Regulatory Affairs Market (By Service: Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Other Services; By Service Provider:In-house, Outsourcing; Company Size: Small, Medium, Large: By Categories:Drugs, Medical Devices, Biologics; By Product Stage, By Indication, By End-use) - Global Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook and Forecast 2021-2030

The global Regulatory Affairs market size is expected to be worth around US$ 20.5 billion by 2030, according to a new report by Vision Research Reports.

The global Regulatory Affairs market size was valued at US$ 10.98 billion in 2020 and is anticipated to grow at a CAGR of 8.9% during forecast period 2021 to 2030.

Regulatory Affairs Market Size 2021 to 2030

Growth Factors

the market growth over the forecast period. Technological advancements in regulatory software and the growing digital transformation in the healthcare industry are also expected to contribute to market growth. In addition, the introduction of Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) is anticipated to not only change the EU regulatory landscape and increase the stringency of regulations but also increase the number of documents required to be created and maintained by companies.

Furthermore, the changes in the Central Administration for Pharmaceutical Affairs (CAPA) scope in Egypt is anticipated to change the medical device registration process in the country. Such changes in local regulations are anticipated to favor market growth. Furthermore, several regulatory changes related to clinical trials, vaccine development, and product approvals, initiated by the global and local regulatory authorities to expedite patient access to Covid-19 treatments and vaccines, are anticipated to positively affect the market growth. Market players are actively involved in the adoption of advanced technologies, strategic collaborations, and mergers & acquisition, to strengthen their market positions and outperform the competition. For instance, in 2020, ICON acquired MedPass, a medical device CRO, reimbursement, and regulatory consultancy firm. This acquisition is aimed at strengthening the medical device and diagnostic research services portfolio of ICON through the addition of new clinical and regulatory capabilities in Europe.

Report Highlights

The regulatory writing & publishing segment held the largest market share of over 36% in 2020. This can be attributed to the increase in the outsourcing of selected regulatory functions by major life sciences companies while focusing on the core functions. Based on services, the market is categorized into regulatory consulting, legal representation, regulatory writing & publishing, product registration & clinical trial applications, and others.

The legal representation segment is anticipated to witness the fastest growth rate over the forecast period due to geographic expansion plans of biotech/pharma and medical device companies, which is anticipated to increase the demand for local regulatory services. Entering new markets is a challenging process for many pharma/biotech and medical device companies, especially small- and medium-sized ones. This can be attributed to the difference in local regulations and lack of sufficient internal resources to meet the required local expertise, thus creating a need for experienced service providers.

The medical devices segment accounted for the maximum revenue share of over 37% in 2020. This can be attributed to the increased competition due to the high demand for wearables and technological advancements in material science, design languages, personalized healthcare, and additive manufacturing, which encourages manufacturers & technology developers to focus on core competencies and outsource non-core activities. Based on the categories, the market is divided into drugs, biologics, and medical devices. The medical device category is sub-segmented into diagnostics and therapeutics.

The drugs segment is sub-segmented into innovator and generic while the biologics segment is sub-segmented into biosimilars, Advanced Therapy Medicinal Products (ATMPs), and biotech products. Innovative drugs and therapeutic medical devices dominated the market in 2019. Biologics are anticipated to witness the fastest CAGR over the forecast period. The growing number of product approvals and increasing demand for targeted therapies as well as the rise in the development of are anticipated to contribute to segment growth.

The oncology segment dominated the regulatory affairs market in 2020 and accounted for the largest revenue share of over 33%. The segment will expand further on account of the increasing prevalence of chronic diseases, such as cancer, along with the presence of several innovative pipeline products. 

The clinical-stage led the market and accounted for 46.02% of the global revenue share in 2020. The increasing prevalence of chronic diseases and the emergence of new diseases are anticipated to increase the number of  conducted to meet healthcare needs. Furthermore, several companies conduct clinical trials on existing molecules for either indication expansion or combination therapy. 

Such activities are anticipated to increase the need for regulatory services related to medical writing and regulatory labeling services. The preclinical stage is anticipated to grow at the fastest CAGR over the forecast period. This can be attributed to the increasing number of molecules in the preclinical stage. 

The outsourcing segment accounted for the largest market share of more than 57% in 2020 and is anticipated to expand further at the fastest CAGR over the forecast period. Several start-up medical devices, pharmaceutical, and biotechnology companies generally lack the budget and infrastructure for a sustainable in-house regulatory affairs team and mainly rely on outsourcing, thus providing huge opportunities for service providers.

The medium-sized companies segment led the market and accounted for a revenue share of over 46%. The basis for the company size is employee strength and not revenue. The presence of several midsized established providers is anticipated to contribute to this segment’s growth.

The large-sized companies segment is anticipated to register the fastest CAGR over the forecast period. Large-size companies generally tend to prefer service providers of similar size to meet various regulatory needs arising due to their large geographic network & wide product lines and tend to seek long-term partnerships with service providers.

The pharmaceutical companies segment accounted for the largest revenue share of over 38% in 2020 and is projected to grow at the fastest CAGR from 2020 to 2027. This growth is attributed to the increase in the number of approved pharmaceutical products. For instance, the U.S. FDA approved 22, 46, and 59 novel drugs in 2016, 2017, and 2018, respectively.

Based on end use, the market has been segmented into pharmaceutical, biotechnology, and medical device companies. The end-use segment was introduced in addition to the categories segment, owing to one company catering to multiple categories but recognizing itself as part of one of the aforementioned three industries.

Asia Pacific was the dominant regional market in 2020 and accounted for more than 39% of the overall share. It is also anticipated to be the fastest-growing region owing to relatively lower cost for outsourcing, skilled workforce with technical expertise, tax benefits, and expansion of healthcare companies in countries, such as India, Singapore, and China. A supportive regulatory landscape is also anticipated to favor the region’s growth. In 2019, more than 95 biosimilars were approved in India.

This can be attributed to a less rigorous approval pathway for biosimilars in the country and other similar emerging markets as compared to highly-regulated markets. The implementation of the In-vitro Diagnostics Regulation (IVDR) and new Medical Device Regulation (MDR) is anticipated to increase the time and cost required for entering the Europe market, thereby increasing the regulatory complications in the regional market.

Report Coverage Details
Market Size US$ 20.5 billion by 2030
Growth Rate CAGR of 8.9% from 2021 to 2030
Base Year 2020
Forecast Period 2021-2030
Segments Covered Service, Service Provider, Company Size, Categories, Product Stage, Indication, End-use, Region
Companies Mentioned Accell Clinical Research, LLC., GenPact Ltd., Criterium, Inc., PRA Health Sciences, Promedica International, WuXi AppTec, Inc., Medpace, Icon plc, Covance, Parexel International Corporation, Freyr

Key Players

  • Accell Clinical Research, LLC.

  • GenPact Ltd.

  • Criterium, Inc.

  • PRA Health Sciences

  • Promedica International

  • WuXi AppTec, Inc.

  • Medpace

  • Charles River Laboratories International, Inc.

  • Icon plc

  • Covance

  • Parexel International Corporation

  • Freyr

Market Segmentation

  • Service Outlook

    • Regulatory Consulting

    • Legal Representation

    • Regulatory Writing & Publishing

    • Product Registration & Clinical Trial Application

    • Other Services

  • Service Provider Outlook 

    • In-house

    • Outsourcing

  • Company Size Outlook 

    • Small

    • Medium

    • Large

  • Categories Outlook

    • Drugs

      •  Innovator

        • Preclinical

        • Clinical

        • Post Market

      •  Generic

        • Preclinical

        • Clinical

        • Post Market

    • Biologics

      • Biotech

        • Preclinical

        • Clinical

        • Post Market

      • ATMP

        • Preclinical

        • Clinical

        • Post Market

      • Biosimilar

        • Preclinical

        • Clinical

        • Post Market

    • Medical Devices

      • Diagnostic

        • Preclinical

        • Clinical

        • Post Market

      • Therapeutic

        • Preclinical

        • Clinical

        • Post Market

  • Product Stage Outlook

    • Preclinical

    • Clinical

    • PMA

  • Indication Outlook

    • Oncology

    • Neurology

    • Cardiology

    • Immunology

    • Others

  • End-use Outlook

    • Medical Device Companies

    • Pharmaceutical Companies

    • Biotechnology Companies

  • Regional Outlook

    • North America

      • U.S.

      • Canada

    • Europe

      • U.K.

      • Germany

      • France

      • Italy

      • Spain

      • Russia

      • Turkey

      • The Netherlands

      • Switzerland

      • Sweden

    • Asia Pacific

      • Japan

      • China

      • India

      • Australia

      • South Korea

      • Indonesia

      • Malaysia

      • Singapore

      • Thailand

      • Taiwan

    • Latin America

      • Brazil

      • Mexico

      • Argentina

      • Colombia

      • Chile

    • MEA

      • South Africa

      • Saudi Arabia

      • UAE

      • Egypt

      • Israel

The Regulatory Affairs 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 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 market status, future forecast, growth opportunity, key market and key players. The study objectives are to present the Regulatory Affairs 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 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 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 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 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 market companies.

Regarding the analysis of the industry chain, the research of this report covers the raw materials and equipment of Regulatory Affairs 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 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 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 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 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 market. These factors have benefited the growth of the global market for Regulatory Affairs. 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. 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 are as follows:

  • Historic Year: 2017-2020
  • Base Year: 2020
  • 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.

Report Detail

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