HER2 저발현 위 또는 위식도 접합부(GEJ) 선암 시장 : 1차 조사(KOL의 인사이트) - 시장 인텔리전스 - 역학과 시장 예측(-2034년)
상품코드:1349828
리서치사:Mellalta Meets LLP
발행일:On Demand Report
페이지 정보:영문 200 Pages
라이선스 & 가격 (부가세 별도)
한글목차
HER2 저발현 위 또는 위식도 접합부(GEJ) 선암 시장은 화학요법, 면역요법, 표적치료제가 크게 기여하고 있으며, 2034년까지 새로운 신흥 치료제의 도입이 HER2 저발현 위 또는 위식도 접합부(GEJ) 선암 치료제 시장에 극적인 변화를 초래하는 주요 돌파구가 될 것으로 예상됩니다. 포인트가 될 것으로 예상됩니다.
전문가들은 위암 및 기타 여러 암이 HER2를 발현하고 HER2 표적치료제에 반응할 수 있다고 생각합니다. 따라서 이러한 암, 특히 HER2 발현이 낮은 환자에서 T-DXd의 사용에 대한 연구에 대한 관심이 높아지고 있습니다.
위 및 위식도 접합부(GEJ) 선암은 치료 옵션이 제한적인 침습성 악성 종양으로, HER2 저발현 종양은 면역조직화학(IHC) 분석에서 1점 또는 IHC 스코어2에서 in situ hybridization(ISH) 음성으로 정의됩니다. 이 종양의 하위 집합은 위 또는 GEJ 선암에서 충분히 특징이 밝혀지지 않았으며, 그 임상적 의미는 아직 명확하지 않습니다. 그러나 최근 증거에 따르면 HER2 저발현이 예후에 영향을 미치고 치료 결정의 지침이 될 수 있음을 시사하고 있습니다.
HER2 저발현 위 또는 위식도 접합부 선암 환자들은 치료 선택에 있으며, 어려움을 겪고 있습니다. 트루스투주맙과 같은 기존의 HER2 표적치료제는 이 환자군에서 제한적인 효과만을 보여주었습니다. 따라서 이들 환자의 결과를 개선하기 위해 대체 치료 전략을 고려해야 합니다.
세계의 HER2 저발현 위 또는 위식도 접합부(GEJ) 선암 시장에 대해 조사했으며, 시장 현황과 함께 증례수의 동향, 환자 동향, 경쟁 제품 시장 포지셔닝, 시장의 기회 등을 제공하고 있습니다.
목차
제1장 주요 요약
제2장 HER2 저발현 위 또는 위식도 접합부(GEJ) 선암 질환 배경
HER2 저발현 위 또는 위식도 접합부(GEJ) 선암의 정의
원인과 증상
병태생리학
HER2 저발현에 기여하는 요인
제3장 HER2 저발현 위 또는 위식도 접합부(GEJ) 선암 진단
제4장 현재의 치료법과 의료 행위
주요 조사 결과
치료 알고리즘
제5장 미충족 요구
제6장 새로운 치료법
주요 조사 결과
파이프라인의 개요
HER2 저발현 위 또는 위식도 접합부(GEJ) 선암 영역에서 주목할 만한 진전
제7장 HER2 저발현 위 또는 위식도 접합부(GEJ) 선암 출시 스케줄과 주요 시장 이벤트
제8장 HER2 저발현 위 또는 위식도 접합부(GEJ) 선암 - 가격과 상환
제9장 KOL 인사이트(미국, EU, 일본)
제10장 향후 치료 패러다임
HER2 저발현 위 또는 위식도 접합부(GEJ) 선암의 경쟁 구도와 승인
향후 치료 알고리즘과 경쟁 포지셔닝
새로운 치료법에 관한 주요 데이터의 개요
현재 및 향후 치료의 연간 비용
HER2 저발현 위 또는 위식도 접합부(GEJ) 선암에서 후기 치료의 전략적 고려사항
제11장 시장 전망
주요 조사 결과
개요
2034년까지의 국가별 시장 예측
제12장 시장 촉진요인과 억제요인
제13장 부록
제14장 조사 방법
KSA
영문 목차
영문목차
The HER2-Low Gastric / Gastroesophageal Junction (GEJ) Adenocarcinoma market is hugely contributed by chemotherapy, immunotherapy, and targeted therapies. By 2034, the uptake of novel emerging therapies will serve as a major breakpoint to get a drastic change in the HER2-Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma therapeutics market.
"Experts believe that gastric cancer and some other cancers express HER2 and respond to HER2-targeted therapies. This has led to a growing interest in studying the use of T-DXd in these cancers, particularly in patients with low expression of HER2."
Gastric and gastroesophageal junction (GEJ) adenocarcinomas are aggressive malignancies with limited treatment options. HER2-low tumors are defined as having a score of 1+ on immunohistochemical (IHC) analysis or an IHC score of 2+ with negative results on in situ hybridization (ISH). This subset of tumors has not been well characterized in gastric or GEJ adenocarcinomas, and their clinical significance remains unclear. However, recent evidence suggests that HER2-low expression may have prognostic implications and could potentially guide treatment decisions.
Patients with HER2 low gastric or gastroesophageal junction adenocarcinoma pose a challenge in terms of treatment selection. Traditional HER2-targeted therapies, such as trastuzumab, have shown limited efficacy in this subgroup. Therefore, alternative treatment strategies need to be explored to improve outcomes for these patients.
The poor prognosis observed in patients with HER2-low gastric or GEJ adenocarcinoma highlights the need for novel treatment approaches and pharmaceutical companies are now exploring the development of novel agents specifically designed to address the needs of this patient population.
Provider-Patient (PPP) Perspective:
Cost-effectiveness of treatment; Better Diagnostic Identification; Access to appropriate treatments and improved options.
The total incident cases of HER2-Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma in the G7 countries are anticipated to increase by a significant number of cases by 2034 for the study period (2020-2034). As per estimates, the United States will present with the highest incidence of HER2-Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma cases in 2034. Among the EU5, Germany had the highest HER2-Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma cases, followed by the UK, France, Italy, and Spain. Japan is reported to have the highest number of treated cases after the United States, Germany, and the UK.
A retrospective study evaluated HER-2 expression in early-stage gastric cancer using immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) and found that 8.3% of patients had HER2-positive tumors, 31.8% had HER2-low tumors, and 50.3% had HER2-negative tumors.
The current standard of care is limited to chemotherapy, immunotherapy, and targeted therapy. Recent developments have shown that ADCs, such as DS-8201 and Disitamab vedotin, release intracellular toxins that can exert a killing effect on neighboring cells without target expression. This bystander effect allows patients with HER2 Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma to benefit from HER2-targeted therapy. Therefore, ADCs may expand the population that can benefit from HER2-targeted therapy and are expected to be a novel option for patients whose tumors have low HER2 expression.
The advent of anti-HER2 therapies, such as trastuzumab and trastuzumab deruxtecan (T-DXd), has revolutionized the treatment landscape for HER2-positive gastric or gastroesophageal junction adenocarcinoma. However, the efficacy of these therapies in HER2-low tumors remains uncertain. Recent studies have shown promising results with T-DXd in patients with HER2-low gastric cancer, suggesting that HER2-low tumors may still benefit from HER2-targeted treatments. Based on the results of the DESTINY-Gastric01 trial, T-DXd was approved in Japan for the treatment of patients with HER2-positive unresectable advanced or recurrent gastric cancer that has progressed after chemotherapy. T-DXd is now recommended in the Japanese Gastric Cancer Association treatment guidelines as the third-line treatment for HER2-positive gastric cancer. Additional studies on T-DXd for the treatment of AGC are also ongoing. The DESTINY-Gastric02 trial (NCT04014075) is an open-label, single-arm phase II trial to assess the efficacy and safety of T-DXd in HER2-positive AGC patients who have been treated with previous trastuzumab containing chemotherapy in non-Asian populations. The primary endpoint is the ORR by independent central review, similar to the DESTINY-Gastric01 trial. Seventy-two patients will be enrolled.
Mellalta Meets Current Treatment Strategies in Gastric Cancer
Current Treatment Strategies in Gastric Cancer Source: Daisuke Kotani et al 2021
In the 2024-2034 forecast period, there will be tremendous growth and shift in therapeutic market with the launch of novel emerging therapies like DB-1303 (Duality Biologics), Trastuzumab deruxtecan (AstraZeneca/Daiichi Sankyo), and more. We expect a greater uptake of the new therapies which will result in better treatment outcomes for HER2-Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma market space. The launch of these upcoming therapies will drive the highly competitive therapeutic market in the coming time.
Questions Answered:
What is the size of clinically and commercially relevant drug-treatable HER2 low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma populations, and how will drug-treatment rates of HER2 change over time?
Potential challenges and opportunities in implementing targeted therapies for HER2-low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma.
What are the most promising agents in the pipeline, and how will they shape the future of this therapy market?
What key drivers and constraints will affect the HER2 low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma therapy market over the forecast period?
Report Highlights:
HER2-Low Gastroesophageal Junction (GEJ) Adenocarcinoma - Current Market Trends
HER2-Low Gastroesophageal Junction (GEJ) Adenocarcinoma - Current & Forecasted Cases across the G7 Countries
HER2-Low Gastroesophageal Junction (GEJ) Adenocarcinoma - Market Opportunities and Sales Potential for Agents
2. HER2-Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Disease Background
2.1. HER2-Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Definition
2.2. Cause & Symptoms
2.3. Pathophysiology
2.4. Factors contributing to the HER2-Low Expression in Breast Cancer
3. HER2-Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma-Diagnosis
3.1. HER2 Assessment with Immunohistochemistry (IHC) and In Situ Hybridization (ISH) (ASCO/CAP Guidelines)
3.2. Epidemiology and Patient Populations
3.3. Key Findings
3.4. Methods and data Sources
3.4.1. Country Specific Incident cases of Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (US, Germany, France, Italy, Spain, UK, and Japan)
3.4.2. Country Specific Incident cases of HER2-Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
3.4.3. Country Specific Treated cases of HER2-Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
3.4.4. Key Sources for HER2-Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Epidemiology and Model Parameters
3.4.4.1. United States
3.4.4.1.1. United States Incident cases of Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (US, Germany, France, Italy, Spain, UK, and Japan)
3.4.4.1.2. United States Incident cases of HER2-Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
3.4.4.1.3. United States Treated cases of HER2-Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
3.4.4.2. Germany
3.4.4.2.1. Germany Incident cases of Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (US, Germany, France, Italy, Spain, UK, and Japan)
3.4.4.2.2. Germany Incident cases of HER2-Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
3.4.4.2.3. Germany Treated cases of HER2-Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
3.4.4.3. France
3.4.4.4. France Incident cases of Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (US, Germany, France, Italy, Spain, UK, and Japan)
3.4.4.5. France Incident cases of HER2-Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
3.4.4.6. France Treated cases of HER2-Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
3.4.5. Italy
3.4.5.1. Italy Incident cases of Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (US, Germany, France, Italy, Spain, UK, and Japan)
3.4.5.2. Italy Incident cases of HER2-Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
3.4.5.3. Italy Treated cases of HER2-Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
3.4.5.4. Spain
3.4.5.4.1. Spain Incident cases of Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (US, Germany, France, Italy, Spain, UK, and Japan)
3.4.5.4.2. Spain Incident cases of HER2-Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
3.4.5.4.3. Spain Treated cases of HER2-Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
3.4.5.5. United Kingdom
3.4.5.5.1. United Kingdom Incident cases of Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (US, Germany, France, Italy, Spain, UK, and Japan)
3.4.5.5.2. United Kingdom Incident cases of HER2-Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
3.4.5.5.3. United Kingdom Treated cases of HER2-Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
3.4.5.6. Japan
3.4.5.6.1. Japan Incident cases of Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (US, Germany, France, Italy, Spain, UK, and Japan)
3.4.5.6.2. Japan Incident cases of HER2-Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
3.4.5.6.3. Japan Treated cases of HER2-Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
4. Current Therapy and Medical Practice
4.1. Key Findings
4.2. Treatment Algorithm
5. Unmet Needs
6. Emerging Therapy
6.1. Key Findings
6.2. Pipeline Overview
6.3. Notable Developments in the HER2-Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma space
6.3.1. Product Analysis
6.3.1.1. DB-1303 (Duality Biologics)
6.3.1.1.1. Product Profile
6.3.1.1.2. Clinical Development
6.3.1.1.3. Market & Sales Opportunity Forecasted to 2034
