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시장보고서
상품코드
2082836
삼중음성유방암(TNBC) : 시장 인사이트, 역학 및 예측(2036년)Triple Negative Breast Cancer (TNBC) - Market Insight, Epidemiology, and Market Forecast - 2036 |
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DelveInsight
삼중음성유방암 시장 규모 및 전망
본 삼중음성유방암 시장 보고서는 표준 치료, 임상 실무, 진화하는 치료 알고리즘 등 현재 시장 상황에 대한 종합적인 분석을 제공합니다. 또한, TNBC 환자의 부담 동향, 수익 및 시장 점유율 동향, 정점 시기의 환자 점유율 및 치료 도입률 분석을 평가하여, 주요 7개 국가 및 지역 전체에 걸친 상세한 시장 규모 평가와 성장률 예측(과거 데이터 및 2022-2036년 예측)을 제시합니다. 본 보고서에서는 TNBC 분야의 주요 미충족 의료 수요를 부각시키고, 경쟁 구도 및 임상 환경을 분석하여 고부가가치의 성장 기회를 도출함으로써, 향후 시장 성장 가능성에 대한 명확한 전망을 제시하고 있습니다.
북미 : 미국
유럽 : 독일, 프랑스, 이탈리아, 스페인, 영국
아시아태평양 : 일본
삼중음성유방암(TNBC)의 개요와 진단
유방암은 유전학적·임상적으로 다양성이 있으며, 다양한 아형이 존재하는 질환입니다. 이러한 하위 유형의 분류는 시대에 따라 변화해 왔습니다. 가장 일반적으로 사용되며 널리 인정받는 분류 체계는 면역조직화학적 분석에 기반한 것으로, 에스트로겐 수용체(ER), 프로게스테론 수용체(PR), 인간 상피 성장 인자 수용체 2(HER2) 등의 호르몬 수용체 발현을 조사하는 것입니다. TNBC 특유의 간질 면역 환경은 혈관내피성장인자, 종양 침윤 림프구(TIL), 종양 관련 대식세포(TAM), 그리고 종양 세포의 증식 및 이동을 촉진하는 기타 분자의 수치가 상승해 있는 것이 특징이며, TNBC의 발병, 진행 및 전이에 있어 이중적인 역할을 수행하고 있습니다.
TNBC 진단에 일반적으로 사용되는 영상 진단법으로는 유방촬영술, 초음파 검사, MRI 등이 있습니다. 진단에 사용되는 일반적인 생검법으로는 코어 생검, 세침 흡인 생검, 스테레오택틱 생검, 외과적 생검 등이 있습니다.
TNBC의 현재 치료 현황
TNBC의 현재 치료 상황에는 과제가 있습니다. 호르몬 수용체(에스트로겐 및 프로게스테론)가 결핍되어 있고, HER2 단백질의 발현도 극히 미미하기 때문에 호르몬 요법이나 HER2 표적 요법이 효과를 발휘하지 못해 치료가 어려운 상황입니다. 그 결과, 모든 병기에서 화학요법이 TNBC 치료의 주축으로 자리 잡고 있습니다.
초기 TNBC의 경우, 종양을 축소하고 치료 반응을 평가하기 위해 수술 전 화학요법이 종종 사용됩니다. 이러한 접근 방식은 유방 보존 수술을 가능하게 함으로써 수술 결과를 개선할 수도 있습니다. 수술 후 잔존 병변의 상태에 따라 재발 위험을 줄이기 위해 수술 후 화학요법이 권장되는 경우가 있습니다. 또한, 특히 림프절 전이가 있거나 유방 보존 수술을 받은 경우에는 방사선 치료도 고려됩니다.
TNBC의 보조요법으로는 재발 위험을 낮추고 잔존 암세포를 제거하기 위해 다양한 화학요법 요법이 사용되고 있습니다. 일반적인 병용 요법으로는 시클로포스파미드, 독소르비신, 파클리탁셀의 조합, 시클로포스파미드와 독소르비신, 또는 도세탁셀의 조합이 있습니다. 파클리탁셀은 단독 요법으로 사용되기도 하지만, 잔존 병변에 대해서는 카페시타빈이 투여되는 경우가 많습니다. 또한, 특정 보조 치료 프로토콜에서는 시클로포스파미드, 플루오로우라실, 메토트렉세이트가 사용됩니다.
TNBC의 역학 분석 및 예측에 관한 주요 조사 결과
펜브롤리주맙, 올라파립, 타라조파립, 사시츠주맙·고비테칸, 아테졸리주맙은 TNBC 치료 패러다임이 진화하고 있음을 보여줍니다. 치료의 초점은 화학요법 단독에서 면역요법과 표적요법을 통합한 보다 개인 맞춤형 접근 방식으로 전환되고 있으며, 이에 따라 환자의 예후가 크게 개선되고 있습니다. 그러나 TNBC의 높은 침습성과 불량한 예후로 인해, 치료 옵션을 확대하고 생존율을 높이기 위한 연구와 임상시험이 현재도 계속되고 있습니다. 이러한 최근 동향이 나타나기 전에는 탁산계 화학요법이 전이성 질환, 특히 1차(1L) 치료에서 표준 치료법으로 자리 잡혀 있었습니다. 백금계 항암요법도 1차 치료 단계에서 때때로 사용됩니다. 그러나 이러한 치료법은 매우 심각한 부작용을 동반하는 경향이 있으며, 치료 성과(무재발 생존 기간 : PFS)도 그리 양호하지 않기 때문에 의사들 사이에서 그 사용 여부에 대해 격렬한 논쟁이 벌어지고 있습니다.
TNBC의 약물 분류별 및 주요 신흥 치료법에 대한 인사이트(2022-2036년 전망)
TNBC Market size and forecast
DelveInsight's 'Triple Negative Breast Cancer (TNBC)- Market Insights, Epidemiology and Market Forecast - 2036' report delivers an in-depth understanding of TNBC, historical and forecasted epidemiology, as well as the TNBC market trends in the United States, EU4 (Germany, Spain, Italy, and France), the United Kingdom, and Japan.
The TNBC market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates, TNBC 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 the 7MM regions. The report highlights key unmet medical needs in TNBC and maps the competitive and clinical landscape to uncover high-value opportunities, providing a clear outlook on future market growth potential.
North America: The United States
Europe: Germany, France, Italy, Spain and the United Kingdom
Asia-Pacific: Japan
Triple Negative Breast Cancer (TNBC) Overview and Diagnosis
Breast cancer is a disease that is both genetically and clinically diverse, with various subtypes. The categorization of these subtypes has changed over time. The most commonly used and widely recognized classification system is based on immune histochemical analysis, which looks at the expression of hormone receptors such as Estrogen Receptor (ER), Progesterone Receptor (PR), and Human Epidermal Growth Factor Receptor 2 (HER2). The distinctive immune microenvironment of TNBC, which features elevated levels of vascular endothelial growth factors, Tumor-infiltrating Lymphocytes (TILs), Tumor-associated Macrophages (TAMs), and other molecules that support tumor cell growth and migration, plays a dual role in the development, progression, and spread of TNBC.
Common imaging methods for diagnosing TNBC include mammography, ultrasound, and MRI. Common biopsy techniques used for diagnosis include core biopsy, fine needle aspiration, stereotactic biopsy, and surgical biopsy.
Current TNBC Treatment Landscape
The current treatment landscape for TNBC is challenging due to the lack of hormone receptors (estrogen and progesterone) and minimal HER2 protein expression, which makes hormonal and HER2-targeted therapies ineffective. Consequently, chemotherapy remains the cornerstone of TNBC treatment across all stages.
In early-stage TNBC, neoadjuvant chemotherapy is often used to reduce tumor size and assess treatment response. This approach can also improve surgical outcomes by enabling breast-conserving surgery. Depending on residual disease after surgery, adjuvant chemotherapy may be recommended to decrease the risk of recurrence. Radiation therapy is also considered, especially when lymph nodes are involved, or breast-conserving surgery is performed.
As adjuvant therapy for TNBC, various chemotherapy regimens are employed to reduce recurrence risk and eliminate residual cancer cells. Common combinations include cyclophosphamide, doxorubicin, and paclitaxel, as well as cyclophosphamide with doxorubicin or docetaxel. Paclitaxel is also used as a standalone agent, while capecitabine is often administered for residual disease. Additionally, cyclophosphamide, fluorouracil, and methotrexate are utilized in select adjuvant treatment protocols.
Triple Negative Breast Cancer (TNBC) Unmet Needs
The section "unmet needs of TNBC" 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.
Key Findings from TNBC Epidemiological Analysis and Forecast
Triple Negative Breast Cancer (TNBC) Drug Analysis & Competitive Landscape
The TNBC drug chapter provides a detailed, market-focused review of the emerging pipeline across Phase I-II clinical trials. It covers mechanism of action, clinical trial data, regulatory approvals, patents, collaborations, strategic partnerships upcoming key catalyst for each therapy, along with their advantages, limitations, and recent developments. This section offers critical insights into the TNBC treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the TNBC therapeutics market.
Approved Therapies for TNBC
Pembrolizumab (KEYTRUDA): Merck
Pembrolizumab (KEYTRUDA) is an immunotherapy that enhances the body's ability to recognize and attack cancer cells. As a humanized monoclonal antibody, it blocks the interaction between the PD-1 receptor and its ligands, Programmed Death-ligand 1 and 2 (PD-L1) and (PD-L2), thereby activating T lymphocytes, which can affect both tumor and healthy cells. In TNBC, KEYTRUDA has been studied in combination with chemotherapy to improve treatment outcomes.
TNBC Marketed/Approved Therapies
Drug/Therapy Company Indication Molecule Type MoA RoA Marketed Region
Pembrolizumab
(KEYTRUDA) Merck TNBC Monoclonal antibody PD-1 inhibitor IV infusion US: 2020 and 2021,
EU: 2021 and 2022,
JP: 2021 and 2022
Sactizumab govitecan-hziy
(TRODELVY) Gilead Sciences TNBC Monoclonal antibody DNA topoisomerase I inhibitor IV infusion US: 2021,
EU: 2021,
JP: 2024
Triple Negative Breast Cancer (TNBC) Pipeline Analysis
DATROWAY (Datopotamab Deruxtecan): AstraZeneca/Daiichi Sankyo
Datopotamab Deruxtecan (Dato-DXd) is an investigational antibody-drug conjugate (ADC) designed to selectively target cancer cells and deliver a potent chemotherapy payload. It is being developed as a precision medicine for the treatment of TNBC and is currently under evaluation across various TNBC subtypes in multiple clinical trials. Dato-DXd, also known as DATROWAY, is being studied both as a monotherapy and in combination with IMFINZI (durvalumab). This combination is being explored in the neoadjuvant and adjuvant settings for TNBC, as well as for PD-L1-positive patients with locally recurrent inoperable or metastatic TNBC, aiming to improve treatment outcomes for high-risk patients.
TNBC Key Players, Market Leaders and Emerging Companies
TNBC Drug Updates
Pembrolizumab, olaparib, talazoparib, sacituzumab govitecan, and atezolizumab-demonstrate the evolving TNBC treatment paradigm. The focus has shifted from chemotherapy alone to a more personalized approach integrating immunotherapy and targeted therapies, significantly improving patient outcomes. However, the aggressive nature of TNBC and its poor prognosis ongoing research and clinical trials to enhance therapeutic options and survival rates. Prior to these recent developments, taxane-based chemotherapies have remained the standard of care for metastatic disease, specifically in 1L treatment. Platinum-based chemotherapies are also used at times in the 1L treatment setting. Still, their usage is highly debated among physicians, as they tend to have very severe adverse effects and do not have that good of treatment outcome (PFS) either.
Drug Class/Insights into Leading Emerging Therapies in TNBC (2022-2036 Forecast)
Triple Negative Breast Cancer (TNBC) 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 TNBC drug's uptake, performance at peak, factors affecting performance during prime years of growth, patient uptake by therapy, and anticipated sales generated by each drug.
AstraZeneca/Daiichi Sankyo is leading in the TNBC pipeline with multiple therapies targeting different stages and lines of treatment. Their key Phase III candidate, Datopotamab deruxtecan (DATROWAY) combined with Durvalumab (IMFINZI), is under investigation for 1L therapy, with data expected after 2026. This includes the TROPION-Breast04 trial for neoadjuvant/adjuvant TNBC and TROPION-Breast05 for PD-L1-positive metastatic TNBC. Another trial, TROPION-Breast03, evaluates Datroway with or without IMFINZI for adjuvant residual disease in TNBC. These trials explore a precision medicine approach, focusing on TROP-2 ADC combined with PD-L1 immunotherapy.
It is expected to be launched in the EU4 and UK market by 2028. The therapy is anticipated to experience Medium-fast market uptake and reach peak sales within 6 years of its introduction. It offers a promising new treatment option for patients with this aggressive form of cancer.
Detailed insights of emerging therapies' drug uptake is included in the report
Market Access and Reimbursement of therapies in Triple Negative Breast Cancer (TNBC)
The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of 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.
Reimbursement is a crucial factor that affects the drug's access to the market. Often, the decision to reimburse comes down to the price of the drug relative to the benefit it produces in treated patients. To reduce the healthcare burden of these high-cost therapies, many payment models are being considered by payers and other industry insiders.
NOTE: Further Details are provided in the final report....
Triple Negative Breast Cancer (TNBC) therapies Price Scenario & Trends
Pricing and analogue assessment of TNBC 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.
Several drugs have been approved for treating TNBC, each offering different mechanisms of action. In the US, pembrolizumab (KEYTRUDA) by Merck is approved for two TNBC indications: as neoadjuvant treatment with chemotherapy for high-risk early-stage TNBC, continued as adjuvant monotherapy post-surgery and in combination with chemotherapy for locally recurrent or metastatic TNBC with PD-L1 expression. It is the first immunotherapy to demonstrate a statistically significant overall survival benefit as both pre-operative and post-operative treatment compared to chemotherapy alone in high-risk early-stage TNBC.
Industry Experts and Physician Views for Triple Negative Breast Cancer (TNBC)
To keep up with TNBC 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 TNBC 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 TNBC, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.
DelveInsight's analysts conducted with 8+ KOLs to gather insights at country level. Centers such as the Icahn School of Medicine, Dana-Farber Cancer Institute, University of Tubingen, Institut Gustave Roussy etc. were contacted.
Their opinion helps understand and validate current and emerging TNBC therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in TNBC.
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 TNBC, 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