Table of Contents
Worldwide statistics indicate that there is a high cholesterol burden despite the presence of many cholesterol-lowering drugs in the market. Out of all the available options, statins have been ubiquitously prescribed over the last 25 years. Researchers have concluded that reduction of plasma LDL cholesterol (LDLC) is the cornerstone of assessing heart risk. Irrespective of baseline cholesterol concentration, each mmol/L LDLC reduction translates to cardiovascular risk reduction by one-fifth. Although statins are well tolerated and reduce LDLC levels to the targets specified by NCEP and NICE guidelines, there is a residual cardiovascular risk. Heart diseases are the leading cause of death in the US and most of them are due to high cholesterol.
Statins, though the mainstay therapy for lowering cholesterol, have been associated with some adverse events. These have deterred their use in a subset of population termed as ‘Statin Intolerant’. Furthermore, patients with some genetic conditions such as Familial Hypercholesterolemia do not respond to statin therapy. Due to the long historical use of statins and the launch of generics (providing price advantage), the novel drugs will initially target only specific subset of patients for whom statins are clearly not the best treatment option. This need in the market for drugs that work through a different mechanism of action is coupled with a huge opportunity presented by a target population of around 20 million in the US and the EU5 countries.
SCOPE OF THE REPORT
The ‘PCSK9 and Other Novel Hypercholesterolemia Drugs, 2014 - 2024’ report provides an extensive study of the new class of prescription drugs being evaluated for the treatment of high cholesterol levels caused both by genetic and lifestyle factors.
During the period 2012-2013, three such drugs - Juxtapid, Kynamro, and Lipaglyn - received market authorization. With the recent BLA and MAA filing of the first PCSK9 inhibitor, Amgen’s Evolocumab, the future of therapy looks promising for this disease area. Several more novel molecules are in clinical trials. These new drugs have different mechanism of actions: inhibiting or activating genes / proteins in cholesterol metabolism. Examples include CETP inhibitors, MTTP inhibitors, ApoB inhibitors and PPAR agonists. In addition, researchers are also evaluating gene silencing approach.
The report offers an in-depth analysis of four of the five novel classes of drugs mentioned above (PCSK9 inhibitors, MTTP inhibitors, ApoB gene silencers and CETP inhibitors). One of the key objectives is to provide readers a detailed insight into the landscape of novel prescription drugs for treatment of hypercholesterolemia. This is done by:
- Identifying drug candidates based on their mechanism of cholesterol-lowering actions
- Reviewing key efficacy and safety parameters for drugs in late-stage clinical trials
- Reviewing the technologies behind drug-development
- Understanding drivers and constraints of each drug-class
- Assessing the competitive landscape, recent market developments such as relevant investments and partnerships
- Evaluating the development and sales potential for each of the key molecules under consideration.
The possibility of a drug to become blockbuster depends on various factors. In addition to safety and efficacy, other factors include cost, mode of administration, side effects and their approval and availability in various geographies. For each of these new classes of drugs, we have highlighted the key drivers and limiting factors. We have also presented our own perspective on how the acceptance and evolution of these drugs is likely to advance in the coming years. The analysis is backed by an extensive review of the hypercholesterolemia / dyslipidemia landscape and familial hypercholesterolemia (HoFH and HeFH) markets.
The base year for the report is 2013. The report provides market forecasts for the following two time horizons: 2014 - 2019 (short-midterm) and 2019 - 2024 (long term), respectively. The figures mentioned in this report are in USD, unless otherwise specified.
1. With statins going off-patent, pharmaceutical companies are hunting for next blockbusters for hypercholesterolemia. The approval and launch of Kynamro (ISIS Pharmaceuticals / Genzyme) and Juxtapid (Aegerion Pharmaceuticals) in late 2012 / early 2013 has changed the treatment paradigm for homozygous familial hypercholesterolemia.
2. The market for developing novel cholesterol lowering drugs has gained attention of a number of multinational pharmaceutical companies including Amgen, Sanofi, Pfizer, GSK, Eli Lilly, Roche, Johnson & Johnson and more. Overall, there are 27 companies developing 29 molecules in clinical trials.
3. Evolocumab, being developed by Amgen, has been filed with the FDA and EMA for approval. Four more drugs are being evaluated in Phase III clinical trials. Three of these five late stage drugs are PCSK9 inhibitors, all of which are being developed by large multinational pharmaceutical companies.
4. These PCSK9 inhibitors in late stage development are all monoclonal antibodies. Other approaches being investigated by drug developers include the use of antisense / siRNA and synthetic molecules.
5. 2015 is likely to witness parallel launch of two anti-PCSK9 mAbs. We expect Evolocumab and Alirocumab to be made commercially available during 2015, while Bococizumab is expected to be available by 2017.
6. Anacetrapib, an oral CETP inhibitor from Merck, can give head to head competition to PCSK9 inhibitors in dyslipidemia / hypercholesterolemia market if the Phase III outcome trial REVEAL shows positive results.
7. In the base scenario, we forecast the market to hit USD 10 billion + sales by 2020. The upside is likely to be higher as the same drugs also start getting evaluated for treatment in the non-US and non-EU5 regions.
Most of the data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.
The secondary sources of information include
- Annual reports
- Investor presentations
- SEC filings
- Industry databases
- News releases from company websites
- Government policy documents
- Industry analysts’ views
While the focus has been on forecasting the market over the coming ten years, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.
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
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