Report Overview

According to the deep-dive market assessment study by Growth Plus Reports, the global PCSK9 inhibitor market was valued at US$ 1.47 billion in 2021 and is expected to register a revenue CAGR of 5.4% to reach US$ 2.13 billion by 2030.

PCSK9 Inhibitor Market Fundamentals

PCSK9 inhibitors are biologically active compounds that lower low-density blood lipoprotein (LDL) cholesterol levels compared to traditional statin therapy. They are used as an alternative to statins in patients intolerant to statins or as an additional therapy when statins are ineffective in lowering the levels of serum low-density lipoprotein. PCSK9 protein is representative of the subtilis protease K subfamily. It encodes the Bacillus subtilis protein, preprotein invertase. Additionally, every individual possesses a gene called proprotein convertase subtilisin/kexin type 9 (PCSK9), which immediately impacts the body’s LDL receptor count. This protein is released into the peripheral circulation after autocatalytic maturation in the endoplasmic reticulum. It binds to various receptors or molecules to produce various biological effects. PCSK9 causes hypercholesterolemia by attaching the LDL receptors on the surface of hepatocytes, where it is internalized and transferred to lysosomes for destruction. It reduces the amount of LDL receptors on the hepatocyte surface, decreasing LDL-C clearance from the blood and higher serum LDL-C levels. PCSK9 has emerged as a significant cholesterol metabolism regulator. Higher LDL cholesterol levels are related to increased activity. Specific gain of function mutations induces autosomal dominant familial hypercholesterolemia, with very high cholesterol levels, early atherosclerotic vascular disease, and the formation of tendon xanthomas. Those with lower PCSK9 activity had lower cholesterol levels and a lower risk of cardiovascular disease, whether due to genetic variation or injection of monoclonal antibodies to PCSK9.

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PCSK9 Inhibitor Market Dynamics

The global PCSK9 inhibitor market is driven significantly by the increasing emergence of dyslipidemia and other diseases related to lipid metabolism owing to compromised lifestyles and rising tobacco and alcohol consumption. The major lifestyle aspect that directly and favorably affects health is diet. In urban civilizations, along with an increased geriatric population, a poor diet and its effects, such as obesity, are prevalent health issues. Urban living causes nutrition issues, such as eating fast food and unhealthy foods, which increases illnesses, including cardiovascular diseases and dyslipidemia. WHO estimates that 60% of factors that affect a person’s health and quality of life are related to their lifestyle. An unhealthy lifestyle can contribute to metabolic disorders, joint and bone problems, cardiovascular diseases, hypertension, obesity, and violence. The link between lifestyle and health diseases must be carefully considered as the most crucial factor fueling the need for dyslipidemia therapy. Therefore, PCSK9 inhibitor is emerging worldwide as a new therapeutic solution. The market for PCSK9 inhibitor is anticipated to be driven by upcoming biotechnological products, such as antisense oligonucleotides (ASOs), siRNAs, CRISPR/Cas9 gene editing systems, and other new strategies for treating lipid disorders. Understanding the function of significant lipid molecules has been made possible by recent developments in technology that may be used to investigate lipids’ composition, structure, and localization. Thus, advanced research and development greatly influence the global PCSK9 inhibitor market revenue growth. 

Governments worldwide are taking the necessary steps to raise public awareness of the existing treatments for conditions, such as hypothyroidism, polycystic ovarian syndrome (PCOS), Cushing syndrome, and metabolic syndrome, that can be fatal. Governments are planning and launching several awareness programs, events, and marathons, to raise awareness about the importance of lipid reduction. For instance, the National Lipid Association released the National Lipid Association Recommendation for Patient-centered Management of Dyslipidemia, which aims at offering guidelines for patients with dyslipidemia about the usage of cholesterol-lowering medications, including PCSK9 inhibitors. The demand for PCSK9 inhibitors and other medications for treating lipid metabolism disorders is anticipated to rise with increased initiative and awareness programs.

However, the lack of significant financial investment needed for medicine development is a major restraining factor for the global PCSK9 inhibitor market revenue growth. Further, a new drug’s marketing approval process is an extremely drawn-out and expensive process that takes about eight years and costs hundreds of millions. Only a small percentage of newly developed medicines are ever approved for sale, of which a very small percentage are successful. Moreover, frequent discontinuation of study on drug compound is another important factor to hinder the global PCSK9 inhibitor market revenue growth. For instance, in 2016, Pfizer Inc. announced discontinuing the global clinical development program for bococizumab due to its inability to provide value to patients and stakeholders.

PCSK9 Inhibitor Market Ecosystem

The global PCSK9 inhibitor market is analyzed from three perspectives: drug, application, and region.

PCSK9 Inhibitor Market by Drug

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Based on the drug, the global PCSK9 inhibitor market is segmented as monoclonal antibody, nucleic acid drugs, and others. 

The monoclonal antibody segment accounted for the largest revenue share of the global PCSK9 inhibitor market in 2021. The monoclonal antibody has the ability to reduce plasma levels of low-density lipoprotein. Individuals, along with patients with high-risk cardiovascular disease, have benefited from monoclonal antibodies due to their high efficiency. Currently, the U.S. Food and Drug Administration (FDA) has approved the PCSK9 monoclonal antibodies alirocumab and evolocumab for treating hypercholesterolemia, comprising primary hypercholesterolemia and inherited hypercholesterolemia. Additionally, in conjunction with statins, alirocumab showed a significant reduction in low-density lipoprotein compared to those who got ezetimibe or double the recommended dose of statins alone. Alirocumab, sold under the brand name Praluent, is a medication used as a second-line treatment for high cholesterol for adults whose cholesterol is not controlled by diet and statin treatment. Evolocumab (Repatha) is a monoclonal antibody medication designed to treat hyperlipidemia.

Human monoclonal antibodies against proprotein convertase subtilisin/kexin type 9 (PSCK9) constitute a novel approach for managing lipid diseases and reducing cardiovascular risks in contrast to standard medication. The key advantage over anti-PCSK9 monoclonal antibodies and conventional medications is its convenient delivery schedule (0-90-180 days), which should result in significantly higher adherence. Clinical trials completed so far have confirmed the tolerance and efficacy of monoclonal antibodies in long-term PCSK9 and LDL-C level reductions. A quick follow-up on the medication’s safety revealed a positive safety profile. To evaluate the long-term tolerability, efficacy, and safety of monoclonal antibodies, it is still crucial that ongoing and future clinical trials be carried out on a broader population.

PCSK9 Inhibitor Market by Application

Based on the application, the global PCSK9 inhibitor market is segmented as hyperlipidemia, atherosclerosis, myocardial ischemia, carcinoma, sepsis, viral disease, and others. 

The hyperlipidemia segment accounted for the largest revenue share of the global PCSK9 inhibitor market in 2021. The primary lifestyle constituent that directly and favorably affects health is diet. In civic nations, a poor diet, and its effects, such as obesity, are prevalent health issues. Excessive fast-food consumption and improper eating habits are linked to diseases, including dyslipidemia and cardiovascular disease. People suffer illnesses, develop disabilities, or even pass away. Due to the high prevalence of lipid metabolism co-morbidities, the growing global geriatric population, which is more susceptible to cardiovascular diseases, is the most important factor influencing the PCKS9 inhibitor market revenue growth. Worldwide, the percentage of people over 65 is increasing rapidly, and older people are at higher risk of developing hyperlipidemia. 

The atherosclerosis segment is expected to account for the fastest revenue CAGR during the forecast period, as over time, the prevalence of atherosclerosis and other cardiovascular diseases rises with age. With each decade of life, the likelihood of developing peripheral artery disease, cerebrovascular disease, and abdominal aortic aneurysm more than doubles. The arterial wall continuously changes during atherosclerosis, culminating in the final stage of calcification. According to a study employing intravascular ultrasonography, young survivors of myocardial infarction (MI) experience constrictive remodeling (shrinkage), which is typically accompanied by plaque degradation, and expansive remodeling (enlargement) predominates in older participants. Thus, the global PCSK9 inhibitor market is propelled owing to the elevated geriatric population with emerging cardiovascular diseases. 

PCSK9 Inhibitor Market by Region

Based on the region, the global PCSK9 inhibitor market is segmented into North America, Europe, Asia Pacific, and the Rest of the World.

North America accounted for the largest revenue share of the global PCSK9 inhibitor market in 2021. The presence of major players, the high prevalence of obesity and other lifestyle disorders, and the well-established healthcare infrastructure are some of the main factors responsible for the region’s huge market revenue share. Additionally, a larger prevalence of familial mixed hyperlipidemia, advantageous government initiatives, and increased treatment knowledge are anticipated to boost market expansion. The United States has the highest revenue share in North America. About 7% of American children and adolescents aged 6 to 19 have high total cholesterol, according to the Centers for Chronic Disease Prevention (CDC). Thus, the prevalence of these diseases is expected to rise, driving up the demand for PCSK9 inhibitor treatment in this region.

Asia Pacific is the fastest-growing region in the global PCSK9 inhibitor market. A massive number of individuals are suffering from obesity and heart ailments due to excessive levels of bad cholesterol and harmful fats, which can be related to the expanding teen population and the high adoption of sedentary lifestyles.

PCSK9 Inhibitor Market Competitive Landscape

The leading players in the PCSK9 inhibitor market are:

• Amgen Plc.
• Eli Lilly & Co. 
• Sanofi S.A.
• Pfizer Inc.
• Novartis AG
• Merck & Co. KGaA
• Alnylam
• AstraZeneca
• Affiris
• LIB Therapeutics LLC
• Ionis Pharmaceuticals
• CiVi Biopharma
• F. Hoffmann-La Roche Ltd. 
• Regeneron Pharmaceuticals, Inc. 
• Acrobiosystems, Inc.

PCSK9 Inhibitor Market Strategic Developments

• In July 2022, Novartis Pharmaceuticals started a clinical study to evaluate the efficacy of inclisiran compared to placebo on top of maximally tolerated statin therapy in reducing total coronary atheroma volume assessed by coronary computed tomography angiography. According to February 2023 update, the study is in phase III. 
• In July 2022, Cedars-Sinai Medical Center, in collaboration with Amgen, updated the phase III trial for the study to check the effect of evolocumab on coronary artery plaque volume and composition by coronary CTA (CCTA) and microcalcification by F18-NaF PET.
• In November 2022, LIB Therapeutics LLC, in collaboration with Medpace, Inc., updated the phase III trial for lerodalcibep along with a placebo to check the reduction efficiency of the LDL-C. 

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