Vertical integration of contract development and manufacturing organisations (CDMOs) involved in antibody-drug conjugates (ADCs) manufacturing has the potential to streamline supply chains and drive cost reductions. However, it also introduces challenges, particularly when it comes to maintaining expertise across every stage of production.
ADCs are sophisticated therapeutic agents that combine monoclonal antibodies (MAbs) with cytotoxic drugs, enabling targeted treatment of cancer cells while minimising damage to healthy tissue. Due to their complexity, the manufacturing of ADCs typically requires multiple CDMOs, each with specialised expertise at different phases of the process.
CDMOs also play a vital role in ensuring consistent, high-volume production to meet the growing market demand for ADCs, while navigating complex regulatory and compliance requirements.
According to GlobalData, ADCs are expected to emerge as the fastest-growing class of therapies by 2025, with 268 ADC drugs currently in clinical development. However, only 6% of ADCs have been commercially launched to date, suggesting significant market potential in the coming years.
With demand for ADCs on the rise, consolidating production within a single vertically integrated CDMO can deliver substantial cost savings and greater resilience. By streamlining operations and improving communication across production stages, vertical integration can reduce dependency on international partners, minimising risks of disruption. However, the model is not without its drawbacks.
Advantages of vertical integration in ADC production
ADCs are a complex class of targeted cancer therapies with highly specialised requirements.
Vertical integration allows companies to oversee every step of ADC production, from the synthesis of MAbs to the manufacturing of the drug-linker conjugate. This ensures greater control over the quality and consistency of the final product, which is critical for the safety and efficacy of ADCs. Because ADC production is highly sensitive to even small variations in components, maintaining control can prevent inconsistencies that may lead to production delays or quality concerns.
In ADC production, critical components such as cytotoxic drugs, linkers, and antibodies must be sourced from reliable vendors. A vertically integrated model simplifies the supply chain by reducing reliance on external suppliers for key components, along with decreasing lead times and mitigating risks with disruptions. This can be particularly important during clinical trials or commercial-scale production, where delays could have significant financial and regulatory consequences.
In addition, vertical integration reduces the need for third-party contracts and outsourcing. The result is potential cost savings in areas such as manufacturing, logistics, and quality control. This can be especially beneficial when scaling up ADC production for commercialisation, as in-house production can reduce the cost per unit and improve overall margins.
With direct oversight of the entire production process, vertically integrated companies can react more swiftly to changes, adjust production schedules, and ensure a faster time-to-market. In the fast-moving biopharmaceutical market, where speed can be the difference between securing market share or losing it to competitors, this is particularly crucial.
Additionally, the greater control over vertically integrated allows for streamlined regulatory submissions and approvals.
Controlling the production process internally can better safeguard proprietary information and intellectual property. ADCs are often the result of complex proprietary technologies, and vertically integrated companies are in a better position to protect their IP by keeping key processes and technologies in-house. This reduces the risk of knowledge leaks and enhances the protection of valuable assets.
Disadvantages of vertical integration in ADC production
One of the biggest drawbacks with vertical integration is the significant upfront capital required to build and maintain the necessary infrastructure. In ADC production, this could involve setting up advanced manufacturing facilities, acquiring specialised equipment, and hiring highly skilled personnel. The cost of investing in production facilities, research and development, and regulatory compliance can be prohibitively high for some companies, especially smaller or early-stage biopharma firms.
Managing the entire production process, from raw material sourcing to final product distribution, can be complex and require a high level of expertise across various disciplines. For ADC production, this includes the handling of sensitive biological materials, ensuring quality control at every step, and dealing with regulatory hurdles. For many companies, the complexity of managing such a broad scope of operations can lead to inefficiencies and difficulties in scaling production effectively.
Vertical integration can lead to overextension of resources, both in terms of finances and human capital. A company that tries to take on too much may find it difficult to maintain the level of specialisation needed for high-quality ADC production. There is also the risk that focusing too heavily on internal production may detract from the company’s core competencies or lead to missed opportunities in other areas of the business such as research or commercialisation.
While vertical integration offers more control, it can also reduce a company’s flexibility in adapting to changes in the market or regulatory environment. For instance, a company that has heavily invested in a specific production facility or technology may be slow to pivot or adopt new, more efficient methods. Furthermore, if an internal production issue arises, it could halt the entire production chain, potentially delaying critical timelines and impacting market readiness.
Vertical integration in ADC production can also introduce significant regulatory challenges. ADCs are highly regulated due to their complexity and the risk associated with their components, particularly the cytotoxic drugs used. Managing regulatory compliance across a vertically integrated supply chain requires significant resources and expertise. Failing to maintain the necessary regulatory standards at every step of production can lead to delays, fines, or even the rejection of products in critical markets.
The substantial capital investment, operational complexity, and potential for overextension can create hurdles, particularly for smaller firms.
Ultimately, the decision to vertically integrate should be made on a case-by-case basis, weighing the potential benefits against the inherent risks. Companies must carefully assess their resources, capabilities, and long-term strategy before committing to a fully integrated production model.
An effective alternative to full vertical integration
While vertical integration can be an attractive model, it is not always the most practical or efficient approach in the rapidly evolving ADC landscape. An alternative strategy adopted by some players is to combine deep expertise in critical manufacturing steps with carefully selected partnerships across the ADC value chain.
Indena illustrates this approach through its strong focus on payload and linker development, supported by long-standing experience in GMP high-potency chemistry. Rather than providing full vertical integration at this stage, the company collaborates with specialised CDMOs in bioconjugation and antibodies, allowing clients to access an effectively integrated ADC manufacturing pathway while maintaining flexibility and technical depth at each stage.
At the same time, this partnership-led model does not preclude future integration. Indena is actively evaluating significant investments in ADC CDMO capabilities, including bioconjugation, as it assesses how best to align its internal strengths with the evolving needs of ADC developers. This adaptive strategy reflects a broader industry trend: prioritising scientific expertise and client requirements first, while retaining the option to expand towards greater integration as the market matures.
High-quality ADC production services
Vertical integration in ADC production offers the potential for cost savings, streamlined supply chains, and improved resilience. However, it comes with the challenge of ensuring consistent expertise across all phases of production, which requires significant investment in training, technology, and quality control processes.
For companies seeking an effective alternative to full vertical integration, Indena provides a trusted, comprehensive solution. By partnering with industry leaders and investing in innovative technologies, Indena ensures that its clients have access to high-quality, reliable ADC production services that meet regulatory standards and deliver safe, effective therapies.
To learn more about Indena’s services and solutions, download the document below.
