Navigating key news stories in pharma
Featured Stories
The CDMO industry saw significant growth in 2024, as biotech and pharmaceutical companies continued the trend toward outsourcing R&D activities. This surge was evident in the global CDMO market value, which ended the year with a valuation of USD 185 billion.
Samsung Biologics has signed a USD 1.4 bn contract with an undisclosed European pharmaceutical company, involving the manufacturing of a biomedicine at its Songdo, Korea, facilities from late 2024 through 2030. As a result of the contract, the company now collaborates with 17 of the world’s top 20 pharmaceutical firms.
The U.S. government has awarded Moderna USD 590 mn to advance its mRNA-based avian influenza vaccine, mRNA-1018, into late-stage clinical trials amid rising human H5N1 infections. The funding also supports clinical studies for up to five additional pandemic influenza subtypes.
Two Australian CDMOs, BioCina and NovaCina, have announced a strategic merger to operate as a single contract manufacturing company under the BioCina name.
Dealmaking
Samsung Biologics has signed a USD 1.4 bn contract with an undisclosed European pharmaceutical company, involving the manufacturing of a biomedicine at its Songdo, Korea, facilities from late 2024 through 2030. As a result of the contract, the company now collaborates with 17 of the world’s top 20 pharmaceutical firms.
Two Australian CDMOs, BioCina and NovaCina, have announced a strategic merger to operate as a single contract manufacturing company under the BioCina name.
Indian CDMO, Aragen, has secured a USD 100 mn investment from Singapore-based private equity firm Quadria Capital to enhance the company's capacity and multi-modality services - including the expansion of its infrastructure and capabilities in areas such as oligonucleotides, peptides, ADCs, biology services, and biologics, and to integrate AI and machine learning into its drug discovery and manufacturing processes.
Biologics and biosimilars CDMO, Tanvex, has successfully completed its acquisition of Bora Biologics, a subsidiary of Bora Pharmaceuticals. The companies will merge their biosimilar expertise and Tanvex’s FDA-licensed commercial-scale facility in San Diego with Bora Biologics' early-stage biologics CDMO capabilities in Taiwan to offer comprehensive, efficient end-to-end biologics solutions.
Future Biopharma
The CDMO industry saw significant growth in 2024, as biotech and pharmaceutical companies continued the trend toward outsourcing R&D activities. This surge was evident in the global CDMO market value, which ended the year with a valuation of USD 185 billion.
Pharmaceutical industry deals have hit a decade-low in 2024, with only 558 deals totalling USD 67.2 bn by late November - the lowest since 2016. The largest biotech purchase of 2024, Vertex's USD 4.9 bn acquisition of Alpine Immune Sciences, is dwarfed by Pfizer's USD 43 bn Seagen takeover in 2023.
The decline in major acquisitions can be attributed to several factors: pharma companies digesting previous large deals, high valuations of listed biotech's deterring potential buyers, a focus on smaller, "bolt-on" deals under USD 5 bn, and antitrust concerns and political uncertainty in an election year.
Aizon has raised $20 million in Series C financing, with NewVale Capital leading the round with support from current backers. This funding boost is set to advance their AI-based platform for pharmaceutical manufacturing and aid in deploying their latest electronic batch record (eBR) system.
Sponsored by Expert Insights and Orientation Marketing, a panel of senior executives from the development and manufacturing partners charged with scaling and supplying medicines to patients were optimistic about 2024, but reflected on some of the challenges the industry will face too.
R&D
Pharmaceutical packaging company, SCHOTT Pharma, has introduced its SCHOTT TOPPAC® infuse polymer syringe system; a new cap design for prefillable polymer syringes featuring tamper evidence at the individual syringe level.
Medical device company, Terumo, has announced the launch of its injection filter needle, marking the first step in its INFINO™ Development Program. The innovative needle design enhances safety and efficacy in hypodermic and intravitreal injections by incorporating a built-in filter to prevent the injection of particulates.
An AI proof-of-concept study from Dandelion Health has identified an additional 44 million lower-risk cardiovascular patients who could benefit from a GLP-1 treatment. Using inclusion criteria similar to the Novo Nordisk-sponsored trial that helped convince the FDA that Wegovy had heart benefits, Dandelion examined whether GLP-1 use might reduce the risk of major adverse cardiac events such as heart attack or stroke in overweight and obese patients in lower-risk patients that didn’t have severe pre-existing cardiovascular disease.
Pfizer’s experimental drug, ponsegromab, has shown promising results in a Phase 2 clinical trial aimed at treating cancer cachexia - a serious condition characterized by muscle and weight loss. Presented at the 2024 ESMO conference, the candidate achieved weight gains of up to 5.6% in patients suffering from cachexia due to lung, pancreatic, or colorectal cancer, surpassing the 5% threshold deemed clinically significant. Pfizer is planning to commence Phase 3 trials by 2025, and aims to provide the first FDA-approved treatment for this life-threatening condition, which currently relies on nutritional support and anti-inflammatory treatments.
Expansion
CDMO, Samsung Biologics, has announced plans to construct a sixth manufacturing plant at its Bio Campus in Songdo, South Korea. Pending board approval, the expansion would increase the company's total production capacity to 964,000 liters by 2027. In addition, the company aims to establish a regional office in Tokyo, Japan by year-end to better serve its growing client base in one of the leading global markets.
Governor Shapiro and Department of Community and Economic Development Secretary, Rick Siger, recently visited one of Adare Pharma Solutions’ facilities in Philadelphia to celebrate the company’s success and highlight the State’s commitment to economic growth.
Israeli biopharmaceutical company Scinai Immunotherapeutics has launched a U.S.-based CDMO subsidiary, Scinai Bioservices Inc., in Delaware, following the launch of its CDMO unit at the company's HQ in Jerusalem, Israel last year. CEO Amir Reichman announced the company’s first U.S. contract with Serpin Pharma for clinical manufacturing and expressed optimism about the growth potential of their U.S. presence.
South Korean Biopharma, Celltrion Group, is bolstering its CDMO services with a new research center in India which will operated by the newly established subsidiary Celltrion BioSolutions. With an initial capital of USD 6.9 mn, the manufacturing capacity will start at 100,000 liters to serve Celltrion's internal needs, with potential expansion to 200,000 liters. The company aims to recruit or internally train 500 Ph.D.-level scientists to support its sites in Korea, the U.S., Europe, and India.
Strategy
At JPM 2025, James Park, CEO of Lotte Biologics, outlined the company’s dual CDMO strategy. The company will focus on small- to medium-scale drug production - including ADCs - at their Syracuse, New York facility, while large-scale drug production will be handled at the planned Songdo bio-campus in Korea.
Singaporean biotech, DotBio, is aiming to revolutionize cancer treatment by targeting exhausted T-cells with its tri-specific antibody, DB007. The antibody, built using DotBio’s modular DotBody technology, is designed to treat a broad range of solid tumors either as a standalone therapy or in combination with others.
Novo Holdings, the controlling shareholder of Novo Nordisk, intends to significantly expand Catalent, the contract drug manufacturer it completed its acquisition of in December 2024. Novo aims to potentially double Catalent's size over the next five years, aligning with anticipated U.S. policies under President Trump that emphasize domestic manufacturing.
U.S. CRDMO, BioDuro, has opened a new solid-phase peptide synthesis scale-up facility at its Shanghai campus to support peptide synthesis up to 800 mmol for a wide range of peptides, including linear and cyclic peptides, as well as peptide-drug conjugates.
Regulatory
The U.S. government has awarded Moderna USD 590 mn to advance its mRNA-based avian influenza vaccine, mRNA-1018, into late-stage clinical trials amid rising human H5N1 infections. The funding also supports clinical studies for up to five additional pandemic influenza subtypes.
Eli Lilly has requested to join a lawsuit opposing compounding pharmacies and the FDA over the agency's determination that Lilly's weight-loss and diabetes drugs are no longer in shortage.
The European Commission has granted unconditional approval for Novo Holdings A/S to acquire Catalent, Inc., with the acquisition expected to close by the end of 2024. Catalent's CEO Alessandro Maselli has welcomed the approval, while Novo Holdings' Senior Partner Jonathan Levy affirmed their commitment to supporting Catalent's future growth. The transaction remains subject to final regulatory clearances and closing conditions.
The BIOSECURE Act - intended to address national security concerns by restricting U.S. government contracts with certain Chinese biotechnology companies - has been omitted from the 2025 National Defense Authorization Act (NDAA), providing a temporary reprieve to targeted Chinese firms like WuXi AppTec, WuXi Biologics, and BGI Group.
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