The life sciences industry is undergoing rapid transformation, driven by increasing complexity, stringent regulations, the need for faster innovation, and a growing emphasis on digitalization. These factors are driving the demand for pharmaceutical and biotech consulting services, including drug development, regulatory affairs, scientific writing, economic affairs, quality assurance and compliance, real-world evidence (rwe), and pharmacovigilance (pv).
The demand for consulting services in advanced therapies is on the rise. Advanced therapies, such as cell and gene therapies and personalized vaccines, require specialized expertise throughout the development, manufacturing, and regulatory processes. Keeping up with the rapidly evolving landscape of advanced therapy medicinal products is essential for successfully developing products and obtaining centralized market authorization (ma) in Europe or a biologic license authorization in the us. The expanding research in cell and gene therapies has led to a robust demand for consulting services, which necessitate experts with specific experience in regulatory strategy, cmc, medical communications, and clinical development.
Product commercialization and market access have become pivotal elements for the success of new drugs. In addition to efficacy and safety, pharmaceutical companies are now required to demonstrate how their new drugs improve patient outcomes, reduce the burden on healthcare systems, and provide value for their cost. Meeting these criteria involves taking a holistic view of patient treatment, providing better real-world evidence, and establishing strong value propositions for decision-makers. The complex regulatory and reimbursement pathways, diverse evidence requirements, and lengthy procedural timelines pose risks to successful market access and launch. As a result, there is a growing demand for market access services, such as health economics and outcomes research (heor), pharmacovigilance (pv), and real-world evidence (rwe) strategy and consulting.
The pharmaceutical and biotech industry is increasingly seeking technology and IT consulting services to digitize operations, migrate to the cloud, leverage advanced technologies such as artificial intelligence (AI) and machine learning (ML), and modernize existing IT infrastructures.
North America holds a significant market share in global life sciences consulting services revenues. This is primarily attributed to the thriving biopharmaceutical industry, substantial R&D spending in the US, the presence of major pharmaceutical companies like J&J and Pfizer in the region, rapid adoption of digital technologies and IT, stringent FDA regulations, and a strong focus on advanced therapies.
The global life sciences consulting services market is highly competitive and fragmented. Key players in this market include IQVIA, Parexel, Certara, Huntsworth, PharmaLex, Halloran Consulting, Ashfield, Fishawack, Envision Pharma, Science Group, Indegene, Fingerpaint, Eversana, Lumanity, ClearView, ProPharma, ProductLife Group, Deallus, RTI, Evidera (PPD), Target RWE, OPEN Health, Genesis Research, and QbD Group.
Companies in the life sciences consulting services market are utilizing inorganic growth strategies to expand their market share. One of these strategies involves adding or expanding services such as RWE, HEOR, PV, medical communications, and analytics. Recent mergers and acquisitions (M&As) reflect this trend, such as TriNetX acquiring Advera Health Analytics in January 2023 and IMC Group acquiring Porterhouse Medical Group in July 2022. Private equity firms are also making investments in this space to capitalize on growth opportunities, as seen with Lumanity (acquired by Arsenal Capital Partners in 2022), Clearview Healthcare Partners (acquired by GHO Capital in 2021), and ProPharma (acquired by Odyssey Investment Partners in 2020).