PUBLISHER: DelveInsight | PRODUCT CODE: 1576912
PUBLISHER: DelveInsight | PRODUCT CODE: 1576912
The US FDA has approved a total of 13 ADCs and the first ADC to be approved was MYLOTARG. But later in 2017, MYLOTARG was voluntarily withdrawn from the market after subsequent confirmatory trials failed to verify clinical benefit and demonstrated safety concerns, including a high number of early deaths.
The development of Antibody Drug Conjugate market is a global endeavor, with companies across the world investing significant resources. Currently, over ~200 antibody-drug conjugates are in various stages of pre-clinical and clinical development, indicating the widespread interest and potential of this field.
The Antibody Drug Conjugate Market has certain key players. A lot of companies are actively developing antibody drug conjugate in the 7MM, and many of them are large-cap companies actively working in this space, such as Roche, Takeda, Gilead Sciences, Pfizer, GlaxoSmithKline, Daiichi Sankyo/AstraZeneca, and others. Daiichi Sankyo is expected to lead a new era of antibody-drug conjugates.
Recently sat ASCO 2024, AbbVie presented new data from its innovative ADC platform that showcased data across three different ADCs i.e., ABBV-706, telisotuzumab vedotin, and ABBV-400 in solid tumors.
In a late-breaking session at the ASCO 2024, GSK announced noteworthy results in the DREAMM-8 Study, particularly in light of GSK's decision in late 2022 to withdraw BLENREP from the US market. The new data could support a case for the reintroduction of BLENREP to the market. Regulatory decision (US, EU, JP) based on DREAMM-7/8 trial in second line and above multiple myeloma and regulatory submission based on DREAMM-8 trial in multiple myeloma is planned in 2025.
DelveInsight's "Antibody Drug Conjugate Market - Competitive Landscape, and Market Forecast - 2034" report delivers an in-depth understanding of the antibody-drug conjugates, historical and competitive landscape as well as the antibody-drug conjugates market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
The antibody drug conjugate market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM antibody drug conjugate market size from 2020 to 2034. The report also covers current antibody-drug conjugates treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.
Antibody drug conjugate is a new emerging class of highly potent pharmaceutical drugs, which is a great combination of chemotherapy and immunotherapy. Antibody-drug conjugates empower the selective delivery of highly potent drugs to tumor cells while sparing healthy cells, attenuating the main clinical obstacle of traditional chemotherapy, thus providing a broad therapeutic window. One of the most important aspects of antibody-drug conjugate development for cancer is the identification of the unique antigenic target of the monoclonal antibody component. The selected antigen needs to fulfill several requirements. First, the target antigen needs to have high expression in the tumor and no or low expression in the healthy cell. Second, the target antigen should be displayed on the surface of the tumor cell to be available to the circulated monoclonal antibody. Third, the target antigen should possess internalization properties as it will facilitate the antibody-drug conjugate to transport into the cell, which will in turn enhance the efficacy of the cytotoxic agent.
The 13 US FDA-approved antibody-drug conjugates are KADCYLA, ADCETRIS, BESPONSA, MYLOTARG, LUMOXITI, POLIVY, PADCEV, TRODELVY, ENHERTU, BLENREP, ZYNLONTA, TIVDAK, and ELAHERE.
Antibody Drug Conjugate Qualitative Analysis
We perform qualitative and market intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.
Conjoint Analysis analyses multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.
In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in event-free survival, one of the most important primary outcome measures is event-free survival and overall survival.
Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.
Antibody Drug Conjugate Market Access and Reimbursement
Market Access refers to the ability of all patients to have access to a given product quickly, conveniently, and affordably. Reimbursement is the negotiation of a price between the manufacturer and payer that allows the manufacturer access to that market. It is provided to reduce the high costs and make essential drugs affordable. Reimbursement is the price negotiation between the manufacturer and payer that allows the manufacturer access to that market. It is provided to reduce the high costs and make essential drugs affordable. In the US healthcare system, both Public and Private health insurance coverage are included. In addition, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs, including Medicare, Medicaid, the Children's Health Insurance Program (CHIP), and the state and federal health insurance marketplaces, are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs), and third-party organizations that provide services and educational programs to aid patients are also present.
The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.