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시장보고서
상품코드
2082960
비전이성 전립선암(nmPC) : 시장 인사이트, 역학 및 시장 예측(2036년)Non-metastatic Prostate Cancer (nmPC) - Market Insight, Epidemiology, and Market Forecast - 2036 |
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DelveInsight
주요 7개국 비전이성 전립선암 시장 규모 및 전망
비전이성 전립선암 시장 보고서에서는 표준 치료, 임상 실무, 진화하는 치료 알고리즘 등 현재 시장 상황에 대한 종합적인 분석을 제공합니다. 비전이성 전립선암 환자의 부담 동향, 수익 및 시장 점유율 동향, 정점 시기의 환자 점유율 및 치료 도입 현황에 대한 분석을 평가하는 한편, 전 세계 각 지역 시장 규모에 대한 상세한 평가 및 성장률 예측(과거 데이터 및 2022년-2036년 예측)을 제시하고 있습니다. 본 보고서에서는 비전이성 전립선암 분야의 주요 미충족 의료 수요에 초점을 맞추어, 경쟁 구도와 임상 환경을 분석함으로써 고부가가치 기회를 도출하고, 향후 시장 성장 가능성에 대한 명확한 전망을 제시하고 있습니다.
질병의 조기 발견 및 선별 검사 증가
PSA 검사의 보급과 영상 진단 기술의 발전으로 인해, 전이되지 않은 전립선암의 조기 진단이 증가하고 있습니다.
표적 치료의 확대
진행 지연에 대한 효능이 입증된 차세대 안드로겐 수용체 억제제(예: 아파르타미드, 엔잘타미드, 달로르타미드)의 도입이 시장 침투를 뒷받침하고 있습니다.
조사 및 파이프라인 혁신
신약 및 병용 요법의 개발이 지속적으로 진행되고 있으며, 이는 치료 선택지의 확대와 투자 유치로 이어지고 있습니다.
비전이성 전립선암의 개요와 진단
비전이성 전립선암이란, 원격 전이의 징후가 없고 전립선 또는 그 주변의 국소 조직에 국한된 전립선암을 말합니다. 이 질환은 초기 단계에서는 무증상인 경우가 많으며, 전립선 특이 항원(PSA) 수치의 상승이나 직장 수지 검사(DRE) 중 발견된 이상을 통해 발견되는 경우가 빈번합니다. 진단은 전립선 생검을 통해 확정되며, 이를 통해 종양의 악성 정도와 침습성을 판단합니다. 한편, 다중 매개변수 MRI, CT 스캔, 골스캔 등의 영상 진단법을 이용하여 국소적인 확산 정도를 평가하고, 원격 전이의 유무를 확인합니다. PSA 수치, 글리슨 점수 및 종양의 병기를 바탕으로 한 위험도 분류는 치료 방침을 결정하는 데 있어 매우 중요한 역할을 합니다. 비전이성 전립선암은 일반적으로 예후가 양호하며, 적극적인 경과 관찰, 수술, 방사선 치료 등 폭넓고 효과적인 치료 옵션이 있으므로 조기 진단이 필수적입니다.
비전이성 전립선암의 진단
비전이성 전립선암의 진단은 임상 평가와 진단 검사를 종합하여 이루어집니다. 일반적으로 전립선 특이 항원(PSA) 수치의 상승이나 직장 수지 검사(DRE)에서 이상 소견이 확인되는 남성의 경우, 이 질환이 의심됩니다. 확정 진단을 위해 전립선 생검이 시행되며, 이를 통해 종양의 악성 정도와 침습성을 판정합니다. 다중 매개변수 MRI 등의 영상 진단 기술을 활용하여 국소적인 종양의 확산 정도를 평가하고, CT 스캔이나 골스캔을 통해 원격 전이의 유무를 배제함으로써, 정확한 병기 분류와 적절한 치료 계획 수립이 이루어집니다.
비전이성 전립선암의 치료
비전이성 전립선암의 치료는 질환의 위험도, 환자의 연령, 전신 건강 상태에 따라 결정되며, 삶의 질(QOL)을 유지하면서 암을 관리하는 것을 목표로 합니다. 일반적인 치료법으로는 저위험군 환자에 대한 적극적인 경과 관찰과, 고위험군 환자에 대한 근치적 전립선 적출술이나 방사선 치료 등의 근치적 치료가 있습니다. 특정 환자의 경우, 안드로겐 차단 요법(ADT)이 많은 경우 방사선 요법과 병행하여 시행되기도 합니다. 그 밖의 치료 옵션으로는 국소 병변에 대한 국소 치료법(동결 요법이나 고밀도 집속 초음파 등)이 있으며, 특정 고위험 비전이성 사례의 경우 차세대 호르몬 요법이 고려되기도 합니다. 전반적으로 다양한 치료법을 통해 환자 개개인에 맞춘 관리가 가능하며, 적절한 치료를 받으면 대부분의 환자가 양호한 예후를 기대할 수 있습니다.
비전이성 전립선암의 역학 분석 및 예측에 관한 주요 조사 결과
전립선암 시장은 급격한 변화를 겪고 있으며, 기존의 안드로겐 차단 요법(ADT)이나 화학요법에 대한 의존에서 벗어나, 보다 표적을 좁힌 정밀 의학 중심의 치료 방식으로 전환되고 있습니다. 엔잘타미드나 아파르타미드와 같은 차세대 안드로겐 수용체 억제제, 그리고 PARP 억제제 및 방사성 리간드 요법의 활용 확대는 작용기전에 기반한 질환 수정 전략으로의 전환을 반영하고 있습니다. 이러한 발전으로 인해 표적 치료에 대한 임상적 신뢰도가 높아지고, 비전이성 및 전이성 환자 모두의 치료 상황에서 치료 선택지가 확대됨에 따라 경쟁 구도가 재편되고 있습니다.
DNA 손상 복구를 표적으로 하는 치료법, 방사성 의약품, 병용 요법 등의 분야에서 지속적인 혁신이 이루어짐에 따라, 전립선암 치료 패러다임은 조기 표적 치료의 성공이 향후 파이프라인 확대를 주도하는 다른 종양학 시장과 마찬가지로 진화하고 있습니다. 미국은 유럽이나 일본에 비해 높은 발병률, 광범위한 PSA 선별검사, 첨단 치료법의 조기 도입, 그리고 탄탄한 의료 인프라에 힘입어 여전히 최대 시장으로 자리 잡고 있습니다.
전반적으로, 새로운 표적 치료제의 도입, 진단 및 영상 진단 기술의 향상, 그리고 초기 단계 질환 관리에 대한 인식 제고에 힘입어, 2036년까지 주요 7개국(G7) 규모의 전립선암 시장은 꾸준한 성장을 이룰 것으로 예상되며, 기존 치료법과 신흥 파이프라인 자산 모두에 큰 상업적 기회가 창출될 전망입니다.
Non-metastatic Prostate Cancer Market Size and Forecast in the 7MM
DelveInsight's 'Non-metastatic Prostate Cancer (nmPC) - Market Insights, Epidemiology and Market Forecast - 2036' report delivers an in-depth understanding of the non-metastatic prostate cancer, historical and forecasted epidemiology, as well as the Non-metastatic Prostate Cancer market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.
The Non-metastatic Prostate Cancer market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates, Non-metastatic Prostate Cancer patient burden trends, revenue & market share dynamics, peak patient share & therapy uptake analysis, and provides an in-depth market size assessment, and growth rate projections (Historical & Forecast 2022-2036) across global regions. The report highlights key unmet medical needs in Non-metastatic Prostate Cancer and maps the competitive and clinical landscape to uncover high-value opportunities, providing a clear outlook on future market growth potential.
Key Factors Driving the Non-metastatic Prostate Cancer Market
Rising Disease Detection and Screening
Widespread use of PSA testing and improved diagnostic imaging increases early diagnosis of non metastatic prostate cancer.
Expansion of Targeted Therapies
Adoption of next generation androgen receptor inhibitors (e.g., apalutamide, enzalutamide, darolutamide) with proven efficacy in delaying progression fuels market uptake.
Research and Pipeline Innovation
Ongoing development of novel agents and combination strategies continues to expand therapeutic options and attract investment.
Non-metastatic Prostate Cancer Overview and Diagnosis
Non-metastatic Prostate Cancer refers to prostate cancer that is confined to the prostate gland or surrounding local tissues without evidence of distant metastasis. The condition is often asymptomatic in its early stages and is frequently identified through elevated prostate-specific antigen (PSA) levels or abnormalities detected during a digital rectal examination (DRE). Diagnosis is confirmed via prostate biopsy, which determines tumor grade and aggressiveness, while imaging modalities such as multiparametric MRI, CT scans, or bone scans are used to assess local spread and exclude distant disease. Risk stratification based on PSA levels, Gleason score, and tumor staging plays a critical role in guiding management. Early diagnosis is essential, as non-metastatic prostate cancer is generally associated with favorable prognosis and a wide range of effective treatment options, including active surveillance, surgery, and radiation therapy.
Non-metastatic Prostate Cancer Diagnosis
Diagnosis of Non-metastatic Prostate Cancer is based on a combination of clinical evaluation and diagnostic testing. It is typically suspected in men with elevated prostate-specific antigen (PSA) levels or abnormal findings on digital rectal examination (DRE). Confirmation is achieved through a prostate biopsy, which determines tumor grade and aggressiveness. Imaging techniques such as multiparametric MRI are used to assess local tumor extent, while CT scans or bone scans help rule out distant metastasis, ensuring accurate staging and appropriate treatment planning.
Non-metastatic Prostate Cancer Treatment
Treatment of Non-metastatic Prostate Cancer depends on disease risk, patient age, and overall health, with the goal of controlling cancer while preserving quality of life. Common approaches include active surveillance for low-risk cases and definitive treatments such as radical prostatectomy or radiation therapy for higher-risk disease. In selected patients, androgen deprivation therapy (ADT) may be used, often in combination with radiation. Additional therapeutic options include focal therapies (such as cryotherapy or high-intensity focused ultrasound) for localized lesions, and in certain high-risk non-metastatic settings, next-generation hormonal therapies may be considered. Overall, a range of treatment modalities allows for personalized management, with most patients achieving a favorable prognosis when treated appropriately.
Non-metastatic Prostate Cancer Unmet Needs
The section "unmet needs of Non-metastatic Prostate Cancer" outlines the critical gaps between the current state of patient care, diagnosis, and the ideal & effective management of the disease. It highlights the obstacles experienced by patients, clinicians, and researchers and identifies potential solutions for future progress.
Comprehensive unmet needs insights in Non-metastatic Prostate Cancer and their strategic implications are provided in the full report.
Key Findings from Non-metastatic Prostate Cancer Epidemiological Analysis and Forecast
Non-metastatic Prostate Cancer Drug Chapters & Competitive Analysis
The Non-metastatic Prostate Cancer drug chapter provides a detailed, market-focused review of approved therapies and the emerging pipeline across Phase I-III clinical trials. It covers the mechanism of action, clinical trial data, regulatory approvals, patents, collaborations, and strategic partnerships for each therapy, along with their advantages, limitations, and recent developments. This section offers critical insights into the Non-metastatic Prostate Cancers treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the Non-metastatic Prostate Cancer therapeutics market.
Approved Therapies for Non-metastatic Prostate Cancer
Apalutamide (ERLEADA): Janssen Pharmaceutical
Apalutamide (ERLEADA) is a small molecule androgen receptor antagonist which binds to the intracellular receptor and prevents its translocation to the nucleus and subsequent DNA binding, thereby blocking its activity. Apalutamide is a third generation, oral nonsteroidal antiandrogen used to treat non-metastatic castration-resistant prostate cancer. Therapy with apalutamide lowers residual testosterone levels after surgical castration in men with prostate cancer and has been shown to prolong metastasis free survival in men with castration-resistant prostate cancer with rising levels of prostate-associated antigen (PSA) without measurable metastatic disease.
Enzalutamide (XTANDI): Astellas Pharma/Pfizer
XTANDI (enzalutamide) is an orally bioavailable, organic, non-steroidal small molecule targeting the AR with potential antineoplastic activity. Through a mechanism 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 overexpression in prostate cancer represents a key mechanism associated with prostate cancer hormone resistance.
In November 2023, XTANDI Approved by US FDA for Non-metastatic Castration-Sensitive Prostate Cancer, First ARSI Option With or Without GnRH Therapy.
Non-metastatic Prostate Cancer Pipeline Analysis
Relugolix (ORGOVYX): Sumitomo Pharma/Pfizer
ORGOVYX (relugolix) is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist approved by the FDA for treating adult patients with advanced prostate cancer. As a GnRH antagonist, ORGOVYX blocks the GnRH receptor and reduces the production of testicular testosterone, a hormone known to stimulate the growth of prostate cancer. Relugolix is a non-peptide GnRH receptor antagonist that competitively binds to pituitary GnRH receptors, thereby reducing the release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) and, consequently, testosterone.
Eligible patients in clinical trial were treated with leuprolide acetate or degarelix with abiraterone or apalutamide prior to baseline, at which time they were transitioned to relugolix. Assessments included reporting of adverse events, clinical laboratory tests, vital sign measurements, electrocardiogram (ECG) parameters, and testosterone serum concentrations. The drug ORGOVYX is presently undergoing evaluation in a Phase I clinical trial to assess its safety and tolerability in patients.
CAN-2409: Candel Therapeutics
CAN-2409, Candel's most advanced viral immunotherapy candidate, is a replication-defective adenovirus that delivers the herpes simplex virus thymidine kinase (HSV-tk) gene to cancer cells. HSV-tk is an enzyme that locally converts orally administered Val acyclovir into a toxic metabolite that kills nearby cancer cells. The intra-tumoral administration results in the release of tumor-specific neoantigens in the microenvironment. At the same time, the adenoviral serotype 5 capsid protein elicits a strong pro-inflammatory signal in the tumor microenvironment, which is designed to create the optimal conditions to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor.
The drug CAN-2409 is presently undergoing evaluation in a Phase III clinical trial to assess its safety and tolerability in patients.
Non-metastatic Prostate Cancer (nmPC) Key Players, Market Leaders and Emerging Companies
Non-metastatic Prostate Cancer (nmPC) Drug Updates
Drug Class Insights
The Prostate Cancer market is undergoing a notable transformation, moving beyond traditional reliance on androgen deprivation therapy (ADT) and chemotherapy toward more targeted and precision-driven treatment approaches. The expanding use of next-generation androgen receptor inhibitors such as Enzalutamide and Apalutamide, along with PARP inhibitors and radioligand therapies, reflects a shift toward mechanism-based, disease-modifying strategies. These advancements are strengthening clinical confidence in targeted interventions and reshaping the competitive landscape by broadening therapeutic options across both non-metastatic and metastatic settings.
With continued innovation in areas such as DNA damage repair-targeted therapies, radiopharmaceuticals, and combination regimens, the prostate cancer treatment paradigm is evolving in line with other oncology markets where early targeted successes drive further pipeline expansion. The United States remains the largest market, supported by high disease prevalence, widespread PSA screening, early adoption of advanced therapies, and strong healthcare infrastructure, compared to Europe and Japan.
Overall, the introduction of novel targeted agents, improved diagnostic and imaging techniques, and increasing awareness of early-stage disease management are expected to drive steady growth in the 7MM prostate cancer market through 2036, with significant commercial opportunities for both established therapies and emerging pipeline assets.
Drug Class/Insights into Leading Emerging and Marketed Therapies in Non-metastatic Prostate Cancer (2022-2036 Forecast)
The Non-metastatic Prostate Cancer market comprises androgen deprivation therapies, next-generation androgen receptor inhibitors, and emerging targeted agents, alongside surgical, radiation, and supportive approaches, each addressing key biological drivers such as androgen signaling, tumor progression, and resistance mechanisms underlying disease development and progression.
Non-metastatic Prostate Cancer Drug Uptake
This section focuses on the uptake rate of potential drugs expected to be launched in the market during the forecast period (2026-2036). The analysis covers the Non-metastatic Prostate Cancer market's uptake by drugs, patient uptake by therapy, and sales of each drug.
The uptake of therapies in Non-metastatic Prostate Cancer (nmPC) is expected to vary across next-generation androgen receptor inhibitors and conventional androgen deprivation therapies. Established targeted therapies such as Apalutamide (ERLEADA) and Enzalutamide (XTANDI) demonstrate strong and sustained uptake, while Darolutamide (NUBEQA) is anticipated to show steady and increasing adoption, supported by its favorable safety profile and lower central nervous system-related adverse effects. Their use is primarily driven by their proven ability to delay metastasis and improve metastasis-free survival, along with the limitations of conventional ADT alone in controlling disease progression.
In comparison, these next-generation androgen receptor inhibitors are expected to maintain consistent and competitive uptake as long-term efficacy and safety data continue to mature, and as they become more firmly embedded in treatment guidelines. Their adoption is further supported by increasing physician confidence, expanding clinical evidence, and a growing emphasis on early intervention to delay disease progression, reinforcing their central role in the evolving nmPC treatment landscape.
Market Access and Reimbursement of nmPC
The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.
Non-metastatic Prostate Cancer Therapies Price Scenario & Trends
Pricing and analogue assessment of Non-metastatic Prostate Cancer therapies highlights evolving price dynamics structures. This section summarizes the cost of approved treatments, closest and most appropriate analogue selection for emerging therapies, and understanding of how pricing influences market access, adherence, and long-term uptake.
Apalutamide (ERLEADA) is administered at a recommended dose of 240 mg orally once daily. The list price for a supply of approximately 30 days (120 tablets of 60 mg) is around USD 15,356.89, translating to an estimated annual therapy cost of approximately USD 184,000-185,000, depending on treatment duration and adherence.
Further details are provided in the final report....
Industry Experts and Physician Views for Non-metastatic Prostate Cancer
To keep up with nmPC market trends, we take Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on the nmPC emerging therapies, evolving treatment landscape, patient adherence to conventional therapies, therapy switching trends, drug adoption and uptake, accessibility challenges, and epidemiology and real-world prescription patterns in nmPC, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.
DelveInsight's analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 6+ KOLs in the 7MM. Centers such as the University of North Carolina at Chapel Hill, Berlin Institute of Health at Charite, and the University of Nottingham, etc. were contacted. Their opinion helps understand and validate current and emerging nmPC therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in nmPC.
Qualitative Analysis: SWOT and Conjoint Analysis
We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and conjoint analysis.
In the SWOT analysis of Non-metastatic Prostate Cancer (nmPC), strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.
Conjoint analysis analyzes emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.
The team of analysts analyzes promising emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. In efficacy, the trial's primary and secondary outcome measures are evaluated, whereas the therapies' safety is evaluated, wherein the acceptability, tolerability, and adverse events are majorly observed. In addition, the scoring is also based on the route of administration, order of entry, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.
Market Insights