Key Findings
The pharmaceutical industry is bracing for a ‘patent cliff’ between 2025 and 2030, with approximately $300 billion worth of branded drug revenues at risk due to patent expirations. This impending challenge has spurred pharmaceutical companies to intensify efforts in portfolio expansion and cost-efficiency initiatives. In response to this trend, Contract Development and Manufacturing Organizations (CDMOs) are under pressure to significantly expand their service capabilities to meet escalating demand, as highlighted by the CEO of Fujifilm Biotechnologies. A notable development in this landscape is Samsung Biologics’ acquisition of Switzerland-based PolyPeptide Group AG for $1.8 billion on July 19, 2026, marking Samsung’s strategic entry into the peptide-based active pharmaceutical ingredient (API) sector.
Technical/Clinical Details
- CDMO Capacity Expansion: As pharmaceutical companies increasingly focus on R&D and outsource manufacturing, CDMOs are making substantial capital investments and technological enhancements to address the growing demand for biologics, cell and gene therapies, and novel modalities. Companies facing the patent cliff are particularly accelerating the development and manufacturing of biosimilars, generics, and innovative new drug modalities to secure new revenue streams.
- Samsung Biologics’ Entry into Peptide Market: The acquisition of PolyPeptide Group AG by Samsung Biologics represents a strategic diversification, extending its business beyond traditional biopharmaceutical manufacturing services into peptide synthesis and production. Peptides are crucial API components in numerous therapeutic areas, including oncology and diabetes. This expansion strengthens Samsung Biologics’ service portfolio and enhances its competitive position in the market.
- Expansion of ADC Production Capacity: Lonza has announced plans to increase its antibody-drug conjugate (ADC) production capacity at its Stein, Switzerland facility to support an expanded long-term collaboration with an undisclosed major pharmaceutical company. Similarly, Fujifilm is also augmenting its ADC production capabilities at its Toyama plant in Japan, scheduled to be operational next year. ADCs are a new class of highly potent anticancer drugs, combining specific antibodies with cytotoxic agents, requiring sophisticated technology and facilities for their manufacturing. These investments are aimed at meeting the demands of the growing ADC market.
Background & Context
The pharmaceutical industry is at a significant inflection point, with numerous blockbuster drugs nearing patent expiration. This necessitates that pharmaceutical companies introduce new drug modalities, diversify their pipelines, and accelerate manufacturing process efficiency and outsourcing to recover R&D costs and sustain revenues. CDMOs are expanding their role as partners to pharmaceutical companies within this evolving industry structure, requiring advanced manufacturing technologies and flexible service offerings. CDMOs worldwide, including those in the Asia-Pacific region, are making aggressive capital expenditures to meet this demand.
Strategic Significance & Outlook
The patent cliff, while a challenge for pharmaceutical companies, presents a substantial growth opportunity for CDMOs. Strategic acquisitions and large-scale investments by companies such as Samsung Biologics, Lonza, and Fujifilm exemplify this adaptation to market shifts. Particularly, the strengthening of manufacturing capabilities for emerging modalities like peptides and ADCs reflects future trends in drug development. The ability of CDMOs to meet more complex and specialized manufacturing needs will be a critical factor determining industry competitiveness. These developments are also expected to contribute to the diversification and resilience of the global pharmaceutical supply chain.
Source: https://endpoints.news/the-patent-cliff-is-looming-and-cdmos-need-to-be-prepared-fujifilm-ceo-says/
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