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市場調查報告書

心房纖維顫動的中風預防 (SPAF)

Stroke prevention in Atrial Fibrillation Market and Forecast Analysis to 2024

出版商 Datamonitor Healthcare 商品編碼 365168
出版日期 內容資訊 英文 369 Pages
商品交期: 最快1-2個工作天內
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心房纖維顫動的中風預防 (SPAF) Stroke prevention in Atrial Fibrillation Market and Forecast Analysis to 2024
出版日期: 2018年03月15日 內容資訊: 英文 369 Pages
簡介

心房纖維顫動的中風預防 (SPAF)的市場規模,由於新的口服抗凝固藥 (NOAC)類的分子獲得拮抗劑的核準,以及醫生增加採用這些藥物,預計急速成長。

本報告以心房纖維顫動的中風預防 (SPAF) 為焦點,提供帶給SPAF的銷售額最大影響的患者亞群、市場,拮抗劑的認證帶給NOAC類採用的影響,SPAF的Savaysa的認證帶給市場動態的影響,瓣膜症性心房纖維顫動、非瓣膜症性心房纖維顫動雙方的發作預防之最常處方的治療藥,影響處方趨勢的最重要的要素等相關分析。

預測:心房纖維顫動的中風預防

  • 摘要整理
  • 市場概要、趨勢
  • 調查手法、市場定義
  • Eliquis (apixaban)
  • Pradaxa (dabigatran)
  • Savaysa (edoxaban)
  • Xarelto (rivaroxaban)
  • 1次調查手法

治療:心房纖維顫動的中風預防

  • 摘要整理
  • 1次調查手法
  • 疾病定義、診斷
  • 目前治療選擇
  • 處方趨勢

流行病學:心房纖維顫動

  • 摘要整理
  • 疾病的背景
  • 來源、手法
  • 預測
  • 流行病學者的考察
  • 能力與限制

上市藥:心房纖維顫動的中風預防

  • 摘要整理
  • 產品概要
  • 產品簡介:Eliquis
  • 產品簡介:Pradaxa
  • 產品簡介:Savaysa
  • 產品簡介:Xarelto

開發平台:心房纖維顫動的中風預防

  • 摘要整理
  • 開發平台趨勢

附錄

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目錄
Product Code: DMKC12571

Disease Overview

Atrial fibrillation is the most common chronic cardiac arrhythmia, and is usually associated with other cardiovascular diseases. Atrial fibrillation is characterized by an irregular heartbeat, where the atria may not contract properly. While the disease is not considered life-threatening in itself, atrial fibrillation is one of the leading causes of stroke, with the disease conferring a fivefold increased risk.

Market Snapshot

Strong efficacy and safety data are expected to drive NOACs at the expense of warfarin over the forecast period.

Survey of 213 cardiologists in the US, Japan, and five major EU markets sheds light on prescribing trends in SPAF.

Diagnosed prevalent cases of atrial fibrillation are estimated to increase by more than 40% during the forecast period.

The development of antidotes for the NOAC drug class is likely to substantially increase their uptake.

Drug developers will need to identify reversal agents in order for pipeline medications to be able to compete with marketed drugs.

EU payers limit use due to high cost, while US payers support uptake.

Table of Contents

10 FORECAST: STROKE PREVENTION IN ATRIAL FIBRILLATION (SPAF) (Published on 15 March 2018)

10 OVERVIEW

11 RECENT FORECAST UPDATES

12 MARKET DYNAMICS

16 FORECAST AND FUTURE TRENDS

27 MARKET DEFINITION AND METHODOLOGY

32 PRIMARY RESEARCH METHODOLOGY

34 BIBLIOGRAPHY

35 PRODUCT PROFILE: ELIQUIS

49 PRODUCT PROFILE: PRADAXA

63 PRODUCT PROFILE: SAVAYSA

78 PRODUCT PROFILE: XARELTO

93 TREATMENT: STROKE PREVENTION IN ATRIAL FIBRILLATION (Published on 11 December 2017)

93 OVERVIEW

94 EXECUTIVE SUMMARY

95 PRIMARY RESEARCH METHODOLOGY

97 DISEASE DEFINITION AND DIAGNOSIS

107 CURRENT TREATMENT OPTIONS

108 PRESCRIBING TRENDS

126 EPIDEMIOLOGY: ATRIAL FIBRILLATION (Published on 08 December 2017)

126 OVERVIEW

127 EXECUTIVE SUMMARY

128 DISEASE BACKGROUND

132 METHODOLOGY

139 FORECAST

153 EPIDEMIOLOGIST INSIGHT

154 STRENGTHS AND LIMITATIONS

156 BIBLIOGRAPHY

159 APPENDIX: ADDITIONAL SOURCES

161 MARKETED DRUGS: STROKE PREVENTION IN ATRIAL FIBRILLATION (SPAF) (Published on 15 March 2018)

161 OVERVIEW

162 PRODUCT OVERVIEW

163 PRODUCT PROFILE: ELIQUIS

177 PRODUCT PROFILE: PRADAXA

191 PRODUCT PROFILE: SAVAYSA

206 PRODUCT PROFILE: XARELTO

221 NOACS PRICING, REIMBURSEMENT, AND ACCESS (Published on 10 May 2017)

221 OVERVIEW

222 EXECUTIVE SUMMARY

223 REGULATORY LABELS

229 GLOBAL PAYER AND KEY OPINION LEADER INSIGHTS

253 US PRICING

254 US REIMBURSEMENT

268 JAPAN

272 PRICING IN THE FIVE MAJOR EU MARKETS

273 FRANCE

301 GERMANY

316 ITALY

322 SPAIN

328 UK

362 METHODOLOGY

366 PIPELINE: STROKE PREVENTION IN ATRIAL FIBRILLATION (SPAF) (Published on 15 March 2018)

366 OVERVIEW

367 PIPELINE TRENDS

LIST OF FIGURES

  • 12 Figure 1: SPAF - Current and future market dynamics analysis
  • 13 Figure 2: Datamonitor Healthcare's assessment summary of key marketed drugs for SPAF
  • 16 Figure 3: SPAF drug sales across the US, Japan, and five major EU markets, by country, 2017-26
  • 21 Figure 4: Trajectories of Xarelto, Eliquis, and Pradaxa sales for SPAF across the US, Japan, and five major EU markets, 2017-26
  • 22 Figure 5: Savaysa sales for SPAF across the US, Japan, and five major EU markets, by country, 2017-26
  • 23 Figure 6: Trajectories of Xarelto and Eliquis sales for SPAF across the US, Japan, and five major EU markets, 2017-26
  • 28 Figure 7: Patient-based forecast methodology for SPAF
  • 30 Figure 8: Price sources and calculations, by country
  • 42 Figure 9: Eliquis for SPAF - SWOT analysis
  • 43 Figure 10: Datamonitor Healthcare's drug assessment summary of Eliquis for SPAF
  • 44 Figure 11: Datamonitor Healthcare's drug assessment summary of Eliquis for SPAF
  • 46 Figure 12: Eliquis sales for SPAF across the US, Japan, and five major EU markets, by country, 2017-26
  • 56 Figure 13: Pradaxa for SPAF - SWOT analysis
  • 57 Figure 14: Datamonitor Healthcare's drug assessment summary of Pradaxa for SPAF
  • 58 Figure 15: Datamonitor Healthcare's drug assessment summary of Pradaxa for SPAF
  • 60 Figure 16: Pradaxa sales for SPAF across the US, Japan, and five major EU markets, by country, 2017-26
  • 71 Figure 17: Savaysa for SPAF - SWOT analysis
  • 72 Figure 18: Datamonitor Healthcare's drug assessment summary of Savaysa for SPAF
  • 73 Figure 19: Datamonitor Healthcare's drug assessment summary of Savaysa for SPAF
  • 75 Figure 20: Savaysa sales for SPAF across the US, Japan, and five major EU markets, by country, 2017-26
  • 86 Figure 21: Xarelto for SPAF - SWOT analysis
  • 87 Figure 22: Datamonitor Healthcare's drug assessment summary of Xarelto for SPAF
  • 88 Figure 23: Datamonitor Healthcare's drug assessment summary of Xarelto for SPAF
  • 90 Figure 24: Xarelto sales for SPAF across the US, Japan, and five major EU markets, by country, 2017-26
  • 99 Figure 25: Mean percentage of atrial fibrillation patients diagnosed with each type of atrial fibrillation in the US, Japan, and five major EU markets, by country
  • 105 Figure 26: Mean percentage of atrial fibrillation patients in each category of atrial fibrillation in the US, Japan, and five major EU markets, by country
  • 108 Figure 27: Mean percentage of valvular atrial fibrillation patients receiving long-term stroke prevention treatment, by country
  • 109 Figure 28: Mean percentage of valvular atrial fibrillation patients receiving each of the top five antiplatelet/anticoagulation therapies at first line, by country
  • 111 Figure 29: Mean percentage of valvular atrial fibrillation patients receiving each of the top five antiplatelet/anticoagulation therapies at second line, by country
  • 112 Figure 30: Mean percentage of non-valvular atrial fibrillation patients with CHADS-VASc scores of 0 receiving long-term stroke prevention treatment, by country
  • 113 Figure 31: Mean percentage of non-valvular atrial fibrillation patients with CHADS-VASc scores of 0 receiving each of the top five therapies at first line, by country
  • 115 Figure 32: Mean percentage of non-valvular atrial fibrillation patients with CHADS-VASc scores of 0 receiving each of the top five therapies at second line, by country
  • 116 Figure 33: Mean percentage of non-valvular atrial fibrillation patients with CHADS-VASc scores of 1 receiving long-term stroke prevention treatment, by country
  • 117 Figure 34: Mean percentage of non-valvular atrial fibrillation patients with CHADS-VASc scores of 1 receiving each of the top five therapies at first line, by country
  • 119 Figure 35: Mean percentage of non-valvular atrial fibrillation patients with CHADS-VASc scores of 1 receiving each of the top five therapies at second line, by country
  • 120 Figure 36: Mean percentage of non-valvular atrial fibrillation patients with CHADS-VASc scores ≥2 receiving long-term stroke prevention treatment, by country
  • 121 Figure 37: Risk of adverse events in patients with various CHADS-VASc scores, Swedish Atrial Fibrillation cohort study, 2005
  • 122 Figure 38: Mean percentage of non-valvular atrial fibrillation patients with CHADS-VASc scores ≥2 receiving each of the top five therapies at first line, by country
  • 123 Figure 39: Mean percentage of non-valvular atrial fibrillation patients with CHADS-VASc scores ≥2 receiving each of the top five therapies at second line, by country
  • 128 Figure 40: Clinical implications of AF
  • 131 Figure 41: Prevalence of co-morbidities in patients with AF, by organ system
  • 144 Figure 42: Trend in diagnosed prevalent cases of AF in the US, Japan, and five major EU markets, by country, 2016-36
  • 145 Figure 43: Absolute change in diagnosed prevalent cases of AF in the US, Japan, and five major EU markets, by country, 2016-36
  • 147 Figure 44: Trend in age-specific diagnosed prevalent cases of AF in the US, Japan, and five major EU markets, by country, 2016-36
  • 170 Figure 45: Eliquis for SPAF - SWOT analysis
  • 171 Figure 46: Datamonitor Healthcare's drug assessment summary of Eliquis for SPAF
  • 172 Figure 47: Datamonitor Healthcare's drug assessment summary of Eliquis for SPAF
  • 174 Figure 48: Eliquis sales for SPAF across the US, Japan, and five major EU markets, by country, 2017-26
  • 184 Figure 49: Pradaxa for SPAF - SWOT analysis
  • 185 Figure 50: Datamonitor Healthcare's drug assessment summary of Pradaxa for SPAF
  • 186 Figure 51: Datamonitor Healthcare's drug assessment summary of Pradaxa for SPAF
  • 188 Figure 52: Pradaxa sales for SPAF across the US, Japan, and five major EU markets, by country, 2017-26
  • 199 Figure 53: Savaysa for SPAF - SWOT analysis
  • 200 Figure 54: Datamonitor Healthcare's drug assessment summary of Savaysa for SPAF
  • 201 Figure 55: Datamonitor Healthcare's drug assessment summary of Savaysa for SPAF
  • 203 Figure 56: Savaysa sales for SPAF across the US, Japan, and five major EU markets, by country, 2017-26
  • 214 Figure 57: Xarelto for SPAF - SWOT analysis215 Figure 58: Datamonitor Healthcare's drug assessment summary of Xarelto for SPAF
  • 216 Figure 59: Datamonitor Healthcare's drug assessment summary of Xarelto for SPAF
  • 218 Figure 60: Xarelto sales for SPAF across the US, Japan, and five major EU markets, by country, 2017-26

LIST OF TABLES

  • 17 Table 1: SPAF drug sales across the US, Japan, and five major EU markets, by country ($m), 2017-26
  • 19 Table 2: Proportion of SPAF total market sales according to patient subgroup (%), 2017-26
  • 21 Table 3: SPAF total market sales according to patient subgroup ($m), 2017-26
  • 25 Table 4: Average cost of treatment, CAGRs, and proportions of sales and patients across the US, Japan, and five major EU markets, by country, 2017-26
  • 31 Table 5: Exchange rates used for calculating prices
  • 32 Table 6: Cardiologists surveyed for the SPAF primary research study, 2017
  • 35 Table 7: Eliquis drug profile
  • 37 Table 8: Eliquis pivotal trial data in SPAF
  • 39 Table 9: Eliquis late-phase trial data in SPAF
  • 41 Table 10: Eliquis ongoing late-phase clinical trial in SPAF
  • 47 Table 11: Eliquis sales for SPAF across the US, Japan, and five major EU markets, by country ($m), 2017-26
  • 49 Table 12: Pradaxa drug profile
  • 51 Table 13: Pradaxa pivotal trial data in SPAF
  • 53 Table 14: Pradaxa late-phase trial data in SPAF
  • 55 Table 15: Pradaxa ongoing late-phase clinical trials in SPAF
  • 61 Table 16: Pradaxa sales for SPAF across the US, Japan, and five major EU markets, by country ($m), 2017-26
  • 63 Table 17: Savaysa drug profile
  • 65 Table 18: Savaysa pivotal trial data in SPAF
  • 67 Table 19: Savaysa late-phase trial data in SPAF
  • 69 Table 20: Savaysa ongoing late-phase clinical trials in SPAF
  • 76 Table 21: Savaysa sales for SPAF across the US, Japan, and five major EU markets, by country ($m), 2017-26
  • 78 Table 22: Xarelto drug profile
  • 80 Table 23: Xarelto pivotal trial data in SPAF
  • 82 Table 24: Xarelto late-phase trial data in SPAF
  • 85 Table 25: Xarelto ongoing late-phase clinical trial in SPAF
  • 91 Table 26: Xarelto sales for SPAF across the US, Japan, and five major EU markets, by country ($m), 2017-26
  • 95 Table 27: Cardiologists surveyed for the stroke prevention in atrial fibrillation primary research study, 2017
  • 98 Table 28: Overview of different atrial fibrillation classifications
  • 100 Table 29: Overview of risk factors for atrial fibrillation
  • 101 Table 30: Mean percentage of valvular atrial fibrillation patients who have co-morbidities in the US, Japan, and five major EU markets, by co-morbidity and country (%)
  • 102 Table 31: Mean percentage of non-valvular atrial fibrillation patients who have co-morbidities in the US, Japan, and five major EU markets, by co-morbidity and country (%)
  • 103 Table 32: Atrial fibrillation symptoms
  • 104 Table 33: Overview of the CHA2DS2-VASc scoring system
  • 107 Table 34: Treatments available for stroke prevention in atrial fibrillation across the US, Japan, and five major EU markets
  • 133 Table 35: Sources used for the epidemiological analysis of diagnosed prevalence of AF in the US, Japan, and five major EU markets, by country
  • 136 Table 36: Sources used for the epidemiological analysis of diagnosed incidence of AF in the US, Japan, and five major EU markets, by country
  • 141 Table 37: Diagnosed prevalent cases of AF in the US, Japan, and five major EU markets, by country, 2016-36
  • 146 Table 38: Age-specific diagnosed prevalent cases of AF in the US, Japan, and five major EU markets, by country, 2016
  • 148 Table 39: Gender-specific diagnosed prevalent cases of AF in the US, Japan, and five major EU markets, by country, 2016
  • 150 Table 40: Diagnosed incident cases of AF in the US, Japan, and five major EU markets, by country, 2016-36
  • 162 Table 41: Key marketed drugs for SPAF
  • 163 Table 42: Eliquis drug profile
  • 165 Table 43: Eliquis pivotal trial data in SPAF
  • 167 Table 44: Eliquis late-phase trial data in SPAF
  • 169 Table 45: Eliquis ongoing late-phase clinical trial in SPAF
  • 175 Table 46: Eliquis sales for SPAF across the US, Japan, and five major EU markets, by country ($m), 2017-26
  • 177 Table 47: Pradaxa drug profile
  • 179 Table 48: Pradaxa pivotal trial data in SPAF
  • 181 Table 49: Pradaxa late-phase trial data in SPAF
  • 183 Table 50: Pradaxa ongoing late-phase clinical trials in SPAF
  • 189 Table 51: Pradaxa sales for SPAF across the US, Japan, and five major EU markets, by country ($m), 2017-26
  • 191 Table 52: Savaysa drug profile
  • 193 Table 53: Savaysa pivotal trial data in SPAF
  • 195 Table 54: Savaysa late-phase trial data in SPAF
  • 197 Table 55: Savaysa ongoing late-phase clinical trials in SPAF
  • 204 Table 56: Savaysa sales for SPAF across the US, Japan, and five major EU markets, by country ($m), 2017-26
  • 206 Table 57: Xarelto drug profile
  • 208 Table 58: Xarelto pivotal trial data in SPAF
  • 210 Table 59: Xarelto late-phase trial data in SPAF
  • 213 Table 60: Xarelto ongoing late-phase clinical trial in SPAF
  • 219 Table 61: Xarelto sales for SPAF across the US, Japan, and five major EU markets, by country ($m), 2017-26
  • 224 Table 62: Marketed NOAC products and approved indications in the US, Japan, and five major EU markets
  • 233 Table 63: Levers impacting access to anticoagulants in the five major EU markets
  • 236 Table 64: Levers impacting access to NOACs in the US and five major EU markets
  • 242 Table 65: French and German HTA decisions
  • 253 Table 66: US pricing of key marketed drugs
  • 256 Table 67: Prior authorization criteria for NOACs in six major health plans
  • 258 Table 68: Formulary placement of NOACs in selected 2016 commercial formularies
  • 260 Table 69: Formulary placement of NOACs in top 10 2016 Medicare Part D formularies
  • 265 Table 70: Formulary placement of NOACs in selected large Medicaid states' preferred drug lists
  • 268 Table 71: Pricing premiums given to medicines that can demonstrate benefit over comparators in Japan
  • 269 Table 72: Pricing of NOACs in Japan
  • 270 Table 73: Price calculation methodologies for NOACs in Japan
  • 272 Table 74: Pricing of key NOACs in the five major EU markets
  • 274 Table 75: Transparency Commission's ASMR ratings and pricing implications
  • 275 Table 76: Transparency Committee's SMR ratings and pricing implications
  • 276 Table 77: Transparency Commission's assessment of SPAF treatments in France
  • 288 Table 78: Transparency Commission's assessment of VTE treatments in France
  • 294 Table 79: Transparency Commission's assessment of Praxbind (reversal agent for Pradaxa) in France
  • 302 Table 80: G-BA assessment of key SPAF therapies in Germany
  • 308 Table 81: G-BA assessment of key VTE therapies in Germany
  • 317 Table 82: AIFA's reimbursement decisions for NOACs in Italy
  • 319 Table 83: Reimbursement conditions for antidotes in Italy
  • 320 Table 84: Local formulary decisions for NOACs in Italy
  • 324 Table 85: Spain regional assessments of anticoagulants
  • 330 Table 86: NICE assessments of key SPAF therapies in the UK
  • 338 Table 87: NICE assessments of key VTE therapies in the UK
  • 345 Table 88: Regional formulary decisions for SPAF therapies in the UK
  • 347 Table 89: Regional formulary decisions for VTE therapies in the UK
  • 349 Table 90: SMC decisions on key SPAF therapies
  • 354 Table 91: SMC decisions on key VTE therapies
  • 359 Table 92: SMC decisions on key antidotes
  • 363 Table 93: Price sources and calculations, by country
  • 364 Table 94: Exchange rates used for calculating prices

 

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