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市場調査レポート

注目市場の分析:遺伝性血管性浮腫 (HAE)

Market Spotlight: Hereditary Angioedema

発行 Datamonitor Healthcare 商品コード 594576
出版日 ページ情報 英文 38 Pages
納期: 即日から翌営業日
価格
本日の銀行送金レート: 1USD=108.77円で換算しております。
注目市場の分析:遺伝性血管性浮腫 (HAE) Market Spotlight: Hereditary Angioedema
出版日: 2019年11月18日 ページ情報: 英文 38 Pages
概要

当レポートでは、遺伝性血管性浮腫 (HAE) の治療薬市場について分析し、疾患の概要や患者数の推移・見通し、現段階での主な治療法、現在開発中の治験の進行状況と上市スケジュール、主な治療薬の市場動向見通し (今後10年間分)、資本取引の動きなどを調査しております。

分析のポイント

疾患の背景事情

  • 亜類型 (サブタイプ)

治療法

  • C1-INH濃縮物
  • 血漿由来C1-INH (PdC1-INH)
  • 遺伝子組み換え型C1-INH (RhC1-INH)
  • カリクレイン阻害剤
  • ブラジキニン受容体拮抗剤

疫学

上市済み医薬品

  • 各国での認証状況

パイプライン上の医薬品

間もなく生じる主な出来事

ライセンス契約・資産買収取引

  • PharmingがRuconest関連の権利を取り戻し、影響力の拡大を図る

母体特許

収益機会

治験情勢

  • スポンサー数:ステータス別
  • スポンサー数:フェーズ (相) 別
  • Shire:新バージョンのCinryzeで、HAE市場でのCSL Behringとの新たな競合の方法を探る
  • ShireのCEOの談話:「SHP643の開発成果が、Dyaxの買収・M&A戦略につながる」
  • CSL Behring:投与が容易なHAE予防薬で、市場に接近する

関連分析

  • 処方薬の情報

付録

目次
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)