Regulatory Affairs Outsourcing Market (By Service: Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product Registration & Clinical Trial Applications; By Company Size: Small, Medium, Large; By Category: Drugs, Biologics, Medical devices; By Indication: Oncology, Neurology, Cardiology, Immunology; By Stage: Preclinical, Clinical, PMA (Post Market Authorization); By End-use: Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies) - Global Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook 2022 – 2030

Published Date : Feb 2022 | No. of Pages : 250 Pages | Category : Healthcare

The global Regulatory Affairs Outsourcing market size is expected to be worth around US$ 12.9 billion by 2030, according to a new report by Vision Research Reports.

The global Regulatory Affairs Outsourcing market size was valued at US$ 6.6 billion in 2020 and is anticipated to grow at a CAGR of 8.5% during forecast period 2021 to 2030.

Regulatory Affairs Outsourcing Market Size 2022 to 2030

Report Coverage

Report Scope Details
Market Size US$ 12.9 billion by 2030
Growth Rate CAGR of 8.5% From 2022 to 2030
Largest Market Asia Pacific
Base Year 2021
Forecast Period 2022 to 2030
Segments Covered Service, CompanySsize, Category, Indication, Stage,  Enduse
Regional Scope North America, Europe, Asia Pacific, Latin America, Middle East & Africa
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.

Growth Factors

A significant increase in the fixed costs of in-house resources for regulatory affairs and operation activities, like training, technology, specialized knowledge, and facilities, is driving the outsourcing of regulatory affairs functions.

Addressing local regulatory challenges and constant changes in the regulations of the major markets, such as the U.S., Europe, and Asia, are creating demand for the services. Compliance with the current regulations has become an immense chore, leave alone trying to stay up to date with developments around the world. Amendments to current regulations are likely to simplify the regulatory pathway for the industry but, in turn, complicate the operation for healthcare product manufacturing companies. Thus, leading to the regulatory affairs outsourcing to service providers.

Report Highlights

The regulatory writing and publishing segment led the market with a revenue share of 36.7% in 2020. These services are offered from the early stages of product development to the premarket approval phase. The segment is also anticipated to dominate the regulatory affairs outsourcing market during the forecast period owing to increased outsourcing of these services by large- and mid-size biopharmaceutical and medical device companies. For instance, as of 2019, regulatory writing and pharmacovigilance services by IQVIA within the Asia Pacific region contributed toward high revenue generation.

The legal representation segment is anticipated to expand at the fastest CAGR of 12.7% over the forecast period. This may be due to the increasing demand for legal representatives across the globe caused by the globalization of medical device companies. For instance, companies not locally present in Europe require legal representatives to gain market authorization.

Medium-sized companies held the largest share of 46.8% in 2020. The presence of several midsized established providers, especially privately held ones, is anticipated to contribute to the segment growth. These companies have a strong presence in selected markets or multiple markets across the globe.

Based on category, the medical devices segment led the market with a share of 37.8% in 2020. This may be attributed to the fact that medical device companies are now focusing on their core competencies and outsourcing non-core functions to increase their productivity and operational efficiency.

The biologics segment is projected to grow rapidly during the forecast period. The R&D productivity of small molecule drugs is declining, hence shifting the focus on biologics, which are expected to register productive growth in the coming years. Various pharma industries are focusing on the development of several biopharmaceutical products to keep up with the industry trends and maintain their market position, thus eventually contributing to the segment growth.

The oncology segment held the largest revenue share of 33.1% in 2020. 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, thereby contributing to the segment growth.

Other indications included in the scope of the study are neurology, cardiology, immunology, and others. The neurology segment is expected to register a high CAGR over the forecast period. Neurology disorders are recognized as a major cause of death globally. According to the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) Report 2016, around 95% of people were suffering from neurological disease. It is estimated that the global population will reach 9 billion by 2050. Proactive government initiatives and an increase in external funding for R&D are among the key factors driving the market. Furthermore, rapid advancement in the field of neurology and technology has provided startups with opportunities to investigate new products.

Moreover, the coronavirus pandemic has further increased the demand for regulatory services. The global urgency to identify and commercialize an effective cure and/or vaccine for the COVID-19 disease has led to an increase in the number of clinical trials across the globe. Furthermore, supportive regulatory actions such as shortening of trial approval time, waiving of the waiting period, the release of industry guidance documents, and funding of clinical trials undertaken by regulatory authorities are anticipated to further boost the segment growth.

The pharmaceutical companies led the market and accounted for more than 38.0% share of the global revenue in 2020. The segment is also anticipated to expand at the fastest CAGR over the forecast period. This is attributed to the growth in evolving areas, such as biosimilar, orphan drugs, personalized medicines, companion diagnostics, and adaptive trial designs, which is creating more demand for regulatory services, thereby boosting the segment growth.

The Asia Pacific led the market with a share of 37.9% in 2020. The region is also projected to witness lucrative growth 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 countries, such as India and China. 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 regional growth.

Key Players

  • WuXi AppTec, Inc.

  • Medpace

  • Pharmaceutical Product Development, LLC (PPD)

  • Charles River Laboratories International, Inc.

  • ICON plc

  • Covance

  • Parexel International Corporation, Inc.

  • Freyr

  • Accell Clinical Research, LLC

  • Genpact Ltd.

  • Criterium, Inc.

  • PRA Health Sciences

  • Promedica International

Market Segmentation

  • Service Outlook 

    • Regulatory Consulting

    • Legal Representation

    • Regulatory Writing & Publishing

    • Product Registration & Clinical Trial Applications

    • Other Services

  • Company Size Outlook

    • Small

    • Medium

    • Large

  • Category Outlook 

    • Drugs

      • Generics

      • Innovators

    • Biologics

      • Biotech

      • ATMPs

      • Biosimilars

    • Medical devices

      • Therapeutic

      • Diagnostic

  • Indication Outlook 

    • Oncology

    • Neurology

    • Cardiology

    • Immunology

    • Others

  • Stage Outlook 

    • Preclinical

    • Clinical

    • PMA (Post Market Authorization)

  • End-user Outlook 

    • Medical Device Companies

    • Pharmaceutical Companies

    • Biotechnology Companies

  • Regional Outlook 

    • North America

      • U.S.

      • Canada

    • Europe

      • U.K.

      • Germany

      • France

      • Italy

      • Spain

      • Russia

      • Turkey

      • Netherlands

      • Switzerland

      • Sweden

      • Azerbaijan

      • Belarus

      • Kazakhstan

      • Moldova

      • Georgia

      • Ukraine

    • Asia Pacific

      • Japan

      • China

      • India

      • Australia

      • South Korea

      • Indonesia

      • Malaysia

      • Singapore

      • Thailand

      • Taiwan

      • Armenia

      • Kyrgyzstan

      • Tajikistan

      • Uzbekistan

      • Turkmenistan

    • Latin America

      • Brazil

      • Mexico

      • Argentina

      • Colombia

      • Chile

    • Middle East & Africa

      • South Africa

      • Saudi Arabia

      • UAE

      • Egypt

      • Israel

The Regulatory Affairs Outsourcing market research report covers definition, classification, product classification, product application, development trend, product technology, competitive landscape, industrial chain structure, industry overview, national policy and planning analysis of the industry, the latest dynamic analysis, etc., and also includes major. The study includes drivers and restraints of the global market. It covers the impact of these drivers and restraints on the demand during the forecast period. The report also highlights opportunities in the market at the global level.

The report provides size (in terms of volume and value) of Regulatory Affairs Outsourcing market for the base year 2020 and the forecast between 2021 and 2030. Market numbers have been estimated based on form and application. Market size and forecast for each application segment have been provided for the global and regional market.

This report focuses on the global Regulatory Affairs Outsourcing market status, future forecast, growth opportunity, key market and key players. The study objectives are to present the Regulatory Affairs Outsourcing market development in United States, Europe and China.

It is pertinent to consider that in a volatile global economy, we haven’t just conducted Regulatory Affairs Outsourcing market forecasts in terms of CAGR, but also studied the market based on key parameters, including Year-on-Year (Y-o-Y) growth, to comprehend the certainty of the market and to find and present the lucrative opportunities in market.

In terms of production side, this report researches the Regulatory Affairs Outsourcing capacity, production, value, ex-factory price, growth rate, market share for major manufacturers, regions (or countries) and type.

In terms of consumption side, this report focuses on the consumption of Regulatory Affairs Outsourcing by regions (countries) and application.

Buyers of the report will have access to verified market figures, including global market size in terms of revenue and volume. As part of production analysis, the authors of the report have provided reliable estimations and calculations for global revenue and volume by Type segment of the global Regulatory Affairs Outsourcing market. These figures have been provided in terms of both revenue and volume for the period 2017 to 2030. Additionally, the report provides accurate figures for production by region in terms of revenue as well as volume for the same period. The report also includes production capacity statistics for the same period.

With regard to production bases and technologies, the research in this report covers the production time, base distribution, technical parameters, research and development trends, technology sources, and sources of raw materials of major Regulatory Affairs Outsourcing market companies.

Regarding the analysis of the industry chain, the research of this report covers the raw materials and equipment of Regulatory Affairs Outsourcing market upstream, downstream customers, marketing channels, industry development trends and investment strategy recommendations. The more specific analysis also includes the main application areas of market and consumption, major regions and Consumption, major Chinese producers, distributors, raw material suppliers, equipment providers and their contact information, industry chain relationship analysis.

The research in this report also includes product parameters, production process, cost structure, and data information classified by region, technology and application. Finally, the paper model new project SWOT analysis and investment feasibility study of the case model.

Overall, this is an in-depth research report specifically for the Regulatory Affairs Outsourcing industry. The research center uses an objective and fair way to conduct an in-depth analysis of the development trend of the industry, providing support and evidence for customer competition analysis, development planning, and investment decision-making. In the course of operation, the project has received support and assistance from technicians and marketing personnel in various links of the industry chain.

The Regulatory Affairs Outsourcing market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies’ focus related to Regulatory Affairs Outsourcing market.

Prominent players in the market are predicted to face tough competition from the new entrants. However, some of the key players are targeting to acquire the startup companies in order to maintain their dominance in the global market. For a detailed analysis of key companies, their strengths, weaknesses, threats, and opportunities are measured in the report by using industry-standard tools such as the SWOT analysis. Regional coverage of key companies is covered in the report to measure their dominance. Key manufacturers of Regulatory Affairs Outsourcing market are focusing on introducing new products to meet the needs of the patrons. The feasibility of new products is also measured by using industry-standard tools.

Key companies are increasing their investments in research and development activities for the discovery of new products. There has also been a rise in the government funding for the introduction of new Regulatory Affairs Outsourcing market. These factors have benefited the growth of the global market for Regulatory Affairs Outsourcing. Going forward, key companies are predicted to benefit from the new product launches and the adoption of technological advancements. Technical advancements have benefited many industries and the global industry is not an exception.

New product launches and the expansion of already existing business are predicted to benefit the key players in maintaining their dominance in the global market for Regulatory Affairs Outsourcing. The global market is segmented on the basis of region, application, en-users and product type. Based on region, the market is divided into North America, Europe, Asia-Pacific, Latin America and Middle East and Africa (MEA).

In this study, the years considered to estimate the market size of Regulatory Affairs Outsourcing are as follows:

  • Historic Year: 2017-2020
  • Base Year: 2021
  • Forecast Year 2021 to 2030

Reasons to Purchase this Report:

- Market segmentation analysis including qualitative and quantitative research incorporating the impact of economic and policy aspects
- Regional and country level analysis integrating the demand and supply forces that are influencing the growth of the market.
- Market value USD Million and volume Units Million data for each segment and sub-segment
- Competitive landscape involving the market share of major players, along with the new projects and strategies adopted by players in the past five years
- Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players

Research Methodology:

In-depth interviews and discussions were conducted with several key market participants and opinion leaders to compile the research report.

This research study involved the extensive usage of both primary and secondary data sources. The research process involved the study of various factors affecting the industry, including the government policy, market environment, competitive landscape, historical data, present trends in the market, technological innovation, upcoming technologies and the technical progress in related industry, and market risks, opportunities, market barriers and challenges. The following illustrative figure shows the market research methodology applied in this report.

Market Size Estimation

Top-down and bottom-up approaches are used to estimate and validate the global market size for company, regional division, product type and application (end users).

The market estimations in this report are based on the selling price (excluding any discounts provided by the manufacturer, distributor, wholesaler or traders). Market share analysis, assigned to each of the segments and regions are achieved through product utilization rate and average selling price.

Major manufacturers & their revenues, percentage splits, market shares, growth rates and breakdowns of the product markets are determined through secondary sources and verified through the primary sources.

All possible factors that influence the markets included in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data. The market size for top-level markets and sub-segments is normalized, and the effect of inflation, economic downturns, and regulatory & policy changes or others factors are accounted for in the market forecast. This data is combined and added with detailed inputs and analysis from Vision Research Reports and presented in this report.

Market Breakdown and Data Triangulation

After complete market engineering with calculations for market statistics; market size estimations; market forecasting; market breakdown; and data triangulation. Extensive primary research was conducted to gather information and verify and validate the critical numbers arrived at. In the complete market engineering process, both top-down and bottom-up approaches were extensively used, along with several data triangulation methods, to perform market estimation and market forecasting for the overall market segments and sub-segments listed in this report.

Secondary Sources

Secondary Sources occupies approximately 25% of data sources, such as press releases, annual reports, Non-Profit organizations, industry associations, governmental agencies and customs data, and so on. This research study includes secondary sources; directories; databases such as Bloomberg Business, Wind Info, Hoovers, Factiva (Dow Jones & Company), TRADING ECONOMICS, and avention; Investing News Network; statista; Federal Reserve Economic Data; annual reports; investor presentations; and SEC filings of companies.

Primary Sources

 In the primary research process, various sources from both the supply and demand sides were interviewed to obtain qualitative and quantitative information for this report. The primary sources from the supply side include product manufacturers (and their competitors), opinion leaders, industry experts, research institutions, distributors, dealer and traders, as well as the raw materials suppliers and producers, etc.

The primary sources from the demand side include industry experts such as business leaders, marketing and sales directors, technology and innovation directors, supply chain executive, end users (product buyers), and related key executives from various key companies and organizations operating in the global market.

The study objectives of this report are:

  • To analyze and study the global market capacity, production, value, consumption, status (2017-2020) and forecast (2021-2030);
  • Focuses on the key manufacturers, to study the capacity, production, value, market share and development plans in future.
  • Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players
  • To define, describe and forecast the market by type, application and region.
  • To analyze the global and key regions market potential and advantage, opportunity and challenge, restraints and risks.
  • To identify significant trends and factors driving or inhibiting the market growth.
  • To analyze the opportunities in the market for stakeholders by identifying the high growth segments.
  • To strategically analyze each submarket with respect to individual growth trend and their contribution to the market
  • To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market
  • To strategically profile the key players and comprehensively analyze their growth strategies.

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