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市場調查報告書

市場焦點:胃腸道基質腫瘤(GIST)

Market Spotlight: Gastrointestinal Stromal Tumor (GIST)

出版商 Datamonitor Healthcare 商品編碼 939983
出版日期 內容資訊 英文 43 Pages
商品交期: 最快1-2個工作天內
價格
市場焦點:胃腸道基質腫瘤(GIST) Market Spotlight: Gastrointestinal Stromal Tumor (GIST)
出版日期: 2020年04月16日內容資訊: 英文 43 Pages
簡介

根據Datamonitor Healthcare,估計2019年在世界發生100,200件腸胃間品質腫瘤(GIST)的病例,預計至2028年其數增加到109,000件。

本報告提供胃腸道基質腫瘤 (GIST) 市場上主要的已上市藥、開發平台藥物,近幾年的動向和分析師的見解,臨床試驗,不久將來的動向、規定趨勢,成功的可能性,專利資訊,及10年的發病率預測,授權、資產取得交易,以及各類醫藥品的收益預測等相關分析。

概要

要點

疾病的背景

治療

  • 手術
  • 標靶治療
  • 其他治療

流行病學

已上市藥物

開發平台藥物

近幾年的動向、分析師的見解

  • Ripretinib(2019年8月13日)
  • Mektovi(2019年6月17日)
  • Ripretinib(2019年6月11日)
  • Cabometyx / Cometriq(2019年6月3日)
  • Ayvakit(2018年11月15日)

不久的將來的動向

主要的法規的動向

  • 金融的關注趨勢:革命醫藥品持續2020年的IPO後的趨勢
  • Blueprint Medicines是最初的醫藥品,Precision Medicine Ayvakit取得美國核准
  • Blueprint Medicines,使用Avapritinib NDA,以基因性定義的GIST適應為目標

成功概率

授權、資產收購交易

  • Deciphera,將Ripretinib獨家授權GRC (大中華區) 的再鼎

本源專利

商機

臨床試驗環境

  • 贊助商:各狀態
  • 贊助商:各階段
  • 近幾年的動向

文件

附錄

目錄
Product Code: DMKC0182656

This Market Spotlight report covers the Gastrointestinal Stromal Tumor (GIST) market, comprising key marketed and pipeline drugs, recent events and analyst opinion, clinical trials, upcoming and regulatory events, probability of success, patent information, a 10-year disease incidence forecast, licensing and asset acquisition deals, and drug-specific revenue forecasts.

Key Takeaways:

  • Datamonitor Healthcare estimates that in 2019, there were 100,200 incident cases of gastrointestinal stromal tumor (GIST) worldwide, and expects that number to increase to 109,000 incident cases by 2028. The approved drugs in the GIST space target BCR-ABL fusion protein, KIT/c-KIT, platelet-derived growth factor receptor, Raf kinase, VEGF receptor, and FMS-like tyrosine kinase 3. These therapies are administered via the oral route.
  • The largest proportion of industry-sponsored drugs in active clinical development for GIST are in Phase II, with one drug in the NDA/BLA phase.
  • Therapies in development for GIST focus on a wide variety of targets. The majority of pipeline drugs in development are administered orally, with the remainder being tested in intravenous formulations.
  • High-impact upcoming events in the GIST space comprise an expected PDUFA date for ripretinib; and topline Phase III trial results, an expected PDUFA date, as well as a CHMP opinion for Ayvakit.
  • The overall likelihood of approval of a Phase I solid tumors asset is 5.7%, and the average probability a drug advances from Phase III is 41.9%. Drugs, on average, take 9.4 years from Phase I to approval, compared to 9.3 years in the overall oncology space.
  • There have been only four licensing and asset acquisition deals involving GIST drugs during 2015-20. The exclusive collaboration and licensing agreement for $386m signed in June 2018 between Blueprint and CStone to develop and commercialize avapritinib, BLU-554, and BLU-667 in mainland China, Hong Kong, Macau, and Taiwan, either as monotherapies or combination therapies, was the largest deal.
  • The distribution of clinical trials across Phase I-IV indicates that the majority of trials for GIST have been in the early and midphases of development, with 82% of trials in Phase I-II, and only 18% in Phase III-IV.
  • The US has a substantial lead in the number of GIST clinical trials globally. France leads the major European markets, while China has the top spot in Asia.
  • Clinical trial activity in the GIST space is dominated by completed trials. Novartis has the highest number of completed clinical trials for GIST, with 63 trials.
  • Novartis leads industry sponsors with by far the highest overall number of clinical trials for GIST.

TABLE OF CONTENTS

OVERVIEW

KEY TAKEAWAYS

DISEASE BACKGROUND

TREATMENT

  • Surgery
  • Targeted therapy
  • Other treatments

EPIDEMIOLOGY

MARKETED DRUGS

PIPELINE DRUGS

RECENT EVENTS AND ANALYST OPINION

  • Ripretinib for GIST (August 13, 2019)
  • Mektovi for GIST (June 17, 2019)
  • Ripretinib for GIST (June 11, 2019)
  • Cabometyx / Cometriq for GIST (June 3, 2019)
  • Ayvakit for GIST (November 15, 2018)

KEY UPCOMING EVENTS

KEY REGULATORY EVENTS

  • Finance Watch: Revolution Medicines Continues 2020's Post-IPO Trend
  • Blueprint Medicines Gains US Approval For First Drug, Precision Medicine Ayvakit
  • Blueprint Medicines Aims For Genomically Defined GIST Indication With Avapritinib NDA

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

  • Deciphera Grants Zai Exclusive Ripretinib Rights In Greater China

PARENT PATENTS

REVENUE OPPORTUNITY

CLINICAL TRIAL LANDSCAPE

  • Sponsors by status
  • Sponsors by phase
  • Recent events

BIBLIOGRAPHY

  • Prescription information

APPENDIX

LIST OF FIGURES

  • Figure 1: Trends in incident cases of GIST, 2019-28
  • Figure 2: Overview of pipeline drugs for GIST in the US
  • Figure 3: Pipeline drugs for GIST, by company
  • Figure 4: Pipeline drugs for GIST, by drug type
  • Figure 5: Pipeline drugs for GIST, by classification
  • Figure 6: Ripretinib for GIST (August 13, 2019): Phase III - INVICTUS
  • Figure 7: Ayvakit for GIST (November 15, 2018): Phase I - NAVIGATOR
  • Figure 8: Key upcoming events in GIST
  • Figure 9: Probability of success in the GIST pipeline
  • Figure 10: Licensing and asset acquisition deals in GIST, 2015-20
  • Figure 11: Parent patents in GIST
  • Figure 12: Clinical trials in GIST
  • Figure 13: Top 10 drugs for clinical trials in GIST
  • Figure 14: Top 10 companies for clinical trials in GIST
  • Figure 15: Trial locations in GIST
  • Figure 16: GIST trials status
  • Figure 17: GIST trials sponsors, by phase

LIST OF TABLES

  • Table 1: Incident cases of GIST, 2019-28
  • Table 2: Incidence of GIST
  • Table 3: Marketed drugs for GIST
  • Table 4: Pipeline drugs for GIST in the US
  • Table 5: Ripretinib for GIST (August 13, 2019)
  • Table 6: Mektovi for GIST (June 17, 2019)
  • Table 7: Ripretinib for GIST (June 11, 2019)
  • Table 8: Cabometyx / Cometriq for GIST (June 3, 2019)
  • Table 9: Ayvakit for GIST (November 15, 2018)
  • Table 10: Historical global sales, by drug ($m), 2014-18
  • Table 11: Forecasted global sales, by drug ($m), 2020-24