The market for androgen receptor-targeted therapies is projected to expand substantially in the years ahead. This growth is being driven by rising cancer incidence, greater awareness of these therapies, and an increasing pipeline of androgen receptor-targeted treatments currently in clinical trials and awaiting regulatory approval from multiple companies.
LAS VEGAS, Aug. 27, 2025 /PRNewswire/ -- DelveInsight's Androgen Receptor Targeted Therapies Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, addressable patient population, which includes top indications such as prostate cancer, breast cancer, and other malignancies. The selected indications are based on approved therapies and ongoing pipeline activity. The report also provides insights into the emerging androgen receptor targeted therapies, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into the leading markets (the US, EU4, UK, and Japan).
Androgen Receptor Targeted Therapies Market Summary
- As per DelveInsight's analysis, the total market size of androgen receptor targeted therapies in the leading markets (the US, EU4, UK, and Japan) is expected to surge significantly by 2034.
- The report provides the total potential number of patients in the indications, such as prostate cancer, breast cancer, and other malignancies.
- Leading androgen receptor targeted therapies companies, such as Arvinas, Genentech, and others, are developing novel androgen receptor targeted therapies that can be available in the androgen receptor targeted therapies market in the coming years.
- Some of the key androgen receptor targeted therapies in clinical trials include Luxdegalutamide (ARV-766), RG6537, and others.
Discover which indication is expected to grab the major androgen receptor targeted therapies market share @ Androgen Receptor Targeted Therapies Market Report
Key Factors Driving the Growth of the Androgen Receptor Targeted Therapies Market
Rising prostate cancer burden and ageing populations
Prostate cancer incidence rises strongly with age; global population aging and improved detection are increasing the number of diagnosed patients who may need AR-directed treatment, which expands the addressable population for AR inhibitors and related therapies. In 2024, within the United States, the five-year prevalent cases of mCSPC surpassed those of mCRPC, with approximately 70K cases of mCSPC.
Approved indications expanding and guideline adoption
Key approved therapies, such as XTANDI, ERLEADA, and NUBEQA, have set a high benchmark in terms of efficacy and survival outcomes, driving consistent market growth. These drugs have expanded their indications across various stages of prostate cancer, including non-metastatic and hormone-sensitive settings, which further broadens the patient population.
Androgen receptor targeted therapies competitive landscape driven by industry leaders
The competitive landscape is dominated by large pharmaceutical players like Pfizer/Astellas, Johnson & Johnson, and Bayer, who hold strong patent positions and market access in developed regions.
Androgen Receptor Targeted Therapies Market Analysis
Androgen receptor-targeted therapies have transformed prostate cancer management and remain a cornerstone of treatment. Key agents like ERLEADA (apalutamide), XTANDI (enzalutamide), and NUBEQA (darolutamide) have shown strong efficacy, particularly in metastatic castration-resistant prostate cancer (mCRPC), and their use has now expanded across multiple stages of the disease.
ERLEADA is a next-generation oral androgen receptor inhibitor that blocks androgen signaling in prostate cancer cells. It is approved for both nmCRPC and mCSPC. Taken once daily with or without food, ERLEADA received FDA approval in February 2018 for nmCRPC and in September 2019 for mCSPC after priority review. It was also approved by the European Commission in January 2019 for nmCRPC and in January 2020 for mHSPC following the TITAN trial. In Japan, the PMDA approved ERLEADA in March 2019 for nmCRPC and expanded its use for metastatic disease in May 2020, reflecting its global reach.
XTANDI is an orally bioavailable, non-steroidal androgen receptor inhibitor with antitumor activity. It is indicated for patients with metastatic castration-resistant prostate cancer who have previously received docetaxel. Enzalutamide works via a distinct mechanism compared to other AR antagonists, inhibiting androgen receptor signaling and reducing prostate cancer cell proliferation and PSA levels. Since its initial FDA approval in August 2012 for post-docetaxel mCRPC, XTANDI's indications have steadily broadened - approved in 2014 for mCRPC without prior chemotherapy, in 2018 for both non-metastatic and metastatic CRPC, and in 2019 for mCSPC based on ARCHES trial data. These approvals highlight the drug's expanding importance in prostate cancer care.
The FDA approved darolutamide for mCSPC, making it the first androgen receptor inhibitor approved for mCSPC with or without chemotherapy. In the U.S., NUBEQA is approved in combination with or without docetaxel for mCSPC, and also for non-metastatic castration-resistant prostate cancer. It is currently the only FDA-approved AR inhibitor for mHSPC in combination with ADT, with or without chemotherapy. This latest approval follows positive Phase III ARANOTE trial results, extending darolutamide's indication in mHSPC and reinforcing its favorable safety and tolerability across all approved uses.
Learn more about the androgen receptor targeted therapies @ Androgen Receptor Targeted Therapies Analysis
Androgen Receptor Targeted Therapies Competitive Landscape
Several key players, including Arvinas (Luxdegalutamide), Genentech (RO7656594), and others, are involved in developing androgen receptor targeted therapies for various indications, such as prostate cancer, and others.
ARV-766 is an experimental oral PROTAC-based protein degrader specifically engineered to target and eliminate the androgen receptor (AR). In preclinical studies, it has shown effectiveness not only in models with normal AR expression but also in tumors that carry AR mutations or gene amplification - both of which are common resistance mechanisms to currently approved AR-targeted therapies. In April 2024, Arvinas signed a global licensing agreement with Novartis to develop and commercialize luxdegalutamide (ARV-766) for prostate cancer treatment. This deal also involved transferring the AR-V7 program to Novartis.
RO7656594 is another orally bioavailable androgen receptor degrader with potential anticancer activity. After oral administration, it binds to and induces degradation of the androgen receptor, thereby blocking AR-driven signaling pathways and suppressing the growth of AR-overexpressing tumor cells. The androgen receptor is a hormone-regulated transcription factor essential for tumor growth in castration-resistant prostate cancer (CRPC).
The anticipated launch of these emerging therapies are poised to transform the androgen receptor targeted therapies market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the androgen receptor targeted therapies market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
To know more about androgen receptor targeted therapies clinical trials, visit @ Androgen Receptor Targeted Therapies Treatment
Recent Developments in the Androgen Receptor Targeted Therapies Market
- In June 2025, Bayer announced that the US FDA had approved its oral androgen receptor inhibitor (ARi) NUBEQA (darolutamide) in combination with androgen deprivation therapy (ADT) for use in patients with metastatic castration-sensitive prostate cancer (mCSPC), which is also known as metastatic hormone-sensitive prostate cancer (mHSPC).
Androgen Receptor Targeted Therapies Overview
Antiandrogens, also called androgen receptor inhibitors or testosterone blockers, are a group of drugs that stop male hormones like testosterone and dihydrotestosterone (DHT) from exerting their effects in the body. They do this either by blocking the androgen receptors or by reducing the production of these hormones. In that sense, they act opposite to androgen receptor agonists such as natural androgens, anabolic steroids (like testosterone, DHT, nandrolone), and selective androgen receptor modulators (SARMs) like enobosarm. Antiandrogens belong to the class of sex hormone antagonists alongside antiestrogens and antiprogestogens.
Androgen Receptor Targeted Therapies Epidemiology Segmentation
The androgen receptor targeted therapies market report proffers epidemiological analysis for the study period 2020-2034 in the 7MM, segmented into:
- Total Cases of Selected Indications for Androgen Receptor Targeted Therapies
- Total Eligible Patient Pool of Selected Indications for Androgen Receptor Targeted Therapies
- Total Treated Cases of Selected Indications for Androgen Receptor Targeted Therapies
Androgen Receptor Targeted Therapies Market Report Metrics | Details |
Study Period | 2020-2034 |
Androgen Receptor Targeted Therapies Market Report Coverage | 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] |
Key Indications Covered in the Androgen Receptor Targeted Therapies Market Report | Prostate cancer, breast cancer, and other malignancies |
Key Androgen Receptor Targeted Therapies Companies | Arvinas, Genentech, Johnson & Johnson Innovative Medicine, Astellas Pharma, Pfizer, Bayer Healthcare, and others |
Key Androgen Receptor Targeted Therapies | Luxdegalutamide (ARV-766), RG6537, ERLEADA, XTANDI, NUBEQA, and others |
Scope of the Androgen Receptor Targeted Therapies Market Report
- Androgen Receptor Targeted Therapies Therapeutic Assessment: Androgen Receptor Targeted Therapies' current marketed and emerging therapies
- Androgen Receptor Targeted Therapies Market Dynamics: Conjoint Analysis of Emerging Androgen Receptor Targeted Therapies Drugs
- Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
- Unmet Needs, KOL's views, Analyst's views, Androgen Receptor Targeted Therapies Market Access and Reimbursement
Discover more about androgen receptor targeted therapies in development @ Androgen Receptor Targeted Therapies Clinical Trials
Table of Contents
1 | Androgen Receptor Targeted Therapies Market Key Insights |
2 | Androgen Receptor Targeted Therapies Market Report Introduction |
3 | Executive Summary of Androgen Receptor Targeted Therapies |
4 | Key Events |
5 | Epidemiology and Market Forecast Methodology of Androgen Receptor Targeted Therapies |
6 | Androgen Receptor Targeted Therapies Market Overview at a Glance in the 7MM |
6.1 | Androgen Receptor Targeted Therapies Market Share (%) Distribution by Indications in 2024 |
6.4 | Androgen Receptor Targeted Therapies Market Share (%) Distribution by Indications in 2034 |
7 | Androgen Receptor Targeted Therapies: Background and Overview |
8 | Treatment and Management |
9 | Androgen Receptor Targeted Therapies Target Patient Pool |
9.1 | Key Findings |
9.2 | Assumptions and Rationale: 7MM |
9.3 | Androgen Receptor Targeted Therapies Epidemiology Scenario in the 7MM |
9.3.1 | Total Cases of Selected Indications for Androgen Receptor Targeted Therapies |
9.3.2 | Total Eligible Patient Pool for Androgen Receptor Targeted Therapies in Selected Indications |
9.3.3 | Total Treated Cases in Selected Indications for Androgen Receptor Targeted Therapies |
10 | Androgen Receptor Targeted Therapies Marketed Therapies |
10.1 | Key Competitors |
10.2 | ERLEADA (apalutamide): Johnson & Johnson Innovative Medicine |
10.2.1 | Product Description |
10.2.2 | Regulatory milestones |
10.2.3 | Other developmental activities |
10.2.4 | Clinical development |
10.2.5 | Safety and efficacy |
10.3 | XTANDI (enzalutamide): Astellas Pharma/Pfizer |
List to be continued in the report | |
12 | Emerging Androgen Receptor Targeted Therapies |
12.1 | Key Competitors |
12.2 | RO7656594 (RG6537/GDC-2992): Genentech |
12.2.1 | Product Description |
12.2.2 | Other developmental activities |
12.2.3 | Clinical development |
12.2.4 | Safety and efficacy |
12.3 | Luxdegalutamide (ARV-766): Arvinas |
List to be continued in the report | |
13 | Androgen Receptor Targeted Therapies: Seven Major Market Analysis |
13.1 | Key Findings |
13.2 | Market Outlook of Androgen Receptor Targeted Therapies |
13.3 | Conjoint Analysis of Androgen Receptor Targeted Therapies |
13.4 | Key Market Forecast Assumptions of Androgen Receptor Targeted Therapies |
13.4.1 | Cost Assumptions and Rebates |
13.4.2 | Pricing Trends |
13.4.3 | Analogue Assessment |
13.4.4 | Launch Year and Therapy Uptakes |
13.5 | Total Market Size of Androgen Receptor Targeted Therapies in the 7MM |
13.6 | Market Size of Androgen Receptor Targeted Therapies by Indications in the 7MM |
13.7 | Market Size of Androgen Receptor Targeted Therapies by Therapies in the 7MM |
13.8 | The United States |
13.8.1 | Market Size of Androgen Receptor Targeted Therapies by Indications in the United States |
13.8.2 | Market Size of Androgen Receptor Targeted Therapies by Therapies in the United States |
13.9 | EU4 and the UK |
13.10 | Japan |
14 | SWOT Analysis of Androgen Receptor Targeted Therapies |
15 | KOL Views of Androgen Receptor Targeted Therapies |
16 | Unmet Needs of Androgen Receptor Targeted Therapies |
17 | Market Access and Reimbursement |
18 | Bibliography |
19 | Report Methodology |
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