The CDMO space does not have the capacity to meet fill-finish demand, says Lonza

Pipeline expansions are placing pressure on fill-finish capabilities and have caused a surge of investment in infrastructure, says Peter Droc, head of drug product services at Lonza.

Swiss contract development manufacturing organization (CDMO) Lonza has made a string of investments to bolster its fill-finish capabilities. In July 2022, the firm forked out $521 million to construct a commercial large-scale fill-finish facility at its site in Stein, Switzerland. And less than a year before this – at the same plant – it added additional drug product manufacturing capabilities to accelerate its service offerings in Basel and Visp. Additionally, in August 2021 Lonza installed an aseptic fill-finish manufacturing line at its mammalian plant located in Guangzhou, China.

In this interview with BioProcess Insider, Droc discusses the current challenges associated with fill-finish production, how the CDMO space is responding to the continued demand for this capability,  and what trends he expects to see in the future.

Peter Droc, head of drug product services at Lonza. Image c/o Lonza

BioProcess Insider (BI): What would you identify as the current challenges associated with fill- finish production?

Peter Droc (PD): The early 2020s have seen a huge surge in fill-finish infrastructure investment. While this was largely driven by the pandemic, the level of investment and capacity expansion remains strong. Fundamentally, there are two factors. First, there is a large and growing biologics pipeline that is driven by scientific innovation. Second, global demographic shifts and population trends are driving this sustained demand – including aging populations, increasing global obesity, and the diagnosis of related chronic illnesses. Emerging markets also contribute to steady upward growth in fill-finish investments.

BI: What pressure do you think this places on fill-finish capabilities?

PD: This evolution and expansion of the biopharma pipeline are placing new pressures on fill-finish capacity and capabilities. These pressures were exacerbated by COVID-19, which not only consumed capacity across the industry but also caused a backlog of services as a result. This has boosted demand for fill-finish services via CDMO’s to keep up with the pace of production.

BI: And can CDMOs keep up with the pace of production and demand?

PD: Currently, global capacity remains insufficient. One of the most significant trends we are seeing as a result of this need is the continued rapid growth of the CDMO market for fill and finish production. This sector is forecast to expand at a CAGR of 6 in the next 8 years, with an expected market size of $14 billion by 2030. Ongoing infrastructure investments, particularly by CDMOs, will ease this capacity gap in the near term.

BI: Why do you think there is rapid growth in the CDMO market for fill-finish services?

PD: If we look at the big picture, more and more new drug approvals are being filed by emerging and small biotechs. These companies cannot rely on an in-house development and manufacturing capacity and can significantly benefit from collaborating with a single CDMO throughout their development and manufacturing journey.

BI: Looking forward to 2023, do you think the demand will remain?

PD: Today, drug product sales are still dominated by oral dosage forms, mainly driven by small molecules. There is a shift underway, however, as injectables (driven by biologics) are set to become the largest market segment by 2026. This has opened up a significant market opportunity in the fill-finish space.

BI: Where is the demand coming from?

PD: Today, almost 90% of our biologics drug products are sterile injectables, which are packaged into vials and syringes. Injectables have seen considerable investment in recent years to meet surging demand. In particular, pre-filled syringes are a growing fill-finish trend, and we expect a third of the current product pipeline will end up in pre-filled syringes. Many smaller companies prefer to outsource this work to CDMO’s, tapping into the historical knowledge, equipment and infrastructure, and skilled talent bases. With this in mind, we expect to see greater investment in outsourcing the fill-finish of many of these injectables in the near future.