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By PharmaCompass
2023-07-13
Impressions: 3875
Over the last few years, we have seen contract development and manufacturing organizations (CDMOs) increase their exposure to advanced therapies, such as biologics, cell and gene (C&G) therapies, and highly potent active pharmaceutical ingredients (HPAPIs). That trend continued through the second quarter of 2023, as CDMOs expanded operations by signing new deals, setting up new plants, and increasing capacities.
According to Research and Markets, the global CDMO market was valued at US$ 172.7 billion in 2022, and is projected to reach US$ 246.6 billion by 2026, growing at a CAGR of 9.3 percent. The market is dominated by players like Lonza, Catalent, Recipharm AB, Thermo Fisher, Cambrex Corporation, Seqens, Piramal Pharma Solutions, Curia, Siegfried AG, Samsung Biologics, and Fujifilm Diosynth Biotechnologies.
View CDMO Activity Tracker of Q2 2023 (Free Excel Available)
Baxter sells biopharma unit for US$ 4.25 bn; Pfizer offloads Perth injectable plant
During the pandemic, supply chain shortages had become rampant. These were followed by rising costs of raw materials, labor and transportation, prompting companies like Baxter International and Pfizer to restructure some of their operations. While Baxter sold off its biopharma solutions, Pfizer sold its sterile injectable plant in Perth to global private investment firm Bridgewest Group.
Pfizer’s Perth plant will now operate as a CDMO. Bridgewest Group will upgrade and modernize the plant, which will continue to produce drug products for Pfizer under a master services agreement.
Baxter, a medical device maker, reached an agreement with a private-equity group that includes Warburg Pincus and Advent International to sell its biopharma solutions unit for US$ 4.25 billion. The Baxter unit supports drugmakers in the formulation, development and commercialization of drugs typically given by infusion or injection, such as vaccines.
Samsung Biologics, the biotech division of Samsung Group, has bagged two new deals with Pfizer for US$ 897 million. The agreements involve the manufacturing of biosimilar products, including those for oncology, inflammation, and immunotherapy, at Samsung Biologics’ new plant in South Korea until 2029. Samsung Biologics has so far received orders totaling US$ 1.08 billion from Pfizer this year.
Among other deals, Paris-based special purpose acquisition company — eureKING — has made an offer to acquire Oleron Pharma, the parent company of French CDMO Skyepharma (known for its expertise in drug development and oral technologies).
And Bora Pharmaceuticals and Celltrion Asia Pacific have inked a deal to contract manufacture and commercialize a variety of oral solid dosage drugs in the Asia-Pacific region. These products will be manufactured at Bora’s Zhunan site in Taiwan.
View CDMO Activity Tracker of Q2 2023 (Free Excel Available)
Vertex, Lonza join hands to advance cell therapies for type 1 diabetes
C&G therapies have emerged as a high-growth area for CDMOs. Recently, the US Food and Drug Administration (FDA) approved BioMarin Pharmaceutical’s one-time gene therapy – Roctavian – priced at US$ 2.9 million. Roctavian has joined the league of other expensive C&G therapies such as CSL’s Hemgenix and Bluebird bio’s Skysona and Zynteglo.
There were several deals in the area of C&G therapies. For instance, Vertex and Lonza entered into a collaboration to support the production of experimental cell therapies — VX-880 and VX-264 — for type 1 diabetes. This partnership includes process development and scale-up to manufacture Vertex’s portfolio of cell therapies. Additionally, the two companies plan to invest in a new 130,000-sq-ft facility in Portsmouth, New Hampshire, that will be operated by Lonza and will create up to 300 jobs.
Moreover, Lonza is acquiring Synaffix, a biotech specializing in antibody-drug conjugates (ADCs), for up to €160 million (US$ 176.5 million) in order to strengthen its bioconjugate offering.
Curia has entered into a licensing agreement with MilliporeSigma, the North American life sciences business of Merck KGaA. This agreement enables Curia and its clients to use MilliporeSigma’s proprietary CHOZN platform for the production of therapeutic proteins and antibodies.
Catalent is manufacturing Elevidys, a newly approved gene therapy by Sarepta Therapeutics, for the treatment of children aged four to five with Duchenne muscular dystrophy. And Rentschler Biopharma and gene therapy developer Ikarovec have joined hands to develop a gene therapy targeting geographic atrophy (GA), a common form of vision loss in the elderly.
View CDMO Activity Tracker of Q2 2023 (Free Excel Available)
WuXi Biologics expands German operations; Cerbios-sets up new facility for HPAPIs
The quarter saw several CDMOs announce expansion plans. Leading CDMO Catalent initiated a US$ 20 million expansion project at its clinical supply facility in Schorndorf, Germany, to enhance storage and handling of clinical trial supplies. This was despite the fact that Catalent reported a larger-than-expected quarterly loss. The Schorndorf project includes a new bottle filling line that is expected to be complete by H1 2024. Catalent has also expanded services at its Shiga, Japan, facility.
WuXi Biologics is expanding its operations in Germany to boost its production capacity. The Leverkusen facility, acquired from Bayer in 2020, will add a second filling line for fill/freeze-drying operations. WuXi is also doubling the capacity at its Wuppertal drug substance plant. Last year, the company invested US$ 1.4 billion to construct a new R&D and production center in Singapore.
Cerbios-Pharma’s new facility in Lugano, Switzerland, bagged approval by Swissmedic. This facility specializes in manufacturing HPAPIs for oncology. With advanced technology and containment measures, the state-of-the-art plant provides flexible capacity for both clinical and commercial production stages.
EUROAPI will invest €50 million (US$ 55.12 million) in a new production plant at its Budapest site to increase capacity and construct advanced multi-purpose manufacturing equipment. The project is expected to significantly increase the overall prostaglandin capacity, doubling it by 2027.
Last month, Aspen API inaugurated its laboratory to facilitate work with genetically modified organisms and develop new enzymes. These enzymes will reduce its reliance on chemical steps.
Meanwhile, Aurigene Pharmaceutical Services, a subsidiary of Dr. Reddy’s Laboratories, is set to invest US$ 40 million to construct a production facility for therapeutic proteins, antibodies and viral vectors. The facility will be situated in Hyderabad’s Genome Valley biotech park (India) and is expected to be operational by the first half of 2024.
Meridian Medical Technologies, a Kindeva Drug Delivery Company, plans to expand its manufacturing capabilities in Bridgeton, Missouri, by investing over US$ 100 million in a 155,000-sq-ft facility to support the increased production of drug-device combination products and sterile fill-finish capabilities.
View CDMO Activity Tracker of Q2 2023 (Free Excel Available)
Our view
Increase in scientific research and the concomitant evolution of the biopharma industry has certainly made CDMOs more customer-driven. With rise in specialized expertise, CDMOs are emerging as important partners in the innovation of new drugs.
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Image Credit : CDMO Activity Tracker of Q2 2023 by PharmaCompass license under CC BY 2.0
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