DelveInsight’s PCSK9 Inhibitors Market Insights report includes a comprehensive understanding of current treatment practices, PCSK9 Inhibitors emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM (the United States, the EU5 (the United Kingdom, Italy, Spain, France, and Germany), and Japan.
The PCSK9 Inhibitors market dynamics are anticipated to change in the coming years owing to the improvement in the rise in the number of healthcare spending across the world and rising cases of statin resistance in patients with Familial Hypercholesterolemia as well as increasing risk of cardiovascular conditions such as myocardial infarction, coronary revascularization etc. Key players, such as LIB Therapeutics, Ionis Pharmaceuticals, AstraZeneca, CiVi Biopharma, and others are currently developing PCSK9 Inhibitors drugs.
Key Takeaways from the PCSK9 Inhibitors Market Report
- According to DelveInsight estimates the PCSK9 Inhibitors market size in the 7MM was found to be approximately USD 1.1 billion in 2021.
- As per the analysis, the total number of Familial Hypercholesterolemia prevalent cases in the 7MM was approximately 3.1 million in 2021.
- Leading PCSK9 Inhibitors companies LIB Therapeutics, AstraZeneca, CiVi Biopharma, Sanofi, Regeneron Pharmaceuticals, Amgen, Novartis, Alnylam Pharmaceuticals, Ionis Pharmaceuticals, Akeso Biopharma, Innovent Biologics, and others are working to develop a new PCSK9 Inhibitors medications which can be available in the PCSK9 Inhibitors market in the upcoming years.
- The PCSK9 Inhibitors therapies in the pipeline include LIB003, AZD8233 (ION449), Cepadacursen sodium (CIVI-007), CiVi-008, and others.
- PCSK9 Inhibitors market is expected to grow significantly owing to the use of PCSK9 inhibitors in statin-intolerant patients, promising future strategies of PCSK9 inhibition, implications of PCSK9 inhibitors in broader therapy areas, and PCSK9 inhibition in a prophylactic setting, which can relieve the CVD burden.
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PCSK9 Inhibitors Overview
Proprotein convertase subtilisin/Kexin type 9 (PCSK9) regulates low-density lipoprotein (LDL) receptor degradation and reduces the clearance of circulating LDL particles, which is important in cholesterol metabolism. PCSK9 is primarily produced by hepatocytes, with the intestines and kidneys serving as secondary sources. PCSK9 decreases the number of LDLR in hepatocytes by promoting their metabolism and subsequent destruction, preventing the receptors from being broken down and allowing them to continue to lower blood cholesterol. PCSK9 inhibitors indications include familial hypercholesterolemia patients who are resistant to statins or have increased LDL-C levels while being on maximally tolerated statin therapy. The PCSK9 inhibitors are also approved for the treatment of existing cardiovascular disease to minimize the risk of myocardial infarction, stroke, and coronary revascularization.
PCSK9 Inhibitors Epidemiology Segmentation in the 7MM
- Total Prevalent Cases of Familial Hypercholesterolemia
- Total Diagnosed Cases of Familial Hypercholesterolemia
- Type-specific Cases of Familial Hypercholesterolemia
- Age group-specific Cases of Familial Hypercholesterolemia
- Mutation-specific Cases of Familial Hypercholesterolemia
- Risk factor-specific Cases of PCSK9 Inhibitors in Prophylactic/Preventive setting
- Total Treated Cases
PCSK9 Inhibitors Market Insights
Monoclonal antibodies directed at PCSK9 are the first to be approved. There are currently two FDA approved PCSK9 inhibitors namely, alirocumab and evolocumab available in the United States for adult patients to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease as an adjunct to diet, alone or in combination with other lipid-lowering therapies, for the treatment of adults with primary hyperlipidemia (including HeFH) to reduce LDL-cholesterol. Evolocumab is also approved as an adjuvant to diet and other LDL-reducing treatments in individuals with HoFH who require further LDL-C reduction. The mAb PCSK9 inhibitors evolocumab and alirocumab reduce LDL-C levels by roughly 60% when combined with statin treatment and reduce the risk of severe vascular events. Both of these PCSK9 Inhibitors drugs have the same PCSK9 Inhibitors mechanism of action. In addition, large PCSK9 Inhibitors trials have demonstrated that PCSK9 inhibitors, when added to the statin-based treatment, cut ASCVD risk even more, and their usage may need to be restricted to individuals at greatest risk for ASCVD.
PCSK9 Inhibitors Pipeline Therapies and Key Companies
- LIB003 (Lerodalcibep): LIB Therapeutics
- AZD8233 (ION449): AstraZeneca and Ionis Pharmaceuticals
- Cepadacursen sodium (CIVI-007): CiVi Biopharma
- CiVI-008: CiVi Biopharma
PCSK9 Inhibitors Market Dynamics
The PCSK9 Inhibitors market dynamics is expected to change in the coming years due to several factors such as the improvement in the rise in the number of healthcare spending globally and rising cases of statin resistance in patients with familial hypercholesterolemic as well increasing risk of cardiovascular conditions such as myocardial infarction, coronary revascularization etc. Furthermore, the PCSK9 inhibition in a prophylactic setting can relieve the CVD burden and thus impacting the PCSK9 Inhibitors market positively. In addition, the implications of PCSK9 inhibitors in broader therapy areas also contribute towards the growth of the PCSK9 Inhibitors market. Though monoclonal antibodies have, for the time being, established themselves as the most clinically useful inhibitors of PCSK9, other novel therapies are currently in various stages of development and will be available soon in the PCSK9 Inhibitors market.
PCSK9 Inhibitors Market Growth Factors
However, certain factors are limiting the growth of the PCSK9 Inhibitors market. To date, little information is available on the real impact of PCSK9 inhibitors in terms of reducing cholesterolemia, events, and the actual tolerability. This lack of information is substantially majorly related to the fact that these drugs have only been marketed recently and thus impacting the PCSK9 Inhibitors market growth. Moreover, despite manufacturers working for years on generating evidence, there are still reimbursement restrictions for the two PCSK9 agents in large European PSCK9 Inhibitors markets such as France, the UK, Italy, Germany, and Spain. In addition, the commercial payer actions affect PCSK9 Inhibitors market access and sales of Repatha. Furthermore, the use of off-label therapies and generics are also among the factors that are hindering the PCSK9 Inhibitors market growth.
Scope of the PCSK9 Inhibitors Market Report
- Study Period: 2019-2032
- Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
- Key PCSK9 Inhibitors Companies: Sanofi, Regeneron Pharmaceuticals, Amgen, Novartis, Alnylam Pharmaceuticals, LIB Therapeutics, AstraZeneca, Ionis Pharmaceuticals, CiVi Biopharma, Akeso Biopharma, Innovent Biologics, and others
- Key PCSK9 Inhibitors Therapies: LIB003, AZD8233 (ION449), Cepadacursen sodium (CIVI-007), Ebronucimab, Tafolecimab, and others
- Therapeutic Assessment: PCSK9 Inhibitors current marketed and emerging therapies
- PCSK9 Inhibitors Market Dynamics: PCSK9 Inhibitors market drivers and barriers
- Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies
- Unmet Needs, KOL’s views, Analyst’s views, PCSK9 Inhibitors Market Access and Reimbursement
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Table of content
1. Key Insights
2. Executive Summary of PCSK9 Inhibitors
3. Competitive Intelligence Analysis for PCSK9 Inhibitors
4. PCSK9 Inhibitors: Market Overview at a Glance
5. PCSK9 Inhibitors: Disease Background and Overview
7. PCSK9 Inhibitors Epidemiology and Patient Population
8. Treatment Algorithm, Current Treatment, and Medical Practices
9. Unmet Needs
10. Key Endpoints of PCSK9 Inhibitors Treatment
11. Marketed Products
12. Emerging Therapies
13. PCSK9 Inhibitors: Seven Major Market Analysis
14. Attribute analysis
15. 7MM: Market Outlook
16. Access and Reimbursement Overview of PCSK9 Inhibitors
17. KOL Views
18. Market Drivers
19. Market Barriers
20. Appendix
21. DelveInsight Capabilities
22. Disclaimer
23. About DelveInsight
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