Regulatory Consulting Outsourcing Services Market To Reach USD 1.90 Billion By 2030

Regulatory Consulting Outsourcing Services Market Growth & Trends

The global regulatory consulting outsourcing services market size is expected to reach USD 1.90 billion by 2030, registering at a CAGR of 8.36%, according to a new report by Grand View Research, Inc. Rising number of outsourcing players to curb costs associated with clinical trials and stringent regulatory compliance are key drivers for this market. Healthcare regulatory compliance is complex and constantly evolving. Outsourcing allows organizations to access specialized expertise in regulatory affairs, compliance, and quality assurance without having to maintain an in-house team.

The regulatory consulting firms provide clinical trial regulatory services globally, assisting them through faster trial start-ups by combining centralized data administration with the capacity to manage various regulatory submissions simultaneously. For instance, in June 2023, FDA Announces Further Measures to Modernize Clinical Trials. The Agency Seeks Input on the Proposed Guidelines and Their Applicability Across a Range of Trial Varieties and Data Resources. As regulatory frameworks evolve and clinical trial processes modernize, healthcare companies encounter greater complexity in navigating compliance requirements. This complexity is expected to drive demand for regulatory consultancy services to ensure adherence to changing regulations.

Globalization of biopharmaceuticals and medical device companies is likely to be one of the major market drivers. Biopharmaceutical and medical device companies expanded their operations globally to tap into new markets. Emerging economies like China, India, Brazil, and others offer significant growth opportunities due to rising healthcare expenditures, increasing demand for advanced medical treatments, and improving regulatory environments. Regulatory consulting firms are crucial in facilitating market entry by providing strategic advice on regulatory pathways, product registration, and compliance strategies tailored to specific markets.

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Regulatory Consulting Outsourcing Services Market Report Highlights

• By Category, the drugs segment held the largest share in 2023. This is attributed to the complex and evolving regulatory landscape of the pharmaceutical industry

• Oncology held a substantial market share in 2023. This can be attributed to the high prevalence of cancer, prompting a need for safe and effective treatment options

• Pharmaceutical companies held a major share in regulatory consulting outsourcing services with a revenue share of over 40.24% in 2023. The patent expiry of several branded drugs is anticipated to boost regulatory services for generic applications and related services, thereby facilitating market growth

• The mid-size companies segment holds a major revenue share in 2023. Mid-size companies in such industries frequently encounter shortages in resources and technology, leading them to engage with suppliers on a project-by-project basis and commonly delegate application and submission management to consultants through outsourcing arrangements

• North America held the largest share of over 30% in the regulatory consulting outsourcing services market in 2023. The presence of established consulting firms with deep expertise in regulatory compliance and a strong track record of delivering effective solutions attracts businesses seeking regulatory support to drive regional market growth

Regulatory Consulting Outsourcing Services Market Segmentation

Grand View Research has segmented the global regulatory consulting outsourcing services market based on category, indication, end-use, company size, and region.

Regulatory Consulting Outsourcing Services Category Outlook (Revenue, USD Billion, 2018 - 2030)

• Drugs

• Biologics

• Medical Devices

Regulatory Consulting Outsourcing Services Indication Outlook (Revenue, USD Billion, 2018 - 2030)

• Oncology

• Neurology

• Cardiology

• Immunology

• Infectious Disease

• Others

Regulatory Consulting Outsourcing Services End-use Outlook (Revenue, USD Billion, 2018 - 2030)

• Biotechnology Companies

• Pharmaceutical Companies

• Medical Device Companies

Regulatory Consulting Outsourcing Services Company Size Outlook (Revenue, USD Billion, 2018 - 2030)

• Small

• Medium

• Large

Regulatory Consulting Outsourcing Services Regional Outlook (Revenue, USD Billion, 2018 - 2030)

• North America

  • U.S.

  • Canada

• Europe

  • U.K.

  • Germany

  • France

  • Italy

  • Spain

  • Sweden

  • Norway

  • Denmark

• Asia Pacific

  • Japan

  • China

  • India

  • South Korea

  • Australia

  • Thailand

• Latin America

  • Brazil

  • Mexico

  • Argentina

• Middle East & Africa

  • South Africa

  • Saudi Arabia

  • UAE

  • Kuwait

List of Key Players in the Regulatory Consulting Outsourcing Services Market

• Parexel International Corporation

• ICON plc

• IQVIA

• Syneos Health

• Navigant Consulting, Inc.

• Premier Research

• Weinberg Group

• ProPharma

• PharmaLex GmbH

• LabCorp