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Table of Content
April 2025
Principal Consultant
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The global medical affairs outsourcing market size is calculated at USD 2.25 billion in 2024, grew to USD 2.55 billion in 2025, and is projected to reach around USD 8.07 billion by 2034. The market is expanding at a CAGR of 13.64% between 2025 and 2034. The growing research and development activities, expanding product pipeline, and technological advancements drive the market.
Medical affairs focus on scientific communication, education, and ensuring the safe and effective utilization of products within pharmaceutical and medical device companies. The primary functions of medical affairs encompass medical monitoring, medical writing and publishing, provision of medical information, and the activities of medical science liaisons. Numerous companies outsource their medical affairs services to contract research organizations (CROs), enabling them to focus on product marketing. This helps reduce operational costs, minimize regulatory compliance risk, and prevent process delays.
The growing research and development activities, along with stringent regulatory guidelines, are major growth factors of the market. The rapidly expanding drug and medical device pipeline facilitates companies to outsource medical affairs. The burgeoning pharmaceutical and biotechnology sectors also contribute to market growth. The increasing investments and collaborations favor outsourcing services. Additionally, the rising adoption of advanced technologies in CROs leads to the latest innovations and advanced services.
Artificial intelligence (AI) transforms the operations of outsourcing services, providing advanced solutions. It can introduce automation in medical affairs functions, streamlining the entire workflow. It reduces human intervention, thereby decreasing manual errors and the overall time required for data generation and analysis. AI can advance data-based prioritization and strategy execution. AI and machine learning (ML) algorithms can analyze vast amounts of data as well as store and manage data from numerous organizations. AI can revolutionize external engagement by providing tailored medical content across all channels, enhancing decision-making for healthcare providers and patients. It can improve hypotheses and study designs of complex clinical procedures supporting drug lifecycle management. It can also identify and fill data gaps in the clinical practice landscape.
Increasing Number of Clinical Trials
The major growth factor of the medical affairs outsourcing market is the increasing number of clinical trials. The growing research and development activities lead to the development of novel drugs, biologicals, and medical devices, thereby increasing clinical trials. There are around 532,357 total clinical trials registered on the clinicaltrials.gov website, including active, completed, and terminated. This necessitates corresponding involvement from medical affairs in preparing submissions, analyzing, rationalizing, and disseminating the results. Outsourcing these services enables organizations to stay compliant with regulatory requirements and generate robust scientific evidence. This helps them make informed decisions across the product development lifecycle. These services allow companies to meet the expectations of regulators, payers, physicians, and patients, enabling them to stay competitive.
Loss of Control
The major challenge of the market is the loss of control over essential operations and decision-making procedures. Organizations have limited authority over some operations and strategic directions when relying on outsourcing services. The lack of trust among organizations and CROs may affect decision-making, restricting market growth.
Rising Number of Startups
The future of the medical affairs outsourcing market is promising, driven by the rising number of pharmaceutical and biotechnology startups. The burgeoning pharmaceutical sector and increasing venture capital investments promote the opening of new startups. Medical affairs outsourcing services are not only utilized and beneficial for large pharmaceutical companies but also for small companies. The increasing collaborations between smaller firms and CROs enable startups to benefit from their expertise and deliver advanced solutions. Leveraging the expertise of consultants can bring an outside perspective and new ideas, along with medical affairs solutions. This helps startups focus on developing other aspects of the business. Moreover, outsourcing enables flexibility and scalability, allowing organizations to adjust resources according to fluctuating needs and effectively adapt to changing requirements. Thus, medical affairs outsourcing creates ample opportunities for startups, enabling them to strengthen their market position.
By services, the medical writing & publishing segment held a dominant presence in the medical affairs outsourcing market in 2024. Medical writing refers to writing scientific documents, including regulatory, research-related, publication articles, content for healthcare websites, etc. It is crucial for clinical research, regulatory affairs, marketing, and education. Outsourcing can enhance the quality of research reporting and speed up the publication process. Thus, it can significantly reduce the time for writing and provide relevant expertise, reducing manual errors. The increasing number of clinical trials and new product launches potentiate the need for medical writing and publishing, augmenting the segment’s growth.
By services, the medical science liaison segment is anticipated to grow with the highest CAGR in the market during the studied years. Medical science liaisons (MSLs) are scientific experts who are part of the product’s lifecycle within the pharmaceutical, biotechnology, medical device, CRO, and other healthcare industries. MSLs act as a bridge between healthcare professionals and pharmaceutical companies, allowing patients to gain access to appropriate medicines. Outsourcing these services can help healthcare organizations manage their scientific communications with numerous providers cost-effectively. This results in enhanced scientific communication and reduced training and management burden on companies.
By industry, the pharmaceutical segment held the largest share of the medical affairs outsourcing market in 2024. The growing demand for small molecules as therapeutics and increasing research and development activities boost the segment’s growth. There are currently 13,187 small-molecule drugs. The rising number of publications and post-marketing surveillance of therapeutics also necessitate the outsourcing of medical affairs. It simplifies the tasks of pharmaceutical companies, improving their operational efficiency. The growing number of pharmaceutical startups also contributes to the segment’s growth.
By industry, the biopharmaceutical segment is expected to grow at the fastest rate in the market during the forecast period. The increasing number of biologicals as therapeutics and the burgeoning biotech sector potentiate the segment’s growth. There are more than 4,200 biologicals available as therapeutics. Biopharmaceuticals have comparatively stringent regulatory requirements and complex approval procedures, requiring the need for outsourcing services. Outsourcing the medical affairs of biopharmaceutical companies can simplify tasks for professionals and provide valuable insights on post-market monitoring.
North America dominated the global medical affairs outsourcing market share by 36% in 2024. The rising prevalence of chronic disorders leads to the development of novel drugs and medical devices for their prevention, diagnosis, and treatment. State-of-the-art research and development facilities and favorable government policies support the market. The increasing investments and collaborations among pharmaceutical companies and CROs favor market growth. Advancements in medical technology and the abundance of patient and provider data are also responsible for market growth.
New product launches facilitate the need for medical affairs outsourcing. The Food and Drug Administration approved seven new therapeutics from January 2025 to March 2025. The U.S. conducts the highest number of clinical trials globally. A total of 180,814 clinical trials are registered on the clinicaltrials.gov website, including active, recruiting, completed, and terminated.
The increasing number of pharmaceutical and biotechnology companies contributes to market growth. There are more than 3,000 pharmaceutical companies in Canada. Numerous companies are relying on outsourcing medical affairs to strengthen their market position. The Canadian government is investing $14.3 million to address labor shortages in the healthcare sector to remove pressure on healthcare workers.
Asia-Pacific is anticipated to grow at the fastest rate in the medical affairs outsourcing market during the forecast period. The rising number of pharmaceutical startups and the burgeoning pharma/biotech sectors augment the market. The growing research and development activities and the rapidly expanding healthcare sector promote the market. Several government and private organizations provide funding for pharma startups and large pharmaceutical companies, enabling them to opt for medical affairs outsourcing. The availability of low-cost expertise also potentiate market growth.
China has more than 10,000 major pharmaceutical companies. The growing research activities lead to an increasing number of publications and patents. In 2023, approximately 728,700 SCI papers were published by Chinese scholars, accounting for one-third of the global total. Additionally, many companies are aiming to expand their presence in China, necessitating outsourcing services.
Out of the total 140,803 startups reported by the Department for Promotion of Industry and Internal Trade (DPIIT), around 2,127 were from the pharmaceutical sector as of June 2024. India is the second-largest venture capital destination in Asia-Pacific. In 2024, 13.7 billion were raised in venture capitals, a 1.4-times increase from 2023.
Europe is expected to grow at a considerable rate in the medical affairs outsourcing market in the upcoming period. The stringent regulatory protocols and the growing emphasis on patient safety promote the demand for outsourcing services for documentation, clinical trial applications, product registrations, and legal representation. The increasing number of clinics, hospitals, research facilities, and pharmaceutical/clinical laboratories facilitate market growth. The rising adoption of advanced technologies in healthcare organizations and CROs also fosters market growth.
The increasing number of clinical trials and CROs necessitates medical affairs outsourcing. There are more than 120 CROs in Germany providing outsourcing services. Germany is ranked third in the 2024 World Index of Healthcare Innovation. It is also the largest exporter of pharmaceutical products, exporting $113 billion in pharmaceutical products in 2023.
Jeff James, Executive Vice President, Alliance Management, ICON plc, commented that the clinical research industry has undergone transformational changes that resulted in new outsourcing models and operational strategies driven by an increasingly prevalent partnership between large pharmaceutical companies and CROs. This provides tailored models depending on the sponsor’s specific configuration, capacity, and desired outcomes.
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