Healthcare Regulatory Affairs Outsourcing Market - Forecast(2024 - 2030)

Report Code: HCR 75827 Report Format: PDF + Excel

Healthcare Regulatory Affairs Outsourcing Market Overview

Healthcare Regulatory Affairs Outsourcing Market size is valued at $2.40 Bn in 2019, and is estimated to reach $3.37 Bn by 2025, growing at CAGR of 7.2% during the forecast period of 2020-2025. Healthcare regulatory affairs outsourcing are the regulatory policies that are implemented to ensure that companies obey with certain performance standards in relation to their business. These policies aim to protect public health and well-being by ensuring the safety of healthcare and pharmaceutical products. Outsourcing of healthcare regulation includes the medical writing and publication of regulatory documents provided by quality control and experienced medical writers and publishers who play a vital role in developing high-quality documentation for clinical research projects. The global Healthcare Regulatory Affairs Outsourcing Market growth is primarily attributed to the rising number of patent expiration along with growing costs of research and development activities. The service providers have been shifting their focus to outsource healthcare regulatory activities for reducing costs and focusing on core competencies, which helps to increase the growth of the Global Healthcare Regulatory Affairs Outsourcing Market over the forecast years 2020-2025. 

Healthcare Regulatory Affairs Outsourcing Market Report Coverage

The report: “Healthcare Regulatory Affairs Outsourcing Market Forecast (2020-2025)”, by Industry ARC, covers an in-depth analysis of the following segments of the Healthcare Regulatory Affairs Outsourcing Market.

By Service Type: Clinical Trial Applications and Product Registrations, Regulatory Consulting and Legal Representation, Regulatory Submissions, Regulatory Writing and Publishing, and others.
By End User: Biotechnology Companies, Medical Device Companies, and Pharmaceutical Companies.
By Geography: North America, Europe.

Key Takeaways

  • Geographically, North America dominated the market with a share of 54% in the year 2019 owing to the huge number of R&D activities in the field of drug discovery carried out in the region.
  • The global demand for the Healthcare Regulatory Affairs Outsourcing Market is owing to the rising number of patent expirations around the globe.
  • The prices of the services are not clearly stated, and price fluctuations are estimated to restrain the market growth during the forecast period 2020-2025.
  • Detailed analysis on the Strength, Weakness and Opportunities of the prominent players operating in the market will be provided in the Healthcare Regulatory Affairs Outsourcing Market report.

Healthcare Regulatory Affairs Outsourcing Market Segment Analysis - By Service Type

The global Healthcare Regulatory Affairs Outsourcing Market based on Mode of Service Type, can be further segmented into Clinical Trial Applications and Product Registrations, Regulatory Consulting and Legal Representation, Regulatory Submissions, Regulatory Writing and Publishing, and others. Regulatory Writing and Publishing segment registered for the highest revenue of $865m in 2019 and is estimated to grow at highest CAGR of 7.5% over the forecast years 2020-2025. This is owing to the growing demand for the regulatory writing and publishing services to develop the regulatory filing documents in comprehensive, standard, reliable, and convincing manner, which drives the growth of the segment. However, the increasing need for high-quality documents to support timely drug approvals in developing countries is estimated to boost the demand for the segment over the forecast period 2020-2025.

Healthcare Regulatory Affairs Outsourcing Market Segment Analysis - By End User

The global Healthcare Regulatory Affairs Outsourcing Market based on End User, can be further segmented into Biotechnology Companies, Medical Device Companies, and Pharmaceutical Companies. The Pharmaceutical Companies segment registered for highest revenue of $947m in 2019 and projected to grow at the highest CAGR of 6.3% during the forecast period 2020-2025 owing to the increasing need for efficient development and manufacturing of pharmaceutical products, which subsequently increases the adoption of full-time regulatory affairs outsourcing models to minimize the overall manufacturing cost. The Pharmaceutical companies are actively working to improve productivity and efficiency, streamline clinical trials, and meet strict healthcare regulatory outsourcing and quality assurance requirements to keep pace with the high competition, which is driving the segment.

Healthcare Regulatory Affairs Outsourcing Market Segment Analysis - By Geography

The global Healthcare Regulatory Affairs Outsourcing Market based on Geography, can be further segmented into North America, Asia-Pacific, Europe, and Rest of World. North America registered for the highest revenue of $1.30 Bn in 2019 and is set to grow at highest CAGR of 7.7% over the forecast period 2020-2025 owing to the increasing number of R&D activities in the field of drug discovery carried out in the region. It have a large presence of multinational biotech and pharma companies which carry out a large number of clinical trials and also has the well developed and advanced healthcare infrastructure. However, Europe is estimated to outpace all the regions by clocking the highest CAGR of 7.3% during the forecast period 2020-2025 owing to the health care needs and government funding towards research activities. Moreover, many biotech and pharma companies have started outsourcing their drug development services to various countries like Italy, Germany, and France which is further boosting the market growth for healthcare regulatory affairs outsourcing market. 

Healthcare Regulatory Affairs Outsourcing Market Drivers 

Increasing the number of patent expirations

The global Healthcare Regulatory Affairs Outsourcing industry growth is primarily attributed to the rising number of patent expiration along with growing costs of research and development activities. Biopharmaceutical and healthcare organizations are likely to team up with many outsourcing companies for getting their devices and drugs approved but the approval time of a drug or device is expensive, long time procedure, and is also a documentation centric procedure. So, the service providers have been shifting their focus to outsource healthcare regulatory activities for reducing costs and focusing on core competencies which helps to increase the growth of the Global Healthcare Regulatory Affairs Outsourcing Market over the forecast years 2020-2025.

Healthcare Regulatory Affairs Outsourcing Market Challenges

Fluctuations in Prices

There is an increase in the instances where prices of the services are not clearly stated in the healthcare regulatory affairs outsourcing market, which is acting as a challenge to the market. Besides, the additional costs are said to be involved in the services with the increasing use of technological platforms such as software for the clinical data management, content management, and database & document management. The technological advances no doubt improves the overall process but adds to the total costs as well which are restraining the market growth during the forecast period 2020-2025. 

Healthcare Regulatory Affairs Outsourcing Market Industry outlook:

Product launches, mergers and acquisitions, joint ventures, and geographical expansions are key strategies adopted by players in the Healthcare Regulatory Affairs Outsourcing Market. Key companies of this market Accell Clinical Research, LLC, Charles River Laboratories International, Inc, Clinilabs Inc, Criterium Inc, Covance Inc, Cardinal Health, Freyr, ICON PLc, IQVIA, and Medpace, Inc.

Acquisitions/Product Launches:

  • In July 2020, Covance acquired GlobalCare, a global industry leader in patient-centric decentralized clinical trials (DCTs) to flourish the offerings of Covance DCTs into global markets and manage the growing demand for patient-centric trial designs.
  • In April 2019, Cardinal Health has acquired mscripts. This acquisition will enhance the capabilities that company deliver to their customers and strengthen the relationship between healthcare provider’s payers, pharmacies and patients.

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1. Healthcare Regulatory Affairs Outsourcing Market- Overview
    1.1 Definitions and Scope
2. Healthcare Regulatory Affairs Outsourcing Market- Executive Summary
    2.1 Market Revenue, Market Size and Key Trends
    2.2 Key trends by Service Type
    2.3 Key trends by End User
    2.4 Key trends by Geography
3. Healthcare Regulatory Affairs Outsourcing Market– Comparative Analysis
    3.1 Product Benchmarking – Key Companies
    3.2 Financial Analysis – Key Companies
    3.3 Market Value Split by Key Companies 
    3.4 Patent Analysis – Key Companies
    3.5 Pricing Analysis
4. Healthcare Regulatory Affairs Outsourcing Market- Startup Companies Scenario Premium
    4.1 Key Startup Company Analysis by
        4.1.1 Investment
        4.1.2 Revenue
        4.1.3 Venture Capital and Funding Scenario
5. Healthcare Regulatory Affairs Outsourcing Market– Industry Market Entry Scenario Premium Premium
    5.1 Regulatory Framework Overview
    5.2 New Business and Ease of Doing business index
    5.3 Case Studies of Successful Ventures
6. Healthcare Regulatory Affairs Outsourcing Market Forces
    6.1 Market Drivers
    6.2 Market Constraints/Challenges
    6.3 Porters five force model
        6.3.1 Bargaining power of suppliers
        6.3.2 Bargaining powers of customers
        6.3.3 Threat of new entrants
        6.3.4 Rivalry among existing players
        6.3.5 Threat of substitutes 
7. Healthcare Regulatory Affairs Outsourcing Market– Strategic Analysis
    7.1 Value Chain Analysis
    7.2 Opportunities Analysis
    7.3 Market Life Cycle
8. Healthcare Regulatory Affairs Outsourcing Market- By Service Type (Market Size -$Million/$Billion)
    8.1 Clinical Trial Applications and Product Registrations
    8.2 Regulatory Consulting and Legal Representation
    8.3 Regulatory Submissions
    8.4 Regulatory Writing and Publishing
    8.5 Others
9. Healthcare Regulatory Affairs Outsourcing Market– By End User (Market Size –$Million/$Billion)
    9.1 Biotechnology Companies
    9.2 Medical Device Companies
    9.3 Pharmaceutical Companies
10. Healthcare Regulatory Affairs Outsourcing Market- By Geography (Market Size –$Million/$Billion)
    10.1 North America
        10.1.1 U.S.
        10.1.2 Canada
        10.1.3 Mexico
    10.2 Europe
        10.2.1 U.K.
        10.2.2 Germany
        10.2.3 France
        10.2.4 Italy
        10.2.5 Spain
        10.2.6 Rest of Europe
11. Healthcare Regulatory Affairs Outsourcing Market- Entropy
12. Healthcare Regulatory Affairs Outsourcing Market– Industry/Segment Competition Landscape Premium
    12.1 Market Share Analysis
        12.1.1 Global Market Share – Key Companies
        12.1.2 Market Share by Region – Key companies
        12.1.3 Market Share by Countries – Key Companies
        12.1.4 Best Practices for Companies
13. Healthcare Regulatory Affairs Outsourcing Market– Key Company List by Country Premium Premium
14. Healthcare Regulatory Affairs Outsourcing Market Company Analysis
    14.1 Accell Clinical Research, LLC.
    14.2 Charles River Laboratories International, Inc.
    14.3 Clinilabs, Inc
    14.4 Criterium Inc.
    14.5 Covance, Inc.
    14.6 Cardinal Health
    14.7 Freyr
    14.8 ICON PLc.
    14.9 IQVIA
    14.10 Medpace, Inc.
    14.11 PAREXEL International Corporation
    14.12 Pharmaceutical Product Development, (PPD) LLC.
    14.13 Promedica International
    14.14 PRA Health Sciences
    14.15 WuXi App Tec
"*Financials for private companies would be provided on a best efforts basis”.

LIST OF TABLES

1.Global Healthcare Regulatory Affairs Outsourcing Market Analysis and Forecast, By Services Market 2023-2030 ($M)
1.1 By Services Market 2023-2030 ($M) - Global Industry Research
1.1.1 Regulatory Writing and Publishing Market 2023-2030 ($M)
1.1.2 Regulatory Submissions Market 2023-2030 ($M)
1.1.3 Clinical Trial Applications and Product Registrations Market 2023-2030 ($M)
1.1.4 Regulatory Consulting and Legal Representation Market 2023-2030 ($M)
2.Global Healthcare Regulatory Affairs Outsourcing Market Analysis and Forecast, By End User Market 2023-2030 ($M)
2.1 By End User Market 2023-2030 ($M) - Global Industry Research
2.1.1 Large Pharmaceutical Companies Market 2023-2030 ($M)
2.1.2 Mid-Size Pharmaceutical Companies Market 2023-2030 ($M)
2.1.3 Biotechnology Companies Market 2023-2030 ($M)
2.1.4 Medical Devices Companies Market 2023-2030 ($M)
2.1.5 Food Beverage Companies Market 2023-2030 ($M)
3.Global Healthcare Regulatory Affairs Outsourcing Market Analysis and Forecast, By Services Market 2023-2030 (Volume/Units)
3.1 By Services Market 2023-2030 (Volume/Units) - Global Industry Research
3.1.1 Regulatory Writing and Publishing Market 2023-2030 (Volume/Units)
3.1.2 Regulatory Submissions Market 2023-2030 (Volume/Units)
3.1.3 Clinical Trial Applications and Product Registrations Market 2023-2030 (Volume/Units)
3.1.4 Regulatory Consulting and Legal Representation Market 2023-2030 (Volume/Units)
4.Global Healthcare Regulatory Affairs Outsourcing Market Analysis and Forecast, By End User Market 2023-2030 (Volume/Units)
4.1 By End User Market 2023-2030 (Volume/Units) - Global Industry Research
4.1.1 Large Pharmaceutical Companies Market 2023-2030 (Volume/Units)
4.1.2 Mid-Size Pharmaceutical Companies Market 2023-2030 (Volume/Units)
4.1.3 Biotechnology Companies Market 2023-2030 (Volume/Units)
4.1.4 Medical Devices Companies Market 2023-2030 (Volume/Units)
4.1.5 Food Beverage Companies Market 2023-2030 (Volume/Units)
5.North America Healthcare Regulatory Affairs Outsourcing Market Analysis and Forecast, By Services Market 2023-2030 ($M)
5.1 By Services Market 2023-2030 ($M) - Regional Industry Research
5.1.1 Regulatory Writing and Publishing Market 2023-2030 ($M)
5.1.2 Regulatory Submissions Market 2023-2030 ($M)
5.1.3 Clinical Trial Applications and Product Registrations Market 2023-2030 ($M)
5.1.4 Regulatory Consulting and Legal Representation Market 2023-2030 ($M)
6.North America Healthcare Regulatory Affairs Outsourcing Market Analysis and Forecast, By End User Market 2023-2030 ($M)
6.1 By End User Market 2023-2030 ($M) - Regional Industry Research
6.1.1 Large Pharmaceutical Companies Market 2023-2030 ($M)
6.1.2 Mid-Size Pharmaceutical Companies Market 2023-2030 ($M)
6.1.3 Biotechnology Companies Market 2023-2030 ($M)
6.1.4 Medical Devices Companies Market 2023-2030 ($M)
6.1.5 Food Beverage Companies Market 2023-2030 ($M)
7.South America Healthcare Regulatory Affairs Outsourcing Market Analysis and Forecast, By Services Market 2023-2030 ($M)
7.1 By Services Market 2023-2030 ($M) - Regional Industry Research
7.1.1 Regulatory Writing and Publishing Market 2023-2030 ($M)
7.1.2 Regulatory Submissions Market 2023-2030 ($M)
7.1.3 Clinical Trial Applications and Product Registrations Market 2023-2030 ($M)
7.1.4 Regulatory Consulting and Legal Representation Market 2023-2030 ($M)
8.South America Healthcare Regulatory Affairs Outsourcing Market Analysis and Forecast, By End User Market 2023-2030 ($M)
8.1 By End User Market 2023-2030 ($M) - Regional Industry Research
8.1.1 Large Pharmaceutical Companies Market 2023-2030 ($M)
8.1.2 Mid-Size Pharmaceutical Companies Market 2023-2030 ($M)
8.1.3 Biotechnology Companies Market 2023-2030 ($M)
8.1.4 Medical Devices Companies Market 2023-2030 ($M)
8.1.5 Food Beverage Companies Market 2023-2030 ($M)
9.Europe Healthcare Regulatory Affairs Outsourcing Market Analysis and Forecast, By Services Market 2023-2030 ($M)
9.1 By Services Market 2023-2030 ($M) - Regional Industry Research
9.1.1 Regulatory Writing and Publishing Market 2023-2030 ($M)
9.1.2 Regulatory Submissions Market 2023-2030 ($M)
9.1.3 Clinical Trial Applications and Product Registrations Market 2023-2030 ($M)
9.1.4 Regulatory Consulting and Legal Representation Market 2023-2030 ($M)
10.Europe Healthcare Regulatory Affairs Outsourcing Market Analysis and Forecast, By End User Market 2023-2030 ($M)
10.1 By End User Market 2023-2030 ($M) - Regional Industry Research
10.1.1 Large Pharmaceutical Companies Market 2023-2030 ($M)
10.1.2 Mid-Size Pharmaceutical Companies Market 2023-2030 ($M)
10.1.3 Biotechnology Companies Market 2023-2030 ($M)
10.1.4 Medical Devices Companies Market 2023-2030 ($M)
10.1.5 Food Beverage Companies Market 2023-2030 ($M)
11.APAC Healthcare Regulatory Affairs Outsourcing Market Analysis and Forecast, By Services Market 2023-2030 ($M)
11.1 By Services Market 2023-2030 ($M) - Regional Industry Research
11.1.1 Regulatory Writing and Publishing Market 2023-2030 ($M)
11.1.2 Regulatory Submissions Market 2023-2030 ($M)
11.1.3 Clinical Trial Applications and Product Registrations Market 2023-2030 ($M)
11.1.4 Regulatory Consulting and Legal Representation Market 2023-2030 ($M)
12.APAC Healthcare Regulatory Affairs Outsourcing Market Analysis and Forecast, By End User Market 2023-2030 ($M)
12.1 By End User Market 2023-2030 ($M) - Regional Industry Research
12.1.1 Large Pharmaceutical Companies Market 2023-2030 ($M)
12.1.2 Mid-Size Pharmaceutical Companies Market 2023-2030 ($M)
12.1.3 Biotechnology Companies Market 2023-2030 ($M)
12.1.4 Medical Devices Companies Market 2023-2030 ($M)
12.1.5 Food Beverage Companies Market 2023-2030 ($M)
13.MENA Healthcare Regulatory Affairs Outsourcing Market Analysis and Forecast, By Services Market 2023-2030 ($M)
13.1 By Services Market 2023-2030 ($M) - Regional Industry Research
13.1.1 Regulatory Writing and Publishing Market 2023-2030 ($M)
13.1.2 Regulatory Submissions Market 2023-2030 ($M)
13.1.3 Clinical Trial Applications and Product Registrations Market 2023-2030 ($M)
13.1.4 Regulatory Consulting and Legal Representation Market 2023-2030 ($M)
14.MENA Healthcare Regulatory Affairs Outsourcing Market Analysis and Forecast, By End User Market 2023-2030 ($M)
14.1 By End User Market 2023-2030 ($M) - Regional Industry Research
14.1.1 Large Pharmaceutical Companies Market 2023-2030 ($M)
14.1.2 Mid-Size Pharmaceutical Companies Market 2023-2030 ($M)
14.1.3 Biotechnology Companies Market 2023-2030 ($M)
14.1.4 Medical Devices Companies Market 2023-2030 ($M)
14.1.5 Food Beverage Companies Market 2023-2030 ($M)

LIST OF FIGURES

1.US Healthcare Regulatory Affairs Outsourcing Trends Analysis Market Revenue, 2023-2030 ($M)
2.Canada Healthcare Regulatory Affairs Outsourcing Trends Analysis Market Revenue, 2023-2030 ($M)
3.Mexico Healthcare Regulatory Affairs Outsourcing Trends Analysis Market Revenue, 2023-2030 ($M)
4.Brazil Healthcare Regulatory Affairs Outsourcing Trends Analysis Market Revenue, 2023-2030 ($M)
5.Argentina Healthcare Regulatory Affairs Outsourcing Trends Analysis Market Revenue, 2023-2030 ($M)
6.Peru Healthcare Regulatory Affairs Outsourcing Trends Analysis Market Revenue, 2023-2030 ($M)
7.Colombia Healthcare Regulatory Affairs Outsourcing Trends Analysis Market Revenue, 2023-2030 ($M)
8.Chile Healthcare Regulatory Affairs Outsourcing Trends Analysis Market Revenue, 2023-2030 ($M)
9.Rest of South America Healthcare Regulatory Affairs Outsourcing Trends Analysis Market Revenue, 2023-2030 ($M)
10.UK Healthcare Regulatory Affairs Outsourcing Trends Analysis Market Revenue, 2023-2030 ($M)
11.Germany Healthcare Regulatory Affairs Outsourcing Trends Analysis Market Revenue, 2023-2030 ($M)
12.France Healthcare Regulatory Affairs Outsourcing Trends Analysis Market Revenue, 2023-2030 ($M)
13.Italy Healthcare Regulatory Affairs Outsourcing Trends Analysis Market Revenue, 2023-2030 ($M)
14.Spain Healthcare Regulatory Affairs Outsourcing Trends Analysis Market Revenue, 2023-2030 ($M)
15.Rest of Europe Healthcare Regulatory Affairs Outsourcing Trends Analysis Market Revenue, 2023-2030 ($M)
16.China Healthcare Regulatory Affairs Outsourcing Trends Analysis Market Revenue, 2023-2030 ($M)
17.India Healthcare Regulatory Affairs Outsourcing Trends Analysis Market Revenue, 2023-2030 ($M)
18.Japan Healthcare Regulatory Affairs Outsourcing Trends Analysis Market Revenue, 2023-2030 ($M)
19.South Korea Healthcare Regulatory Affairs Outsourcing Trends Analysis Market Revenue, 2023-2030 ($M)
20.South Africa Healthcare Regulatory Affairs Outsourcing Trends Analysis Market Revenue, 2023-2030 ($M)
21.North America Healthcare Regulatory Affairs Outsourcing Trends Analysis By Application
22.South America Healthcare Regulatory Affairs Outsourcing Trends Analysis By Application
23.Europe Healthcare Regulatory Affairs Outsourcing Trends Analysis By Application
24.APAC Healthcare Regulatory Affairs Outsourcing Trends Analysis By Application
25.MENA Healthcare Regulatory Affairs Outsourcing Trends Analysis By Application