CPHI米兰CDMO会议：William Blair称原料药与制剂商业制造需求"健康"

Contract development and manufacturing organizations (CDMOs) attending the CPHI Milan conference in Italy last week reported that commercial manufacturing demand remains strong across drug substance and finished dose, according to William Blair analysts who cover the pharmaceutical outsourcing and services sector.

After meeting with more than 30 companies at the conference, the analysts in a note to investors reported they are feeling more optimistic about the outlook for the outsourced pharma services industry based on demand that is supported by a broad range of products.

“Our conversations with CDMOs generally pointed to robust commercial demand across drug substance as well as finished dose manufacturing, especially for traditional biologics, with several companies also noting peptides and antibody-drug conjugates (ADCs) remain particularly attractive areas, while oligonucleotide production is emerging as another area of high demand,” the analysts wrote.

A recent report from MarketsandMarkets estimates the global oligonucleotide CDMO market will grow from $2.51 billion in 2024 to $6.73 billion by 2029, with a compound annual growth rate of 21.8% during the forecast period. Contract manufacturers are strengthening their European footprints as suppliers of peptide and oligonucleotide active ingredients to meet growing demand and mitigate supply chain risks.

Swiss-headquartered Lonza is particularly well positioned to capitalize on improving near-term industry demand, according to William Blair analysts, who said they left CPHI Milan with “more conviction” in the global CDMO.

The analysts continue to see Lonza’s $1.2 billion acquisition in 2024 of Roche’s large-scale mammalian drug substance facility in Vacaville, California as a “home run” with general industry feedback from CPHI supporting the CDMO’s claim that large-scale mammalian capacity remains in high demand.

“This U.S. capacity and Lonza’s global footprint should become increasingly valuable given the evolving trend toward manufacturing localization,” the analysts wrote. “Further, we believe Lonza’s recent moves to expand its sterile fill-finish operations are well-timed given consistent industry commentary around constrained capacity following the Catalent acquisition [by Novo Nordisk] as well as high-volume GLP-1 demand absorption.”

Although GLP-1s were a popular topic at CPHI Milan, given the significant growth of these therapies which have rewarded peptide manufacturers and certain fill-finish providers, the analysts noted that CDMOs “also highlighted durable demand drivers in oncology, cytotoxic compounds, ADCs, and other complex therapies.”

Lonza continues to increase its investment in infrastructure to support the complex, multi-step production process required to make ADCs. Lonza’s campus in Visp, Switzerland is designed as an integrated end-to-end ADC manufacturing center to better serve customers’ increasingly complex molecules with connected capabilities across multiple platforms, including antibody production, payload manufacturing, and bioconjugation.

Clinical demand shows improvement

On the clinical side, commentary from CDMOs was mixed at CPHI Milan but the overall tone was incrementally more positive compared to last year, according to William Blair analysts. While multiple companies noted an improvement in biotech funding and early-stage opportunities relative to the post-COVID downturn, others indicated they have yet to see a meaningful increase in clinical manufacturing activity.

“Several CDMOs noted an uptick in early-stage opportunities and improving activity from biotech customers, which they attributed in part to better funding conditions and an increase in strategic transactions involving smaller biotechs,” the analysts said. “Others, however, indicated that it remains too early to see a meaningful recovery in early-stage manufacturing volumes.”

Overall, the analysts contend this selectivity is ultimately positive for the CDMO industry, even if it limits the pace of the near-term recovery.

“During the pandemic, abundant capital supported a broader range of biotech programs, some of which were not underpinned by sufficiently strong science,” the analysts said. Today, funding appears more discerning, with greater emphasis on clinical data and the likelihood of technical and commercial success. While this may constrain the volume of early-stage work relative to prior peaks, it should support a healthier pipeline of programs that are more likely to advance into later-stage development and commercial manufacturing.”

Tariffs, pricing, and China

A major topic of conversation at CPHI Milan was the potential impact on the CDMO industry from the Trump administration’s pharma-specific tariff and drug pricing policies, according to William Blair analysts, with localization creating selective opportunities for U.S.-based CDMOs — particularly in new programs — but the scale and timing of the direct benefit remain difficult to quantify, they said.

“While tariffs are prompting some customers to consider U.S. manufacturing options, we think the near-term impact on CDMO demand is likely to be more limited than some headlines suggest,” the analysts wrote. “We believe CDMOs with established U.S. capacity and flexible global footprints are best positioned to capture opportunities as customers reassess supply chains.”

At the same time, the analysts observed that localization appears to be an “incremental consideration” in supplier selection rather than a wholesale shift away from established manufacturing hubs. Despite ongoing geopolitical tensions with the Trump administration, they said the overall feedback at CPHI Milan suggests China continues to represent a highly competitive source of pharmaceutical manufacturing capacity.

“Our conversations suggested that the impact of the BIOSECURE Act and tariff and pricing measures has been mixed, with some customers seeking to limit exposure to Chinese providers, while others remain comfortable working with established suppliers,” the analysts said. “Importantly, we heard little evidence of widespread customer withdrawals from China. Rather, some manufacturers described customers as seeking to establish alternative suppliers to mitigate concentration risk without necessarily moving existing programs away from their incumbent manufacturers.”

While Chinese CDMOs are bolstered by substantial manufacturing scale, competitive technical expertise, and aggressive pricing, India remains a credible alternative for many small-molecule manufacturing needs and benefits from attractive costs, export-oriented infrastructure, and improving technical capabilities, according to the analysts.

Discussions at CPHI Milan “emphasized that China retains advantages in certain highly specialized processes, and that price differences between Asian and Western providers can be substantial,” the analysts said, noting that one company cited Asian manufacturing prices — depending on the product and stage of development — that can be several times lower than U.S. and European pricing.