Regulatory Affairs Outsourcing Market Size, Share & Trends Analysis Report By Category (Biologics, Medical Devices), By Company Size (Medium, Large), By Indication, By Stage, By Services, By End Use - Global Industry Analysis, Share, Growth, Regional Outlook and Forecasts, 2022-2030

According to Nova one advisor, the global Regulatory Affairs Outsourcing market size is expected to hit around USD 13.85 billion by 2030 from valued at USD 6.20 billion in 2021 and growing at a CAGR of 8.40% from 2022 to 2030.

Key Takeaways:

  • By Service, the U.S. Regulatory Affairs Outsourcing market was valued at USD 1.15 Billion in 2021 and expected to witness growth at a CAGR of 9.9% from 2022 to 2030.
  • The regulatory writing & publishing services segment dominated the market with the maximum revenue share in 2021as they are offered from the early stages of development to the post-marketing authorization phase and are vital for the success of a product
  • The large companies segment is projected to witness the fastest CAGR during the forecast period. The availability of a wide variety of services and the presence of these providers in various geographies are the key factors driving the segment growth
  • The clinical studies stage segment accounted for the largest market share in 2021 due to the increasing demand for clinical trials in developing countries
  • The pharmaceutical companies end-use segment is anticipated to witness the fastest growth rate over the forecast period due to evolving areas, such as orphan drugs and personalized therapies
  • Asia Pacific held the maximum revenue share of the global market in 2021 owing to higher off shoring of such services into regions of economic benefits and the expansion of life sciences companies in countries, such as India & China

The global regulatory affairs outsourcing market is driven by increase in the number of clinical trials, growth of the life sciences industry, and advancements in biosimilars, personalized medicine, orphan pharmaceuticals

Rise in investment in R&D activities to develop biosimilar, orphan, and generic drugs, increase in investment in clinical research, surge in focus on product development to expand supply, strict government regulation, and rise in the number of FDA-approved manufacturing plants boost the growth of the global regulatory affairs outsourcing market

The global regulatory affairs outsourcing market presents significant opportunities to global and mid-sized market players such as delivery of low-cost regulatory services and boosting marketing activities

COVID-19 pandemic has placed many regulatory and outsourcing teams under pressure; however, it has also had a positive effect on the bio/pharmaceutical outsourcing industry, wherein the demand for R&D activity is growing, leading to surge in regulatory affairs assistance

Report Scope of the Regulatory Affairs Outsourcing Market

Report Coverage

Details

Market Size

USD 13.85 Billion by 2030

Growth Rate

CAGR of 8.40% from 2022 to 2030

Largest Market

North America

Fastest Growing Market

Asia Pacific

Base Year

2021

Forecast Period

2022 to 2030

Segments Covered

 Service, company size, category, indication, stage,  endues And Region

Companies Mentioned

 Accell Clinical Research LLC; GenPact Ltd; Criterium, Inc.; PRA Health Sciences; Promedica International; Dr. Regenold GmbH; BioMapas; Zeincro Group; Covance; Freyr;WuXiAppTec Inc.; Medpace; Charles River Laboratories International, Inc.; ICON plc; Covance; PAREXEL International Corporation, Inc.; Pharmalex GMBH; NDA Group AB; Pharmexon Consulting s.r.o; Qvigilance; BlueReg Group; Cambridge Regulatory Services; APCER Life Sciences, Inc.; Real Regulatory Ltd.; Voisin Consulting Life Sciences; PrimeVigilance; ProPharma Group MIS Limited; Regulatory Pharma Net Srl.

 

Service Insights

On the basis of services, the global market has been further divided into regulatory consulting, legal representation, regulatory writing & publishing, product registration & clinical trial applications, and other services. The regulatory writing & publishing segment led the market in 2021 and accounted for the highest share of more than 37.1% of the global revenue. These services are offered from the early stages of product development to the post-marketing authorization phase. The segment is also anticipated to dominate the market during the forecast period owing to the adoption of outsourcing of these services by large- and mid-sized biopharmaceutical and medical device companies.

The legal representation services segment is anticipated to witness the fastest growth rate over the forecast period. This is due to the increasing demand for legal representatives across the globe on account of the globalization of medical devices and pharmaceutical companies. The regulations are very complex and ever-changing. Changing the regulatory landscape in regions, such as Asia Pacific, MEA, and Latin America increases the demand for local experts for legal representation for obtaining regulatory approvals and custom clearance. These factors are promoting the demand for legal representation services globally.

Company Size Insights

The large companies segment is projected to register the fastest growth rate of more than 9.7% over the forecast period. Large companies generally prefer to establish long-term relations with their service providers to avoid sudden disruption in their operations and thus, prefer a service provider that can meet their regulatory needs to support their various cross-scale and ramp-up operations. Apart from this, according to an article published by GEP (2020), large-scale pharma companies generally outsource about 50% of their regulatory affairs needs. These factors are contributing to the growth of this segment.

On the basis of company sizes, the market has been divided into small, medium, and large. The medium-sized companies segment accounted for the maximum revenue share in 2021 and is estimated to expand further retaining the leading position over the forecast period. The presence of several mid-sized established providers, especially privately-held ones, is anticipated to contribute to this segment share. Moreover, the medium-sized pharmaceutical and medical device companies do not have enough capital to develop an in-house regulatory affairs team, which is further driving the demand for regulatory affairs outsourcing among medium-sized companies.

Category Insights

On the basis of category, the global market has been further segmented into drugs, biologics, and medical devices. The medical device segment accounted for the largest share of more than 38.5% of the global revenue in 2021. This can be attributed to the fact that medical devices companies are now focusing on their core competencies and outsourcing noncore functions to increase their productivity and operational efficiency. The growing demand for advanced medical devices and new technological advancements in medical devices are further contributing to the growth of the segment.

However, the biologics segment is projected to register the forecast CAGR over the forecast period. The R&D productivity of small molecule drugs is declining, hence the focus is shifting to biologics, which is expected to register productive growth in the years to come. Various pharmaceutical companies are focusing on the development of new biopharmaceutical products to keep up with the industry trends and maintain their position in the global market. In addition, biologics drugs have to follow complex and rigorous regulations, which, in turn, is further driving the demand for regulatory outsourcing for biologics, thereby driving the segment.

Indication Insights

The oncology segment accounted for the largest share of more than 34% of the global revenue in 2021. The recent advances in the biology of cancer and the emergence of new tools for genome analysis have opened a clinical perspective in oncology, which has led to personalized medicine. Scientific progress is driving an increase in the number of personalized medicine products and services subject to regulatory review. Hence, contributing to the market growth. Other indications included in the scope of the study are neurology, cardiology, immunology, and others.

The immunology segment is expected to grow at the fastest CAGR over the forecast.This isdue to its potential in facilitating the treatment of various cardiovascular, neurological, oncological, and inflammatory diseases. The strategic initiatives undertaken by market players for immunology are anticipated to facilitate the segment growth. For instance, in 2020, Eli Lilly entered into an agreement to acquire Dermira’s immunology portfolio. In addition, the COVID-19 pandemic had created an urgent need for vaccines. Thus, the development of vaccines for COVID-19 is likely to have a positive impact on segment growth.

Stage Insights

On the basis of stages, the global market has been divided into preclinical, clinical studies, and PMA. The clinical studies segment accounted for the largest share of more than 47.0% in 2021. This can be attributed to the increasing number of clinical trial registrations over the past few years. According to ClinicalTrials.gov, nearly 401,716 trials were registered in January 2022, as compared to around 325,834 by the end of 2019. Moreover, this rise in the number of biologics, high demand for advanced technologies, and a requirement for personalized orphan drugs & medicine are other factors likely to fuel segment growth during the forecast period.

The preclinical segment is anticipated to grow at the fastest CAGR over the forecast period. The rising demand for novel disease treatments, such as COVID-19, Zika virus, and Ebola, and the increasing prevalence of existing diseases, such as CVDs, cancer, and neurological diseases are the key factors contributing to the preclincial segment’s growth. Moreover, stringent regulations related to preclinical studies, laid down by global regulatory bodies, such as International Conference on Harmonization (ICH), WHO, FDA, EMEA (Europe), PMDA (Japan), ANVISA (Brazil), MHRA (UK), & ROEB (Canada), are further driving the demand for regulatory affairs outsourcing agency for preclinical studies.

End-use Insights

On the basis of end uses, the global market has been further segmented into medical device companies, pharmaceutical companies, and biotechnology companies. The pharmaceutical companies end-use segment accounted for the largest share of more than 39% of the global revenue in 2021. The segment is anticipated to expand further at the fastest CAGR retaining its leading market position over the forecast period. This is due to the growth in evolving areas, such as biosimilar, orphan drugs, and personalized medicines, which are creating more demand for regulatory services, thereby boosting the segment growth.

In addition, the significant number of new drugs entering the pharmaceutical industry has further improved the segment growth. The medical device and biotechnology segments both have registered a substantial share in the market in 2021. This can be attributed to the increased demand for biopharmaceuticals, vaccines, advanced medical devices, and others. The growing demand for wearable technologies along with recent epidemic events is further contributing to the share of these segments.

Regional Insight

On the basis of geographies, the market has been further divided into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. The Asia Pacific region accounted for the maximum share of more than 39% of the global revenue in 2021. The region is also projected to witness the fastest CAGR over the forecast period. This can be attributed to the increasing number of clinical trials and the rising number of companies trying to enter markets in developing countries, such as India and China. Furthermore, the availability of a skilled workforce in the region at lower costs compared to the U.S. is another factor expected to propel the regional market growth.

The North America regional market also reported a significant share in the global industry. The presence of key pharmaceutical and medical devices companies and the rise in the R&D spending in the region and some of the key factors driving the market in North America. North America and Europe are expected to be the key markets for regulatory affairs outsourcing owing to the presence of two major international regulatory agencies, the European Medicines Agency (EMA) and U.S. FDA, which regulate more than half of medical devices worldwide.

Some of the prominent players in the 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

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 Outsourcing market

  • Services
    • Regulatory Consulting
    • Legal Representation
    • Regulatory Writing & Publishing
    • Product Registration & Clinical Trial Applications
    • Other Services
  • Company Size
    • Small
    • Medium
    • Large
  • Category
    • Drugs
      • Generics
      • Innovators
    • Biologics
      • Biotech
      • ATMPs
      • Biosimilars
    • Medical devices
      • Therapeutic
      • Diagnostic
  • Indication
    • Oncology
    • Neurology
    • Cardiology
    • Immunology
    • Others
  • Stage
    • Preclinical
    • Clinical
    • PMA (Post Market Authorization)
  • End-use
    • Medical Device Companies
    • Pharmaceutical Companies
    • Biotechnology Companies

By Regional Outlook

North America

  • U.S.
  • Canada

Europe

  • Germany
  • France
  • United Kingdom
  • Rest of Europe

Asia Pacific

  • China
  • Japan
  • India
  • Southeast Asia
  • Rest of Asia Pacific

Latin America

  • Brazil
  • Rest of Latin America

Middle East & Africa (MEA)

  • GCC
  • North Africa
  • South Africa
  • Rest of Middle East & Africa

Key Benefits for Stakeholders

  • This report provides a quantitative analysis of the market segments, current trends, estimations, and dynamics of the global Regulatory Affairs Outsourcing industry analysis from 2022 to 2030 to identify the prevailing Regulatory Affairs Outsourcing industry opportunity.
  • The market research is offered along with information related to key drivers, restraints, and opportunities.
  • Porter's five forces analysis highlights the potency of buyers and suppliers to enable stakeholders make profit-oriented business decisions and strengthen their supplier-buyer network.
  • In-depth analysis of the global Regulatory Affairs Outsourcing industry segmentation assists to determine the prevailing market opportunities.
  • Major countries in each region are mapped according to their revenue contribution to the global market.
  • Market player positioning facilitates benchmarking and provides a clear understanding of the present position of the market players.
  • The report includes the analysis of the regional as well as global Regulatory Affairs Outsourcing industry trends, key players, market segments, application areas, and market growth strategies.

Report Detail

  • Report Code:7054
  • No. of Pages:150+
  • Format:PDF/PPT/Excel

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