ADC Contract Manufacturing Market, 2022-2035 - Roots Analysis

1. ANTIBODY DRUG CONJUGATES: THE FUTURE OF NOVEL THERAPEUTICS Antibody drug conjugates (ADCs) are an upcoming class of targeted therapeutic agents that have garnered the attention of pharmaceutical companies, and academic / research institutions across the world. Fundamentally, these complex biotherapeutic entities represent the combination of the target specificity of an antibody and the therapeutic features of a chemotherapy / cytotoxic drug.

2. Such conjugates are believed to be more efficient and effective in specifically identifying and eliminating cells / pathogens that are associated with disease(s). ADCs are presently an established therapeutic concept with 11 approved products. Examples of recently approved ADCs include Enhertu (2021), Blenrep (2020) and Polivy (2020). Despite the challenges associated with the development and manufacturing of such interventions, they are still considered a revolutionary technology over products based on their individual components, namely the antibodies and cytotoxic drugs (cytotoxins). What are the technical challenges related to ADC manufacturing? As a result of the wide range of capabilities and technical expertise required in the production of ADCs, the manufacturing of such therapeutic products is associated with several challenges, some of which are listed below: ▪ Concerns related to the antibody retaining its binding activity after conjugation to the cytotoxic payload ▪ Concerns related to the cytotoxic payload retaining its biological activity after conjugation to the antibody ▪ Challenges associated with the conjugation of the antibody component to the drug-linker complex; this typically requires cGMP rooms / suites ▪ Challenges associated with both cell culture and synthetic chemistry methods, since a developer must possess expertise in both the aforementioned technologies ▪ Concerns related to the cytotoxic nature of the payload; typically, such drug molecules require highly contained facilities and established working precautions and protocols to prevent exposure to hazardous levels of product (it is recommended that OELs be maintained in the range of 10-9 gram/m3).

3. What is the need for outsourcing ADC production? ADC manufacturing is a time-consuming process fraught with a number of challenges; this necessitates ADC developers to outsource operations to contract service providers What are the key trends that are shaping up the ADC contract manufacturing market? As per the recent market report by Roots Analysis, around 35 ADC contract manufacturers are currently active in this domain. Moreover, stakeholders claim to offer a range of services, across different scales of operations; over 35% of such companies have established their facilities across different geographies.