Regulatory Affairs Market Estimated At USD 27.0 Billion By 2030

 San Francisco, 2 Feb 2024: The Report Regulatory Affairs Market Size, Share & Trends Analysis Report By Services, By Categories, By Service Provider, By Company Size, By Product Stage, By Indication, By End-use, By Region, And Segment Forecasts, 2023 - 2030

The global regulatory affairs market is expected to reach USD 27.0 billion by 2030, expanding at a CAGR of 8.7% from 2023 to 2030, according to a new report by Grand View Research, Inc. The factors expected to contribute to the growth of this market include changing regulatory requirements based on business activities and geographies, an increase in clinical trials & drug approvals along with accelerated regulatory approval, and technological advancement in regulatory software. Also, the evolution of personalized medicines, the increasing need for companies to focus on core business activities, and economic and competitive pressures are other factors that are contributing to the growth of the market.

The pharmaceutical and regulatory agencies joined forces to rapidly develop vaccines and medical products required to fight against the COVID-19 infection. The regulatory authorities take numerous precautions to ensure patient and personnel safety during a clinical trial, as well as data integrity and good laboratory practices are maintained. Growth in markets for biosimilars, orphan drugs, personalized medicines, companion diagnostics, and adaptive trial designs is projected to boost the demand for regulatory specialization in these areas. As companies venture into newer fields, the growing need to comply with regulations is boosting the demand for specialized service providers with expertise in regulatory affairs. Patent expiration of biologics, such as Simulect, Vectibix, Mircera, and Kineret, is increasing the demand and development of biosimilars, thereby contributing to the demand for regulatory services.

Several companies are actively involved in collaborations and new product development to gain leadership in the personalized medicine market, indicating a need for supportive regulatory affairs. For instance, in May 2020, Regeneron Pharmaceuticals, Inc. collaborated with Colorado Center for Personalized Medicine to design advancements in personalized medicine and human genetics.

Access Research Report of Regulatory Affairs Market @ https://www.grandviewresearch.com/industry-analysis/regulatory-affairs-market

Regulatory Affairs Market Report Highlights

• In terms of services, the regulatory writing & publishing segment dominated the market in 2022 with a revenue share of 36.6%. This is due to an increase in the outsourcing of these services by large- and mid-size medical device and biopharmaceutical companies
• Based on indications, the oncology segment accounted for the largest revenue share, 32.9%, in 2022. The segment share is attributed to the high prevalence of cancer, which is creating the need for safe and effective treatments
• Based on end-use, the pharmaceutical companies segment is anticipated to witness the highest growth rate of 9.0% from 2023 to 2030. A rise in the number of approved pharmaceutical products is the key factor responsible for the segment’s growth
• Based on company size, the medium-sized companies segment dominated the global market in 2022 and accounted for the largest share of more than 47.0% of the overall revenue in the same year. An increasing number of medium-sized companies are penetrating the regulatory affairs market. Thereby, the segment held the lion’s share in 2022 and across.
• Based on category, the biologics segment is anticipated to witness a stable growth rate of 8.0% during the analysis timeframe. The increasing pipeline of biologics to further boosts demand for its regulatory services, thus supporting segmental growth.
• Based on the product stage segment, the preclinical segment is anticipated to register the fastest growth of 9.4% across the analysis period. The high growth of the segment is majorly due to the increasing pipeline of small molecules and biosimilars across the globe.
• Based on the service provider segment, the outsourcing segment is anticipated to register the fastest growth of 10.3% across the analysis period. The high growth of the segment is majorly due to the increasing demand for cost-effective contract services.
• Asia Pacific is projected to witness the fastest growth rate of 9.3% during the forecast period on account of the improved regulatory landscape and growing venture activities by biopharmaceutical companies.

Regulatory Affairs Market Report Scope

Report Attribute	Details
Market size value in 2023	USD 15.1 billion
Revenue Forecast in 2030	USD 27.0 billion
Growth rate	CAGR of 8.7% from 2023 to 2030
Base year for estimation	2022
Historical data	2018 - 2021
Forecast period	2023 - 2030

List of Key Players of Regulatory Affairs Market

• Accell Clinical Research, LLC
• Genpact
• Criterium, Inc.
• ICON plc
• Promedica International
• WuXi AppTec
• Medpace
• Charles River Laboratories.
• Labcorp Drug Development
• Parexel International Corporation
• Freyr
• Pharmalex GmbH
• NDA Group AB
• Pharmexon
• Qvigilance
• BlueReg
• Cambridge Regulatory Services
• VCLS

Access Press Release of Regulatory Affairs Market @ https://www.grandviewresearch.com/press-release/global-regulatory-affairs-market