市場調查報告書

市場焦點:心房纖維顫動 (AF)

Market Spotlight: Atrial Fibrillation

出版商 Datamonitor Healthcare 商品編碼 920045
出版日期 內容資訊 英文 64 Pages
商品交期: 最快1-2個工作天內
價格
市場焦點:心房纖維顫動 (AF) Market Spotlight: Atrial Fibrillation
出版日期: 2019年11月28日內容資訊: 英文 64 Pages
簡介

本報告提供全球心房纖維顫動 (AF) 治療藥市場相關調查分析,主要的開發平台、上市藥,法規,專利資訊,10年的盛行率預測,許可證、取得交易等系統性資訊。

概要

要點

疾病的背景

  • 定義
  • 危險因素
  • 診斷
  • 患者區分

治療

  • 心律調節
  • 韻律調節
  • 血栓性栓塞症的預防藥

流行病學

上市藥

開發平台藥物

最近的趨勢和分析師的見解

今後趨勢

主要的法規趨勢

成功的可能性

許可證、資產取得交易

本源專利

商機

臨床實驗形勢

  • 贊助商:各狀態
  • 贊助商:各階段等

參考文獻

附錄

目錄
Product Code: DMKC0209060

This Market Spotlight report covers the Atrial Fibrillation market, comprising key marketed and pipeline drugs, clinical trials, recent events and analyst opinion, 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..

Key Takeaways

Datamonitor Healthcare estimates that in 2018, there were approximately 47.2 million prevalent cases of atrial fibrillation worldwide, and forecasts that number to increase to 56.7 million prevalent cases by

2027. The approved drugs in the atrial fibrillation/flutter space focus on targets such as beta adrenergic receptors, alpha adrenergic receptors, potassium channels, sodium channels, and calcium channel. The majority of marketed drugs are administered via the intravenous or oral routes, with only one product being available in a transdermal formulation.

The approved drugs in the stroke prevention in atrial fibrillation (SPAF) space focus on targets such as vitamin K epoxide reductase, coagulation factor X, adenosine diphosphate P2Y12 receptor, and thrombin (coagulation factor IIa). All of the marketed drugs for SPAF are administered via the oral route.

The largest proportion of industry-sponsored drugs in active clinical development for atrial fibrillation/flutter are in Phase II, with one drug in the NDA/BLA space.

Therapies in development for atrial fibrillation/flutter focus on targets such as potassium channels, sodium channels, and beta adrenergic receptors. The majority of these drugs are administered via the oral route, with one product being tested in an intravenous formulation.

The only industry-sponsored drug in active clinical development for SPAF is in Phase II.

The only therapy in development for SPAF targets coagulation factor XI. It is administered via the subcutaneous route. High-impact upcoming events in the atrial fibrillation/flutter space comprise an FDA advisory panel meeting and expected PDUFA date for Brinavess.

The overall likelihood of approval of a Phase I atrial fibrillation/flutter asset is 2.4%, and the average probability a drug advances from Phase III is 60%. Drugs, on average, take 12.0 years from Phase I to approval, compared to 10.0 years in the overall cardiovascular space.

The overall likelihood of approval of a Phase I SPAF asset is 9.8%, and the average probability a drug advances from Phase III is 85.7%. Drugs, on average, take 6.2 years from Phase I to approval, compared to 9.0 years in the overall hematology space.

There have been 13 licensing and asset acquisition deals involving atrial fibrillation drugs during 2014-19. The $250m joint venture agreement signed in February 2019 between Blackstone Life Sciences and Novartis to launch Anthos Therapeutics, which focuses on the development of drugs for cardiovascular diseases, was the largest deal. As part of the launch, Novartis has licensed MAA868, an antibody directed at factor XI and XIa, key components of the intrinsic coagulation pathway, to Anthos.

The distribution of clinical trials across Phase I-IV indicates that the majority of trials for atrial fibrillation have been in the late phases of development, with 76% of trials in Phase III-IV, and only 24% in Phase I-II.

The US leads in terms of the number of atrial fibrillation clinical trials globally. Germany leads the major EU markets, while South Korea has the top spot in Asia.

Clinical trial activity in the atrial fibrillation space is dominated by completed trials. Bayer has the highest number of completed clinical trials for atrial fibrillation, with 34 trials.

TABLE OF CONTENTS

CONTENTS

7 OVERVIEW

8 KEY TAKEAWAYS

10 DISEASE BACKGROUND

10 Definition

10 Risk factors

10 Diagnosis

10 Patient segmentation

12 TREATMENT

12 Rate control strategy

12 Rhythm control strategy

13 Medications to prevent thromboembolism

16 EPIDEMIOLOGY

19 MARKETED DRUGS

19 Atrial fibrillation/flutter

22 SPAF

24 PIPELINE DRUGS

24 Atrial fibrillation/flutter

27 SPAF

31 RECENT EVENTS AND ANALYST OPINION

31 Parasym Device for Atrial Fibrillation/Flutter (May 9, 2019)

32 eMURMUR ID for Atrial Fibrillation/Flutter (May 7, 2019)

33 HeartLight Endoscopic Ablation System for Atrial Fibrillation/Flutter (March 25, 2019)

35 Apple Watch for Atrial Fibrillation/Flutter (March 16, 2019)

36 MAA868 for SPAF (February 27, 2019)

37 Kardia for Atrial Fibrillation/Flutter (November 11, 2018)

37 Brinavess for Atrial Fibrillation/Flutter (October 23, 2018)

39 Apple Watch for Atrial Fibrillation/Flutter (September 12, 2018)

41 Arctic Front Catheter for Atrial Fibrillation/Flutter (August 28, 2018)

43 KEY UPCOMING EVENTS

44 KEY REGULATORY EVENTS

44 Brinavess To Have An Advisory Committee Review

44 Biotronik Addresses US CRM Market With Its Rivacor And Acticor Lines

44 Global Device Approvals Snapshot

44 FDA Explains Why It Approved Apple Watch's De Novo Despite Missing Primary Endpoint

45 CardioFocus' HeartLight X3 Endoscopic AFib Ablator Earns CE Mark

45 Boston Scientific's Watchman FLX Earns CE Mark

45 EU Safety Review Starts For Oral Anticoagulants

45 US FDA Approves Abbott's Sensor-Enabled TactiCath AF Catheter

47 PROBABILITY OF SUCCESS

47 Atrial fibrillation/flutter

47 SPAF

49 LICENSING AND ASSET ACQUISITION DEALS

49 Attune Gets Exclusive Rights To Stanford IP

49 Verily And iRhythm Agree To Collaborate On Atrial Fibrillation

50 AtriCure Adds Lariat LAA Closure System With $300M SentreHeart Acquisition

50 Medtronic And Philips Collaborate On Image-Guided Ablation For Atrial Fibrillation

50 Start-Up Anthos Licenses Novartis' Antithrombotic Candidate

51 Deals Shaping The Medical Industry, February 2019

52 PARENT PATENTS

53 REVENUE OPPORTUNITY

55 CLINICAL TRIAL LANDSCAPE

56 Sponsors by status

57 Sponsors by phase

58 Recent events

61 BIBLIOGRAPHY

62 Prescription information

63 APPENDIX

LIST OF FIGURES

  • 18 Figure 1: Trends in prevalent cases of atrial fibrillation, 2018-27
  • 24 Figure 2: Overview of pipeline drugs for atrial fibrillation/flutter in the US
  • 24 Figure 3: Pipeline drugs for atrial fibrillation/flutter, by company
  • 25 Figure 4: Pipeline drugs for atrial fibrillation/flutter, by drug type
  • 25 Figure 5: Pipeline drugs for atrial fibrillation/flutter, by classification
  • 27 Figure 6: Overview of pipeline drugs for SPAF in the US
  • 27 Figure 7: Pipeline drugs for SPAF, by company
  • 28 Figure 8: Pipeline drugs for SPAF, by drug type
  • 28 Figure 9: Pipeline drugs for SPAF, by classification
  • 42 Figure 10: Arctic Front Catheter for Atrial Fibrillation/Flutter (August 28, 2018): Cryo4 Persistent AF (France, Germany)
  • 43 Figure 11: Key upcoming events for atrial fibrillation/flutter
  • 47 Figure 12: Probability of success in the atrial fibrillation/flutter pipeline
  • 48 Figure 13: Probability of success in the SPAF pipeline
  • 49 Figure 14: Licensing and asset acquisition deals in atrial fibrillation, 2014-19
  • 52 Figure 15: Parent patents in atrial fibrillation
  • 55 Figure 16: Clinical trials in atrial fibrillation
  • 55 Figure 17: Top 10 drugs for clinical trials in atrial fibrillation
  • 56 Figure 18: Top 10 companies for clinical trials in atrial fibrillation
  • 56 Figure 19: Trial locations in atrial fibrillation
  • 57 Figure 20: Atrial fibrillation trials status
  • 58 Figure 21: Atrial fibrillation trials sponsors, by phase

LIST OF TABLES

  • 17 Table 1: Prevalent cases of atrial fibrillation, 2018-27
  • 20 Table 2: Marketed drugs for atrial fibrillation/flutter
  • 23 Table 3: Marketed drugs for SPAF
  • 26 Table 4: Pipeline drugs for atrial fibrillation/flutter in the US
  • 29 Table 5: Pipeline drugs for SPAF in the US
  • 31 Table 6: Parasym Device for Atrial Fibrillation/Flutter (May 9, 2019)
  • 33 Table 7: eMURMUR ID for Atrial Fibrillation/Flutter (May 7, 2019)
  • 34 Table 8: HeartLight Endoscopic Ablation System for Atrial Fibrillation/Flutter (March 25, 2019)
  • 35 Table 9: Apple Watch for Atrial Fibrillation/Flutter (March 16, 2019)
  • 36 Table 10: MAA868 for SPAF (February 27, 2019)
  • 37 Table 11: Kardia for Atrial Fibrillation/Flutter (November 11, 2018)
  • 38 Table 12: Brinavess for Atrial Fibrillation/Flutter (October 23, 2018)
  • 39 Table 13: Apple Watch for Atrial Fibrillation/Flutter (September 12, 2018)
  • 41 Table 14: Arctic Front Catheter for Atrial Fibrillation/Flutter (August 28, 2018)
  • 53 Table 15: Historical global sales, by drug ($m), 2014-18
  • 54 Table 16: Forecasted global sales, by drug ($m), 2019-23