Regulatory Affairs Outsourcing Market – Insights
Regulatory affairs outsourcing are the services utilized by the pharmaceutical, biotech and medical devices manufacturing companies for gaining fast regulatory approvals from various organizations.
The Global Regulatory Affairs Outsourcing Market size was valued at US$ 3,683.7 million in 2019, and is expected to exhibit a CAGR of 12.0% over the forecast period (2019 – 2027).
Figure 1. Global Regulatory Affairs Outsourcing Market Value (US$ Mn), by Region, 2019
Source: Coherent Market Insights Analysis (2019)
Increasing incidence of refractive disorders is expected to propel growth of the regulatory affairs outsourcing market
Increasing research and development expenditure in the healthcare sector is expected to drive growth of the regulatory affairs outsourcing market. According to the National Bureau of Statistics, February 2018, China’s expenditure on research and development increased by 11.6% in 2017 from 10.6% in 2016, reaching US$ 280 Mn in 2017.
The companies offering outsourcing services have higher product approval potential, in comparison to pharmaceutical or biotechnology companies owing to the specific expertise in the field of regulatory affairs. For instance, ProEd Regulatory, a subsidiary of Health Consultancy Group, stated that it has 80% success rate and it takes around 8 to 10 drugs through a regulatory process to get approval each year.
However the risks associated with data sharing and outsourcing are major factors that are expected to hamper the regulatory outsourcing market growth over the forecast period. Moreover, many outsourcing partners have access to sensitive data of pharmaceutical or other industries, which may pose a threat to the companies security and data sharing.
Figure 2. Global Regulatory Affairs Outsourcing Market Share (%), by Therapeutic Applications, 2019 and 2027
Source: Coherent Market Insights Analysis (2019)
Increasing adoption of acquisition strategies in North America is expected to bolster the market growth
North America holds a dominant position in the global regulatory affairs outsourcing market, owing to increasing merger and acquisition strategies adopted by market players. For instance, in 2015, BioClinica, Inc. acquired Synowledge, headquartered in Miami, U.S., to expand its offering in the drug safety and regulatory business process outsourcing market. Synowledge specializes in regulatory affairs and information technology services for biopharmaceutical companies. Similarly, in 2014, Certara, a technology-enabled drug development and drug safety consultancy, announced the acquisition of specialty contract research organization (CRO) Synchrogenix Information Strategies Inc. Synchrogenix offers regulatory writing and related services to pharmaceutical, biotechnology and medical device manufacturers worldwide.
Moreover, increasing research and development expenditure is a major factor driving the regulatory outsourcing market growth in North America. For instance, according to Pharmaceutical Research and Manufacturers of America, in 2016, the biopharmaceutical industry invested an estimated US$ 90 billion in research and development activities in the U.S.
Major players operating in the global regulatory affairs outsourcing market include WuXi AppTec Co., Ltd., Charles River Laboratories, Inc., Accell Clinical Research, LLC, PRA Health Sciences, Inc., Parexel International Corporation, Clinilabs Inc., Criterium Inc., IQVIA Holdings Inc., Medpace Inc., and Certara, L.P.
Regulatory affairs outsourcing market has grown significantly over the last decade. Increasing research and development expenditure in healthcare sector and increasing adoption of various growth strategies has boosted demand for regulatory outsourcing services in recent years. These services are majorly offered in the pharmaceutical and medical devices segment. Rising number of clinical trials is expected to fuel the Regulatory affairs outsourcing market growth over the forecast period.
Increasing number of clinical trials and research and development expenditure in the healthcare sector is expected to drive the market growth. According to Clinical Trials.gov, the number of clinical studies registered in 50 states and 209 countries in 2018 and around 293,353 and 262,371 in 2017.
Companies engaged in the Regulatory affairs outsourcing market are expected to generate significant return-on-investment (ROI) over the forecast period owing to the increasing adoption of business growth strategies such as partnership, acquisition by the market players. For instance, in June 2018, Medpace, Inc. and International Health Management Associates, Inc. announced collaboration for offering clinical trials in the infectious diseases domain. Similarly, in August 2018, Synchrogenix, subsidiary of Certara, L.P., announced partnership with PleaseTech Ltd., a review specialist and provider of document redaction services
Key players in the market are focused on facility expansions in order to enhance their share in potential markets, which, in turn, is expected to propel the market growth over the forecast period. For instance, in July 2019, Health Advances LLC, a healthcare consulting and subsidiary of Parexel International Corporation, launched Health Advances Asia Limited and extended its offering in drug development and commercialization services to the Asia Pacific region.
Key features of the study:
“*” marked represents similar segmentation in other categories in the respective section.
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