삼중음성유방암(TNBC) : 시장 인사이트, 역학, 시장 예측(2032년)
Triple Negative Breast Cancer (TNBC) - Market Insight, Epidemiology And Market Forecast - 2032
상품코드 : 1376837
리서치사 : DelveInsight
발행일 : 2023년 11월
페이지 정보 : 영문 200 Pages
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한글목차

유방암은 유전적으로도 임상적으로도 불균일한 질환으로 여러 가지 아형이 존재합니다. 이러한 아형의 분류는 수년간 진화해 왔습니다. 가장 일반적이고 널리 받아들여지는 유방암 분류는 면역조직화학적 관점에서 에스트로겐(ER), 프로게스테론(PR), 인간상피세포성장인자(HER2) 등 호르몬 수용체의 발현을 기준으로 한 것입니다.

TNBC의 특징적인 면역미세환경은 높은 수준의 혈관내피성장인자, 종양침윤림프구(TIL), 종양관련 대식세포(TAM) 및 종양세포의 증식과 이동을 촉진하는 기타 분자를 포함하고 있으며, 이 질환의 발생, 증식 및 전이에서 이중적인 역할을 합니다.

TNBC의 위험인자는 비수정 가능한 것과 수정 가능한 것으로 분류됩니다. 나이, 성별, 유전자 돌연변이, 유전력, 유방 조직 밀도 등은 비수정 가능한 위험 변수입니다. 수정 가능한 위험인자로는 약물, BMI, 불충분한 비타민 보충제, 화학물질 및 약물 노출 등이 있습니다.

TNBC는 다른 유형의 유방암에 비해 악성도가 높은 악성종양으로 먼저 나타나며, 더 공격적인 임상 경과를 보일 수 있습니다. 또한 원격 전이 비율이 높고, 원격 전이까지의 평균 기간이 짧습니다. TNBC는 내분비 수용체의 발현이 없기 때문에 개입이 제한적이며, TNBC는 비 TNBC보다 예후가 나쁘고 잔존율과 함께 사망률이 높지만, 이는 진행성, 높은 재발률 및 대체 요법이 제한되어 있기 때문입니다.

TNBC의 역학과 관련해서는 미국이 주요 7개국에서 TNBC의 전체 사례의 약 42%를 차지합니다. 미국 시장 규모는 주요 7개국 중 가장 큰 것으로 나타났습니다. 미국은 주요 7개국 지역 전체 시장 규모의 약 61%를 차지하고 있습니다.

2022년 미국이 주요 7개국 중 가장 큰 시장 규모를 차지해 주요 7개국 전체 시장 규모의 61%를 차지했습니다. 주요 7개국 중 2022년 시장 규모가 가장 작은 국가는 스페인으로 주요 7개국 지역 시장 규모의 3%를 차지했고, EU 4개국 지역에서는 독일이 가장 큰 시장 규모를 차지해 EU 4개국 지역 전체 시장 규모의 -29%를 차지했습니다.

주요 7개국에서 삼중음성유방암(TNBC) 시장에 대해 조사했으며, 시장의 개요와 역학, 환자 동향, 새로운 치료법, 2032년까지 시장 규모 예측 및 의료 미충족 요구 등을 제공하고 있습니다.

목차

제1장 중요한 인사이트

제2장 리포트의 서론

제3장 삼중음성유방암(TNBC) 시장 개요

제4장 TNBC의 개요

제5장 질환 배경과 개요

제6장 치료와 관리

제7장 조사 방법

제8장 역학과 환자 수

제9장 환자 동향

제10장 출시 제품

제11장 새로운 치료법

제12장 TNBC- 주요 7개국 시장 분석

제13장 시장 접근과 상환

제14장 KOL의 견해

제15장 미충족 요구

제16장 SWOT 분석

제17장 부록

제18장 DelveInsight 서비스 내용

제19장 면책사항

제20장 DelveInsight 소개

KSA
영문 목차

영문목차

Key Highlights:

Report Summary

Market

Various key players are currently leading the treatment landscape of TNBC, such as G1 Therapeutics, AstraZeneca, Zenith Epigenetics, etc. The details of the country and therapywise market size have been provided below.

Triple Negative Breast Cancer (TNBC) Drug Chapters

The section dedicated to drugs in the Triple Negative Breast Cancer (TNBC) report provides an in-depth evaluation of both the marketed drugs and late-stage pipeline drugs (Phase III and Phase II) related to TNBC. Among the FDA-approved treatments are LYNPARZA (olaparib), TALZENNA (talazoparib), KEYTRUDA (pembrolizumab), and others. There are several emerging therapies, and detailed coverage of the same has been provided in the report.

The drug chapters section provides valuable information on various aspects related to clinical trials of TNBC, including specific details, such as the pharmacological mechanisms of the drugs involved, agreements and partnerships, approval status, patent information, and a comprehensive analysis of the pros and cons associated with each drug. Furthermore, it presents the most recent news updates and press releases related to drugs targeting TNBC.

Marketed Therapies

LYNPARZA (olaparib)

LYNPARZA (olaparib) is a poly (ADP-ribose) polymerase (PARP) inhibitor. LYNPARZA is indicated for the treatment of adult patients with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with prior endocrine therapy or be considered inappropriate for endocrine therapy.

TALZENNA (talazoparib)

Talazoparib is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, including PARP1 and PARP2, which play a role in DNA repair. TALZENNA is indicated as a single agent for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA)-mutated (gBRCAm) human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA.

Triple Negative Breast Cancer (TNBC) Market Outlook

Unlike other forms of breast cancer, TNBC does not respond with hormonal or HER2-targeted treatment. Hence, for a long time, systemic chemotherapy has remained the mainstay treatment for metastatic TNBC. Even for resectable/non-metastatic disease, chemotherapy and surgery in neoadjuvant or adjuvant therapy have been widely used.

But the recent approval of various immune checkpoint inhibitors (like pembrolizumab) and targeted therapies (like olaparib and talazoparib) has led to a dynamic shift in the treatment landscape, with their increased usage across various lines of therapy, leading to significant improvement in treatment outcomes and patient prognosis.

In patients with localized TNBC, dose-dense doxorubicin-cyclophosphamide, and paclitaxel were the standard neoadjuvant chemotherapy backbone until 2021. With the approval of neoadjuvant pembrolizumab, chemotherapy with immunotherapy is the new standard of care for localized TNBC.

Before these recent developments, taxane-based chemotherapies have remained the standard of care for metastatic disease, specifically in first-line treatment. However, with their recent approvals, immune checkpoint inhibitors like pembrolizumab and atezolizumab have established their effectiveness when combined with taxane-based chemotherapies; however, their usage is limited to patients with high levels of PD-L1 expression. Due to their superior results, they remain the most preferred form of treatment in the first-line setting.

The TNBC market is witnessing significant growth and evolution due to increased awareness, technological advancements, therapeutic advancements, and integration into clinical trials. However, challenges related to cost, access, and market competition remain important considerations for TNBC, keeping the dynamic market scenario in mind.

Drug Class Insights

Treatment for triple-negative breast cancer (TNBC) is more difficult since there is no apparent therapeutic target, as there is for ER/PR-positive or HER2-positive breast cancer. TNBC is treated with surgery, chemotherapy, and radiation.

The second most preferred form of treatment are poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitors LYNPARZA (olaparib) and TALZENNA (talazoparib); their usage is preferred in patients with germline BRCA1/2 mutations. Platinum-based chemotherapies are also used at times in the first-line treatment setting, but 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.

For patients with recurrent/refractory metastatic TNBC (mTNBC), the antibody-drug conjugate TRODELVY (sacituzumab govitecan-hziy) has emerged as an effective treatment option, in the second-line of the treatment. It targets Trop-2, which is present in most patients with triple-negative disease.

Triple Negative Breast Cancer (TNBC) Disease Understanding and Treatment

Triple Negative Breast Cancer (TNBC) Overview

Triple-negative breast cancer (TNBC) encompasses a heterogeneous group of fundamentally different diseases with different histologic, genomic, and immunologic profiles, which are aggregated under this term because of their lack of estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 expressions. Massively parallel sequencing and other omics technologies have demonstrated the level of heterogeneity in TNBCs and shed light on the pathogenesis of this therapeutically challenging entity in breast cancer.

Triple Negative Breast Cancer (TNBC) diagnosis

The phrase "triple negative breast cancer (TNBC) diagnosis" is a bit misleading. TNBC refers to the cellular composition of some breast tumors, which might impact a patient's prognosis rather than an official medical diagnosis. Pathology for these malignancies typically reveals that the cancer cells tested negative for three hormone receptors: estrogen, progesterone, and HER-2/neu. The first step in developing an effective treatment strategy is to confirm any breast cancer diagnosis. A triple negative test result means these hormones will not promote cancer development. Another problem is that standard breast cancer hormone treatment, such as tamoxifen or aromatase inhibitors, is unsuccessful in treating these tumors.

Further details related to country-based variations are provided in the report…

Triple Negative Breast Cancer (TNBC) Treatment

Triple-negative breast cancer (TNBC) represents a small but aggressive subtype of breast cancer with high mortality, partly because many cancers become metastatic. Relapse is common in TNBC, including for women with localized disease. TNBCs test negative for progesterone, estrogen receptors, and excess HER2 protein. For these reasons, this cancer type is not responsive to hormonal or HER2-targeted therapies.

In contrast to hormone receptor (ER/PR)-positive and HER2-positive breast cancers, there are few FDA-approved targeted therapies for triple-negative breast cancer. Historically, chemotherapy has been the main systemic treatment, especially for patients with metastatic disease; although TNBC tends to respond well to chemo initially, recurrences are frequent.

Patients have a worse prognosis with fewer treatment options than other breast cancer subtypes, and TNBC is more resistant to conventional treatment. Overall survival rates for TNBC patients with advanced or Stage IV disease is approximately 12 months compared to 36 months for those with ER-positive/PR-positive/HER2-negative disease.

But, of late, this pattern of treatment and survival is changing, as with an increased understanding of the disease's pathophysiology, TNBC is classified into several distinct molecular subtypes based on gene expression profiles rather than being considered a single disease. Following these developments, accompanied by newer therapies being recently approved, there has been improvement in the prognosis of patients.

Further details related to treatment and management are provided in the report…

Triple Negative Breast Cancer (TNBC) Epidemiology

The Triple Negative Breast Cancer (TNBC) epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Total Incident Cases of Triple Negative Breast Cancer (TNBC), Subtype-specific Cases of Triple Negative Breast Cancer (TNBC), Gene Mutation-specific Cases of Triple Negative Breast Cancer (TNBC), Stage-specific Cases of Triple Negative Breast Cancer (TNBC), Age-specific Cases of Triple Negative Breast Cancer (TNBC) and Line wise Treated Cases of Triple Negative Breast Cancer (TNBC) in the 7MM covering the United States, EU4 countries (Germany, France, Italy, Spain) and the United Kingdom, and Japan from 2019 to 2032.

KOL Views

To stay abreast of the latest trends in the market, we conduct primary research by seeking the opinions of Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) who work in the relevant field. This helps us fill any gaps in data and validate our secondary research.

We have reached out to industry experts to gather insights on various aspects related to Triple Negative Breast Cancer (TNBC), including the evolving treatment landscape, patients' reliance on conventional therapies, their acceptance of therapy switching, drug uptake, and challenges related to accessibility. The experts we contacted included medical/scientific writers, professors, and researchers from prestigious universities in the US, Europe, the UK, and Japan.

Our team of analysts at DelveInsight connected with more than 10 KOLs across the 7MM. We contacted institutions such as the National Cancer Center Hospital, University of Messina, Icahn School of Medicine, and Tufts Medical Center, among others. By obtaining the opinions of these experts, we gained a better understanding of the current and emerging treatment patterns in the Triple Negative Breast Cancer (TNBC) market, which will assist our clients in analyzing the overall epidemiology and market scenario.

Qualitative Analysis

We conduct qualitative and market intelligence analysis by employing the SWOT analysis approach. Within the SWOT analysis framework, we assess the strengths, weaknesses, opportunities, and threats pertaining to various aspects such as disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies. This analysis provides a comprehensive evaluation of the current situation and helps identify areas of advantage, areas for improvement, potential opportunities, and potential challenges in the specified domains.

Market Access and Reimbursement

Cancer treatments are funded in several countries through public reimbursement programs. This type of support promotes equitable access for people by removing direct fees from patients. The escalating prices of cancer medications have compelled several nations to seek cost-cutting measures.

Cancer drugs are highly specialized medicines with limited authorized indications, frequently specific to one or a combination of tumor sites, chemotherapy regimens, and treatment sequences. Typically, public payers limit reimbursement to certain specific conditions.

Patients with Medicare may or may not have to pay a portion of the cost of KEYTRUDA (pembrolizumab) based on their insurance plan. For example, with a Medicare Advantage plan, 41% of patients had no out-of-pocket costs for the 200 mg dose of KEYTRUDA. Roughly 80% of patients are responsible for a portion of the cost paid between USD 0 and USD 925 per infusion after meeting their deductible. Most patients with Medicaid typically pay USD 4-8 per KEYTRUDA infusion. The copay part, which needs to be paid by the patient, ranges from USD 12,045.

Further details related to reimbursement will be provided in the report….

Triple Negative Breast Cancer (TNBC) Report Insights

Triple Negative Breast Cancer (TNBC) Report Key Strengths

Triple Negative Breast Cancer (TNBC) Report Assessment

Key Questions

Table of Contents

1. Key Insights

2. Report Introduction

3. Triple Negative Breast Cancer (TNBC) Market Overview at a Glance

4. Executive Summary of TNBC

5. Disease Background and Overview

6. Treatment and Management

7. Methodology

8. Epidemiology and Patient Population

9. Patient Journey

10. Marketed Products

11. Emerging Therapies

12. TNBC-Seven Major Market Analysis

13. Market Access and Reimbursement

14. KOL Views

15. Unmet Needs

16. SWOT Analysis

17. Appendix

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight

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