8.1.1 To gain a comprehensive understanding of the pricing dynamics for the outsourced development and manufacture of an ADC, Nice Insight spoke one-to-one with key opinion leaders (KOLs) from ADC innovator companies and independent consultants who are all subject matter experts (SMEs) in the ADC space. Representative price points for the relevant CDMO services associated with ADC development and production were obtained for 12 different CDMOs which provide ADC drug substance, ADC drug product, or both. CDMO price point ranges were validated by independent industry KOLs, along with information relating to critical starting material pricing for GMP-grade antibody production, along with chemical-based linkers and HPAPI payloads.
8.1.2 Nice Insight obtained information from 12 CDMOs providing conjugation services that encompass the following types of characteristics:
Seven drug product
Five integrated DS/DP
8.1.3 Geography of our CDMO pricing information encompasses the following:
Two in North America
Three in Europe
Four in the United Kingdom
Two in China
One in Australia
8.1.4 We obtained the same information from three innovators who are located:
One in North America
Two in the United Kingdom
8.1.5 We also spoke to five SMEs who provided insights into pricing trends and supply chain dynamics for ADC outsourcing.
Nice Insight provides customers with the latest trends in the market, hard-to-find pricing, and analysis of important scientific innovation and challenges. Our research reports help innovators understand the price they'll pay for a contractor and what challenges they should anticipate, and allow CDMOs to evaluate their position in the market.Nice Insight provides customers with the latest trends in the market, hard-to-find pricing, and analysis of important scientific innovation and challenges. Our research reports help innovators understand the price they'll pay for a contractor and what challenges they should anticipate, and allow CDMOs to evaluate their position in the market.
8.2.1 We have a separate report that includes detailed pricing of APIs, the Active Pharmaceutical Ingredients, API: 2024 Market Insight, CDMO Pricing and Competitor Benchmarking study. The payloads on ADCs are often HPAPIs, and therefore will cost more to manufacture that noncytotoxic products. In general, a demo batch of a custom HPAPI will cost $225,000 to $800,000, not including consumables or development. We have included smaller batch sizes of some common payloads in Table 28.
Nice Insight provides customers with the latest trends in the market, hard-to-find pricing, and analysis of important scientific innovation and challenges. Our research reports help innovators understand the price they'll pay for a contractor and what challenges they should anticipate, and allow CDMOs to evaluate their position in the market.Nice Insight provides customers with the latest trends in the market, hard-to-find pricing, and analysis of important scientific innovation and challenges. Our research reports help innovators understand the price they'll pay for a contractor and what challenges they should anticipate, and allow CDMOs to evaluate their position in the market.
8.3.1 One of the innovator companies we spoke with outsources all aspects of antibody development and manufacture to established CDMOs, along with production of the linker and HPAPI, specific for clinical production. However, they retain experts in-house for the overall design of the ADC, along with innovative R&D teams focused on the discovery of next-generation linkers and payloads. Furthermore, they perform their own process development for their clinical assets, only transferring the details to a CDMO when required. By adopting this approach, they retain complete control and oversight of their innovation and R&D — utilizing CDMO partners only after the design and conjugation processes are fully defined in-house. They then work closely with the CDMOs to tech transfer and oversee the CMC aspects of the ADC manufacturing. They stated their belief that the linker is the most critical component of an ADC, as it connects the mAb to the cytotoxic payload and determines the ADC’s overall stability, pharmacokinetics, and pharmacodynamics. They went on to explain that linker stability is the most important criterion for an ADC to maintain its concentration in the bloodstream, as premature linker cleavage can lead to early release of the cytotoxic drug in circulation, resulting in unwanted adverse effects.
Nice Insight provides customers with the latest trends in the market, hard-to-find pricing, and analysis of important scientific innovation and challenges. Our research reports help innovators understand the price they'll pay for a contractor and what challenges they should anticipate, and allow CDMOs to evaluate their position in the market.Nice Insight provides customers with the latest trends in the market, hard-to-find pricing, and analysis of important scientific innovation and challenges. Our research reports help innovators understand the price they'll pay for a contractor and what challenges they should anticipate, and allow CDMOs to evaluate their position in the market.
8.4.1 When probed on the cost drivers associated with the GMP manufacture of ADCs, the majority of those interviewed agreed that they are mainly attributable to the additional process, safety, and analytical requirements conferred by conjugation of the biologic to the highly active linker–payload component. Consolidated pricing (DS & DP) — obtained from innovators, consultants, and some manufacturers — is shown in Table 31. To our knowledge, this report is the first ADC CDMO pricing study published. ADC manufacturing facilities require high capital investment and extensive specialized training of operators, resulting in high overhead costs for CDMOs, another cost driver for the prices seen in Table 31.
Nice Insight provides customers with the latest trends in the market, hard-to-find pricing, and analysis of important scientific innovation and challenges. Our research reports help innovators understand the price they'll pay for a contractor and what challenges they should anticipate, and allow CDMOs to evaluate their position in the market.Nice Insight provides customers with the latest trends in the market, hard-to-find pricing, and analysis of important scientific innovation and challenges. Our research reports help innovators understand the price they'll pay for a contractor and what challenges they should anticipate, and allow CDMOs to evaluate their position in the market.
8.5.1 The ADC supply chain consists of both standalone and integrated drug product (DP) CDMOs. Consolidated pricing for ADC formulation and DP sterile filling from these CDMOs is presented in Table 31.
Nice Insight provides customers with the latest trends in the market, hard-to-find pricing, and analysis of important scientific innovation and challenges. Our research reports help innovators understand the price they'll pay for a contractor and what challenges they should anticipate, and allow CDMOs to evaluate their position in the market.Nice Insight provides customers with the latest trends in the market, hard-to-find pricing, and analysis of important scientific innovation and challenges. Our research reports help innovators understand the price they'll pay for a contractor and what challenges they should anticipate, and allow CDMOs to evaluate their position in the market.
8.6.1 As discussed, the global CDMO supply chain for an ADC is highly complex, combining development and manufacturing capabilities in pharma and biopharma, underpinned by a strong analytical capability. Most CDMOs specialize within a defined capability area. As full ADC development and manufacture requires several outsourced partners distributed globally, pricing is driven by market forces and as such there appears to be little differentiation seen. Overall, the average price (shown in Table 32) for the CMC development and manufacturing program for first-in-human trials is ~$5.85M (low: ~$5.7M; high: ~$6.2M) for a standard ADC.
Nice Insight provides customers with the latest trends in the market, hard-to-find pricing, and analysis of important scientific innovation and challenges. Our research reports help innovators understand the price they'll pay for a contractor and what challenges they should anticipate, and allow CDMOs to evaluate their position in the market.Nice Insight provides customers with the latest trends in the market, hard-to-find pricing, and analysis of important scientific innovation and challenges. Our research reports help innovators understand the price they'll pay for a contractor and what challenges they should anticipate, and allow CDMOs to evaluate their position in the market.