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비전이성 전립선암(nmPC) : 시장 인사이트, 역학 및 시장 예측(2036년)

Non-metastatic Prostate Cancer (nmPC) - Market Insight, Epidemiology, and Market Forecast - 2036

발행일: | 리서치사: 구분자 DelveInsight | 페이지 정보: 영문 230 Pages | 배송안내 : 2-10일 (영업일 기준)

    
    
    




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영문목차

비전이성 전립선암(nmPC)에 대한 인사이트와 동향

  • DelveInsight의 분석에 따르면, 2025년 주요 시장(미국, EU4(독일, 프랑스, 이탈리아, 스페인), 영국 및 일본)의 nmPC 시장 규모는 약 36억 달러인 것으로 나타났습니다.
  • 전립선암은 전립선에 비정상적인 세포가 형성되어 증식함으로써 발병합니다. 양성(비암성) 종양과 달리, 이러한 종양은 암성(악성)입니다. 전립선암이 ‘전이성’이 되어 전립선 밖으로 퍼지면 생명을 위협할 수 있습니다. 전립선암의 초기 단계에서는 증식에 테스토스테론이 필수적이며, 경우에 따라 테스토스테론 수치를 낮춤으로써 증식을 억제할 수 있습니다.
  • 거세 저항성 전립선암(CRPC)은 진행성 전립선암의 일종입니다. 전립선암이 CRPC로 진단된 경우, 테스토스테론 수치가 낮더라도 암이 증식하거나 전이될 가능성이 있습니다. 또한, 비전이성 CRPC(nmCRPC)의 경우, 암은 호르몬 치료에 반응하지 않게 됩니다. PSA(전립선 특이 항원) 수치의 상승 등 증식 징후는 보이지만, 암은 전립선 내부에만 존재하며 전이되지는 않았습니다.
  • 대부분의 경우, nmCRPC 환자에게는 증상이 나타나지 않습니다. 의사가 PSA 수치의 상승을 알아차리지 않는 한, 대부분의 남성은 암이 진행되고 있는지 여부를 판단할 수 없습니다. 경과 관찰을 위해 혈액 검사, 신체 검사, 그리고 CT, 골스캔, PET 스캔 등의 영상 검사가 실시됩니다.
  • 현재 nmCRPC의 치료 현황을 보면, 미국 FDA의 승인을 받은 약물은 엔잘타미드(XTANDI, 화이자 및 아스테라스), 아파르타미드(ERLEADA, 얀센 바이오텍), 다롤타미드(NUBEQA, 바이엘) 등 3종뿐입니다.
  • 한편, 개발 중인 nmPC 치료제 파이프라인은 여전히 비교적 제한적이지만, 레르고릭스(ORGOVYX), CAN-2409, KPG-121, OVM-200 등 소수의 중기 및 후기 단계 후보 약물이 평가되고 있습니다.

주요 7개국 비전이성 전립선암 시장 규모 및 전망

  • 2025년 nmPC 시장 규모 : 약 36억 달러
  • 2036년 비전이성 전립선암(nmPC) 시장 규모 전망: 55억 달러
  • nmPC의 성장률(2026년-2036년) : 연평균 성장률(CAGR) 4%

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.

비전이성 전립선암 시장을 주도하는 주요 요인

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 이해와 치료 알고리즘

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

비전이성 전립선암의 역학 분석 및 예측에 관한 주요 조사 결과

  • DelveInsight사의 추산에 따르면, 2025년 미국의 비전이성 전립선암 시장 규모는 약 2,500이었습니다.
  • G7 국가 중 스페인 시장 규모는 가장 작았으며, 2025년에는 약 1억 1,000만 달러를 기록했습니다.
  • 2025년 기준으로, 비전이성 전립선암 시장은 주요 7개국 전립선암 시장 전체의 약 25%를 차지하고 있습니다.
  • 미국에서는 남성 9명 중 약 1명이 일생 중 어느 시점에 이 질환으로 진단받고 있습니다. 미국암협회(2019년)에 따르면, 전립선암은 폐암에 이어 미국 남성의 암 사망 원인 중 2위를 차지하고 있습니다.

비전이성 전립선암(nmPC) 시장 전망

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.

  • 비전이성 전립선암 시장은 치료의 초점이 기존의 안드로겐 차단 요법에서 차세대 안드로겐 수용체 억제제 및 표적 치료로 전환됨에 따라 변화하고 있으며, 아파르타미드, 엔잘타미드, 달롤타미드 등의 약물은 전이 지연에 대한 입증된 효능, 양호한 안전성 프로파일, 그리고 질병 관리의 초기 단계로의 도입 확대를 통해 시장 채택을 주도하고 있습니다.
  • 지역별 시장 동향을 살펴보면, 미국은 높은 진단율, PSA 선별검사의 보급, 차세대 안드로겐 수용체 억제제의 조기 도입, 그리고 탄탄한 보험 급여 제도에 힘입어 매출액 부문에서 1위를 유지하고 있습니다. 반면, 일본과 유럽에서는 진단 기술의 발전, 첨단 치료법의 단계적 도입, 그리고 체계적인 의료 제도 내에서 혁신적인 치료에 대한 접근성 확대에 힘입어 꾸준한 성장을 보이고 있습니다.
  • 2036년에는 비전이성 전립선암(nmPC)을 대상으로 하는 모든 치료법 중에서 XTANDI(엔잘타미드)는 시장 내 선도적 지위와 적응증 확대를 바탕으로 예측 기간 동안 비전이성 전립선암 시장에서 매출 1위를 차지하는 치료법으로 자리매김할 것으로 예측됩니다.
  • 종양 용해성 유전자 치료: CAN-2409는 아데노바이러스 벡터를 이용한 임상시험 단계의 유전자 치료법으로, 단순 헤르페스 바이러스 티미딘 키나아제(HSV-tk) 유전자를 종양 세포에 직접 전달하고, 전구약물 투여를 통해 표적 세포의 사멸을 유도하도록 설계되었습니다. 이는 직접적인 종양 세포 독성과 전신적인 항종양 면역 반응을 모두 자극함으로써, 전립선암에 대한 유전자 매개 면역 요법의 가능성을 부각시키고 있습니다.
  • 안드로겐 수용체 억제제: 아파르타미드(ERLEADA)는 전립선암 진행의 주요 원인인 안드로겐 수용체의 신호 전달을 억제하는 차세대 안드로겐 수용체 억제제입니다. 전이되지 않은 거세 저항성 전립선암의 경우, 전이 및 질병 진행을 지연시키는 효과가 입증되어, 초기 단계에서 표준 치료법으로서의 역할이 뒷받침되고 있습니다.
  • 안드로겐 수용체 억제제: 엔잘타미드(XTANDI)는 안드로겐 수용체의 핵 내 이동 및 DNA 결합을 억제하는 강력한 안드로겐 수용체 신호전달 억제제입니다. 전이 무재발 생존 기간의 연장 및 질병 진행 지연에 있어 유의미한 효과가 입증되었으며, 이는 전립선암 치료에서 안드로겐 신호 전달 경로를 표적으로 삼는 것의 중요성을 뒷받침하고 있습니다.

자주 묻는 질문

  • 비전이성 전립선암(nmPC) 시장 규모는 어떻게 예측되나요?
  • 비전이성 전립선암(nmPC)의 주요 치료제는 무엇인가요?
  • 비전이성 전립선암(nmPC)의 진단 방법은 무엇인가요?
  • 비전이성 전립선암(nmPC)의 치료 옵션은 어떤 것들이 있나요?
  • 비전이성 전립선암(nmPC) 시장의 주요 성장 요인은 무엇인가요?

목차

제1장 주요 인사이트

제2장 서론

제3장 주요 요약

제4장 주요 이벤트

제5장 역학 및 시장 예측 조사 방법

제6장 비전이성 전립선암(nmPC) : 시장 개요

제7장 비전이성 전립선암(nmPC) : 질환 배경과 개요

제8장 비전이성 전립선암(nmPC) : 치료 가이드라인

제9장 비전이성 전립선암(nmPC) : 역학 및 환자 인구

제10장 비전이성 전립선암(nmPC) : 환자 경과

제11장 시판 치료제

제12장 신흥 치료제

제13장 비전이성 전립선암(nmPC) : 주요 7개국 분석

제14장 비전이성 전립선암(nmPC) : 미충족 요구

제15장 비전이성 전립선암(nmPC) : SWOT 분석

제16장 비전이성 전립선암(nmPC) : KOL(Key Opinion Leader)의 견해

제17장 비전이성 전립선암(nmPC) : 시장 참여 및 상환

제18장 부록

제19장 DelveInsight의 서비스 내용

제20장 면책사항

제21장 DelveInsight에 대해

LSH

Non-metastatic Prostate Cancer (nmPC) Insights and Trends

  • According to DelveInsight's analysis, nmPC market size was found to be ~USD 3,600 million in the leading markets (the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan) in 2025.
  • Prostate cancer happens when abnormal cells form and grow in the prostate gland. Unlike benign (or non-cancerous) growths, these growths are cancerous (malignant). Prostate cancer can be life-threatening if it becomes "metastatic" and spreads beyond the prostate. Early stages of prostate cancer rely on testosterone to grow; sometimes, lowering testosterone can control growth.
  • Castration-resistant prostate cancer (CRPC) is a form of advanced prostate cancer. If prostate cancer is diagnosed as CRPC, it can grow or spread even with low testosterone levels, and with non-metastatic CRPC (nmCRPC), the cancer no longer responds to hormone treatment. It shows signs of growth, like a rising PSA (prostate-specific antigen) level, but it is only found in the prostate and has not spread.
  • Often, there are no symptoms for patients with nmCRPC. Most men cannot tell if the cancer is growing unless the doctor notices a rise in the PSA level. Changes are tracked with blood tests, physical exams, and scans, such as CT, bone, and PET scans.
  • The current nmPC treatment landscape includes only three drugs have been approved by the US FDA for nmCRPC, including Enzalutamide (XTANDI, Pfizer and Astellas), Apalutamide (ERLEADA, Janssen Biotech), and Darolutamide (NUBEQA, Bayer).
  • Whereas the emerging nmPC pipeline remains relatively limited, a small number of late- and mid-stage assets such as Relugolix (ORGOVYX), CAN-2409, KPG-121, and OVM-200 are being evaluated.

Non-metastatic Prostate Cancer Market Size and Forecast in the 7MM

  • 2025 nmPC Market Size: ~USD 3,600 million
  • 2036 Projected nmPC Market Size: USD 5,500million
  • nmPC Growth Rate (2026-2036): 4% CAGR

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 Understanding and Treatment Algorithm

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.

1. Lack of curative therapy

2. Need for early diagnosis

3. Lack of consensus on genetic testing and treatment

4. Cross-resistance between available androgen receptor pathway inhibitors, and others.....

Comprehensive unmet needs insights in Non-metastatic Prostate Cancer and their strategic implications are provided in the full report.

Non-metastatic Prostate Cancer Epidemiology

Key Findings from Non-metastatic Prostate Cancer Epidemiological Analysis and Forecast

  • According to DelveInsight's estimates, the total market size of Non-metastatic Prostate Cancer in the US were approximately 2,500 in 2025.
  • Spain accounted for the least market size among the 7MM countries which was ~USD 110 million in 2025.
  • The market for the non-metastatic prostate cancer accounts for around 25% of the 7MM's overall market size of prostate cancer in 2025.
  • Approximately one in nine men in the US is diagnosed with this disease at some point. As per the American Cancer Society, 2019, prostate cancer is the second leading cause of cancer death in American men, behind only lung cancer.

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

  • Janssen Pharmaceutical
  • Astellas Pharma/Pfizer
  • Bayer
  • Myovant
  • Sumitomo Pharma
  • Takeda
  • Accord
  • Candel Therapeutics
  • Kangpu Biopharmaceuticals
  • Oxford Vacmedix, and others

Non-metastatic Prostate Cancer (nmPC) Drug Updates

  • In March 2026, Candel Therapeutics to present extended follow-up data from Phase III CAN-2409 trial in localized prostate cancer at AUA 2026 annual meeting.
  • In October 2025, Astellas to showcase innovative portfolio and pipeline developments at ESMO 2025.
  • In September 2025 Candel Therapeutics showcases Phase III CAN-2409 clinical trial in localized prostate cancer at ASTRO 2025.
  • In May 2025, FDA grants Regenerative Medicine Advanced Therapy (RMAT) designation to Candel Therapeutics' CAN-2409 for prostate cancer treatment.

Drug Class Insights

Non-metastatic Prostate Cancer (nmPC) Market Outlook

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.

  • The Non-metastatic Prostate Cancer market is evolving as treatment focus shifts from conventional androgen deprivation therapy to next-generation androgen receptor inhibitors and targeted therapies, with agents such as Apalutamide, Enzalutamide, and Darolutamide driving adoption due to their proven efficacy in delaying metastasis, favorable safety profiles, and increasing integration into earlier stages of disease management.
  • Regional market dynamics show the United States leading in revenue, driven by high diagnosis rates, widespread PSA screening, early adoption of next-generation androgen receptor inhibitors, and strong reimbursement frameworks. In contrast, Japan and Europe demonstrate steady growth, supported by improving diagnosis, gradual uptake of advanced therapies, and expanding access to innovative treatments within structured healthcare systems.
  • In 2036, among all the therapies for nmPC, XTANDI (enzalutamide) is expected to remain the top revenue-generating therapy in the non-metastatic prostate cancer market over the forecast period due to its market leadership and expanded indications.

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.

  • Oncolytic gene therapy: CAN-2409 is an investigational adenoviral vector-based gene therapy designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene directly into tumor cells, enabling targeted cell death upon administration of a prodrug. It stimulates both direct tumor cytotoxicity and systemic anti-tumor immune responses, highlighting the potential of gene-mediated immunotherapy in prostate cancer.
  • Androgen receptor inhibitors: Apalutamide (ERLEADA) is a next-generation androgen receptor inhibitor that blocks androgen receptor signaling, a key driver of prostate cancer progression. It has demonstrated efficacy in delaying metastasis and disease progression in non-metastatic castration-resistant prostate cancer, supporting its role as a standard of care in earlier disease settings.
  • Androgen receptor inhibitors: Enzalutamide (XTANDI) is a potent androgen receptor signaling inhibitor that prevents androgen receptor nuclear translocation and DNA binding. It has shown significant benefit in improving metastasis-free survival and delaying disease progression, reinforcing the importance of targeting androgen signaling pathways in prostate cancer management

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 United States

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.

  • Pricing of Non-metastatic Prostate Cancer Approved Drugs

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.

Scope of the Report:

  • The report covers a segment of key events, an executive summary, a descriptive overview of nmPC, explaining its causes, signs and symptoms, pathogenesis, and currently available treatments.
  • Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of the diagnosis rate, and disease progression along treatment guidelines.
  • Additionally, an all-inclusive account of both the current and emerging treatments, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
  • A detailed review of the market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
  • The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM non-metastatic Prostate Cancer (nmPC) market.

Report Insights

  • nmPC Patient Population Forecast
  • nmPC Therapeutics Market Size
  • nmPC Pipeline Analysis
  • nmPC Market Size and Trends
  • nmPC Market Opportunity (Current and forecasted)

Report Key Strengths

  • Epidemiology-based (Epi-based) Bottom-up Forecasting
  • Artificial Intelligence (AI)-enabled Market Research Report
  • 11-year forecast
  • nmPC Market Outlook (North America, Europe, Asia-Pacific)
  • Patient Burden Trends (by geography)
  • nmPC Treatment Addressable Market (TAM)
  • nmPC Competitive Landscape
  • nmPC Major Companies Insights
  • nmPC Price Trends and Analogue Assessment
  • nmPC Therapies Drug Adoption/Uptake
  • nmPC Therapies Peak Patient Share analysis

Report Assessment

  • nmPC Current Treatment Practices
  • nmPC Unmet Needs
  • nmPC Clinical Development Analysis
  • nmPC Emerging Drugs Product Profiles
  • nmPC Market Attractiveness
  • nmPC Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs:

Market Insights

  • What was the nmPC market size, the market size by therapies, market share (%) distribution in 2025, and what would it look like by 2036? What are the contributing factors for this growth?
  • What are the anticipated pricing variations among different geographies for the emerging therapies in the future?
  • What can be the future treatment paradigm of nmPC?
  • What are the disease risks, burdens, and unmet needs of nmPC? What will be the growth opportunities across the 7MM concerning the patient population with nmPC?
  • Who is the major future competitor in the market, and how will the competitors affect their market share?
  • What are the current options for the treatment of nmPC? What are the current guidelines for treating nmPC in the US, Europe, and Japan?

Reasons to Buy:

  • The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the nmPC market.
  • Bottom up forecasting builds from the affected population to product forecasts, delivering a robust, data driven approach ideal for new therapies and novel classes.
  • Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
  • Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
  • Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
  • Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
  • To understand KOLs' perspectives on the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
  • Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.
  • This Artificial Intelligence (AI) enabled report summarize and simplify complex datasets within the report into clear, actionable insights for stakeholders, investors, and healthcare providers, enabling faster, data driven decisions.

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary

4. Key Events

  • 4.1. Upcoming Key Catalysts
  • 4.2. Key Transactions And Collaborations
  • 4.3. News Flow

5. Epidemiology and Market Forecast Methodology

6. nmPC Market Overview at a Glance

  • 6.1. Clinical Landscape Analysis (By Phase, Molecule Type, and RoA)
  • 6.2. Market Share (%) Distribution of nmPC By Therapies in the 7MM, in 2025
  • 6.3. Market Share (%) Distribution of nmPC By Therapies in the 7MM, in 2036

7. Disease Background and Overview of Non-Metastatic Prostate Cancer (nmPC)

  • 7.1. Introduction
  • 7.2. Types
  • 7.3. Symptoms
  • 7.4. Causes
  • 7.5. Pathophysiology
  • 7.6. Diagnosis
  • 7.7. Treatment

8. Treatment Guidelines of Non-Metastatic Prostate Cancer (nmPC)

  • 8.1. American College of Rheumatology
  • 8.2. EULAR/Pres Recommendations for the Diagnosis and Management of Still's Disease
  • 8.3. Japan College of Rheumatology Clinical Practice Guidelines

9. Epidemiology and Patient Population of Non-Metastatic Prostate Cancer (nmPC)

  • 9.1. Key Findings
  • 9.2. Assumptions and Rationale
  • 9.3. Diagnosed Prevalent Cases of nmPC in the 7MM
  • 9.4. The United States
    • 9.4.1. Total Diagnosed Prevalent Cases of nmPC in the United States
    • 9.4.2. Age-specific Diagnosed Prevalent Cases of nmPC in the United States
    • 9.4.3. Stage-specific Diagnosed Prevalent Cases of nmPC in the United States
    • 9.4.4. Total Line-wise Treated Cases of nmPC in the United States
  • 9.5. EU4 and the UK
    • 9.5.1. Total Diagnosed Prevalent Cases of nmPC in EU4 and the UK
    • 9.5.2. Age-specific Diagnosed Prevalent Cases of nmPC in EU4 and the UK
    • 9.5.3. Stage-specific Diagnosed Prevalent Cases of nmPC in EU4 and the UK
    • 9.5.4. Total Line-wise Treated Cases of nmPC in EU4 and the UK
  • 9.6. Japan
    • 9.6.1. Total Diagnosed Prevalent Cases of nmPC in Japan
    • 9.6.2. Age-specific Diagnosed Prevalent Cases of nmPC in Japan
    • 9.6.3. Stage-specific Diagnosed Prevalent Cases of nmPC in Japan
    • 9.6.4. Total Line-wise Treated Cases of nmPC in Japan

10. Patient Journey of Non-Metastatic Prostate Cancer (nmPC)

11. Marketed Therapies

  • 11.1. Marketed Competitive Landscape of Non-Metastatic Prostate Cancer (nmPC)
  • 11.2. Apalutamide (ERLEADA): Janssen Pharmaceutical
    • 11.2.1. Drug Description
    • 11.2.2. Regulatory Milestones
    • 11.2.3. Other Developmental Activities
    • 11.2.4. Summary of Pivotal Trials
    • 11.2.5. Clinical Development
      • 11.2.5.1. Clinical Trial Information
    • 11.2.6. Analyst Views
  • 11.3. Enzalutamide (XTANDI): Astellas Pharma/Pfizer
    • 11.3.1. Drug Description
    • 11.3.2. Regulatory Milestones
    • 11.3.3. Other Developmental Activities
    • 11.3.4. Summary of Pivotal Trials
    • 11.3.5. Clinical Development
      • 11.3.5.1. Clinical Trial Information
    • 11.3.6. Analyst Views
  • 11.4. Darolutamide (NUBEQA): Bayer
    • 11.4.1. Drug Description
    • 11.4.2. Regulatory Milestones
    • 11.4.3. Other Developmental Activities
    • 11.4.4. Summary of Pivotal Trials
    • 11.4.5. Clinical Development
      • 11.4.5.1. Clinical Trial Information
    • 11.4.6. Analyst Views

12. Emerging Drugs

  • 12.1. Emerging Competitive Landscape of Non-Metastatic Prostate Cancer (nmPC)
  • 12.2. Relugolix (ORGOVYX): Myovant/Sumitomo Pharma/Takeda/Accord
    • 12.2.1. Drug Description
    • 12.2.2. Other Developmental Activities
    • 12.2.3. Clinical Development
      • 12.2.3.1. Clinical Trials Information
    • 12.2.4. Analyst Views
  • 12.3. CAN-2409: Candel Therapeutics
    • 12.3.1. Drug Description
    • 12.3.2. Other Developmental Activity
    • 12.3.3. Clinical Development
      • 12.3.3.1. Clinical Trials Information
    • 12.3.4. Analyst Views
  • 12.4. KPG-121: Kangpu Biopharmaceuticals
    • 12.4.1. Drug Description
    • 12.4.2. Clinical Development
      • 12.4.2.1. Clinical Trial Information
    • 12.4.3. Safety and Efficacy
    • 12.4.4. Analyst Views

13. Non-Metastatic Prostate Cancer (nmPC): 7MM Analysis

  • 13.1. Key Findings
  • 13.2. Market Outlook of Non-Metastatic Prostate Cancer (nmPC)
  • 13.3. Conjoint Analysis of Non-Metastatic Prostate Cancer (nmPC)
  • 13.4. Key Market Forecast Assumptions
    • 13.3.1. Cost Assumptions
    • 13.3.2. . Pricing Trends
    • 13.3.3. Analogue Assessment
    • 13.3.4. Launch Year and Therapy Uptakes
  • 13.5. Total Market Size of nmPC in the 7MM
  • 13.6. Total Market Size of nmPC by Therapies in the 7MM
  • 13.7. The United States
    • 13.7.1. Total Market Size of nmPC in the United States
    • 13.7.2. Total Market Size of nmPC by Therapies in the United States
  • 13.8. EU4 and the UK
    • 13.8.1. Total Market Size of nmPC in EU4 and the UK
    • 13.8.2. Total Market Size of nmPC by Therapies in EU4 and the UK
  • 13.9. Japan
    • 13.9.1. Total Market Size of nmPC in Japan
    • 13.9.2. Total Market Size of nmPC by Therapies in Japan

14. Unmet Needs of Non-Metastatic Prostate Cancer (nmPC)

15. SWOT Analysis of Non-Metastatic Prostate Cancer (nmPC)

16. KOL Views of Non-Metastatic Prostate Cancer (nmPC)

17. Market Access and Reimbursement of Non-Metastatic Prostate Cancer (nmPC)

  • 17.1. The United States
  • 17.2. EU4 and the UK
    • 17.2.1. Germany
    • 17.2.2. France
    • 17.2.3. Italy
    • 17.2.4. Spain
    • 17.2.5. United Kingdom
  • 17.3. Japan
  • 17.4. Summary and comparison of Market Access and Pricing Policy Developments in 2025
  • 17.5. Market Access and Reimbursement of Non-Metastatic Prostate Cancer (nmPC) Therapies

18. Appendix

  • 18.1. Bibliography
  • 18.2. Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

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