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. Such conjugates are believed to be more efficient and effective in specifically identifying and eliminating cells / pathogens that are associated with disease(s).
Conventional cancer treatments, such as chemotherapy, surgery and radiation therapy, have demonstrated very limited efficacy in late-stage cancers. Additionally, chemotherapy and radiation therapy are associated with several side effects. Such treatment options usually destroy large populations of healthy and rapidly proliferating cells, along with the tumor cells. Their non-specific nature has severe detrimental effects on the patient’s quality of life. Therefore, there is an urgent unmet need of innovative and effective cancer treatments for patients with late-stage and refractory cancer.
According to the Roots Analysis the global antibody drug conjugate market is estimated to be worth USD 7.72 billion in 2023 and expected to grow at compounded annual growth rate (CAGR) of 9.63% during the forecast period.
Amidst the widespread initiatives to develop more targeted anti-cancer therapies, antibody drug conjugates have emerged as a highly specific and potent option to eradicate tumor cells with minimal side effects. In the past few years, great strides have been made in the field of personalized medicine; targeted therapies, such as ADCs, are on the forefront of next generation technologies that are anticipated to revolutionize the cancer treatment landscape.
With six marketed drugs, ADCs are presently recognized as a potent class of targeted anticancer therapies, with the potential to be used to treat a variety of other disease indications. The success of such products can be attributed to their ability to effectively identify and eliminate disease associated cells / pathogens, with substantially lower risk of treatment related side effects.
What are the technical challenges related to Antibody Drug Conjugates Industry?
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).
Of these, nearly 40% are in the clinical phase of development, while the rest are in the preclinical / discovery stage. Presently, most of such therapeutic leads are being developed against the HER2 antigen; other popular biological targets include CD30 and EGFR.
Around 40% of these intellectual property documents were filed / granted in the US; other key regions with significant intellectual capital include China, Japan, Canada, Korea and Taiwan. Leading non industry players (in terms of the size of intellectual property portfolio) include INSERM, University of California, Leland Stanford Junior University and University of Pennsylvania.
References:
https://www.rootsanalysis.com/blog/antibody-drug-conjugates-market/
https://www.rootsanalysis.com/blog/10-key-facts-about-antibody-drug-conjugates-market/
https://www.rootsanalysis.com/reports/antibody-drug-conjugates-market/270.html
