Market Spotlight: Atrial Fibrillation
|出版日期||內容資訊||英文 64 Pages
|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||
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。
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..
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.
10 Risk factors
10 Patient segmentation
12 Rate control strategy
12 Rhythm control strategy
13 Medications to prevent thromboembolism
19 Atrial fibrillation/flutter
24 Atrial fibrillation/flutter
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)
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 Atrial fibrillation/flutter
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
56 Sponsors by status
57 Sponsors by phase
58 Recent events
62 Prescription information