Regulatory Affairs Outsourcing Industry Overview
The global regulatory affairs outsourcing market size was estimated at USD 6.5 billion in 2021 and is anticipated to expand at a compound annual growth rate (CAGR) of 8.9% from 2022 to 2030.
The outsourcing of regulatory affairs has become an increasingly important practice in the healthcare industry. An increase in geoconnectgalaxyical expansion activities by companies that aim for speedy approvals in local markets is expected to contribute to the adoption of outsourcing models for regulatory services. The outsourcing market for regulatory affairs is expanding rapidly due to the increase in RD activities, augmenting the volume of clinical trial applications and product registration.
Gather more insights about the market drivers, restrains and growth of the Global Regulatory Affairs Outsourcing Market
Companies are under constant pressure to procure timely clinical approvals from regulators in different regions. Such actions are further promoting the demand for regulatory affairs services thus contributing to the market growth. Regulatory affairs functions are challenging. The increasing demand to obtain approval for new products while maintaining compliance and doing more with fewer drives the market. The pressure to reduce costs by life sciences companies is also very high. The use of generics and demand for drugs medical devices at lesser prices are expected to rise to reduce healthcare costs.
An increase in out-of-pocket expenses, uneven economic growth, and measures taken by various governments to contain the cost of drugs are expected to contribute to the economic and competitive pressure, which, in turn, is expected to drive the demand for regulatory affairs outsourcing among the life science companies. Product-specific clinical advice strategy along with regulatory compliance at the early stages of the product development can be critical to product approval. Failure to address regulatory compliance in the early development stage often leads to delay in the approval process owing to inappropriately designed studies, manufacturing oversights, omitted studies, and other failures to meet the regulatory requirements.
Such factors are likely to improve the demand for regulatory affairs outsourcing in the life sciences industry. The outbreak of the COVID-19 pandemic has created a negative impact on the market. The initial lockdown had led to the closure of clinical trial sites and related activities. Moreover, regulatory bodies paused their activities for a while focusing on tracking the supply chain activities. Nearly all the components critical to drug development to reduce the spread of the virus at the beginning of the pandemic had affected the market negatively.
However, the pandemic had created an urgent need for treatment of COVID-19 infection, owing to which, regulatory authorities, such as the U.S. FDA, and the European Union (EU), had given emergency use authorization for various COVID-19 testing devices and treatments. Such actions by the regulatory agencies are expected to improve the demand for regulatory affairs outsourcing in the market post-pandemic. The market witnessed a rebound in revenue in 2021 as several companies focused on the development of novel therapeutics for the treatment of COVID-19 infection. Moreover, the growth in RD activities for new vaccines, therapeutics, and medical devices has further driven the market growth post-2020.
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- Clinical Trials Market - The global clinical trials market size was valued at USD 47.0 billion in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 5.8% from 2022 to 2030. However, the market growth was hindered in 2020 due to the COVID-19 pandemic.
- Biologics Market - The global biologics market size was valued at USD 315.32 billion in 2019 and is expected to expand at a compound annual growth rate (CAGR) of 3.9% from 2020 to 2025. These products represent cutting-edge research and also enable the latest scientific discoveries. Such discoveries can be translated into novel therapies that provide new treatment options for patients.
Regulatory Affairs Outsourcing Market Segmentation
Grand View Research has segmented the global regulatory affairs outsourcing market based on services, company size, category, indication, stage, end user, and region:
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)
- Small
- Medium
- Large
Regulatory Affairs Outsourcing Category Outlook (Revenue, USD Million, 2018 - 2030)
- Drugs
- Generics
- Innovators
- Biologics
- Biotech
- ATMPs
- Biosimilars
- Medical Devices
- Therapeutic
- Diagnostic
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
- Asia Pacific
- Latin America
- Middle East Africa
Key Companies profiled:
Some prominent players in the global regulatory affairs outsourcing market include
- Accell Clinical Research, LLC
- GenPact Ltd.
- Criterium, Inc.
- PRA Health Sciences
- Promedica International
- Dr. Regenold GmbH
- BioMapas
- Zeincro Group
- Parexel International Corp.
- Charles River Laboratories International, Inc.
- ICON plc
- Covance
- Freyr
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