Traditionally, CMOs have thrived by aggregating demand and delivering benefits of economies of scale. However, with the fading era of blockbuster drugs dispensed to large patient pools and shift to precision medicine, focus on niche indications, and increased R&D in biologics, pharma sponsors are increasingly turning to CMOs as strategic partners instead of contractors. Sponsors are looking for partnerships to not only append their existing capacity and get access to new markets, but also to mitigate risk and bring overhaul in manufacturing technologies. Consequently, safety, efficacy, and product quality are outweighing cost-saving considerations.

CMOs are also stepping up to the growing demand by investing in containment technology to meet HPAPI demand, introducing distributed manufacturing to take manufacturing closer to the patient, and adopting continuous manufacturing and digitization of processes. For example, CMOs are partnering with third-party vendors for layered analytics with the aim of optimizing processes, introducing preventive maintenance, and making supply chains transparent. This research service covers these technology trends with case examples of how some CMOs are ahead of the curve in adopting these technologies.

This study also covers the global market for pharmaceutical contract manufacturing for Active Pharmaceutical Ingredient (API) and Finished Dosage Form (FDF) manufacturing. It provides a comprehensive and critical analysis of subsectors, including generic APIs, novel APIs, HPAPIs, solid dosage forms, and injectable dosages. The study also examines top developed and emerging national markets, challenges in each of these markets, and hidden opportunities. For example, in the US, where generic drug penetration is heavy at almost 80% and China, India, Russia, and Mexico where levels are as high as 90%, the CMO market has reached saturation and, therefore, CMOs can explore opportunities in lifecycle management of legacy products and redesigning synthesis routes to create high-tech generics.

This study also captures sponsors’ outlook for outsourcing by products and by stage of drug lifecycle and the new engagement models being sought. In conjunction with the opportunities in product selection and manufacturing technologies, the study also has a detailed discussion on opportunities in the packaging segment in the light of new serialization requirements, track-and-trace solutions designed to reduce to counterfeit medicine, primary and secondary packaging to meet regional and local regulatory requirements, as well as opportunities to collaborate with CROs for new drug development. The study also discusses the impact of ongoing consolidation, profiles of leading CMOs, key CMOs to watch for, and, most importantly, the interest of private equity firms in the segment.

Key Issues Addressed
  • What is the total market size and projected growth of the global pharmaceutical contract manufacturing market? Which are the largest growth segments to be pursued?
  • How are the various regions around the globe positioned to monetize the market opportunities? What are the key regional barriers to entry?
  • Which are the biggest opportunities for small- and mid-sized companies in the highly fragmented market? What are the key challenges in the near and mid term?
  • How are business models evolving across the value chain and impacting the different stakeholders?
  • How are product offerings in this market likely to emerge? What is the rate of innovation adoption, and how is it solving the unmet needs of customers?
  •  Which are the key game-changing companies in the segment and how are they riding the growth curve?