Pcsk9 Inhibitors Psck9i Market

DelveInsight’s ‘PCSK9 Inhibitors (PCSK9i) - Market Insights, Epidemiology, and Market Forecast—2030’ report delivers an in-depth understanding of PCSK9i, historical and forecasted epidemiology as well as the PCSK9 Inhibitors market trends in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.

 

The PCSK9 Inhibitors market report provides disease areas, emerging drugs, PCSK9 Inhibitors market share of the individual therapies, current and forecasted PCSK9 Inhibitors market size from 2018 to 2030 segmented by seven major markets. The Report also covers current PCSK9 Inhibitors prescription eligibility criteria, approved and emerging therapies, market drivers, market barriers, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Geography Covered

  • The United States
  • EU5 (Germany, France, Italy, Spain, and the United Kingdom)
  • Japan

Study Period: 2018–2030

PCSK9 Inhibitors (PCSK9i): Background and Overview

PCSK9 Inhibitors Overview

Proprotein convertase subtilisin/Kexin type 9 serine protease (PCSK9) plays a vital role in cholesterol metabolism by regulating low-density lipoprotein (LDL) receptor degradation, which reduces the clearance of circulating LDL particles. PCSK9 activity is inversely related to LDL cholesterol (LDL-C) level: Gain-of-function PCSK9 gene mutations are one cause of elevated LDL-C and cardiovascular risk in familial hypercholesterolemia (FH), whereas loss-of-function mutations cause low LDL-C and reduced risk of atherosclerotic cardiovascular disease (ASCVD).

 

PCSK9 inhibitors, in combination with other LDL lowering drugs, have been demonstrated to be highly effective for some people. Studies have shown that these drugs reduce LDL-C by 40–65% beyond the effect of other lipid-lowering drugs. The use of a PCSK9 inhibitor can reduce the chance of heart attack and stroke. New PCSK9 inhibitors are in development and are currently in clinical trials. The development of PCSK9 inhibitors, which are monoclonal antibodies directed against PCSK9, led to a significant enhancement of the lipid-lowering armamentarium, as PCSK9 inhibitors result in a consistent and robust reduction in LDL-C serum concentrations, substantially improving CV outcomes.

 

Statin therapy is without doubt the cornerstone of any LDL-C-lowering therapy. Therefore, any novel LDL-C-lowering medication would need to show efficacy on top of statin therapy or only be indicated in the minority of patients not tolerating statins. The metabolic changes induced by treatment with antibodies against PCSK9 and statin therapy are not identical. While both approaches lower LDL-C, triglycerides, apolipoprotein B, and increase HDL cholesterol, statins additionally reduce C-reactive protein (CRP), which PSCK9 antibodies do not.

 

PCSK9 binds to the LDL receptor. After internalizing the LDL receptor bound to PCSK9 (and an LDL particle), the LDL receptor is degraded. PCSK9 can be inhibited pharmacologically by using monoclonal antibodies that bind and neutralize PCSK9 or by RNA-targeting drugs which contain an RNA strand complementary to PCSK9 mRNA and lead to the assembly of an RNA-induced silencing complex (RISC) which degrades PCSK9 mRNA for a prolonged period of time and thereby inhibits the production of PCSK9. The consequence of both approaches is a lower concentration of PCSK9 that can bind the LDL receptor, which after internalization, more often cycles back to the cell surface and can take up further LDL particles, leading to lower LDL cholesterol serum concentrations.

PCSK9 Inhibitors Epidemiology

The PCSK9 Inhibitors epidemiology division provides insights about historical and current PCSK9 Inhibitors patient pool and forecasted trends for every seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the DelveInsight report also provides the diagnosed patient pool and their trends along with assumptions undertaken.

 

Key Findings

In the year 2020, the total prevalent cases of Familial Hypercholestrolemia was 3.1 million cases in the 7MM which are expected to grow during the study period, i.e., 2018–2030.

 

The disease epidemiology covered in the report provides historical as well as forecasted Von Hippel-Lindau disease epidemiology [segmented as Total prevalent cases of Familial Hypercholesterolemia, Total diagnosed cases of Familial Hypercholesterolemia, Total type-specific cases of Familial Hypercholesterolemia, Total age group-specific cases of Familial Hypercholesterolemia, Total mutation-specific cases of Familial Hypercholesterolemia, Total risk factor-specific cases of PCSK9 Inhibitors in Prophylactic/Preventive setting, and Total Treated cases of PCSK9 Inhibitors] in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2018 to 2030.

Country Wise- PCSK9 Inhibitors Epidemiology

Estimates show that the highest cases of Familial Hypercholesterolemia in the 7MM were in the United States, followed by Japan, France, the United Kingdom, Germany, Italy, and Spain in 2020.

  • In the United States, the total number of prevalent cases of Familial Hypercholesterolemia was 1.5 million cases in the year 2020 which are expected to grow during the study period, i.e., 2018–2030.
  • In the year 2020, the total prevalent cases of Familial Hypercholesterolemia were 1.3 million cases in EU-5 which are expected to grow during the study period, i.e., 2018–2030.
  • In Japan, the total number of prevalent cases of Familial Hypercholesterolemia was 0.4 million cases in the year 2020 which are expected to grow during the study period, i.e., 2018–2030.

PCSK9 Inhibitors Drug Chapters

The drug chapter segment of the PCSK9 Inhibitors report encloses the detailed analysis of PCSK9 Inhibitors marketed drugs and clinical stage (Phase-III, Phase-II and Phase I) pipeline drugs. It also helps to understand the PCSK9 Inhibitors clinical trial details, expressive pharmacological action, agreements and collaborations, approvals and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

 

PCSK9 Inhibitors Approved Drugs

 

Praluent/Alirocumab (Sanofi and Regeneron Pharmaceuticals)

Praluent (Alirocumab) is marketed by brand name Praluent, a human monoclonal antibody that binds to proprotein convertase subtilisin Kexin type 9 (PCSK9). PCSK9 binds to the low-density lipoprotein receptors (LDLR) on the surface of hepatocytes to promote LDLR degradation within the liver. LDLR is the primary receptor that clears circulating LDL; therefore, the decrease in LDLR levels by PCSK9 results in higher blood levels of LDL-C. By inhibiting the binding of PCSK9 to LDLR, alirocumab increases the number of LDLRs available to clear LDL, thereby lowering LDL-C levels. Alirocumab reduces free PCSK9 in a concentration-dependent manner. Following a single subcutaneous administration of alirocumab 75 or 150 mg, maximal suppression of free PCSK9 can be observed within 4–8 h. Free PCSK9 concentrations return to baseline when alirocumab concentrations decrease below the limit of quantitation. In June 2017, Praluent received Orphan Drug designation for the treatment of Homozygous Familial Hypercholesterolemia. Praluent was initially approved in July 2015, September 2015, and July 2016 by the US FDA, EMA, and Japan MHLW, respectively.

 

Repatha/Evolocumab (Amgen)

Evolocumab is a human monoclonal immunoglobulin G2 (IgG2) directed against human PCSK9. Evolocumab has an approximate molecular weight (MW) of 144 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. Evolocumab binds to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein (LDL) receptor (LDLR), preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface. By inhibiting the binding of PCSK9 to LDLR, evolocumab increases the number of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels. In September 2013, the US FDA granted Orphan Drug designation to Repatha for the treatment of Homozygous Familial Hypercholesterolemia. Repatha was initially approved in August 2015, May 2015, and June 2019 by the US FDA, EMA, and Japan MHLW, respectively.

 

Leqvio/Inclisiran (Novartis and Alnylam Pharmaceuticals)

Leqvio (inclisiran, KJX839) is the first and only small interfering RNA (siRNA) therapy developed by Novartis to reduce LDL-C levels via an RNA interference (RNAi) mechanism of action and could help improve outcomes for patients with atherosclerotic cardiovascular disease (ASCVD), a deadly form of cardiovascular disease. With two doses a year and effective and sustained LDL-C reduction, Leqvio works as a complement to statins. Leqvio works differently from other therapies by preventing the production of the target protein in the liver, increasing hepatic uptake of LDL-C, and clearing it from the bloodstream. Inclisiran is a long-acting, synthetic siRNA directed against PCSK9, and it has been shown to significantly decrease hepatic production of PCSK9 and cause a marked reduction in LDL-C levels. It is conjugated to triantennary N-acetylgalactosamine carbohydrates administered via subcutaneous injection. These carbohydrates bind to abundant liver-expressed asialoglycoprotein receptors, leading to the uptake of inclisiran specifically into the hepatocytes. Even though Leqvio has been approved in Europe in December 2020, it is yet to be approved in the US. In December, the FDA rejected the drug but the company has refiled Leqvio, or inclisiran, to the FDA with a new manufacturing location and might be approved soon.

Note: Detailed current therapies assessment will be provided in the final report.

 

PCSK9 Inhibitors Emerging Drugs

 

LIB003/Lerodalcibep (LIB Therapeutics)

LIB003 (Lerodalcibep) is a PCSK9 Inhibitor being that is administered subcutaneously. The PCSK9 protein is an essential regulator of circulating LDL‐C levels through its inhibitory action on recycling the LDL receptor (LDLR). LDLR on the liver cell surface binds to LDL, and the LDLR–LDL complex is then internalized, after which the LDLR is normally recycled back to the cell surface up to 150 times. Secreted PCSK9 binds to the LDLR on the surface of the hepatocyte, leading to the internalization and degradation of the LDLR in the lysosomes, and reducing the number of LDLRs on the cell surface. Inhibition of secreted PCSK9 should increase the number of available LDLRs on the cell surface and increase uptake of LDL‐C into the cell. PCSK9 inhibition thus offers a novel therapeutic mechanism for lowering LDL‐C levels. Currently, LIB003 is in the Phase III stage of clinical development for patients with various PCSK9 inhibitor related diseases.

 

AZD8233/ION449 (AstraZeneca and Ionis Pharmaceuticals)

AZD8233 (ION449), formerly IONIS-AZ4-2.5-LRx, is a ligand-conjugated (LICA) investigational antisense medicine. AstraZeneca is developing ION449 as part of a collaboration between Ionis Pharmaceuticals and AstraZeneca. It is designed to reduce blood cholesterol levels in patients with dyslipidemia by targeting proprotein convertase subtilisin/Kexin type 9 (PCSK9), an important regulator of low-density lipoprotein cholesterol (LDL-C). It is a chemically modified 16-mer antisense oligonucleotide linked to N-acetyl galactosamine (GalNAc) for efficient targeting of PCSK9 mRNA in hepatocytes to prevent the synthesis of PCSK9. In September 2015, Isis Pharmaceuticals announced that its collaboration with AstraZeneca to discover and develop antisense drugs for cardiovascular, metabolic, and renal diseases had received clearance under the Hart–Scott–Rodino Antitrust Improvements Act. AZD8233 is currently in Phase II clinical developmental stage in treating dyslipidemia, including Hyperlipidemia (Hypercholesterolemia).

 

CIVI-007/Cepadacursen Sodium (CiVi Biopharma)

CIVI 007 is a long-acting, third-generation PCSK9 in development for the treatment of hypercholesterolemia and prevention of atherosclerotic cardiovascular disease (ASCVD) by CiVi Biopharma. According to the company, CIVI 007 has the potential to combine mAb-like LDL efficacy with improved dosing convenience and a low cost of goods. CiVi 007 lowers LDL cholesterol using the latest technology available to block the production of a key enzyme, PCSK9, at the level of its synthesis by mRNA. By directing CiVi 007 to the liver and knocking out this protein, dramatically increases the longevity of receptors in the liver that take up LDL and reducing the amount of harmful LDL cholesterol circulating in the bloodstream. Recently, in 2020, CiVi-007 completed one Phase I and one Phase II clinical trial. Currently, an oral formulation of this drug, CiVi-008, is being developed as an oral treatment for hypercholesterolemia and the prevention of atherosclerotic cardiovascular disease. It is in the preclinical development stage as of now, and the company is planning to initiate clinical studies for this drug soon.

Note: Detailed emerging therapies assessment will be provided in the final report.

PCSK9 Inhibitors Market Outlook

Understanding the role of PCSK9 in cholesterol metabolism suggested that inhibiting its actions might lower LDL-C levels therapeutically. Monoclonal antibodies directed at PCSK9 are the first to be approved. Currently, there are two PCSK9 inhibitors available in the United States: alirocumab and evolocumab, approved by the FDA 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 adjunct to diet and other LDL-lowering therapies in patients with HoFH who require additional lowering of LDL-C.

 

The product was launched in the US at a list price of around USD 14,000 per patient per year—a considerable premium on the costs of primarily genericized statins. This disparity was highlighted in cost-benefit analyses by health-technology assessment bodies such as the Institute for Clinical and Economic Review (ICER) in the US, which concluded that the PCSK9 inhibitors were significantly overpriced even in the light of the FOURIER and ODYSSEY outcomes data. In October 2018, Amgen announced that it was cutting the US list price of Repatha by 60% to USD 5,850 per year. Sanofi and Regeneron struck an agreement with Express Scripts in May 2018 to lower the net price of Praluent within the range USD 4,460 to USD 7,975 per year. Later, in February 2019, Sanofi and Regeneron went further and cut the US list price of Praluent by 60% to USD 5,850 per year.

 

Price discounting has also proved an effective market-access tool for the PCSK9 inhibitors outside the US. In the UK, for example, NICE recommended both Repatha and Praluent for funding through the National Health Service in England. However, NICE’s final draft guidance restricted usage in patients with primary hypercholesterolemia or mixed dyslipidemia whose cholesterol remained too high despite lifestyle changes and treatment with other cholesterol-lowering drugs.

 

At present, a few companies have initiated clinical trials that are investigating new PCSK9 inhibitors. Key players such as AstraZeneca and Ionis Pharmaceuticals (AZD8233, ION449), LIB Therapeutics (LIB003, lerodalcibep), CiVi Biopharma (Cepadacursen sodium, CIVI-007), and a few others are investigating their candidates as novel PCSK9 inhibitors in the 7MM. In a nutshell, a few potential PCSK9 inhibitors are being investigated.

 

Key Findings

The PCSK9 Inhibitors market size in the 7MM is expected to change during the study period 2018–2030. The therapeutic market of PCSK9 Inhibitors in the seven major markets is expected to increase during the study period (2018–2030) with a CAGR of 16.5%. According to the estimates, the highest market size of PCSK9 Inhibitors is found in the United States followed by Japan.

 

The United States Market Outlook

The total market size of PCSK9 Inhibitors in the United States is expected to increase with a CAGR of 11.4% in the study period (2018–2030).


EU-5 Countries: Market Outlook

The total market size of PCSK9 Inhibitors in EU-5 countries is expected to increase with a CAGR of 24.3% in the study period (2018–2030).

 

Japan Market Outlook

The total market size of PCSK9 Inhibitors in Japan is expected to increase with a CAGR of 23.2% in the study period (2018–2030).

PCSK9 Inhibitors Pipeline Development Activities

The drugs which are in pipeline include:

  1. LIB003/Lerodalcibep (LIB Therapeutics)
  2. AZD8233/ION449 (AstraZeneca and Ionis Pharmaceuticals)
  3. CIVI-007/Cepadacursen Sodium (CiVi Biopharma)

Note: Detailed emerging therapies assessment will be provided in the final report.

Analyst Commentary

  • Due to lack of approved treatment options in VHL, currently surgery is the preferred choice of treatment. Entry of belzutifan (MK-6482) is expected to impact the VHL market dynamics significantly.
  • Limited pipeline activity in the VHL space can be observed and the possible hurdles might be rarity of disorder, data scarcity on the latest epidemiology studies across the geographies and limited understanding about the VHL pathophysiology.
  • Among the emerging therapies, Merck’s belzutifan (MK-6482) appears to be the only drug which has the potential to transform the VHL on market owing to impressive clinical data. Merck has filed the New Drug Application (NDA) for the belzutifan (MK-6482) for the potential treatment of patients with VHL disease-associated renal cell carcinoma (RCC), not requiring immediate surgery. Owing to impressive clinical data, expected monopoly in near future, drug is expected to generate a huge revenue in the 7MM by 2030 from the VHL associated RCC. Company is also trying to expand the belzutifan (MK-6482) in other tumor types as well and this might provide additional opportunities.
  • Novartis with DFF332 is trying to enter into the VHL space and planned a phase I trial for the same. Due to lack of clinical evidences, it is too early to predict the drug’s potential in VHL market.

Access and Reimbursement Scenario in Von Hippel-Lindau disease Therapies

Pharmacological treatment of hypercholesterolemia and dyslipidemia is recommended in primary and secondary CVD prevention in patients with familial hypercholesterolemia and those at high and very high risk of CVD. Despite an appropriate adherence to pharmacological treatment, approximately 30% of patients with very high and high CV risk and around 20% of patients with familial hypercholesterolemia do not reach target low-density lipoprotein cholesterol (LDL-C) levels and require alternative therapies.

 

An early report from the Institute for Clinical and Economic Review (ICER) proposed that the PCSK9 inhibitors should cost 85% less than what they were listed. Moreover, the 2018 American Heart Association/American College of Cardiology cholesterol guideline stated consideration of PCSK9 inhibitors is reasonable, although the treatment was not given a Class I recommendation due to cost, according to the presentation. Therefore, since 2015, there has been a 60% price reduction for PCSK9 inhibitors from USD 14,000 per year to USD 5,850 per year for both evolocumab (Repatha, Amgen) and alirocumab.

 

As per the Italian Medicines Agency (AIFA), hypercholesterolemia is now universally recognized as a modifiable cardiovascular risk factor on which it is possible to act both through lifestyle changes and through a capable pharmacological approach to modify the serum level of this parameter. The relationship between LDL-C levels and the occurrence of cardiovascular events has, in fact, been extensively studied, and the advent of statins, molecules capable of reducing LDL-C levels significantly, resulted in an important reduction in cardiovascular risk, in particular in high-risk patients. Molecules such as ezetimibe are already available to the clinician. It is a selective inhibitor of the Niemann–Pick C1-Like 1 (NPC1L1) protein involved in the transport of cholesterol taken via the diet from the intestinal lumen to enterocytes and biliary recirculation. In addition, PCSK-9 inhibitors such as evolocumab (Repatha), agents targeting and inactivating proprotein convertase subtilsin-kexin type 9 (PCSK9), a hepatic protease that attaches and internalizes LDL receptors into lysosomes hence promoting their destruction, has also shown to be effective in reducing the occurrence of MACE.

 

In Germany, Spain, and the UK, reimbursement policies generally support the use of PCSK9 inhibitors in patients who are at high or very high risk of cardiovascular events. In all three countries, PCSK9i are reimbursed for use in patients who have been diagnosed with or are under evaluation for FH as well as patients with hypercholesterolemia who have underlying CVD or a history of CV events, those who have been unable to attain treatment goals with standard non-PCSK9 inhibitor treatment (i.e., statin with or without ezetimibe), and those who are statin intolerant.

 

Across Europe, the annual costs for PCSK9i treatment range up to approximately EUR 8,500. The costs of PCSK9i therapy thus markedly exceed that of conventional oral lipid-lowering agents, which are currently available in generic form. Consequentially, there is controversy as to whether the budget for these medicines is economically justified across many national health care systems.

 

In an effort to alleviate affordability concerns, starting in late 2018, one manufacturer of PCSK9 inhibitors made these products available at a 60% reduction to the original list price, and another manufacturer followed in 2019. Seema Verma, CMS Administrator, in a public letter to members of Congress in August, recognized that PCSK9 inhibitor prices dropped below the Part D specialty tier cost threshold (USD 670 per month in 2020), which she believed would allow Medicare beneficiaries to access the products on lower-cost tiers. CMS caps coinsurance for Part D plan specialty tiers between 25% and 33%, but cost-sharing for nonpreferred drug tiers can be as high as 50%. Also, following the HTA outcome, the G-BA had explicitly excluded both PCSK9 drugs from prescription – a measure unprecedented in Germany and justified by the high annual therapy cost of ~EUR 10,000 as well as the lack of incremental clinical benefit. Similarly, France, UK, Italy, and Spain have restricted the reimbursement of PCSK9 to the highest risk dyslipidemia patients after long price negotiations.

Note: Detailed HTA assessment will be provided in the final report.

KOL-Views

To keep up with current market trends, we take KOLs and SME’s opinion working in the PCSK9 Inhibitors domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps to understand and validate current and emerging therapies treatment patterns or PCSK9 Inhibitors market trends. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.

Competitive Intelligence Analysis

We perform Competitive and Market Intelligence analysis of the PCSK9 Inhibitors Market by using various Competitive Intelligence tools that includes – SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report

  • The PCSK9 Inhibitors report covers a detailed overview explaining various construction approaches for PCSK9 Inhibitors, and treatment patterns.
  • The PCSK9 Inhibitors Report and Model provide an overview of the risk factors and global trends of PCSK9 Inhibitors in the seven major markets (7MM: The United States, Germany, France, Italy, Spain, the United Kingdom, and Japan).
  • The report provides insight about the historical and forecasted patient pool of PCSK9 Inhibitors in seven major markets covering the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.
  • The report helps to recognize the growth opportunities in the 7MM concerning the patient population.
  • The report assesses the disease risk and burden and highlights the unmet needs of PCSK9 Inhibitors.
  • The report provides the segmentation of the Familial Hypercholesterolemia epidemiology by total prevalent cases in the 7MM.
  • The report provides the segmentation of the Familial Hypercholesterolemia epidemiology by total diagnosed cases in the 7MM.
  • The report provides the segmentation of the Familial Hypercholesterolemia epidemiology by type-specific cases in the 7MM.
  • The report provides the segmentation of the Familial Hypercholesterolemia epidemiology by age group-specific cases in the 7MM.
  • The report provides the segmentation of the Familial Hypercholesterolemia epidemiology by mutation-specific cases in the 7MM.
  • The report provides the segmentation of the PCSK9 Inhibitors epidemiology by mutation-specific cases in the 7MM.
  • The report provides the segmentation of the PCSK9 Inhibitors epidemiology by risk factor-specific cases in prophylactic/preventive setting in the 7MM.
  • The report provides the segmentation of the PCSK9 Inhibitors epidemiology by total treated cases in the 7MM.

Report Highlights

  • In the coming years, the Von Hippel-Lindau disease market is set to change due to the upcoming therapies with a novel mechanism of action which are under investigation; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
  • The companies and academics are working to assess challenges and seek opportunities that could influence Von Hippel-Lindau disease R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
  • Major players are involved in developing therapies for Von Hippel-Lindau disease. The launch of emerging therapies will significantly impact the Von Hippel-Lindau disease market.
  • A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for Von Hippel-Lindau disease.
  • Our in-depth analysis of the pipeline assets across different stages of development (Phase III to Phase I), different emerging trends, and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

PCSK9 Inhibitors Report Insights

  • Patient Population
  • Therapeutic Approaches
  • PCSK9 Inhibitors Pipeline Analysis
  • PCSK9 Inhibitors Market Size and Trends
  • Market Opportunities
  • Impact of upcoming Therapies

PCSK9 Inhibitors Report Key Strengths

  • 10 Years Forecast
  • 7MM Coverage
  • PCSK9 Inhibitors Epidemiology Segmentation
  • Key Cross Competition
  • Highly Analyzed Market
  • Drugs Uptake

PCSK9 Inhibitors Report Assessment

  • SWOT Analysis
  • Current Treatment Practices
  • Unmet Needs
  • Pipeline Product Profiles
  • Conjoint Analysis
  • Market Attractiveness
  • Market Drivers and Barriers

Key Questions

Market Insights:

  • What was the PCSK9 Inhibitors Market share (%) distribution in 2018 and how it would look like in 2030?
  • What would be the PCSK9 Inhibitors total market size as well as market size by therapies across the 7MM during the study period (2018–2030)?
  • What are the key findings of the market across the 7MM and which country will have the largest PCSK9 Inhibitors market size during the study period (2018–2030)?
  • At what CAGR, the PCSK9 Inhibitors market is expected to grow in the 7MM during the study period (2018–2030)?
  • What would be the PCSK9 Inhibitors market outlook across the 7MM during the study period (2018–2030)?
  • What would be the PCSK9 Inhibitors market growth till 2030 and what will be the resultant market size in the year 2030?
  • How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
  • PCSK9 Inhibitors patient types/pool where unmet need is more and whether emerging therapies will be able to address the residual unmet need?
  • How emerging therapies are performing on the parameters like efficacy, safety, route of administration (RoA), treatment duration, and frequencies based on their clinical trial results?
  • Among the emerging therapies, what are the potential therapies which are expected to disrupt the V PCSK9 Inhibitors market?

 

Epidemiology Insights:

  • What are the disease risks, burdens, and unmet needs of the PCSK9 Inhibitors related disease?
  • What is the historical PCSK9 Inhibitors patient pool in the 7MM covering the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan?
  • What would be the forecasted patient pool of PCSK9 Inhibitors in the 7MM covering the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan?
  • What will be the growth opportunities in the 7MM concerning the patient population about PCSK9 Inhibitors?
  • Out of all the 7MM countries, which country would have the highest prevalent population of PCSK9 Inhibitors during the study period (2018–2030)?
  • At what CAGR the population is expected to grow in the 7MM during the study period (2018–2030)?
  • What are the various recent and upcoming events which are expected to improve the prescription of PCSK9 Inhibitors?

 

Current Treatment Scenario and Emerging Therapies:

  • What are the current options for PCSK9 Inhibitors?
  • What are the current treatment guidelines for PCSK9 Inhibitors in the US, Europe, and Japan?
  • How many companies are developing PCSK9 Inhibitors therapies?
  • How many therapies are developed by each company for PCSK9 Inhibitors?
  • How many emerging therapies are in the mid-stage and late stages of development for PCSK9 Inhibitors?
  • What are the key collaborations (Industry–Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the PCSK9 Inhibitors therapies?
  • What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
  • What are the clinical studies going on for PCSK9 Inhibitors and their status?
  • What are the key designations that have been granted for the emerging therapies of PCSK9 Inhibitors?
  • What is the global historical and forecasted market of PCSK9 Inhibitors?

Reasons to buy

  • The report will help in developing business strategies by understanding trends shaping and driving the PCSK9 Inhibitors market.
  • To understand the future market competition in the PCSK9 Inhibitors market and Insightful review of the key market drivers and barriers.
  • Organize sales and marketing efforts by identifying the best opportunities for PCSK9 Inhibitors in the US, Europe (Germany, France, Italy, Spain, and the United Kingdom), and Japan.
  • Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
  • Organize sales and marketing efforts by identifying the best opportunities for the PCSK9 Inhibitors market.
  • To understand the future market competition in PCSK9 Inhibitors market.

1. Key Insights

2. Report Introduction

3. PCSK9 Inhibitors Market Overview at a Glance

3.1. Market Share (%) Distribution of PCSK9 Inhibitors in 2018

3.2. Market Share (%) Distribution of PCSK9 Inhibitors in 2030

4. Executive Summary of PCSK9 Inhibitors (PCSK9i)

5. Key Events

5.1. Epidemiology and Market Methodology

6. PCSK9 Inhibitors (PCSK9i) Background and Overview

7. Introduction

7.1. PCSK9 gene biology

7.2. Functional mechanics of PCSK9

7.3. PCSK9 Inhibitors

7.4. PCSK9 Inhibition Strategies

7.5. The Approval Status of PCSK9 Inhibitors

7.6. Disease Areas of PCSK9 Inhibitors

7.6.1. Primary Hyperlipidemia

7.6.2. Prevention of Myocardial Infarction, Stroke, and Unstable Angina Requiring Hospitalization

8. Guidelines

8.1. ESC/EAS Guidelines for the Management of Dyslipidemias

8.2. American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines

8.3. Recommendations From an Expert Panel of the National Lipid Association

8.4. Recommendations of the Spanish Society of Arteriosclerosis (SEA)

8.5. NICE guidelines

8.6. Japan Atherosclerosis Society (JAS) Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases

8.7. Comparison of guidelines

9. Epidemiology and Patient Population

9.1. Key Findings

9.2. Epidemiology of PCSK9 Inhibitors

9.3. Epidemiology Scenario

9.3.1. Total Prevalent Cases of Familial Hypercholestrolemia

9.3.2. Total Diagnosed Cases of Familial Hypercholesterolemia

9.3.3. Total Type-specific Cases of Familial Hypercholesterolemia

9.3.4. Total Age-specific Cases of Familial Hypercholesterolemia

9.3.5. Total Mutation-specific Cases of Familial Hypercholesterolemia

9.3.6. Total Risk factor-specific Cases of PCSK9 Inhibitors in Prophylactic/Preventive setting

9.3.7. Total Treated Cases of PCSK9 Inhibitors

10. Patient Journey

11. Key Endpoints in PCSK9 inhibitor Clinical Trials

12. Marketed Drugs

12.1. Praluent (Alirocumab): Sanofi/Regeneron Pharmaceuticals

12.1.1. Drug Description

12.1.2. Regulatory Milestones

12.1.3. Other Developmental Activities

12.1.4. Pivotal Clinical Trial

12.1.5. Ongoing Current Pipeline Activity

12.2. Repatha (Evolocumab/AMG 145): Amgen

12.2.1. Drug Description

12.2.2. Regulatory Milestones

12.2.3. Other Developmental Activities

12.2.4. Pivotal Clinical Trial

12.2.5. Ongoing Current Pipeline Activity

12.3. Leqvio (Inclisiran): Novartis/Alnylam Pharmaceuticals

12.3.1. Drug Description

12.3.2. Regulatory Milestones

12.3.3. Other Developmental Activities

12.3.4. Pivotal Clinical Trial

12.3.5. Ongoing Current Pipeline Activity

13. Emerging Therapies

13.1. LIB003 (Lerodalcibep): LIB Therapeutics

13.1.1. Drug Description

13.1.2. Clinical Development

13.1.3. Safety and Efficacy

13.2. AZD8233 (ION449): AstraZeneca and Ionis Pharmaceuticals

13.2.1. Drug Description

13.2.2. Other Developmental Activities

13.2.3. Clinical Development

13.2.4. Safety and Efficacy

13.3. Cepadacursen sodium (CIVI-007): CiVi Biopharma

13.3.1. Product Description

13.3.2. Other Developmental Activities

13.3.3. Clinical Development

13.3.4. Safety and Efficacy

14. PCSK9 inhibitors: 7 Major Market Analysis

14.1. Key Findings

14.2. Market Outlook

14.3. Market of PCSK9 Inhibitors (PCSK9i)

14.4. Market Size of PCSK9 inhibitors

14.4.1. Total Market Size of PCSK9 inhibitors

14.4.2. Market Size of PCSK9 inhibitors by Therapies (Treatment and Secondary Prevention)

15. Market Access and Reimbursement

15.1. Key HTA decisions for PCSK9i

15.2. Reimbursement

15.3. Patient Access Programs

16. KOL Views

17. Market Drivers

18. Market Barriers

19. SWOT Analysis

20. Unmet Needs

21. Appendix

21.1. Bibliography

21.2. Report Methodology

22. DelveInsight Capabilities

23. Disclaimer

24. About DelveInsight

List of Table

Table 1: Summary of PCSK9 inhibitors, Market, Epidemiology, and Key Events (2018–2030)

Table 2: Molecular Genetic Testing Used in FH

Table 3: The Dutch Lipid Clinics Network Criteria Score (DLCNS)

Table 4: Recommendations for Pharmacological Low-density Lipoprotein Cholesterol-lowering

Table 5: Recommendations for the Detection and Treatment of Patients With Heterozygous Familial Hypercholesterolemia

Table 6: Recommendations for Lipid-lowering Drugs in Patients With Peripheral Arterial Disease (Including Carotid Artery Disease)

Table 7: Recommendations for Lipid-lowering Therapy in Very High-risk Patients With Acute Coronary Syndromes

Table 8: Recommendations for Statin Therapy Use in Patients With ASCVD

Table 9: Recommendations for Primary Severe Hypercholesterolemia (LDL-C ≥190 mg/dL [≥4.9 mmol/L])

Table 10: Recommendations for Primary Severe Hypercholesterolemia (LDL-C ≥190 mg/dL [≥4.9 mmol/L])

Table 11: Recommendations and Level of Evidence for the Prescription of a PCSK9 inhibitor Concerning the Patient’s Clinical Situation and LDL-C Levels

Table 12: LDL-C concentrations above which PCSK9s are recommended by NICE

Table 13: Comparison of Recommendations for PCSK9-mAb Use

Table 14: Total Prevalent Cases of Familial Hypercholestrolemia (2018–2030)

Table 15: Total Diagnosed Cases of Familial Hypercholesterolemia (2018–2030)

Table 16: Total Type-specific Cases of Familial Hypercholesterolemia (2018–2030)

Table 17: Total Age-specific Cases of Familial Hypercholesterolemia (2018–2030)

Table 18: Total Mutation-specific Cases of Familial Hypercholesterolemia (2018–2030)

Table 19: Total Risk factor-specific Cases of PCSK9 Inhibitors in Prophylactic/Preventive setting (2018–2030)

Table 20: Total Treated Cases of PCSK9 Inhibitors (2018–2030)

Table 21: Praluent (Alirocumab), Clinical Trial Description, 2021

Table 22: Repatha (Evolocumab/AMG 145), Clinical Trial Description, 2021

Table 23: Leqvio (Inclisiran), Clinical Trial Description, 2021

Table 24: LIB003 (Lerodalcibep), Clinical Trial Description, 2021

Table 25: AZD8233 (ION449), Clinical Trial Description, 2021

Table 26: CIVI-007 (Cepadacursen Sodium), Clinical Trial Description, 2021

Table 27: 7MM Market Size of PCSK9 inhibitors in USD Million (2018–2030)

Table 28: 7MM Market Size of PCSK9 inhibitors by Therapies in USD Million (2018–2030)

Table 29: Therapywise Market Size of PCSK9 inhibitors by Treatment Setting in the 7MM, USD Million

Table 30: Therapywise Market Size of PCSK9 inhibitors in Secondary Prevention in the 7MM, USD Million

Table 31: Inclisiran – Probability and Extent of Added Benefit

Table 32: Key HTA Decisions

Table 33: Average costs for Repatha with Medicare drug coverage

List of Figures

Figure 1: Epidemiology and Market Methodology

Figure 2: Intracellular and Extracellular Pathways of PCSK9

Figure 3: Mechanism and Role of PCK9 in Low-density Lipoprotein–Cholesterol Metabolism

Figure 4: Pharmacologic approaches to lower LDL cholesterol

Figure 5: Mechanism of Action for PCSK9-mAb and siRNA

Figure 6: Timeline of PCSK9 Inhibitors

Figure 7: Timeline of ICER’s Evaluation of PCSK9 Inhibitors

Figure 8: Difference Between HeFH and HoFH

Figure 9: Diagnostic Considerations by the American Heart Association

Figure 10: Algorithm for Consideration of PCSK9 Treatment in Severe FH Patients Without ASCVD

Figure 11: Secondary Prevention in Patients With Clinical ASCVD

Figure 12: Algorithm for Consideration of PCSK9 Inhibitor Treatment in Very High-risk Patients, i.e., With Atherosclerotic Cardiovascular Disease (ASCVD) or Diabetes Mellitus

Figure 13: Treatment Flow Chart for Adult (15 years or over) Heterozygous FH

Figure 14: Treatment Flow Chart for Adult (15 Years or Over) Homozygous FH

Figure 15: Total Prevalent Cases of Familial Hypercholestrolemia in the 7MM (2018–2030)

Figure 16: Total Diagnosed Cases of Familial Hypercholesterolemia in the 7MM (2018–2030)

Figure 17: Total Type-specific Cases of Familial Hypercholesterolemia in the 7MM (2018–2030)

Figure 18: Total Age-specific Cases of Familial Hypercholesterolemia in the 7MM (2018–2030)

Figure 19: Total Mutation-specific Cases of Familial Hypercholesterolemia in the 7MM (2018–2030)

Figure 20: Total Risk factor-specific Cases of PCSK9 Inhibitors in Prophylactic/Preventive setting in the 7MM (2018–2030)

Figure 21: Total Treated Cases of PCSK9 Inhibitors in the 7MM (2018–2030)

Figure 22: CiVi-007 MOA: Comparison to approved Anti-PCSK9 MAB’S

Figure 23: Market Size of PCSK9 inhibitors in the 7MM, USD Million (2018–2030)

Figure 24: 7MM Market Size of PCSK9 inhibitors by Therapies in USD Million (2018–2030)

Figure 25: Therapywise Market Size of PCSK9 inhibitors by Treatment Setting in the 7MM, USD Million (2018–2030)

Figure 26: Therapywise Market Size of PCSK9 inhibitors in Secondary Prevention in the 7MM, USD Million (2018–2030)

Sanofi
Regeneron Pharmaceuticals
Amgen
Novartis
Alnylam Pharmaceuticals
LIB Therapeutics
AstraZeneca and Ionis Pharmaceuticals
CiVi Biopharma

 

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