(Albany, USA) DelveInsight’s TROP-2 Inhibitors Market Insights report includes a comprehensive understanding of current treatment practices, emerging TROP-2 inhibitors, market share of individual therapies, and current and forecasted TROP-2 inhibitors market size from 2020 to 2034, segmented into 7MM [the United States, the EU-4 (Italy, Spain, France, and Germany), the United Kingdom, and Japan].
Key Takeaways from the TROP-2 Inhibitors Market Report
- As per DelveInsight’s analysis, the TROP-2 inhibitors market is anticipated to grow at a significant CAGR by 2034.
- Leading TROP-2 inhibitor companies such as Daiichi Sankyo, AstraZeneca, Kelun Biotech, Merck, DualityBio, BioNTech, BiOneCure Therapeutics, and others are developing novel TROP-2 inhibitors that can be available in the TROP-2 inhibitors market in the coming years.
- Some of the key TROP-2 inhibitors include Datopotamab deruxtecan, MK-2870/SKB-264, DB-1305/BNT325, and BIO-106, among others.
- In February 2024, AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for Dato-DXd was accepted in the US for the treatment of adult patients with locally advanced or metastatic NSCLC who have received prior systemic therapy. The PDUFA date is during the fourth quarter of 2024.
Discover which therapies are expected to grab the TROP-2 inhibitors market share @ TROP-2 Inhibitors Market Report
TROP-2 Inhibitors Market Dynamics
The TROP-2 inhibitors market is experiencing significant growth due to the increasing prevalence of cancers where TROP-2 is overexpressed, such as breast, lung, and pancreatic cancers. The development of targeted therapies that inhibit TROP-2 signaling pathways has garnered interest from pharmaceutical companies and researchers. Furthermore, advancements in drug delivery technologies, such as antibody-drug conjugates and small molecule inhibitors, have broadened the therapeutic options for TROP-2 inhibition, providing more precise and effective treatments for patients. With ongoing clinical trials and promising preclinical studies, the TROP-2 inhibitors market is set for further expansion, driven by the pursuit of innovative cancer therapies with improved efficacy and safety profiles.
However, the TROP-2 inhibitors market faces challenges, including the need for comprehensive biomarker-driven patient stratification strategies to identify those most likely to benefit from TROP-2 targeted therapies. Additionally, issues related to drug resistance and tumor heterogeneity present obstacles to achieving sustained treatment responses. Collaborative efforts between academia, industry, and regulatory agencies are crucial to addressing these challenges and optimizing the clinical development and commercialization of TROP-2 inhibitors. Despite these challenges, the growing understanding of TROP-2 biology and its role in cancer progression, along with advancements in drug discovery technologies, highlights the potential of TROP-2 inhibitors to transform cancer treatment paradigms and improve patient outcomes.
TROP-2 Inhibitors Treatment Market
TROP-2 inhibitors were under investigation as potential treatments for various cancer types. The rationale for targeting TROP-2 in cancer therapy is based on its increased presence in numerous cancers, its association with aggressive tumors, metastasis, and poor prognoses. The goal of inhibiting TROP-2 is to disrupt the signaling pathways essential for cancer progression and spread. Different forms of TROP-2 inhibitors, including monoclonal antibodies, ADCs, small molecule inhibitors, and CAR-T cell therapy, are incorporated into treatment strategies to selectively target cancer cells with high TROP-2 expression.
TRODELVY (Sacituzumab govitecan), initially developed by Immunomedics and later acquired by Gilead Sciences in September 2020, is an antibody-drug conjugate. It consists of a humanized monoclonal antibody hRS7 IgG1k targeting TROP-2, linked with SN-38, the active metabolite of irinotecan (IRI), a topoisomerase I inhibitor.
In April 2020, the FDA approved TRODELVY for treating metastatic triple-negative breast cancer (mTNBC) in adults who had undergone at least two prior therapies. This approval made it the first FDA-approved ADC targeting TROP-2. Later, in April 2021, the drug received FDA approval for second-line treatment of TNBC and accelerated approval for second-line treatment of advanced urothelial carcinoma.
Further extending its approvals, in February 2023, TRODELVY gained FDA approval for treating HR+/HER2- breast cancer in adult patients who had previously received endocrine-based therapy and at least two other systemic treatments in the metastatic setting.
Learn more about the FDA-approved TROP-2 inhibitors @ TROP-2 Inhibitors Drugs and therapies
Key Emerging TROP-2 Inhibitors and Companies
Some of the drugs in the pipeline include Datopotamab deruxtecan (Daiichi Sankyo/AstraZeneca), MK-2870/SKB-264 (Kelun Biotech/Merck), DB-1305/BNT325 (DualityBio/BioNTech), and BIO-106 (BiOneCure Therapeutics), among others.
Datopotamab deruxtecan (Dato-DXd, DS-1062) is a new type of treatment under investigation, aimed at targeting TROP2. It is developed using Daiichi Sankyo’s specialized DXd ADC technology. Dato-DXd is made up of a modified human anti-TROP2 IgG1 antibody linked to a topoisomerase I inhibitor called exatecan derivative (DX-8951 derivative, DXd) using a specific tetrapeptide-based linker that can be broken down.
In February 2024, AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for Dato-DXd was accepted in the United States. This application targets the treatment of adults with locally advanced or metastatic non-small cell lung cancer who have previously undergone systemic therapies. The anticipated approval decision date (PDUFA) is set for the fourth quarter of 2024, based on the significant results from the TROPION-Lung01 Phase III trial.
Furthermore, Dato-DXd is being investigated for NSCLC in combination with other immune checkpoint-targeting medications. Beyond NSCLC, ongoing Phase III trials are assessing Dato-DXd for breast cancer treatment. Additionally, Phase II and Phase I/II trials are examining its effectiveness for gastric cancer, urothelial carcinoma, and various other solid tumors.
SKB264, an innovative ADC designed to target TROP2, was developed through a collaboration between Merck and Sichuan Kelun-Biotech. It features a humanized monoclonal antibody aimed at TROP-2 and a novel topoisomerase I inhibitor linked by an enzymatically cleavable linker. The medication is currently in Phase III trials for specific non-small cell lung cancer patients and individuals with previously treated endometrial carcinoma. Additionally, Merck is conducting a Phase I/II study for MK-2870 in other advanced unresectable/metastatic solid tumors. Results from a Phase II expansion study involving patients with locally advanced or metastatic NSCLC were presented at the 2023 ASCO annual meeting.
DB-1305 is a specialized ADC combining an anti-TROP-2 antibody with a new topoisomerase I inhibitor, P1021, utilizing an enzymatically cleaved tetrapeptide linker. It is currently undergoing Phase I/II testing in individuals with advanced solid tumors.
In January 2024, the FDA granted FTD to DB-1305 for treating patients with platinum-resistant ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer who have undergone one to three previous systemic treatment regimens.
The anticipated launch of these emerging therapies is set to transform the TROP-2 inhibitors market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the TROP-2 inhibitors market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
To know more about TROP-2 inhibitors clinical trials, visit @ TROP-2 Inhibitors Treatment Drugs
TROP-2 Inhibitors Overview
Trophoblast cell surface antigen-2 (TROP-2) is a 35-kDa protein found on the surface of cells, functioning as a calcium signal transducer. It is encoded by the TACSTD2 gene and shares structural similarities with the epithelial cell adhesion molecule (EpCAM). This gene is active in various normal human tissues such as breast, cervix, kidney, lung, and pancreas, playing a role in the development of embryos. It has also been observed to be elevated in a range of cancers including head and neck squamous cell carcinoma, gastric cancer, gallbladder cancer, cervical cancer, lung cancer, breast cancer, colon cancer, pancreatic cancer, ovarian carcinoma, and endometrioid endometrial carcinoma. Consequently, targeting TROP-2 with medications could potentially offer treatment avenues for numerous challenging cancers.
TROP-2 has emerged as a promising protein target despite its potential in cancer therapy being recognized some years back. Recent advancements in targeted therapies and immunotherapies have underscored TROP-2’s significance due to its involvement in cancer cell proliferation, spread, and its increased presence in various cancer types.
TROP-2 Inhibitors Epidemiology Segmentation
The TROP-2 inhibitors report takes into the account of historical, current, and forecasted TROP-2 inhibitors patient pool. According to the European Society for Medical Oncology (ESMO), NSCLC is the most common type of lung cancer, accounting for 80─90% of all lung cancer cases.
The TROP-2 Inhibitors market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:
- Total Incident Cases of Selected Indications (Breast Cancer, NSCLC, Urothelial Carcinoma, Ovarian cancer, and Others) for TROP-2 Inhibitors
- Total Eligible Patient Pool for TROP-2 Inhibitors in Selected Indications
- Total Treated Cases in Selected Indications for TROP-2 Inhibitors
Download the report to understand what epidemiologists are saying about how TROP-2 inhibitors patient trends in 7MM @ TROP-2 Inhibitors Market Dynamics and Trends
Scope of the TROP-2 Inhibitors Market Report
- Study Period: 2020–2034
- TROP-2 Inhibitors Report Coverage: 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]
- Key TROP-2 Inhibitors Companies: Daiichi Sankyo, AstraZeneca, Kelun Biotech, Merck, DualityBio, BioNTech, BiOneCure Therapeutics, and others
- Key TROP-2 Inhibitors: Datopotamab deruxtecan, MK-2870/SKB-264, DB-1305/BNT325, and BIO-106, among others
- TROP-2 Inhibitors Therapeutic Assessment: TROP-2 Inhibitors current marketed and emerging therapies
- TROP-2 Inhibitors Market Dynamics: Attribute Analysis of Emerging TROP-2 Inhibitors Drugs
- Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
- Unmet Needs, KOL’s views, Analyst’s views, TROP-2 Inhibitors Market Access and Reimbursement
Discover more about TROP-2 Inhibitors drugs in development @ TROP-2 Inhibitors Clinical Trials and FDA Approvals
Table of Contents
1. TROP-2 Inhibitors Market Key Insights
2. TROP-2 Inhibitors Market Report Introduction
3. TROP-2 Inhibitors Market Overview at a Glance
4. TROP-2 Inhibitors Market Executive Summary
5. Disease Background and Overview
6. TROP-2 Inhibitors Treatment and Management
7. TROP-2 Inhibitors Epidemiology and Patient Population
8. Patient Journey
9. TROP-2 Inhibitors Marketed Drugs
10. TROP-2 Inhibitors Emerging Drugs
11. Seven Major TROP-2 Inhibitors Market Analysis
12. TROP-2 Inhibitors Market Outlook
13. Potential of Current and Emerging Therapies
14. KOL Views
15. Unmet Needs
16. SWOT Analysis
17. Appendix
18. DelveInsight Capabilities
19. Disclaimer
20. About DelveInsight
About DelveInsight
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