Metastatic Prostate Cancer Market

Emerging therapies for metastatic prostate cancer, including NUBEQA (darolutamide), ERLEADA (apalutamide), MGC018 (vobramitamab duocarmazine), Bavdegalutamide (ARV-110), and others, are expected to drive growth in the metastatic prostate cancer market in the coming years.

DelveInsight’s latest report, “Metastatic Prostate Cancer – Market Insights, Epidemiology, and Market Forecast to 2034,” provides a comprehensive analysis of the disease, covering historical and projected epidemiology as well as market trends across the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.

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During the ERS Congress 2025 in September 2025, several biotechnology and pharmaceutical companies shared notable advancements in pulmonary and cardiopulmonary research:

• In September 2025, Diagonal Therapeutics presented new preclinical data highlighting the potential of its lead clustering antibody, DIAG723, as a disease-modifying therapy for pulmonary arterial hypertension (PAH).

• In September 2025, a study revealed that babies raised with dogs may have a reduced risk of developing childhood asthma.

• In September 2025, Savara shared data from the Phase 3 IMPALA-2 trial of Molgramostim Inhalation Solution for patients with autoimmune pulmonary alveolar proteinosis (aPAP).

• In September 2025, AllRock Bio, Inc. reported encouraging Phase 1 results for ROC-101, a first-in-class oral pan-ROCK inhibitor for cardiopulmonary and fibrotic diseases.

• In September 2025, Gossamer Bio, Inc., in collaboration with Chiesi Group, announced five scientific presentations on seralutinib for PAH and PH-ILD.

• In September 2025, Boehringer Ingelheim presented pooled analyses from the Phase III FIBRONEER™ program on nerandomilast, an investigational oral PDE4B inhibitor, showing a nominally significant reduction in mortality risk across IPF and PPF.

• In September 2025, Kaia Health launched a pilot program of Kaia Breathe, a digital pulmonary rehabilitation solution for COPD patients, in partnership with MedImprove.

• In September 2025, aTyr Pharma, Inc. shared additional findings from the Phase 3 EFZO-FIT™ study of efzofitimod in 268 patients with pulmonary sarcoidosis, a key form of interstitial lung disease.

Some of the key facts of the Metastatic Prostate Cancer Market Report:

• In 2023, the metastatic castration-resistant prostate cancer (mCRPC) market across the seven major markets (7MM) was valued at approximately USD 7 billion, with steady growth expected through 2034. The United States accounted for the largest share of both the mCRPC (63%) and mCSPC (61%) markets, followed by the EU4 and the United Kingdom.

• In March 2025, the FDA expanded the use of Pluvicto for adult patients with PSMA-positive mCRPC who had previously received androgen receptor pathway inhibitors and taxane-based chemotherapy. In February 2025, the FDA granted Fast Track designation to 67Cu-SAR-bisPSMA for PSMA-positive mCRPC patients previously treated with androgen receptor pathway inhibitors, facilitating the development of this novel radiopharmaceutical.

• In the U.S., roughly 60% of prostate cancer cases were diagnosed at a localized or locally advanced stage, followed by cases in the biochemical recurrence/progressive stage.

• Despite the introduction of generic ZYTIGA in the U.S. (2019) and Europe (late 2022), which impacted revenue—especially in the U.S.—abiraterone acetate continues to be evaluated in combination with novel therapies, helping it maintain a strong patient base. XTANDI (Janssen) remains the leading revenue-generating therapy, maintaining stable growth since 2021, despite increasing competition. Alongside XTANDI, ZYTIGA, ERLEADA, and Bayer’s NUBEQA have emerged as key contenders, particularly in the mCSPC segment. Bayer is pursuing expanded use of NUBEQA, especially for chemotherapy-ineligible patients, via the ongoing ARANOTE Phase III trial.

• The mCRPC treatment landscape was significantly advanced by the FDA approval of Novartis’ PLUVICTO radioligand therapy in 2022, which rapidly gained traction in the third-line treatment setting, with plans to expand its indication to mHSPC by 2025.

• PARP inhibitors are also gaining importance for patients with HRR gene mutations (e.g., BRCA1/2). Key approvals include AstraZeneca’s LYNPARZA (first-line and beyond), RUBRACA (third-line), and 2023 approvals for TALZENNA, AKEEGA, along with additional first-line indications for LYNPARZA.

• The overall prostate cancer market—covering both mCRPC and mHSPC—is projected to grow substantially, driven by an aging population, increased disease awareness, broader use of approved therapies, and the introduction of novel treatments. According to DelveInsight estimates, total prevalent prostate cancer cases across the 7MM reached approximately 8.24 million in 2023, with the U.S. representing the largest share at around 1.51 million cases.

• Multiple investigational therapies are in development by companies including AstraZeneca (capivasertib), Arvinas (ARV-110), Daiichi Sankyo (D-7300), Essa Pharma (EPI-7386), and others, reflecting ongoing innovation in the field.

• In February 2025, Ibex Medical Analytics received FDA 510(k) clearance for its Ibex Prostate Detect system, an AI-powered diagnostic tool that generates heatmaps to detect subtle or rare prostate cancers, providing additional support for pathologists.

• In September 2024, Ipsen reported results from the Phase III CONTACT-02 trial, evaluating Cabometyx® with atezolizumab for mCRPC. While the study did not achieve a significant improvement in overall survival, it met its progression-free survival (PFS) endpoint. That same month, Foundation Medicine gained FDA approval for FoundationOne®CDx and FoundationOne®Liquid CDx tests as companion diagnostics for LYNPARZA in patients with BRCA-mutated mCRPC.

• Key companies actively developing new therapies for metastatic prostate cancer include AstraZeneca, Arvinas, Madison Vaccines, Phosplatin Therapeutics, Hinova Pharmaceuticals, Bristol Myers Squibb, Merck, MacroGenics, Daiichi Sankyo, Seagen/Merck, Taiho Pharmaceutical, Modra Pharmaceuticals, Xencor, Point Biopharma, Lantheus Holdings, Zenith Epigenetics, Essa Pharma, Telix Pharmaceuticals, Kintor Pharmaceutical, AB Science, Eli Lilly and Company, Exelixis, among others.

• Promising therapies in development include NUBEQA (darolutamide), ERLEADA (apalutamide), MGC018 (vobramitamab duocarmazine), Bavdegalutamide (ARV-110), and several others, indicating a dynamic and expanding treatment landscape.

Metastatic Prostate Cancer Overview

Prostate cancer is a type of cancer that begins in the prostate gland, a key component of the male reproductive system. When the disease spreads beyond the prostate to other areas of the body, it is called metastatic or advanced prostate cancer. The cancer most commonly spreads to the lymph nodes or bones, but it can also affect organs such as the lungs.

Metastatic hormone-sensitive prostate cancer (mHSPC) describes cases where the cancer has spread beyond the prostate but still responds to hormone therapy. In contrast, metastatic castration-resistant prostate cancer (mCRPC) refers to cancer that continues to progress despite ongoing hormone treatment.

Metastatic Prostate Cancer Market Outlook

Metastatic Castration-Resistant Prostate Cancer (mCRPC) is an advanced stage of prostate cancer in which the disease has spread to other areas, such as the lymph nodes or bones, and no longer responds to testosterone-lowering therapies. Despite available treatments, mCRPC remains highly aggressive and ultimately fatal. Androgen deprivation therapy (ADT) is usually the first-line treatment for metastatic prostate cancer, but most patients eventually progress to mCRPC and require additional systemic therapies, which can be challenging to manage.

Before 2010, docetaxel was the only therapy proven to improve overall survival in mCRPC, receiving FDA approval in 2004 when combined with prednisone. Patients who progressed after docetaxel had limited options for many years. However, the treatment landscape has since expanded with the approval of several new therapies, including JEVTANA, ZYTIGA, XTANDI, LYNPARZA, TALZENNA, and AKEEGA.

PARP inhibitors have become a major advancement in targeted therapy. In 2023, AKEEGA (Janssen), TALZENNA (Pfizer/Astellas), and LYNPARZA (AstraZeneca/Merck) were approved for mCRPC, offering new options for patients with specific genetic mutations.

The approval of PLUVICTO has also marked a significant milestone in the treatment of advanced, treatment-resistant mCRPC, demonstrating survival benefits and achieving a stronger-than-expected launch in the U.S. market.

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Metastatic Prostate Cancer Marketed Drugs

• NUBEQA (darolutamide): Bayer

• ERLEADA (apalutamide): Janssen

Metastatic Prostate Cancer Emerging Drugs

• MGC018 (vobramitamab duocarmazine): MacroGenics

• Bavdegalutamide (ARV-110): Arvinas

Scope of the Metastatic Prostate Cancer Market Report

• Study Period: 2020-2034

• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]

• Key Metastatic Prostate Cancer Companies: AstraZeneca, Arvinas, Madison Vaccines, Phosplatin Therapeutics, Hinova Pharmaceuticals, Bristol Myers Squibb, Merck, MacroGenics, Daiichi Sankyo, AstraZeneca, Seagen/Merck, Bristol Myers Squibb, Taiho Pharmaceutical, Modra Pharmaceuticals, Xencor, Point Biopharma, Lantheus Holdings, Zenith Epigenetics, Essa Pharma, Telix Pharmaceuticals, Kintor Pharmaceutical, AB Science, Eli Lilly and Company, Exelixis, and others

• Key Metastatic Prostate Cancer Therapies: NUBEQA (darolutamide), ERLEADA (apalutamide), MGC018 (vobramitamab duocarmazine), Bavdegalutamide (ARV-110), and others.

• Metastatic Prostate Cancer Therapeutic Assessment: Metastatic Prostate Cancer current marketed and Metastatic Prostate Cancer emerging therapies

• Metastatic Prostate Cancer Market Dynamics: Metastatic Prostate Cancer market drivers and Metastatic Prostate Cancer market barriers

• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies

• Metastatic Prostate Cancer Unmet Needs, KOL’s views, Analyst’s views, Metastatic Prostate Cancer Market Access and Reimbursement

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Key benefits of the Metastatic Prostate Cancer Market Report:

1. Metastatic Prostate Cancer market report covers a descriptive overview and comprehensive insight of the Metastatic Prostate Cancer Epidemiology and Metastatic Prostate Cancer market in the 7MM (the United States, EU5 (Germany, Spain, France, Italy, UK) & Japan).

2. The Metastatic Prostate Cancer market report provides insights into the current and emerging therapies.

3. The Metastatic Prostate Cancer market report provides a global historical and forecasted market covering drug outreach in 7MM.

4. The Metastatic Prostate Cancer market report offers an edge that will help in developing business strategies by understanding trends shaping and driving the Metastatic Prostate Cancer market.

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Table of Contents

1. Report Introduction

2. Executive Summary

3. SWOT analysis

4. Metastatic Prostate Cancer Patient Share (%) Overview at a Glance

5. Metastatic Prostate Cancer Market Overview at a Glance

6. Metastatic Prostate Cancer Disease Background and Overview

7. Metastatic Prostate Cancer Epidemiology and Patient Population

8. Country-Specific Patient Population of Metastatic Prostate Cancer

9. Metastatic Prostate Cancer Current Treatment and Medical Practices

10. Unmet Needs

11. Metastatic Prostate Cancer Emerging Therapies

12. Metastatic Prostate Cancer Market Outlook

13. Country-Wise Metastatic Prostate Cancer Market Analysis (2020–2034)

14. Market Access and Reimbursement of Therapies

15. Market drivers

16. Market barriers

17. Appendix

18. Metastatic Prostate Cancer Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

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Metastatic Prostate Cancer Pipeline Insights, DelveInsight

“Metastatic Prostate Cancer Pipeline Insight, 2024” report by DelveInsight outlines comprehensive insights of present clinical development scenarios and growth prospects across the Metastatic Prostate Cancer market. A detailed picture of the Metastatic Prostate Cancer pipeline landscape is provided, which includes the disease overview and Metastatic Prostate Cancer treatment guidelines.

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

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