Published Date : 2022-08-09
Published Date : 2022-08-09
Updated On : 2023-07-13
Pages : 151
Thelansis’s “Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2022 To 2032" covers disease overview, epidemiology, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential Non-Metastatic Castration-Resistant Prostate Cancer treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).
Non-metastatic castration-resistant prostate cancer (nmCRPC), or M0 CRPC, is a transitional stage in which patients exhibit resistance to castration (testosterone levels drop below 50 ng/mL) after undergoing ADT. At this stage, no visible metastases appear on standard imaging exams, PSA levels continue to rise, reaching a minimum increase of 25% from their lowest point (starting with a PSA level of at least 1.0 ng/mL) and a minimum rise of 2 ng/mL, with confirmation required from a second measurement. PSA progression can happen before the detection of metastases, either due to local recurrence in the prostate bed after prostatectomy or persistent local disease following radical radiation therapy, or in cases where no disease is detected at the primary site, no involved lymph nodes are found in computed tomography (CT) or magnetic resonance imaging (MRI) (lymph nodes smaller than 1.5 cm in the pelvis are not considered). No disease is observed in bones or visceral organs. Most nonmetastatic castration-resistant prostate cancer patients eventually develop metastatic lesions, leading to morbidity and mortality of prostate cancer. Next-generation imaging (NGI) techniques have improved diagnostic accuracy and capabilities. Modalities such as whole-body diffusion-weighted MRI and positron emission tomography (PET) using targeted radiotracers like prostate-specific membrane antigen (PSMA) PET, NaF PET, 11C-choline, and 18F-fluciclovine PET/CT have significantly enhanced the ability to detect metastases. The U.S. Food and Drug Administration (FDA) has approved the use of two androgen receptor antagonists, enzalutamide and apalutamide, as treatments for nonmetastatic castration-resistant prostate cancer.
North America- the United States and Canada
Europe- EU5 (Germany, France, Italy, Spain, and the United Kingdom)
Other countries- Japan & China
This section of the study covers country-specific current clinical practice, the standard of care, and significant limitations around addressing the unmet needs. Retrospective analysis and bench-marking of clinical study outcomes are presented in terms of Pre-treatment & post-treatment clinical and demographic patient characteristics. Essentially, this section will cover the evolution of the current competitive landscape and its impact on the future treatment paradigm.
KOLs across 8 MM markets from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs
- Data Inputs with sourcing
- Market Event and Product Event
- Country-specific Forecast Model
- Market uptake and patient share uptake
- Attribute Analysis
- Analog Analysis
- Disease burden and pricing scenario
- Summary and Insights
Optimization of cash flow/ revenue flow concerning all fixed and variable investments throughout the product development process. The rate of return on an investment is a critical indicator to ensure the profitability and break-even of the project.
The competitive landscape includes country-specific approved as well as pipeline therapies. Any asset/product-specific designation or review such as Orphan drug designation, Fast track, Priority Review, Breakthrough Therapy Designation, Rare Pediatric Disease Designation, and Accelerated Approval are tracked and supplemented with analyst commentary.
Detailed clinical trial data analysis and critical product positioning include trial design, primary outcomes, secondary outcomes, dosing and schedules, inclusion and exclusion criteria, recruitment status and essentially covers the reported adverse events. Majorly the trial analysis helps determine the potential of the critical assets and their probable filing and launch date.
This report presents the most important clinical unmet needs in the treatment, according to Thelansis research and analysis. Other essential unmet needs identified through our study include decreased cost burden on patients, improved administration convenience, and improved patient compliance.
S. no | Asset | Company | Stage |
1 | Apalutamide (ARN-509) | Aragon Pharmaceuticals, Inc. | Phase 3 |
2 | Darolutamide | Bayer | Phase 2 |
3 | Relugolix | Myovant Sciences GmbH | Phase 1 |
4 | KPG-121 Plus Enzalutamide, Abiraterone or Apalutamide | Kangpu Biopharmaceuticals, Ltd. | Phase 1 |
KOLs across 8 MM market from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs.
COUNTRY | No. Of KOLs |
USA | 17 |
GERMANY | 4 |
UK | 4 |
SPAIN | 3 |
FRANCE | 2 |
ITALY | 3 |
JAPAN | 3 |
CHINA | 4 |
Data Inputs with sourcing, Market Event, Product Event, Country specific Forecast Model, Market uptake and patient share uptake, Attribute Analysis, Analog Analysis, Disease burden, and pricing scenario, Summary, and Insights.
1. Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC) – Key Findings Summary |
1.1. Clinical findings |
1.1.1. Disease overview |
1.1.2. Therapeutic practices |
1.1.3. Future outlook |
1.2. Commercial findings |
1.2.1. Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC) market scenario 2022 |
1.2.2. Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC) market scenario 2025 |
1.2.3. Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC) market scenario 2032 |
2. Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC) Overview |
2.1. Disease Introduction |
2.2. Pathophysiology |
2.3. Signs and Symptoms |
2.4. Risk Factors |
2.5. Etiology |
2.6. Classification |
2.7. Pathogenesis |
2.8. Diagnosis |
2.9. Complications |
2.10. Treatment Algorithm |
2.10.1. Treatment in US (guidelines) |
2.10.2. Treatment in EU-5 (guidelines) |
2.10.3. Treatment in Japan (guidelines) |
2.10.4. Treatment in China (guidelines) |
2.11. Treatment Goals for Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC) |
2.12. Referral Patterns |
2.12.1. Referral Scenario in US |
2.12.2. Referral Scenario in EU-5 |
2.12.3. Referral Scenario in Japan |
2.12.4. Referral Scenario in China |
2.13. Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC) Prognosis |
2.14. Healthcare burden |
2.14.1. Healthcare burden in US |
2.14.2. Healthcare burden in EU-5 |
2.14.3. Healthcare burden in Japan |
2.14.4. Healthcare burden in China |
2.15. Unmet Needs in Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC) management |
2.16. Market Opportunity for Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC) |
2.17. KOL Comments on current and upcoming/expected treatment practices in Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC) |
3. Epidemiology |
3.1. Epidemiology Overview |
3.2. Epidemiology by Geography |
3.2.1. Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC) Epidemiology in US (2022-2032) |
3.2.1.1. Incidence of Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC) |
3.2.1.2. Diagnosed cases |
3.2.1.3. Treatable Patient Pool |
3.2.1.4. Epidemiology Trends |
3.2.2. Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC) Epidemiology in EU-5 (2022-2032) |
3.2.2.1. Incidence of Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC) |
3.2.2.2. Diagnosed cases |
3.2.2.3. Treatable Patient Pool |
3.2.2.4. Epidemiology Trends |
3.2.3. Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC) Epidemiology in Japan (2022-2032) |
3.2.3.1. Incidence of Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC) |
3.2.3.2. Diagnosed cases |
3.2.3.3. Treatable Patient Pool |
3.2.3.4. Epidemiology Trends |
3.2.4. Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC) Epidemiology in China (2022-2032) |
3.2.4.1. Incidence of Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC) |
3.2.4.2. Diagnosed cases |
3.2.4.3. Treatable Patient Pool |
3.2.4.4. Epidemiology Trends |
3.3. Epidemiology Trends (World-wide) |
4. Market Outlook |
4.1. US Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC) Market Forecast 2022-2032 |
4.1.1. Market Progression (Futuristic) |
4.1.2. Market Trends and Expectations |
4.1.2.1. Worst case scenario |
4.1.2.2. Base Case Scenario |
4.1.2.3. Best Case Scenario |
4.1.3. Drivers and Barriers |
4.2. UK Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC) Market Forecast 2022-2032 |
4.2.1. Market Progression (Futuristic) |
4.2.2. Market Trends and Expectations |
4.2.2.1. Worst case scenario |
4.2.2.2. Base Case Scenario |
4.2.2.3. Best Case Scenario |
4.2.3. Drivers and Barriers |
4.3. France Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC) Market Forecast 2022-2032 |
4.3.1. Market Progression (Futuristic) |
4.3.2. Market Trends and Expectations |
4.3.2.1. Worst case scenario |
4.3.2.2. Base Case Scenario |
4.3.2.3. Best Case Scenario |
4.3.3. Drivers and Barriers |
4.4. Germany Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC) Market Forecast 2022-2032 |
4.4.1. Market Progression (Futuristic) |
4.4.2. Market Trends and Expectations |
4.4.2.1. Worst case scenario |
4.4.2.2. Base Case Scenario |
4.4.2.3. Best Case Scenario |
4.4.3. Drivers and Barriers |
4.5. Italy Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC) Market Forecast 2022-2032 |
4.5.1. Market Progression (Futuristic) |
4.5.2. Market Trends and Expectations |
4.5.2.1. Worst case scenario |
4.5.2.2. Base Case Scenario |
4.5.2.3. Best Case Scenario |
4.5.3. Drivers and Barriers |
4.6. Spain Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC) Market Forecast 2022-2032 |
4.6.1. Market Progression (Futuristic) |
4.6.2. Market Trends and Expectations |
4.6.2.1. Worst case scenario |
4.6.2.2. Base Case Scenario |
4.6.2.3. Best Case Scenario |
4.6.3. Drivers and Barriers |
4.7. Japan Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC) Market Forecast 2022-2032 |
4.7.1. Market Progression (Futuristic) |
4.7.2. Market Trends and Expectations |
4.7.2.1. Worst case scenario |
4.7.2.2. Base Case Scenario |
4.7.2.3. Best Case Scenario |
4.7.3. Drivers and Barriers |
4.8. China Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC) Market Forecast 2022-2032 |
4.8.1. Market Progression (Futuristic) |
4.8.2. Market Trends and Expectations |
4.8.2.1. Worst case scenario |
4.8.2.2. Base Case Scenario |
4.8.2.3. Best Case Scenario |
4.8.3. Drivers and Barriers |
4.9. Key Expected Milestones (world-wide) Impacting the Market |
5. Competitive Landscape |
5.1. Pipeline Therapies Overview |
5.1.1. Phase III Therapies |
5.1.1.1. Current Status |
5.1.1.2. Trial details, results |
5.1.1.3. Approval Timeline |
5.1.1.4. Likelihood of approval |
5.1.1.5. Expected Product Positioning |
5.1.1.2. All other Phase III Therapies ….. |
5.1.1.3. Attribute Analysis of Phase III molecules |
5.1.2. Phase II and Phase I/II Therapies |
5.1.2.1. Current Status |
5.1.2.2. Trial details, results |
5.1.2.3. Approval Timelines |
5.1.3. List of active Pre-clinical Therapies |
5.1.3.1. Status in Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC) |
5.1.3.2. Company positioning |
5.1.3.2. All other pre-clinical therapies |
5.1.4. List of Inactive/discontinued assets |
5.1.4.1. Business impact of discontinuations on current pipeline |
5.1.5. Potential winners from Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC) Pipeline |
5.1.5.1. Potential Blockbusters across the pipeline |
6. Regulatory/Approval Scenario |
6.1. Regulatory/Approval Framework in US |
6.1.1. Policy Framework |
6.1.2. Payer Expectations |
6.2. Regulatory/Approval Framework in UK |
6.2.1. Policy Framework |
6.2.2. Payer Expectations |
6.3. Regulatory/Approval Framework in France |
6.3.1. Policy Framework |
6.3.2. Payer Expectations |
6.4. Regulatory/Approval Framework in Germany |
6.4.1. Policy Framework |
6.4.2. Payer Expectations |
6.5. Regulatory/Approval Framework in Italy |
6.5.1. Policy Framework |
6.5.2. Payer Expectations |
6.6. Regulatory/Approval Framework in Spain |
6.6.1. Policy Framework |
6.6.2. Payer Expectations |
6.7. Regulatory/Approval Framework in Japan |
6.7.1. Policy Framework |
6.7.2. Payer Expectations |
6.8. Regulatory/Approval Framework in China |
6.8.1. Policy Framework |
6.8.2. Payer Expectations |
7. Clinical Trial Assessment – Current and Future Paradigm |
7.1. Distribution of Primary Endpoints across trials |
7.2. Distribution of Secondary Endpoints across trials |
7.3. Evolution and acceptance of surrogate endpoints |
7.4. Key Investigator initiated trials |
7.5. Attrition analysis |
7.5.1. Suspended/Discontinued Assets |
7.5.2. Failed Trials, Reasons and Business Impact |
7.5.3. Terminated Trials, Reasons and Business Impact |
7.5.4. Withdrawn Trials, Reasons and Business Impact |
7.6. Trial enrollment scenario and challenges |
7.7. Clinical Trial Guidance (across geographies) |
8. Thelansis Commentary |
8.1. Key Unmet needs in Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC) |
8.2. Possible Best-case Clinical Trial Strategies |
8.3. Possible Best Case Targeted Product Profile (TPP) |
8.4. Possible Best-case Market positioning strategies |
8.5. Possible Best-case Market Access Strategies |
8.6. Possible Best-case LCM Strategies |
8.7. Overall View on Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC) Market in Dollar Value |
9. Report Methodology |
9.1. Secondary research |
9.2. Primary research |
9.3. Data collation |
9.4. Insight Generation |
10. About Thelansis |
10.1. Our Capabilities |
10.2. Our Services |
10.3. Our Contacts |
10.4. Disclaimer |