of medical regulatory documentation which is offered by experienced quality control publishers and auditors and medical writers, who play an important role in the development of high-quality documents for clinical research projects. Regulatory submissions refer to submission of any information or documentation related to healthcare products to a regulatory body in order to get it reviewed. There are also other outsourcing services like regulatory consulting, legal representations, and clinical trial applications. All these services are in high demand from all the end-user companies ranging from pharma to food and beverages.

Many countries are increasing their investments in the research and development activities which have triggered the development and launch of new products in the market. With the rising guidelines by the regulatory authorities all over the world, there has been a growing alliance between the drug developers, CRO’s and CMO’s to mitigate risks. Since CMO’s and CRO’s help the companies in these risks, companies are able to focus on their core businesses. Therefore, patent expirations, along with increasing R&D activities have been identified as the major factors fueling the growth of the healthcare regulatory affairs outsourcing market. The rise in demand for services offered by healthcare regulatory affairs outsourcing market has also resulted in increasing documentation during device and drug manufacturing. Thus the small and mid-sized pharmaceutical companies are facing problems of extensive documentation. Due to the stringent policies, the regulatory authorities demand skilled and trained regulatory professionals who are capable of handling registration, evaluation, and compilation of data efficiently. Consequently, the biotechnology and pharmaceutical companies are seeking help from the regulatory service providers, thus boosting the market growth for healthcare regulatory affairs outsourcing. 

The healthcare regulatory affairs outsourcing market is segmented based on services and end-user. Based on services, the market is segmented into regulatory writing and publishing, regulatory submissions, legal representation, and regulatory consulting, clinical trial applications and services registrations, and other regulatory affairs. The end-user segment is divided into biotechnology companies, mid-size pharmaceutical companies, medical device companies, large pharmaceutical companies, and food and beverage companies.

North America and Europe hold the largest share in the healthcare regulatory affairs outsourcing market. This growth is mainly attributed to the huge number of R&D activities in the field of drug discovery carried out in these two regions. These regions also have a large presence of multinational biotech and pharma companies which carry out a large number of clinical trials and also have well developed and advanced healthcare infrastructure. Due to high healthcare investment and rising government funding Europe also holds a maximum share of the market followed by North America. Asia Pacific region is also witnessing significant growth rate owing to the unmet health care needs and raised government funding towards research activities. Also, many biotech and pharma companies have started outsourcing their drug development services to various developing countries like China, Malaysia, India, and Singapore which is further boosting the market growth for healthcare regulatory affairs outsourcing market.

Some of the leading players in healthcare regulatory affairs outsourcing market include Medpace, Inc., Promedica International, PARAXEL International Corporation, Covance, Inc., Freyr Solutions, Criterium, Inc., Accell Clinical Research, PRA Health Sciences, Inc., Wuxi AppTec and Quintiles IMS Holdings, Inc. There has been a trend of a strategic partnership between services providers for increasing service portfolio to expand regional presence. For instance, Shin Nippon Biomedical Laboratories Ltd. (SNBL), leading provider of development services to biopharmaceuticals, formed a joint venture with PPD to provide clinical development services in Japan which includes function-based services such as pharmacovigilance.