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

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Published: December 01, 2016 Report Code: GDHC138PIDR-ST

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GlobalData estimates sales of dyslipidemia therapeutics 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. Despite the launch of such efficacious lipid-lowering therapies, there is ample opportunity for pipeline drugs targeting the broader mixed dyslipidemia market. As pricing is expected to be the strongest barrier to uptake in the dyslipidemia space, cost-effective therapies will be more successful at penetrating the market.

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.

Key Highlights

The level of unmet needs in the dyslipidemia market remains high. Will the pipeline drugs fulfil these unmet needs of the market? Key Opinion Leaders (KOLs) interviewed by GlobalData provide insights and highlight opportunities for drug developers.

The 10-year forecast period will mark the launch of several biologics targeting PCSK9. How will the market be impacted? Which of the marketed and pipeline drugs will have the highest peak sales at the highest CAGR, and why?

Pricing has a strong influence over drug uptake. How will reimbursement affect the adoption of combination therapy in the different markets?

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

Table of Contents

1Table of Contents

1.1List of Tables

1.2List of Figures

2Introduction

2.1Catalyst

2.2Related Reports

3Disease Overview

3.1Etiology and Pathophysiology

3.1.1Etiology

3.1.2Pathophysiology

3.2Symptoms

3.3Prognosis

3.4Quality of Life

4Epidemiology

4.1Disease Background

4.2Risk Factors and Comorbidities

4.3Global Trends

4.4Forecast Methodology

4.4.1Sources Used Tables

4.4.2Forecast Assumptions and Methods

4.4.3Sources Not Used

4.5Epidemiological Forecast for Dyslipidemia (2015–2025)

4.5.1Dyslipidemia

4.5.2Familial Hypercholesterolemia

4.5.3Increased Low-Density Lipoprotein Cholesterol

4.5.4High Triglycerides

4.5.5Very High Triglycerides

4.5.6Low High-Density Lipoprotein Cholesterol

4.6Discussion

4.6.1Epidemiological Forecast Insight

4.6.2Limitations of the Analysis

4.6.3Strengths of the Analysis

5Disease Management

5.1Diagnosis and Treatment Overview

5.1.1Diagnosis

5.1.2Treatment Guidelines and Leading Prescribed Drugs

5.1.3Clinical Practice

5.2US

5.35EU

5.4Japan

6Competitive Assessment

6.1Overview

6.2Statins

6.2.1Overview of drug class

6.2.2Crestor (Rosuvastatin)

6.3Zetia (Ezetimibe)

6.3.1Overview

6.3.2Efficacy

6.3.3Safety

6.3.4SWOT Analysis

6.3.5Forecast

6.4Praluent (Alirocumab)

6.4.1Overview

6.4.2Efficacy

6.4.3Safety

6.4.4SWOT Analysis

6.4.5Forecast

6.5Repatha (Evolocumab)

6.5.1Overview

6.5.2Efficacy

6.5.3Safety

6.5.4SWOT Analysis

6.5.5Forecast

6.6Vytorin (Simvastatin/Ezetimibe)

6.6.1Overview

6.6.2Efficacy

6.6.3Safety

6.6.4SWOT Analysis

6.6.5Forecast

6.7Kynamro (Mipomersen)

6.7.1Overview

6.7.2Efficacy

6.7.3Safety

6.7.4SWOT Analysis

6.7.5Forecast

6.8Juxtapid (Lomitapide)

6.8.1Overview

6.8.2Efficacy

6.8.3Safety

6.8.4SWOT Analysis

6.8.5Forecast

6.9Niacin/Nicotinic Acid

6.9.1Overview

6.9.2Efficacy

6.9.3Safety

6.9.4SWOT Analysis

6.9.5Forecast

6.10Fibrates

6.10.1Overview of Drug Class

6.10.2Tricor/Trilipix (Fenofibrate/Fenofibric acid)

6.11Omega-3 Fatty Acids

6.11.1Overview

6.11.2Lovaza (omega-3 acid ethyl esters)

6.11.3Vascepa (Icosapent Ethyl)

6.11.4Epanova (omega-3 carboxylic acids)

6.12Bile Acid Sequestrants

6.12.1Overview

6.12.2Efficacy

6.12.3Safety

6.12.4SWOT Analysis

6.12.5Forecast

7Unmet Needs Assessment and Opportunity Analysis

7.1Overview

7.2Therapies that Target Lipoprotein(a)

7.2.1Unmet Need

7.2.2Gap Analysis

7.2.3Opportunity

7.3Cost-Effective Therapies for Dyslipidemia

7.3.1Unmet Need

7.3.2Gap Analysis

7.3.3Opportunity

7.4Efficacious TG-Lowering Therapies

7.4.1Unmet Need

7.4.2Gap Analysis

7.4.3Opportunity

7.5Improved Diagnosis, Patient Education, and Long-Term Compliance

7.5.1Unmet Need

7.5.2Gap Analysis

7.5.3Opportunity

7.6HoFH Therapies with Reduced Side Effects

7.6.1Unmet Need

7.6.2Gap Analysis

7.6.3Opportunity

7.7Therapies that Prevent or Reverse the Buildup of Atherosclerotic Plaque

7.7.1Unmet Need

7.7.2Gap Analysis

7.7.3Opportunity

8Pipeline Assessment

8.1Overview

8.2Promising Drugs in Clinical Development

8.2.1LY3015014

8.2.2Anacetrapib

8.2.3AMG-899 (TA-8995/DEZ-001)

8.2.4Bempedoic Acid (ETC-1002)

8.2.5Volanesorsen

8.2.6CER-001

8.2.7ALN-PCSsc

8.2.8Gemcabene

8.2.9Pemafibrate (K-877)

8.3Other Drugs in Development

9Current and Future Players

9.1Overview

9.2Trends in Corporate Strategy

9.3Company Profiles

9.3.1AbbVie

9.3.2Aegerion Pharmaceuticals, Inc.

9.3.3Akcea Therapeutics, Inc. and Ionis Pharmaceuticals

9.3.4Amarin

9.3.5Amgen

9.3.6AstraZeneca

9.3.7Cerenis Therapeutics, Inc.

9.3.8Daiichi Sankyo

9.3.9Eli Lilly

9.3.10Esperion Therapeutics, Inc.

9.3.11Genzyme

9.3.12Merck & Co.

9.3.13Regeneron Pharmaceuticals, Inc.

9.3.14Sanofi

9.3.15The Medicines Company

10Market Outlook

10.1Global Markets

10.1.1Forecast

10.1.2Drivers and Barriers – Global Issues

10.2US

10.2.1Forecast

10.2.2Key Events

10.2.3Drivers and Barriers

10.35EU

10.3.1Forecast

10.3.2Key Events

10.3.3Drivers and Barriers

10.4Japan

10.4.1Forecast

10.4.2Key Events

10.4.3Drivers and Barriers

11Appendix

11.1Bibliography

11.2Abbreviations

11.3Methodology

11.4Forecasting Methodology

11.4.1Diagnosed Dyslipidemia Patients

11.4.2Percent Drug-Treated Patients

11.4.3Drugs Included in Each Therapeutic Class

11.4.4Launch and Patent Expiry Dates

11.4.5General Pricing Assumptions

11.4.6Individual Drug Assumptions

11.4.7Generic Erosion

11.4.8Pricing of Pipeline Agents

11.5Primary Research – KOLs Interviewed for this Report

11.6Primary Research – Prescriber Survey

11.7About the Authors

11.7.1Analyst

11.7.2Therapy Area Director

11.7.3Epidemiologist

11.7.4Director of Epidemiology

11.7.5Global Director of Therapy Analysis and Epidemiology

11.8About GlobalData

11.9Disclaimer

Table

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

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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