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 â€“ at the same plant â€“ 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, Â and what trends he expects to see in the future.
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 â€“ 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 CDMOâ€™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 CDMOâ€™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.