Metastatic Castration Sensitive Prostate Cancer Mcspc Market

DelveInsight's "Metastatic Castration-Sensitive Prostate Cancer (mCSPC)- Market Insights, Epidemiology, and Market Forecast-2032" report delivers an in-depth understanding of the mCSPC, historical and forecasted epidemiology as well as the mCSPC market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.

 

The mCSPC market report provides current treatment practices, emerging drugs, mCSPC market share of the individual therapies, current and forecasted mCSPC market Size from 2019 to 2032 segmented by seven major markets. The Report also covers current mCSPC 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
  • EU5 (Germany, France, Italy, Spain, and the United Kingdom)
  • Japan

Study Period: 2019-2032

mCSPC 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.

 

Patients who have never received i.e. are sensitive to ADT known as hormone-sensitive prostate cancer (HSPC) or castrate-sensitive prostate cancer (CSPC).

 

mCSPC 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 mCSPC due to label expansion, and entry of new emerging therapies.

mCSPC Epidemiology

The mCSPC epidemiology division provides insights about historical and current mCSPC 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 DelveInsight 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 mCSPC 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 CSPC and total treated cases of metastatic CSPC in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2019 to 2032.

Country Wise mCSPC Epidemiology

  • Estimates show that the highest cases of mCSPC in the 7MM were in the United States, followed by Japan, Germany, the United Kingdom, Italy, France, and Spain in the year 2021.
  • As per DelveInsight estimates, the total prevalent population of prostate cancer in the seven major markets was 7,726,394 cases in 2021. The cases in the 7MM are expected to increase during the study period, i.e., 2019–2032.
  • As per DelveInsight estimates the diagnosed cases of prostate cancer were highest in the United States. The diagnosed cases of Prostate cancer in 2021 in the US were 1,327,642 cases.
  • According to the estimated, the United States accounted for 169,647, 738,038, 1,128,665, 525,093, and 131,171 for the age group ≤ 54 years, 55-64 years, 65-74 years, 75-84 years, and >84 years in 2021.
  • In EU5, the total diagnosed prevalent cases of prostate cancer by clinical stages were around 656,570, 378,363, and 77,898 cases for locally advanced (Stage I–III), biochemical recurrence/progressive, and metastatic, respectively in 2021.
  • Among EU5 countries, Germany had the maximum total cases of metastatic CSPC with 14,600 cases in 2021 while Spain accounted for the least number of cases. Spain accounted for 4,381 cases of metastatic CSPC in 2021.
  • As per DelveInsight estimates, treated cases of metastatic CSPC in Japan were 11,094 in 2021.

mCSPC Drug Chapters

Drug chapter segment of the mCSPC report encloses the detailed analysis of mCSPC marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the mCSPC 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 (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 December 2019, Pfizer and Astellas announced that the US FDA approved a sNDA for Xtandi for the treatment of patients with mCSPC. The approval is based on results from ARCHES, a randomized phase III study which evaluated 1,150 men with mCSPC and met its primary endpoint of rPFS. In April 2021, the company announced that the EC approved an additional indication for Xtandi for adult men with mHSPC. In May 2020, the company announced that the Japanese MHLW approved the drug for the treatment of prostate cancer patients with distant metastasis.

 

Erleada (Janssen Pharmaceutical)

Erleada (apalutamide) 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 mCSPC. It is taken orally, once daily, with or without food. Erleada inhibits the growth of cancer cells in three ways: by preventing the binding of androgen to the AR; by stopping the AR from entering the cancer cells; and by preventing the AR from binding to the DNA of the cancer cell. In February 2018, Erleada received approval from the US FDA for the treatment of patients with nmCRPC. Later to that year, i.e., in September 2019, the US FDA approved Erleada for the treatment of patients with mCSPC. In January 2019, the EC granted marketing authorization for Erleada for the treatment of adult patients with nmCRPC who are at high risk of developing metastatic disease. In January 2020, the EC approved Erleada for use in combination with ADT for the treatment of adult men with mHSPC. In March 2019, Janssen obtained the MHLW approval of Erleada 60mg tablet for the treatment for adults with mCRPC. In May 2020, Nippon Shinyaku announced that Janssen Pharmaceutical which is the marketing authorization holder of the drug has obtained an expanded approval for the treatment of men with prostate cancer with distant metastases from the Ministry of Health, Labor and Welfare (MHLW).

 

Orgovyx (Myovant Sciences)

Orgovyx (relugolix) is a small molecule, gonadotropin-releasing hormone (GnRH) receptor antagonist, and an oral investigational drug candidate for the treatment of advanced prostate cancer. As a GnRH receptor antagonist, relugolix binds to and blocks the GnRH receptor (GnRHR) in the anterior pituitary gland. Blocking GnRH receptors decreases the release of gonadotropins – luteinizing hormone (LH) and follicle-stimulating hormone (FSH) – thereby decreasing the downstream production of estrogen and progesterone by the ovaries in women and testosterone by the testes in men. Myovant is developing relugolix 120 mg following a single 360 mg loading dose as a monotherapy, investigating whether this monotherapy decreases testosterone to low levels. Takeda has granted Myovant an exclusive, worldwide license (excluding Japan and certain other Asian countries) to relugolix. In December 2020 the company announced that the FDA approved relugolix for the treatment of adults with advanced prostate cancer. EC decision on the advanced prostate cancer MAA is expected in calendar year 2022

Note: Detailed Current therapies assessment will be provided in the full report of mCSPC

 

mCSPC Emerging Drugs

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

 

Talazoparib (Pfizer)

Talazoparib is an inhibitor of PARP enzymes, which play a role in DNA response. Preclinical studies have demonstrated that talazoparib blocks PARP enzyme activity and traps PARP at the site of DNA damage, leading to decreased cancer cell growth and cancer cell death. Talazoparib is being evaluated in several ongoing clinical trials in prostate cancer, as well as other novel combinations with targeted therapies in various solid tumors. With the introduction of PARP inhibitors in the mCRPC setting, it is important to explore how a combination approach may impact outcomes for men with the metastatic castration-sensitive disease. The company also anticipated that the prognosis for men with advanced prostate cancer has significantly improved since the introduction of novel hormone therapies, but additional therapeutic options are needed for the approximately 25 percent of men with tumors harboring DNA damage response (DDR) gene mutations, who may have poorer outcomes. Combining enzalutamide – which has a proven clinical benefit in men with mCSPC – with talazoparib – active in DDR-mutated cancer – may offer a new treatment that targets the underlying genetic mechanisms associated with DDR-mutated mCSPC.

 

Nubeqa (Bayer)

Nubeqa (darolutamide) is an oral ARi with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells. The compound is also being investigated in a Phase III study in mHSPC (ARASENS). Nubeqa is currently indicated for treating patients with nmCRPC. Darolutamide is approved under the brand name Nubeqa in several markets around the world, including the US, the EU, Brazil, Canada, Japan, and China, for the treatment of men with nmCRPC, who are at high risk of developing metastatic disease.

 

Keytruda (Merck Sharp & Dohme)

Keytruda, also known as pembrolizumab, is a PD-1 blocking antibody. It is mainly used for advanced cancers, have spread to other parts of the body or are not responding to other treatments. In some cancers, it is only given to patients whose tumors produce high levels of a protein known as PD-L1. It is approved for multiple types of cancer. This is currently being investigated in phase III clinical trial in combination with enzalutamide to treat patients affected by mHSPC.

 

Niraparib (Janssen)

Niraparib is an orally-administered selective PARP inhibitor that is currently being studied by Janssen for the treatment of patients with metastatic castration-resistant prostate cancer and BRCA1/2 DNA repair gene defects. Ongoing studies include the Phase III AMPLITUDE study evaluating Niraparib in combination with abiraterone acetate plus prednisone in a biomarker-selected patient population with mHSPC and the Phase III MAGNITUDE study evaluating Niraparib in combination with abiraterone acetate plus prednisone in adults with mCRPC. In the US, Niraparib is indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. Niraparib is currently marketed as Zejula by Tesaro, an oncology-focused business within GSK devoted to providing transformative therapies to people facing cancer

 

Rubraca (Clovis Oncology)

Clovis Oncology is investigating one of their lead candidates named Rubraca (Rucaparib) for various cancer indications. It is an oral, small-molecule inhibitor of PARP1, PARP2, and PARP3 being developed in prostate cancer and ovarian cancer and several additional solid tumor indications. Upon administration, rucaparib selectively binds to PARP-1, PARP-2, and PARP-3 and inhibits PARP1-mediated repair of ssDNA breaks via the base-excision repair pathway. This enhances the accumulation of DNA strand breaks and promotes genomic instability and apoptosis. Rucaparib may potentiate the cytotoxicity of DNA damaging agents and reverse tumor cell resistance to chemotherapy and radiation therapy. PARP catalyzes post-translational ADP-ribosylation of nuclear proteins and is activated by ssDNA breaks. Rubraca is the first PARP inhibitor approved in a prostate cancer setting. As per the press release, the company has also anticipated that three top-line Phase III data read-outs for Rubraca are expected in 2022, with the potential to address larger ovarian and prostate cancer patient populations in earlier lines of therapy.

 

Other products in development include Opdivo (nivolumab) by Bristol-Myers Squibb, Capivasertib by AstraZeneca, 177Lu-PSMA-617 by Novartis, Firmagon (Degarelix) by Ferring Pharmaceuticals, Tecentriq (Atezolizumab) by Genentech, and Cabometyx (Cabozantinib): Exelixis/ Bristol-Myers Squibb.

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

mCSPC Market Outlook

mCSPC, also referred to as mHSPC in literature refers to prostate cancer that still responds to testosterone suppression therapy. Moreover, patients with newly diagnosed metastatic disease and high-risk disease characteristics tend to have a poorer prognosis.

 

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. The findings of this trial have shown statistically significant improvements in both OS and rPFS. At the time of a prespecified interim analysis, the hazard ratio for overall survival was 0.67, and median overall survival was not reached in either arm. The hazard ratio for the rPFS improvement was 0.48. The median rPFS was not reached with apalutamide plus ADT and was 22.1 months with placebo plus ADT.

 

With this approval, Janssen has strengthened its spot in the prostate cancer drug market. In contrast, drugs like Zytiga have started facing generic competition from the past few years. Approval of Erleada for mCSPC has put a barrier to the growth of the sales of Zytiga, which is already facing competition.

 

In December 2019, the US FDA approved Xtandi for patients with mCSPC. Prior to this, the US FDA approved Xtandi for patients with CRPC. With this approval, Xtandi became first and only oral treatment approved by the US FDA in three distinct types of advanced prostate cancer—nonmetastatic and CRPC and mCSPC. The efficacy of Xtandi was investigated in the ARCHES trial (NCT02677896). All enrolled patients received a GnRH analog or had a prior bilateral orchiectomy. In this study, the main efficacy endpoint was rPFS. However, median rPFS was not reached in the Xtandi arm compared to 19.4 months in the placebo arm. However, a significant improvement reported on the Xtandi arm compared to placebo in time to initiation of a new antineoplastic therapy. The use of Xtandi plus ADT significantly reduced the risk of radiographic progression or death by 61% compared to placebo plus ADT. At the time of rPFS analysis of this drug, OS data was not established. This approval had put direct competition between Zytiga and Xtandi. Besides, it is anticipated that in coming years, both drugs could hold a considerable market share for mCSPC/HSPC treatment paradigm.

 

In December 2020, Orgovyx – a small molecule, GnRH receptor antagonist was approved for the treatment of advanced prostate cancer. The US FDA approval was based on Phase III HERO clinical trial evaluating relugolix as a monotherapy in men with advanced prostate cancer. In November 2019, company announced that Phase III HERO study of once-daily, oral relugolix met its primary efficacy endpoint and all six key secondary endpoints in men with advanced prostate cancer. Company also anticipates future regulatory submissions in Europe and Japan.

 

From the past few years, improvements in the field of prostate cancer have shown that treatments are more effective when used early. However, combination therapy has yet to be proven beneficial. In order to achieve that, it is necessary to possess a profound understanding of the market, and the associated unmet needs. Reflecting on these issues, the significance of dedicating resources on R&D is also imperative. Moreover, to achieve significant success in mHSPC pricing, policies must be considered, because this further will help in the launch of a product that is truly attractive and appropriate to the market, where it is launched. All these factors help in building a strong product-market fit.

 

The mCSPC pipeline possesses drugs in the late-stage development, many of which hold the potential to get launched in the forecast period. The key players include Bayer (Nubeqa), Merck Sharp & Dohme (Keytruda/), Pfizer (Talazoparib), Janssen (Niraparib), Clovis Oncology (Rubraca), Bristol-Myers Squibb (Opdivo), AstraZeneca (Capivasertib), Novartis (177Lu-PSMA-617), and others investigating their candidates for the treatment of mCSPC in the 7MM.

 

According to DelveInsight, mCSPC market in 7MM is expected to witness a major change in the study period 2019-2032.

 

Key Findings

  • The market size of mCSPC in the seven major markets is expected to rise from USD 679.1million in 2021 during the study period (2019–2032).
  • The therapies with the potential to get launched in the forecast period include Bayer (Nubeqa), Merck Sharp & Dohme (Keytruda), Pfizer (Talazoparib), Janssen (Niraparib), Clovis Oncology (Rubraca), Bristol-Myers Squibb (Opdivo), AstraZeneca (Capivasertib), Novartis (177Lu-PSMA-617), and others. The launch of these therapies may increase market size in the coming years, assisted by an increasing patient pool of mCSPC patients.
  • The United States accounts for the largest market size of mCSPC compared to EU5 (Germany, the United Kingdom, Italy, France, and Spain) and Japan.
  • In the United States, the market size of mCSPC is anticipated to rise from USD 502.7 million in 2021 during the forecast period.
  • Among the EU5 countries, Germany had the largest market size (USD 49.1 million) in 2021, while Spain had the smallest with USD 14.3 million.
  • In 2021, Japan accounted for a market size of USD 35.6 million.

 

The United States Market Outlook

The total market size of mCSPC in the United States is expected to increase with a CAGR of 25.8% in the study period (2019–2032).

 

EU-5 Countries: Market Outlook

The total market size of mCSPC in EU5 is expected to increase with a CAGR of 31.1% in the study period (2019–2032).

 

Japan Market Outlook

The total market size of mCSPC in the Japan is expected to increase with a CAGR of 28.8% 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 mCSPC 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, incomparison to the US and Japan. In Japan, less chemotherapy usage is observed.
  • Many drugs can be used in the treatment algorithm for mCSPC, 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 mCSPC 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.
  • Our analysis suggests that prostate cancers with HRR gene alterations are more aggressive. These alterations are augmented in patients with metastatic disease and respond very well to PARP inhibitors. Although the efficacy of PARP inhibitors has been established in patients with metastatic castration-resistant prostate cancer in previous studies, the use of these agents earlier on in the disease process has yet to be evaluated. Trials such Phase III AMPLITUDE trial evaluating the use of standard ADT plus Zytiga and prednisone with or without the PARP inhibitor Zejula in patients with HRR gene–mutated mCSPC might address this knowledge gap. We believe that these agents may provide clinical benefits in this patient pool.
  • We believe that Orgovyx (Relugolix) holds the potential to address the unmet needs in the field. The drug may prove to be a blockbuster considering the scarcity of approved therapy for mCSPC patients, provided that the drug demonstrates promising efficacy and safety data in the ongoing trial.
  • Other therapies Nubeqa (darolutamide) + ADT ± docetaxel and Capivasertib + Abiraterone: PTEN deficient have the potential to change the market dynamics. The anticipation is based on the recent data presented by the companies.
  • According to our analysis, Orgovyx (Relugolix) has the potential to grab a major patient pool during the forecast period. The oral route of administration and the company’s visibility around the product may set the drug for approval by 2022 by EMA, and PMDA by 2023. The drug’s potential is attributed to the strong safety and efficacy demonstrated by the drug during the clinical development activity.
  • Although the current pipeline landscape is not robust, the entry of pharmaceutical firms exploring novel medicines for mCSPC/mHSPC 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 mCSPC 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.

mCSPC Drugs Uptake

This section focusses on the rate of uptake of the potential drugs recently launched in the mCSPC market or expected to get launched in the market during the study period 2019-2032. The analysis covers mCSPC 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 recently 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. Bayer intends to disclose these significant findings at an upcoming scientific conference and to discuss them with health officials. Given the optimistic results from the Phase III mCSPC 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 market in 2022 and the EU and Japanese market in 2023.

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

mCSPC Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase II and Phase III stage. It also analyses mCSPC 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 mCSPC emerging therapies.

Reimbursement Scenario in mCSPC

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 mCSPC 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

We perform Competitive and Market Intelligence analysis of the mCSPC 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 mCSPC, explaining its causes, signs and symptoms, pathophysiology, diagnosis and currently available therapies
  • Comprehensive insight has been provided into the mCSPC epidemiology and treatment in the 7MM
  • Additionally, an all-inclusive account of both the current and emerging therapies for mCSPC are provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape
  • A detailed review of mCSPC 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 mCSPC market

Report Highlights

  • In the coming years, mCSPC 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 mCSPC 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 mCSPC. Launch of emerging therapies will significantly impact the mCSPC market
  • A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for mCSPC
  • 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

mCSPC Report Insights

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

mCSPC Report Key Strengths

  • 11 Years Forecast
  • 7MM Coverage
  • mCSPC Epidemiology Segmentation
  • Key Cross Competition
  • Highly Analyzed Market
  • Drugs Uptake

mCSPC Report Assessment

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

Key Questions

Market Insights:

  • What was the mCSPC drug class share (%) distribution in 2019 and how it would look like in 2032?
  • What would be the mCSPC 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 mCSPC market size during the forecast period (2019-2032)?
  • At what CAGR, the mCSPC market is expected to grow in 7MM during the forecast period (2019-2032)?
  • What would be the mCSPC market outlook across the 7MM during the forecast period (2019-2032)?
  • What would be the mCSPC 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 mCSPC?
  • What are the key factors driving the epidemiology trend for seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
  • What is the historical mCSPC patient pool in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
  • What would be the forecasted patient pool of mCSPC in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
  • Where will be the growth opportunities in the 7MM with respect to the patient population pertaining to mCSPC?
  • Out of all mCSPC countries, which country would have the highest prevalent population of mCSPC 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 mCSPC treatment in addition to the approved therapies?
  • What are the current treatment guidelines for the treatment of mCSPC in the USA, Europe, and Japan?
  • What are the mCSPC 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 mCSPC?
  • How many therapies are in-development by each company for mCSPC treatment?
  • How many are emerging therapies in mid-stage, and late stage of development for mCSPC treatment?
  • What are the key collaborations (Industry - Industry, Industry - Academia), Mergers and acquisitions, licensing activities related to the mCSPC 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 mCSPC 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 mCSPC?
  • What are the global historical and forecasted market of mCSPC?

Reasons to buy

  • The report will help in developing business strategies by understanding trends shaping and driving the mCSPC market
  • To understand the future market competition in the mCSPC market and Insightful review of the key market drivers and barriers
  • Organize sales and marketing efforts by identifying the best opportunities for mCSPC 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 mCSPC market
  • To understand the future market competition in the mCSPC market

1. Key Insights

2. Report Introduction

3. Metastatic Castration-Sensitive Prostate Cancer (mCSPC) Market Overview at a Glance

3.1. Market Share (%) Distribution of Metastatic Castration-Sensitive Prostate Cancer (mCSPC) in 2022

3.2. Market Share (%) Distribution of Metastatic Castration-Sensitive Prostate Cancer (mCSPC) in 2032

4. Executive Summary of Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

5. Key Events

6. Epidemiology and Market Forecast Methodology

7. SWOT Analysis

8. Disease Background and Overview

8.1. Signs and Symptoms of Prostate Cancer

8.2. Risk Factors and Causes of Prostate Cancer

8.3. Pathophysiology of Prostate Cancer

8.4. Prostate Neoplasia

8.5. Genetics of Prostate Cancer

9. Diagnosis of Prostate Cancer

9.1. Screening Tests for Prostate Cancer

9.2. Tests to Diagnose Prostate Cancer

9.3. Stages and Grades of Prostate Cancer

10. Treatment and Management of Prostate Cancer

10.1. Treatment Algorithm of Prostate Cancer

10.2. Observation or Active Surveillance

10.3. Surgery

10.3.1. Open or Laparoscopic Radical Prostatectomy

10.3.2. Risks of Prostate Surgery

10.4. Radiation Therapy

10.4.1. Types of Radiation Therapy

10.5. Hormone Therapy

10.5.1. Types of Hormone Therapy

10.6. Immunotherapy

10.6.1. Vaccine

10.6.2. Immune checkpoint inhibitors

10.7. Chemotherapy

11. American Urological Association (AUA) Guidelines for mHSPC:  2020

12. Guidelines for mHSPC: Abiraterone acetate combined with castration is another standard (European Association of Urology, 2018)

13. National Institute for health and care excellence (NICE) Recommendation Guidelines for mCSPC/mHSPC: 2022

14. SEOM Clinical Guidelines for mCSPC/mHNPC: 2021

15. Updated NCCN Guidelines for mCSPC

16. Epidemiology and Patient Population

16.1. Key Findings

16.2. Total Prevalent Cases of Prostate Cancer in the 7MM

16.3. Total Diagnosed Cases of Prostate Cancer in the 7MM

16.4. Total Metastatic Cases of CSPC/HSPC in the 7MM

16.5. Total Treated Cases of Metastatic CSPC/HSPC in the 7MM

16.6. Assumptions and Rationale

16.7. The United States

16.7.1. Total Diagnosed Cases of Prostate Cancer in the United States

16.7.2. Age-specific Cases of Prostate Cancer in the United States

16.7.3. Total Diagnosed Cases of Prostate Cancer by Clinical Stages in the United States

16.7.4. Total Metastatic Cases of CSPC/HSPC in the United States

16.7.5. Total Treated Cases of Metastatic CSPC/HSPC in the United States

16.8. EU-5 Epidemiology

16.8.1. Total Diagnosed Prevalent cases of Prostate Cancer in EU5

16.8.2. Age-specific Diagnosed Prevalent Cases of Prostate Cancer in EU5

16.8.3. Total Diagnosed Prevalent cases of Prostate Cancer by Clinical Stages in EU5

16.8.4. Total Metastatic Cases of CSPC/HSPC in EU5

16.8.5. Total Treated Cases of Metastatic CSPC/HSPC in EU5

16.9. Japan

16.9.1. Total Diagnosed Prevalent cases of Prostate Cancer in Japan

16.9.2. Age-specific Diagnosed Prevalent cases of Prostate Cancer in Japan

16.9.3. Total Diagnosed Prevalent cases of Prostate Cancer by Clinical Stages in Japan

16.9.4. Total Metastatic Cases of CSPC/HSPC in Japan

16.9.5. Total Treated Cases of Metastatic CSPC/HSPC in Japan

17. Organizations contributing towards Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

18. Marketed Therapies

18.1. Key Competitors

18.2. Xtandi (enzalutamide): Astellas Pharma/Pfizer

18.2.1. Product Description

18.2.2. Regulatory Milestones

18.2.3. Other Developmental Activities

18.2.4. Clinical Development activity

18.2.5. Safety and Efficacy

18.3. Erleada (apalutamide): Janssen Pharmaceutical

18.3.1. Product Description

18.3.2. Regulatory Milestones

18.3.3. Other Developmental Activities

18.3.4. Clinical Development activity

18.3.5. Safety and Efficacy

18.4. Orgovyx (relugolix): Myovant Sciences/Takeda

18.4.1. Product Description

18.4.2. Regulatory Milestones

18.4.3. Clinical Development activity

18.4.4. Safety and Efficacy

19. Emerging Therapies

19.1. Key Competitors

19.2. Emerging Drugs

19.2.1. Nubeqa (Darolutamide): Bayer

19.2.2. Keytruda (Pembrolizumab/MK-3475): Merck Sharp & Dohme

19.2.3. Talazoparib: Pfizer

19.2.4. Niraparib: Janssen

19.2.5. Rubraca (Rucaparib): Clovis Oncology

19.2.6. Opdivo (Nivolumab): Bristol-Myers Squibb

19.2.7. Capivasertib (AZD 5363): AstraZeneca

19.2.8. 177Lu-PSMA-617: Novartis Pharmaceuticals

19.2.9. Firmagon (Degarelix): Ferring Pharmaceuticals

19.2.10. Tecentriq (Atezolizumab): Genentech

19.2.11. Cabometyx (Cabozantinib): Exelixis/ Bristol-Myers Squibb

20. Metastatic Castration-Sensitive Prostate Cancer (mCSPC): Seven Major Market Analysis

20.1. Key Findings 

20.2. Total Market Size of MHSPC/mCSPC in the 7MM

20.3. Market Size of MHSPC/mCSPC by therapies in the 7MM

20.4. Market Outlook

20.5. Key Market Forecast Assumptions

20.6. United States Market Size

20.6.1. Total Market Size of mHSPC/mCSPC in the United States

20.6.2. Market Size of MHSPC/mCSPC by Therapies in the United States

20.7. EU-5 Market Size

20.7.1. Total Market size of mHSPC/mCSPC in EU5

20.7.2. Market Size of mHSPC/mCSPC by Therapies in EU5

20.8. Japan

20.8.1. Total Market size of mHSPC/mCSPC in Japan

20.8.2. Market Size of mHSPC/mCSPC by Therapies in Japan

21. Market Drivers

22. Market Barriers

23. Unmet Needs

24. Reimbursement and Market Access

25. Appendix

25.1. Bibliography

26. Report Methodology

27. DelveInsight Capabilities

28. Disclaimer

29. About DelveInsight

List of Table

Table 1: Summary of Metastatic Castration-Sensitive Prostate Cancer (mCSPC) Market, and Epidemiology (2019–2032)

Table 2: Key Events

Table 3: Genetic Changes Associated with Prostate Cancer Tumorigenesis

Table 4: New guidelines to Consider for Metastatic Hormone-sensitive Prostate Cancer

Table 5: Total Prevalent Cases of Prostate Cancer in the 7MM

Table 6: Total Diagnosed Cases of Prostate Cancer in the 7MM

Table 7: Total Diagnosed Prevalent Cases of mCSPC/mHSPC in the 7MM

Table 8: Total Treated Cases of mHSPC/mCSPC in the 7MM

Table 9: Total Diagnosed Cases of Prostate Cancer in the United States

Table 10: Age-specific Cases of Prostate Cancer in the United States

Table 11: Total Diagnosed Cases of Prostate Cancer by Clinical Stages in the US

Table 12: Total Diagnosed Prevalent Cases of mCSPC/mHSPC in the United States

Table 13: Total Treated Cases of mHSPC/mCSPC in the United States

Table 14: Total Diagnosed Prevalent Population of Prostate Cancer in EU5

Table 15: Age-specific Diagnosed Prevalent Cases of Prostate Cancer in EU5

Table 16: Total Diagnosed Prevalent cases of Prostate Cancer by Clinical Stages in EU5

Table 17: Total Diagnosed Prevalent Cases of mCSPC/mHSPC in EU5

Table 18: Total Treated Cases of Metastatic CSPC/HSPC in EU5

Table 19: Total Diagnosed Prevalent cases of Prostate Cancer in Japan

Table 20: Age-specific Diagnosed Prevalent cases of Prostate Cancer in Japan

Table 21: Total Diagnosed Prevalent Cases of Prostate Cancer by Clinical Stages in Japan

Table 22: Total Diagnosed Prevalent Cases of mCSPC/mHSPC in Japan

Table 23: Total Treated Cases of Metastatic CSPC/HSPC in Japan

Table 24: Organizations Contributing Toward the Fight Against Metastatic Hormone-Sensitive Prostate Cancer

Table 25: Comparison of Marketed drugs

Table 26: Xtandi, Clinical Trial Description, 2022

Table 27: Erleada, Clinical Trial Description, 2022

Table 28: Relugolix, Clinical Trial Description, 2022

Table 29: Comparison of emerging drugs under development

Table 30: Nubeqa, Clinical Trial Description, 2022

Table 31: Keytruda, Clinical Trial Description, 2022

Table 32: Market Size of MHSPC/mCSPC in the 7MM in USD Million

Table 33: Market Size of MHSPC/mCSPC by Therapies in the 7MM in USD Million

Table 34: Key Market Forecast Assumptions for Nubeqa (Darolutamide)

Table 35: Key Market Forecast Assumptions for Talazoparib

Table 36: Key Market Forecast Assumptions for Niraparib

Table 37: Key Market Forecast Assumptions for Rubraca (Rucaparib)

Table 38: Key Market Forecast Assumptions for Capivasertib (AZD 5363)

Table 39: Key Market Forecast Assumptions for 177Lu-PSMA-617

Table 40: Key Market Forecast Assumptions for Keytruda (Pembrolizumab)

Table 41: Key Market Forecast Assumptions for Opdivo

Table 42: Market Size of mHSPC/mCSPC in the US, USD Million

Table 43: Market Size of MHSPC/mCSPC by Therapies in the US, USD Million

Table 44: EU5 Market Size of mHSPC/mCSPC in USD Million

Table 45: EU5 Market Size of mHSPC/mCSPC by Therapies in USD Million

Table 46: Japan Market Size of mHSPC/mCSPC in Japan, USD Million

Table 47: Market Size of mHSPC/mCSPC by Therapies in Japan, USD Million

Table 48: National Institute for Health and Care Excellence (NICE) Decisions for mHSPC Therapies

Table 49: Haute Autorité de santé (HAS) Decisions for mHSPC Therapies

Table 50: IQWiG Decisions for mHSPC Therapies

List of Figures

Figure 1: Prostate Cancer

Figure 2: Sign and Symptoms of Prostate Cancer

Figure 3: Risks Factors of Prostate Cancer

Figure 4: Pathophysiology of Prostate Cancer

Figure 5: Progression of Prostate Cancer and the Development of mCRPC

Figure 6: Diagnosis of Prostate Cancer

Figure 7: Gleason Score of Prostate Cancer

Figure 8: Localized Disease Treatment Algorithm

Figure 9: High-risk Localized and Locally Advanced Disease Treatment Algorithm

Figure 10: Metastatic Disease Treatment Algorithm

Figure 11: Suggested Treatment Paradigm for Molecular Biomarkers in Advanced Prostate Cancer

Figure 12: Total Prevalent Cases of Prostate Cancer in the 7MM

Figure 13: Total Diagnosed Cases of Prostate Cancer in the 7MM

Figure 14: Total Diagnosed Prevalent Cases of mCSPC/mHSPC in the 7MM

Figure 15: Total Treated Cases of mHSPC/mCSPC in the 7MM

Figure 16: Global Heat Map of Prostate Cancer

Figure 17: Total Diagnosed Cases of Prostate Cancer in the United States

Figure 18: Age-specific Cases of Prostate Cancer in the United States

Figure 19: Total Diagnosed Cases of Prostate Cancer by Clinical Stages in the US

Figure 20: Total Diagnosed Prevalent Cases of mCSPC/mHSPC in the United States

Figure 21: Total Treated Cases of mHSPC/mCSPC in the United States

Figure 22: Total Diagnosed Prevalent Cases of Prostate Cancer in EU5

Figure 23: Age-specific Diagnosed Prevalent Cases of Prostate Cancer in EU5

Figure 24: Total Diagnosed Prevalent cases of Prostate Cancer by Clinical Stages in EU5

Figure 25: Total Diagnosed Prevalent Cases of mCSPC/mHSPC in EU5

Figure 26: Total Treated Cases of Metastatic CSPC/HSPC in EU5

Figure 27: Total Diagnosed Cases of Prostate Cancer in Japan

Figure 28: Age-specific Diagnosed Prevalent cases of Prostate Cancer in Japan

Figure 29: Total Diagnosed Prevalent Cases of Prostate Cancer by Clinical Stages in Japan

Figure 30: Total Diagnosed Prevalent Cases of mCSPC/mHSPC in Japan

Figure 31: Total Treated Cases of Metastatic CSPC/HSPC in Japan

Figure 32: Market Size of MHSPC/mCSPC in the 7MM in USD Million

Figure 33: Market Size of MHSPC/mCSPC by Therapies in the 7MM in USD Million

Figure 34: Market Size of mHSPC/mCSPC in the US, USD Millions

Figure 35: Market Size of MHSPC/mCSPC by Therapies in the US, USD Million

Figure 36: Market Size of mHSPC/mCSPC in EU5, USD Million

Figure 37: EU5 Market Size of mHSPC/mCSPC by Therapies in USD Million

Figure 38: Market Size of mHSPC/mCSPC in Japan, USD Million

Figure 39: Japan Market Size of mHSPC/mCSPC by Therapies, USD Million

Astellas Pharma
Pfizer
Janssen Pharmaceutical
Myovant Sciences
Takeda
Bayer
Merck Sharp & Dohme
Clovis Oncology
Bristol-Myers Squibb
Novartis Pharmaceuticals
Ferring Pharmaceuticals
Genentech
Exelixis

 

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