CMOs will represent four of the top five bioproduction capacities in 2025: CPhI Worldwide Report
The third part of the CPhI annual report is published with key findings for biologics manufacturing, biotechnology and CDMOs.
CPhI experts – Dawn Ecker, Managing Director, bioTRAK Database Services, BDO and Fiona Barry, Editor, GlobalData PharmSource – are looking to 2025 to predict future biologics demand by volume, as well as total available capacity and impact on short- medium term of the multiplication of COVID-19 supply contracts.
These new findings are released ahead of the in-person event, which takes place at Fiera Milano, Italy – with an online platform from October 25 to November 19 – and is expected to accommodate the end-to-end pharmaceutical supply chain. . . Over 1,200 exhibitors will be in attendance, including manufacturers of finished dosages and ingredients, pharmaceutical packaging specialists, CDMOs, bio-companies and pharmaceutical machine suppliers. All registered participants will receive an advanced copy of the entire CPhI report.
Tara Dougal, Content and Knowledge Manager, CPhI Worldwide, added, âThis year’s program will explore many of these questions, and we have a session, produced in collaboration with BioProduction, that specifically examines the viability and business challenges. of the manufacture of large organic products. Another webinar will focus on building the capacity and capabilities of viral vectors to realize the promise of gene therapies, as the manufacturing challenges of gene therapies have been severely exacerbated by the demand for mRNA vaccines, which also requires the manufacture of vectors. viral.
Ecker predicted that biologics manufacturing volume would increase by around eight percent per year, reaching around 3,900 kL [up from 2,700kL in 2020]. However, during the same period, the global organic manufacturing capacity will increase to 7,500 kL. [up from 5,200kL], but significantly, the location and type of businesses that have the capacity will show a marked change from five years ago.
By 2025, almost half of all capacity (44%) will shift from in-house manufacturing to CMO / hybrid companies. In fact, according to Ecker’s findings, five of the top six companies in terms of capacity volume in 2025 will be CMOs or hybrids. The exception being Hoffman-La Roche, which will maintain its position as a company with the largest total capacity of organic products. A number of CMOs are currently investing heavily in increasing their volumetric capacity and, in 2025, Samsung Biologics, Lonza, WuXi Biologics and Fujifilm Diosynth Biotechnologies will occupy places two to five respectively, with the latter two rapidly rising from outside the top ten. in the 2020 ranking.
âWhat’s interesting is that at the same time as CMOs are increasing capacity, we are also seeing a geographic shift in the location of capacity, with Europe and Asia growing much faster than the North America. In 2025, Europe will be home to the largest organic capacity in the world, overtaking North America, âEcker commented.
Another important change, according to Ecker’s research, is the scale of manufacture needed for future products under development, with more than half of recombinant products currently in late stages of development (phases II and III) expected to be completed. ‘only need a single 2000L or 5000L bioreactor to meet commercial demand.
âAs capacity increases over the next five years, the demand for capacity – outside of the pandemic – will increase at an almost equivalent rate, allowing some near-term relaxation of capacity constraints, but after 2025 a tightening of capabilities could occur. In recent years, the industry has experienced capacity constraints on a clinical scale due to very high clinical demand and has responded in kind with a wave of facility expansions. However, many of the current COVID-19 treatments and prevention require large-scale capacity. With new bioreactor installations reflecting a pre-pandemic demand profile, we are observing how the industry adapts to the challenge of meeting both typical and additional capacity demands. In another layer of uncertainty, if additional Alzheimer’s drugs and PDL / PDL-1 checkpoint inhibitors are approved, demand could be much higher than expected, with increasing pressure on them. large-scale manufacturing networks, âEcker added.
Another boon for the contract manufacturing industry – widely seen as a big beneficiary of demand for the past two years – reports from GlobalData show that there have been more than 230 contract manufacturing agreements disclosed for vaccines and COVID-19 therapies, with many more (undisclosed) likely to exist. The largest biologics CMOs have been among the big winners in demand for outsourced vaccine supply, and with booster injections already underway and other approvals to come (over 30 to date for vaccines and COVID-19 therapies), demand is likely to remain strong for many years to come.
Barry, reflecting on how CMOs won due to the sudden need for additional capacity, commented: Due to its well-documented inspection difficulties by the FDA. Emergent’s contracts are geared towards vaccine manufacturing, while Catalent and Lonza’s contracts are more evenly split between vaccines and therapies. But other large contract development and manufacturing (CDMO) organizations have also benefited greatly. “
In fact, many of these COVID supply contracts are not only for large volumes, but also span long periods – for example, Lonza has signed a ten-year active pharmaceutical ingredients agreement with Moderna.
Orhan Caglayan, Brand Director, CPhI Worldwide, said: âWhen we look at the collective findings of Dawn and Fiona, we see that biotech may continue to face challenges in accessing available capacity at the right time. Many of the more established CMOs have large COVID contracts and the capacity is drifting away from the United States. This means that biotech and pharmaceutical partners without sufficient internal capacity will have to expand their networks of potential partners. What we are seeing at CPhI Worldwide is that proactive companies are now looking for new partners and how they can ensure continuity and flexibility of supply.