REGULATORY AFFAIRS OUTSOURCING MARKET ANALYSIS

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

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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

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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.

Key Players

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.