Regulatory Affairs Market (By Services: Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product Registration & Clinical Trial Applications, Other Services; By Category: Drugs, Biologics, Medical Devices; By Indication; By Stage; By Service Provider; By Company; By End User)- Global Industry Analysis, Share, Growth, Regional Outlook and Forecasts, 2022-2030

The global Regulatory Affairs market size is expected to hit around USD 31 billion by 2030 from valued at USD 13.9 billion in 2021 and poised to grow at a compound annual growth rate (CAGR) of 9.32% during the future period 2022 to 2030.

Key Takeaways:

  • By services, the regulatory writing & publishing segment accounted revenue share of over 37% in 2021.
  • By product stage, the clinical studies segment contributed 46.5% revenue share in 2021.
  • By service providers, the outsourcing service dominated the market with 57% revenue share in 2021.
  • By company size, the medium-sized segment registered 48% revenue share in 2021.
  • By indication, the oncology segment has garnered revenue share of 33.5% in 2021.
  • By end-uses, the pharmaceutical companies segment accounted 39% revenue share in 2021.
  • The Asia Pacific region dominated the market with market share of 38% in 2021.

The main drivers of this market are growth in emerging fields, such as orphan drugs, immunotherapies, personalized medicines, specialty therapies, and combination therapies, changes in regulatory requirements, and a rise in the prevalence of new diseases that require effective vaccines and therapies, which necessitate regulatory guidelines to maintain safety, quality, and effectiveness. Also, the COVID-19 pandemic has significantly impacted the market.

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.

The pharmaceutical and regulatory agencies joined forces to rapidly develop vaccines and medical products required to fight against COVID-19. 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 are 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 in this segment.

Report Scope of the Regulatory Affairs Market

Report Coverage

Details

Market Size in 2022

USD 15.2 Billion

Market Size by 2030

USD 31 Billion

Growth Rate from 2022 to 2030

CAGR of 9.32%

Base Year

2021

Forecast Period

2022 to 2030

Segments Covered

Services, Category, Indication, Stage, Service Provider, Company, End User, Geography

Companies Mentioned

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

Service Insights

Based on services, the global market for regulatory affairs can be been further categorized 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 37% 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. This is due to the increase in complexity of regulations in the healthcare and the increase in healthcare reforms, especially in emerging regions like the Asia Pacific and MEA. For instance, clinical trials in Europe cannot be conducted by sponsors who do not have their registered entity in the European Union and there is a mandatory requirement of legal representation provided by companies based in Europe to conduct clinical trials in any of the European Union member states.

Categories Insights

Based on categories, the global market for regulatory affairs can be broadly categorized 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. This segment is anticipated to expand further at the fastest CAGR retaining its dominant market position throughout the forecast years. This growth can be attributed to the increasing outsourcing activities of medical devices by pharmaceutical companies so they can focus on their core competencies.

The medical devices segment is further sub-categorized into diagnostics and therapeutics. Medical device regulations help ensure the safety & effectiveness of products and increase the transparency of a medical device that is useful for both manufacturer and insurer. 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).

Product Stage Insights

The clinical studies product stage segment dominated the global market in 2021 and accounted for the maximum share of more than 46.5% of the global revenue. The emergence of new diseases and the rising prevalence of chronic diseases are the key factors that are anticipated to increase the number of clinical trials conducted to meet healthcare needs. These regulations make sure that the clinical studies are carried out transparently and guided so that the trials are authentic and are adequately exposed to humans and show credible data.

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 product stages, the global market for regulatory affairs can be further segmented into preclinical, clinical, and PMA stages.

Service Provider Insights

Based on service providers, the global market for regulatory affairs has been further sub-categorized into in-house services and outsourcing services. The outsourcing service provider segment dominated the global market in 2021 and accounted for the maximum share of more than 57% of the overall revenue in the same year. The outsourcing service provider segment is anticipated to expand further at the fastest growth rate maintaining its dominant industry position throughout the forecast period.

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. The in-house service provider segment is also anticipated to grow at a significant CAGR during the forecast period and account for the second-highest share of the global revenue by 2030.

Company Size Insights

Based on company size, the global market has been further sub-categorized into small-sized, medium-sized, and large-sized companies. The medium-sized companies segment dominated the global market in 2021 and accounted for the largest share of more than 48% 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. These companies have a strong presence in multiple or selected markets around the world and provide various services, from a few to full length.

Large-scale service providers are popular among the leading pharma, biotechnology, and medical device firms. The presence of a broad range of services and the availability of these providers in various geographies can enable ease of business and thus act as the primary factor contributing to their popularity, especially among larger companies. Furthermore, large pharma companies generally prefer to have a long-term collaboration with their service providers to avoid sudden disturbances in their operations and, thus, prefer a service provider that can meet their regulatory needs to support their various ramp-up and cross-scale operations.

Indication Insights

The oncology segment accounted for the maximum revenue share of 33.5% in 2021. This can be attributed to the high prevalence of cancer, prompting a need for safe and effective treatment options. Furthermore, oncology is one of the most profitable markets for pharmaceutical & biotechnology companies, thereby increasing the R&D projects undertaken by these players. 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.

This can be attributed to the presence of immune cells throughout the body, as well as the presence of tissue-specific immune cells in organs. These include microglia in the brain, T cells & resident dendritic in the skin, and gut resident immune cells. Based on indications, the global market has been further categorized into oncology, neurology, cardiology, immunology, and other indications. The others segment includes dermatology, ophthalmology, endocrinology, pain management, gastroenterology, pulmonary & respiratory, hematology, infectious diseases, vaccine & virology urology, and nephrology.

End-use Insights

Based on end-uses, the global market for regulatory affairs has been further sub-divided into medical device companies, biotechnology companies, and pharmaceutical companies. The pharmaceutical companies segment dominated the market in 2021 and accounted for the maximum share of more than 39% of the global revenue. The segment is also projected to register the fastest growth rate from 2022 to 2030. This growth can be attributed to the increase in the number of approved pharmaceutical products. For instance, in 2021, the U.S. FDA approved 50 novel drugs.

Thus, a rise in the commercialization of new drugs in the U.S. is anticipated to increase the demand, product approval, registration, licensing, and related regulatory services. 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.

Regional Insights

The Asia Pacific dominated the market & accounted for the largest revenue share of more than 38% in 2021. The region is anticipated to expand further at the fastest CAGRfrom 2022 to 2030 owing to the improved regulatory landscape, cost savings, growing number of clinical trials conducted in the region, and an increasing number of biopharmaceutical companies venturing into the region. Furthermore, the availability of a skilled workforce within the region at a lower cost compared to the U.S. is another factor expected to propel market growth. According to Worldometer, Asia Pacific accounts for 59.77% of the world’s population.

The growing geriatric population, rising prevalence of chronic diseases among people, and increase in government support for the healthcare sector are expected to increase the demand for cost-effective medicines. This is anticipated to increase the number of market entrants, thereby creating the need for regulatory services. North America is projected to be the second-fastest-growing regional market over the forecast period. This region has the most outstanding regulatory system in the world. The main driving factors for this market are, a rise in biologics approvals; an increase in outsourcing of regulatory affairs services by large biopharmaceuticals; and growing R&D expenditure.

Some of the prominent players in the Regulatory Affairs Market include:

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

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2017 to 2030. For this study, Nova one advisor, Inc. has segmented the global Regulatory Affairs market

By Services

  • Regulatory Consulting
  • Legal Representation
  • Regulatory Writing & Publishing
    • Writing
    • Publishing
  • Product Registration & Clinical Trial Applications
  • Other Services

By Category

  • Drugs
    • Innovator
    • Preclinical
    • Clinical
    • Post Market
    • Generics
    • Preclinical
    • Clinical
    • Post Market
  • Biologics
    • Biotech
    • Preclinical
    • Clinical
    • Post Market
    • ATMP
    • Preclinical
    • Clinical
    • Post Market
    • Biosimilars
    • Preclinical
    • Clinical
    • Post Market
  • Medical Devices
    • Diagnostics
    • Preclinical
    • Clinical
    • Post Market
    • Therapeutics
    • Preclinical
    • Clinical
    • Post Market

By Indication

  • Oncology
  • Neurology
  • Cardiology
  • Immunology
  • Others

By Stage

  • Preclinical
  • Clinical studies
  • PMA

By Service Provider

  • In-house
  • Outsourced

By Company

  • Small
  • Medium
  • Large

By End User

  • Medical Device Companies
  • Pharmaceutical Companies
  • Biotechnology Companies

By Geography

North America

  • U.S.
  • Canada

Europe

  • Germany
  • France
  • United Kingdom
  • Rest of Europe

Asia Pacific

  • China