The total metastatic castration-resistant prostate cancer market size in the 7MM was estimated to be nearly USD 2.1 billion in 2022. The market size of the metastatic castration-sensitive prostate cancer market is anticipated to change in the coming years owing to the rise in the number of patients, emergence of therapies, and increase in no. of companies taking an interest in the development of specific drugs for mCSPC along with increasing awareness.
LAS VEGAS, Dec. 6, 2023 /PRNewswire/ — DelveInsight’s Metastatic Castration-Sensitive Prostate Cancer Market Insights report includes a comprehensive understanding of current treatment practices, mCSPC emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan].
Key Takeaways from the Metastatic Castration-Sensitive Prostate Cancer Market Report
- In 2022, the United States held the highest mCSPC market share in the 7MM, at 61%, respectively, followed by the EU4 countries and the UK.
- As per DelveInsight estimates, in 2022, the total diagnosed prevalent cases of metastatic castration-sensitive prostate cancer were around 100K in the 7MM. These cases are expected to increase by 2032.
- Leading metastatic castration-sensitive prostate cancer companies such as Myovant Sciences, Pfizer, Bayer, Orion, Novartis, AstraZeneca, Pfizer, Janssen, Merck, Eli Lilly, and others are developing novel mCSPC drugs that are expected to be available in the mCSPC market in the coming years.
- The promising metastatic castration-sensitive prostate cancer therapies in the pipeline include NUBEQA, PLUVICTO, Capivasertib, TALZENNA, AKEEGA, VERZENIO, and others.
- The landscape of mHSPC has evolved tremendously in the past decades. The treatment paradigm has shifted from androgen deprivation therapy (ADT) alone to doublet combinations comprising ADT with docetaxel or an androgen receptor inhibitor, and now triplet therapy involving all three classes of agents.
- Apart from XTANDI, ZYTIGA, ERLEADA, and ORGOVYX in the mCSPC market, Bayer’s NUBEQA is another rising contender with a strong uptake in a short period. Bayer is further strategizing to increase the prescription by volume for NUBEQA by label expansion in patients who are not eligible for chemotherapy in the ARANOTE Phase III trial. Approval in mHSPC has proved to be an inflection point in NUBEQA’s prescription uptake. Given the step up in the prescription trend, NUBEQA has already surpassed all expectations in the year 2022. This momentum is going to continue on the back of doublet approval based on the ARANOTE study.
Discover which therapies are expected to grab the major mCSPC market share @ Metastatic Castration-Sensitive Prostate Cancer Market Report
Metastatic Castration-Sensitive Prostate Cancer Epidemiology
65-74 years age group, accounted for the highest number of mCSPC cases in 2022 in the US, as per DelveInsight analysi. Among EU4 countries, Germany accounted for the highest cases of mCSPC while Spain accounted for the lowest number of cases in 2022.
The mCSPC market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into:
- Total Prevalent Cases of Prostate Cancer
- Total Diagnosed Cases of Prostate Cancer
- Age-Specific Cases of Prostate Cancer
- Total Diagnosed Cases of Prostate Cancer by Clinical Stages
- Total Metastatic Cases of CSPC
- Total Treated Cases of mCSPC
Metastatic Castration-Sensitive Prostate Cancer Treatment Market
mCSPC, commonly known as mHSPC in the literature, denotes prostate cancer that remains responsive to testosterone suppression therapy. Patients with newly diagnosed metastatic disease and high-risk characteristics generally face a less favorable prognosis. In 2018, the combination of Zytiga (abiraterone acetate) and prednisone received approval for treating metastatic high-risk CSPC, based on findings from the Phase III LATITUDE trial. Zytiga had initially gained approval in 2011 for patients with mCRPC who had undergone prior chemotherapy. The indication was later expanded in 2012 to include patients with mCRPC.
Furthermore, in September 2019, the US FDA sanctioned the use of Erleada for individuals diagnosed with mHSPC.This approval further solidifies Janssen’s position in the prostate cancer drug market. Conversely, medications like Zytiga have encountered generic competition in recent years. The approval of Erleada for mCSPC introduces a hurdle to the sales growth of Zytiga, already contending with competitive challenges.
To know more about mCSPC treatment guidelines country-wise, visit @ Metastatic Castration-Sensitive Prostate Cancer Management
Metastatic Castration-Sensitive Prostate Cancer Pipeline Therapies and Key Companies
- ORGOVYX (relugolix): Myovant Sciences/Pfizer
- NUBEQA (darolutamide) + ADT: Bayer/Orion
- NUBEQA (darolutamide) + ADT ± docetaxel: Bayer/Orion
- PLUVICTO (177Lu-PSMA-617) + SOC (ARDT + ADT): Novartis
- Capivasertib + ZYTIGA (abiraterone): AstraZeneca
- TALZENNA (talazoparib) + XTANDI (enzalutamide): Pfizer
- AKEEGA (ZEJULA + abiraterone acetate + prednisone): Janssen/Merck/Tesaro (now a part of GlaxoSmithKline)
- VERZENIO (abemaciclib) + abiraterone + prednisone: Eli Lilly and Company
Learn more about the FDA-approved drugs for mCSPC @ Drugs for mCSPC Treatment
Metastatic Castration-Sensitive Prostate Cancer Market Dynamics
The dynamics of the metastatic castration-sensitive prostate cancer are expected to change in the coming years. The drug pipeline for prostate cancer is robust, featuring an abundance of therapies in the late phase of development encompassing diverse drug classes like PARPi, PD-L1i, radioligand therapies, novel hormone therapies, and AKTi. However, in contrast to the dynamic landscape for mCRPC, the developmental pipeline for mCSPC has been relatively dry. After a period of inactivity, there has been a resurgence in research and development efforts within the mCSPC drug pipeline, aided by organizations such as the Prostate Cancer Foundation, Hormone, and Urology Care Foundation, working to enhance awareness of prostate cancer and its contributing factors.
In December 2020, the US FDA approved ORGOVYX (relugolix) for the mCSPC patient population, marking a significant milestone. This approval positions ORGOVYX as the fourth drug to be approved for mCSPC patients after ZYTIGA, ERLEADA, and XTANDI The triplet regimen including NUBEQA with the chemotherapy docetaxel, plus ADT also gained FDA approval for patients with mHSPC in August 2022. Unlike XTANDI and ERLEADA, which used ADT as the control arm, NUBEQA was added to a combination of ADT and docetaxel, a regimen recommended in treatment guidelines for mHSPC.
The landscape of mCSPC treatment has witnessed a dramatic shift driven by advances in upfront hormonal and chemo-hormonal therapy. PARP inhibitors such as AKEEGA and TALZENNA are also currently being evaluated in the mHSPC space alone and with ARIs with expected entries soon.
However, several factors may impede the growth of the mCSPC market. Among the current unmet needs in prostate cancer, the lack of therapeutic options for mCSPC, along with the imperative need to delay the onset of castration-resistant mHNPC, are the most pressing challenges. The unmet need in the imaging perspective is focused on detecting the early spread of cancer in high-risk individuals and people with recurrent disease. Despite mCSPC’s high mortality rate, the majority of attention in the field of prostate cancer remains restricted to patients with mCRPC. The exact cause of prostate cancer is still unknown, leading to an unmet need to understand the condition’s etiology.
Despite improvements in patient outcomes with novel treatment modalities, a substantial unmet need for therapies exhibiting enhanced efficacy and improved safety and tolerability persists. Therefore, the therapeutic management of newly diagnosed mHSPC presents an enormous commercial opportunity for drug developers. While most mCSPC cases cannot be cured by ADT and may progress to mCRPC, the treatment landscape of CSPC, once unevolved, is now characterized by several companies investigating novel therapies. Consequently, the forecast period may witness stiff competition among upcoming therapies striving to capture a significant share of the mCSPC patient pool.
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mCSPC Market Report Metrics |
Details |
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Study Period |
2019–2032 |
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Coverage |
7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. |
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Metastatic Castration-Sensitive Prostate Cancer Market CAGR |
22 % |
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Metastatic Castration-Sensitive Prostate Cancer Market Size in 2022 |
Around USD 2.1 billion |
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Key Metastatic Castration-Sensitive Prostate Cancer Companies |
Myovant Sciences, Pfizer, Bayer, Orion, Novartis, AstraZeneca, Pfizer, Janssen, Merck, Eli Lilly, and others |
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Key Pipeline Metastatic Castration-Sensitive Prostate Cancer Therapies |
NUBEQA, PLUVICTO, Capivasertib, TALZENNA, AKEEGA, VERZENIO, and others |
Scope of the Metastatic Castration-Sensitive Prostate Cancer Market Report
- mCSPC Therapeutic Assessment: Metastatic Castration-Sensitive Prostate Cancer current marketed and emerging therapies
- Metastatic Castration-Sensitive Prostate Cancer Market Dynamics: Key Market Forecast Assumptions of Emerging Metastatic Castration-Sensitive Prostate Cancer Drugs and Market Outlook
- Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
- Unmet Needs, KOL’s views, Analyst’s views, Metastatic Castration-Sensitive Prostate Cancer Market Access and Reimbursement
Discover more about mCSPC drugs in development @ Metastatic Castration-Sensitive Prostate Cancer Clinical Trials
Table of Contents
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1 |
KEY INSIGHTS |
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2 |
REPORT INTRODUCTION |
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3 |
EXECUTIVE SUMMARY OF PROSTATE CANCER |
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4 |
KEY EVENTS |
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5 |
EPIDEMIOLOGY AND MARKET FORECAST METHODOLOGY |
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6 |
PROSTATE CANCER MARKET OVERVIEW AT A GLANCE |
|
6.1 |
MARKET SHARE (%) DISTRIBUTION OF mCSPC/mHSPC BY CLASS IN 2022 |
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6.2 |
MARKET SHARE (%) DISTRIBUTION OF mCSPC/mHSPC BY CLASS IN 2032 |
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7 |
DISEASE BACKGROUND AND OVERVIEW |
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7.1 |
SIGNS AND SYMPTOMS OF PROSTATE CANCER |
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7.2 |
EARLY SYMPTOMS OF PROSTATE CANCER |
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7.3 |
ADVANCED PROSTATE CANCER SYMPTOMS |
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7.3.1 |
Recurrent Prostate Cancer Symptoms |
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7.4 |
RISK FACTORS AND CAUSES OF PROSTATE CANCER |
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7.5 |
PATHOPHYSIOLOGY OF PROSTATE CANCER |
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7.6 |
PROSTATE NEOPLASIA |
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7.7 |
GENETICS OF PROSTATE CANCER |
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7.7.1 |
Somatic Copy Number Alteration |
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7.7.2 |
Structural Rearrangements |
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7.7.3 |
Point Mutations |
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7.7.4 |
Single nucleotide polymorphisms (SNPs) |
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7.8 |
DIAGNOSIS OF PROSTATE CANCER |
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7.8.1 |
Screening Tests for Prostate Cancer |
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7.8.2 |
Tests to Diagnose Prostate Cancer |
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7.8.3 |
Stages and Grades of Prostate Cancer |
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8 |
TREATMENT AND MANAGEMENT OF PROSTATE CANCER |
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8.1 |
TREATMENT ALGORITHM OF PROSTATE CANCER |
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8.2 |
OBSERVATION OR ACTIVE SURVEILLANCE |
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8.3 |
SURGERY |
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8.3.1 |
Open or Laparoscopic Radical Prostatectomy |
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8.3.2 |
Risks of Prostate Surgery |
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8.4 |
RADIATION THERAPY |
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8.4.1 |
Types of Radiation Therapy |
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8.5 |
HORMONE THERAPY |
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8.5.1 |
Types of Hormone Therapy |
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8.6 |
IMMUNOTHERAPY |
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8.6.1 |
Vaccine |
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8.6.2 |
Immune checkpoint inhibitors |
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8.7 |
CHEMOTHERAPY |
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9 |
TREATMENT GUIDELINES |
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9.1 |
GUIDELINES FOR THE MANAGEMENT OF PROSTATE CANCER (NATIONAL COMPREHENSIVE CANCER NETWORK, 2023) |
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9.2 |
EUROPEAN SOCIETY FOR MEDICAL ONCOLOGY (ESMO) TREATMENT RECOMMENDATIONS FOR PROSTATE CANCER |
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9.3 |
ADVANCED PROSTATE CANCER: AUA/SUO GUIDELINE |
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9.4 |
JAPANESE UROLOGICAL ASSOCIATION: 2016 |
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9.4.1 |
Prostate Cancer Screening |
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9.4.2 |
Prostate Cancer Treatment |
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9.5 |
ADVANCED PROSTATE CANCER CONSENSUS CONFERENCE (APCCC): 2021 |
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9.6 |
NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE (NICE) RECOMMENDATION GUIDELINES FOR mCSPC/mHSPC: 2022 |
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9.7 |
SEOM CLINICAL GUIDELINES FOR MCSPC/MHNPC: 2021 |
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9.8 |
EUROPEAN ASSOCIATION OF UROLOGY GUIDELINES ON PROSTATE CANCER (2023) |
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9.9 |
CLINICAL GUIDELINES FOR THE TREATMENT OF ADVANCED PROSTATE CANCER (SPANISH SOCIETY OF MEDICAL ONCOLOGY, 2020) |
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9.10 |
GUIDELINES FOR THE TREATMENT OF ADVANCED PROSTATE CANCER (NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE, 2021) |
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9.11 |
GUIDELINES FOR THE ADVANCED PROSTATE CANCER (CANCER COMMITTEE OF THE FRENCH ASSOCIATION OF UROLOGY, 2020) |
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10 |
EPIDEMIOLOGY AND PATIENT POPULATION |
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10.1 |
KEY FINDINGS |
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10.2 |
ASSUMPTIONS AND RATIONALE |
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10.3 |
TOTAL METASTATIC CASES OF PROSTATE CANCER IN THE 7MM |
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10.4 |
THE UNITED STATES |
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10.4.1 |
Total Prevalent Cases of Prostate Cancer in the United States |
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10.4.2 |
Total Diagnosed Prevalent Cases of Prostate Cancer in the United States |
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10.4.3 |
Age-specific Cases of Prostate Cancer in the United States |
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10.4.4 |
Total Diagnosed Cases of Prostate Cancer by Clinical Stages in the United States |
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10.4.5 |
Total Cases of mCSPC/mHSPC in the United States |
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10.4.6 |
Total Treated Cases of mCSPC/mHSPC in the United States |
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10.5 |
EU4 AND THE UK |
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10.5.1 |
Total Prevalent Cases of Prostate Cancer in EU4 and the UK |
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10.5.2 |
Total Diagnosed Prevalent Cases of Prostate Cancer in EU4 and the UK |
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10.5.3 |
Age-specific Cases of Prostate Cancer in EU4 and the UK |
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10.5.4 |
Total Diagnosed Cases of Prostate Cancer by Clinical Stages in EU4 and the UK |
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10.5.5 |
Total Cases of mCSPC/mHSPC in EU4 and the UK |
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10.5.6 |
Total Treated Cases of mCSPC/mHSPC in EU4 and the UK |
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10.6 |
JAPAN |
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10.6.1 |
Total Prevalent Cases of Prostate Cancer in Japan |
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10.6.2 |
Total Diagnosed Cases of Prostate Cancer in Japan |
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10.6.3 |
Age-specific Cases of Prostate Cancer in Japan |
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10.6.4 |
Total Diagnosed Cases of Prostate Cancer by Clinical Stages in Japan |
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10.6.5 |
Total Cases of mCSPC/mHSPC in Japan |
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10.6.6 |
Total Treated Cases of mCSPC/mHSPC in Japan |
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11 |
PATIENT JOURNEY |
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12 |
MARKETED THERAPIES |
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12.1 |
KEY COMPETITORS |
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12.2 |
ERLEADA (APALUTAMIDE): JANSSEN PHARMACEUTICAL |
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12.2.1 |
Product Description |
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12.2.2 |
Regulatory Milestones |
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12.2.3 |
Other Developmental Activities |
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12.2.4 |
Clinical Development |
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12.2.5 |
Safety and Efficacy |
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12.3 |
ORGOVYX (RELUGOLIX): MYOVANT SCIENCES |
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12.3.1 |
Product Description |
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12.3.2 |
Regulatory Milestones |
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12.3.3 |
Other Developmental Activities |
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12.3.4 |
Clinical Development |
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12.3.5 |
Safety and Efficacy |
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12.4 |
ZYTIGA (ABIRATERONE ACETATE): JANSSEN BIOTECH |
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12.4.1 |
Product Description |
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12.4.2 |
Regulatory Milestones |
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12.4.3 |
Other Developmental Activities |
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12.4.4 |
Safety and Efficacy |
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12.5 |
XTANDI (ENZALUTAMIDE): ASTELLAS PHARMA/PFIZER |
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12.5.1 |
Product Description |
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12.5.2 |
Regulatory Milestones |
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12.5.3 |
Other Developmental Activities |
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12.5.4 |
Clinical Development activity |
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12.5.5 |
Safety and Efficacy |
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12.6 |
NUBEQA (DAROLUTAMIDE): BAYER |
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12.6.1 |
Product Description |
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12.6.2 |
Regulatory Milestones |
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12.6.3 |
Other Development Activities |
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12.6.4 |
Clinical Development |
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12.6.5 |
Safety and Efficacy |
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13 |
EMERGING THERAPIES |
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13.1 |
KEY COMPETITORS |
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13.2 |
PLUVICTO (177LU-PSMA-617): NOVARTIS PHARMACEUTICALS |
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13.2.1 |
Product Description |
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13.2.2 |
Other Development Activities |
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13.2.3 |
Clinical Development |
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13.2.4 |
Safety and Efficacy |
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13.3 |
AKEEGA (NIRAPARIB AND ABIRATERONE ACETATE): JANSSEN |
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13.3.1 |
Product Description |
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13.3.2 |
Other Developmental Activities |
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13.3.3 |
Clinical Development |
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13.3.4 |
Safety and Efficacy |
|
13.4 |
TALZENNA (TALAZOPARIB): PFIZER |
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13.4.1 |
Product Description |
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13.4.2 |
Other Developmental Activities |
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13.4.3 |
Clinical Development |
|
13.4.4 |
Safety and Efficacy |
|
13.5 |
CAPIVASERTIB (AZD 5363): ASTRAZENECA |
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13.5.1 |
Product Description |
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13.5.2 |
Clinical Development |
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13.5.3 |
Safety and Efficacy |
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13.6 |
VUDALIMAB: XENCOR |
|
13.6.1 |
Product Description |
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13.6.2 |
Clinical Development |
|
13.6.3 |
Safety and Efficacy |
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13.7 |
VERZENIO (ABEMACICLIB/LY2835219): ELI LILLY AND COMPANY |
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13.7.1 |
Product Description |
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13.7.2 |
Clinical Development |
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13.7.3 |
Safety and Efficacy |
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14 |
PROSTATE CANCER: SEVEN MAJOR MARKET ANALYSIS |
|
14.1 |
KEY FINDINGS |
|
14.2 |
TOTAL MARKET SIZE OF mCSPC/mHSPC IN THE 7MM |
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14.3 |
MARKET OUTLOOK |
|
14.4 |
KEY MARKET FORECAST ASSUMPTIONS |
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14.5 |
UNITED STATES |
|
14.5.1 |
Total Market Size of mCSPC/mHSPC in the United States |
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14.5.2 |
Market Size of mCSPC/mHSPC by Therapies in the United States |
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14.6 |
EU4 AND THE UK |
|
14.6.1 |
Total Market Size of mCSPC/mHSPC in EU4 and the UK |
|
14.6.2 |
Market Size of mCSPC/mHSPC by Therapies in EU4 and the UK |
|
14.7 |
JAPAN |
|
14.7.1 |
Total Market Size of mCSPC/mHSPC in Japan |
|
14.7.2 |
Market Size of mCSPC/mHSPC by Therapies in Japan |
|
15 |
UNMET NEEDS |
|
15.1 |
METASTATIC PROSTATE CANCER |
|
16 |
SWOT ANALYSIS |
|
17 |
KOL VIEWS |
|
18 |
MARKET ACCESS AND REIMBURSEMENT |
|
18.1 |
UNITED STATES |
|
18.1.1 |
Centre for Medicare & Medicaid Services (CMS) |
|
18.2 |
EU4 AND THE UK |
|
18.2.1 |
Germany |
|
18.2.2 |
France |
|
18.2.3 |
Italy |
|
18.2.4 |
Spain |
|
18.2.5 |
United Kingdom |
|
18.3 |
JAPAN |
|
18.3.1 |
MHLW |
|
18.4 |
PROSTATE CANCER MARKET ACCESS AND REIMBURSEMENT |
|
18.4.1 |
The United States |
|
18.4.2 |
Germany |
|
18.4.3 |
France |
|
18.4.4 |
Italy |
|
18.4.5 |
Spanish Agency of Medicines and Medical Products (AEMPS) |
|
18.4.6 |
The United Kingdom |
|
19 |
APPENDIX |
|
19.1 |
BIBLIOGRAPHY |
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19.2 |
REPORT METHODOLOGY |
|
20 |
DELVEINSIGHT CAPABILITIES |
|
21 |
DISCLAIMER |
|
22 |
ABOUT DELVEINSIGHT |
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