Proprotein Convertase Subtilisin/Kexin Type 9 Market Size, Share, Industry, Forecast and outlook (2024-2031)

Global Proprotein Convertase Subtilisin/Kexin Type 9 Market is Segmented By Product (DCRPCSK-9, SX-PCK9, K-312, LY3015014, Others),  By Application(HomozygousLiver Disease, Familial Hypercholesterolemia, Cardiovascular Disease, Metabolic Syndrome, Others ), and by Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis,  2022-2029

Proprotein Convertase Subtilisin/Kexin Type 9 Market Overview

The Global "Proprotein Convertase Subtilisin/Kexin Type 9 Market" is expected to reach at a high CAGR  during the forecast period (2022-2029). Proprotein convertase subtilisin/Kexin type 9 (PCSK9) is a serine protease that facilitates the degradation of receptors for low-density lipoprotein cholesterol (LDL-C) within hepatocytes. These are novel medications for familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease requiring additional lipid-lowering beyond dietary measures and statin use.

Proprotein Convertase Subtilisin/Kexin Type 9 Market Scope

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Proprotein Convertase Subtilisin/Kexin Type 9 Market Dynamics

The global proprotein convertase subtilisin/Kexin type 9 market growth is driven by the increasing prevalence of atherosclerotic cardiovascular disease, hypercholesterolemia, a growing number of pipeline studies and the rising involvement of key players in developing the treatment options for atherosclerotic cardiovascular disease.

The growing usage of PCSK9 inhibitors in familial hypercholesterolemia (FH) or clinical atherosclerotic cardiovascular disease (ASCVD) patients is expected to drive market growth

PCSK9 inhibitors (PCSK9i) have been developed as a novel class of medications for use in high-risk populations. In 2015, two monoclonal antibodies that inactivate PCSK9, alirocumab and evolocumab, have been approved by the Food and Drug Administration (FDA) for use along with diet and maximally tolerated statin therapy in patients with familial hypercholesterolemia (FH) or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional LDL-C lowering. Alirocumab and evolocumab reduce LDL-C levels by up to 60% and may decrease major adverse cardiovascular events. For instance, On April 6, 2020, Sanofi finalized the planned restructuring related to Praluent (alirocumab) with Regeneron Pharmaceuticals, Inc. Effectively from April 1, 2020, Sanofi will have sole responsibility for Praluent outside the U.S. Regeneron will have sole responsibility for Praluent in the U.S. The restructuring simplifies the antibody collaboration between the companies, increases efficiency, and streamlines operations for Praluent.

Furthermore, on December 11, 2020, Novartis announced that the European Commission (EC) has approved Leqvio (inclisiran) for the treatment of adults with hypercholesterolemia

An increase in the prevalence of atherosclerotic cardiovascular diseases and familial hypercholesterolemia is expected to drive the market growth

Atherosclerosis is a leading cause of vascular diseases. For instance, according to the American Heart Association, Inc., the mortality rate of vascular disease is 700 per 100,000 people per year in the country. The rise in the number of people with cardiovascular diseases is likely to fuel the growth of the global Proprotein Convertase Subtilisin/Kexin Type 9 market. For instance, according to the American Heart Association, in 2018, 92.1 million Americans lived with cardiovascular diseases. According to an article published in NCBI, atherosclerosis accounted for more than 90% of cases of peripheral artery disease. The maximum incidences of cardiovascular diseases can be attributed to the sedentary lifestyle in developed countries. The sedentary lifestyle leads to a high prevalence of high blood pressure, high cholesterol, obesity, and high alcohol consumption, contributing to a high incidence of cardiovascular diseases. Therefore, the sedentary lifestyle leading to a high prevalence of cardiovascular diseases and increasing awareness of the treatment options are expected to drive the market.

Familial Hypercholesterolemia (FH) is a genetic and hereditary disorder, which leads to a high level of LDL (bad) cholesterol. The condition begins at birth and can cause heart attacks at an early age. FH is an autosomal-dominant disorder associated with mutations in the LDL receptor gene resulting in elevated plasma low-density lipoprotein cholesterol levels and premature atherosclerotic cardiovascular disease (ASCVD). According to the National Center for Chronic Disease Prevention and Health Promotion, Division for Heart Disease and Stroke Prevention, the total prevalent population of Familial Hypercholesterolemia (FH) accounted for 2,367,466 in 2017. However, the total diagnosed prevalent patient population of Familial Hypercholesterolemia (FH) was 965,405 in 2017, which is anticipated to increase by 2030. The diagnosed prevalence of FH was found to be 244,214 in the United States in 2017. France had the most diagnosed prevalence of Familial Hypercholesterolemia (FH) in the European Countries in 2017, followed by Italy. Japan accounted for 221,519 cases of diagnosed prevalent population Familial Hypercholesterolemia (FH) in 2017.

The high cost of PCSK9 inhibitors is likely to hamper the market growth

However, alirocumab and evolocumab are significantly more expensive than other lipid-lowering therapies, with an average cost of $14 300 per year. These costs pose a significant challenge to healthcare payers, especially in light of these drugs' uncertain long-term clinical effectiveness.

Global Proprotein Convertase Subtilisin/Kexin Type 9 Market- Industry Analysis

Supply Chain Analysis

Epidemiology

COVID-19 Impact Analysis On Proprotein Convertase Subtilisin/Kexin Type 9

As the COVID-19 outbreak continues to endanger global health and hamper the world economy, there are concerns and reconsiderations for medication taken by patients with cardiometabolic disorders as they are more vulnerable to COVID-19. It has been widely observed that patients with existing cardiovascular diseases experience higher complications due to COVID-19. But, statins and proprotein convertase subtilisin/Kexin type 9 (PCSK9) inhibitors interfere with several pathophysiological pathways of coronavirus disease 2019 (COVID-19).

Statins may directly affect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by inhibiting its main protease. Statin-induced up-regulation of angiotensin-converting enzyme 2 (ACE2) may also be beneficial, whereas cholesterol reduction might significantly suppress SARS-CoV-2 by either blocking its host-cell entry through the disruption of lipid rafts or by inhibiting its replication. The available human studies have shown the beneficial effects of statins and PCSK9 inhibitors on pneumonia and sepsis. These drugs may act as immunomodulators in COVID-19 and protect against major complications, such as acute respiratory distress syndrome and cytokine release syndrome. Considering their antioxidative, anti-arrhythmic, antithrombotic properties and their beneficial effect on endothelial dysfunction, along with the increased risk of mortality of patients at high cardiovascular risk infected by SARS-CoV-2, statins, and PCSK9 inhibitors might prove effective against the cardiovascular and thromboembolic complications of COVID-19. Therefore, these drugs showed a positive impact on the growth of the market.

Global Proprotein Convertase Subtilisin/Kexin Type 9 Market- Segment Analysis

The homozugous familial hypercholesterolemia segment is expected to hold the largest share in this market segment

Homozygous familial hypercholesterolemia is a rare genetic condition that leads to extremely high cholesterol levels and an increased risk of early heart disease. The most serious and more rare form of FH is HoFH. It is estimated to affect as many as 1 in 300,000 people all over the world. Untreated, HoFH often causes heart disease (heart attacks and aortic valve disease) beginning in the early teen years and sometimes earlier in life. According to the World Health Organization, in 2020, 39 million children under 5 years accounted overweight or obese. An increased intake of energy-dense foods high in fat and sugars, and an upsurge in physical immobility due to the increasingly static nature of many forms of work, changing modes of transportation, and increasing urbanization are factors propelling the high cholesterol rates and ultimately boosting the segment growth.

Furthermore, the approval of novel cholesterol-reducing drugs enhances segment growth. For example, the drugs alirocumab (Praluent) and evolocumab (Repatha) belong to a novel category of medications known as PCSK9 inhibitors, which dramatically lower harmful LDL cholesterol values more than the ones 50%. These types of new treatment drugs fuels segment growth. The increasing patient pool and rising approvals of new drugs enhance the segment growth.

Proprotein Convertase Subtilisin/Kexin Type 9 Market Geographical Analysis

North America region holds the largest market share of the global proprotein convertase subtilisin/Kexin type 9 market

North America is expected to dominate the overall market throughout the forecast period. The market growth is due to the factors such as the presence of key players, high prevalence of cardiovascular diseases and atherosclerosis, established healthcare infrastructure, key developments by market players, growing R&D approvals, key mergers, and acquisitions. For instance, Regeneron Pharmaceuticals Inc, ALIROCUMAB PCSK9 antibody is in Phase 3 clinical trials for heterozygous familial hypercholesterolemia (HeFH) in pediatrics. This product approval will strengthen its portfolio in the U.S. are some of the key factors accountable for its large share in the market. Furthermore, beneficial government initiatives and increased research partnerships are some of the drivers expected to increase market growth. In this region, the United States has the maximum share due to supportive healthcare policies, a high number of patients, and a developed healthcare market. About 647,000 Americans die from heart disease each year, 1 in every 4 deaths. Heart disease costs the United States about USD 219 billion each year.

Proprotein Convertase Subtilisin/Kexin Type 9 Market Competitive Landscape

The global proprotein convertase subtilisin/Kexin type 9 market is highly competitive with the presence of local as well as global companies. Some of the key players contributing to the market's growth include AFFiRiS AG, Sanofi and Regeneron Pharmaceuticals Inc, Novartis AG, Dicerna Pharmaceuticals Inc, Kowa Co Ltd, Amgen and Serometrix LLC. The major players are adopting several growth strategies such as product launches, acquisitions, and collaborations, which contribute to the market's growth globally. For instance, On October 20, 2017, Affiris AG completed its Phase 1 study of the low-density lipoprotein cholesterol (LDLc)-lowering activity of 2 different proprotein convertase subtilisin/Kexin Type 9 (PCSK9) targeting AFFITOPE.

Global Proprotein Convertase Subtilisin/Kexin Type 9 Market – Market Key Companies to Watch

Novartis AG

Overview: Novartis AG is a Swiss multinational pharmaceutical company based in Basel, Switzerland, established in 1996. The company has over 105,794 employees and operates business through two divisions: Innovative medicine, Sandoz. Made up of two business units– Novartis Pharmaceuticals, which includes Novartis Gene Therapies, and Novartis Oncology – our Innovative Medicines Division commercializes innovative patented medicines to enhance health outcomes for patients and healthcare professionals. Sandoz is a global leader in generic pharmaceuticals and biosimilars that pioneers novel approaches to help people worldwide access high-quality medicines.

Product Portfolio:  Leqvio (inclisiran, KJX839) is the first and only small interfering RNA (siRNA) therapy to reduce low-density lipoprotein cholesterol (LDL-C) levels via an RNA interference (RNAi) mechanism of action. It could help improve outcomes for patients with atherosclerotic cardiovascular disease (ASCVD), a deadly form of cardiovascular disease. Novartis has obtained global rights to develop, manufacture and commercialize Leqvio under a license and collaboration agreement with Alnylam Pharmaceuticals, a leader in RNAi therapeutics.

Key Developments: On September 01, 2021, Novartis completed its agreement with the NHS in England as part of a collaboration to pioneer a first-of-its-kind population health management approach to address elevated LDL-C in eligible patients with atherosclerotic cardiovascular disease (ASCVD) across England.