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Chapter 2 provides an executive summary of the insights captured in our research. The summary offers a high level view on the likely evolution of hypercholesterolemia market with PCSK9 and other novel classes of upcoming cholesterol-lowering drugs.
Chapter 3 provides a general introduction to hypercholesterolemia, the current therapeutic options, their limitations, and emergence of new drug-classes. We discuss in detail about the role of cholesterol and how its high level in blood can be a threat to the community.
Chapter 4 provides the pipeline of novel drugs under development for treatment of high cholesterol levels. We have analysed the pipeline by mechanism of action, phase of development, drug developers, and type of molecule. We have also discussed the competitive landscape for three major indication areas – dyslipidemia, HoFH and HeFH.
Chapter 5 presents the profiles of two recently approved drugs, Juxtapid and Kynamro. In this chapter, we have discussed the mechanisms, pharmacokinetics, dosage, and cost, phase III clinical studies details, present development status, partnerships, drivers and constraints related to both Juxtapid and Kynamro. In addition, we have also reviewed Isis’ anti-sense technology.
Chapter 6 presents the profiles of monoclonal antibodies that work by inhibiting PCSK9. We have profiled three late-stage biological drugs covering information about their discovery, mechanism of action, technology, completed / ongoing clinical trials, drivers and constraints.
Chapter 7 provides a detailed profile of Anacetrapib, a CETP inhibitor in phase III. In addition, we have discussed HDL as a cardiovascular marker, current HDL-raising interventions and other CETP inhibitors in development.
Chapter 8 provides analysis on the overall market outlook for the next ten years (2014 – 2024). We have followed a ‘bottom-up’ approach to estimate the likely sales potential of each of the molecules which are either marketed or are in advanced stages of clinical trials.
Chapter 9 summarizes the overall report. In this chapter, we provide a recap of the key takeaways and our independent opinion based on the research and analysis described in previous chapters.
Chapter 10 is an appendix, which provides tabulated data and numbers for all the figures provided.
Chapter 11 is an appendix, which provides the list of companies and organizations.
1. PREFACE
1.1 Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines
2. EXECUTIVE SUMMARY
3. HYPERCHOLESTEROLEMIA: A MAJOR PROBLEM
3.1. Cholesterol: A Primer
3.2. Hypercholesterolemia
3.2.1. Familial Hypercholesterolemia
3.3. LDL Cholesterol (LDLC): An Important Target For High Cholesterol Management
3.4. Population Suffering From Hypercholesterolemia
3.5. Current Therapeutic Interventions and Their Limitations
3.5.1. Statins
3.5.2. Risks Associated With Statins
3.5.3. Lower Reduction of Mortality and High NNT
3.5.4. Other Marketed Drug Classes
3.6. New Emerging Therapies: PCSK9 and Others
3.7. Barriers to Success
3.7.1. New Cholesterol Management Guidelines
3.7.2. Route of Delivery and Price
4. CURRENT MARKET LANDSCAPE
4.1. Scope and Observations
4.2. Two Novel Drugs Approved for Homozygous Familial Hypercholesterolemia
4.3. Another First In Class Cholesterol Lowering Drug Approved in India
4.4. Market Attracting Both Large and Small Pharma Companies
4.5. Five Novel Drugs in Late Stage Development
4.6. Companies Evaluating Different Molecule Types: From Synthetics to Biologics
4.7. PCSK9 Inhibitors: The Most Sought After Drug Class Under Development
4.7.1. PCSK9 Inhibitors Pipeline Analysis
4.8. Competitive Analysis of Key Indication Areas For Cholesterol Lowering Drugs
4.8.1. Hypercholesterolemia/Dyslipidemia Market
4.8.2. HoFH Market
4.8.3. HeFH Market
5. NOVEL MARKETED DRUGS: MTTP INHIBITORS AND Apo B GENE SILENCER
5.1. Recently Approved Drugs for Familial Hypercholesterolemia
5.2. Juxtapid / Lojuxta (Lomitapide)
5.2.1. Overview
5.2.2. Structure and Mechanism of Action
5.2.3. Adverse Reactions and Warnings
5.2.4. Drug Interactions
5.2.5. Dosage, Cost and Manufacturing
5.2.6. History of Development
5.2.7. Orphan Drug Status
5.2.8. Patents
5.2.9. Phase III Results
5.2.10. Current State of Development
5.2.11. Partnerships
5.2.12. Historical Sales
5.3. Kynamro (Mipomersen)
5.3.1. Overview
5.3.2. Structure and Mechanism of Action
5.3.3. Patents
5.3.4. Antisense Technology
5.3.4.1. Overview
5.3.4.2. Patents Covering Technology
5.3.5. Pharmacokinetics
5.3.6. Adverse Reactions and Warnings
5.3.7. Dosage, Cost and Manufacturing
5.3.8. Phase III Results
5.3.9. Current State of Development
5.3.10. Partnerships
5.3.10.1. Genzyme
5.3.10.2. Gilead Sciences
5.3.10.3. Other Collaborations
5.3.11. Awards
5.3.11.1. Breakthrough Alliance Award
5.3.11.2. Partners in Progress Corporate Award
5.4. Mipomersen and Lomitapide: Roots Analysis’ Perspective
6. PCSK9 INHIBITORS: KEY MOLECULES AND FUTURE OUTLOOK
6.1. Discovery of PCSK9 Inhibitors
6.2. Mechanism of Action
6.3. Evolocumab (AMG 145)
6.3.1. Overview
6.3.2 Evolocumab has the First Mover Advantage
6.3.3. Current Phase of Development
6.3.4. Drug Delivery Systems Under Review
6.3.5. Partnerships
6.4. Alirocumab (REGN727 / SAR236553)
6.4.1. Overview
6.4.2. Providing Close Competition to Evolocumab with Expedited Review
6.4.3 VelocImmune Technology
6.4.3.1. Overview
7.4.3.2. Patent Portfolio
6.4.4. Current Phase of Development
6.4.5. Drug Delivery Systems Under Review
6.4.6. Partnerships
6.4.6.1. Sanofi Aventis
6.4.6.2. American College of Cardiology (ACC)
6.4.6.3. Academic VelocImmune Investigators’ Program
6.4.6.4. Astellas Pharmaceuticals
6.4.6.5. AstraZeneca
6.5 Bococizumab (RN-316/PF-04950615)
6.5.1. Overview
6.5.2. ENHANZE Technology
6.5.3. Current Phase of Development
6.5.4. Drug Delivery Systems under Review
6.5.5. Partnerships
6.6. PCSK9 Inhibitors: Roots Analysis’ Perspective
7. CETP INHIBITORS: KEY MOLECULES AND FUTURE OUTLOOK
7.1. HDL: The Target for CETP Inhibitors
7.2. HDL Formation and Reverse Cholesterol Transport
7.3. Current Therapies Raising HDLC and the Need to Develop New Ones
7.4. Mechanism of CETP Inhibition
7.5. CETP Inhibitors in Phase III Development
7.6. Anacetrapib
7.6.1. Overview
7.6.2. Structure
7.6.3. Patent Portfolio
7.6.4. Pharmacokinetics
7.6.5 Current Development Status
7.7. CETP Inhibitors: Roots Analysis’ Perspective
8. OVERALL MARKET OUTLOOK
8.1. Chapter Overview
8.2. Scope and Methodology
8.3. Overall Market Forecast
8.4. Juxtapid
8.4.1. Sales Forecast, Short-Mid Term (2014 - 2019)
8.4.2. Sales Forecast, Long Term (2019 – 2024)
8.5. Kynamro
8.5.1. Sales Forecast, Short-Mid Term (2014 - 2019)
8.5.2. Sales Forecast, Long Term (2019 - 2024)
8.6. Evolocumab
8.6.1. Sales Forecast, Short-Mid Term (2014 - 2019)
8.6.2. Sales Forecast: Long Term (2019 - 2024)
8.7. Alirocumab
8.7.1. Sales Forecast, Short-Mid Term (2014 - 2019)
8.7.2. Sales Forecast, Long Term (2019 - 2024)
8.8. Bococizumab
8.8.1. Sales Forecast, Short-Mid Term (2014 - 2019)
8.8.2. Sales Forecast, Long Term (2019 - 2024)
8.9. Anacetrapib
8.9.1. Sales Forecast, Short-Mid Term (2014 - 2019)
8.9.2. Sales Forecast, Long Term (2019 - 2024)
9. CONCLUSION
9.1. A Valuable Weapon Against Cardiovascular Diseases
9.2. Statin Refractory and/or Familial Hypercholesterolemia Patients Will be the Key Drivers
9.3. Kynamro and Juxtapid Will Dominate the HoFH Market in Short Term
9.4. Future Growth Hinged Upon Results of Long-term Clinical Safety and Cardiovascular Outcome Studies
9.5 Concluding Remarks
10. APPENDIX 1: TABULATED DATA
11. APPENDIX 2: LIST OF COMPANIES
Figure 3.1 Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL): Comparison
Figure 3.2 Forms of Cardiovascular Diseases
Figure 3.3 Statins: Mechanism of Action
Figure 4.1 Pipeline Analysis: Distribution by Drug Development
Figure 4.2 Pipeline Analysis: Distribution by Phase of Development
Figure 4.3 Pipeline Analysis: Distribution by Type of Molecule
Figure 4.4 Pipeline Analysis: Distribution by Drug Class
Figure 4.5 PCSK9 Pipeline Analysis: Distribution by Phase of Development
Figure 4.6 PCSK9 Pipeline Analysis: Distribution by Type of Drug
Figure 5.1 Structure of Lomitapide
Figure 5.2 MTTP Inhibitor and apoB Gene Silencer: Drivers and Restraints
Figure 6.1 PCSK9 Inhibitors: Drivers and Restraints
Figure 7.1 Anacetrapib: Chemical Structure
Figure 7.2 CETP Inhibitors: Drivers and Restraints
Figure 8.1 Overall PCSK9 and Other Novel Cholesterol Lowering Drugs Market Forecast: Base Scenario (USD Million)
Figure 8.2 Juxtapid Sales Forecast: Short-Mid Term, Base Scenario (2014-2019, USD Million)
Figure 8.3 Juxtapid Sales Forecast: Long Term, Base Scenario (2019-2024, USD Million)
Figure 8.4 Kynamro Sales Forecast: Short-Mid Term, Base Scenario (2014-2019, USD Million)
Figure 8.5 Kynamro Sales Forecast: Long Term, Base Scenario (2019-2024, USD Million)
Figure 8.6 Evolocumab Sales Forecast: Short-Mid Term, Base Scenario (2014-2019, USD Million)
Figure 8.7 Evolocumab Sales Forecast: Long Term, Base Scenario (2019-2024, USD Million)
Figure 8.8 Alirocumab Sales Forecast: Short-Mid Term, Base Scenario (2014-2019, USD Million)
Figure 8.9 Alirocumab Sales Forecast: Long Term, Base Scenario (2019-2024, USD Million)
Figure 8.10 Bococizumab Sales Forecast: Short-Mid Term, Base Scenario (2014-2019, USD Million)
Figure 8.11 Bococizumab Sales Forecast: Long Term, Base Scenario (2019-2024, USD Million)
Figure 8.12 Anacetrapib Sales Forecast: Short-Mid Term, Base Scenario (2014-2019, USD Million)
Figure 8.13 Anacetrapib Sales Forecast: Long Term, Base Scenario (2019-2024, USD Million)
Table 3.1 Cholesterol Levels in HeFH and HoFH
Table 3.2 Statins: Efficacy, Sales, and Patent Expiry
Table 3.3 Details of Cholesterol Lowering Drugs Other Than Statins
Table 4.1 Pipeline of Novel Cholesterol Lowering Drugs, 2014
Table 4.2 Marketed and Phase III Drugs: List by Type of Molecule
Table 4.3 PCSK9 Inhibitors in Early Stage Development, 2014
Table 4.4 Comparison of Drugs in Market and Pipeline for Hypercholesterolemia, 2014
Table 4.5 Comparison of Treatment Options Available for HoFH, 2014
Table 4.6 Key Phase III Parameters and Results for Kynamro, Juxtapid and Evolocumab
Table 4.7 Comparison of Treatment Options Available for HeFH, 2014
Table 4.8 Comparison of Drugs under Development for HeFH, 2014
Table 5.1 Lomitapide: Pharmacokinetic Properties
Table 5.2 Lomitapide: Dosage and Capsule Details
Table 5.3 Lomitapide: Approval Timeline
Table 5.4 Lomitapide: Patent Portfolio
Table 5.5 Lomitapide: Phase III Study for HoFH
Table 5.6 Lomitapide: Ongoing Phase III Clinical Trials
Table 5.7 Lomitapide: Historical Sales (USD Million)
Table 5.8 Mipomersen: Patent Portfolio
Table 5.9 Drugs based on Antisense Technology
Table 5.10 ISIS Antisense Technology: Patent Portfolio
Table 5.11 Mipomersen: Pharmacokinetic Properties
Table 5.12 Mipomersen: Completed Phase III Studies
Table 5.13 Mipomersen: Ongoing Clinical Trials
Table 5.14 Antisense Technology: Partnerships
Table 6.1 Evolocumab: Completed Phase III Studies
Table 6.2 Evolocumab: Ongoing Clinical Trials
Table 6.3 VelocImmune Technology: Antibodies in Pipeline
Table 6.4 VelocImmune Technology: Patent Portfolio
Table 6.5 Alirocumab: Phase I and Phase II Completed Studies
Table 6.6 Alirocumab: Completed Phase III Studies
Table 6.7 Alirocumab: Ongoing ODYSSEY Trials
Table 6.8 Alirocumab: Interim Results from Phase III Trials
Table 6.9 Alirocumab: Other Active Studies
Table 6.10 Companies Using ENHANZE Technology
Table 6.11 ENHANZE: Patent Portfolio
Table 6.12 Bococizumab: Phase I and Phase II Completed Studies
Table 6.13 Bococizumab: Phase II Details of NCT01592240
Table 6.14 Bococizumab: Active Phase III Studies
Table 7.1 Drugs Targeting Increase in HDLC
Table 7.2 Phase III CETP Inhibitors: Development Status
Table 7.3 Anacetrapib: Patent Portfolio
Table 7.4 Pharmacokinetic Properties of Anacetrapib
Table 7.5 Anacetrapib: Active Phase III Clinical Trials
Table 9.1 Long Term Safety / Efficacy and Outcome Studies
Table 10.1 Pipeline Analysis: Distribution by Phase of Development
Table 10.2 Pipeline Analysis: Distribution by Type of Molecule
Table 10.3 Pipeline Analysis: Distribution by Drug Class
Table 10.4 PCSK9 Pipeline Analysis: Distribution by Phase of Development
Table 10.5 PCSK9 Pipeline Analysis: Distribution by Type of Drug
Table 10.6 Overall PCSK9 and Other Novel Cholesterol Lowering Drugs Market Forecast: Base Scenario (USD Million)
Table 10.7 Overall PCSK9 and Other Novel Cholesterol Lowering Drugs Market Forecast: Conservative Scenario (USD Million)
Table 10.8 Overall PCSK9 and Other Novel Cholesterol Lowering Drugs Market Forecast: Optimistic Scenario (USD Million)
Table 10.9 Juxtapid Sales Forecast: Short-Mid Term, Base Scenario (2014-2019, USD Million)
Table 10.10 Juxtapid Sales Forecast: Short-Mid Term, Conservative Scenario (2014-2019, USD Million)
Table 10.11 Juxtapid Sales Forecast: Short-Mid Term, Optimistic Scenario (2014-2019, USD Million)
Table 10.12 Juxtapid Sales Forecast: Long Term, Base Scenario (2019-2024, USD Million)
Table 10.13 Juxtapid Sales Forecast: Long Term, Conservative Scenario (2019-2024, USD Million)
Table 10.14 Juxtapid Sales Forecast: Long Term, Optimistic Scenario (2019-2024, USD Million)
Table 10.15 Kynamro Sales Forecast: Short-Mid Term, Base Scenario (2014-2019, USD Million)
Table 10.16 Kynamro Sales Forecast: Short-Mid Term, Conservative Scenario (2014-2019, USD Million)
Table 10.17 Kynamro Sales Forecast: Short-Mid Term, Optimistic Scenario (2014-2019, USD Million)
Table 10.18 Kynamro Sales Forecast: Long Term, Base Scenario (2019-2024, USD Million)
Table 10.19 Kynamro Sales Forecast: Long Term, Conservative Scenario (2019-2024, USD Million)
Table 10.20 Kynamro Sales Forecast: Long Term, Optimistic Scenario (2019-2024, USD Million)
Table 10.21 Evolocumab Sales Forecast: Short-Mid Term, Base Scenario (2014-2019, USD Million)
Table 10.22 Evolocumab Sales Forecast: Short-Mid Term, Conservative Scenario (2014-2019, USD Million)
Table 10.23 Evolocumab Sales Forecast: Short-Mid Term, Optimistic Scenario (2014-2019, USD Million)
Table 10.24 Evolocumab Sales Forecast: Long Term, Base Scenario (2019-2024, USD Million)
Table 10.25 Evolocumab Sales Forecast: Long Term, Conservative Scenario (2019-2024, USD Million)
Table 10.26 Evolocumab Sales Forecast: Long Term, Optimistic Scenario (2019-2024, USD Million)
Table 10.27 Alirocumab Sales Forecast: Short-Mid Term, Base Scenario (2014-2019, USD Million)
Table 10.28 Alirocumab Sales Forecast: Short-Mid Term, Conservative Scenario (2014-2019, USD Million)
Table 10.29 Alirocumab Sales Forecast: Short-Mid Term, Optimistic Scenario (2014-2019, USD Million)
Table 10.30 Alirocumab Sales Forecast: Long Term, Base Scenario (2019-2024, USD Million)
Table 10.31 Alirocumab Sales Forecast: Long Term, Conservative Scenario (2019-2024, USD Million)
Table 10.32 Alirocumab Sales Forecast: Long Term, Optimistic Scenario (2019-2024, USD Million)
Table 10.33 Bococizumab Sales Forecast: Short-Mid Term, Base Scenario (2014-2019, USD Million)
Table 10.34 Bococizumab Sales Forecast: Short-Mid Term, Conservative Scenario (2014-2019, USD Million)
Table 10.35 Bococizumab Sales Forecast: Short-Mid Term, Optimistic Scenario (2014-2019, USD Million)
Table 10.36 Bococizumab Sales Forecast: Long Term, Base Scenario (2019-2024, USD Million)
Table 10.37 Bococizumab Sales Forecast: Long Term, Conservative Scenario (2019-2024, USD Million)
Table 10.38 Bococizumab Sales Forecast: Long Term, Optimistic Scenario (2019-2024, USD Million)
Table 10.39 Anacetrapib Sales Forecast: Short-Mid Term, Base Scenario (2014-2019, USD Million)
Table 10.40 Anacetrapib Sales Forecast: Short-Mid Term, Conservative Scenario (2014-2019, USD Million)
Table 10.41 Anacetrapib Sales Forecast: Short-Mid Term, Optimistic Scenario (2014-2019, USD Million)
Table 10.42 Anacetrapib Sales Forecast: Long Term, Base Scenario (2019-2024, USD Million)
Table 10.43 Anacetrapib Sales Forecast: Long Term, Conservative Scenario (2019-2024, USD Million)
Table 10.44 Anacetrapib Sales Forecast: Long Term, Optimistic Scenario (2019-2024, USD Million)
The following companies and organisations have been mentioned in this report.