PCSK9 Inhibitor Market Size, Share, and Forecast (2024-2031)

PCSK9 Inhibitor Market is Segmented By Drug Class, Application, Distribution Channel And By Region (North America, Latin America, Europe, Asia Pacific, Middle East And Africa) – Share, Size, Outlook, And Opportunity Analysis, 2024-2031

Market Overview

The global PCSK9 inhibitor market reached US$ XX million in 2023 and is expected to reach US$ XX million by 2031, growing at a CAGR of XX% during the forecast period 2024-2031.

PCSK9 inhibitors are a class of drugs that are administered subcutaneously. They are used in reducing low-density lipoprotein cholesterol (LDL-C levels) as well as in decreasing the occurrence of cardiovascular problems. A PCSK9 inhibitor is likely to be given to patients suffering from familial hyperlipidemia or those prone to cardiovascular disease heart disease who cannot take statins, or when high statin doses have failed to achieve the treatment goals.

PCSK9 inhibitors have been launched to attach to proprotein convertase subtilisin/kexin type 9, known herein as PCSK9. PCSK9 attaches itself to low-density lipoprotein receptors (referred to as LDL receptors or LDLR) found on the liver cells or hepatocytes. The inhibition of PCSK9, in return, leads to increased levels of LDLRs available to clear out the LDL thereby reducing the levels of low density lipoprotein; cholesterol (LDL-C).

Executive Summary

Market Dynamics: Drivers & Restraints

Rising Prevalence of Cardiovascular Diseases

The accelerating incidence of cardiovascular disorders (CVDs) is one of the factors that is likely to stimulate the growth of the global PCSK9 inhibitors market. Millions of people are ill from this and a significant proportion of health care spending is incurred because of this issue.

As the prevalence of cardiovascular conditions increases, especially among elderly individuals and in areas with rising obesity and diabetes rates, the need for safe and effective alternative treatment options also increases. PCSK9 inhibitors are a powerful remedy to this effect because they enable patients to attain very low levels of LDL-C and thus, reduce the chances of experiencing adverse cardiovascular events. Such appetite for lowering cholesterol levels has helped grow the market of PCSK9 inhibitors making these drugs a foundation therapy for high-risk patients and helping to enhance the overall market.

For instance, according to British Heart Foundation, cardiovascular disease remains the leading cause of death in both men and women throughout the world. In the year of 2023 the world’s population is 8 billion out of those approximately 620 million are suffering from cardiac and vascular illnesses everywhere across the globe. Every year approximately sixty million individuals in the globe will be diagnosed with heart or circulatory disease. It has been suggested that one out of every 13 patients has heart or circulatory ailments. Cardiovascular diseases are responsible for roughly 1 out of 3 deaths in the world; these accounted for - over 20.5 million deaths worldwide in 2021 – which is 56,000 lost lives every day or almost one every 1 and ½ second.

High Cost Associated with the Drugs

PCSK9 inhibitors are effective, but they are among the most expensive treatments for cholesterol. In most cases, it costs thousands of dollars per year, per patient, to suffer this treatment. The pricing factor constitutes a significant deterrent, more so in the cases of health care systems with little or no funding. For example, in Europe where health care systems are mostly publicly financed and managed, the costs may be too high even for the entire budget hence in most cases payers limit their reimbursement only to the very few patients whom the conventional treatment has failed in treating.

For instance, within the U.S., the cost for alirocumab and evolocumab is in the range from $5,800 to $6,500 per year and inclisiran costs $9,750 in the first year and $6500 annually after that. All these drugs need prior authorization. Usually suggested to patients with established or at high risk for cardiovascular disease who are unable to lower LDL-C adequately with maximally tolerated doses of statin ± ezetimibe, or who are intolerant to statins.

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Segment Analysis

The global PCSK9 inhibitor market is segmented based on drug class, application, distribution channel and region.

Drug class:

Alirocumab segment is expected to dominate the PCSK9 inhibitor market share

The alirocumab segment holds a major portion of the PCSK9 inhibitor market share and is expected to continue to hold a significant portion of the PCSK9 inhibitor market share during the forecast period.

The monoclonal antibody alirocumab, which targets PCSK9 protein, has been resulted in decreasing blood low-density lipoprotein (LDL) cholesterol and apolipoprotein B100 (ApoB). While studies in mice and in vitro have demonstrated that PCSK9 inhibitors function by lowering LDL through increased hepatic LDL receptor activity, there have been no studies conducted in humans that describe the effect of PCSK9 inhibitors on lipoprotein metabolism. In particular, inhibition of PCSK9 does not clarify whether any influence on very low-density lipoprotein or intermediate-density lipoprotein (IDL) metabolism exists. Additionally, plasma lipoprotein (a) levels are also decreased by the inhibition of PCSK9.

For instance, in March 2024, Regeneron Pharmaceuticals, Inc announced the U. S Food & Drug Administration (FDA) has approved an additional indication for Praluent (alirocumab) in addition to other diet and low-density lipoprotein cholesterol (LDL-C) lowering treatments for pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).

Evolocumab segment is the fastest-growing segment in the PCSK9 inhibitor market share

The evolocumab segment is the fastest-growing segment in the PCSK9 inhibitor market share and is expected to hold the market share over the forecast period.

As a leading PCSK9 inhibitor, Evolocumab is an important drug within the global PCSK9 inhibitors market owing to its -efficacy, wide clinical application as well as a good safety record. As approved for use among patients with high levels of bad cholesterol who are prone to cardiovascular events, this drug reduces LDL-C levels effectively has in clinical trials demonstrated reduced incidence of heart attack and stroke.

One of the key driving factors for Evolocumab’s success is its effectiveness for patients with familial hypercholesterolemia (FH) and those non-responders for statins-only cholesterol reduction. Its flexible dosing options including bi-weekly and monthly injections are convenient which promotes adherence especially for long - term use. In addition, as health care providers and payers accepted the role of Evolocumab as a cheaper means of controlling cardiovascular diseases, the number of insurance providers and health systems offering coverage has increased access.

Geographical Analysis

North America is expected to hold a significant position in the PCSK9 inhibitor market share

North America holds a substantial position in the PCSK9 inhibitor market and is expected to hold most of the market share due to high prevalence of cardiovascular diseases and aging population. Private insurance coverage and reimbursement programs have made these treatments more accessible, especially for patients with statin intolerance or high cardiovascular risk. The well-developed healthcare infrastructure and focus on innovative treatments have also enabled wider adoption of PCSK9 inhibitors. The increasing awareness among healthcare professionals about their efficacy in reducing cardiovascular events supports market growth in North America.

For instance, in August 2023, Merck, announced the commencement of the company’s Phase 3 clinical program, CORALreef, for MK-0616, an investigational orally administered proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor seeking to treat adult patients with hypercholesterolemia. This is the first Phase 3 clinical program of oral PCSK9 formulation. Two registrational Phase 3 trials assessing low-density lipoprotein (LDL) cholesterol levels; CORALreef Lipids and CORALreef HeFH have now started enrolling their first participants.

Moreover, in April 2024, A study has found that adding lerodalcibep to standard cholesterol-lowering medication for one year can reduce LDL levels by over half in patients at high or very high risk for heart attacks or strokes. Furthermore, 90% of patients treated with lerodalcibep achieved newer, more stringent guideline-recommended LDL targets set by the American College of Cardiology and other expert organizations.

Europe is growing at the fastest pace in the PCSK9 inhibitor market

Europe holds the fastest pace in the PCSK9 inhibitor market and is expected to hold most of the market share due to increasing prevalence of cardiovascular diseases and an aging population. Countries with established healthcare systems are incorporating PCSK9 inhibitors into treatment protocols, especially for patients who don't respond to statins or have genetic conditions. Clinical evidence supporting their efficacy in reducing heart attacks and strokes has gained confidence from healthcare providers and regulators. Favourable reimbursement policies in many European countries offset the high cost of these therapies, making them more accessible. Further research and positive long-term outcomes continue to boost PCSK9 inhibitor adoption in Europe.

For instance, in October 2024, AstraZeneca has signed an exclusive license agreement with CSPC Pharmaceutical Group Ltd to develop a novel small molecule Lipoprotein (a) disruptor. The asset aims to provide additional benefits for patients with dyslipidemia and address the major risk factors driving chronic cardiovascular disease. AstraZeneca will access CSPC's pre-clinical candidate small molecule, YS2302018, an oral Lp(a) disruptor, with the aim of developing it as a novel lipid-lowering therapy for various cardiovascular disease indications, including PCSK9 inhibitor, AZD0780.

Competitive Landscape

The major global players in the PCSK9 inhibitor market include Regeneron Pharmaceuticals, Amgen, Novartis AG, LIB Therapeutics, LLC, Shanghai Junshi Biosciences Co., Ltd, Merck & Co., Inc, Innovent Bio, Esperion Therapeutics among others.

Emerging Players

The emerging players in the PCSK9 inhibitor market include Alnylam Pharmaceuticals, Akeso, Inc, Arrowhead Pharmaceuticals, Hanmi Pharmaceutical Co., Ltd and among others.

Key Developments

• In November 2023, LIB Therapeutics Inc. has completed two registration-enabling Phase 3 trials for Lerodalcibep, a third-generation PCSK9 inhibitor, for patients at high and high risk of cardiovascular disease. The trials are part of the Phase 3 LIBerate Program, which includes four key studies of 2,387 patients dosed for up to 52 weeks, with over 2,200 patients continuing in an open-label extension study of 72 weeks.

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• To visualize the global PCSK9 inhibitor market segmentation based on drug class, application, distribution channel, and region and understand key commercial assets and players.
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The global PCSK9 inhibitor market report would provide approximately 56 tables, 52 figures, and 164 pages.

Target Audience 2023

• Manufacturers/ Buyers
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