The Functional Service Providers (FSP) Market Size was valued at USD 14.58 billion in 2022, and is expected to reach USD 26.98 billion by 2030, and grow at a CAGR of 8% over the forecast period 2023-2030.
Functional Service Provider (FSP) is a clinical development outsourcing model that allows biotech, pharmaceutical, healthcare facilities and research institutes to outsource all or partial aspects of specific functions to a contract research organization.
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FSPs are companies that are contracted by other organizations to perform specific tasks while retaining overall control of operations. The global market for functional service providers is expanding due to the increase in clinical trials and R&D investment.
DRIVERS
Increased use of FSP outsourcing in drug development
Rising R&D spending
The number of clinical trials is increasing.
Reduced operational costs and higher service quality
RESTRAINTS
Scarcity of skilled labour
OPPORTUNITIES
The digital transformation of biopharma and biotech
The COVID-19 epidemic has increased the need for functioning service providers. Many biotechnology and pharmaceuticals organisations have used FSPs to manage variable workloads and obtain access to highly competent people. The COVID-19 pandemic had an impact on hundreds of clinical trials, with a 79%decrease in patient enrollment on a global average year over year. Companies are using FSP more frequently in reaction to emergencies. Companies that want to begin testing novel COVID-19 diagnostics, therapies, or vaccinations, or repurpose currently available medications for COVID-19, use FSP services. Companies in the biopharmaceutical and biotechnology industries are now working to create new drugs for novel disease treatments. This has led to an increase in R&D activity across the world. The COVID-19 outbreak has been quickly spreading throughout the world. The growing demand for FSP solutions from end users has, however, led to an increase in their demand.
VALUE CHAIN ANALYSIS
The market for functional service providers is expanding steadily and is anticipated to do so over the course of the research period at a significant rate. This is because established players are contributing more frequently to improve the effectiveness of their services. Four key elements make up the value chain analysis for the market for functional service providers: client acquisition, service customization, client purchase support, and client fulfilment & post-buy support.
By Type
Regardless matter how innovative they are, clinical studies must demonstrate that new treatments and devices are secure for the users. Consequently, an FSP team consists of drug safety associates, pharmacovigilance experts, medical directors, pharmacoepidemiologists, drug safety physicians, and medical information technicians. These professionals support companies in the biotechnology, pharmaceutical, and medical device industries in tracking and managing the advantages and risks of their products during the course of their product lifecycles. From the earliest phases of development to approval and post-marketing, it offers end-to-end safety services.
Planning biological investigations, collecting and analyzing data from them, and interpreting the findings are all included in biostatistics and programming. The development of study protocols, statistical analysis plans, analyses for clinical trial reports, and the creation of integrated safety & efficacy parts of regulatory submissions are all tasks that FSPs assist with. Additionally, in order to gather, analyses, and display data in accordance with regulatory requirements, biostatisticians and PhD statisticians contribute to the decision-making process. Utilizing integrated data and technology, professional advice, and regulatory affairs professionals, FSPs provides regulatory affairs services to solve increasingly complex regulatory challenges and stay ahead of evolving rules. FSP collaborates with external agencies and internal regulatory departments to enable submissions, product registration, market authorization submissions, post-approval submissions, tracking agency interactions, and lifecycle maintenance, among other things.
By Stage
Clinical trials must be a part of every clinical development program. They are in charge of compiling data on a product's effectiveness and disseminating data on its safety. Data from trials must be collected and reported in accordance with regulatory requirements. FSPs assist biotechnology and biopharmaceutical firms by offering efficient drug development processes and procedures for creating novel new medications at the clinical development stage. Thus, to increase flexibility, speed up the drug development process, and have access to a skilled team, cutting-edge technology, and clinical trial protocols, biotechnology and biopharmaceutical businesses sponsor outsourcing clinical development procedures to functional service providers.
Research is more and more needed for the biopharmaceutical and biotechnology industries to demonstrate value and effectiveness in post-approval scenarios and to learn how to communicate this knowledge to payers, health authorities, and other decision-makers. In addition, to maintain marketing authorization, the MA owner must adopt & maintain quality management, resolve safety surveillance issues, and comply with renewal requirements. This requires ongoing work updates to guarantee that the approved documentation is still current. Additionally, the demand for post-asapproval services, which FSPs provide, is growing a result of shifting drug regulatory environments.
By Application
The quickly developing biopharmaceutical industry and rising use of FSPs to carry out the whole range of clinical trial operations are the key drivers behind the segmentation expansion of biopharmaceutical firms in the global market. Applied Clinical Trials Research claims that the adoption of FSP by biopharma companies is growing at a pace of more than 13% annually.
The rising number of new drug approvals and growing emphasis on customized treatment are the major drivers of the market expansion of the biotechnology businesses segment.
The quickly developing biopharmaceutical industry and rising use of FSPs to carry out the whole range of clinical trial operations are the key drivers behind the segmentation expansion of biopharmaceutical firms in the global market. Applied Clinical Trials Research claims that the adoption of FSP by biopharma companies is growing at a pace of more than annually.
The rising number of new drug approvals and growing emphasis on customized treatment are the major drivers of the market expansion of the biotechnology businesses segment.
The prevalence of chronic diseases is rising, medical device companies are investing more in R&D, and more clinical trials are being conducted to distinguish their class III/II products from those of rivals, all of which contribute to the growth of the medical device businesses segment of the global market. In addition, medical device businesses outsource FSPs because of pressures to decrease costs, expanding product pipelines, and escalating regulatory demands from regulatory bodies.
The rapid expansion of research and development into biopharmaceuticals, biotechnology, and medical devices is mostly to blame for this market segment's rise.
The rapid expansion of biotechnology, biopharmaceutical, and medical device research and development is mostly to blame for this market segment's rise. Academic institutions employ FSP solutions for preclinical research and clinical trials administration to help them scale their staff as necessary and offer specialised support for different projects and programmes. Furthermore, this market is expanding as a result of increased research funding for academic institutions.
By Type
Clinical monitoring
Medical writing
Data management
Biostatistics/programming
Regulatory affairs
By Stage
Clinical development
Post approval
By Application
Biopharma companies
Biotech companies
Medical devices companies
Research centers and academic institutes
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According to the SNS Insider analysis report, North America will dominate the worldwide functional service provider market during the assessment period. The primary factor driving the regional market's growth is the region's well-developed healthcare infrastructure. Another important factor driving the expansion of the regional industry is the abundance of clinical trials in the area. There are numerous significant market leaders in the area, including Parexel (US), Labcorp Drug Development (US), and IQVIA (US), who are accelerating the expansion of the local market. The two countries that contribute most to regional market growth are the US and Canada.
REGIONAL COVERAGE:
North America
USA
Canada
Mexico
Europe
Germany
UK
France
Italy
Spain
The Netherlands
Rest of Europe
Asia-Pacific
Japan
south Korea
China
India
Australia
Rest of Asia-Pacific
The Middle East & Africa
Israel
UAE
South Africa
Rest of Middle East & Africa
Latin America
Brazil
Argentina
Rest of Latin America.
Major key players are BioPoint Inc., PPD Inc., Icon Plc, RHO, Inc. KPS Life, LLC, IQVIA Inc., Parexel International Corporation, Wuxi AppTec Co., Ltd. Quanticate International Limited, Laboratory Corporation of America Holdings and Oother Players.
| Report Attributes | Details |
|---|---|
| Market Size in 2022 | US$ 14.58 Billion |
| Market Size by 2030 | US$ 26.98 Billion |
| CAGR | CAGR of 8% From 2023 to 2030 |
| Base Year | 2022 |
| Forecast Period | 2023-2030 |
| Historical Data | 2020-2021 |
| Report Scope & Coverage | Market Size, Segments Analysis, Competitive Landscape, Regional Analysis, DROC & SWOT Analysis, Forecast Outlook |
| Key Segments | • By Type (Clinical monitoring, medical writing, Data management, Pharmacovigilance, Biostatistics/programming, Regulatory affairs) • By Stage (Clinical development, Post approval) • By Application (Biopharma companies, Biotech companies, medical devices companies, Research centers and academic institutes) |
| Regional Analysis/Coverage | North America (USA, Canada, Mexico), Europe (Germany, UK, France, Italy, Spain, Netherlands, Rest of Europe), Asia-Pacific (Japan, South Korea, China, India, Australia, Rest of Asia-Pacific), The Middle East & Africa (Israel, UAE, South Africa, Rest of Middle East & Africa), Latin America (Brazil, Argentina, Rest of Latin America) |
| Company Profiles | BioPoint Inc., PPD Inc., Icon Plc, RHO, Inc. KPS Life, LLC, IQVIA Inc., Parexel International Corporation, Wuxi AppTec Co., Ltd. Quanticate International Limited, Laboratory Corporation of America Holdings. |
| Key Drivers | • Rising R&D spending. • The number of clinical trials is increasing. |
| RESTRAINTS | • Scarcity of skilled labour. |
Ans. The Functional Service Providers (FSP) market is expected to grow at a CAGR of 8% over the forecast period 2023-2030.
Ans: The Functional Service Providers (FSP) Market size is estimated to reach US$ 5.49 Bn by 2030.
Ans. The Functional Service Providers (FSP) Market size was valued at US$ 14.58 billion in 2022.
Ans. The market for functional service providers is expanding steadily and is anticipated to do so over the course of the research period at a significant rate. This is because established players are contributing more frequently to improve the effectiveness of their services.
Ans. BioPoint Inc., PPD Inc., Icon Plc, RHO, Inc. KPS Life, LLC, IQVIA Inc., Parexel International Corporation, Wuxi AppTec Co., Ltd. Are the key plyers of the Functional Service Providers (FSP) market.
Table of Contents
1. Introduction
1.1 Market Definition
1.2 Scope
1.3 Research Assumptions
2. Research Methodology
3. Market Dynamics
3.1 Drivers
3.2 Restraints
3.3 Opportunities
3.4 Challenges
4. Impact Analysis
4.1 COVID-19 Impact Analysis
4.2 Impact of Ukraine- Russia war
4.3 Impact of ongoing Recession
4.3.1 Introduction
4.3.2 Impact on major economies
4.3.2.1 US
4.3.2.2 Canada
4.3.2.3 Germany
4.3.2.4 France
4.3.2.5 United Kingdom
4.3.2.6 China
4.3.2.7 Japan
4.3.2.8 South Korea
4.3.2.9 Rest of the World
5. Value Chain Analysis
6. Porter’s 5 forces model
7. PEST Analysis
8. Functional Service Providers Market Segmentation, By Type
8.1 Clinical monitoring
8.2 Medical writing
8.3 Data management
8.4 Pharmacovigilance
8.5 Biostatistics/programming
8.6 Regulatory affairs
9. Functional Service Providers Market Segmentation, By Stage
9.1 Clinical development
9.2 Post approval
10. Functional Service Providers Market Segmentation, By Application
10.1 Biopharma companies
10.2 Biotech companies
10.3 Medical devices companies
10.4 Research centers and academic institutes
11. Regional Analysis
11.1 Introduction
11.2 North America
11.2.1 USA
11.2.2 Canada
11.2.3 Mexico
11.3 Europe
11.3.1 Germany
11.3.2 UK
11.3.3 France
11.3.4 Italy
11.3.5 Spain
11.3.6 The Netherlands
11.3.7 Rest of Europe
11.4 Asia-Pacific
11.4.1 Japan
11.4.2 South Korea
11.4.3 China
11.4.4 India
11.4.5 Australia
11.4.6 Rest of Asia-Pacific
11.5 The Middle East & Africa
11.5.1 Israel
11.5.2 UAE
11.5.3 South Africa
11.5.4 Rest
11.6 Latin America
11.6.1 Brazil
11.6.2 Argentina
11.6.3 Rest of Latin America
12. Company Profiles
12.1 BioPoint Inc.
12.1.1 Financial
12.1.2 Products/ Services Offered
12.1.3 SWOT Analysis
12.1.4 The SNS view
12.2 PPD Inc.
12.3 Icon Plc
12.4 RHO, Inc.
12.5 KPS Life, LLC
12.6 IQVIA Inc.
12.7 Parexel International Corporation
12.8 Wuxi AppTec Co., Ltd.
12.9 Quanticate International Limited
12.10 Laboratory Corporation of America Holdings
13. Competitive Landscape
13.1 Competitive Benchmark
13.2 Market Share Analysis
13.3 Recent Developments
14. Conclusion
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