The dynamics of the PCSK9 Inhibitors market 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.
LAS VEGAS, May 11, 2022 /PRNewswire/ -- 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.
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.
Discover more about therapies set to grab major PCSK9 Inhibitors market share @ PCSK9 Inhibitors Market Landscape
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.
Among the PCSK9 inhibitors list, there are three drugs, Repatha (evolocumab), Leqvio (inclisiran) and Praluent (alirocumab), and others are being developed at the moment. The most common PCSK9 Inhibitors side effects are minor. They include back pain and cold or flu symptoms as it is administered as a PCSK9 Inhibitor injection. These PCSK9 Inhibitor drugs may also cause allergic reactions in certain persons.
PCSK9 Inhibitors Epidemiology Segmentation
As per DelveInsight, there were approx 3.1 million Familial Hypercholesterolemia prevalent cases in the 7MM in 2021.
Among 7MM countries, the US had the highest Familial Hypercholesterolemia prevalence in 2021.
The PCSK9 Inhibitors Market Report proffers epidemiological analysis for the study period 2019-2032 in the 7MM segmented into:
- 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 of PCSK9 Inhibitors
Download the report to understand which factors are driving PCSK9 Inhibitors epidemiology trends @ PCSK9 Inhibitors Epidemiological Insights
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.
Moreover, in 2015, the European Commission approved the commercialization of alirocumab and evolocumab. Furthermore, Inclisiran received its first approval in Europe in 2020 to treat primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia followed by US FDA approval in December 2021 for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of low-density lipoprotein cholesterol (LDL-C).
To know more about PCSK9 Inhibitors medications visit @ PCSK9 Inhibitors Guidelines
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 dynamics of the PCSK9 Inhibitors market 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.
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
Discover more about PCSK9 Inhibitors in development @ PCSK9 Inhibitors Clinical Trials
Table of Contents
1. |
PCSK9 Inhibitors Market Key Insights |
2. |
PCSK9 Inhibitors Market Report Introduction |
3. |
PCSK9 Inhibitors Market Overview at a Glance |
4. |
PCSK9 Inhibitors Market Executive Summary |
5. |
Disease Background and Overview |
6. |
PCSK9 Inhibitors Treatment and Management |
7. |
PCSK9 Inhibitors Epidemiology and Patient Population |
8. |
Patient Journey |
9. |
PCSK9 Inhibitors Marketed Drugs |
10. |
PCSK9 Inhibitors Emerging Drugs |
11. |
7 Major PCSK9 Inhibitors Market Analysis |
12. |
PCSK9 Inhibitors Market Outlook |
13. |
Potential of Current and Emerging Therapies |
14. |
KOL Views |
15. |
PCSK9 Inhibitors Market Drivers |
16 |
PCSK9 Inhibitors Market Barriers |
17. |
Unmet Needs |
18. |
SWOT Analysis |
19. |
Appendix |
20. |
DelveInsight Capabilities |
21. |
Disclaimer |
22. |
About DelveInsight |
Get in touch with our Business executive @ Healthcare Due Diligence Services
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