Healthcare Regulatory Affairs Outsourcing Market

The global Healthcare Regulatory Affairs Outsourcing Market is valued at USD 6.48 Billion in 2024 and is projected to reach a value of USD 20.075 Billion by 2035 at a CAGR (Compound Annual Growth Rate) of 10.95% between 2025 and 2035.

Premium Insights

Market growth can be ascribed to several critical factors, including the rising expenditure on research and development (R&D), an increasing number of clinical trials, the cost-effectiveness of outsourcing, and a shortage of in-house skilled professionals. For instance, as of March 2021, ClinicalTrials gov reported 410,703 studies in 220 countries, comprising 318,134 interventional studies and 90,926 observational studies. According to the same source, the number of clinical trial studies is projected to rise from 325,775 in 2020 to 399,532 by 2023. Consequently, this upward trend in clinical trial studies is expected to boost the demand for regulatory affairs outsourcing in the foreseeable future.

Furthermore, the market is set to benefit from the increased investments in research and development by pharmaceutical and biotechnology companies. According to the PhRMA (Pharmaceutical Research and Manufacturers of America), its member companies invested approximately USD 83 billion in R&D activities in 2019. Additionally, PhRMA reported the development of over 260 vaccines for various diseases, including COVID-19, in 2020. These significant investments and ongoing research efforts are anticipated to drive market growth.

• According to sources, the rising share of pharmaceutical research and development being contracted out is expected to propel the Contract Research Organization (CRO) industrys future expansion, with an estimated growth rate of 10–12%.
• North America generated more than 41.30% of revenue share in 2022.
• Asia Pacific is expected to grow at the quickest rate from 2023 to 2030.
• The Clinical Trial Applications segment accounted for the most significant market growth and contributed over 32.5% of the total revenue share in 2022.
• Large Pharmaceutical Companies segment revealed the most significant market growth, contributing more than 32.3% of the total revenue share in 2022.

Economic Insights

Economic changes can significantly impact the Healthcare Regulatory Affairs Outsourcing market. For example, during times of economic downturn, companies may look to outsource regulatory affairs activities as a cost-saving measure. Outsourcing can reduce overhead costs and allow companies to focus on their core competencies. On the other hand, during economic growth, companies may have more resources and choose to handle regulatory affairs in-house. In addition, the Healthcare Regulatory Affairs Outsourcing market is also influenced by changes in the supply chain. As regulations and guidelines evolve, companies may need to adapt their supply chain processes to ensure compliance. This can include changes in product labeling, packaging, and distribution practices. Outsourcing can help companies navigate these changes by leveraging the expertise and experience of third-party service providers specializing in regulatory affairs.

Top Market Trends

• Increasing complexity of regulatory requirements: Healthcare regulations are becoming more stringent and complex, requiring specialized knowledge and expertise. Outsourcing regulatory affairs tasks to dedicated experts can ensure compliance with these evolving regulations. For example, pharmaceutical companies may outsource obtaining regulatory authorities' approval to launch new drugs.
• Cost reduction: Outsourcing regulatory affairs tasks can help healthcare companies reduce operational costs. By engaging external service providers, companies can avoid the need to hire and train in-house regulatory affairs professionals, saving on recruitment and training expenses. For instance, medical device manufacturers may outsource preparing and submitting regulatory documents to gain product approvals.
• Global expansion and market access: Regulatory compliance can be challenging when entering new markets or expanding operations internationally. Outsourcing regulatory affairs functions can help healthcare companies navigate the specific requirements of different countries, ensuring compliance and expedited market access. A pharmaceutical company planning to enter a new global market may outsource the registration and submission of product dossiers to comply with local regulations.
• Rapid technological advancements: The healthcare industry continuously evolves with new technologies, therapies, and digital solutions. Outsourcing regulatory affairs can give you access to professionals who are knowledgeable about the most recent developments and who can effectively handle the regulatory procedures related to new technology. For example, outsourcing regulatory affairs can help digital health companies navigate the complex regulations surrounding telemedicine services.
• Focus on core competencies: By outsourcing regulatory affairs tasks, healthcare companies can allocate their internal resources to core activities such as research and development, manufacturing, and sales. This allows companies to enhance their competitiveness and speed up time-to-market for new products and services. Biotechnology companies may outsource preclinical and clinical trial data compilation to regulatory experts, enabling them to concentrate on advancing their drug pipeline.

Market Segmentation

The Global Healthcare Regulatory Affairs Outsourcing Market is divided into the below-mentioned segments as:

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Based on Services

Clinical Trial Applications holds the largest share

Clinical Trial Applications hold the majority of the market share in 2022. Globally, the number of clinical trials has been rising significantly. The desire to meet unmet medical needs, the rising demand for novel cures, and the development of technology in the healthcare industry are all factors in this. Managing the regulatory aspects of multiple clinical trials can be daunting for companies, leading them to outsource these activities to specialized service providers. For instance, per the same source, clinical trial studies are expected to increase from 325,775 in 2020 to 399,532 by 2023.

Based on End User

Large Pharmaceutical Companies dominated the market

Large Pharmaceutical Companies are accounted to have potential market growth in 2022. The regulatory landscape in the healthcare industry has become increasingly complex and stringent. Large pharmaceutical companies are required to comply with numerous regulations and standards set by regulatory authorities such as the FDA and the EMA in Europe. This complexity has made it challenging for companies to manage and adhere to all regulatory requirements in-house, leading to the need for outsourcing solutions. In addition, large pharmaceutical companies often prefer to focus their internal resources and capabilities on their core activities, such as drug discovery, research, and development. By outsourcing regulatory affairs to external experts, companies can free up their resources and concentrate on their core competencies, increasing productivity and efficiency.

Based on Region

North America led the market

North America mentioned the potential growth of the market in 2022. North Americas healthcare regulatory outsourcing services sector is experiencing growth driven by various factors. One significant driver is the pricing pressure resulting from shifts in reimbursement policies and increased competition from generic drugs. This pressure has prompted major pharmaceutical companies to outsource their regulatory affairs activities, further fueling the expansion of this sector in North America. Additionally, the region is witnessing a surge in research and development activities, particularly an increase in clinical trials, which is expected to contribute to market growth. Furthermore, recent data from Clinicaltrials.gov, as of November 2021, reveals that 32% of registered clinical trials are in the United States. Many of these trials pertain to various drugs, creating a favorable environment for regulatory affairs outsourcing and consequently driving market growth.

Competitive Landscape

Prominent players in the market are making substantial investments in research and development to broaden their range of products, thereby fostering further growth in the Healthcare Regulatory Affairs Outsourcing sector. Market participants are also engaging in various strategic initiatives to extend their reach. Notable market developments encompass new products, contractual partnerships, mergers and acquisitions, increased investments, and collaborations with other entities. To thrive in an increasingly competitive and evolving market environment, the Healthcare Regulatory Affairs Outsourcing Industry must offer cost-efficient solutions. For instance, ICON plc purchased PRA Health Sciences, Inc in a deal of roughly USD 12 billion in cash and equity. This acquisition has strengthened the medical affairs service offering of the company.

The players in the global Healthcare Regulatory Affairs Outsourcing market include ProPharma Group (U.S.) among others.

Recent Market Developments

• In November 2022, IQVIA™ collaborated with Clalit, the largest health services organization in Israel, to launch the first Prime Site in the country. The collaboration combines IQVIA and Clalit’s capabilities in clinical trial delivery, real-world research, data and genomics.
• In September 2022, Parexel opened a new clinical trial supplies and logistics depot in Suzhou, China. This strategically located facility provides local and international biopharmaceutical customers conducting clinical trials in the region with timely access to supplies and investigative treatments to distribute to clinical sites and patients around the world.
• In August 2021, ProPharma Group acquired India-based iSafety Systems. This acquisition pursues to strengthen ProPharma Group’s position as the prime global provider of regulatory and compliance consulting, pharmacovigilance, clinical research services, and medical information.
• In February 2021, ICON plc acquired PRA Health Sciences, Inc. in a cash and stock transaction valued at approximately USD 12 billion. This acquisition has strengthened the medical affairs service offering of the company.

Segmentation of the Global Healthcare Regulatory Affairs Outsourcing Market