Regulatory Affairs Outsourcing Market Size, Share, Growth, Trends And Forecast 2019-2026.

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Regulatory Affairs Outsourcing Market Size, Share, Growth, Trends And Forecast 2019-2026

​The global ​regulatory affairs outsourcing market size is expected to reach approximately USD 14.7 billion by 2026 and the market is predicted to witness a CAGR of 12.7% through the estimated years 2019 to 2026.

Economic and competitive pressures in the healthcare industry continue to motivate life sciences companies to explore ways of cutting costs across operations and increase their focus on product innovations, research activities, and improved turnaround time of deliverables. Companies aspiring to widen their global reach are increasing investments on R&D activities and new products are entering clinical trials and the market at a rapid pace. Undertaking regulatory affairs and the maintenance of vast volumes data generated during the process can be a daunting task for companies having a vast product portfolio and operations spread across diverse regional markets.

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An increase in geographical expansion activities by companies that aim for speedy approvals in global markets is expected to contribute to the adoption of outsourcing models for healthcare regulatory affairs services. The outsourcing market for healthcare regulatory affairs is expanding rapidly due to the increase in the R&D activities, clinical trial applications, product registration, and drug pipeline. Companies are under constant pressure to procure timely clinical approvals from regulators in different regions.

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Regulatory approval procedures are becoming more stringent and time-consuming, and market players aim to obtain approval for the product in the first attempt to gain higher market shares. Companies are required to have an in-house regulatory affairs department or they are outsourcing the regulatory affairs department due to stringent regulatory requirements in developed countries and changing regulations in developing countries. Establishing an in-house regulatory affairs department in offshore countries is not feasible. Hence, companies are adopting different outsourcing models based on the size and priority of the projects, thereby contributing to the market for healthcare regulatory affairs outsourcing.

Regulatory affairs outsourcing functions are challenging. The increasing demand to obtain approval for new products, maintain compliance, and doing more with less have increased during the last decade. Simultaneously, investments in the regulatory information systems have increased considerably to keep pace with the need to automate activities like regulatory publishing and operations. In this scenario, outsourcing is gradually becoming a vital part of the regulatory capability mix.

The pressure to reduce costs by life sciences companies is very high. The shift toward outcome-based model, increase in use of generics, and demand for drugs and medical devices at a lesser price are expected to increase the need to reduce healthcare costs. An Increase in out-of-pocket expenses, uneven economic growth, and measures taken by various governments to maintain the cost of drugs are expected to contribute to the economic and competitive pressure.

Life science companies are now focusing on their core competencies and outsourcing noncore functions to increase their productivity and operational efficiency. These companies commonly outsource R&D functions to emerging markets, such as the Asia Pacific and MEA, and have now started outsourcing regulatory affairs function to CROs or service providers for reducing cost and increasing focus on core functions.

Clinical Trial Application and Product Registration Services to be Key Enabler of Growth

Of the key regulatory affair services outsourced by life sciences companies, regulatory writing and publishing is presently the largest market segment, accounting for a share of more than 43% across the global market in 2017. Owing to the diverse and continuously changing regulations across local, regional, national, and international markets, companies spend a vast share in their overall regulatory investments for timely updating data such as regulatory submissions and standard operating procedures. It is owing to this fact that the segment of regulatory writing and publishing leads the regulatory affairs outsourcing market. By the end of 2023, this segment is estimated to be worth US$2,406.6 million.

Over the next few years, however, the market for regulatory affairs outsourcing is witness the highest gains from the clinical trial applications and product registration segment. Factors such as patent expiries and the rising prevalence of a number of chronic, viral, and bacterial diseases have prompted biopharmaceutical companies in the development of a large number of new products. With the rising number of products in clinical trials, the demand for clinical trial application and product registration services is expected to substantially rise in the next few years.

Low-cost Clinical Trial Centers in Emerging Economies to be Key Enabler of Growth

In the years to come, regulatory affairs service providers in emerging economies across regions such as Latin America and Asia Pacific are expected to bag the most numbers of outsourcing projects across the globe. An increased number of biopharmaceutical companies are using emerging economies as a launch pad for their venture in larger markets such as North America and Europe.

Product development, research, and commercialization units are being set up at an increased rate across emerging economies owing to cheap resources and raw material costs. The vast population base of Asia Pacific also makes it a lucrative regional market for the medical industry. These factors are acting in favor of the regulatory affairs outsourcing markets in these regions and will help strengthen the market’s foothold in the next few years. As a result, the market for regulatory affairs outsourcing market in emerging economies will offer the most lucrative and sustained growth opportunities for the global market.

Emerging Nations Holding Immense Growth Opportunities

On the basis of geography it is expected that the emerging nations in Latin America and Asia Pacific will turn out to be extremely promising markets for regulatory affairs outsourcing. Product development, rise in the commercialization units, increasing number of researches and availability of cheap resources and raw materials will drive the growth of this market in emerging economies. Also, the vast pool of patient population in Asia Pacific will create a favorable environment for growth. Many new entrants are using emerging nations for launching themselves in order to later on venture into the bigger markets of North America and Europe.

Realization that Outsourcing is Cost Effective and Resource Effective Favoring Demand

According to the lead author of the support, the rising pace with which innovations are taking place in the medical sector, growing investments in research and development activities, and increasing competition between the players are helping the regulatory affairs outsourcing market to grow. Companies within the market are finding ways of reducing cost in order to attract more customers. The market is also growing due to the rising awareness and realization that outsourcing is cost-effective and resource effective way for the managing of data generated during approvals, clinical trials, and patent approvals.

Presence of Strict Regulatory Framework Governing Aspects of Marketing and Development of Drugs to Boost Growth of Market

Also, in many countries there is a presence of strict regulatory framework which governs each aspect of development and marketing of clinical drugs and medical devices, which makes it necessary that the regulatory documents be as per the define guidelines. This is driving the preference for professional service providers who all free services such as efficient handling of data relating to regulatory affairs.

The report analyzes and forecasts the regulatory affairs outsourcing market at global and regional levels. The market has been forecast based on volume (Tons) and value (US$ Mn) from 2019 to 2026. 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. For the region and all segments, the sales, revenue and their market share, growth rate are key research objects; we can research the manufacturers' sales, price, revenue, cost and gross profit and their changes. What's more, we will display the main consumers, raw material manufacturers, distributors, etc.

This report first introduces the background of regulatory affairs outsourcing, including the definition, classification, application, industrial chain structure, industry overview, national policy and planning analysis of the industry, and the latest dynamic analysis. 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 companies.

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

The report comprises a detailed value chain analysis, which provides a comprehensive view of the global regulatory affairs outsourcing market. The Porter’s Five Forces model has also been included to help understand the competitive landscape of the market. The study encompasses market attractiveness analysis, wherein various applications have been benchmarked based on their market size, growth rate, and general attractiveness.

The study provides a decisive view of the regulatory affairs outsourcing market by segmenting it in terms of form and application. The segment has been analyzed based on the present and future trends. Regional segmentation includes the current and projected demand in North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.

The report provides size (in terms of volume and value) of regulatory affairs outsourcing market for the base year 2018 and the forecast between 2019 and 2026. 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.

Company Profiles

The report also profiles major players in the this market on the basis of various attributes such as company overview, financial overview, business strategies, product portfolio, and recent developments. Key players in the global regulatory affairs outsourcing market are Criterium, Inc., Covance, Inc., Clinilabs, Inc., Charles River Laboratories International, Inc., and Accell Clinical Research, LLC.

Market Segmentation

Market By Service

  • Regulatory consulting
  • Legal representation
  • Regulatory writing and publishing
  • Product registration and clinical trial application
  • Other regulatory service
  • Market By Geography

  • North America
  • Europe
  • UK
  • Germany
  • France
  • Rest of Europe
  • Asia-Pacific
  • China
  • Japan
  • India
  • Australia
  • Rest of Asia-Pacific
  • Latin America
  • Brazil
  • Chile
  • Rest of Latin America
  • Middle East and Africa (MEA)
  • South Africa
  • Saudi Arabia
  • Rest of MEA
  • Research Methodology:

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

    Primary research represents a bulk of research efforts, supplemented by extensive secondary research. Annual reports, press releases, and relevant documents of key players operating in various application areas have been reviewed for competition analysis and market understanding.

    Secondary research also includes recent trends, technical writing, Internet sources, and statistical data from government websites, trade associations, and agencies. These have proved to be reliable, effective, and successful approaches for obtaining precise market data, capturing market participants’ insights, and recognizing business opportunities.

    The study objectives of this report are:

  • To analyze and study the global regulatory affairs outsourcing capacity, production, value(revenue), growth rate (CAGR), market share, historical, consumption, status (2014-2018) and forecast (2019-2026)
  • Market value USD Million and volume Units Million data for each segment and sub-segment
  • Focuses on the key regulatory affairs outsourcing manufacturers, to study the capacity, production, value, market share and development plans in future
  • Focuses on the global key manufacturers, to define, describe and analyze the market competition landscape, SWOT analysis
  • 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
  • Table of Content

    CHAPTER 1. INDUSTRY OVERVIEW

    1.1. Definition and Scope1.1.1. Definition of Regulatory Affairs Outsourcing1.1.2. Market Segmentation1.1.3. List of Abbreviations1.2. Summary1.2.1. Market Snapshot1.2.2. Regulatory Affairs Outsourcing Market By Service1.2.2.1. Global Regulatory Affairs Outsourcing Market Revenue and Growth Rate Comparison By Service (2015-2026)1.2.2.2. Global Regulatory Affairs Outsourcing Market Revenue Share By Service in 20171.2.2.3. Regulatory consulting1.2.2.4. Legal representation1.2.2.5. Regulatory writing and publishing1.2.2.6. Product registration and clinical trial application1.2.2.7. Other regulatory service1.2.3. Regulatory Affairs Outsourcing Market by Geography1.2.3.1. Global Regulatory Affairs Outsourcing Market Revenue and Growth Rate Comparison by Geography (2015-2026)1.2.3.2. North America Regulatory Affairs Outsourcing Market Revenue and Growth Rate (2015-2026)1.2.3.3. Europe Regulatory Affairs Outsourcing Market Revenue and Growth Rate (2015-2026)1.2.3.4. Asia-Pacific Regulatory Affairs Outsourcing Market Revenue and Growth Rate (2015-2026)1.2.3.5. Latin America Regulatory Affairs Outsourcing Market Revenue and Growth Rate (2015-2026)1.2.3.6. Middle East and Africa (MEA) Regulatory Affairs Outsourcing Market Revenue and Growth Rate (2015-2026)

    CHAPTER 2. MARKET DYNAMICS AND COMPETITION ANALYSIS

    2.1. Market Drivers2.2. Restraints and Challenges2.3. Growth Opportunities2.4. Porter’s Five Forces Analysis2.4.1. Bargaining Power of Suppliers2.4.2. Bargaining Power of Buyers2.4.3. Threat of Substitute2.4.4. Threat of New Entrants2.4.5. Degree of Competition2.5. Value Chain Analysis2.6. Cost Structure Analysis2.6.1. Raw Material and Suppliers2.6.2. Manufacturing Process Analysis2.7. Regulatory Compliance2.8. Competitive Landscape, 20172.8.1. Player Positioning Analysis2.8.2. Key Strategies Adopted By Leading Players

    CHAPTER 3. MANUFACTURING PLANTS ANALYSIS

    3.1. Capacity and Commercial Production Date of Global Regulatory Affairs Outsourcing Major Manufacturers in 20173.2. Manufacturing Plants Distribution of Global Regulatory Affairs Outsourcing Major Manufacturers in 20173.3. R&D Status and Technology Source of Global Regulatory Affairs Outsourcing Major Manufacturers in 20173.4. Raw Materials Sources Analysis of Global Regulatory Affairs Outsourcing Major Manufacturers in 2017

    CHAPTER 4. REGULATORY AFFAIRS OUTSOURCING MARKET BY SERVICE

    4.1. Global Regulatory Affairs Outsourcing Revenue By Service4.2. Regulatory consulting4.2.1. Market Revenue and Growth Rate, 2015 - 2026 ($Million)4.2.2. Market Revenue and Forecast, By Region, 2015 - 2026 ($Million)4.3. Legal representation4.3.1. Market Revenue and Growth Rate, 2015 - 2026 ($Million)4.3.2. Market Revenue and Forecast, By Region, 2015 - 2026 ($Million)4.4. Regulatory writing and publishing4.4.1. Market Revenue and Growth Rate, 2015 - 2026 ($Million)4.4.2. Market Revenue and Forecast, By Region, 2015 - 2026 ($Million)4.5. Product registration and clinical trial application4.5.1. Market Revenue and Growth Rate, 2015 - 2026 ($Million)4.5.2. Market Revenue and Forecast, By Region, 2015 - 2026 ($Million)4.6. Other regulatory service4.6.1. Market Revenue and Growth Rate, 2015 - 2026 ($Million)4.6.2. Market Revenue and Forecast, By Region, 2015 - 2026 ($Million)

    CHAPTER 5. NORTH AMERICA REGULATORY AFFAIRS OUTSOURCING MARKET BY COUNTRY

    5.1. North America Regulatory Affairs Outsourcing Market Revenue and Growth Rate, 2015 - 2026 ($Million)5.2. North America Regulatory Affairs Outsourcing Market Revenue Share Comparison, 2015 & 2026 (%)5.3. U.S.5.3.1. U.S. Regulatory Affairs Outsourcing Market Revenue and Forecast By Service, 2015 - 2026 ($Million)5.3.2. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)5.4. Canada5.4.1. Market Revenue and Forecast By Service, 2015 - 2026 ($Million)5.4.2. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)5.5. Mexico5.5.1. Market Revenue and Forecast By Service, 2015 - 2026 ($Million)5.5.2. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)

    CHAPTER 6. EUROPE REGULATORY AFFAIRS OUTSOURCING MARKET BY COUNTRY

    6.1. Europe Regulatory Affairs Outsourcing Market Revenue and Growth Rate, 2015 - 2026 ($Million)6.2. Europe Regulatory Affairs Outsourcing Market Revenue Share Comparison, 2015 & 2026 (%)6.3. UK6.3.1. Market Revenue and Forecast By Service, 2015 - 2026 ($Million)6.3.2. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)6.4. Germany6.4.1. Market Revenue and Forecast By Service, 2015 - 2026 ($Million)6.4.2. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)6.5. France6.5.1. Market Revenue and Forecast By Service, 2015 - 2026 ($Million)6.5.2. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)6.6. Spain6.6.1. Market Revenue and Forecast By Service, 2015 - 2026 ($Million)6.6.2. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)6.7. Rest of Europe6.7.1. Market Revenue and Forecast By Service, 2015 - 2026 ($Million)6.7.2. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)

    CHAPTER 7. ASIA-PACIFIC REGULATORY AFFAIRS OUTSOURCING MARKET BY COUNTRY

    7.1. Asia-Pacific Regulatory Affairs Outsourcing Market Revenue and Growth Rate, 2015 - 2026 ($Million)7.2. Asia-Pacific Regulatory Affairs Outsourcing Market Revenue Share Comparison, 2015 & 2026 (%)7.3. China7.3.1. Market Revenue and Forecast By Service, 2015 - 2026 ($Million)7.3.2. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)7.4. Japan7.4.1. Market Revenue and Forecast By Service, 2015 - 2026 ($Million)7.4.2. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)7.5. India7.5.1. Market Revenue and Forecast By Service, 2015 - 2026 ($Million)7.5.2. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)7.6. Australia7.6.1. Market Revenue and Forecast By Service, 2015 - 2026 ($Million)7.6.2. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)7.7. South Korea7.7.1. Market Revenue and Forecast By Service, 2015 - 2026 ($Million)7.7.2. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)7.8. Rest of Asia-Pacific7.8.1. Market Revenue and Forecast By Service, 2015 - 2026 ($Million)7.8.2. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)

    CHAPTER 8. LATIN AMERICA REGULATORY AFFAIRS OUTSOURCING MARKET BY COUNTRY

    8.1. Latin America Regulatory Affairs Outsourcing Market Revenue and Growth Rate, 2015 - 2026 ($Million)8.2. Latin America Regulatory Affairs Outsourcing Market Revenue Share Comparison, 2015 & 2026 (%)8.3. Brazil8.3.1. Market Revenue and Forecast By Service, 2015 - 2026 ($Million)8.3.2. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)8.4. Argentina8.4.1. Market Revenue and Forecast By Service, 2015 - 2026 ($Million)8.4.2. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)8.5. Rest of Latin America8.5.1. Market Revenue and Forecast By Service, 2015 - 2026 ($Million)8.5.2. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)

    CHAPTER 9. MIDDLE EAST REGULATORY AFFAIRS OUTSOURCING MARKET BY COUNTRY

    9.1. Middle East Regulatory Affairs Outsourcing Market Revenue and Growth Rate, 2015 - 2026 ($Million)9.2. Middle East Regulatory Affairs Outsourcing Market Revenue Share Comparison, 2015 & 2026 (%)9.3. Saudi Arabia9.3.1. Market Revenue and Forecast By Service, 2015 - 2026 ($Million)9.3.2. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)9.4. UAE9.4.1. Market Revenue and Forecast By Service, 2015 - 2026 ($Million)9.4.2. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)9.5. Rest of Middle East9.5.1. Market Revenue and Forecast By Service, 2015 - 2026 ($Million)9.5.2. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)

    CHAPTER 10. AFRICA REGULATORY AFFAIRS OUTSOURCING MARKET BY COUNTRY

    10.1. Africa Regulatory Affairs Outsourcing Market Revenue and Growth Rate, 2015 - 2026 ($Million)10.2. Africa Regulatory Affairs Outsourcing Market Revenue Share Comparison, 2015 & 2026 (%)10.3. South Africa10.3.1. Market Revenue and Forecast By Service, 2015 - 2026 ($Million)10.3.2. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)10.4. Egypt10.4.1. Market Revenue and Forecast By Service, 2015 - 2026 ($Million)10.4.2. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)10.5. Rest of Africa10.5.1. Market Revenue and Forecast By Service, 2015 - 2026 ($Million)10.5.2. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)

    CHAPTER 11. COMPANY PROFILE

    11.1. Medpace Inc.11.1.1. Company Snapshot11.1.2. Overview11.1.3. Financial Overview11.1.4. Product Portfolio11.1.5. Key Developments11.1.6. Strategies11.2. Accell Clinical Research11.2.1. Company Snapshot11.2.2. Overview11.2.3. Financial Overview11.2.4. Product Portfolio11.2.5. Key Developments11.2.6. Strategies11.3. Wuxi AppTec11.3.1. Company Snapshot11.3.2. Overview11.3.3. Financial Overview11.3.4. Product Portfolio11.3.5. Key Developments11.3.6. Strategies11.4. PRA International11.4.1. Company Snapshot11.4.2. Overview11.4.3. Financial Overview11.4.4. Product Portfolio11.4.5. Key Developments11.4.6. Strategies11.5. Criterium Inc.11.5.1. Company Snapshot11.5.2. Overview11.5.3. Financial Overview11.5.4. Product Portfolio11.5.5. Key Developments11.5.6. Strategies11.6. PAREXEL International Corporation11.6.1. Company Snapshot11.6.2. Overview11.6.3. Financial Overview11.6.4. Product Portfolio11.6.5. Key Developments11.6.6. Strategies11.7. Clinilabs Inc.11.7.1. Company Snapshot11.7.2. Overview11.7.3. Financial Overview11.7.4. Product Portfolio11.7.5. Key Developments11.7.6. Strategies11.8. Quintiles Transnational Holdings11.8.1. Company Snapshot11.8.2. Overview11.8.3. Financial Overview11.8.4. Product Portfolio11.8.5. Key Developments11.8.6. Strategies11.9. Charles River Laboratories International Inc.11.9.1. Company Snapshot11.9.2. Overview11.9.3. Financial Overview11.9.4. Product Portfolio11.9.5. Key Developments11.9.6. Strategies11.10. Others11.10.1. Company Snapshot11.10.2. Overview11.10.3. Financial Overview11.10.4. Product Portfolio11.10.5. Key Developments11.10.6. Strategies

    CHAPTER 12. RESEARCH APPROACH

    12.1. Research Methodology12.1.1. Initial Data Search12.1.2. Secondary Research12.1.3. Primary Research

    12.2. Assumptions and Scope​

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