Ahead of CPhI North America (August 10-12, 2021) a new report (CPhI US Pharma Market 2022 and Beyond) predicts rapid advances in therapy innovation, process technologies and macro changes will deliver a post-pandemic surge across the USA pharma industry. Exploring supply chain and manufacturing implications, the findings present an extremely bullish case for growth in the United States. In particular, high-value manufacturing is identified as a primary expansion area for companies – with cell and gene therapy, biologics and viral vector capacity in demand across both the short and medium term. Significantly for attendees at CPhI North America (this year hosted as a hybrid edition), the report’s experts identified a huge quantity of pent-up demand for deal-making and forecast a ‘supercharged period of partnering’ over the next 18-months in the United States. Companies that establish supply and partnering networks earliest – as opposed to waiting until 2022 – will undoubtedly see the best medium-term prospects, as well as capturing the majority of growth from the expected post-COVID boom. “Our report indicates we are entering an incredibly important time for pharma companies’ business prospects in North America, with experts anticipating a huge number of new supplier contracts in the next year. That’s why we are running as a hybrid event, with an in-person exhibition alongside a three-week digital content and networking platform. The hybrid event will facilitate pharma manufacturing companies and offer them a well needed environment to source new technologies, advance new therapies and drug development and learn about the latest trends in pharma,” said Anthony Pombal, Brand Director Americas at Informa Markets. The USA market report was compiled by a team of independent pharma experts, with reshoring predicted to most acutely benefit CDMOs and companies working in high value manufacturing. Significantly, this is creating a large acquisitional demand for the best US facilities and companies, with EBITA’s of over 20x forecast in the year ahead. In terms of API manufacturing however, the report suggests the US will remain strategically aligned with overseas production centres in China and India – except in cases of the most critical supplies or in high-margin areas (e.g. HPAPI). Reflecting on the M&A environment, Bikash Chatterjee, Chief Executive Officer at Pharmatech Associates added: “In 2020, more than 40% of the mergers and acquisitions in the US were CDMOs. In terms of where you need to put your energies in the US, cell and gene therapy is going to continue to grow, and there are a couple of areas that make complete sense: so if I had $100,000,000, I’d go out and buy a CDMO tomorrow.” In response to the high demand, and due to the convergence of recent manufacturing technologies [making US facilities more cost effective] and private equity capital, many companies will adopt a ‘buy’, ‘build’ and ‘add’ strategy across the North American region. “There are opportunities for the United States to lead in particular for advanced biologicals. But there are also medium- and long-term opportunities for manufacturers capable of manufacturing mRNA-based vaccines & therapies, as well as vector manufacturing for recombinant vector vaccines, gene therapy and gene modified cell therapy,” commented Peter Shapiro, Senior Director of Drugs and Business Fundamentals at GlobalData Adding to the prospects for US manufacturers, capital ($10 Bn) from Operation Warp Speed[i] was designated to increase development and manufacturing capacity domestically. This investment will likely provide further stimulus to advanced therapy medicinal products (ATMPs) and the approval of the two mRNA vaccines has validated an entirely new approach to vaccine delivery. “It’s going to be the most exciting 10 years for US pharma. There is no question about it. I think it’s going to be unbelievable in terms of the innovation we are going to see. This applies from new drugs and therapies to advanced manufacturing techniques for cell and gene therapies and continuous processing,” added Chatterjee. For large pharma, this increasingly competitive manufacturing landscape may mean we see not only the well documented strategic partnerships, but also, the pre-booking of reserve capacity in advance of any need. Consequently, in a further boon to supply chain partners, the report anticipates deeper partnerships, as well as the ability to demand longer contracts and more favourable terms. In fact, not only will access to manufacturing capacity continue to be a highly competitive space, but so too will access to qualified pharma personnel. The US is therefore expected to see high growth in salaries for R&D scientists, as well as for manufacturing personnel both in-house and at outsourcing partners. In the short term – while capacity catches up with demand in the United States – European CDMOs and Asian giants like WuXi Biologics and Samsung Biologics, will continue to see strong demand for manufacturing contracts of recently approved US biologicals (either as primary or secondary suppliers). Similarly, international small molecule CDMOs with containment facilities are also expected to see strong growth rates for innovative API production – with the oncology pipeline continuing to drive growth. However, for final dosage manufacturing and packaging, US based partners are likely to be the biggest beneficiaries of recent reshoring goals. Shapiro, added, “over the next few years, it’s going to be a really positive environment in the United States with specialised skillsets, whether it’s for advanced dose technologies, advanced biologics technologies or cell and gene platforms”. Additionally, the report suggests increasing number of biotechs will use US partners for computational processes to explore target options, chemistries and biologies – providing an alternative to the existing modus operandi of outsourcing chemistry services to Asia. Registration for CPhI North America (August 10-12, 2021 at the Pennsylvania Convention Center) is now open, with the online event held July 26 – August 6. For more information please visit https://www.cphi.com/northamerica/en or to download the report please visit https://www.cphi-online.com/us-pharma-market-2022-and-beyond-download-report-news112920.html

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