Metastatic Prostate Cancer - Market Insight, Epidemiology And Market Forecast - 2032

This "Metastatic Prostate Cancer - Market Insights, Epidemiology, and Market Forecast-2032" report delivers an in-depth understanding of the metastatic prostate cancer, historical and forecasted epidemiology as well as the metastatic prostate cancer market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

The metastatic prostate cancer market report provides current treatment practices, emerging drugs, metastatic prostate cancer market share of the individual therapies, current and forecasted metastatic prostate cancer market Size from 2019 to 2032 segmented by seven major markets. The Report also covers current metastatic prostate cancer treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate best of the opportunities and assesses the underlying potential of the market.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2019-2032

Metastatic Prostate Cancer Disease Understanding and Treatment Algorithm

Prostate cancer is a type of malignancy that occurs in the prostate gland, which is a part of male reproductive system. Prostate cancer is the 3rd most prevalent type of cancer in the US and the fourth most common worldwide. Approximately 1 in 9 men in the US will be diagnosed with prostate cancer at some point in their lives. As per American Cancer Society, 2019, prostate cancer is the second leading cause of cancer death in American men, behind only lung cancer.

Treatment options of prostate cancers include mainly hormonal therapies (also known as androgen-deprivation therapy or ADT), chemotherapy, immunotherapy, radiation therapy, and surgery. For localized or locally advanced prostate cancer has active surveillance, surgery, and radiation therapy is the 3 major treatment options.

AKEEGA (niraparib and abiraterone acetate) and a combination of XTANDI (enzalutamide) with TALZENNA (talazoparib) are recently approved (2023) to treat patients with mCRPC.

NUBEQA (darolutamide) in combination with docetaxel received approval in 2022 in the US and recently in 2023 in EU and Japan for adult patients with metastatic hormone-sensitive prostate cancer (mHSPC).

Metastatic prostate cancer market is expected to witness a significant growth rate owing to rising prevalence of prostate cancer cases due to rapidly aging population and growing awareness among people, market penetration in metastatic prostate cancer due to label expansion, and entry of new emerging therapies.

Metastatic Prostate Cancer Epidemiology

The metastatic prostate cancer epidemiology division provides insights about historical and current metastatic prostate cancer patient pool and forecasted trends for every seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the report also provides the diagnosed patient pool and their trends along with assumptions undertaken.

Key Findings

The disease epidemiology covered in the report provides historical as well as forecasted metastatic prostate cancer epidemiology [segmented as 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 prostate cancer and total treated cases of metastatic CRPC and metastatic CSPC in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2019 to 2032.

Country Wise Metastatic Prostate Cancer Epidemiology

Estimates show that the highest cases of metastatic prostate cancer in the 7MM were in the United States, followed by Germany, Japan, France, Italy, the United Kingdom, and Spain in the year 2022.

• As per the publisher's estimates, the total prevalent population of prostate cancer in the seven major markets was nearly 7,977,000 cases in 2022. The cases in the 7MM are expected to increase during the study period, i.e., 2019-2032.
• As per the publisher's estimates the diagnosed cases of prostate cancer were highest in the United States. The diagnosed cases of Prostate cancer in 2022 in the US were approximately 1,462,000 cases.
• According to the estimates, most cases of prostate cancer occur in people aged 54 years and older in the United States. The United States accounted for around 124,000 cases for the age group = 54 years in 2022.
• In EU4 and the UK, the total diagnosed prevalent cases of prostate cancer by clinical stages were around 745,000, 430,000, and 88,000 cases for locally advanced (Stage I-III), biochemical recurrence/progressive, and metastatic, respectively in 2022.
• Among EU4 and the UK, Germany had the maximum total cases of metastatic prostate cancer with approximately 30,000 cases in 2022 while Spain accounted for the least number of cases. Spain accounted for 8,800 cases of metastatic prostate cancer in 2022.
• As per the publisher's estimates, treated cases of metastatic CRPC in Japan were roughly 25,000 in 2022.

Metastatic Prostate Cancer Drug Chapters

Drug chapter segment of the metastatic prostate cancer report encloses the detailed analysis of metastatic prostate cancer marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the metastatic prostate cancer 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 Drugs

XTANDI (enzalutamide): Astellas Pharma/Pfizer

XTANDI is an orally bioavailable, organic, non-steroidal small molecule targeting the AR with potential antineoplastic activity. Through a mechanism that is reported to be different from other approved AR antagonists, enzalutamide inhibits the activity of prostate cancer cell ARs, which may result in a reduction in prostate cancer cell proliferation and, correspondingly, a reduction in the serum PSA level. AR over-expression in prostate cancer represents a key mechanism associated with prostate cancer hormone resistance. In August 2012, XTANDI was approved by the US FDA for treating patients with mCRPC who have previously received docetaxel.

ERLEADA (apalutamide): Janssen Pharmaceutical

ERLEADA is a next-generation oral AR inhibitor that blocks the androgen signaling pathway in prostate cancer cells. It is indicated for the treatment of patients with nmCRPC and for the treatment of patients with metastatic CSPC. It is taken orally, once daily, with or without food. In September 2019, the US FDA approved ERLEADA for the treatment of patients with metastatic CSPC.

Note: Detailed current therapies assessment will be provided in the full report of metastatic prostate cancer

Emerging Drugs

MGC018 (vobramitamab duocarmazine): MacroGenics

MGC018 (vobramitamab duocarmazine) is an investigational ADC. MacroGenics began enrolling the TAMARACK Phase II study of vobra duo in patients with mCRPC under an amended protocol during the second quarter and anticipates enrolling a majority of the study patients in 2023 and expects to provide a clinical update by 2024.

Bavdegalutamide (ARV-110): Arvinas

ARV-110 is an oral PROTAC protein degrader that targets the AR for potentially treating men with mCRPC and who have progressed on existing therapies. The company plans to initiate a global Phase III trial with a confirmed bavdegalutamide dose in metastatic castration-resistant prostate cancer (mCRPC) for patients with AR T878/H875 tumor mutations by the second half of 2023.

Other products in development include Ceralasertib by AstraZeneca, Bavdegalutamide (ARV-110) by Arvinas, PT-112 by Phosplatin Therapeutics, and others.

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

Metastatic Prostate Cancer Market Outlook

Metastatic CSPC, also referred to as mHSPC in literature refers to prostate cancer that still responds to testosterone suppression therapy. mCRPC is another type of prostate cancer that is highly talked about and holds huge market potential. It is a stage of prostate cancer that has spread to other parts of the body, such as lymph nodes or bones, and no longer responds to treatment that lowers testosterone. Moreover, patients with newly diagnosed metastatic disease and high-risk disease characteristics tend to have a poorer prognosis.

Currently, the market holds a diverse range of therapeutic alternatives for treatment, including PARP inhibitors, androgen receptor inhibitors, CYP17 inhibitors, microtubule inhibitors, ionizing radiation emitters, and others in different lines of treatment.

In 2018, ZYTIGA (abiraterone acetate) in combination with prednisone was approved for the treatment of metastatic high-risk CSPC. Approval in this category was based on the results of the Phase III LATITUDE trial. Before this, ZYTIGA was approved in 2011 initially for patients with mCRPC who had received prior chemotherapy and expanded the indication in 2012 for patients with mCRPC.

Moreover, in September 2019, the US FDA also approved ERLEADA for patients with mHSPC. The efficacy of ERLEADA was evaluated in TITAN trial.

Most recently, PARP inhibitors have shown tremendous development in metastatic prostate cancer with AKEEGA (Janssen), followed by TALZENNA (Pfizer/Astellas Pharma) and LYNPARZA in combination (AstraZeneca/Merck) getting approved in mCRPC in the year 2023.

Over the past few years, improvements in CRPC have shown that treatments are more effective when used early. However, combination therapy has yet to be proven beneficial. To achieve that, it is necessary to possess a profound understanding of the market and the associated unmet needs.

Currently, several companies have indulged themselves in initiating clinical trials that investigate new treatment options or studying how to use existing treatment options better. Companies like Bayer/Orion, Novartis, Astrazeneca, Pfizer, and others are investigating their key products for managing metastatic prostate cancer.

According to the publisher, metastatic prostate cancer market in 7MM is expected to witness a major change in the study period 2019-2032.

Key Findings

• The market size of metastatic CRPC in the seven major markets was approximately USD 6400 million in 2022, which is expected to rise from during the study period (2019-2032).
• The therapies with the potential to get launched in the forecast period include AstraZeneca (Capivasertib), Arvinas (ARV-110), MacroGenics (MGC018) and others. The launch of these therapies may increase market size in the coming years, assisted by an increasing patient pool of metastatic prostate cancer patients.
• The United States accounts for the largest market size of metastatic prostate cancer compared to EU4 (Germany, Italy, France, and Spain) and the United Kingdom, and Japan.
• In the United States, the market size of metastatic CSPC was nearly USD 1300 million in 2022 and is anticipated to rise from during the forecast period.
• Among the EU4 and the UK, Germany had the largest market size of approximately USD 580 million in 2022, while Spain had the smallest with nearly USD 170 million in mCRPC.
• In 2022, Japan accounted for a market size of around USD 191 million in mCSPC.

The United States Market Outlook

The total market size of metastatic CRPC and metastatic CSPC in the United States is expected to increase with a CAGR of 8.9% and 23.5% respectively, in the study period (2019-2032).

EU-5 Countries: Market Outlook

The total market size of metastatic CRPC and metastatic CSPC in EU4 and the UK is expected to increase with a CAGR of 5.1% and 18.3% respectively, in the study period (2019-2032).

Japan Market Outlook

The total market size of metastatic CRPC and metastatic CSPC in the Japan is expected to increase with a CAGR of 3.1% and 20.3% respectively, in the study period (2019-2032).

Analyst Commentary

• Most of the attention in the field of advanced prostate cancer was restricted to the research and development of drugs for patients with CRPC even though CSPC is burdened with poor prognosis and impaired quality of life. However, recent years have witnessed an expansion in the field of metastatic prostate cancer which led to approval of a handful of drugs for this patient pool. Owing to handful of drugs approved in this field, the market poses an opportunity for the upcoming drugs. Any medication, if approved, may capture a major share of the market due to less competitive scenario.
• According to secondary source, chemotherapy usage is higher in EU, in comparison to the US and Japan. In Japan, less chemotherapy usage is observed.
• Many drugs can be used in the treatment algorithm for metastatic prostate cancer, but the standard of care continues to be androgen deprivation therapy with either docetaxel, enzalutamide (XTANDI), apalutamide (ERLEADA), or abiraterone acetate (ZYTIGA). Additionally, darolutamide (NUBEQA) could potentially be added to this treatment. The established markets of the already approved drugs may provide a fair competition to the upcoming therapies.
• For decades, the SOC for metastatic CSPC has been ADT. Although it is initially effective in most of the patient population, eventually, the disease progresses and develops castration resistance; this occurs at a median time of approximately 1 year. Our analysis suggest that intensifying ADT with additional agents, specifically docetaxel or androgen receptor pathway inhibitors has improved PFS and OS. Thus, the market possess a void and potential opportunity for development of treatment options as monotherapy or combination therapies to provide PFS to this patient pool.
• Other therapy such as Capivasertib + Abiraterone: PTEN deficient has the potential to change the market dynamics. The anticipation is based on the recent data presented by the company.
• The entry of pharmaceutical firms exploring novel medicines for metastatic prostate cancer in the future label extension of currently approved medications can contribute to the overall market size.
• To summarize, various possible treatments for the management of metastatic prostate cancer will be researched in the near future, and it is safe to expect that the therapeutic space will suffer substantial influence throughout the forecast period, 2022-2032.

Metastatic Prostate Cancer Drugs Uptake

This section focusses on the rate of uptake of the potential drugs recently launched in the metastatic prostate cancer market or expected to get launched in the market during the study period 2019-2032. The analysis covers metastatic prostate cancer market uptake by drugs; patient uptake by therapies; and sales of each drug. For example-

NUBEQA (darolutamide) Based on the key Phase III ARAMIS trial findings, Nubeqa was approved in the United States in 2019 for the treatment of patients with nmCRPC. According to the company, strong launch performance has been observed in men with high-risk nmCRPC to date. NUBEQA has made significant advances, owing to increased volumes in the United States. The company is also experiencing promising early signs in Europe. So far, the price and reimbursement environment in Germany has been positive. In Germany, it is the only second-generation ARi to receive significant benefits from IQWIG and GB-A. Finally, a good market share increase in nmCRPC, along with a sustained rise in new prescribers and favorable consumer opinion, will encourage continued acceptance of this candidate in the United States and other countries as well. In males with mHSPC, a Phase III ARASENS study met the primary endpoint of OS for NUBEQA + docetaxel + ADT. ARASENS is part of a larger NUBEQA development package that involves another ongoing Phase III study in mHSPC, ARANOTE, which is evaluating NUBEQA + ADT. Approval for NUBEQA + docetaxel + ADT was received in August 2022 in the US based on Phase III ARASENS trial. Recently, it was approved in EU4 and the UK and Japan in March 2023 and February 2023, respectively. Given the recent approval in metastatic CSPC trial and robust performance of NUBEQA in nmCRPC so far, it is reasonable to expect that NUBEQA'S potential in men with metastatic HSPC will provide a new therapeutic alternative. It is expected that the drug may enter the US and EU market by 2025 and Japanese market by 2026 with its other combination i.e., NUBEQA + ADT.

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

Metastatic Prostate Cancer Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase II and Phase III stage. It also analyses metastatic prostate cancer key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing, patent details and other information for metastatic prostate cancer emerging therapies.

Reimbursement Scenario in Metastatic Prostate Cancer

• Pfizer and Astellas are committed to helping patients access XTANDI by providing them with access and reimbursement support resources, including information regarding patient healthcare coverage options and financial assistance options that may be available to help patients with financial needs. The XTANDI Patient Savings Program is for eligible patients with commercial prescription insurance. The Astellas Patient Assistance Program provides XTANDI at no cost to patients who meet the program eligibility requirements. All patients in this program who qualify receive their XTANDI prescription at no cost.
• To comfort mHSPC patients, Janssen has initiated support for patients using commercial or private insurance to pay for medication. Janssen CarePath Savings Program for ERLEADA can help eligible patients receive instant savings on their out-of-pocket medication costs for ERLEADA. Depending on the patient's health insurance plan, savings may apply toward co-pay, co-insurance, or deductible. Eligible patients will pay USD 0 per month with a USD 15,000 maximum program benefit per calendar year or one-year supply, whichever comes first (Janssen). Further, the Janssen CarePath Savings Program for ZYTIGA aims to help eligible patients receive instant savings on their out-of-pocket medication costs for ZYTIGA. Depending on the patient's health insurance plan, savings may apply toward co-pay, co-insurance, or deductible.

KOL- Views

To keep up with current market trends, we take KOLs and SME's opinion working in the domain through primary research to fill the data gaps and validate our secondary research. Some of the leaders are Senior Vice President and Head of Oncology Development, Bayer Pharmaceuticals, - M.D. and Professor, University of Utah School of Medicine and others. Their opinion helps to understand and validate current and emerging therapies treatment patterns or metastatic prostate cancer market trend. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.

Competitive Intelligence Analysis

The publisher performed Competitive and Market Intelligence analysis of the metastatic prostate cancer Market by using various Competitive Intelligence tools that include - SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report

• The report covers the descriptive overview of metastatic prostate cancer, explaining its causes, signs and symptoms, pathophysiology, diagnosis and currently available therapies
• Comprehensive insight has been provided into the metastatic prostate cancer epidemiology and treatment in the 7MM
• Additionally, an all-inclusive account of both the current and emerging therapies for metastatic prostate cancer are provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape
• A detailed review of metastatic prostate cancer market; historical and forecasted is included in the report, covering drug outreach in the 7MM
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the global metastatic prostate cancer market

Report Highlights

• In the coming years, metastatic prostate cancer market is set to change due to the rising awareness of the disease, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market
• The companies and academics are working to assess challenges and seek opportunities that could influence metastatic prostate cancer R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition
• Major players are involved in developing therapies for metastatic prostate cancer. Launch of emerging therapies will significantly impact the metastatic prostate cancer market
• A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for metastatic prostate cancer

- Our in-depth analysis of the pipeline assets across different stages of development (Phase III and Phase II), different emerging trends and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities

Metastatic Prostate Cancer Report Insights

• Patient Population
• Therapeutic Approaches
• Metastatic Prostate Cancer Pipeline Analysis
• Metastatic Prostate Cancer Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

Metastatic Prostate Cancer Report Key Strengths

• 10 Years Forecast
• 7MM Coverage
• Metastatic Prostate Cancer Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market

- Drugs Uptake

Metastatic Prostate Cancer Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Market Drivers and Barriers

Key Questions Answered

Market Insights:

• What was the metastatic prostate cancer drug class share (%) distribution in 2019 and how it would look like in 2032?
• What would be the metastatic prostate cancer total market size as well as market size by therapies across the 7MM during the forecast period (2019-2032)?
• What are the key findings pertaining to the market across 7MM and which country will have the largest metastatic prostate cancer market size during the forecast period (2019-2032)?
• At what CAGR, the metastatic prostate cancer market is expected to grow in 7MM during the forecast period (2019-2032)?
• What would be the metastatic prostate cancer market outlook across the 7MM during the forecast period (2019-2032)?
• What would be the metastatic prostate cancer market growth till 2032, and what will be the resultant market Size in the year 2032?
• How would the unmet needs affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights:

• What is the disease risk, burden and regional/ethnic differences of the metastatic prostate cancer?
• What are the key factors driving the epidemiology trend for seven major markets covering the United States, EU4 (Germany, France, Italy and Spain) and the UK, and Japan?
• What is the historical metastatic prostate cancer patient pool in seven major markets covering the United States, EU4 (Germany, France, Italy and Spain) and the UK, and Japan?
• What would be the forecasted patient pool of metastatic prostate cancer in seven major markets covering the United States, EU4 (Germany, France, Italy and Spain) and the UK, and Japan?
• Where will be the growth opportunities in the 7MM with respect to the patient population pertaining to metastatic prostate cancer?
• Out of all metastatic prostate cancer countries, which country would have the highest prevalent population of metastatic prostate cancer during the forecast period (2019-2032)?
• At what CAGR the patient population is expected to grow in 7MM during the forecast period (2019-2032)?

Current Treatment Scenario, Marketed Drugs and Emerging Therapies:

• What are the current options for the metastatic prostate cancer treatment in addition to the approved therapies?
• What are the current treatment guidelines for the treatment of metastatic prostate cancer in the USA, Europe, and Japan?
• What are the metastatic prostate cancer marketed drugs and their respective MOA, regulatory milestones, product development activities, advantages, disadvantages, safety and efficacy, etc.?
• How many companies are developing therapies for the treatment of metastatic prostate cancer?
• How many therapies are in-development by each company for metastatic prostate cancer treatment?
• How many are emerging therapies in mid-stage, and late stage of development for metastatic prostate cancer treatment?
• What are the key collaborations (Industry - Industry, Industry - Academia), Mergers and acquisitions, licensing activities related to the metastatic prostate cancer therapies?
• What are the recent novel therapies, targets, mechanisms of action and technologies being developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for metastatic prostate cancer and their status?
• What are the current challenges faced in drug development?
• What are the key designations that have been granted for the emerging therapies for metastatic prostate cancer?
• What are the global historical and forecasted market of metastatic prostate cancer?

Reasons to Buy

• The report will help in developing business strategies by understanding trends shaping and driving the metastatic prostate cancer market
• To understand the future market competition in the metastatic prostate cancer market and Insightful review of the key market drivers and barriers
• Organize sales and marketing efforts by identifying the best opportunities for metastatic prostate cancer in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom) and Japan
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors
• Organize sales and marketing efforts by identifying the best opportunities for metastatic prostate cancer market
• To understand the future market competition in the metastatic prostate cancer market