The global regulatory affairs outsourcing market is anticipated to be worth USD 13.9 billion by 2030, progressing at a CAGR of 8.9% during the forecast period. The concept of regulatory affairs stems from the desire of governments across the globe for protecting public health through control of product efficacy and safety. These products include veterinary medicines, pharmaceuticals, agrochemicals and pesticides, cosmetics, medical devices, and complementary medicines. The companies manufacturing these products are expected to take charge of the research and discovery, manufacturing, testing, and marketing involved so that they offer a tangible contribution to the public and society.
There has been a constant increase with regard to fixed costs involved in various regulatory affairs activities conducted in-house, such as training, facilities, specialized knowledge, and implementation of technology, which has led to firms becoming keen on outsourcing these regulatory affairs functions. With frequent changes and amendments to regulations and policies becoming a norm in recent years, it has become very difficult for companies to keep up with such developments, which also impacts their core functions. The consistently-growing incidences of R&D activities, as well as the need to accelerate clinical trial processes and product registration, have resulted in the healthy growth of the industry.
Pharmaceutical and biotechnology companies have made significant investments in research and development activities in the past few years. As per Pharmaceutical Research and Manufacturers of America (PhRMA), in 2019, its members invested around USD 83 billion in various R&D activities; furthermore, PhRMA in 2020 stated that over 260 vaccines were in development for COVID-19 as well as other diseases. Such factors are anticipated to create significant growth opportunities for regulatory affairs outsourcing companies. Additionally, strategic initiatives, such as the acquisition of GlobalCare by Covance in July 2021, are expected to keep the industry moving in the coming years.
The COVID-19 pandemic led to a significant decline in the regulatory affairs outsourcing market, on account of an abrupt halt in clinical trial activities across the globe. A published study by Frontier in Medicine in December 2021, titled “COVID-19 Pandemic and Trends in Clinical Trials: A Multi-Region and Global Perspective”, stated that there was a consistent reduction in clinical trials on a month-by-month comparison between 2019 and 2020, with new clinical trials for diseases apart from COVID-19 showing an average reduction of 7.5%, while this value stood at 5.1% in 2020 for reduction percentage in reported results. However, the market demand has rebounded since 2021, on account of the provision of emergency use authorization (EUA) for a number of medical devices and drugs.
Regulatory Affairs Outsourcing Market Report Key Takeaways
- With regard to services provided, the legal representation segment is anticipated to advance at the highest growth rate during the projection period, aided by the rising demand for legal representatives globally. The regulatory landscape across regions is complicated and changes frequently, which necessitates the need for local legal experts for regulatory approvals
- In terms of company size, the medium-sized segment drove the regulatory affairs outsourcing market revenue in 2021, on account of the rapidly growing presence of mid-sized medical device and pharmaceutical companies, coupled with their lack of capital for the establishment of an in-house regulatory affairs space
- On the basis of stage, the clinical studies segment held the dominant share in 2021. There has been a steady growth in registrations for clinical trials in recent years, as evidenced by data from ClinicalTrials.gov, which states that around 401,716 trials have been registered in January 2022, thus propelling the demand for regulatory affairs outsourcing in this aspect
- The end-use segments in the market include medical device companies, biotechnology companies, and pharmaceutical companies, of which the pharmaceutical companies segment contributed the most significantly to the revenue in 2021. Areas such as orphan drugs, biosimilars, and personalized medicines are witnessing rapid growth, which is advancing this segment
- The Asia Pacific and North America accounted for the bulk of the market share in 2021; the former has witnessed an increasing number of clinical trials and significant expansion of the life sciences industry in economies such as Japan, China, South Korea, and India. On the other hand, the North American region is home to notable medical device and pharmaceutical companies, while also being a hub of clinical trials and R&D
- Companies involved in the regulatory affairs outsourcing market undertake various strategies to ensure their growth, such as mergers and acquisitions, collaborations, and geographic expansions. The COVID-19 pandemic further highlighted the significance of this industry, on account of the launch of various vaccines and drugs to combat the outbreak
Regulatory Affairs Outsourcing Market Segments
- Regulatory Affairs Outsourcing Services Outlook (Revenue, USD Million, 2018 - 2030)
- Regulatory Consulting
- Legal Representation
- Regulatory Writing & Publishing
- Product Registration & Clinical Trial Applications
- Other Services
- Regulatory Affairs Outsourcing Company Size Outlook (Revenue, USD Million, 2018 - 2030)
- Regulatory Affairs Outsourcing Category Outlook (Revenue, USD Million, 2018 - 2030)
- Drugs
- Biologics
- Biotech
- ATMPs
- Biosimilars
- Medical Devices
- Regulatory Affairs Outsourcing Stage Outlook (Revenue, USD Million, 2018 - 2030)
- Preclinical
- Clinical
- PMA (Post Market Authorization)
- Regulatory Affairs Outsourcing Indication Outlook (Revenue, USD Million, 2018 - 2030)
- Oncology
- Neurology
- Cardiology
- Immunology
- Others
- Regulatory Affairs Outsourcing End-use Outlook (Revenue, USD Million, 2018 - 2030)
- Medical Device Companies
- Pharmaceutical Companies
- Biotechnology Companies
- Regulatory Affairs Outsourcing Regional Outlook (Revenue, USD Million, 2018 - 2030)
- North America
- Europe
- U.K.
- Germany
- France
- Italy
- Spain
- Russia
- Turkey
- The Netherlands
- Switzerland
- Sweden
- Europe CIS Countries
- Asia Pacific
- Japan
- China
- India
- Australia
- South Korea
- Indonesia
- Malaysia
- Singapore
- Thailand
- Taiwan
- Asia Pacific CIS Countries
- Latin America
- Brazil
- Mexico
- Argentina
- Colombia
- Chile
- Middle East & Africa
- South Africa
- Saudi Arabia
- UAE
- Egypt
- Israel
- List of Key Players in the Regulatory Affairs Outsourcing Market
- Accell Clinical Research, LLC
- GenPact Ltd.
- Criterium, Inc.
- PRA Health Sciences
- Promedica International
- Dr.Regenold GmbH
- BioMapas
- Zeincro Group
- Medpace
- ICON plc
- Covance
- Parexel International Corp.
- Freyr
