表紙
市場調查報告書

關注市場分析:遺傳性血管水腫 (HAE)

Market Spotlight: Hereditary Angioedema

出版商 Datamonitor Healthcare 商品編碼 594576
出版日期 內容資訊 英文 38 Pages
商品交期: 最快1-2個工作天內
價格
關注市場分析:遺傳性血管水腫 (HAE) Market Spotlight: Hereditary Angioedema
出版日期: 2019年11月18日內容資訊: 英文 38 Pages
簡介

本報告提供遺傳性血管水腫 (HAE)的治療藥市場相關分析,疾病概要和患者數的變化、預測,目前的主要的調查治療方法,現在與開發中臨床實驗的進展與上市計劃,主要的治療藥的市場趨勢預測 (今後10年份),資本交易的動向等。

分析的要點

疾病的背景情況

  • 亞型

治療方法

  • C1-INH濃縮物
  • 血漿來源C1-INH (PdC1-INH)
  • 基因改造型C1-INH (RhC1-INH)
  • 激肽釋放酶抑制劑
  • 緩激肽受體拮抗劑

流行病學

已上市醫藥品

  • 各國的認證情形

開發平台上的醫藥品

將產生的主要事件

授權合約、資產收購交易

  • Pharming取回Ruconest相關的權利,以擴大影響力

母體專利

商機

臨床實驗形勢

  • 贊助商數:各狀態
  • 贊助商數:各相位
  • Shire:新版本的Cinryze,HAE市場上的CSL 探尋跟Behring的新競爭方法
  • Shire的CEO的講話:「SHP643開發成果,導致Dyax的收購、M&A策略」
  • CSL Behring:容易給藥的HAE預防藥,接近市場

相關分析

  • 處方藥的資訊

附錄

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目錄
Product Code: DMKC0180962

Overview

This Market Spotlight report covers the Hereditary Angioedema 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 prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.

Datamonitor Healthcare estimates that in 2017, there were approximately 402,700 prevalent cases of hereditary angioedema (HAE) worldwide, and forecasts that number to increase to 440,600 prevalent cases by

2026. The approved drugs in the HAE space target complement proteins, androgen receptors, follicle-stimulating hormone, gonadotropin-releasing hormone, progesterone receptor, bradykinin B2 receptor, and the kinin-kallikrein system. These are commonly administered via the intravenous or subcutaneous routes, with one product being available in an oral formulation.

The majority of industry-sponsored drugs in active clinical development for HAE are in Phase I. Therapies in development for HAE focus on targets such as the kinin-kallikrein system and bradykinin B2 receptor. The majority of pipeline drugs are administered via the oral route, with two products also being tested in a subcutaneous formulation.

High-impact upcoming events for drugs in the HAE space comprise topline Phase II trial results for KVD900, topline Phase III trial results for BCX7353, and a data exclusivity expiration for Ruconest.

The overall likelihood of approval of a Phase I autoimmune/immunology-other asset is 22.5%, and the average probability a drug advances from Phase III is 71.1%. Drugs, on average, take 10.0 years from Phase I to approval, compared to 9.0 years in the overall autoimmune/immunology space.

There have been only four licensing and asset acquisition deals involving HAE drugs during 2014-19. The $125m licensing agreement signed in 2016 between Pharming Group and Bausch Health for the acquisition of North American commercialization rights for Ruconest was the largest deal.

The distribution of clinical trials across Phase I-IV indicates that the majority of trials for HAE have been in the early and midphases of development, with 53% of trials in Phase I-II, and 47% in Phase III-IV.

The US has the highest number of HAE clinical trials globally. The UK leads the major EU markets, while Israel has the top spot in Asia.

Clinical trial activity in the HAE space is dominated by completed trials. Takeda has the highest number of completed clinical trials for HAE, with 19 trials.

Takeda leads industry sponsors with the highest overall number of clinical trials for HAE, followed by BioCryst.

TABLE OF CONTENTS

CONTENTS

6 OVERVIEW

7 KEY TAKEAWAYS

8 DISEASE BACKGROUND

8 Subtypes

9 TREATMENT

9 C1-INH concentrates

9 Plasma-derived C1-INH (pdC1-INH)

9 Recombinant C1-INH (rhC1-INH)

9 Kallikrein inhibitor

9 Bradykinin receptor antagonist

11 EPIDEMIOLOGY

15 MARKETED DRUGS

18 PIPELINE DRUGS

22 RECENT EVENTS AND ANALYST OPINION

22 BCX7353 for HAE (May 21, 2019)

23 BCX7353 for HAE (September 4, 2018)

26 KEY UPCOMING EVENTS

27 KEY REGULATORY EVENTS

27 England's NICE OKs Shire's Takhzyro For Rare Hereditary Disease

27 Anticancers, Orphans & The First CAR-Ts: New EU Drug Approvals In 2018

28 PROBABILITY OF SUCCESS

29 LICENSING AND ASSET ACQUISITION DEALS

30 PARENT PATENTS

31 CLINICAL TRIAL LANDSCAPE

32 Sponsors by status

33 Sponsors by phase

33 Recent events

35 BIBLIOGRAPHY

35 Prescription information

37 APPENDIX

LIST OF FIGURES

  • 14 Figure 1: Trends in prevalent cases of HAE, 2017-26
  • 18 Figure 2: Overview of pipeline drugs for HAE in the US
  • 18 Figure 3: Pipeline drugs for HAE, by company
  • 19 Figure 4: Pipeline drugs for HAE, by drug type
  • 19 Figure 5: Pipeline drugs for HAE, by classification
  • 23 Figure 6: BCX7353 for HAE (May 21, 2019): Phase III - APeX-2
  • 25 Figure 7: BCX7353 for HAE (September 4, 2018): Phase II - ZENITH-1
  • 26 Figure 8: Key upcoming events in HAE
  • 28 Figure 9: Probability of success in the HAE pipeline
  • 29 Figure 10: Licensing and asset acquisition deals in HAE, 2014-19
  • 30 Figure 11: Parent patents in HAE
  • 31 Figure 12: Clinical trials in HAE
  • 31 Figure 13: Top 10 drugs for clinical trials in HAE
  • 32 Figure 14: Top 10 companies for clinical trials in HAE
  • 32 Figure 15: Trial locations in HAE
  • 33 Figure 16: HAE trials status
  • 33 Figure 17: HAE trials sponsors, by phase

LIST OF TABLES

  • 12 Table 1: Prevalent cases of HAE, 2017-26
  • 16 Table 2: Marketed drugs for HAE
  • 20 Table 3: Pipeline drugs for HAE in the US
  • 22 Table 4: BCX7353 for HAE (May 21, 2019)
  • 24 Table 5: BCX7353 for HAE (September 4, 2018)