Regulatory Affairs Outsourcing Market By Service (Legal Representation, Product Registration & Clinical Trial Application, Regulatory Consulting, Regulatory Writing & Publication, and Others), By Category (Biologics, Medical Devices, and Drugs), By Application (Neurology, Immunology, Oncology, Cardiology, and Others), By End-user (Biotechnology Company, Medical Device Company, and Pharmaceutical Company), Region and Companies – Industry Segment Outlook, Market Assessment, Competition Scenario, Trends and Forecast 2024-2033

Report Overview

The Regulatory Affairs Outsourcing Market size is expected to be worth around USD 15.0 billion by 2033 from USD 6.8 billion in 2023, growing at a CAGR of 8.2% during the forecast period 2024 to 2033.

Outsourcing regulatory affairs has become an essential strategy in the healthcare industry, driven by companies seeking to expedite market approvals during geographic expansions. The growing demand for regulatory outsourcing is fueled by increased R&D activities, the rising focus on personalized medicine, and the surge in biologics, which has led to a higher volume of clinical trial applications and product registrations.

Healthcare companies face constant pressure to secure timely approvals from regulatory bodies across different countries, further accelerating the need for outsourced regulatory services. As companies strive to maintain compliance while obtaining approvals for new products, the demand for regulatory affairs solutions continues to rise. According to a survey sponsored by Genpact, 72% of life sciences executives consider regulatory compliance one of the top three challenges facing the industry.

Regulatory departments often struggle with managing multiple complex tasks while adhering to strict regulatory standards, making outsourcing an attractive option. Additionally, the push to expand global market presence and secure rapid approvals further supports the shift toward outsourcing. Life sciences companies are also under pressure to reduce development costs, and the growing demand for generics and affordable medical devices is expected to enhance the adoption of regulatory affairs outsourcing, ultimately lowering healthcare costs.

Key Takeaways

• In 2023, the market for Regulatory Affairs Outsourcing generated a revenue of USD 6.8 billion, with a CAGR of 8.2%, and is expected to reach USD 15.0 billion by the year 2033.
• The service segment is divided into legal representation, product registration & clinical trial application, regulatory consulting, regulatory writing & publication, and others, with product registration & clinical trial application taking the lead in 2023 with a market share of 42.7%.
• Considering category, the market is divided into biologics, medical devices, and drugs. Among these, drugs held a significant share of 42.3%.
• Furthermore, concerning the application segment, the market is segregated into neurology, immunology, oncology, cardiology, and others. The oncology sector stands out as the dominant player, holding the largest revenue share of 41.5% in the Regulatory Affairs Outsourcing market.
• The end-user segment is segregated into biotechnology company, medical device company, and pharmaceutical company, with the pharmaceutical company segment leading the market, holding a revenue share of 46.3%.
• North America led the market by securing a market share of 40.1% in 2023.

Service Analysis

The product registration & clinical trial application segment led in 2023, claiming a market share of 42.7% owing to the increasing complexity of global regulatory requirements. Pharmaceutical and medical device companies rely on external expertise to navigate various country-specific regulations and streamline the product registration process.

The rising demand for quicker market access and the need to manage multiple clinical trial applications across different regions are expected to drive the growth of this segment. Additionally, the expanding pipeline of new drugs and biologics, particularly in emerging markets, likely fuels the demand for outsourcing services related to product registration and clinical trial applications.

Category Analysis

The drugs held a significant share of 42.3% due to the rising number of drug approvals and the increasing complexity of regulatory compliance. As the pharmaceutical industry continues to innovate and develop new treatments, including biosimilars and gene therapies, regulatory processes have become more challenging.

Companies are increasingly turning to outsourcing partners to manage the regulatory submission process and ensure compliance with global standards. The growing focus on accelerating drug development timelines, coupled with evolving regulatory frameworks, is anticipated to further boost the demand for outsourcing services in the drugs segment.

Application Analysis

The oncology segment had a tremendous growth rate, with a revenue share of 41.5% owing to the increasing number of cancer therapies in development and the stringent regulatory requirements surrounding their approval. The complexity of oncology clinical trials, which often involve novel treatments such as immunotherapies and precision medicine, is likely to drive demand for specialized regulatory services.

Companies seek external expertise to navigate the intricate approval processes for oncology drugs, ensuring timely submissions and compliance with evolving guidelines. The rising incidence of cancer worldwide and the growing focus on fast-tracking innovative oncology treatments likely further propel this segment’s growth.

End-user Analysis

The pharmaceutical company segment grew at a substantial rate, generating a revenue portion of 46.3% due to the growing pressure to bring new drugs to market faster while adhering to strict regulatory standards. Pharmaceutical companies are increasingly outsourcing regulatory affairs to reduce internal burdens, manage rising costs, and access specialized expertise.

The expanding pipeline of innovative drugs, including complex biologics and specialty medicines, is expected to drive the demand for outsourcing services. Additionally, the need for global regulatory compliance, particularly in emerging markets, likely supports the continued growth of this segment as pharmaceutical companies focus on navigating diverse regulatory landscapes efficiently.

Key Market Segments

By Service

• Legal Representation
• Product Registration & Clinical Trial Application
• Regulatory Consulting
• Regulatory Writing & Publication
• Others

By Category

• Biologics
• Medical Devices
• Drugs

By Application

• Neurology
• Immunology
• Oncology
• Cardiology
• Others

By End-user

• Biotechnology Company
• Medical Device Company
• Pharmaceutical Company

Drivers

Rising Demand for Intelligent Solutions

Rising demand for intelligent solutions continues to drive the regulatory affairs outsourcing market as companies seek expertise to handle complex regulatory requirements efficiently. Organizations increasingly prefer outsourcing to firms that offer comprehensive solutions in pharmacovigilance, market access, quality assurance, and regulatory services.

For example, in August 2022, PharmaLex Group merged with Finland-based DRA Consulting, a firm known for providing intelligent, end-to-end services to over 300 clients. This merger highlights the growing need for specialized solutions to streamline compliance and navigate evolving regulations. As industries prioritize efficiency and cost savings, the demand for intelligent outsourcing is projected to grow significantly.

Restraints

Growing Data Security Concerns

Growing concerns over data security restrain the expansion of the regulatory affairs outsourcing market. The sensitive nature of regulatory data, which includes proprietary information, patient data, and clinical trial results, increases the risk of cybersecurity breaches when outsourcing these services. Companies fear that external vendors may not have adequate safeguards in place, raising concerns about data leaks or hacking incidents.

These worries about the potential exposure of confidential information are anticipated to impede the growth of the outsourcing market, particularly in highly regulated industries like pharmaceuticals and biotechnology, where data security remains a top priority.

Opportunities

Growing Advancements in Clinical Trials

Growing advancements in clinical trials present a significant opportunity for the regulatory affairs outsourcing market. As the complexity of clinical trials increases, so does the need for specialized regulatory support to ensure compliance with global standards. In 2023, Syneos Health formed a strategic alliance with Oracle to accelerate the process of finding participants for clinical trials.

By leveraging Oracle’s Cerner Learning Health Network and advanced study startup technologies, this collaboration aims to reduce timelines and broaden patient engagement. Such innovations create opportunities for outsourcing firms to offer enhanced regulatory support, further driving growth in the market as clinical trials continue to evolve.

Impact of Macroeconomic / Geopolitical Factors

Macroeconomic and geopolitical factors have a significant influence on the regulatory affairs outsourcing market, affecting both risks and opportunities. Economic slowdowns can reduce budgets for pharmaceutical and biotech companies, leading to a slowdown in outsourcing services. Geopolitical tensions and trade restrictions may disrupt international collaborations, increasing operational costs and complicating cross-border regulatory processes.

On the positive side, globalization and rising regulatory complexities in different regions drive demand for outsourcing to specialized firms. Emerging markets offer growth potential as governments invest in healthcare infrastructure. Despite challenges, increasing regulatory scrutiny ensures a steady need for outsourcing services, fostering optimism in the market’s future.

Latest Trends

Rising Trend of Acquisitions and Mergers

Companies are expanding their service portfolios and global reach through strategic collaborations. For example, in January 2023, AmerisourceBergen Corporation acquired PharmaLex Holding GmbH, a major service provider in regulatory affairs for the life sciences industry.

This acquisition has significantly broadened AmerisourceBergen’s capabilities in the regulatory sector. Increasing consolidation within the industry is projected to enhance the expertise and geographical presence of key players, making regulatory outsourcing services more comprehensive and efficient. As these mergers continue, the market is likely to see sustained growth and innovation.

Regional Analysis

Asia Pacific is leading the Regulatory Affairs Outsourcing Market

Asia Pacific dominated the market with the highest revenue share of 40.1% owing to the increasing demand for efficient regulatory processes amid a rapidly evolving pharmaceutical landscape. Companies in the region face growing pressure to navigate complex regulatory environments, particularly as they seek to bring innovative therapies and biologics to market. A significant development occurred in January 2023, when GenScript, a provider of contract services for biologic drug development and manufacturing, secured USD 224 million in funding.

This investment is poised to enhance the production capabilities of GenScript’s subsidiary, ProBio, allowing it to scale up the manufacture of biologic drugs used to treat complex diseases, including cancer and autoimmune disorders. The growing focus on research and development in the biopharmaceutical sector, coupled with increased collaborations between companies and regulatory bodies, has further fueled the outsourcing trend. As the market continues to expand, organizations increasingly turn to specialized regulatory affairs providers to streamline their submission processes and ensure compliance with local regulations.

The North America region is expected to experience the highest CAGR during the forecast period

North America is expected to grow with the fastest CAGR owing to the rising complexity of regulatory requirements and the need for timely market entry of pharmaceutical products. The demand for regulatory services is likely to surge as more novel biosimilars receive approval; for instance, by January 2022, approximately 33 biosimilars had received FDA approval in the U.S., with 21 of those commercially available. This trend toward developing and launching biosimilars is projected to enhance the need for expert regulatory guidance and support.

Companies are increasingly recognizing the benefits of outsourcing these functions to specialized firms that can provide the necessary expertise to navigate the intricate regulatory landscape. Additionally, ongoing innovations in drug development and manufacturing processes will likely create further opportunities for regulatory service providers. Overall, the combined factors of a growing number of products requiring regulatory oversight and an increasing emphasis on efficiency will drive substantial growth in the regulatory affairs outsourcing market across North America.

Key Regions and Countries

North America

• US
• Canada

Europe

• Germany
• France
• The UK
• Spain
• Italy
• Russia
• Netherland
• Rest of Europe

Asia Pacific

• China
• Japan
• South Korea
• India
• Australia
• New Zealand
• Singapore
• Thailand
• Vietnam
• Rest of APAC

Latin America

• Brazil
• Mexico
• Rest of Latin America

Middle East & Africa

• South Africa
• Saudi Arabia
• UAE
• Rest of MEA

Key Players Analysis

The major players in the Regulatory Affairs Outsourcing market are actively engaged in the development and introduction of innovative products, as well as implementing strategic initiatives aimed at enhancing their competitive positioning. Key players in the regulatory affairs outsourcing market focus on expanding their global presence by offering region-specific expertise to navigate diverse regulatory environments.

They invest in technology and automation to streamline regulatory processes, improving efficiency and compliance. Collaborating with pharmaceutical and medical device companies allows them to manage complex approval processes and post-market surveillance. Many also enhance their service offerings by integrating risk management and quality assurance solutions. Additionally, targeting emerging markets with evolving regulations helps drive growth and widen their client base.

Top Key Players in the Regulatory Affairs Outsourcing Market

• WuXiAppTec, Inc.
• VCLS
• ProPharma Group
• Medpace
• ICON plc
• Genpact Ltd.
• Freyr
• Covance
• AmerisourceBergen Corporation

Recent Developments

• In April 2022: VCLS partnered with EC Innovations, a Chinese translation services provider with expertise in highly regulated life sciences content. This collaboration is relevant to the growth of the regulatory affairs outsourcing market by enhancing VCLS’s capabilities to manage global regulatory documentation and compliance efficiently.
• In September 2022: AmerisourceBergen Corporation announced an agreement to acquire PharmaLex Holding GmbH, a leading provider of specialized life sciences services. This acquisition strengthens AmerisourceBergen’s position in regulatory affairs outsourcing by expanding its service offerings and expertise in the life sciences sector.
• In August 2021: ProPharma Group acquired iSafety Systems, an India-based company specializing in pharmacovigilance and regulatory services. This acquisition enhances ProPharma Group’s global footprint and positions it as a leader in regulatory compliance, supporting the growth of the regulatory affairs outsourcing market.
• In February 2021: ICON plc acquired PRA Health Sciences, Inc. in a USD 12 billion deal, boosting its medical affairs services. This acquisition is significant for the regulatory affairs outsourcing market as it increases ICON’s ability to provide comprehensive regulatory and clinical services globally.

Report Scope