+353-1-416-8900REST OF WORLD
+44-20-3973-8888REST OF WORLD
1-917-300-0470EAST COAST U.S
1-800-526-8630U.S. (TOLL FREE)

Regulatory Affairs Outsourcing Global Market Report 2024

  • PDF Icon

    Report

  • 200 Pages
  • February 2024
  • Region: Global
  • The Business Research Company
  • ID: 5766680
The regulatory affairs outsourcing market size has grown rapidly in recent years. It will grow from $7.6 billion in 2023 to $8.49 billion in 2024 at a compound annual growth rate (CAGR) of 11.6%. The growth observed in the historic period can be attributed to the globalization of regulatory standards, changes in the regulatory landscape, the implementation of industry-specific regulations, the adoption of cost containment strategies, and a heightened focus on core competencies.

The regulatory affairs outsourcing market size is expected to see rapid growth in the next few years. It will grow to $13.83 billion in 2028 at a compound annual growth rate (CAGR) of 13.0%. The expected growth in the forecast period can be ascribed to the increasing complexity of submissions, the ongoing digital transformation in regulatory processes, a heightened emphasis on compliance and risk management, a shift in product development trends, and the growing intricacy in submissions. Key trends anticipated in the forecast period encompass the expansion of the life sciences industry, a focus on sustainability and adherence to environmental regulations, a rising demand for strategic guidance, the utilization of advanced analytics, and the enhancement of risk management practices.

The anticipated growth in research and development (R&D) activities focused on new vaccines, therapeutics, and medical devices is expected to be a significant driver for the regulatory affairs outsourcing market. Companies operating in the medical device, pharmaceutical, and biotechnological sectors are intensifying their investments in R&D to create innovative products and expand their global reach. Concurrently, these companies are increasingly opting to outsource regulatory affairs to optimize operational costs and expedite the regulatory process by leveraging the expertise of professionals in the field. For example, a March 2022 report from the National Health Expenditures (NHE), prepared by the Office of the Actuary at the Centers for Medicare & Medicaid Services (CMS), forecasts an annual growth rate in national health spending averaging 5.1% from 2021 to 2030, reaching nearly $6.8 trillion by 2030. Consequently, the surge in R&D activities for new vaccines, therapeutics, and medical devices is expected to be a driving force behind the growth of the regulatory affairs outsourcing market.

The expected increase in the number of clinical trials is also poised to drive the growth of the regulatory affairs outsourcing market. Clinical trials, crucial research studies involving human participants to assess the safety and efficacy of new medical treatments, interventions, or diagnostic procedures, are adopting regulatory affairs outsourcing as a strategic approach. This approach aims to streamline and expedite the intricate regulatory processes inherent in drug development. By leveraging external expertise, companies can navigate evolving compliance requirements, ensure efficient interactions with regulatory authorities, and thereby accelerate the overall trial timeline. This strategy facilitates timely market access for new pharmaceutical interventions. For instance, data from ClinicalTrials.gov of the United States National Library of Medicine in May 2023 reveals a global total of 452,604 registered clinical trials, with 64,838 actively recruiting participants - a substantial increase from the 365,000 reported in early 2021. This notable expansion in the clinical research landscape signifies the surge in the number of clinical trials, driving the growth of the regulatory affairs outsourcing market.

The emergence of efficient software designed to manage regulatory affairs is a prominent trend gaining traction in the regulatory affairs outsourcing market. Key players in this market are directing their efforts toward developing software solutions that streamline the recording and management of regulatory affairs. An illustration of this trend is evident in the actions of SureClinical, a provider of health science cloud applications and services. In December 2021, SureClinical introduced the Eclinical Ecosystem ECO Applications and Platform Bundle, which allows clinical research organizations to establish connections across people, projects, programs, and processes for a unified clinical view. Alongside supporting project management, document management, site management, and quality management, the ECO bundle also facilitates multiple audits and centralized data and document management.

In July 2021, ICON, an Ireland-based company specializing in drug and device development and commercialization services, acquired PRA Health Sciences Inc. for approximately $12 billion. ICON's objective with this acquisition is to bolster its consulting, clinical, and commercial services portfolio, expand its geographic presence, enhance therapeutic capabilities, and leverage data-powered healthcare technology to provide globally scaled expertise and solutions. PRA Health Sciences Inc., based in the United States, is a contract research organization (CRO) offering advanced healthcare intelligence and regulatory affairs outsourcing services.

In July 2021, ProductLife Group (PLG), a France-based provider of regulatory services to the life science sector, acquired ELC Group for an undisclosed amount. PLG's strategic acquisition is geared towards broadening its product offerings and strengthening its operational presence in the regulatory services sector on a global scale. ELC Group, based in the Czech Republic, is engaged in providing regulatory consulting services.

Major companies operating in the regulatory affairs outsourcing market report are Thermo Fisher Scientific Inc. (PPD), IQVIA, ICON PLC, Eurofins Scientific, WuXi App Tec, Syneos Health, Catalent Pharma Solutions, Charles River Laboratories International. Inc., Parexel International Corporation, Medpace, Curia, Certara L.P., Amicus GMP, Pace Life Sciences, CTI Clinical Trial & Consulting, Accell Clinical Research LLC, Consumer Product Testing Co., Promedica International, Clinilabs Inc., CliniExperts Pvt. Ltd., Covance Inc., Global Regulatory Services (GRS), Pharma Design Limited, PharmaLex, Hiray Pharma Solutions, LGM Pharma, BlueReg Group, EPiC Auditors Ltd.

North America was the largest region in the regulatory affairs outsourcing market in 2023. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the regulatory affairs outsourcing market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the regulatory affairs outsourcing market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Regulatory affairs outsourcing services cover legal representation, regulatory consulting, product registration & clinical trial application, regulatory writing & publication, and others. Legal representation involves advocates handling legal work on behalf of pharmaceutical and medical device companies for regulatory approvals, covering medical devices, biologics, and drugs for various medical indications such as neurology, oncology, immunology, and cardiology. These outsourcing services are commonly adopted by companies in the medical device, biotechnology, and pharmaceutical sectors.

The regulatory affairs outsourcing market research report is one of a series of new reports that provides regulatory affairs outsourcing market statistics, including regulatory affairs outsourcing industry global market size, regional shares, competitors with regulatory affairs outsourcing market share, detailed regulatory affairs outsourcing market segments, market trends and opportunities, and any further data you may need to thrive in the regulatory affairs outsourcing industry. This regulatory affair outsourcing market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The regulatory affairs outsourcing market includes revenues earned by entities by providing services such as scope representation, full-service representation, ghostwriting representation, and fixed-rate representation. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

Table of Contents

1. Executive Summary2. Regulatory Affairs Outsourcing Market Characteristics3. Regulatory Affairs Outsourcing Market Trends and Strategies
4. Regulatory Affairs Outsourcing Market - Macro Economic Scenario
4.1. Impact of High Inflation on the Market
4.2. Ukraine-Russia War Impact on the Market
4.3. COVID-19 Impact on the Market
5. Global Regulatory Affairs Outsourcing Market Size and Growth
5.1. Global Regulatory Affairs Outsourcing Market Drivers and Restraints
5.1.1. Drivers of the Market
5.1.2. Restraints of the Market
5.2. Global Regulatory Affairs Outsourcing Historic Market Size and Growth, 2018-2023, Value ($ Billion)
5.3. Global Regulatory Affairs Outsourcing Forecast Market Size and Growth, 2023-2028, 2033F, Value ($ Billion)
6. Regulatory Affairs Outsourcing Market Segmentation
6.1. Global Regulatory Affairs Outsourcing Market, Segmentation by Service, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
  • Legal Representation
  • Regulatory Consulting
  • Product Registration & Clinical Trial Application
  • Regulatory Writing & Publication
  • Other Services
6.2. Global Regulatory Affairs Outsourcing Market, Segmentation by Indication, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
  • Neurology
  • Oncology
  • Immunology
  • Cardiology
  • Other Indications
6.3. Global Regulatory Affairs Outsourcing Market, Segmentation by Category, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
  • Biologics
  • Drugs
  • Medical Devices
6.4. Global Regulatory Affairs Outsourcing Market, Segmentation by Company Size, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
  • Small
  • Medium
  • Large
6.5. Global Regulatory Affairs Outsourcing Market, Segmentation by End User, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
  • Medical Device Company
  • Biotechnology Company
  • Pharmaceutical Company
7. Regulatory Affairs Outsourcing Market Regional and Country Analysis
7.1. Global Regulatory Affairs Outsourcing Market, Split by Region, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
7.2. Global Regulatory Affairs Outsourcing Market, Split by Country, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
8. Asia-Pacific Regulatory Affairs Outsourcing Market
8.1. Asia-Pacific Regulatory Affairs Outsourcing Market Overview
Region Information, Impact of COVID-19, Market Information, Background Information, Government Initiatives, Regulations, Regulatory Bodies, Major Associations, Taxes Levied, Corporate Tax Structure, Investments, Major Companies
8.2. Asia-Pacific Regulatory Affairs Outsourcing Market, Segmentation by Service, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
8.3. Asia-Pacific Regulatory Affairs Outsourcing Market, Segmentation by Indication, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
8.4. Asia-Pacific Regulatory Affairs Outsourcing Market, Segmentation by End User, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
9. China Regulatory Affairs Outsourcing Market
9.1. China Regulatory Affairs Outsourcing Market Overview
9.2. China Regulatory Affairs Outsourcing Market, Segmentation by Service, Historic and Forecast, 2018-2023, 2023-2028F, 2033F,$ Billion
9.3. China Regulatory Affairs Outsourcing Market, Segmentation by Indication, Historic and Forecast, 2018-2023, 2023-2028F, 2033F,$ Billion
9.4. China Regulatory Affairs Outsourcing Market, Segmentation by End User, Historic and Forecast, 2018-2023, 2023-2028F, 2033F,$ Billion
10. India Regulatory Affairs Outsourcing Market
10.1. India Regulatory Affairs Outsourcing Market, Segmentation by Service, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
10.2. India Regulatory Affairs Outsourcing Market, Segmentation by Indication, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
10.3. India Regulatory Affairs Outsourcing Market, Segmentation by End User, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
11. Japan Regulatory Affairs Outsourcing Market
11.1. Japan Regulatory Affairs Outsourcing Market Overview
11.2. Japan Regulatory Affairs Outsourcing Market, Segmentation by Service, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
11.3. Japan Regulatory Affairs Outsourcing Market, Segmentation by Indication, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
11.4. Japan Regulatory Affairs Outsourcing Market, Segmentation by End User, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
12. Australia Regulatory Affairs Outsourcing Market
12.1. Australia Regulatory Affairs Outsourcing Market, Segmentation by Service, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
12.2. Australia Regulatory Affairs Outsourcing Market, Segmentation by Indication, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
12.3. Australia Regulatory Affairs Outsourcing Market, Segmentation by End User, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
13. Indonesia Regulatory Affairs Outsourcing Market
13.1. Indonesia Regulatory Affairs Outsourcing Market, Segmentation by Service, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
13.2. Indonesia Regulatory Affairs Outsourcing Market, Segmentation by Indication, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
13.3. Indonesia Regulatory Affairs Outsourcing Market, Segmentation by End User, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
14. South Korea Regulatory Affairs Outsourcing Market
14.1. South Korea Regulatory Affairs Outsourcing Market Overview
14.2. South Korea Regulatory Affairs Outsourcing Market, Segmentation by Service, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
14.3. South Korea Regulatory Affairs Outsourcing Market, Segmentation by Indication, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
14.4. South Korea Regulatory Affairs Outsourcing Market, Segmentation by End User, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
15. Western Europe Regulatory Affairs Outsourcing Market
15.1. Western Europe Regulatory Affairs Outsourcing Market Overview
15.2. Western Europe Regulatory Affairs Outsourcing Market, Segmentation by Service, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
15.3. Western Europe Regulatory Affairs Outsourcing Market, Segmentation by Indication, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
15.4. Western Europe Regulatory Affairs Outsourcing Market, Segmentation by End User, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
16. UK Regulatory Affairs Outsourcing Market
16.1. UK Regulatory Affairs Outsourcing Market, Segmentation by Service, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
16.2. UK Regulatory Affairs Outsourcing Market, Segmentation by Indication, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
16.3. UK Regulatory Affairs Outsourcing Market, Segmentation by End User, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
17. Germany Regulatory Affairs Outsourcing Market
17.1. Germany Regulatory Affairs Outsourcing Market, Segmentation by Service, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
17.2. Germany Regulatory Affairs Outsourcing Market, Segmentation by Indication, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
17.3. Germany Regulatory Affairs Outsourcing Market, Segmentation by End User, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
18. France Regulatory Affairs Outsourcing Market
18.1. France Regulatory Affairs Outsourcing Market, Segmentation by Service, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
18.2. France Regulatory Affairs Outsourcing Market, Segmentation by Indication, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
18.3. France Regulatory Affairs Outsourcing Market, Segmentation by End User, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
19. Italy Regulatory Affairs Outsourcing Market
19.1. Italy Regulatory Affairs Outsourcing Market, Segmentation by Service, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
19.2. Italy Regulatory Affairs Outsourcing Market, Segmentation by Indication, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
19.3. Italy Regulatory Affairs Outsourcing Market, Segmentation by End User, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
20. Spain Regulatory Affairs Outsourcing Market
20.1. Spain Regulatory Affairs Outsourcing Market, Segmentation by Service, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
20.2. Spain Regulatory Affairs Outsourcing Market, Segmentation by Indication, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
20.3. Spain Regulatory Affairs Outsourcing Market, Segmentation by End User, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
21. Eastern Europe Regulatory Affairs Outsourcing Market
21.1. Eastern Europe Regulatory Affairs Outsourcing Market Overview
21.2. Eastern Europe Regulatory Affairs Outsourcing Market, Segmentation by Service, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
21.3. Eastern Europe Regulatory Affairs Outsourcing Market, Segmentation by Indication, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
21.4. Eastern Europe Regulatory Affairs Outsourcing Market, Segmentation by End User, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
22. Russia Regulatory Affairs Outsourcing Market
22.1. Russia Regulatory Affairs Outsourcing Market, Segmentation by Service, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
22.2. Russia Regulatory Affairs Outsourcing Market, Segmentation by Indication, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
22.3. Russia Regulatory Affairs Outsourcing Market, Segmentation by End User, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
23. North America Regulatory Affairs Outsourcing Market
23.1. North America Regulatory Affairs Outsourcing Market Overview
23.2. North America Regulatory Affairs Outsourcing Market, Segmentation by Service, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
23.3. North America Regulatory Affairs Outsourcing Market, Segmentation by Indication, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
23.4. North America Regulatory Affairs Outsourcing Market, Segmentation by End User, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
24. USA Regulatory Affairs Outsourcing Market
24.1. USA Regulatory Affairs Outsourcing Market Overview
24.2. USA Regulatory Affairs Outsourcing Market, Segmentation by Service, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
24.3. USA Regulatory Affairs Outsourcing Market, Segmentation by Indication, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
24.4. USA Regulatory Affairs Outsourcing Market, Segmentation by End User, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
25. Canada Regulatory Affairs Outsourcing Market
25.1. Canada Regulatory Affairs Outsourcing Market Overview
25.2. Canada Regulatory Affairs Outsourcing Market, Segmentation by Service, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
25.3. Canada Regulatory Affairs Outsourcing Market, Segmentation by Indication, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
25.4. Canada Regulatory Affairs Outsourcing Market, Segmentation by End User, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
26. South America Regulatory Affairs Outsourcing Market
26.1. South America Regulatory Affairs Outsourcing Market Overview
26.2. South America Regulatory Affairs Outsourcing Market, Segmentation by Service, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
26.3. South America Regulatory Affairs Outsourcing Market, Segmentation by Indication, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
26.4. South America Regulatory Affairs Outsourcing Market, Segmentation by End User, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
27. Brazil Regulatory Affairs Outsourcing Market
27.1. Brazil Regulatory Affairs Outsourcing Market, Segmentation by Service, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
27.2. Brazil Regulatory Affairs Outsourcing Market, Segmentation by Indication, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
27.3. Brazil Regulatory Affairs Outsourcing Market, Segmentation by End User, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
28. Middle East Regulatory Affairs Outsourcing Market
28.1. Middle East Regulatory Affairs Outsourcing Market Overview
28.2. Middle East Regulatory Affairs Outsourcing Market, Segmentation by Service, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
28.3. Middle East Regulatory Affairs Outsourcing Market, Segmentation by Indication, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
28.4. Middle East Regulatory Affairs Outsourcing Market, Segmentation by End User, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
29. Africa Regulatory Affairs Outsourcing Market
29.1. Africa Regulatory Affairs Outsourcing Market Overview
29.2. Africa Regulatory Affairs Outsourcing Market, Segmentation by Service, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
29.3. Africa Regulatory Affairs Outsourcing Market, Segmentation by Indication, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
29.4. Africa Regulatory Affairs Outsourcing Market, Segmentation by End User, Historic and Forecast, 2018-2023, 2023-2028F, 2033F, $ Billion
30. Regulatory Affairs Outsourcing Market Competitive Landscape and Company Profiles
30.1. Regulatory Affairs Outsourcing Market Competitive Landscape
30.2. Regulatory Affairs Outsourcing Market Company Profiles
30.2.1. Thermo Fisher Scientific Inc. (PPD)
30.2.1.1. Overview
30.2.1.2. Products and Services
30.2.1.3. Strategy
30.2.1.4. Financial Performance
30.2.2. IQVIA
30.2.2.1. Overview
30.2.2.2. Products and Services
30.2.2.3. Strategy
30.2.2.4. Financial Performance
30.2.3. ICON plc
30.2.3.1. Overview
30.2.3.2. Products and Services
30.2.3.3. Strategy
30.2.3.4. Financial Performance
30.2.4. Eurofins Scientific
30.2.4.1. Overview
30.2.4.2. Products and Services
30.2.4.3. Strategy
30.2.4.4. Financial Performance
30.2.5. WuXi App Tec
30.2.5.1. Overview
30.2.5.2. Products and Services
30.2.5.3. Strategy
30.2.5.4. Financial Performance
31. Regulatory Affairs Outsourcing Market Other Major and Innovative Companies
31.1. Syneos Health
31.2. Catalent Pharma Solutions
31.3. Charles River Laboratories International. Inc.
31.4. Parexel International Corporation
31.5. Medpace
31.6. Curia
31.7. Certara L.P.
31.8. Amicus GMP
31.9. Pace Life Sciences
31.10. CTI Clinical Trial & Consulting
31.11. Accell Clinical Research LLC
31.12. Consumer Product Testing Co.
31.13. Promedica International
31.14. Clinilabs Inc.
31.15. CliniExperts Pvt. Ltd.
32. Global Regulatory Affairs Outsourcing Market Competitive Benchmarking33. Global Regulatory Affairs Outsourcing Market Competitive Dashboard34. Key Mergers and Acquisitions in the Regulatory Affairs Outsourcing Market
35. Regulatory Affairs Outsourcing Market Future Outlook and Potential Analysis
35.1 Regulatory Affairs Outsourcing Market in 2028 - Countries Offering Most New Opportunities
35.2 Regulatory Affairs Outsourcing Market in 2028 - Segments Offering Most New Opportunities
35.3 Regulatory Affairs Outsourcing Market in 2028 - Growth Strategies
35.3.1 Market Trend-based Strategies
35.3.2 Competitor Strategies
36. Appendix
36.1. Abbreviations
36.2. Currencies
36.3. Historic and Forecast Inflation Rates
36.4. Research Inquiries
36.5. About the Analyst
36.6. Copyright and Disclaimer

Executive Summary

Regulatory Affairs Outsourcing Global Market Report 2024 provides strategists, marketers and senior management with the critical information they need to assess the market.

This report focuses on regulatory affairs outsourcing market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.

Reasons to Purchase

  • Gain a truly global perspective with the most comprehensive report available on this market covering 50+ geographies.
  • Understand how the market has been affected by the coronavirus and how it is responding as the impact of the virus abates.
  • Assess the Russia-Ukraine war’s impact on agriculture, energy and mineral commodity supply and its direct and indirect impact on the market.
  • Measure the impact of high global inflation on market growth.
  • Create regional and country strategies on the basis of local data and analysis.
  • Identify growth segments for investment.
  • Outperform competitors using forecast data and the drivers and trends shaping the market.
  • Understand customers based on the latest market shares.
  • Benchmark performance against key competitors.
  • Suitable for supporting your internal and external presentations with reliable high quality data and analysis.
  • Report will be updated with the latest data and delivered to you with an Excel data sheet for easy data extraction and analysis.
  • All data from the report will also be delivered in an excel dashboard format.
Description
Where is the largest and fastest growing market for regulatory affairs outsourcing? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward? This report answers all these questions and many more.

The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market’s historic and forecast market growth by geography.
  • The market characteristics section of the report defines and explains the market.
  • The market size section gives the market size ($b) covering both the historic growth of the market, and forecasting its development.
  • The forecasts are made after considering the major factors currently impacting the market. These include:
  • The impact of sanctions, supply chain disruptions, and altered demand for goods and services due to the Russian Ukraine war, impacting various macro-economic factors and parameters in the Eastern European region and its subsequent effect on global markets.
  • The impact of higher inflation in many countries and the resulting spike in interest rates.
  • The continued but declining impact of COVID-19 on supply chains and consumption patterns.
  • Market segmentations break down the market into sub markets.
  • The regional and country breakdowns section gives an analysis of the market in each geography and the size of the market by geography and compares their historic and forecast growth. It covers the growth trajectory of COVID-19 for all regions, key developed countries and major emerging markets.
  • The competitive landscape chapter gives a description of the competitive nature of the market, market shares, and a description of the leading companies. Key financial deals which have shaped the market in recent years are identified.
  • The trends and strategies section analyses the shape of the market as it emerges from the crisis and suggests how companies can grow as the market recovers.

Report Scope

Markets Covered:
1) By Service: Legal Representation; Regulatory Consulting; Product Registration & Clinical Trial Application; Regulatory Writing & Publication; Other Services
2) By Indication: Neurology; Oncology; Immunology; Cardiology; Other Indications
3) By Category: Biologics; Drugs; Medical Devices; By Company Size: Small; Medium; Large
4) By End-user: Medical Device Company; Biotechnology Company; Pharmaceutical Company

Key Companies Mentioned: Thermo Fisher Scientific Inc. (PPD); IQVIA; ICON plc; Eurofins Scientific; WuXi App Tec

Countries: Australia; Brazil; China; France; Germany; India; Indonesia; Japan; Russia; South Korea; UK; USA; Canada; Italy; Spain

Regions: Asia-Pacific; Western Europe; Eastern Europe; North America; South America; Middle East; Africa

Time Series: Five years historic and ten years forecast

Data: Ratios of market size and growth to related markets, GDP proportions, expenditure per capita

Data Segmentation: Country and regional historic and forecast data, market share of competitors, market segments

Sourcing and Referencing: Data and analysis throughout the report is sourced using end notes

Delivery Format: PDF, Word and Excel Data Dashboard

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • Thermo Fisher Scientific Inc. (PPD)
  • IQVIA
  • ICON plc
  • Eurofins Scientific
  • WuXi App Tec
  • Syneos Health
  • Catalent Pharma Solutions
  • Charles River Laboratories International. Inc.
  • Parexel International Corporation
  • Medpace
  • Curia
  • Certara L.P.
  • Amicus GMP
  • Pace Life Sciences
  • CTI Clinical Trial & Consulting
  • Accell Clinical Research LLC
  • Consumer Product Testing Co.
  • Promedica International
  • Clinilabs Inc.
  • CliniExperts Pvt. Ltd.
  • Covance Inc
  • Global Regulatory Services (GRS)
  • Pharma Design Limited
  • PharmaLex
  • Hiray Pharma Solutions
  • LGM Pharma
  • BlueReg Group
  • EPiC Auditors Ltd.

Methodology

Loading
LOADING...