Currently, a total of 15 antibody-drug conjugates (ADCs) are currently approved for marketing globally. The global ADCs market size was valued at USD 5.31 billion in 2021. And in 2022, the total sales of these ADC drugs are nearly $7 billion.
Figure. ADC Market size from 2016 to 2022
From the disclosed FY2022 financial statements, ADC drugs such as Seagen/Takeda's Adcetris, Roche's Kadcyla and Polivy, Gilead's Trodelvy, and Daiichi Sankyo/AstraZeneca's Enhertu, have been approved for new indications and accelerated to seize the market. Of particular interest is the explosive sales growth of Enhertu from Daiichi Sankyo/AstraZeneca, which surged from $426 million to $1.234 billion.
Trade Names | Company | Target antigens | Approved Date | 2021 Sales ($ million) | 2022 Sales ($ million) | Year-over-year |
Mylotarg | Pfizer | CD33 | 2000/5/17; 2017/9/1 | / | / | |
Adcetris | Seagen/Takeda | CD30 | 2011/8/19 | 1306 | 1480 | +12.8% |
Kadcyla | Roche | HER2 | 2013/2/22 | 2178 | 2265 | +7% |
Besponsa | Pfizer | CD22 | 2017/6/28 | 192 | 219 | +14.1% |
Lumoxiti | AstraZeneca | CD22 | 2018/9/13 | / | / | |
Polivy | Roche | CD79B | 2019/6/10 | 326 | 591 | +81.3% |
Padcev | Astellas/Seagen | Nectin-4 | 2019/12/18 | 461 | 754 | +63.6% |
Enhertu | Daiichi Sankyo/AstraZeneca | HER2 | 2019/12/20 | 426 | 1234 | +189.7% |
Trodelvy | Gilead | Trop-2 | 2020/4/22 | 380 | 680 | +78.9% |
Blenrep | GSK | BCMA | 2020/8/5 | 122 | / | |
Akalux | Rakuten Medical | EGFR | 2020/9/25 | / | / | |
Zynlonta | ADC Therapeutics | CD19 | 2021/4/23 | 30 | / | |
Aidixi | RemeGen | HER2 | 2021/6/8 | 10 | / | |
Tivdak | Genmab/Seagen | TF | 2021/9/20 | 6 | / | |
ELAHERE | ImmunoGen | FRα | 2022/11/14 | / | / |
Table. ADCs Sales in 2022
Kadcyla: Top ADC Seller
Kadcyla (Adptrastuzumab emtansine), co-developed by Roche and ImmunoGen, was first approved by the FDA on February 22, 2013 for HER2-positive metastatic breast cancer.
Kadcyla reported revenues of CHF 2.08 billion, or approximately $2.265 billion, in the full year 2022, with year-over-year (CER) growth of 7%, showing slower growth compared to the 16% growth rate in 2021.
In 2023, Roche announced a price cut of more than 50% for Kadcyla in China, hoping to capture the market through price cuts.
Adcetris Sales in 2022
Adcetris® (brentuximab vedotin), originally developed by Seagen (formerly SeattleGenetics) and later co-developed with Takeda, is the first ADC approved for first-line treatment targeting CD30/CD16, and has gained worldwide popularity since its launch. From 2011 to 2021, Adcetris has been approved by the US FDA, China NMPA and EU EMA for the treatment of Hodgkin lymphoma (HL) and relapsed systemic anaplastic large cell lymphoma (sALCL).
Adcetris has global sales of up to $659 million in 2020; doubling to $1.306 billion in 2021 and further growing to $1.48 billion (JPY 194.3 billion) in 2022.
Enhertu Sales in 2022
Enhertu, co-developed by Daiichi Sankyo and AstraZeneca, has shown the fastest sales growth.
In 2019, Enhertu first won FDA approval for some patients with HER2-positive unresectable or metastatic breast cancer. Two years later, the drug won an indication for previously treated HER2-positive advanced gastric cancer and non-small cell lung cancer (NSCLC). It is also the world's first therapy for HER-2 low-expressing breast cancer.
Figure. Enthertu Indications
Benefiting from the approval of new indications in 2022 and the gradual penetration into more markets, Enhertu broke the billion-dollar barrier this time with sales of JPY 161.6 billion (approximately $1.234 billion), an almost twofold increase compared to the previous year's sales of $426 million.
In addition, Enhertu is not just satisfied with its current results. In addition to breast, lung and gastric cancers, Enhertu is also conducting clinical trials for a wide range of cancers, including colorectal, uterine, pancreatic and biliary tract cancers.
Trodelvy Sales in 2022
TRODELVY® (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate. Currently, Trodelvy has been approved in more than 40 countries worldwide, with the first approval in 2020 by the FDA for the treatment of patients with metastatic triple-negative breast cancer (TNBC) who have failed two or more systemic therapies, as well as accelerated approval for the second-line treatment of patients with metastatic uroepithelial cancer.
Trodelvy sales increased 78.9% to $680 million for the full year 2022 compared to 2021. Meanwhile, the drug has just been approved for the treatment of HR+/HER2- breast cancer and is expected to continue its explosive growth in 2023.
Figure. Trodelvy sales 2022
Future Prospects of ADCs
Currently, the enthusiasm for ADC drug development is high. As of June 2022, there are more than 400 ADC drugs in development worldwide, of which more than 200 are in the clinical stage. In terms of targets, except for ADCs targeting HER2 which are mostly laid out in breast cancer and gastric cancer, other products are developed in tumor indications with high expression of target proteins such as TROP2 and Claudin18.2, including solid tumors such as breast cancer, gastric cancer, bladder cancer, (non-)small cell lung cancer, ovarian cancer, pancreatic cancer, and hematologic tumors such as lymphoma and multiple myeloma.
However, there is also a lot of concern in the market about the status of repeated development. Today, some of the target tracks are already more crowded, and the product launch will face more brutal competition The market is also prone to excessive competition from homogeneous R&D.
Currently, the global market for ADCs currently boasts a size of nearly $7 billion. Yet, the market is still under cultivation as most of the approved ADC drugs are backline therapies and most of them have been approved for a relatively short period of time. According to the current market growth rate, it is inevitable that the market space will exceed USD 10 billion soon.
How to avoid laying out popular indications with the help of cutting-edge technology to target differentiated targets and seize market opportunities in the future? This is the question for the companies participating in the ADC field.
Biopharma PEG offers a variety of PEG linkers to facilitate antibody-drug conjugate (ADC) development projects. All PEG linkers are of >95% purity and they are the basic building blocks for a successful ADC.
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Claudin18.2 Targeted Therapies In Cancer