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PharmaPoint: Dyslipidemia - Global Drug Forecast and Market Analysis to 2025

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from $10,995 356 Pages GlobalData December, 2016 GBDT15302906
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Length 356 Pages
Publisher GlobalData
Published Date December, 2016
SKU GBDT15302906
$10,995
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PharmaPoint: Dyslipidemia - Global Drug Forecast and Market Analysis to 2025

Summary

Sales of dyslipidemia therapeutics is estimated to be approximately $11.2B across the 7MM in 2015, encompassing the US, 5EU, and Japan. The dyslipidemia market will grow at a strong CAGR of 10.1% over the forecast period, reaching sales of $29.2B by 2025. The US is the largest market for dyslipidemia therapies, contributing approximately 61.5% of total sales in the base year. GlobalData expects uptake of the revolutionary class of PCSK9 targeting biologics to be the strongest driver of growth in the dyslipidemia market in the 7MM, reaching peak sales of $9.5B in 2025.

Major drivers of Dyslipidemia market growth over the forecast period are -

  • The launches of three PCSK9 inhibitors-Amgen’s Repatha, Sanofi and Regeneron’s Praluent, and Eli Lilly’s LY3015014-which will significantly boost market growth.
  • The launch of several add-on therapies, including Esperion Therapeutic’s ETC-1002 and Merck and Amgen’s cholesteryl ester transfer protein (CETP) inhibitors
  • Increase in global prevalence of dyslipidemia, coupled with growing awareness of the disease.
Although the dyslipidemia market has numerous well-established therapies and the pipeline is promising, there is a considerable level of unmet need. Patient compliance, cost-effective therapies, and drugs targeting rare diseases represent major unmet needs in the dyslipidemia space. Patient compliance remains the biggest issue, and a major contributing factor to this is the asymptomatic nature of this disease, as well as the burden of taking several pills daily to treat this disease.

In addition to this, many patients discontinue therapy, which puts them at considerable risk of experiencing a CV event. The PCSK9 monoclonal antibodies (mAbs), Repatha and Praluent, are expected to address the compliance issue due to their less frequent dosing schedules; however, KOLs indicated that patient education and enhanced disease awareness are important issues that also need to be addressed. While patient education is not a common area of focus for pharmaceutical companies, it’s clear that if diagnosis rates and patient compliance were increased, then this would translate to a boost in drug use and sales.

Companies reviewed in this report: Abbvie, Aegerion Pharmaceuticals Inc., Akcea Therapeutics Inc., Amarin, Amgen, AstraZeneca, Cerenis Therapeutics Inc., Daiichi Sankyo, Eli Lilly, Esperion Therapeutics Inc., Genzyme, Ionis Pharmaceuticals, Merck & Co., Regeneron Pharmaceuticals Inc., Sanofi, The Medicine Company.

Scope
  • Overview of dyslipidemia, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
  • Annualized dyslipidemia therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2015 and forecast for ten years to 2025.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the dyslipidemia therapeutics market.
  • Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.
  • Analysis of the current and future market competition in the global dyslipidemia therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.
Reasons to buy

The report will enable you to -
  • Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline. Additionally a list of acquisition targets included in the pipeline product company list.
  • Develop business strategies by understanding the trends shaping and driving the dyslipidemia therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the dyslipidemia therapeutics market in future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
  • Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
  • Track drug sales in the 7MM dyslipidemia therapeutics market from 2015-2025.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.


1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Introduction
2.1 Catalyst
2.2 Related Reports
3 Disease Overview
3.1 Etiology and Pathophysiology
3.1.1 Etiology
3.1.2 Pathophysiology
3.2 Symptoms
3.3 Prognosis
3.4 Quality of Life
4 Epidemiology
4.1 Disease Background
4.2 Risk Factors and Comorbidities
4.3 Global Trends
4.4 Forecast Methodology
4.4.1 Sources Used Tables
4.4.2 Forecast Assumptions and Methods
4.4.3 Sources Not Used
4.5 Epidemiological Forecast for Dyslipidemia (2015-2025)
4.5.1 Dyslipidemia
4.5.2 Familial Hypercholesterolemia
4.5.3 Increased Low-Density Lipoprotein Cholesterol
4.5.4 High Triglycerides
4.5.5 Very High Triglycerides
4.5.6 Low High-Density Lipoprotein Cholesterol
4.6 Discussion
4.6.1 Epidemiological Forecast Insight
4.6.2 Limitations of the Analysis
4.6.3 Strengths of the Analysis
5 Disease Management
5.1 Diagnosis and Treatment Overview
5.1.1 Diagnosis
5.1.2 Treatment Guidelines and Leading Prescribed Drugs
5.1.3 Clinical Practice
5.2 US
5.3 5EU
5.4 Japan
6 Competitive Assessment
6.1 Overview
6.2 Statins
6.2.1 Overview of drug class
6.2.2 Crestor (Rosuvastatin)
6.3 Zetia (Ezetimibe)
6.3.1 Overview
6.3.2 Efficacy
6.3.3 Safety
6.3.4 SWOT Analysis
6.3.5 Forecast
6.4 Praluent (Alirocumab)
6.4.1 Overview
6.4.2 Efficacy
6.4.3 Safety
6.4.4 SWOT Analysis
6.4.5 Forecast
6.5 Repatha (Evolocumab)
6.5.1 Overview
6.5.2 Efficacy
6.5.3 Safety
6.5.4 SWOT Analysis
6.5.5 Forecast
6.6 Vytorin (Simvastatin/Ezetimibe)
6.6.1 Overview
6.6.2 Efficacy
6.6.3 Safety
6.6.4 SWOT Analysis
6.6.5 Forecast
6.7 Kynamro (Mipomersen)
6.7.1 Overview
6.7.2 Efficacy
6.7.3 Safety
6.7.4 SWOT Analysis
6.7.5 Forecast
6.8 Juxtapid (Lomitapide)
6.8.1 Overview
6.8.2 Efficacy
6.8.3 Safety
6.8.4 SWOT Analysis
6.8.5 Forecast
6.9 Niacin/Nicotinic Acid
6.9.1 Overview
6.9.2 Efficacy
6.9.3 Safety
6.9.4 SWOT Analysis
6.9.5 Forecast
6.10 Fibrates
6.10.1 Overview of Drug Class
6.10.2 Tricor/Trilipix (Fenofibrate/Fenofibric acid)
6.11 Omega-3 Fatty Acids
6.11.1 Overview
6.11.2 Lovaza (omega-3 acid ethyl esters)
6.11.3 Vascepa (Icosapent Ethyl)
6.11.4 Epanova (omega-3 carboxylic acids)
6.12 Bile Acid Sequestrants
6.12.1 Overview
6.12.2 Efficacy
6.12.3 Safety
6.12.4 SWOT Analysis
6.12.5 Forecast
7 Unmet Needs Assessment and Opportunity Analysis
7.1 Overview
7.2 Therapies that Target Lipoprotein(a)
7.2.1 Unmet Need
7.2.2 Gap Analysis
7.2.3 Opportunity
7.3 Cost-Effective Therapies for Dyslipidemia
7.3.1 Unmet Need
7.3.2 Gap Analysis
7.3.3 Opportunity
7.4 Efficacious TG-Lowering Therapies
7.4.1 Unmet Need
7.4.2 Gap Analysis
7.4.3 Opportunity
7.5 Improved Diagnosis, Patient Education, and Long-Term Compliance
7.5.1 Unmet Need
7.5.2 Gap Analysis
7.5.3 Opportunity
7.6 HoFH Therapies with Reduced Side Effects
7.6.1 Unmet Need
7.6.2 Gap Analysis
7.6.3 Opportunity
7.7 Therapies that Prevent or Reverse the Buildup of Atherosclerotic Plaque
7.7.1 Unmet Need
7.7.2 Gap Analysis
7.7.3 Opportunity
8 Pipeline Assessment
8.1 Overview
8.2 Promising Drugs in Clinical Development
8.2.1 LY3015014
8.2.2 Anacetrapib
8.2.3 AMG-899 (TA-8995/DEZ-001)
8.2.4 Bempedoic Acid (ETC-1002)
8.2.5 Volanesorsen
8.2.6 CER-001
8.2.7 ALN-PCSsc
8.2.8 Gemcabene
8.2.9 Pemafibrate (K-877)
8.3 Other Drugs in Development
9 Current and Future Players
9.1 Overview
9.2 Trends in Corporate Strategy
9.3 Company Profiles
9.3.1 AbbVie
9.3.2 Aegerion Pharmaceuticals, Inc.
9.3.3 Akcea Therapeutics, Inc. and Ionis Pharmaceuticals
9.3.4 Amarin
9.3.5 Amgen
9.3.6 AstraZeneca
9.3.7 Cerenis Therapeutics, Inc.
9.3.8 Daiichi Sankyo
9.3.9 Eli Lilly
9.3.10 Esperion Therapeutics, Inc.
9.3.11 Genzyme
9.3.12 Merck & Co.
9.3.13 Regeneron Pharmaceuticals, Inc.
9.3.14 Sanofi
9.3.15 The Medicines Company
10 Market Outlook
10.1 Global Markets
10.1.1 Forecast
10.1.2 Drivers and Barriers - Global Issues
10.2 US
10.2.1 Forecast
10.2.2 Key Events
10.2.3 Drivers and Barriers
10.3 5EU
10.3.1 Forecast
10.3.2 Key Events
10.3.3 Drivers and Barriers
10.4 Japan
10.4.1 Forecast
10.4.2 Key Events
10.4.3 Drivers and Barriers
11 Appendix
11.1 Bibliography
11.2 Abbreviations
11.3 Methodology
11.4 Forecasting Methodology
11.4.1 Diagnosed Dyslipidemia Patients
11.4.2 Percent Drug-Treated Patients
11.4.3 Drugs Included in Each Therapeutic Class
11.4.4 Launch and Patent Expiry Dates
11.4.5 General Pricing Assumptions
11.4.6 Individual Drug Assumptions
11.4.7 Generic Erosion
11.4.8 Pricing of Pipeline Agents
11.5 Primary Research - KOLs Interviewed for this Report
11.6 Primary Research - Prescriber Survey
11.7 About the Authors
11.7.1 Analyst
11.7.2 Therapy Area Director
11.7.3 Epidemiologist
11.7.4 Director of Epidemiology
11.7.5 Global Director of Therapy Analysis and Epidemiology
11.8 About GlobalData
11.9 Disclaimer
1.1 List of Tables
Table 1: Dyslipidemia: Fredrickson Classification System
Table 2: Risk Factors and Comorbidities for Dyslipidemia
Table 3: 8MM, Sources Used to Forecast the Diagnosed Prevalent Cases of Dyslipidemia
Table 4: 8MM, Sources Used to Forecast the Total Prevalent Cases of FH
Table 5: 8MM, Sources Used to Forecast the Total Prevalent Cases of Increased LDL-C
Table 6: 8MM, Sources Used to Forecast the Total Prevalent Cases of High TG
Table 7: 8MM, Sources Used to Forecast the Total Prevalent Cases of Low HDL-C
Table 8: 8MM, Total Prevalent Cases of Dyslipidemia, Ages ≥20 Years, Both Sexes, N, Selected Years 2015-2025
Table 9: 8MM, Diagnosed Prevalent Cases of Dyslipidemia, Ages ≥20 Years, Both Sexes, N, Selected Years 2015-2025
Table 10: 8MM, Total Prevalent Cases of Increased LDL-C, Ages ≥20 Years, Both Sexes, N, Selected Years, 2015-2025
Table 11: 8MM, Total Prevalent Cases of High TG, Ages ≥20 Years, Both Sexes, N, Selected Years, 2015-2025
Table 12: 8MM, Total Prevalent Cases of Very High TG, Ages ≥20 Years, Both Sexes, N, Selected Years, 2015-2025
Table 13: 8MM, Total Prevalent Cases of Low HDL-C, Ages ≥20 Years, Both Sexes, N, Selected Years 2015-2025
Table 14: AACE Optimal/Near-Optimal, Borderline, and High-Risk Serum Lipid Concentrations
Table 15: Factors Considered for Different CVD Risk Calculators
Table 16: Treatment Guidelines for Dyslipidemia
Table 17: Most Prescribed Drugs for Dyslipidemia by Class in the Global Markets, 2015
Table 18: Country Profile - US
Table 19: Market Profile - 5EU
Table 20: Country Profile - Japan
Table 21: Intensity level of commonly used statins
Table 22: Product Profile - Crestor (Rosuvastatin)
Table 23: Efficacy of Rosuvastatin - Lipid and Lipoprotein Parameters
Table 24: Crestor SWOT Analysis, 2015
Table 25: Product Profile - Zetia
Table 26: Efficacy of Zetia - Primary and Secondary Endpoints, IMPROVE-IT study
Table 27: Safety of Zetia (Ezetimibe)
Table 28: Drug Zetia (Ezetimibe) SWOT Analysis, 2015-2025
Table 29: Product Profile - Praluent
Table 30: Efficacy of Praluent (alirocumab) - Primary and Secondary Endpoints, ODYSSEY LONG TERM Phase III Study
Table 31: Safety of Praluent (alirocumab)
Table 32: Praluent (Alirocumab) SWOT Analysis, 2015-2025
Table 33: Product Profile - Repatha
Table 34: Pivotal Trials of Repatha (Evolocumab)
Table 35: Repatha (Evolocumab) SWOT Analysis, 2015-2025
Table 36: Product Profile - Vytorin
Table 37: Efficacy of Vytorin - Primary and Secondary Endpoints, VYVA study
Table 38: Vytorin SWOT Analysis, 2015
Table 39: Product Profile - Kynamro
Table 40: Efficacy of Kynamro - Lipid and Lipoprotein Parameters, RADICHOL 1 Phase III Study
Table 41: Safety of Kynamro (mipomersen)
Table 42: Kynamro SWOT Analysis, 2015
Table 43: Product Profile - Juxtapid
Table 44: Efficacy of Juxtapid - Lipid and Lipoprotein parameters, Phase III Study
Table 45: Juxtapid SWOT Analysis, 2015
Table 46: Product Profile - Niaspan
Table 47: Niacin/Nicotinic Acid SWOT Analysis, 2015
Table 48: Summary of the Therapeutic Properties of Fibrates*
Table 49: Product Profile - Tricor/Trilipix
Table 50: Tricor/Trilipix SWOT Analysis, 2015
Table 51: Product Profile - Lovaza
Table 52: Efficacy of Lovaza - Pivotal Studies for the Treatment of Very High TGs
Table 53: Lovaza SWOT Analysis, 2015
Table 54: Product Profile - Vascepa
Table 55: Efficacy of Vascepa - ANCHOR Phase III Study
Table 56: Vascepa SWOT Analysis, 2015
Table 57: Product Profile - Epanova
Table 58: Efficacy of Epanova - ESPRIT Phase III Study
Table 59: Epanova SWOT Analysis, 2015
Table 60: Product Profile - Welchol
Table 61: Efficacy of Welchol - GLOWS Study
Table 62: Welchol SWOT Analysis, 2015
Table 63: Unmet Need and Opportunity in Dyslipidemia, 2015
Table 64: Product Profile - LY3015014
Table 65: Efficacy of LY3015014
Table 66: LY3015014 SWOT Analysis, 2015
Table 67: Product Profile - Anacetrapib
Table 68: Efficacy of Anacetrapib - Primary and Secondary Endpoints, DEFINE study
Table 69: Safety of Anacetrapib - AEs and Safety Variables, DEFINE study
Table 70: Anacetrapib SWOT Analysis, 2015
Table 71: Product Profile - AMG-899 ( TA-8995/DEZ-001)
Table 72: Efficacy of TA-8995 - Primary Endpoints, TULIP study
Table 73: AMG-899 SWOT Analysis, 2015
Table 74: Product Profile - ETC-1002 (Bempedoic Acid)
Table 75: Efficacy of ETC-1002 - Lipid and lipoprotein parameters
Table 76: ETC-1002 SWOT Analysis, 2015
Table 77: Product Profile - Volanesorsen
Table 78: Efficacy of Volanesorsen - Lipid and Lipoprotein Levels and Glycemic Control
Table 79: Volanesorsen SWOT Analysis, 2015
Table 80: Product Profile - CER-001
Table 81: Efficacy of CER-001
Table 82: CER-001 SWOT Analysis, 2015
Table 83: Product Profile - ALN-PCSsc
Table 84: ALN-PCSsc SWOT Analysis, 2015
Table 85: Product Profile - Gemcabene
Table 86: Efficacy of Gemcabene
Table 87: Gemcabene SWOT Analysis, 2015
Table 88: Product Profile - Pemafibrate
Table 89: Efficacy of Pemafibrate
Table 90: Safety of Pemafibrate
Table 91: Pemafibrate SWOT Analysis, 2015
Table 92: Drugs in Development for Dyslipidemia, 2015
Table 93: Key Companies in the Dyslipidemia Market in the 7MM, 2015
Table 94: Abbvie’s Dyslipidemia Portfolio Assessment, 2015
Table 95: Aegerion Pharmaceuticals’ Dyslipidemia Portfolio Assessment, 2015
Table 96: Ionis Pharmaceuticals’ Dyslipidemia Portfolio Assessment, 2015
Table 97: Amarin’s Dyslipidemia Portfolio Assessment, 2015
Table 98: Amgen’s Dyslipidemia Portfolio Assessment, 2015
Table 99: AstraZeneca’s Dyslipidemia Portfolio Assessment, 2015
Table 100: Cerenis Therapeutics’ Dyslipidemia Portfolio Assessment, 2015
Table 101: Daiichi Sankyo’s Dyslipidemia Portfolio Assessment, 2015
Table 102: Eli Lilly’s Dyslipidemia Portfolio Assessment, 2015
Table 103: Esperion Therapeutics’ Dyslipidemia Portfolio Assessment, 2015
Table 104: Genzyme’s Dyslipidemia Portfolio Assessment, 2015
Table 105: Merck & Co.’s Dyslipidemia Portfolio Assessment, 2015
Table 106: Regeneron Pharmaceuticals’ Dyslipidemia Portfolio Assessment, 2015
Table 107: Sanofi’s Dyslipidemia Portfolio Assessment, 2015
Table 108: The Medicines Company’s Dyslipidemia Portfolio Assessment, 2015
Table 109: Dyslipidemia Market - Global Drivers and Barriers, 2015‒2025
Table 110: Key Events Impacting Sales for Dyslipidemia in the US, 2015-2025
Table 111: Dyslipidemia Market - Drivers and Barriers in the US, 2015‒2025
Table 112: Key Events Impacting Sales for Dyslipidemia in the 5EU, 2015-2025
Table 113: Dyslipidemia Market - Drivers and Barriers in the 5EU, 2015‒2025
Table 114: National Healthcare Authorities in the 5EU Nations
Table 115: National Public Health Initiatives in the 5EU Nations
Table 116: Governmental Drug Pricing Authorities in the 5EU Nations
Table 117: Key Events Impacting Sales for Dyslipidemia in Japan, 2015-2025
Table 118: Dyslipidemia Market - Drivers and Barriers in Japan, 2015‒2025
Table 119: Key Launch Dates for Dyslipidemia
Table 120: Key Patent Expiry Dates for Dyslipidemia
Table 121: High-Prescribing Physicians (non-KOLs) Surveyed, By Country
1.2 List of Figures
Figure 1: Classification of Dyslipidemia
Figure 2: 8MM Total Prevalent Cases of Dyslipidemia, Ages ≥20 Years, Both Sexes, N, 2015-2025
Figure 3: 8MM Diagnosed Prevalent Cases of Dyslipidemia, Ages ≥20 Years, Both Sexes, N, 2015-2025
Figure 4: 8MM, Total Prevalent Cases of FH, Both Sexes, Ages ≥20 Years, N, 2015 and 2025
Figure 5: 8MM, Total Prevalent Cases of Increased LDL-C, Both Sexes, Ages ≥20 Years, N, 2015 and 2025
Figure 6: 8MM, Sex-Specific Total Prevalent Cases of Increased LDL-C, Both Sexes, Ages ≥20 Years, N, 2015
Figure 7: 8MM, Age-Specific Total Prevalent Cases of Increased LDL-C, Both Sexes, Ages ≥20 Years, 2015
Figure 8: 8MM, Age-Standardized Total Prevalence of Increased LDL-C, Both Sexes, Ages ≥20 Years, 2015
Figure 9: 8MM, Total Prevalent Cases of High TG, Both Sexes, Ages ≥20 Years, N, 2015-2025
Figure 10: 8MM, Sex-Specific Total Prevalent Cases of High TG, Both Sexes, Ages ≥20 Years, N, 2015
Figure 11: 8MM, Age-Specific Total Prevalent Cases of High TG, Both Sexes, Ages ≥20 Years, 2015
Figure 12: 8MM, Age-Standardized Total Prevalence of High TG, Both Sexes, Ages ≥20 Years, 2015
Figure 13: 8MM, Total Prevalent Cases of Very High TG, Both Sexes, Ages ≥20 Years, N, 2015-2025
Figure 14: 8MM, Total Prevalent Cases of Low HDL-C, Both Sexes, Ages ≥20 Years, N, 2015-2025
Figure 15: 8MM, Sex-Specific Total Prevalent Cases of Low HDL-C, Ages ≥20 Years, N, 2015
Figure 16: 8MM, Age-Specific Total Prevalent Cases of Low HDL-C, Both Sexes, Ages ≥20 Years, 2015
Figure 17: 8MM, Age-Standardized Total Prevalence of Low HDL-C, Both Sexes, Ages ≥20 Years, 2015
Figure 18: Statin Mechanism of Action
Figure 19: Competitive Assessment of Late-Stage Pipeline Agents in Dyslipidemia, 2015-2025
Figure 20: ACL inhibition
Figure 21: Company Portfolio Gap Analysis in Dyslipidemia, 2015-2025
Figure 22: Global Sales for Dyslipidemia by Region, 2015 and 2025
Figure 23: Global Sales for Dyslipidemia by Drug Class, 2015 and 2025
Figure 24: Global Sales for PCSK9 targeting therapies, 2015-2025
Figure 25: Sales for Dyslipidemia by Drug Class in the US, 2015 and 2025
Figure 26: Sales for Dyslipidemia by Drug Class in the 5EU, 2015 and 2025
Figure 27: Sales for Dyslipidemia by Drug Class in Japan, 2015 and 2025

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