PCSK9 Inhibitors Market Report 2025 (Global Edition)

Global PCSK9 Inhibitors Market Report 2024 Market Size Split by Drug Outlook: (Alirocumab, Evolocumab, Inclisiran, Tafolecimab), by Modality Outlook: (Fully-humanized monoclonal antibodies, siRNA), by...

PCSK9 Inhibitors Market Report Description

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Competitive Landscape of the PCSK9 Inhibitors Market

The market for PCSK9 inhibitors is extremely competitive, with major manufacturers such as Regeneron, Sanofi, and Amgen dominating the market with their Praluent and Repatha medicines. These businesses use intensive marketing campaigns, strategic alliances, and continuing clinical trials to control the market. Furthermore, it is anticipated that the emergence of biosimilars will increase competitiveness by providing less expensive substitutes. Statins and other conventional cholesterol-lowering medications are another source of pressure on the market.

In August 2023, Merck initiated the Phase 3 clinical trial for MK-0616, a potential oral PCSK9 inhibitor. Adults with hypercholesterolemia are being studied for treatment with the oral PCSK9 inhibitor (MK-0616). (Source:https://www.merck.com/news/merck-initiates-phase-3-clinical-program-for-oral-pcsk9-inhibitor-candidate-mk-0616/) In June 2023, Akeso Inc. announced that the National Medical Products Administration (NMPA) of China had approved its New Drug Application (NDA) for ebronucimab (AK102), a fully human anti-PCSK9 monoclonal antibody, for two indications: 1) heterozygous familial hypercholesterolemia (HeFH) and 2) primary hypercholesterolemia and mixed hyperlipidemia. Akeso and AD Pharmaceuticals, a joint venture with Akeso, are working together to develop ebronucimab. (Source: https://www.akesobio.com/en/media/akeso-news/230602/) In March 2023, The Phase 2b clinical trial data for MK-0616, an experimental once-daily oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, were released by Merck for use in adults with hypercholesterolemia. (Source: https://www.merck.com/news/mercks-mk-0616-an-investigational-oral-pcsk9-inhibitor-significantly-reduced-ldl-c-in-patients-with-hypercholesterolemia-in-phase-2b-study/) In April 2021, The Food and Drug Administration (FDA) authorized the injection of praluent (alirocumab) for individuals with homozygous familial hypercholesterolemia (HoFH). (Source:https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-add-therapy-patients-genetic-form-severely-high-cholesterol)

Top Companies Market Share in PCSK9 Inhibitors Industry: (In no particular order of Rank)

• Novartis AG
• Regeneron Pharmaceuticals Inc. (Sanofi)
• LIB Therapeutics LLC
• Amgen Inc.
• Innovent
• AstraZeneca
• Shanghai Junshi Biosciences Co. Ltd
• Merck & Co. Inc.
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Regional Analysis of the PCSK9 Inhibitors Market

Which Region Dominates the PCSK9 Inhibitors Market in 2024?

According to Cognitive Market Research, North America currently dominates the PCSK9 inhibitors market, and the region is expected to have significant growth during the projected period. North America's high prevalence of cardiovascular diseases (CVDs) and excessive cholesterol is predicted to propel the market for PCSK9 inhibitors to significant growth. The area boasts a strong healthcare system that makes access to cutting-edge treatments simple. Furthermore, growing preventive healthcare uptake and awareness of hypercholesterolemia fuel demand for PCSK9 inhibitors. Additionally, the area benefits from robust insurance coverage, regulatory backing, and payment policies for medications that lower cholesterol. North America is still a major market for PCSK9 inhibitors due to its huge aging population and rising number of high-risk patients, which spurs both innovation and uptake.

Which Region is Expanding at the Fastest CAGR?

Asia-Pacific is expected to make significant gains during the projected period, with the greatest compound annual growth rate (CAGR). Due to the increased prevalence of cardiovascular illnesses (CVDs) and elevated cholesterol levels, the Asia Pacific region is anticipated to drive the market for PCSK9 inhibitors. As awareness of lipid problems increases and healthcare access improves, there will likely be a greater need for sophisticated treatments like PCSK9 inhibitors. The elderly population in the area and the trend toward more preventive healthcare practices are also driving market expansion. Increased disposable incomes and the development of healthcare infrastructure in important countries like China and India will probably help PCSK9 inhibitors become widely used in the Asia Pacific.

The current report Scope analyzes PCSK9 Inhibitors Market on 5 major region Split (In case you wish to acquire a specific region edition (more granular data) or any country Edition data then please write us on info@cognitivemarketresearch.com

• North America (United States, Canada, Mexico)
• Europe (United Kingdom, France, Germany, Italy, Russia, Spain, Sweden, Denmark, Netherlands, Switzerland, Belgium)
• Asia-Pacific (China, Japan, Korea, India, Australia, Philippines, Singapore, Malaysia, Thailand, Indonesia, Rest of APAC)
• South America (Brazil, Argentina, Colombia, Peru, Chile, Rest of South America)
• Middle East and Africa (Saudi Arabia, Turkey, Nigeria, UAE, Egypt, South Africa, GCC Countries, Rest of MEA)

The above graph is for illustrative purposes only.

North America PCSK9 Inhibitors

According to Cognitive Market Research, the global PCSK9 Inhibitors market size was estimated at USD 2914.5 Million, out of which North America held the major market share of more than 40% of the global revenue with a market size of USD 1165.80 million in 2024 and will grow at a compound annual growth rate (CAGR) of 17.2% from 2024 to 2031.

• According to Cognitive Market Research, the US had a major share in the PCSK9 Inhibitors market with a market size of USD 919.82 million in 2024 and is projected to grow at a CAGR of 17.0% during the forecast period. The United States has a strong insurance system and healthcare system, which encourages the widespread use of novel treatments.
• The Canada PCSK9 Inhibitors market had a market share of USD 139.90 million in 2024 and is projected to grow at a CAGR of 18.0% during the forecast period. The availability and coverage of PCSK9 inhibitors are guaranteed under Canada's public healthcare system.
• The Mexico PCSK9 Inhibitors market is projected to witness growth at a CAGR of 17.7% during the forecast period, with a market size of USD 106.09 million in 2024.

Europe PCSK9 Inhibitors

According to Cognitive Market Research, the global PCSK9 Inhibitors market size was estimated at USD 2914.5 Million, out of which Europe held the market share of more than 30% of the global revenue with a market size of USD 874.35 million in 2024 and will grow at a compound annual growth rate (CAGR) of 17.5% from 2024 to 2031.

• The United Kingdom PCSK9 Inhibitors market had a market share of USD 146.89 million in 2024 and is projected to grow at a CAGR of 18.3% during the forecast period. In the UK, Growing knowledge of cardiovascular risk factors and cholesterol management is driving demand.
• The France PCSK9 Inhibitors market is projected to witness growth at a CAGR of 16.7% during the forecast period, with a market size of USD 80.44 million in 2024.
• According to Cognitive Market Research, the German PCSK9 Inhibitors market size was valued at USD 173.12 million in 2024 and is projected to grow at a CAGR of 17.7% during the forecast period. The market for novel cholesterol treatments is growing as a result of Germany's emphasis on pharmaceutical research and development.
• The Italy PCSK9 Inhibitors market is projected to witness growth at a CAGR of 16.9% during the forecast period, with a market size of USD 75.19 million in 2024.
• The Russia PCSK9 Inhibitors market is projected to witness growth at a CAGR of 16.5% during the forecast period, with a market size of USD 135.52 million in 2024.
• The Spain PCSK9 Inhibitors market is projected to witness growth at a CAGR of 16.6% during the forecast period with a market size of USD 71.70 million in 2024
• The Luxembourg PCSK9 Inhibitors market is projected to witness growth at a CAGR of 17.6% during the forecast period, with a market size of USD 27.10 million in 2024.
• The Portugal PCSK9 Inhibitors market is projected to witness growth at a CAGR of 17.3% during the forecast period, with a market size of USD 18.36 million in 2024.
• The Greece PCSK9 Inhibitors market is projected to witness growth at a CAGR of 17.8% during the forecast period, with a market size of USD 10.49 million in 2024.
• The Rest of Europe's PCSK9 Inhibitors market is projected to witness growth at a CAGR of 16.2% during the forecast period, with a market size of USD 135.52 million in 2024.

Asia Pacific PCSK9 Inhibitors

According to Cognitive Market Research, the global PCSK9 Inhibitors market size was estimated at USD 2914.5 Million, out of which Asia Pacific held the market share of around 23% of the global revenue with a market size of USD 670.34 million in 2024 and will grow at a compound annual growth rate (CAGR) of 21.0% from 2024 to 2031.

• According to Cognitive Market Research, the China PCSK9 Inhibitors market size was valued at USD 301.65 million in 2024 and is projected to grow at a CAGR of 20.5% during the forecast period. PCSK9 Inhibitors surged in China due to rising CVD and hyperlipidemia prevalence.
• The Japan PCSK9 Inhibitors market is projected to witness growth at a CAGR of 19.5% during the forecast period, with a market size of USD 92.51 million in 2024.
• The India PCSK9 Inhibitors market had a market share of USD 80.44 million in 2024 and is projected to grow at a CAGR of 22.8% during the forecast period. India's growing awareness campaigns about cholesterol levels help explain why PCSK9 inhibitors are becoming more and more popular.
• The South Korean PCSK9 Inhibitors market is projected to witness growth at a CAGR of 20.1% during the forecast period, with a market size of USD 67.03 million in 2024.
• The Australian PCSK9 Inhibitors market is projected to witness growth at a CAGR of 20.7% during the forecast period, with a market size of USD 34.86 million in 2024.
• The South East Asia PCSK9 Inhibitors market is projected to witness growth at a CAGR of 22.0% during the forecast period, with a market size of USD 46.25 million in 2024.
• The Rest of Asia Pacific PCSK9 Inhibitors market is projected to witness growth at a CAGR of 20.8% during the forecast period, with a market size of USD 47.59 million in 2024.

South America PCSK9 Inhibitors

According to Cognitive Market Research, the global PCSK9 Inhibitors market size was estimated at USD 2914.5 Million, out of which Latin America held the market share of around 5% of the global revenue with a market size of USD 145.73 million in 2024 and will grow at a compound annual growth rate (CAGR) of 18.4% from 2024 to 2031.

• According to Cognitive Market Research, the Brazil PCSK9 Inhibitors market size was valued at USD 62.37 million in 2024 and is projected to grow at a CAGR of 19.0% during the forecast period. PCSK9 inhibitors flourished in Brazil due to improved urban healthcare facilities that provided access to more advanced therapies.
• Argentina's PCSK9 Inhibitors market had a market share of USD 24.48 million in 2024 and is projected to grow at a CAGR of 19.3% during the forecast period. The Argentine government's focus on making life-saving treatments accessible promotes market expansion .
• Colombia PCSK9 Inhibitors market is projected to witness growth at a CAGR of 18.2% during the forecast period, with a market size of USD 12.97 million in 2024.
• Peru PCSK9 Inhibitors market is projected to witness growth at a CAGR of 18.6% during the forecast period, with a market size of USD 11.95 million in 2024.
• Chile PCSK9 Inhibitors market is projected to witness growth at a CAGR of 18.7% during the forecast period, with a market size of USD 10.49 million in 2024.
• The Rest of Latin America's PCSK9 Inhibitors market is projected to witness growth at a CAGR of 17.5% during the forecast period, with a market size of USD 23.46 million in 2024.

Middle East and Africa PCSK9 Inhibitors

According to Cognitive Market Research, the global PCSK9 Inhibitors market size was estimated at USD 2914.5 Million, out of which the Middle East and Africa held the major market share of around 2% of the global revenue with a market size of USD 58.29 million in 2024 and will grow at a compound annual growth rate (CAGR) of 18.7% from 2024 to 2031..

• The GCC Countries PCSK9 Inhibitors market is projected to witness growth at a CAGR of 19.5% during the forecast period, with a market size of USD 24.95 million in 2024. PCSK9 Inhibitors sales flourish due to the high prevalence of diabetes and obesity.
• The Egypt PCSK9 Inhibitors market is projected to witness growth at a CAGR of 19.0% during the forecast period, with a market size of USD 6.12 million in 2024.
• The South Africa PCSK9 Inhibitors market is projected to witness growth at a CAGR of 19.7% during the forecast period, with a market size of USD 9.21 million in 2024. PCSK9 Inhibitors sales flourished in South Africa due to South Africa's growing middle class has a greater chance of being able to pay for cutting-edge medical procedures like PCSK9 inhibitors.
• The Turkey PCSK9 Inhibitors market is projected to witness growth at a CAGR of 18.2% during the forecast period, with a market size of USD 5.01 million in 2024.
• The Nigeria PCSK9 Inhibitors market is projected to witness growth at a CAGR of 17.8% during the forecast period, with a market size of USD 6.12 million in 2024.
• The Rest of the MEA PCSK9 Inhibitors market is projected to witness growth at a CAGR of 17.7% during the forecast period, with a market size of USD 6.88 million in 2024.

PCSK9 Inhibitors Market Analysis

How are Segments Performing in the Global PCSK9 Inhibitors Market?

PCSK9 Inhibitors Market Drug Segment Analysis

According to Cognitive Market Research, alirocumab is likely to dominate the PCSK9 Inhibitors Market over the forecast period. The demand for Alirocumab, a well-known PCSK9 inhibitor that is sold under the brand names Praluent by Sanofi and Regeneron, has increased because of its ability to cut LDL cholesterol and lower the risk of cardiovascular disease. Its use is more common among patients who are statin-resistant or have familial hypercholesterolemia. Growing awareness of lipid problems, the incidence of cardiovascular disease, and the drug's approval for new indications are the main factors driving demand for the medication. It is anticipated that Alirocumab will continue to gain traction in the worldwide PCSK9 inhibitors market due to its favorable clinical outcomes and continuous marketing initiatives.

The inclisiran is the fastest-growing segment in the PCSK9 Inhibitors Market. This is due to the fact that Novartis marketed it under the brand name Leqvio, and inclisiran is quickly increasing its market share among PCSK9 inhibitors due to its unique method of action and prolonged dosing schedule. Other PCSK9 inhibitors that need frequent injections have poorer patient compliance than Inclisiran, which is administered twice a year after an initial dosage and a follow-up. Because of its ability to effectively lower LDL cholesterol levels, particularly in individuals who are at high cardiovascular risk or statin-resistant, it is in high demand. As usage and awareness of PCSK9 inhibitors rise, inclisiran is expected to play a major role in the market's growth globally.

The above Chart is for representative purposes and does not depict actual sale statistics. Access/Request the quantitative data to understand the trends and dominating segment of PCSK9 Inhibitors Industry. Request a Free Sample PDF!

PCSK9 Inhibitors Market Modality Segment Analysis

According to Cognitive Market Research, the fully humanized monoclonal antibodies segment holds the largest share of the market. The market for PCSK9 inhibitors is seeing a rise in demand for fully humanized monoclonal antibodies because of their superior selectivity and lower immunological reaction as compared to non-humanized antibodies. By targeting and inhibiting the PCSK9 protein, these biologics—which include medications like Alirocumab (Praluent) and Evolocumab (Repatha)—effectively cut LDL cholesterol levels and lower the risk of cardiovascular disease. Patients with high cholesterol prefer fully humanized monoclonal antibodies because they have better safety profiles, longer half-lives, and fewer side effects. The demand for this method in the PCSK9 inhibitors market is being driven by their increasing use in the treatment of high-risk cardiovascular patients.

In the PCSK9 Inhibitors Market, the siRNA has been expanding at a rapid pace. The market for PCSK9 inhibitors is seeing an increase in demand for siRNA (small interfering RNA) modalities, especially as medications like Inclisiran (Leqvio) are developed. Through the silencing of the PCSK9 gene, siRNA-based therapies stop the creation of the PCSK9 protein, which boosts LDL cholesterol levels. This new method requires fewer doses, usually only twice a year after first treatment, and produces longer-lasting effects than conventional monoclonal antibodies. It is anticipated that the siRNA method will be crucial in increasing therapy options for patients with excessive cholesterol and cardiovascular risks as the market moves toward more practical, long-lasting medicines.

The above Graph is for representation purposes only. This chart does not depict actual Market share.

PCSK9 Inhibitors Indication Outlook: Segment Analysis

PCSK9 Inhibitors Market Indication Segment Analysis

According to Cognitive Market Research, the primary hyperlipidemia segment holds the largest market share. The need for PCSK9 inhibitors to treat primary hyperlipidemia is growing since these medications successfully reduce the excessive levels of LDL cholesterol in this illness. High cholesterol levels that are uncontrollable by lifestyle modifications alone are the result of primary hyperlipidemia, which is frequently brought on by genetic causes such as familial hypercholesterolemia. Patients with this illness, particularly those who do not respond well to statins, have a significant therapeutic alternative in PCSK9 inhibitors like evolocumab and alirocumab. In primary hyperlipidemia, the need for PCSK9 inhibitors is being driven by the increasing awareness of how important it is to control cholesterol.

In the PCSK9 Inhibitors market, the rapidly growing sector is the familial hypercholesterolemia category. Due to PCSK9 inhibitors' ability to effectively lower LDL cholesterol levels, which are markedly high in patients with familial hypercholesterolemia (FH), there is an increasing need for these medications in the treatment of FH. FH is a hereditary condition that raises the risk of early cardiovascular illnesses by causing excessive cholesterol from birth. For FH patients who are statin-resistant or unable to tolerate statins, PCSK9 inhibitors such as evolocumab and alirocumab are especially helpful. The need for PCSK9 inhibitors in this indication, which provides improved cholesterol management, is being driven by the growing number of FH diagnoses and the need for efficient treatments.

• Primary Hyperlipidemia
• Familial Hyper Cholesterolemia
• Prevention of Other Cardiovascular Events

PCSK9 Inhibitors Sales Channel Outlook: Segment Analysis

PCSK9 Inhibitors Market Sales Channel Segment Analysis

According to Cognitive Market Research, the hospital segment dominates the market. Because PCSK9 inhibitors are frequently administered to high-risk cardiovascular patients in hospital settings, the hospital sales channel is vital to the industry. For individuals who need specialist care due to severe hypercholesterolemia or cardiovascular disorders, hospitals are important points of care. PCSK9 inhibitors, such as alirocumab and evolocumab, are given under a doctor's supervision, frequently in hospital stays or outpatient clinics. The need for PCSK9 inhibitors through this channel is anticipated to increase as hospitals concentrate on cutting-edge lipid-lowering treatments for high-risk patients, which will support the market's overall growth.

Specialty clinics are projected to be the fastest-growing segment in the PCSK9 Inhibitors market. Because specialty clinics offer specialized treatment for patients with complex lipid disorders, including severe hyperlipidemia and familial hypercholesterolemia, they constitute a significant sales channel for the PCSK9 inhibitors industry. These clinics frequently serve patients who need cutting-edge treatments like PCSK9 inhibitors and provide individualized treatment strategies. The need for PCSK9 inhibitors in specialized clinics is growing as lipid problems are being more widely recognized and diagnosed, especially for individuals who don't react to standard treatments like statins. These treatments are anticipated to play a bigger part in propelling market expansion as more specialty clinics use them.

• Hospitals
• Specialty Clinics
• Retail Pharmacies
• Online Pharmacies

Author's Detail

Manjiri Kanhere

Senior Research Associate at Cognitive Market Research

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Manjiri Kanhere is an experienced market researcher focused on the Pharma & Healthcare industry. With over 3+ years of experience, She has worked with major pharmaceutical companies and healthcare providers, helping them to understand market trends, identify new business opportunities, and develop effective sales & marketing strategies. Her expertise lies in the ability to analyze complex data sets and deliver insights that drive business decisions. At Cognitive Market Research, she handles the market research related to Pharma and healthcare industry.

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