With today’s growing pipeline of biologics, namely complex oncology products often delivered parenterally, and COVID vaccine production, there is increasing demand for technically advanced manufacturing support, in which contract development and manufacturing organizations (CDMOs) are playing a vital role. Biologics require special procedures and equipment for fill finish operations to ensure product quality and safety, giving rise to the need for flexible aseptic fill finish technologies. With biologics representing a majority of top-selling drugs and the fastest-growing pharmaceutical segment, there is a growing strategic role for CDMOs that specialize in aseptic fill finish for injectable medications. This article offers insights into the parenteral and fill finish manufacturing markets, opportunities, and recent investments in the space.
Parenterals are sterile preparations containing one or more active ingredients for administration by injection or infusion. Parenteral administration is the prominent route, allowing direct administration of drug substances and to ensure bioavailability. Growth in the development of parenteral drugs is driving demand for advanced drug delivery devices such as prefilled syringes, another growing segment in the fill-finish manufacturing market.
According to a market research report by Fact.MR, “Parenteral Drugs Market Forecast, Trend Analysis & Competition Tracking - Global Market Insights 2019 to 2029,” the parenteral drugs market is poised to reach a staggering valuation of $802 billion by the end of the forecast period.1 The report attributes this to increased spending on biologics, the need for faster route of drug administration, increasing preference for single dose administration of vaccines and drugs, and increasing numbers of local manufacturers.1
There were close to 500 parenteral drugs in the pipeline as of 2018 and the proportion of which requiring parenteral administration rose by ~2% from 2018 to 2019, according to the Fact.MR report. Also, according to the report, monoclonal antibodies (mAb) led the global market, contributing a revenue share of 20% in 2018.1
Following upstream bioprocessing and taking place after downstream purification, fill-finish is the final and most critical step in the drug manufacturing process and involves aseptic filling of biologic drugs or medicines, such as sterile liquid, powder, and suspension, in vials, ampoules, bottles syringes, and cartridges. The fill finish manufacturing market was valued at $6.1 billion in 2019 and is projected to reach $12.5 billion by 2027, and is expected to grow at a CAGR of 9.6% from 2020 to 2027, according to a study by The Insight Partners, “Fill Finish Manufacturing Market Forecast to 2027 – COVID-19 Impact and Global Analysis – By Product, End User.”2 The adoption of prefilled syringes for parenteral administration and increased demand for biologics is driving the market.
Furthermore, according to The Insight Partners new research study, “Pharmaceutical Fill and Finish Outsourcing Market Forecast to 2028 - COVID-19 Impact and Global Analysis By State of Finished Products (Solids, Semi-Solids, and Liquids) and Content,” the pharmaceutical fill and finish outsourcing market size is projected to reach $4.0 billion by 2028 from $2.7 billion in 2021, and is expected to register a CAGR of 6.1% from 2021 to 2028.3
With pharma and biopharma companies increasingly focusing program development and manufacturing in the primary markets of the U.S. and EU, Mike Babics, Vice President, Parenteral Services, Alcami, said, “Alcami and other top five most active global sterile drug product contract manufacturers based in the U.S. and EU have been significantly investing in expanding isolator-based fill-finish capacity for both vials (lyo & liquid) and syringes. These investments have been needed to meet the rapidly growing demand for parenteral products and the intensifying regulatory expectations that all sterile manufacturing lines will utilize isolator technology to minimize potential risk to patient safety from the manufacturing process.”
According to Babics, the five most active sterile drug product contract manufacturing organizations (CMOs), along with Alcami, each manufacture more than 20-plus global commercial products for a variety of clients, along with dozens of clinical programs annually. “Alcami alone anticipates helping clients launch two to three commercial products annually, across a variety of formats. All of the leading parenteral CMO's also have capabilities for liquid vials, lyo vials, and liquid pre-filled syringes (PFS),” said Babics.
Additionally, as pharma and biopharma portfolios increasingly focus on rare and ultra-rare indications, there is increased pressure from the accelerated timelines under expedited program reviews, Babics noted. “To expedite timelines, they purposefully seek out CDMO partners that offer extensive formulation and analytical method development, which can be rapidly transferred into non-GMP batches for toxicology material followed by GMP manufacturing,” said Babics.
The impact of the COVID-19 pandemic on the industry is not only driving demand for capacity and capabilities but underscores the importance of relationships. CDMOs are adapting to the current manufacturing environment for parenterals and demand driven by COVID vaccines, doing what they do best — providing flexibility.
Prior to COVID many industries adopted just in time (JIT) manufacturing, a production model in which products are created to meet demand, not in surplus or in advance of need. As such, JIT is a form of inventory management that requires working closely with suppliers so that raw materials arrive as production is scheduled to begin, but no sooner. The goal is to have the minimum amount of inventory on hand to meet demand. Throughout the COVID pandemic this model exacerbated supply chain challenges.
Mike Babics of Alcami, said, “There has been a multi-year global shortage of common components, filters, and raw materials, often leading to a delay of 30-50 weeks. This has been particularly impactful in the CMO industry as many CMOs were utilizing JIT inventory management so their client's components would arrive when production was planned to begin. Their goal of having the minimum amount of inventory, due to the high cost of maintaining that supply, has unfortunately meant that many CMOs have been unable to meet their clients' fill-finish needs. Alcami and other leading CMOs responsible for supplying large numbers of key commercial injectables, fortunately, maintain more extensive inventory stocks than many smaller CMOs.” Additionally, Alcami invested more than $15 million in the most commonly used components to ensure available inventory options for clients looking to initiate new fill finish projects.
Some key advances and modernization of facilities and innovative approaches and processes for parenteral development and manufacturing are helping to address current and anticipated future needs.
Alcami's newest parenteral manufacturing facility in RTP North Carolina is a testament to the entire industry's transformation, according to Mike Babics of Alcami. “Quality by Design (QbD) should not apply only to the manufacturing process but should begin with the initial facility design and run through the final product release. Our most recent fill-finish facility was built using the underlying principles of QbD to optimize the design and construction and ensure that it would meet its intended purpose as a parenteral filling facility.” Babics noted this encompassed dozens of key factors, including but not limited to the physical layout, utilities, air handling, and material flow, and many more items before the installation of new isolator technology utilizing single-use-systems, with flexible volume filling offering minimal line loss. “This approach is at the core of Alcami's investment in our new site offering four filling lines for liquid and lyophilized products,” said Babics.
- Parenteral Drugs Market Forecast, Trend Analysis & Competition Tracking - Global Market Insights 2019 to 2029. https://www.factmr.com/report/3189/parenteral-drug-market
- Fill Finish Manufacturing Market Forecast to 2027. https://www.theinsightpartners.com/reports/fill-finish-manufacturing-market
- Pharmaceutical Fill and Finish Outsourcing Market Forecast to 2028. https://www.theinsightpartners.com/reports/pharmaceutical-fill-and-finish-outsourcing-market
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March 08, 2022
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