The androgen receptor–targeted therapies market is expected to experience significant growth in the coming years. This expansion is fueled by an increasing incidence of cancers, heightened awareness of these therapies, and a robust pipeline of androgen receptor–targeted treatments currently under clinical investigation and pending regulatory approval from various companies.
DelveInsight’s report provides a comprehensive understanding of current treatment practices and the addressable patient population, focusing on top indications such as prostate cancer, breast cancer, and other malignancies. These indications are selected based on approved therapies and ongoing pipeline activity. The report also offers insights into emerging androgen receptor–targeted therapies, market share of individual treatments, and the current and forecasted market size from 2020 to 2034, segmented into leading markets: the US, EU4, UK, and Japan.
Androgen Receptor Targeted Therapies Market Summary
- According to DelveInsight, the total market size of androgen receptor–targeted therapies in the leading markets is projected to grow significantly by 2034.
- The report details the total potential patient population across key indications such as prostate cancer, breast cancer, and other malignancies.
- Leading companies, including Arvinas, Genentech, and others, are actively developing novel androgen receptor–targeted therapies expected to enter the market in the coming years.
- Key androgen receptor–targeted therapies currently in clinical development include Luxdegalutamide (ARV-766), RG6537, and additional investigational drugs.
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Key Factors Driving the Growth of the Androgen Receptor Targeted Therapies Market
Rising Prostate Cancer Burden and Aging Populations
Prostate cancer incidence increases significantly with age. Global population aging, combined with improved detection methods, is raising the number of diagnosed patients who may require androgen receptor (AR)–directed therapies, thereby expanding the addressable population for AR inhibitors and related treatments. In 2024, in the United States, the five-year prevalent cases of metastatic castration-sensitive prostate cancer (mCSPC) exceeded those of metastatic castration-resistant prostate cancer (mCRPC), totaling approximately 70K cases of mCSPC.
Approved Indications Expanding and Guideline Adoption
Key approved therapies, including XTANDI, ERLEADA, and NUBEQA, have demonstrated high efficacy and survival benefits, driving steady market growth. These therapies have expanded indications across multiple stages of prostate cancer, such as non-metastatic and hormone-sensitive settings, further broadening the potential patient population.
Competitive Landscape Driven by Industry Leaders
The androgen receptor–targeted therapy market is dominated by major pharmaceutical players like Pfizer/Astellas, Johnson & Johnson, and Bayer, who maintain strong patent positions and market access in developed regions.
Androgen Receptor Targeted Therapies Market Analysis
Androgen receptor–targeted therapies have redefined prostate cancer management and remain a cornerstone of treatment. Key agents such as ERLEADA (apalutamide), XTANDI (enzalutamide), and NUBEQA (darolutamide) have demonstrated strong efficacy, particularly in mCRPC, and their use has expanded across multiple disease stages.
- ERLEADA (apalutamide): A next-generation oral AR inhibitor that blocks androgen signaling in prostate cancer cells. Approved for both nmCRPC and mCSPC, ERLEADA is taken once daily, with or without food. FDA approval was granted in February 2018 for nmCRPC and September 2019 for mCSPC after priority review. The European Commission approved it in January 2019 (nmCRPC) and January 2020 (mHSPC) following the TITAN trial. In Japan, the PMDA approved ERLEADA in March 2019 (nmCRPC) and expanded its use for metastatic disease in May 2020, highlighting its global adoption.
- XTANDI (enzalutamide): An orally bioavailable, non-steroidal AR inhibitor indicated for mCRPC patients who have previously received docetaxel. XTANDI inhibits androgen receptor signaling, reducing prostate cancer cell proliferation and PSA levels. Since its initial FDA approval in August 2012 for post-docetaxel mCRPC, XTANDI has seen expanding indications: 2014 (mCRPC without prior chemotherapy), 2018 (nmCRPC and mCRPC), and 2019 (mCSPC) based on ARCHES trial data, underscoring its growing role in prostate cancer care.
- NUBEQA (darolutamide): Approved for mCSPC, including use with or without chemotherapy. In the U.S., NUBEQA is also approved for nmCRPC and is currently the only FDA-approved AR inhibitor for mHSPC in combination with ADT, with or without chemotherapy. This approval follows positive Phase III ARANOTE trial results, highlighting darolutamide’s favorable safety and tolerability across all indications.
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Androgen Receptor Targeted Therapies Competitive Landscape
Several leading companies, including Arvinas (Luxdegalutamide), Genentech (RO7656594), and others, are actively developing androgen receptor targeted therapies for multiple indications, including prostate cancer.
ARV-766 is an investigational oral PROTAC-based protein degrader designed to selectively target and eliminate the androgen receptor (AR). Preclinical studies have demonstrated its efficacy in models with normal AR expression as well as in tumors harboring AR mutations or gene amplification, which are common resistance mechanisms against currently approved AR-targeted therapies. In April 2024, Arvinas entered a global licensing agreement with Novartis to develop and commercialize luxdegalutamide (ARV-766) for prostate cancer treatment. This agreement also included the transfer of the AR-V7 program to Novartis.
RO7656594 is another orally administered androgen receptor degrader with promising anticancer potential. Upon administration, it binds to and promotes the degradation of the androgen receptor, effectively inhibiting AR-driven signaling pathways and suppressing the growth of tumor cells overexpressing AR. The androgen receptor is a hormone-regulated transcription factor critical for tumor proliferation in castration-resistant prostate cancer (CRPC).
The expected launch of these emerging therapies is set to transform the androgen receptor targeted therapies market landscape in the coming years. As these advanced treatments progress through development and gain regulatory approval, they are likely to redefine the market, establish new standards of care, and create opportunities for medical innovation and economic growth.
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Recent Developments in the Androgen Receptor Targeted Therapies Market
- In June 2025, Bayer announced that the US FDA approved its oral androgen receptor inhibitor (ARi) NUBEQA (darolutamide) in combination with androgen deprivation therapy (ADT) for patients with metastatic castration-sensitive prostate cancer (mCSPC), also referred to as metastatic hormone-sensitive prostate cancer (mHSPC).
Androgen Receptor Targeted Therapies Overview
Antiandrogens, also known as androgen receptor inhibitors or testosterone blockers, are drugs that inhibit the effects of male hormones like testosterone and dihydrotestosterone (DHT). They achieve this by either blocking androgen receptors or reducing hormone production. In this way, they act opposite to androgen receptor agonists, such as natural androgens, anabolic steroids (e.g., testosterone, DHT, nandrolone), and selective androgen receptor modulators (SARMs) like enobosarm. Antiandrogens belong to the class of sex hormone antagonists, along with antiestrogens and antiprogestogens.
Androgen Receptor Targeted Therapies Epidemiology Segmentation
The androgen receptor targeted therapies market report provides epidemiological analysis for the 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
Scope of the Androgen Receptor Targeted Therapies Market Report
- Androgen Receptor Targeted Therapies Therapeutic Assessment: Evaluation of current marketed and emerging androgen receptor targeted therapies.
- Androgen Receptor Targeted Therapies Market Dynamics: Conjoint analysis of emerging androgen receptor targeted therapy drugs and market outlook.
- Competitive Intelligence Analysis: SWOT analysis and market entry strategies for key players.
- Unmet Needs, KOL’s Views, Analyst’s Views: Insights into market gaps, expert opinions, and analyst perspectives.
- Androgen Receptor Targeted Therapies Market Access and Reimbursement: Assessment of access, pricing, and reimbursement landscape.
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About DelveInsight
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