表紙
市場調查報告書

胃癌的預測、市場分析

Gastric Cancer Forecast and Market Analysis

出版商 Datamonitor Healthcare 商品編碼 955899
出版日期 內容資訊 英文 81 Pages
商品交期: 最快1-2個工作天內
價格
胃癌的預測、市場分析 Gastric Cancer Forecast and Market Analysis
出版日期: 2020年08月05日內容資訊: 英文 81 Pages
簡介

2018年全球20歲以上的成人估計發生了100萬件胃癌的病例,其數預計2027年增加到110萬件。確診的胃癌的約75%在亞洲發生。尤其是在東亞發生率高,日本成為胃癌治療藥的非常大市場。尤其是貧困國家的胃癌主要的病因,是胃壁的幽門螺旋桿菌感染。胃幽門桿菌的盛行率低,有影響未來的病例診斷數的可能性。

本報告提供胃癌的相關調查,治療藥,流行病學,臨床,競爭情形,最近及今後的活動等資訊。

目錄

目錄

概要

  • 最新的要點

疾病的背景

  • 定義
  • 危險因素
  • 症狀
  • 患者的市場區隔
  • 診斷
  • 預後

治療

  • 治療技術
  • 對可切除的局部領域疾病的首選全身療法
  • 對進行性,不能切除,以及復發性疾病的首選全身療法
  • 核準的品牌醫藥品

流行病學

  • 發生調查手法

成藥

開發平台藥物

主要的法規活動

  • Enhertu:在HER2陽性胃癌的有效性
  • Pfizer:美國生物相似藥Trastuzumab的銷售
  • Kanjinti:GMP的問題, 參考產品的複雜化

成功的概率

授權與資產收購交易

  • Henlius與Mabxience的合作(Trastuzumab)
  • 形成醫療產業的交易(2020年2月)
  • 形成醫療產業的交易(2020年1月)
  • BeiGene取得Leap領先的DKK1抗體的亞洲權利
  • RAPT和Hanmi Ink實施在亞洲開發低分子CCR4拮抗劑的共同研究
  • Tonix與哥倫比亞締結今年第2個授權合約
  • Lepu Biotech在系列A輪獲得1億3,100萬美元

臨床試驗情勢

  • 各狀態贊助商
  • 每階段的贊助商
  • 最近的事件

藥物評估模式

市場動態

趨勢

共識預測

最近的活動和分析師的見解

  • ALX148(2020年5月29日)
  • Enhertu(2020年5月29日)
  • Enhertu(2020年1月27日)
  • Motixafortide (2020年1月24日)
  • Bavencio(2019年11月8日)
  • Margetuximab (2019年9月30日)
  • Rivoceranib (2019年6月27日)
  • Kanjinti(2019年6月25日)
  • Keytruda (2019年6月1日)
  • Trodelvy (2019年4月29日)
  • Keytruda (2019年4月25日)
  • Nerlynx (2019年4月1日)
  • Enhertu(2019年3月28日)

主要的今後活動

主要的見解:KOL的洞察

未滿足需求

參考文件

  • 藥方資訊

附錄

圖的清單

表格的清單

目錄
Product Code: DMKC0218996

Disease Overview

Stomach or gastric cancer (GC) refers to any cancer arising in the lining of the stomach. The vast majority (95%) of these cancers are adenocarcinomas, and can be further grouped by anatomic origin. The clearest etiological distinction exists between adenocarcinomas of the gastric cardia (the anterior edge of the stomach surrounding the entry point of the esophagus), and those arising in the other anatomical subsites of the stomach - the fundus, body, pylorus, and the antrum. In most cases, gastric adenocarcinomas will begin in the muscularis mucosae and submucosa, then invading deeper lamina of the gastric wall.

Latest key takeaways

Datamonitor Healthcare estimates that in 2018, there were 1.0 million incident cases of gastric cancer worldwide in adults aged 20 years and older, and forecasts that number to increase to 1.1 million cases by 2027.

The majority of gastric cancer diagnoses (66.1%) worldwide are in males, ranging from 54.3% to 68.3% across regions.

A major etiological factor of gastric cancer, especially in poorer countries, is Helicobacter pylori infection of the stomach wall. The declining prevalence of H. pylori may have an effect on the future number of case diagnoses.

Approximately 75% of all gastric cancer diagnoses are in Asia. Particularly high incidence rates in East Asia make Japan a very large market for gastric cancer medications.

Early-stage gastric cancer is often asymptomatic, meaning that most diagnoses are only made in advanced disease. An exception to this trend is Japan, where proactive screening often discovers tumors in a locoregional setting.

Due to the lack of curative treatments in advanced disease, the prognosis of gastric cancer is rather poor in most countries, with five-year survival rates standing at 20% worldwide. Even in Japan, where screening often catches early-stage tumors, relatively high rates of recurrence keep this rate at 71.5%.

HER2, PD-1, and receptor tyrosine kinases (RTKs) are the most common molecular targets for both branded and pipeline drugs. However, the treatment landscape remains dominated by non-targeted chemotherapies, with most targeted agents confined to one or two treatment settings, where they are typically administered alongside chemotherapy.

Despite a failed expansion to frontline therapy, the vascular endothelial growth factor receptor (VEGFR) antagonist Cyramza is arguably the most successful targeted therapy in gastric cancer, having become the standard of care in second-line disease.

Immune checkpoint inhibitors (ICIs) - specifically PD-1 antagonists Opdivo and Keytruda - are in development in multiple treatment settings but remain largely confined to heavily pretreated (≥3rd-line) patients in Japan and the US, respectively. Keytruda is also approved in second-line disease, but only for microsatellite instability-high (MSI-H) tumors; a small minority of the total population.

No targeted therapies exist for locoregional disease, although Opdivo and Keytruda are in ongoing Phase III trials for this setting.

Trastuzumab biosimilars are now available, leading to a sharp decline in the market share of Herceptin.

Set to succeed Herceptin, next-generation HER2 antibodies margetuximab and Enhertu (an antibody-drug conjugate) are now seeking approval in gastric cancer.

No targeted treatments are available for frontline HER2-negative gastric cancer (approximately 80% of cases), making it one of the largest areas of unmet need in gastric cancer. As a result, multiple drugs - including Opdivo, Yervoy, Keytruda, tislelizumab, bemarituzumab, and zolbetuximab - are now in late-stage development for this setting.

Though most pipeline drugs in late-stage development involve the classic molecular targets of PD-1/PD-L1 and RTKs, the poly (ADP-ribose) polymerase (PARP) inhibitor pamiparib is in development for second-line disease, and zolbetuximab explores the entirely novel target of claudin-18. Additionally, the pipeline ICI MGD013 is a dual-affinity re-targeting antibody (DART) that is bispecific to LAG3 as well as PD-1.

Underwhelming benefits seen in multiple Phase III trials of PD-1 inhibitor monotherapies (including KEYNOTE-062 and KEYNOTE-061 for Keytruda, ATTRACTION-2 for Opdivo, and JAVELIN Gastric 100 for Bavencio) raise the prospect that gastric cancer may be resistant to immunotherapy.

Given the inconclusive results of KEYNOTE-062, Keytruda's approval in first-line HER2-negative disease will likely hinge on KEYNOTE-859, which is evaluating Keytruda combined with chemotherapy and is slated for completion in 2023. As such, the Opdivo-Yervoy dual blockade combination of CheckMate 649 is positioned to reach the frontline gastric cancer market first, as results are expected in 2021.

TABLE OF CONTENTS

CONTENTS

OVERVIEW

  • Latest key takeaways

DISEASE BACKGROUND

  • Definition
  • Risk factors
  • Symptoms
  • Patient segmentation
  • Diagnosis
  • Prognosis

TREATMENT

  • Treatment techniques
  • Preferred systemic therapies for resectable locoregional disease
  • Preferred systemic therapies for advanced, unresectable or recurrent disease
  • Approved branded drugs

EPIDEMIOLOGY

  • Incidence methodology

MARKETED DRUGS

PIPELINE DRUGS

KEY REGULATORY EVENTS

  • Enhertu Breaks Through In HER2-Positive Gastric Cancer
  • Pfizer Launches Biosimilar Trastuzumab In US
  • Kanjinti's Path To Market Complicated By GMP Issues, Reference Product Drift

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

  • Henlius Partners With Mabxience On Trastuzumab
  • Deals Shaping The Medical Industry, February 2020
  • Deals Shaping The Medical Industry, January 2020
  • BeiGene Picks Up Asia Rights To Leap's Lead DKK1 Antibody
  • RAPT, Hanmi Ink Collaboration To Develop Small Molecule CCR4 Antagonist In Asia
  • Tonix Signs Second License This Year With Columbia
  • Lepu Biotech Reigns In $131m Via Series A Round

CLINICAL TRIAL LANDSCAPE

  • Sponsors by status
  • Sponsors by phase
  • Recent events

DRUG ASSESSMENT MODEL

MARKET DYNAMICS

FUTURE TRENDS

  • Brands scramble to launch in frontline HER2-negative advanced gastric cancer
  • New treatment options for HER2-positive patients on the horizon
  • Cyramza is likely to remain a standard of care in second-line disease
  • Declining prevalence of H. pylori may slow gastric cancer incidence growth

CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION

  • ALX148 for Gastric Cancer (May 29, 2020)
  • Enhertu for Gastric Cancer (May 29, 2020)
  • Enhertu for Gastric Cancer (January 27, 2020)
  • Motixafortide for Gastric Cancer (January 24, 2020)
  • Bavencio for Gastric Cancer (November 8, 2019)
  • Margetuximab for Gastric Cancer (September 30, 2019)
  • Rivoceranib for Gastric Cancer (June 27, 2019)
  • Kanjinti for Gastric Cancer (June 25, 2019)
  • Keytruda for Gastric Cancer (June 1, 2019)
  • Trodelvy for Gastric Cancer (April 29, 2019)
  • Keytruda for Gastric Cancer (April 25, 2019)
  • Nerlynx for Gastric Cancer (April 1, 2019)
  • Enhertu for Gastric Cancer (March 28, 2019)

KEY UPCOMING EVENTS

KEY OPINION LEADER INSIGHTS

UNMET NEEDS

BIBLIOGRAPHY

  • Prescription information

APPENDIX

LIST OF FIGURES

  • Figure 1: AJCC prognostic groups for gastric cancer (clinical staging)
  • Figure 2: Definitions of the diagnostic criteria for primary tumor (T), regional lymph nodes (N), and distant metastasis (M) in gastric cancer
  • Figure 3: Trends in incident cases of gastric cancer, 2018-27
  • Figure 4: Overview of pipeline drugs for gastric cancer in the US
  • Figure 5: Pipeline drugs for gastric cancer, by company
  • Figure 6: Pipeline drugs for gastric cancer, by drug type
  • Figure 7: Pipeline drugs for gastric cancer, by classification
  • Figure 8: Probability of success in the gastric cancer pipeline
  • Figure 9: Clinical trials in gastric cancer
  • Figure 10: Top 10 drugs for clinical trials in gastric cancer
  • Figure 11: Top 10 companies for clinical trials in gastric cancer
  • Figure 12: Trial locations in gastric cancer
  • Figure 13: Gastric cancer trials status
  • Figure 14: Gastric cancer trials sponsors, by phase
  • Figure 15: Datamonitor Healthcare's drug assessment summary for gastric cancer
  • Figure 16: Market dynamics in gastric cancer
  • Figure 17: Future trends in gastric cancer
  • Figure 18: Enhertu for Gastric Cancer: Phase II - DESTINY-Gastric01 (Japan/Korea) (May 29, 2020)
  • Figure 19: Enhertu for Gastric Cancer: Phase II - DESTINY-Gastric01 (Japan/Korea) (January 27, 2020)
  • Figure 20: Motixafortide for Gastric Cancer: Phase Ib/II - G/GEJ UMBRELLA (January 24, 2020)
  • Figure 21: Bavencio for Gastric Cancer: Phase III - JAVELIN Gastric 100 (November 8, 2019)
  • Figure 22: Margetuximab for Gastric Cancer: Phase Ib/II - w/Pembrolizumab (September 30, 2019)
  • Figure 23: Rivoceranib for Gastric Cancer: Phase III - ANGEL (June 27, 2019)
  • Figure 24: Keytruda for Gastric Cancer: Phase III - KEYNOTE-062 (First-Line GEJ) (June 1, 2019)
  • Figure 25: Key upcoming events in gastric cancer
  • Figure 26: Unmet needs in gastric cancer

LIST OF TABLES

  • Table 1: Recommended therapies for locally advanced, resectable gastric adenocarcinoma
  • Table 2: Recommended frontline systemic therapies for recurrent/metastatic and unresectable gastric cancer
  • Table 3: Recommended subsequent-line systemic therapies for recurrent/metastatic and unresectable gastric cancer
  • Table 4: Approved branded drugs in gastric cancer
  • Table 5: Incident cases of gastric cancer, 2018-27
  • Table 6: Incident cases of gastric cancer, by gender, 2018
  • Table 7: Marketed drugs for gastric cancer
  • Table 8: Pipeline drugs for gastric cancer
  • Table 9: Historical global sales, by drug ($m), 2015-19
  • Table 10: Forecasted global sales, by drug ($m), 2020-24
  • Table 11: ALX148 for Gastric Cancer (May 29, 2020)
  • Table 12: Enhertu for Gastric Cancer (May 29, 2020)
  • Table 13: Enhertu for Gastric Cancer (January 27, 2020)
  • Table 14: Motixafortide for Gastric Cancer (January 24, 2020)
  • Table 15: Bavencio for Gastric Cancer (November 8, 2019)
  • Table 16: Margetuximab for Gastric Cancer (September 30, 2019)
  • Table 17: Rivoceranib for Gastric Cancer (June 27, 2019)
  • Table 18: Kanjinti for Gastric Cancer (June 25, 2019)
  • Table 19: Keytruda for Gastric Cancer (June 1, 2019)
  • Table 20: Trodelvy for Gastric Cancer (April 29, 2019)
  • Table 21: Keytruda for Gastric Cancer (April 25, 2019)
  • Table 22: Nerlynx for Gastric Cancer (April 1, 2019)
  • Table 23: Enhertu for Gastric Cancer (March 28, 2019)