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Industry Invests Billions in Parenteral Capabilities

Market opportunities have service providers making significant investments via acquisitions, expansion of services and capacities.

By: Kristin Brooks

Managing Editor, Contract Pharma

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 The impact of the COVID-19 pandemic on the industry is also driving demand for capacity and capabilities. 
 
This growth is driving significant investments in advanced manufacturing capabilities. The following highlights several of these recent investments in the parenteral and fill finish space.

Eli Lilly and Co. recently announced plans to invest more than $1 billion to create a new manufacturing site in Concord, NC. The new facility will use the latest advanced technology to manufacture parenteral products and devices and increase the company’s manufacturing capacity. 
 
Alcami is investing $10 million to expand its lab operation in Durham, NC. The investment adds over 6700 ft² to the existing lab footprint, new equipment, and capabilities to enhance drug substance and drug product characterization capabilities for biologics in all phases of development, and the capacity to support parenteral manufacturing projects and stand-alone analytical clients.
 
Earlier this year WuXi STA commissioned its first parenteral formulation manufacturing line at its Wuxi site. This automatic sterile manufacturing line operates in a full isolation system with an annual capacity of two million units. The automatic parenteral filling line features multiple filling modules and a built-in lyophilizer to fill vials, syringes, and cartridges of a full range of sizes, as well as to produce lyophilized powders.

Delpharm has acquired the Boucherville manufacturing plant owned by Sandoz Canada, in Québec. This plant is the largest sterile injectable production facility in Canada and provides medicines to the Canadian and U.S. healthcare systems, mostly hospitals. All Sandoz Canada injectable products will be manufactured by Delpharm. Delpharm plans to invest in the site and pursue business development opportunities to grow the business. 
 
MilliporeSigma, the U.S. and Canada Life Science business sector of Merck KGaA, Darmstadt, Germany, recently closed the transaction to acquire Exelead for approximately $780 million in cash. The business combination is expected to enable the Life Science business to provide comprehensive contract development and manufacturing organization (CDMO) services across the mRNA value chain. The Life Science business plans to further invest over €500 million to scale up Exelead’s technology over the next ten years.
 
Exelead, a biopharmaceutical CDMO, specializes in PEGylated products and complex injectable formulations, including Lipid Nanoparticle (LNP) based drug delivery technology, which is key in mRNA vaccines and therapeutics for use in Covid-19 and many other indications. The company has experience in all development phases from preclinical development to commercial contract manufacturing for LNP formulations, including fill and finish. 
 
Recro Pharma Inc. recently reported key progress in adding fill/finish and lyophilization capabilities to its broad suite of CDMO offerings. All construction and equipment installation related to this service expansion has been completed at the company’s San Diego facility and final validation and commissioning activities are underway.
 
The company expects that its new automated fill/finish line and lyophilization unit will be operational early in the second quarter. Recro has already secured agreements for customer projects involving these new capabilities and continues to work to book additional business for fill/finish and lyophilization projects.
 
The company’s aseptic fill/finish suite will feature a sterile, automated vial filling system with the capability to fill up to 2,000 presterilized vials per hour at a range of volumes. The lyophilization offering incorporates a novel, patented approach to uniformity and instantaneously induces nucleation via pressurization and depressurization. This equipment provides the capacity for lyophilization of approximately 9,000 10 mL vials during each 3-5 day freeze-drying cycle.

Additionally, in January 2021, Thermo Fisher Scientific announced its viral vector manufacturing services through the acquisition of Henogen S.A., Novasep’s viral vector manufacturing business in Belgium, for $875 million. Also, Fujifilm Corp. invested around $928 million into Fujifilm Diosynth Biotechnologies, a CDMO of biologics and advanced therapies.

1. Parenteral Drugs Market Forecast, Trend Analysis & Competition Tracking – Global Market Insights 2019 to 2029. https://www.factmr.com/report/3189/parenteral-drug-market

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