PharmaPoint: Dyslipidemia - Global Drug Forecast and Market Analysis to 2023
GlobalData estimates that the total market size for the 8MM in 2013 was $15.4bn, comprised of $11.0bn in branded drug sales (72%) and $4.4bn in generic sales (28%). GlobalData expects that the dyslipidemia drug market will grow at a CAGR of 9.4% over the ten year forecast period, resulting in a market value of $37.9bn by 2023, of which 71% will be attributed to branded drug sales ($26.9bn) and 29% to generic drug sales ($11.0bn). The current dyslipidemia market is dominated by the statins, the revolutionary drugs that reduce low-density lipoprotein cholesterol (LDL-C) and that have been proven to reduce the risk of cardiovascular events such as heart attack and stroke. Other major lipid-modulating drugs, such as Zetia (ezetimibe), the fibrates, bile acid sequestrants, omega-3 fish oil agents, and rare-disease therapies comprise the remainder of the current dyslipidemia space. The launch of the proprotein convertase subtilisin/kexin type 9 (PCSK9) biologics and the cholesteryl ester transfer protein (CETP) inhibitors will reshape the sales landscape of the dyslipidemia market moving forward.
Key Questions Answered
- How will major clinical trials of currently marketed therapies impact the future of the dyslipidemia market? Particular attention will be given to the HPS2-THRIVE and IMPROVE-IT Phase III studies of niacin and Zetia (ezetimibe).
- What role will statins play in the future of the dyslipidemia market?
- What are the clinical, regulatory, and commercial prospects of the proprotein convertase subtilisin/kexin type 9 monoclonal antibodies (PCSK9 mAbs) from Amgen, Sanofi/Regeneron, and Pfizer and the cholesteryl ester transfer protein (CETP) inhibitors from Eli Lilly, Merck, and Dezima Pharma?
- How will novel lipid-modulating agents, such as Esperion Therapeutics ETC-1002 and Cerenis Therapeutics CER-001, impact the dynamics of the dyslipidemia market?
- What are the key market drivers, barriers, and unmet needs that remain unaddressed by currently marketed therapies? What will remain unaddressed by the current dyslipidemia pipeline?
- The highest-impact driver of the dyslipidemia market will be the launch of the PCSK9 inhibitors, human monoclonal antibody biologics that will be used to treat high LDL-C in addition to statins. Therapeutic novelty combined with biologic pricing will make the PCSK9s the largest contributors to dyslipidemia market growth, even if their use is reserved for niche or high-risk cases.
- The CETP inhibitors in the late-stage pipeline have the potential to bring a novel tool to bear against high LDL-C and low HDL-C. However, their success at the regulatory level will depend heavily on their success in major Phase III cardiovascular outcomes trials, making the CETPs the wild-cards of the dyslipidemia pipeline.
- Due to the maturity of the current dyslipidemia market, new therapies will need to exploit novel mechanisms of action and/or target orphan drug targets and are more likely to be utilized as add-on therapies to existing treatments. There is a unique opportunity in the familial hypercholesterolemia arena, where effective LDL-C lowering therapies are needed that exhibit clean safety/side-effect profiles.
- 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 2013 and forecast for ten years to 2023.
- 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
- 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 the 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 8MM dyslipidemia therapeutics market from 2013-2023.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
.3 Prognosis 35
3.4 Quality of Life 35
4 Epidemiology 36
4.1 Risk Factors and Comorbidities 36
4.2 Global and Historical Trends 37
4.2.1 US 38
4.2.2 5EU 38
4.2.3 Asia 40
4.3 Forecast Methodology 41
4.3.1 Sources Used 49
4.3.2 Forecast Assumptions and Methods 55
4.3.3 Sources Not Used 81
4.4 Prevalent Cases of Dyslipidemia 82
4.4.1 Total Prevalent Cases of Dyslipidemia 82
4.4.2 Age-Specific Total Prevalent Cases of Dyslipidemia 83
4.4.3 Sex-Specific Total Prevalent Cases of Dyslipidemia 85
4.4.4 Age-Standardized Total Prevalence of Dyslipidemia 87
4.5 Epidemiological Forecast for Familial Hypercholesterolemia (2013-2023) 88
4.5.1 Total Prevalent Cases of Familial Hypercholesterolemia 88
4.6 Epidemiological Forecast for Increased LDL-C (2013-2023) 89
4.6.1 Total Prevalent Cases of Increased LDL-C 89
4.6.2 Age-Specific Total Prevalent Cases of Increased LDL-C 91
4.6.3 Sex-Specific Total Prevalent Cases of Increased LDL-C 93
4.6.4 Age-Standardized Total Prevalence of Increased LDL-C 95
4.7 Epidemiological Forecast for Very High TG (