Regulatory Affairs Market Competitive Landscape and Analysis Report 2030

Regulatory Affairs Industry Overview

The global regulatory affairs market size is expected to reach USD 27.0 billion by 2030, registering a CAGR of 8.7% over the forecast years, 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 global market showed lucrative growth during the COVID-19 pandemic.

 U.S. regulatory affairs market size, by category, 2020 - 2030 (USD Billion)

Regulatory Affairs Market Segmentation

Grand View Research has segmented the global regulatory affairs market based on services, category, indication, product stage, service provider, company size, end-use, and region:

Based on the Service Insights, the market is segmented into Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product Registration & Clinical Trial Applications and Other Services.

  • The regulatory writing & publishing segment dominated the market and accounted for the largest revenue share of 36.6% in 2021. This segment is further divided into writing and publishing. The main drivers of this segment are increased outsourcing of these services by large- and mid-size biopharmaceutical and medical device companies.
  • Outsourcing regulatory writing and publishing gives space to big pharma companies to develop their core competencies. The legal representation segment is expected to rise with the fastest CAGR during the forecast period.

Based on the Categories Insights, the market is segmented into Drugs, Biologics and Medical Devices.

  • The medical device segment dominated the global market and accounted for the maximum share of more than 39.5% of the overall revenue in 2021. 
  • The drugs segment is anticipated to account for the second-highest revenue share by 2030. The drugs segment is further sub-segmented into innovator and generics while the biologics segment is sub-segmented into biotech products, biosimilars, and Advanced Therapy Medicinal Products (ATMPs).

Based on the Product Stage Insights, the market is segmented into Preclinical, Clinical studies and PMA.

  • The clinical studies product stage segment dominated the global market in 2021 and accounted for the maximum share of more than 46.00% of the global revenue. 
  • The preclinical product stage segment is expected to register the fastest growth rate during the forecast period. The fastest growth of this segment can be attributed to the increasing demand for novel disease treatments, such as COVID-19, Zika virus, and Ebola, as well as the increasing prevalence of various existing diseases, such as Cardiovascular Diseases (CVDs), cancer, and neurological diseases. 

Based on the Service Provider Insights, the market is segmented into In-house and Outsourced.

  • The outsourcing service provider segment dominated the global market in 2021 and accounted for the maximum share of more than 56.00% of the overall revenue in the same year. 
  • The high growth of this segment can be attributed to the rapidly increasing popularity of these services as outsourcing enables healthcare companies to reduce overall costs, prioritize strategic projects, reduce staff training time and helps in accessing specific technical and regulatory or geographic expertise and improve the overall efficiency as well as provides greater flexibility.

Based on the Company Size Insights, the market is segmented into Small, Medium and Large.

  • The medium-sized companies segment dominated the global market in 2021 and accounted for the largest share of more than 46.5% of the overall revenue in the same year.
  • The presence of various mid-sized established providers, particularly privately held ones, is expected to contribute to this segment’s growth. 
  • Large-scale service providers are popular among the leading pharma, biotechnology, and medical device firms.

Based on the Indication Insights, the market is segmented into Oncology, Neurology, Cardiology, Immunology and Others.

  • The oncology segment accounted for the maximum revenue share of 33.0% in 2021. This can be attributed to the high prevalence of cancer, prompting a need for safe and effective treatment options.
  • The immunology segment is expected to register the fastest CAGR during the forecast period due to its potential in facilitating the treatment of various cardiovascular, neurological, oncological, and inflammatory diseases.

Based on the End-use Insights, the market is segmented into Medical Device Companies, Pharmaceutical Companies and Biotechnology Companies.

  • The pharmaceutical companies segment dominated the market in 2021 and accounted for the maximum share of more than 38.5% of the global revenue.
  • Biotechnology companies are estimated to be the second-fastest-growing end-use segment during the forecast period. This is due to the high demand for biologics, rise in investment in manufacturing of biologics, and improvements in infrastructure, which are anticipated to boost the demand for regulatory services, such as audit & validation, quality & assurance, GMP practices, BLA filings, and patent filings.

Regulatory Affairs Regional Outlook

  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East & Africa

Key Companies Profile & Market Share Insights

The market is highly competitive, marked by the presence of a large number of domestic as well as international players. Companies are engaging in product launches, mergers & acquisitions, collaborations, and expansion of geographic presence to strengthen their market position.

 Some prominent players in the global regulatory affairs market include:

  • Accell Clinical Research, LLC
  • Genpact
  • Criterium, Inc.
  • PRA Health Sciences
  • Promedica International
  • WuXi AppTec, Inc.
  • Medpace
  • Charles River Laboratories International, Inc.
  • ICON plc
  • Covance, Inc.
  • PAREXEL International Corp., Inc.
  • Freyr

Order a free sample PDF of the Regulatory Affairs Market Intelligence Study, published by Grand View Research.

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