NA Pharmaceutical CMO Market Size (2024 - 2029)

North America Pharmaceutical Contract Manufacturing Market Analysis

The North America Pharmaceutical Contract Manufacturing Market was valued at USD 45.13 billion is expected to reach USD 62.04 billion at a CAGR of 5.2% over the forecast period from 2021 - 2026. Generic drugs present a massive opportunity for growth for the CMOs of North America. Traditionally, the CMOs of this region were unwilling to take risks about generics that produce low margins. However, as growing prices push more companies to enter into dermatology products, CMOs with semisolid capabilities benefit from strong generics demand. These generic drug companies are also turning more toward CMOs with injectable skills to overcome the shortage and address issues relating to offshore supplies.

• The pharmaceutical industry is one of the most innovative sectors in Canada. Pharmaceutical, a vital segment of the Canadian economy, is supported by the Canadian government. It provides a business-friendly environment for pharmaceutical companies and can leverage assets for short- and long-term business strategies. In the wake of the patent cliff, pharmaceutical companies in this region are reorganizing and looking for new business models built on third-party partnerships and external networks. This business model mostly relies on outsourcing most of the operations, including manufacturing and providing excellent growth opportunities for CMOs in this region.
• As of 2019, there are more than 800 active Investigational New Drug (IND) waiting for approval with the FDA. These burgeoning approvals and drug-developing pipelines are expected to promise more opportunities to CMOs in the future. Nevertheless, many of the drugs approved had an orphan designation, which suggests that they are targeted for people with rare diseases. Even though high prices deliver larger margins, the volumes are too low for large CMOs looking for growth. Also, the increasing per-capita health expenditure is a reliable indicator of the growing pharmaceutical sector and the pharmaceutical CMO market.
• Canada also holds the advantage of having a skilled workforce. Although Canada is going to face intense competition from the emerging Asian countries, the complex manufacturing processes required for certain drugs, which need qualified personnel, stable political environment, and the proximity to the end market of the United States and Canada, are expected to drive the growth of the pharmaceutical CMO market in this region. With intensifying international competition, CSPs based in Canada will seek to differentiate themselves in quality and advantages of scale in their services to appeal to the demands of global leaders in pharmacy.
• The coronavirus outbreak in China significantly affected the supply of finished drugs and APIs to the US. An estimated 83% of Chinese import lines to the US were human finished dosage forms, while 7.5% were APIs in 2018. Factory lockdowns in China and logistics delays due to coronavirus measures at ports would mean lower production and delays in shipping of APIs to US manufacturers. With the coronavirus spreading in the EU, US pharmaceutical companies will have to brace for cost escalations. Many CMOs, along with pharmaceutical companies in the region, are contemplating the get approval for the clinical trial of vaccines to prevent the COVID-19 infection.

North America Pharmaceutical Contract Manufacturing Industry Segmentation

A contract manufacturing organization (CMO) is an organization that serves the pharmaceutical industry and provides clients with comprehensive services, from drug development to production. Outsourcing to a CMO allows the pharmaceutical client to expand its technical resources without increased overhead. The client can then manage its internal resources and costs by focusing on core competencies and high-value projects while reducing or not adding infrastructure or technical staff. In the pharmaceutical sector, with ongoing growth, the pharmaceutical innovator companies need to stock their pipelines with new drugs. Still, they do not have the resources they once had to discover, develop, and manufacture products. Hence, the requirement for CMOs is quite significant.