Regulatory Affairs Outsourcing Market

Regulatory Affairs Outsourcing Market Study by Regulatory Consulting, Legal Representation, and Regulatory Writing & Publishing for Oncology, Neurology, Radiology, and Immunology from 2024 to 2034

Analysis of Regulatory Affairs Outsourcing Market Covering 30+ Countries Including Analysis of US, Canada, UK, Germany, France, Nordics, GCC countries, Japan, Korea and many more

Regulatory Affairs Outsourcing Market Outlook (2024 to 2034)

Global revenue from regulatory affairs outsourcing is approximated at US$ 17.4 billion in 2024. The market has been projected by this recent report by Fact.MR to register 7.3% CAGR and reach a valuation of US$ 35.31 billion by 2034.

Increasing number of clinical trial applications and growing product registration are key factors boosting the regulatory affairs outsourcing market growth. The ongoing advancements in medicine manufacturing are set to boost the demand for pharmaceutical and biotechnology services outsourcing services. The integration of artificial intelligence, big data analytics, and machine learning in regulatory process are some of the emerging regulatory affairs outsourcing market trends.

Regulatory affairs outsourcing services are widely used to develop generic and orphan drugs. During the COVID-19 pandemic, the need for regulatory affairs outsourcing acquired high importance. Highly contagious and debilitating nature of the disease lead pharmaceutical research organizations and medical companies to come together for the development of anti-COVID drugs and vaccines. This required respective governments at a pan-global level to permit outsourcing of critical medical and pharmaceutical technology to global parties.

Aggressive geographical expansion initiatives by companies that aim for fast approvals in local markets is set to drive the demand for regulatory affairs outsourcing services over the next decade.

Report Attribute Detail
Regulatory Affairs Outsourcing Market Size (2024E) US$ 17.4 Billion
Forecasted Market Value (2034F) US$ 35.31 Billion
Global Market Growth Rate (2024 to 2034) 7.3% CAGR
South Korea Market Value (2034F) US$ 1.63 Billion
East Asia Market Value (2034F) US$ 6.29 Billion
Regulatory Consulting Outsourcing Demand Growth (2024 to 2034) 7.7% CAGR
Key Companies Profiled
  • ICON Plc.
  • Accell Clinical Research LLC
  • Medspace
  • Charles River Laboratories International Inc.
  • GenPact Ltd.
  • Criterium Inc.
  • PRA Health Sciences
  • Promedica International
  • WuxI AppTec Inc.
  • Labcorp

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Which Market Dynamics are Increasing Popularity of Regulatory Affairs Outsourcing Services?

“Ongoing Research and Development Activities in Healthcare Sector Pushing Demand for Regulatory Affairs Outsourcing Services”

Increasing pressure on personal pockets and the growing measures taken by the governments of various countries to improve regulatory approval procedures are expected to boost demand for swift regulatory affairs outsourcing services. The ongoing developments in the healthcare sector along with extensive research and development (R&D) are other salient factors propelling the demand for regulatory affairs outsourcing services.

In addition, the rising need to reduce costs in the life-sciences industry is enhancing the demand for third-party services for regulatory affairs. Furthermore, the advent of efficient software that keeps the record of regulatory affairs is projected to provide a high boost to the market growth in the coming decade.

  • The Australian Commonwealth Scientific and Industrial Research Organisation (CSIRO) recently declared that they have decided to go cleaner and greener by diving into digitalization. The integration of advanced digital technologies is set to change the future of medicine production and the way regulatory process works.

Environmental concerns are further driving the need for sustainability practices and increasing the importance of circular manufacturing economy. The growing promise of precision medicine and integration of AI, ML and big data analytics is set to boost the overall market growth in the coming decade.

“Growing Focus on Development of Precision Medicine Driving Demand for Healthcare Contract Research Outsourcing Services”

Surge in the fixed costs of in-house regulatory affairs functions including technology, facilities, and training is set to boost the demand for reliable regulatory affairs outsourcing services. Big biopharma companies are focusing on the development of precision medicine due to the shift from recreation to prevention. The high expenses of trial and error are driving the popularity of precision medicine. To reduce the costs of drug development many small companies are outsourcing R&D to pre-clinical contract research outsourcing (CRO) services.

What’s Hampering Demand Growth for Regulatory Affairs Outsourcing Services?

“Threats Related to Outsourcing and Data Sharing”

Regulatory affairs outsourcing are highly vulnerable to cyber-attacks and privacy threats. The easy accessibility to several electronic digital solutions and digital documentations makes any organization vulnerable to cyber-attacks. The healthcare sector mainly moves around mergers, acquisitions, and collaborations. Various outsourcing partners have access to the sensitive data of pharmaceutical industries which is a threat to the security of companies. Thus sharing of critical data related patient information and contract increases the chances of cyber threat.

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How Can New Companies Stand Out in This Competitive Space?

“Focus of Advancing Safety Features Related to Data Exchange”

New companies eager to enter the regulatory affairs outsourcing market should focus on the development of secure and reliable services. Data theft and cyber-attack are major challenges faced by end users and to overcome these issues new companies should invest in advancing the safety steps and features controlling data exchange. They can also focus on integrating additional safety steps for verification.

Country-wise Analysis

What’s Influencing Demand for Regulatory Affairs Outsourcing Services in the United States?

“Strong Presence of Pharma and Medical Device Companies”

Attribute United States
Market Value (2024E) US$ 5.6 Billion
Growth Rate (2024 to 2034) 8.4% CAGR
Projected Value (2034F) US$ 12.57 Billion

Presence of established pharmaceutical and medical devices companies is one of the key factors driving the demand for regulatory affairs outsourcing services in the United States. The contribution of the FDA (Food and Drug Administration) is a notable one since they regulate majority of the medical devices globally.

Will South Korea Be a Lucrative Market for Regulatory Affairs Service Providers?

“Market to Benefit from High Investments in Healthcare”

Attribute South Korea
Market Value (2024E) US$ 737.1 Million
Growth Rate (2024 to 2034) 8.3% CAGR
Projected Value (2034F) US$ 1.63 Billion

Fact.MR, a market research and competitive intelligence provider reveals in its updated report that South Korea is projected to account for 26% of the East Asian market share by 2034. Aggressive investments in healthcare sector are set to create ample opportunities for regulatory affairs outsourcing service providers in the coming decade. The availability of skilled workforce and the rapid development of the life sciences sector are expected to increase the regulatory affairs outsourcing market growth in South Korea.

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Category-wise Analysis

Why Does Pre-clinical Outsourcing Hold a Leading Market Share?

“Strict Regulations Governing Pre-clinical Stage”

Attribute Pre-clinical Stage
Segment Value (2024E) US$ 10.42 Billion
Growth Rate (2024 to 2034) 7.4% CAGR
Projected Value (2034F) US$ 21.22 Billion
  • ClinicalTrials.gov estimates that at the start of year 2024 around 477,233 trials are registered and by the end of 2024 it is projected to reach 491,890.

The pre-clinical stage is expected to hold major position due to the rising need for effective therapies for contagious disease such as Zika virus, COVID-19, and Ebola and chronic disorders such as cancer, neurological, and cardiological diseases. Furthermore, strict regulations controlling pre-clinical trials is also driving need for effective regulatory affairs outsourcing services.

How are Pharmaceutical Companies Contributing to Increasing Demand for Regulatory Affairs Outsourcing Services?

“Rising Need for Biosimilars and Customized Medicines”

Attribute Pharmaceutical Companies
Segment Value (2024E) US$ 8.56 Billion
Growth Rate (2024 to 2034) 7.4% CAGR
Projected Value (2034F) US$ 17.44 Billion

Increasing number of new drugs penetrating the pharmaceutical industry is expected to boost the regulatory affairs outsourcing service demand growth during the forecast period. The growing requirement for personalized orphan drugs & medicine, advanced medical technologies, and biologics is expected to offer lucrative opportunities for regulatory affairs outsourcing service providers.

Competitive Landscape

Key players in the global regulatory affairs outsourcing market are focusing on expanding their global influence. For that leading companies are adopting strategies such as partnerships, collaborations, mergers, and acquisitions.

  • In August 2021, ProPharma Group, a portfolio company of Odyssey Investment Partners, announced the acquisition of iSafety Systems an Indian pharmacovigilance outsourcing service provider.
  • In July 2021, ICON Plc. acquired a CRO, called PRA Health Sciences. The objective of the acquisition was to increase the services portfolio of ICON Plc. The company continued with its original name, ICON and brought together 38,000 employees across 47 countries to create the most developed clinical research organization and healthcare intelligence.

Key Segments of Regulatory Affairs Outsourcing Market Research

  • By Service :

    • Regulatory Consulting Outsourcing
    • Legal Representation Outsourcing
    • Regulatory Writing & Publishing Outsourcing
    • Others
  • By Company Size :

    • Small-Sized Companies
    • Medium-Sized Companies
    • Large-Sized Companies
  • By Category :

    • Drugs
    • Biologics
    • Medical Device
  • By Indication :

    • Oncology
    • Neurology
    • Radiology
    • Immunology
    • Others
  • By Stage :

    • Pre-Clinical
    • Clinical
    • Post Market Authorization
  • By End User :

    • Medical Device Companies
    • Pharmaceutical Companies
    • Biotechnology Companies
  • By Region :

    • North America
    • Latin America
    • Europe
    • East Asia
    • South Asia & Oceania
    • Middle East & Africa

- FAQs -

How big is the regulatory affairs outsourcing market size in 2024?

The global regulatory affairs outsourcing market is evaluated at US$ 17.4 billion in 2024.

What is the estimated demand growth for regulatory affairs outsourcing services?

Demand for regulatory affairs outsourcing services is projected to increase at a CAGR of 7.3% during the next 10 years.

What is the forecasted value of the global market for 2034?

The market for regulatory affairs outsourcing is projected to reach US$ 35.31 billion by 2034.

What are the estimated sales of regulatory affairs outsourcing services in South Korea?

The South Korea market is approximated at US$ 737.1 million in 2024.

What are the industry trends in regulatory affairs?

A key market trend is the integration of digital technologies such as AI, ML, and big data analytics in regulatory affairs.

What are the challenges in regulatory affairs?

Shifting policies and strict compliance guidelines are some of the challenges for market growth.

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Regulatory Affairs Outsourcing Market