The ADC oncology market is experiencing rapid growth, attracting over 200 pharmaceutical companies vying for leadership in this innovative therapeutic space. As competition intensifies, advancements in technology and increased investment in research and development are expected to drive significant breakthroughs in cancer treatment, positioning ADCs as a cornerstone in oncology therapeutics.
LAS VEGAS, Oct. 17, 2024 /PRNewswire/ -- DelveInsight's 'Antibody-drug Conjugates in Oncology Competitive Landscape - 2024' report provides comprehensive global coverage of available, marketed, and pipeline antibody-drug conjugates in various stages of clinical development, major pharmaceutical companies working to advance the pipeline space and future growth potential of the antibody-drug conjugates in oncology competitive domain.
Key Takeaways from the Antibody-drug Conjugates in Oncology Pipeline Report
- Over 200+ antibody-drug conjugates companies are evaluating 220+ antibody-drug conjugates in the oncology pipeline in various stages of development, and their anticipated acceptance in the antibody-drug conjugates market would significantly increase market revenue.
- Leading antibody-drug conjugates companies such as Jiangsu Hengrui Medicine Co., Bio-Thera Solutions, MediLink Therapeutics, Byondis, AbbVie, Oxford BioTherapeutics, Iksuda Therapeutics, Novelty Nobility, LegoChem Biosciences, DualityBio, Lepu Biopharma, Ambrx, CSPC ZhongQi Pharmaceutical Technology, MacroGenics, ADC Therapeutics, Genor Biopharma, CStone Pharmaceuticals, AstraZeneca, Alteogen, Biocity Biopharmaceutics, and others are evaluating novel antibody-drug conjugates candidates to improve the treatment landscape.
- Key antibody-drug conjugates in oncology pipeline in various stages of development include SHR A1811, BAT8006, YL202, BYON3521, ABBV-399, OBT 076, IKS03, IKS04, NN3201, LCB14, DB-1303, MRG 003, ARX788, DP303c, MGC018, ADCT-301, GB 251, CS5001, AZD9592, ALT-P7, BC3195, and others.
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Antibody-drug Conjugates in Oncology Overview
Antibody-drug conjugates (ADCs) represent a cutting-edge approach in oncology, combining the targeting ability of monoclonal antibodies with the potent cytotoxicity of small-molecule drugs. These therapeutic agents consist of three main components: a monoclonal antibody that specifically binds to a tumor-associated antigen, a cytotoxic payload (often a chemotherapeutic agent), and a linker that connects the two. The antibody component of the ADC ensures that the cytotoxic drug is delivered primarily to cancer cells, minimizing damage to normal, healthy cells. This targeted delivery mechanism aims to enhance the therapeutic window by allowing the use of highly potent drugs that would otherwise be too toxic if administered systemically.
In oncology, ADCs are being used to treat a variety of cancers, including breast cancer, lymphoma, and urothelial cancer. The efficacy of ADCs depends not only on the specificity of the antibody but also on the stability of the linker, which must ensure that the cytotoxic agent is released only when the ADC is internalized by the cancer cell. Once inside the cell, the cytotoxic drug is released and induces cell death by disrupting vital cellular processes, such as DNA replication or microtubule function. This precision targeting helps reduce the common side effects associated with conventional chemotherapy, such as nausea, hair loss, and bone marrow suppression, while also improving patient outcomes.
Several ADCs have been approved by regulatory agencies, including Trastuzumab emtansine (T-DM1) for HER2-positive breast cancer and Brentuximab vedotin for Hodgkin lymphoma and anaplastic large cell lymphoma. Ongoing research is focused on improving the safety, efficacy, and resistance profiles of ADCs by developing more stable linkers, more potent cytotoxic agents, and antibodies that target novel cancer-specific antigens. ADCs are becoming a crucial component of personalized cancer treatment, offering a highly targeted approach that promises better efficacy with fewer side effects.
Antibody-drug Conjugates in Oncology Pipeline Analysis: Drug Profile
TRODELVY: Gilead Sciences
TRODELVY (sacituzumab govitecan-hziy) is an innovative TROP-2-targeted antibody-drug conjugate. TROP-2, a cell surface antigen, is predominantly expressed in various tumor types, including over 90% of breast and bladder cancers. Trodelvy features a proprietary hydrolyzable linker connected to SN-38, which is a topoisomerase I inhibitor payload. This unique formulation provides significant efficacy against both TROP-2-expressing cells and their surrounding microenvironment. Approved in more than 40 countries, with additional regulatory reviews in progress globally, TRODELVY is indicated for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who have previously undergone two or more systemic therapies, including at least one for metastatic disease. In the U.S., TRODELVY is also approved for certain patients with pre-treated HR+/HER2- metastatic breast cancer and has received accelerated approval for specific patients with second-line metastatic urothelial cancer.
PADCEV: Astellas Pharma
PADCEV (enfortumab vedotin-ejfv) is an antibody-drug conjugate designed for treating advanced bladder cancer and other urothelial cancers. It has received approval for use alongside pembrolizumab in adult patients with locally advanced or metastatic urothelial cancer. PADCEV operates by targeting cancer cells that express a protein known as Nectin-4, delivering a chemotherapy agent directly to these cells. The antibody component of PADCEV binds to Nectin-4 on the surface of cancer cells, facilitating the entry of the chemotherapy drug, which then leads to the cell's destruction.
Find out more about FDA antibody-drug conjugates @ Antibody-drug Conjugates Analysis
Antibody-drug Conjugates in Oncology Market Dynamics
Antibody-drug conjugates have emerged as a transformative approach in oncology, combining the specificity of monoclonal antibodies with the cytotoxic potency of chemotherapeutic agents. The market dynamics surrounding ADCs are shaped by several interrelated factors, including technological advancements, regulatory environments, competitive landscapes, and shifting treatment paradigms. These factors collectively influence the growth trajectory, accessibility, and clinical adoption of ADCs in cancer treatment.
Technological innovation is a primary driver of the ADC market. Companies are increasingly focusing on improving linker technologies and drug payloads to enhance the efficacy and safety profiles of these therapeutics. Advances in biotechnology have allowed for more precise targeting of cancer cells while minimizing damage to healthy tissue. For instance, the development of new payloads that are more potent or have novel mechanisms of action can significantly improve therapeutic outcomes, thus attracting interest from both researchers and investors.
Regulatory pathways also play a crucial role in shaping the ADC market dynamics. The expedited approval processes for innovative therapies, such as the FDA's Breakthrough Therapy designation, encourage the development of ADCs by reducing the time and resources required to bring these products to market. Regulatory agencies are increasingly recognizing the potential of ADCs to fill unmet medical needs, particularly in treating difficult-to-target malignancies. This favorable regulatory landscape fosters a competitive environment where pharmaceutical companies are incentivized to invest in ADC development.
The competitive landscape is characterized by both established pharmaceutical giants and emerging biotech firms. Major players are expanding their portfolios through collaborations, acquisitions, and partnerships to enhance their ADC offerings. This competitive pressure is driving innovation, resulting in a growing number of ADCs entering clinical trials and subsequent commercialization. Additionally, as clinical data supporting the efficacy of ADCs accumulates, more oncologists are likely to adopt these therapies, further propelling market growth.
Lastly, changing treatment paradigms and increasing demand for personalized medicine are shaping the ADC landscape. As more targeted therapies become available, oncologists are seeking options that provide effective treatment while minimizing toxicity. ADCs are particularly appealing in this context, as they can be tailored to target specific cancer markers. The trend toward combination therapies also presents opportunities for ADCs to be integrated into broader treatment regimens, enhancing their market potential.
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A snapshot of the Antibody-drug Conjugates in Oncology Pipeline Drugs mentioned in the report:
Antibody-drug Conjugates | Company | Phase | Indication |
SHR-A1811 | Jiangsu HengRui Medicine Co., Ltd. | III | Adenocarcinoma; Breast cancer; Colorectal cancer; HER2 positive breast cancer |
ABBV-399 | AbbVie | III | Non-small cell lung cancer |
LCB14 | LegoChem Biosciences/Iksuda Therapeutics/Shanghai Fosun Pharmaceutical | III | Breast cancer; HER2 positive breast cancer |
DB-1303 | Duality Biologics/BioNTech | III | Breast cancer; HER2 positive breast cancer |
BAT8006 | Bio-Thera Solutions | II | Solid tumors |
YL202 | MediLink Therapeutics | II | Solid tumors |
BYON 3521 | Byondis | I | Solid tumors |
IKS03 | Iksuda Therapeutics | I | B-cell lymphoma |
OBT 076 | Oxford BioTherapeutics | I | Adenoid cystic carcinoma; Solid tumors |
NN3201 | Novelty Nobility | Preclinical | Cancer |
Discover more about antibody-drug conjugates in clinical development @ Antibody-drug Conjugates in Clinical Trials
Key Developments in the Antibody-drug Conjugates in Oncology Therapeutics Domain
- In June 2024, Hudson Therapeutics announced that Shaperon, an innovative biopharmaceutical company specializing in immune therapeutics, had signed a Memorandum of Understanding (MOU) with Dong-A ST for the development of nanobody-based new drugs. Shaperon is also exploring nanobody-based protein therapeutics, such as antibody-drug conjugates (ADCs) and radiopharmaceutical therapies.
- In June 2024, the US FDA Placed Partial Clinical Hold on Phase I Trial of YL202. The hold on YL202 is due to potential risks at higher doses, with five grade 5 adverse effects reported.
- In October 2023, Daiichi Sankyo and Merck entered into a global development and commercialization agreement for three of Daiichi Sankyo's DXd antibody-drug conjugate (ADC) candidates: patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd) and raludotatug deruxtecan (R-DXd). The companies will jointly develop and potentially commercialize these ADC candidates worldwide, except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo will be solely responsible for manufacturing and supply.
- In May 2023, Bliss Biopharmaceutical announced a clinical trial collaboration agreement with an option for strategic collaboration with Eisai Co., Ltd. for BB-1701, eribulin-payload based ADC directed against Human Epidermal Growth Factor Receptor 2 (HER2) for the treatment of cancers. This collaboration with Eisai is an important advancement in BlissBio's corporate development plan to further develop BB-1701 globally and help advance BB-1701 toward the late stage of development. BB-1701 is currently in Phase I/II studies in the US and China with over one hundred patients dosed in various types of cancers.
- In April 2023, Byondis B.V. announced that Molecular Cancer Therapeutics (an American Association for Cancer Research journal) had published encouraging preclinical data on its investigational, next-generation antibody-drug conjugate (ADC) BYON3521.
Scope of the Antibody-drug Conjugates in Oncology Competitive Landscape Report
- Coverage: Global
- Key Antibody-drug Conjugates in Oncology Companies: Jiangsu Hengrui Medicine Co., Bio-Thera Solutions, MediLink Therapeutics, Byondis, AbbVie, Oxford BioTherapeutics, Iksuda Therapeutics, Novelty Nobility, LegoChem Biosciences, DualityBio, Lepu Biopharma, Ambrx, CSPC ZhongQi Pharmaceutical Technology, MacroGenics, ADC Therapeutics, Genor Biopharma, CStone Pharmaceuticals, AstraZeneca, Alteogen, Biocity Biopharmaceutics, and others
- Key Antibody-drug Conjugates in Oncology Pipeline: SHR A1811, BAT8006, YL202, BYON3521, ABBV-399, OBT 076, IKS03, IKS04, NN3201, LCB14, DB-1303, MRG 003, ARX788, DP303c, MGC018, ADCT-301, GB 251, CS5001, AZD9592, ALT-P7, BC3195, and others.
Table of Contents
1. | Antibody-drug Conjugates in Oncology Pipeline Report Introduction |
2. | Antibody-drug Conjugates in Oncology Pipeline Report Executive Summary |
3. | Antibody-drug Conjugates in Oncology Pipeline: Overview |
4. | Antibody-drug Conjugates in Oncology Marketed Drugs |
4.1. | TRODELVY: Gilead Sciences |
5. | Antibody-drug Conjugates in Oncology Clinical Trial Therapeutics |
6. | Antibody-drug Conjugates in Oncology Pipeline: Late-Stage Products (Pre-registration) |
7. | Antibody-drug Conjugates in Oncology Pipeline: Late-Stage Products (Phase III) |
7.1. | ABBV-399: AbbVie |
8. | Antibody-drug Conjugates in Oncology Pipeline: Mid-Stage Products (Phase II) |
8.1. | BAT8006: Bio-Thera Solutions |
9. | Antibody-drug Conjugates in Oncology Pipeline: Early-Stage Products (Phase I) |
9.1. | BYON 3521: Byondis |
10. | Antibody-drug Conjugates in Oncology Pipeline: Preclinical and Discovery Stage Products |
10.1. | NN3201: Novelty Nobility |
11. | Antibody-drug Conjugates in Oncology Pipeline Therapeutics Assessment |
12. | Inactive Products in the Antibody-drug Conjugates in Oncology Pipeline |
13. | Company-University Collaborations (Licensing/Partnering) Analysis |
14. | Unmet Needs |
15. | Antibody-drug Conjugates in Oncology Market Drivers and Barriers |
16. | Appendix |
Learn more about antibody-drug conjugates for cancer therapy @ Antibody-drug Conjugates Immunotherapy
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