ADC Contract Manufacturing Market: Opportunities Ahead
Antibody Drug Conjugates (ADCs) are a new class of therapeutic drugs consisting of a cytotoxic drug linked to a monoclonal antibody. These novel conjugates are believed to be very effective and efficient in treatment of a disease. However, manufacturing such highly potent toxic molecules is accompanied with several known and unknown challenges.
Kamaruz Zaman, the principal analyst, said, “In-house manufacturing of ADCs is rare primarily because of the complex nature of these molecules. Their manufacturing requires both clean room biologic and high containment cytotoxic facilities. This combination is rare and difficult to achieve, requiring huge capital investment.”
Zaman further stated that, “Even the leading technology providers including Seattle Genetics and ImmunoGen are dependent on contract manufacturers to supply the components.”
- Seattle Genetics and Roche, with seven and six molecules in clinical development respectively, currently have the most developed portfolio of ADC molecules. Relatively new entrants include (indicative list, in alphabetical order) AbGenomics, Abzena, Affinicon, Allozyne, Endo Pharmaceuticals, Formation Biologics, Intellect Neurosciences, Kairos Therapeutics, Menarini Biotech, Mersana Therapeutics, Oxford BioTherapeutics, Philochem, Synthon and Zymeworks; rise of these firms is likely to provide the necessary push, both in terms of technology and innovation.
- Majority of ADC developers are dependent on contract manufacturers to supply the components. Discussions with senior experts in the industry reveal that around 70% of ADC manufacturing is currently outsourced.
- In less than two years, there has been a healthy increase in the number of CMOs providing services specific to ADC development; we have identified over 40 such CMOs. There are more than 20 CMOs with capabilities of manufacturing cytotoxics and providing conjugation services. Over 15 CMOs extend their fill/finish capabilities specific to ADC manufacturing.
- Collaborations have helped the market reach its current growth trajectory. For example, SAFC and Baxter BioPharma Solutions partnered to manufacture and conduct all the steps of ADC manufacturing to cater to the customer needs. Earlier, Goodwin and Coldstream had collaborated to act as full service providers of ADCs.”
Amongst other things, the report covers:
- The current state of the market with respect to developmental stage of pipeline products (both clinical / pre-clinical) and indications targeted.
- Recent partnerships which have taken place over the last five years including product manufacturing agreements, technology collaborations and mergers / acquisitions.
- CMO investments to develop new / expand existing plants and supporting facilities in order to ensure sufficient production capacity and safe handling of these compounds.
- Upcoming growth areas and inherent threats to development in the short and long term.
- Development and sales potential of ADCs in advanced clinical stages and likely outsourcing profile across various steps involved in ADC manufacturing.
The report captures detailed expertise of over 40 CMOs in the field of ADC manufacturing. Other examples of CMOs covered in the report include:
- ACES Pharma
- ALMAC Group
- AMRI Global
- Baxter Biopharma Solutions
- BSP Pharmaceuticals
- CARBOGEN AMCIS
- Catalent Pharma Solution
- Dalton Pharma Services
- FUJIFILM Diosynth Biotechnologies
- Goodwin Biotechnology
- Pierre Fabre Medicament Production
- Piramal Pharma Solutions
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