市場調查報告書

疾病分析:血脂異常症

Disease Analysis: Dyslipidemia

出版商 Datamonitor Healthcare 商品編碼 920046
出版日期 內容資訊 英文 103 Pages
商品交期: 最快1-2個工作天內
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疾病分析:血脂異常症 Disease Analysis: Dyslipidemia
出版日期: 2019年11月29日內容資訊: 英文 103 Pages
簡介

2018年時,推測全球整體有15億名血脂異常症患者 (20歲以上) ,2027年其數將增加到17億人。

本報告提供全球血脂異常症治療藥臨床實驗形勢與市場趨勢預測相關分析,疾病概要和流行病學的預測,目前主要治療藥 (已上市/開發中產品) 和臨床實驗的進展,目前未滿足需求和未來的市場機會,臨床實驗/市場將來相關專家的見解等資訊彙整,為您概述為以下內容。

概要

疾病的背景情況

  • 定義
  • 患者的分類

治療方法

  • 因地區而有所差異治療指南
  • 風險族群著重治療建議
  • 特殊級的建議

流行病學

已上市醫藥品

開發平台醫藥品

近來的法規上的主要動向

成功的可能性

授權合約/資產收購交易

臨床實驗環境

  • 臨床試驗贊助者的分類:各狀況
  • 臨床試驗贊助者的分類:各相位
  • 目前的趨勢

醫藥品的評估模式

  • 降膽固醇藥
  • 降三酸甘油酯藥
  • 降脂質藥/CVOT (心血管結果實驗)的功效資料

市場動態

未來趨勢

  • 新產品的銷售和CVOT資料,促進血脂異常症市場今後的成長
  • 為了戰勝PCSK9抑制劑的競爭關係:競爭成為價格降低是必須的
  • 價格壓力和購買可能性,成為今後也抑制市場成長的主要原因

共識的預測

近幾年的市場趨勢和分析師的見解

今後的市場主要動向

KOL (專家)的見解

  • ADA會議 (Vascepa相關) 中醫生的採訪
  • 對PCSK9的醫療費證券相關採訪:美國的大保險付款者的KOL的情況

未滿足需求

  • 適合斯他汀類不耐症患者的改良型選擇
  • 有降低LDL-C效果,抗性高的口服藥:注射式的PCSK9抑制劑
  • 餘留風險的應對:儘管充分管理LDL-C水準,現在也是高風險患者的相關課題
  • 脂質水平上升時,為了說服患者繼續治療的方法

參考文獻

  • 處方藥的資訊

附錄

目錄
Product Code: DMKC0210072

KET TAKEAWAYS

Datamonitor Healthcare estimates that in 2018 there were approximately 1.5 billion prevalent cases of dyslipidemia in adults aged 20 years and older worldwide, and forecasts that number to increase to 1.7 billion prevalent cases by

2027. The dyslipidemia market is well established and the branded segment has seen declining sales due to generics. However, the market is poised to resume steady growth due to the introduction of novel agents, improved access with price competition, and new cardiovascular outcomes data with label expansions.

In the hypercholesterolemia segment, the injectable PCSK9 inhibitors have struggled due to payer restrictions, but declining net pricing in the US is hoped to improve access and spur growth, though this will depend on the extent to which payers retain prior authorization. Price competition may increase with the introduction of siRNA inclisiran, but Novartis also plans to use inclisiran's more convenient maintenance dosing of every six months to pursue administration in healthcare provider offices, with medical rather than pharmacy benefit coverage, including Medicare Part B, to improve access. Inclisiran's cardiovascular outcomes trial (CVOT) is also designed to show a numerically stronger topline benefit.

Oral bempedoic acid will be limited by modest low-density lipoprotein cholesterol (LDL-C) lowering, particularly on top of statins, but good efficacy with its fixed-dose combination with ezetimibe in statin-intolerant patients will be an important addition to that high-need segment. In addition, its oral route could lead it to be preferred initially in patients failing statins +/- ezetimibe who are not too far from goal, depending on the risk of the patient and whether the particular physician feels that reaching certain LDL-C targets is acceptable rather than driving it as low as possible. Given the large number of hypercholesterolemia patients not meeting goal, either with or without statin intolerance, if bempedoic acid's CVOT is positive, it should still be fairly successful despite its modest efficacy.

In the hypertriglyceridemia segment (including mixed dyslipidemia), positive CVOT data for the omega-3 fatty acid (FA) Vascepa, a formulation of EPA, has already started to drive substantial growth, but while the FDA is sure to grant it a label expansion for secondary prevention, it is unclear what type of primary prevention patients the FDA will include in the indication. The drug's prospects also largely depend on whether Epanova, a mixture of DHA and EPA, likewise has a positive CVOT. Epanova is likely to lag behind Vascepa if results are numerically not as strong, though it could benefit from AstraZeneca's stronger primary care presence. Depending on the details, Epanova's CVOT could also give physicians more confidence in generics of DHA/EPA when used in a high enough dose, though sponsors of other branded formulations, like CaPre, are hoping that would lead some to prefer their own formulations for other features. Vascepa's success could revive interest in triglycerides as a broader target, though its CV benefit may involve a number of other effects as well.

While fibrates have mixed CVOT data and failed to show a benefit in combination with statins in ACCORD, if the PROMINENT trial of pemafibrate is positive, it could bolster subgroup analyses of ACCORD, suggesting a benefit in patients with high triglycerides and low HDL-C. This would increase competition for omega-3 FAs.

In the orphan drug segment, anti-ANGPTL3 monoclonal antibody evinacumab is expected to take share from oral Juxtapid in homozygous familial hypercholesterolemia (HoFH), due to safety and tolerability issues with the latter, but will still be limited by competition with lower-priced PCSK9 inhibitors in eligible patients, assuming evinacumab has orphan pricing. Evinacumab's HoFH trial also involved inconvenient IV dosing, but subcutaneous dosing is being studied in a Phase II trial in patients with persistent hypercholesterolemia, despite treatment even with PCSK9 inhibitors, and the drug additionally lowers triglycerides, so it could expand to other orphan dyslipidemia indications as well. The antisense drug Waylivra, which targets ApoC-III, may not be approved in the US for familial chylomicronemia syndrome due to safety issues. However, other earlier-stage antisense and RNAi drugs targeting ANGPTL3, ApoC-III, and Apo(a) may avoid these safety issues and have gained large pharma interest, including plans for a CVOT for a broader indication.

Given limited budgets for many patients, there will be indirect competition between drugs targeting LDL-C and those targeting triglycerides, if patients are eligible for both, as well as with diabetes drugs that have CV and renal benefits.

In the US, different specialties and primary care physicians may use different dyslipidemia guidelines with varying approaches to lipid targets.

The overall likelihood of approval of a Phase I dyslipidemia asset is 10.4%, and the average probability a drug advances from Phase III is 65.4%. Dyslipidemia drugs, on average, take 8.1 years from Phase I to approval, compared to 9.8 years in the overall cardiovascular space.

There have been 15 licensing and asset acquisition deals involving dyslipidemia drugs during 2014-19. A $1,550m licensing agreement signed in 2019 between Pfizer and Akcea for AKCEA-ANGPTL3-LRx was the largest deal, though only $250m was upfront.

TABLE OF CONTENTS

CONTENTS

8 OVERVIEW

8 Latest key takeaways

10 DISEASE BACKGROUND

10 Definition

10 Patient segmentation

11 TREATMENT

11 Treatment guidelines vary across regions

11 Treatment recommendations focus on risk groups

12 Recommendations on specific classes

16 EPIDEMIOLOGY

20 MARKETED DRUGS

27 PIPELINE DRUGS

35 KEY REGULATORY EVENTS

35 Amarin Seeks EU Fast-Track For Potential Cardiovascular Blockbuster

35 YouTube Video Suggesting Livalo Is Safer Than Other Statins Is Dinged By US FDA

36 PROBABILITY OF SUCCESS

37 LICENSING AND ASSET ACQUISITION DEALS

37 Novartis To Pay $9.7bn For The Medicines Company

38 Pfizer Reaffirms CV Disease Commitment With Deal For Akcea's ANGPTL3 Drug

38 Deal Watch: Novartis Opts In On Lipoprotein A Candidate From Akcea

38 Asia Deal Watch: Boost For Esperion's Cholesterol Candidate As Daiichi Brought On Board

39 Novo Carves Deeper Niche Into CV Market With Staten Dyslipidemia Investment

40 CLINICAL TRIAL LANDSCAPE

41 Sponsors by status

42 Sponsors by phase

43 Recent events

45 DRUG ASSESSMENT MODEL

45 Cholesterol-lowering drugs

47 Triglyceride-lowering drugs

47 Lipid-lowering and CVOT efficacy data

54 MARKET DYNAMICS

59 FUTURE TRENDS

59 New launches and CVOT data will drive growth in the dyslipidemia market over the forecast period

59 Competition among the PCSK9 inhibitors will need to lower net prices more for the class to succeed

60 Price pressures and affordability will continue to be major factors limiting growth

61 CONSENSUS FORECASTS

64 RECENT EVENTS AND ANALYST OPINION

64 Inclisiran for Dyslipidemia (November 16 & 18, 2019)

67 Vascepa for Dyslipidemia (November 18, 2019)

69 Vascepa for Dyslipidemia (November 14, 2019)

71 Vascepa for Dyslipidemia (November 12, 2019)

73 ARO-ANG3 for Dyslipidemia and ARO-APOC3 for Lipoprotein Lipase Deficiency (September 16, 2019)

76 Inclisiran for Dyslipidemia (September 2, 2019)

78 ETC-1002/Ezetimibe FDC for Dyslipidemia (August 29, 2019)

80 Inclisiran for Dyslipidemia (August 26, 2019)

82 Evinacumab for Dyslipidemia (August 14, 2019)

83 Vascepa for Dyslipidemia (August 8, 2019)

85 Inclisiran for Dyslipidemia (May 18, 2019)

87 ETC-1002 for Dyslipidemia (May 5, 2019)

88 ETC-1002 for Dyslipidemia (March 13, 2019)

89 CER-001 for Dyslipidemia (December 5, 2018)

90 Vascepa for Dyslipidemia (November 10, 2018)

96 KEY UPCOMING EVENTS

97 KEY OPINION LEADER INSIGHTS

97 Interviews with physicians at the ADA conference regarding Vascepa

97 Interview regarding PCSK9 reimbursement with a KOL from a large US payer

99 UNMET NEEDS

99 Improved options for statin-intolerant patients

99 A well-tolerated oral drug with LDL-C lowering as good as the current injectable PCSK9 inhibitors when added to a statin

99 Addressing the residual risk remaining in higher-risk patients despite well-controlled LDL-C levels

99 A way to motivate patients to stick with treatment if their lipid levels are elevated

100 BIBLIOGRAPHY

101 Prescription information

102 APPENDIX

LIST OF FIGURES

  • 12 Figure 1: Hypercholesterolemia treatment recommendations in the US
  • 12 Figure 2: Hypercholesterolemia treatment recommendations in Europe and Japan
  • 14 Figure 3: Hypercholesterolemia recommendations for specific drug classes
  • 15 Figure 4: Hypertriglyceridemia recommendations for specific drug classes
  • 15 Figure 5: Usage of major drug classes
  • 19 Figure 6: Trends in prevalent cases of dyslipidemia, 2018-27
  • 27 Figure 7: Overview of pipeline drugs for dyslipidemia in the US
  • 27 Figure 8: Pipeline drugs for dyslipidemia, by company
  • 28 Figure 9: Pipeline drugs for dyslipidemia, by drug type
  • 28 Figure 10: Pipeline drugs for dyslipidemia, by classification
  • 36 Figure 11: Probability of success in the dyslipidemia pipeline
  • 37 Figure 12: Licensing and asset acquisition deals in dyslipidemia, 2014-19
  • 40 Figure 13: Clinical trials in dyslipidemia
  • 40 Figure 14: Top 10 drugs for clinical trials in dyslipidemia
  • 41 Figure 15: Top 10 companies for clinical trials in dyslipidemia
  • 41 Figure 16: Trial locations in dyslipidemia
  • 42 Figure 17: Dyslipidemia trials status
  • 43 Figure 18: Dyslipidemia trials sponsors, by phase
  • 45 Figure 19: Datamonitor Healthcare's drug assessment summary for dyslipidemia
  • 48 Figure 20: Dyslipidemia CVOTs in the statin era
  • 48 Figure 21: Major statin comparison - LDL-C lowering
  • 49 Figure 22: Ezetimibe - LDL-C lowering
  • 49 Figure 23: PCSK9 comparison - LDL-C lowering
  • 50 Figure 24: Inclisiran - LDL-C lowering in Phase III: ASCVD patients (ORION-10, -11) and HeFH (ORION-9)
  • 51 Figure 25: Heterozygous familial hypercholesterolemia comparison - LDL-C lowering
  • 52 Figure 26: Omega-3 FA comparison - triglyceride lowering
  • 53 Figure 27: Fenofibrate - triglyceride lowering
  • 59 Figure 28: Future trends in dyslipidemia
  • 67 Figure 29: Inclisiran for Dyslipidemia (November 16, 2019): Phase III - ORION-10 (US)
  • 67 Figure 30: Inclisiran for Dyslipidemia (November 18, 2019): Phase III - ORION-9 (Heterozygous FH Subjects)
  • 69 Figure 31: Vascepa for Dyslipidemia (Cardiovascular Disease indication; November 18, 2019): Phase II - EVAPORATE
  • 76 Figure 32: ARO-ANG3 for Dyslipidemia and ARO-APOC3 for Lipoprotein Lipase Deficiency (September 16, 2019): Phase I - SAD/MAD (AROAPOC31001)
  • 78 Figure 33: Inclisiran for Dyslipidemia (September 2, 2019): Phase III - ORION-11 (EU)
  • 80 Figure 34: ETC-1002/Ezetimibe FDC for Dyslipidemia (August 29, 2019): Phase II - 1002-058 (T2DM & Elevated LDLCholesterol)
  • 83 Figure 35: Evinacumab for Dyslipidemia (August 14, 2019): Phase III - ELIPSE HoFH
  • 87 Figure 36: Inclisiran for Dyslipidemia (May 18, 2019): Phase II - ORION-3 (OLE)
  • 95 Figure 37: Vascepa for Dyslipidemia (Cardiovascular Disease indication; November 10, 2018): Phase III - REDUCE-IT
  • 96 Figure 38: Key upcoming events in dyslipidemia

LIST OF TABLES

  • 17 Table 1: Prevalent cases of dyslipidemia, 2018-27
  • 21 Table 2: Marketed drugs for dyslipidemia
  • 29 Table 3: Pipeline drugs for dyslipidemia in the US
  • 55 Table 4: Dyslipidemia - hypercholesterolemia segment, current and future market dynamics analysis
  • 57 Table 5: Dyslipidemia - hypertriglyceridemia segment, current and future market dynamics analysis
  • 62 Table 6: Historical global sales, by drug ($m), 2014-18
  • 63 Table 7: Forecasted global sales, by drug ($m), 2019-23
  • 64 Table 8: Inclisiran for Dyslipidemia (November 16 & 18, 2019)
  • 68 Table 9: Vascepa for Dyslipidemia (November 18, 2019)
  • 70 Table 10: Vascepa for Dyslipidemia (November 14, 2019)
  • 72 Table 11: Vascepa for Dyslipidemia (November 12, 2019)
  • 74 Table 12: ARO-ANG3 for Dyslipidemia and ARO-APOC3 for Lipoprotein Lipase Deficiency (September 16, 2019)
  • 77 Table 13: Inclisiran for Dyslipidemia (September 2, 2019)
  • 79 Table 14: ETC-1002/Ezetimibe FDC for Dyslipidemia (August 29, 2019)
  • 81 Table 15: Inclisiran for Dyslipidemia (August 26, 2019)
  • 82 Table 16: Evinacumab for Dyslipidemia (August 14, 2019)
  • 84 Table 17: Vascepa for Dyslipidemia (August 8, 2019)
  • 85 Table 18: Inclisiran for Dyslipidemia (May 18, 2019)
  • 88 Table 19: ETC-1002 for Dyslipidemia (May 5, 2019)
  • 89 Table 20: ETC-1002 for Dyslipidemia (March 13, 2019)
  • 90 Table 21: CER-001 for Dyslipidemia (December 5, 2018)
  • 91 Table 22: Vascepa for Dyslipidemia (November 10, 2018)
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