As oncology pipelines continue to expand and targeted therapies become more sophisticated, contract development and manufacturing organisations (CDMOs) must invest strategically to gain a competitive edge.
CDMOs are operating in an increasingly technically demanding environment, particularly in the production of highly potent active pharmaceutical ingredients (HPAPIs) and antibody-drug conjugates (ADCs).
The pressure to deliver safe, scalable, and cost-efficient manufacturing solutions is growing. Consequently, strategic investments are under way among forward-thinking CDMOs in areas such as integration, containment, and advanced processing technologies.
Greater complexity and challenges for CDMOs
Growing complexity in drug manufacturing means that infrastructure and expertise are more important than ever, pushing CDMOs to rethink traditional production models. For example, oncology is driving demand for complex molecules that require specialist handling, stringent containment, and highly controlled manufacturing environments. These compounds often have extremely low occupational exposure limits (OELs), requiring facilities capable of handling substances at levels as low as 1ng/m³.
At the same time, ADCs – which combine monoclonal antibodies with cytotoxic payloads – introduce additional layers of complexity. Their manufacture requires the production of highly potent payload-linkers, as well as precise conjugation processes and reliable supply chains for critical components. As a result, CDMOs are increasingly investing in end-to-end capabilities that reduce fragmentation across the value chain.
A key strategic response to these challenges is backward integration. By bringing previously outsourced processes in-house, CDMOs can gain greater control over quality and supply reliability. This is particularly important for ADC production, where the availability and consistency of payload-linkers for instance are critical to success.
Optimising CDMO investments
CDMO Indena exemplifies how investments are reshaping capabilities through backward integration in high-containment. The company has established a more reliable and independent supply chain for key Payload-linkers ADC components that mitigates risk and enables faster development timelines, which is an increasingly important factor in competitive oncology markets.
Beyond integration, investment in high-containment infrastructure is essential. The safe handling of HPAPIs requires specialised facilities, including advanced GMP lines, containment laboratories, and precision-engineered environments. Indena’s ongoing investment in these areas supports industrial-scale production of OEB 5/6 HPAPI compounds, while maintaining stringent safety and environmental standards. Such capabilities are becoming a baseline requirement for CDMOs seeking to operate in high-value therapeutic areas.
Another critical area of development is high-containment capabilities such as chromatography and freeze-drying. These technologies are essential for the manufacturing of some HPAPIs and ADC payload- linkers. Indena’s expertise in integrating chromatography and lyophilisation within high-containment environments, including glove box systems, demonstrates how advanced engineering can ensure operator safety while maintaining process performance and product quality.
Overall, these investments contribute to reducing cost and complexity across the supply chain. Fully integrated solutions that span from early-stage development through to commercial production eliminate the need for multiple vendors, streamline communication, and reduce the risk of delays or quality inconsistencies. For small and mid-sized pharmaceutical companies in particular, this integrated model offers a more accessible pathway to market, supported by a single, technically capable partner.
The next wave of innovations for CDMOS in HPAPIs and ADCs
CDMOs are already positioning themselves for the next wave of innovation. These include peptide drug conjugates (PDCs), which combine the targeting capabilities of peptides with potent cytotoxic agents. Strategic collaborations and targeted investment in this area are enabling CDMOs to expand their offering and remain aligned with future therapeutic trends.
The competitive landscape for HPAPI and ADC manufacturing will require manufacturers to combine this technological depth with operational integration. As demand for targeted therapies continues to grow, CDMOs that invest proactively in containment, capability, and collaboration will be the most strongly positioned to deliver value to clients and patients alike.
