Medical affairs outsourcing is the mechanism where by pharmaceutical, biotech, and medical device companies outsource non-commercial science-based activities such as medical writing, medical information, publication planning, regulatory affairs, and key opinion leader (KOL) interaction to outside vendors. Outsourcing these functions enables companies to remain compliant, improve operational efficiency, and focus on core R&D and commercialization efforts.
As regulatory demands have become more complex, pipeline size has increased and real-world evidence and science communication have taken center stage, the demand for medical affairs specialist expertise has mounted. As in-house talent in midsize biotechs and specialty pharma is not enough, this has fueled the third-party vendor industry with specialized service offerings.
The global value-based healthcare and science interactions trend has also fueled the outsourcing movement in medical affairs. Scalability and compliance with regional regulatory requirements can be achieved by firms using the assistance of external partners at reduced costs.
For instance, a Europe-based biopharma company has outsourced its medical information and publication planning function to a U.S.-based CRO, thereby paving the way for faster publication rate coupled with global scientific coverage without necessity of development of an in-house department.
Increased sophistication of the biopharmaceutical business, particularly in regulatory compliance, is among the principal growth drivers to the medical affairs outsourcing industry. With more targeted therapies in place, e.g., oncology, immunotherapy, and orphan disease, the firms are required to develop and communicate more precise clinical data to the authorities, physicians, and payers. In addition, the regulatory landscape in the world is ever-changing, and specialized expertise is needed to adapt to region-specific needs like the FDA, EMA, and PMDA.
Internal personnel, particularly in small- and medium-sized businesses, may lack the bandwidth or regulatory know-how necessary to manage this complexity. As such, their medical affairs function must be outsourced to get products to market quickly while still achieving compliance.
To illustrate, a Canada-based biopharmaceutical firm, while developing a new type of CART therapy, entered Phase III trials, wherein it outsourced regulatory medical writing as well as advisory services to a CRO focused on oncology. This, in turn, let the firm attain streamlined compliance with submission needs in the Europe and the U.S.
Another major driver is the escalating demand for real-world evidence (RWE) and enhanced scientific communication to support value-based healthcare decisions. Payers, regulatory bodies, and medical providers increasingly look to post-market evidence to verify the efficacy, safety, and cost-effectiveness of novel therapies. Medical affairs organizations are pivotal in collecting, analyzing, and reporting RWE in the form of peer-reviewed journals, congress abstracts, and health economics data.
In order to meet this need, pharma companies and biopharma’s seek partner specialists possessing expertise in data analysis, generation of RWE, medical writing, and engaging with KOL. Such partners are not merely proficient in translating challenging data, but also making certain that the message aligns with changing reimbursement and market access planning.
For example, a US-based digital therapeutic firm has collaborated with a medical affairs outsource partner to create RWE for the company's FDA-cleared mental health mobile application.
North America dominates the medical affairs outsourcing market globally, substantially because of the matured biopharmaceutical and biotech landscape, robust regulatory systems, and global acceptance of models of outsourcing. The United States alone houses numerous pharma giants and Contract Research Organizations with specialized medical affairs capabilities. The developed healthcare infrastructure, plus earlier adoption of digital resources, further make it the best place to maintain sophisticated, science-driven medical affairs operations.
Additionally, the evolving US FDA regulatory landscape requires frequent scientific interactions, immediate medical writing, and real-world evidence generation in an effort to maintain compliance. This creates enormous demand for outsourced work, particularly from small- and medium-sized biopharma’s that do not have in-house capabilities.
The reservoir of highly skilled medical affairs professionals, backed by real-time evidence generation investments in data analytics and AI, also further solidifies North America's leadership in the global marketplace. For example, a growing pharma client in Japan hired an outsourced medical affairs firm in California to aid in launching their new medicine. By joining forces, the pair delivered end-to-end services-ranging from advisory board management to scientific publishing and KOL mapping-to aid compliant and streamlined entry into the target new marketplace.
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Medical Affairs Outsourcing Market
