The global regulatory consulting outsourcing services market accounted for USD 1.22 billion in 2023 and is expected to reach USD 2.97 billion by 2034 with a CAGR of 8.39% during the forecast period 2024-2034. The market will grow as a result of the following factors: a rapidly changing regulatory environment, complex compliance requirements, cost reduction and operational efficiency, an emphasis on core competencies, risk mitigation and compliance assurance, and technological advancements.
Companies that produce medical devices and biopharmaceuticals are spreading out their operations throughout the world to enter new markets. The need for regulatory consulting services is brought about by this expansion, as businesses seek assistance in negotiating the many regulatory requirements in each nation. For instance, Parexel stated in November 2023 that it was expanding its Regulatory & Access consulting services to help companies expedite worldwide product clearances and navigate the changing regulatory landscape.
By category, the drugs segment accounted for the highest revenue-grossing segment in the global regulatory consulting outsourcing services market in 2023 owing to the increasing complexity of drug approval processes, stringent regulatory scrutiny, and the need for specialized expertise in navigating pharmaceutical regulations. For instance, ICON announced the debut of its ICON Regulatory Consulting Services in December 2023, providing clients with end-to-end regulatory support throughout the product development lifecycle. Additionally, the biologics segment is predicted to grow at the fastest CAGR during the forecast period owing to the rising demand for biopharmaceutical products, advancements in biotechnology, and increasing regulatory focus on biologics due to their complex manufacturing processes and potential impact on public health.
By indication, the oncology segment accounted for the highest revenue-grossing segment in the global regulatory consulting outsourcing services market in 2023 owing to the growing prevalence of cancer, rapid advancements in oncology treatments, and the need for specialized regulatory expertise to navigate complex approval processes for oncology drugs and therapies. For instance, in January 2024, IQVIA announced the acquisition of Regulatory DataCorp (RDC), a provider of regulatory intelligence, to enhance its regulatory compliance and risk management solutions. Additionally, the immunology segment is predicted to grow at the fastest CAGR during the forecast period owing to the increasing research and development activities in immunotherapy, rising prevalence of autoimmune diseases, and the expanding pipeline of immunology-based drugs and biologics.
By end-user, the pharmaceutical companies segment accounted for the highest revenue-grossing segment in the global regulatory consulting outsourcing services market in 2023 owing to the increasing focus on drug development, stringent regulatory requirements, and the need for expert guidance to ensure compliance and expedite product approvals. For instance, in February 2024, Syneos Health announced the introduction of its Regulatory Consulting Hub, which will provide clients with integrated regulatory solutions to accelerate product development and market access. Additionally, the biotechnology companies’ segment is predicted to grow at the fastest CAGR during the forecast period owing to the expansion of biotechnology research and development, advancements in biopharmaceuticals, and the growing demand for specialized regulatory consulting services in the biotech industry. For instance, in March 2024, Deloitte announced the expansion of its regulatory consulting services by establishing a dedicated Regulatory Transformation Center that will provide strategic regulatory advising and digital solutions.
North American region is anticipated to have the highest revenue share during the forecast period owing to a mature regulatory landscape, concentration of pharmaceutical and biotechnology companies, and robust demand for regulatory consulting services in sectors like healthcare and life sciences. Additionally, the Asia Pacific region is predicted to grow at the fastest CAGR during the forecast period owing to the increasing investments in healthcare infrastructure, rising adoption of pharmaceutical and biotechnology innovations, and evolving regulatory frameworks supporting industry growth.
This extensive research report concentrates on the size and projections of the global and regional markets from 2023 to 2034.
Companies that produce medical devices and biopharmaceuticals are spreading out their operations throughout the world to enter new markets. The need for regulatory consulting services is brought about by this expansion, as businesses seek assistance in negotiating the many regulatory requirements in each nation. For instance, Parexel stated in November 2023 that it was expanding its Regulatory & Access consulting services to help companies expedite worldwide product clearances and navigate the changing regulatory landscape.
By category, the drugs segment accounted for the highest revenue-grossing segment in the global regulatory consulting outsourcing services market in 2023 owing to the increasing complexity of drug approval processes, stringent regulatory scrutiny, and the need for specialized expertise in navigating pharmaceutical regulations. For instance, ICON announced the debut of its ICON Regulatory Consulting Services in December 2023, providing clients with end-to-end regulatory support throughout the product development lifecycle. Additionally, the biologics segment is predicted to grow at the fastest CAGR during the forecast period owing to the rising demand for biopharmaceutical products, advancements in biotechnology, and increasing regulatory focus on biologics due to their complex manufacturing processes and potential impact on public health.
By indication, the oncology segment accounted for the highest revenue-grossing segment in the global regulatory consulting outsourcing services market in 2023 owing to the growing prevalence of cancer, rapid advancements in oncology treatments, and the need for specialized regulatory expertise to navigate complex approval processes for oncology drugs and therapies. For instance, in January 2024, IQVIA announced the acquisition of Regulatory DataCorp (RDC), a provider of regulatory intelligence, to enhance its regulatory compliance and risk management solutions. Additionally, the immunology segment is predicted to grow at the fastest CAGR during the forecast period owing to the increasing research and development activities in immunotherapy, rising prevalence of autoimmune diseases, and the expanding pipeline of immunology-based drugs and biologics.
By end-user, the pharmaceutical companies segment accounted for the highest revenue-grossing segment in the global regulatory consulting outsourcing services market in 2023 owing to the increasing focus on drug development, stringent regulatory requirements, and the need for expert guidance to ensure compliance and expedite product approvals. For instance, in February 2024, Syneos Health announced the introduction of its Regulatory Consulting Hub, which will provide clients with integrated regulatory solutions to accelerate product development and market access. Additionally, the biotechnology companies’ segment is predicted to grow at the fastest CAGR during the forecast period owing to the expansion of biotechnology research and development, advancements in biopharmaceuticals, and the growing demand for specialized regulatory consulting services in the biotech industry. For instance, in March 2024, Deloitte announced the expansion of its regulatory consulting services by establishing a dedicated Regulatory Transformation Center that will provide strategic regulatory advising and digital solutions.
North American region is anticipated to have the highest revenue share during the forecast period owing to a mature regulatory landscape, concentration of pharmaceutical and biotechnology companies, and robust demand for regulatory consulting services in sectors like healthcare and life sciences. Additionally, the Asia Pacific region is predicted to grow at the fastest CAGR during the forecast period owing to the increasing investments in healthcare infrastructure, rising adoption of pharmaceutical and biotechnology innovations, and evolving regulatory frameworks supporting industry growth.
This extensive research report concentrates on the size and projections of the global and regional markets from 2023 to 2034.
Report Scope:
- Base Year: 2023
- Forecast Period: 2024-2034
- Study Coverage
- Market Forecast by Category, Indication, and End-User
- Market Forecast for 5 Regions and 17+ Countries
- North America (U.S. and Canada)
- Europe (Germany, France, UK, Spain, Italy, Russia, Rest of Europe)
- Asia Pacific (China, Japan, India, Australia, South Korea, Rest of APAC)
- Latin America (Brazil, Mexico, Argentina, Rest of LATAM)
- MEA (South Africa, GCC, Rest of MEA)
- Exhaustive Company Profiles of the Top 10+ Major Market Players
Segmentation: Regulatory Consulting Outsourcing Services Market Report 2023 - 2034
Regulatory Consulting Outsourcing Services Market Analysis & Forecast by Category 2023 - 2034 (Revenue USD Bn)
- Drugs
- Biologics
- Medical Devices
Regulatory Consulting Outsourcing Services Market Analysis & Forecast by Indication 2023 - 2034 (Revenue USD Bn)
- Oncology
- Neurology
- Cardiology
- Immunology
- Infectious Disease
- Others
Regulatory Consulting Outsourcing Services Market Analysis & Forecast by End-User 2023 - 2034 (Revenue USD Bn)
- Biotechnology Companies
- Pharmaceutical Companies
- Medical Device Companies
Regulatory Consulting Outsourcing Services Market Analysis & Forecast by Region 2023 - 2034 (Revenue USD Bn)
- North America
- U.S.
- Canada
- Europe
- Germany
- France
- UK
- Spain
- Italy
- Rest of Europe
- Asia Pacific
- China
- Japan
- India
- Australia
- South Korea
- Rest of APAC
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of LATAM
- Middle East & Africa
- South Africa
- GCC
- Rest of MEA
Table of Contents
1. Research Methodology
2. Introduction
4. Market Environment Analysis
5. Market Dynamics
7. Regulatory Consulting Outsourcing Services Market: Category Estimates & Trend Analysis
8. Regulatory Consulting Outsourcing Services Market: Indication Estimates & Trend Analysis
9. Regulatory Consulting Outsourcing Services Market: End-User Estimates & Trend Analysis
10. Regional Market Analysis
11. North America Regulatory Consulting Outsourcing Services Market
12. Europe Global Regulatory Consulting Outsourcing Services Market
13. Asia Pacific Global Regulatory Consulting Outsourcing Services Market
14. Latin America Global Regulatory Consulting Outsourcing Services Market
15. MEA Global Regulatory Consulting Outsourcing Services Market
16. Competitor Analysis
17. Company Profiles
Companies Mentioned
- Parexel International Corporation
- ICON plc
- PRA Health Sciences
- IQVIA
- Covance Inc. (a LabCorp company)
- Syneos Health
- Charles River Laboratories International Inc.
- Accenture
- Deloitte
- KPMG
- Ernst & Young (EY)
- PwC (PricewaterhouseCoopers)
- Kinapse (a Syneos Health company)
- Navitas Life Sciences
- Capgemini.
