Androgen Receptor Targeted Therapies Market

• Androgen receptor targeted therapies market is expected to grow significantly in the coming years. This is due to the increasing number of patients who are being diagnosed with cancer, the growing awareness of androgen receptor targeted therapies, and the increasing number of androgen receptor targeted therapies that are under clinical trials and filed for approval by various companies. 
• Androgen receptor targeted therapies are effective treatments for prostate cancer, breast cancer, and other malignancies. They are also being explored for non-oncologic conditions, including polycystic ovary syndrome (PCOS) and metabolic syndrome. However, their primary clinical use remains in prostate cancer treatment.
• Several Androgen receptor targeted therapies companies, including Johnson & Johnson Innovative Medicine, Astellas Pharma, Pfizer, Bayer, Arvinas, Genentech and others are engaged in the commercialization and development of androgen receptor targeted therapies, with a range of approved and emerging Androgen receptor targeted drugs.
• In the prostate cancer market, XTANDI leads with established dominance and potential expansion into new indications. ERLEADA gains ground with Food and Drug Administration (FDA) approval for metastatic disease, while NUBEQA offers strong safety data but faces competition. 
• XTANDI's sales growth, coupled with promising trial results, positions it favorably, but ERLEADA and NUBEQA pose credible challenges with recent approvals and comparable efficacy.
• In April 2024, the European Commission extended XTANDI's label to include its use as monotherapy or in combination with ADT for adult men with high-risk biochemical recurrence non-metastatic hormone-specific prostate cancer unsuitable for salvage-radiotherapy. These approvals offer new treatment options for patients facing this challenging condition.
• In June 2023, Pfizer announced that the US FDA approved TALZENNA (talazoparib, in combination with XTANDI (enzalutamide), for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).

DelveInsight’s “Androgen Receptor Targeted Therapies Market Size, Target Population, Competitive Landscape, and Market Forecast – 2034” report delivers an in-depth understanding of the Androgen receptor targeted therapies, historical and Competitive Landscape as well as the Androgen receptor targeted therapies market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The Androgen receptor targeted therapies market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM Androgen receptor targeted therapies market size from 2020 to 2034. The Androgen receptor targeted therapies market report also covers current Androgen receptor targeted therapies treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the Androgen receptor targeted therapies market’s potential.

Androgen Receptor Targeted Therapies Market: Understanding 

Androgen Receptor Targeted Therapies Overview

Antiandrogens, also known as Androgen receptor inhibitors or testosterone blockers, are a class of drugs that prevent androgens like testosterone and dihydrotestosterone (DHT) from mediating their biological effects in the body. They act by blocking the androgen receptor (AR) and inhibiting or suppressing androgen production. They can be thought of as the functional opposites of androgen receptor agonists, for example, androgens and anabolic steroids (AAS) like testosterone, dihydrotestosterone, and nandrolone and selective androgen receptor modulators (SARMs) like enobosarm. Antiandrogens are one of three types of sex hormone antagonists, the others being antiestrogens and antiprogestogens.

Anti-androgens are used to treat an assortment of androgen-dependent conditions. In men, antiandrogens are used in the treatment of prostate cancer, enlarged prostate, scalp hair loss, overly high sex drive, unusual and problematic sexual urges, and early puberty. In women, antiandrogens are used to treat acne, seborrhea, excessive hair growth, scalp hair loss, and high androgen levels, such as those that occur in polycystic ovary syndrome (PCOS). Antiandrogens are also used as a component of feminizing hormone therapy for transgender women and as puberty blockers in transgender girls.

Further details related to country-based variations are provided in the report…

Androgen Receptor Targeted therapies Epidemiology

The Androgen receptor targeted therapies epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented as total cases of selected indication for androgen receptor targeted therapies, total eligible patient pool of selected indication for androgen receptor targeted therapies, total treated cases in selected indication for androgen receptor targeted therapies in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan from 2020 to 2034. 

• In 2024, the United States accounted for the highest number of five-year prevalent cases of prostate cancer around 3,751,800.
• Most cases of prostate cancer occur in people aged 65–74 years and older.
• In 2024, within the United States, the five-year prevalent cases of metastatic castration-sensitive prostate cancer (mCSPC) surpassed that of metastatic castration-resistant prostate cancer (mCRPC), with approximately 70,300 cases of mCSPC. 

Androgen Receptor Targeted Therapies Drug Chapters

The drug chapter segment of androgen receptor targeted therapies market reports encloses a detailed analysis of androgen receptor targeted therapies marketed drugs and late-, mid- and early stage pipeline drugs. It also helps understand the androgen receptor targeted therapy’s clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

Marketed Androgen receptor targeted therapies Drugs

ERLEADA (apalutamide): Johnson & Johnson Innovative Medicine

ERLEADA is a next-generation oral androgen receptor inhibitors that blocks the androgen signaling pathway in prostate cancer cells. It is indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and for metastatic castration-sensitive prostate cancer. It is taken orally, once daily, with or without food. It received FDA approval in February 2018 for non-metastatic castration-resistant prostate cancer and in September 2019 for metastatic castration-sensitive prostate cancer after a Priority Review Designation. European Commission approved in January 2019 for non-metastatic castration-resistant prostate cancer, while in January 2020, ERLEADA obtained European Commission approval for metastatic hormone-sensitive prostate cancer (mHSPC) following the TITAN trial. PMDA approved ERLEADA for non-metastatic castration-resistant prostate cancer in March 2019 in Japan and expanded approval for metastatic disease in May 2020, underlining its global impact on prostate cancer treatment.

XTANDI (enzalutamide): Astellas Pharma/Pfizer

It is an orally bioavailable, organic, non-steroidal small molecule targeting the androgen receptor with potential antineoplastic activity. XTANDI is an androgen receptor inhibitors indicated for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel. Through a mechanism that is reported to be different from other approved androgen receptor antagonists, enzalutamide inhibits the activity of prostate cancer cell androgen receptors, which may result in a reduction in prostate cancer cell proliferation and, correspondingly, a reduction in the serum PSA level. Androgen receptor overexpression in prostate cancer represents a key mechanism associated with prostate cancer hormone resistance. Since its FDA approval in August 2012 for metastatic castration-resistant prostate cancer post-docetaxel, XTANDI has gained expanded indications. In September 2014, it was approved for metastatic castration-resistant prostate cancer patients without prior chemotherapy. In July 2018, its use extended to both non-metastatic and metastatic CRPC. Later in 2019 drug received approval for metastatic castration-sensitive prostate cancer based on ARCHES trial data. These milestones mark XTANDI's evolving role in addressing various prostate cancer stages, solidifying its status as a crucial treatment option.

Darolutamide (NUBEQA): Bayer 

The FDA has approved darolutamide (NUBEQA) for the treatment of adult patients with metastatic castration-sensitive prostate cancer (mCSPC), the agency announced in a news release. With this approval, darolutamide becomes the first Androgen receptor inhibitor approved for use in patients with mCSPC with or without chemotherapy. Darolutamide is also indicated in the US for use in combination with and without docetaxel in adult patients with mCSPC, as well as for the treatment of adult patients with non-metastatic castration-resistant prostate cancer. NUBEQA is the first and only in the US and FDA-approved Androgen receptor targeted therapies (ARi) for the treatment of patients with hormone-sensitive prostate cancer (mHSPC), in combination with androgen deprivation therapy (ADT), with or without chemotherapy. This third approval is based on positive results from the pivotal Phase III ARANOTE trial and broadens the indication profile of darolutamide in mHSPC, enabling its use in combination with ADT, with or without chemotherapy (docetaxel) / Darolutamide plus ADT reinforces NUBEQA’s established safety and tolerability profile for prostate cancer patients across all approved indications

Note: Detailed current therapies assessment will be provided in the full report of Androgen receptor targeted therapies

Emerging Androgen receptor targeted therapies

Luxdegalutamide (ARV-766): Arvinas

ARV-766 is an investigational orally bioavailable PROTAC protein degrader designed to selectively target and degrade the androgen receptor. In preclinical studies, ARV-766 has demonstrated activity in models of wild type androgen receptor tumors in addition to tumors with androgen receptor mutations or amplification, both common potential mechanisms of resistance to currently available androgen receptor-targeted therapies. In April 2024, Arvinas entered into a global license agreement with Novartis for the development and commercialization of PROTAC androgen receptor protein degrader luxdegalutamide (ARV-766) for the treatment of prostate cancer. The deal also includes the sale of the AR-V7 program to Novartis. 

RO7656594 (AR Degrader/RG6537): Genentech 

An orally bioavailable androgen receptor degrader, with potential antineoplastic activity. Upon oral administration, AR degrader RO7656594 targets, binds to and degrades androgen receptor, thereby preventing androgen receptor-mediated signaling and inhibiting the proliferation of androgen receptor -overexpressing tumor cells. Androgen receptor, a hormone-regulated transcription factor, plays a key role in tumor cell proliferation in castration-resistant prostate cancer (CRPC). 

Note: Detailed emerging therapies assessment will be provided in the final report.

Androgen Receptor Targeted Therapies Market Outlook 

The market for androgen receptor targeted therapies is expected to grow significantly in the coming years. This is due to the increasing number of patients who are being diagnosed with cancer, the growing awareness of androgen receptor targeted therapies, and the increasing number of androgen receptor targeted therapies that are under clinical trials and filed for approval by various companies. 

Androgen receptor targeted therapies demonstrate the highest efficacy in treating prostate cancer, whether these are established therapies with regulatory approval or emerging treatments. Androgen receptor targeted therapies have revolutionized the management of prostate cancer, representing a pivotal therapeutic approach. Established treatments such as ERLEADA (apalutamide) and XTANDI (enzalutamide), NUBEQA (arolutamide) have demonstrated significant efficacy in metastatic castration-resistant prostate cancer, with expanded indications spanning various disease stages.

Several key players, including Arvinas, Genentech, and others, are involved in developing androgen receptor targeted therapies for various indications such as prostate cancer, and others. Overall, this is an exciting class of agents with great potential for development. The maturation of current studies over the next few years will lead to a better understanding of androgen receptor targeted therapies and define their role in the therapy of cancer.

Androgen Receptor Targeted Therapies Drugs Uptake

This section focuses on the uptake rate of potential approved and emerging androgen receptor targeted therapies expected to be launched in the market during 2025–2034.

Androgen Receptor Targeted Therapies Pipeline Development Activities

The Androgen receptor targeted therapies market report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key Androgen receptor targeted therapies manufacturers involved in developing targeted therapeutics. 

The presence of numerous drugs under different stages is expected to generate immense opportunity for androgen receptor targeted therapies market growth over the forecasted period.

Androgen receptor targeted therapies Clinical Trial Activities

The Androgen receptor targeted drugs market report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Androgen receptor targeted therapies.

KOL Views on Androgen receptor targeted therapies

To keep up with current and future market trends, we take Industry Experts’ opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on Androgen receptor targeted therapies evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, drug uptake, along challenges related to accessibility.

DelveInsight’s analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 5+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging therapy treatment patterns or androgen receptor targeted therapies market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Androgen receptor targeted therapies Market Access and Reimbursement

Reimbursement may be referred to as the negotiation of a price between a manufacturer and payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make the essential drugs affordable. Health technology assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a drug. These recommendations vary widely throughout the seven major markets, even for the same drug. 

In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs including Medicare, Medicaid, the Children's Health Insurance Program (CHIP), and the state and federal health insurance marketplaces are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs), and third-party organizations that provide services, and educational programs to aid patients are also present.

The Androgen receptor targeted therapies market report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved Androgen receptor targeted therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Key Updates on Androgen Receptor Targeted Therapies Clinical Trials

• In June 2025, Bayer announced that the US FDA has 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).

The abstract list is not exhaustive, will be provided in the final report

Scope of the Androgen receptor targeted therapies Market Report

• The Androgen receptor targeted therapies market report covers a segment of key events, an executive summary, and a descriptive overview of the Androgen receptor targeted therapies, explaining its mechanism, and therapies (current and emerging).
• Comprehensive insight into the competitive landscape, and forecasts, the future growth potential of treatment rate, drug uptake, and drug information have been provided.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current landscape.
• A detailed review of the Androgen receptor targeted therapies market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The Androgen receptor targeted therapies market report provides an edge while developing business strategies, by understanding trends, through SWOT analysis, expert insights/KOL views, and treatment preferences that help shape and drive the 7MM Androgen receptor targeted therapies market.

Androgen receptor targeted therapies Market Report Insights

• Androgen receptor targeted therapies Targeted Patient Pool
• Therapeutic Approaches
• Androgen receptor targeted therapies Pipeline Analysis
• Androgen receptor targeted therapies Market Size
• Androgen receptor targeted therapies Market Trends
• Existing and future Androgen receptor targeted therapies Market Opportunity

Androgen receptor targeted therapies Market Report Key Strengths

• Ten years Forecast
• The 7MM Coverage 
• Key Cross Competition 
• Androgen receptor targeted Drugs Uptake
• Key Androgen receptor targeted therapies Market Forecast Assumptions

Androgen receptor targeted therapies Market Report Assessment

• Current Treatment Practices
• Androgen receptor targeted therapies Unmet Needs
• Androgen receptor targeted therapies Pipeline Product Profiles
• Androgen receptor targeted therapies Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

Key Questions

• What was the androgen receptor targeted therapies market size, the market size by therapies, market share (%) distribution, and what would it look like in 2034? What are the contributing factors for Androgen receptor targeted therapies market growth?
• Which Androgen receptor targeted therapy is going to be the largest contributor in 2034?
• Which is the most lucrative market for androgen receptor targeted therapies?
• What are the pricing variations among different geographies for approved therapies?
• How the reimbursement landscape has for androgen receptor targeted therapies evolved since the first one was approved? Do patients have any access issues that are driven by reimbursement decisions?
• What are the risks, burdens, and unmet needs of treatment with androgen receptor targeted therapies? What will be the growth opportunities across the 7MM for the patient population of Androgen receptor targeted therapies?
• What are the key factors hampering the growth of the androgen receptor targeted therapies market?
• What are the indications for which recent novel therapies and technologies have been developed to overcome the limitations of existing treatments?
• What key designations have been granted to the therapies for androgen receptor targeted therapies?
• What is the cost burden of approved Androgen receptor targeted therapies on the patient?
• Patient acceptability in terms of preferred therapy options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved Androgen receptor targeted therapies? 

Reasons to buy

• The Androgen receptor targeted therapies market report will help develop business strategies by understanding the latest trends and changing dynamics driving the androgen receptor targeted therapies market.
• Understand the existing Androgen receptor targeted therapies market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
• Identifying strong upcoming Androgen receptor targeted therapy companies in the Androgen receptor targeted therapies market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of indication-wise current and emerging therapies under the conjoint analysis section to provide visibility around leading indications.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing Androgen receptor targeted therapies market so that the upcoming Androgen receptor targeted therapy companies can strengthen their development and launch strategy.