PCSK9 inhibitors are monoclonal antibody therapy drugs that lower LDL or "bad" cholesterol levels in the blood by blocking a protein called PCSK9. PCSK9 inhibitors work by binding to PCSK9 and preventing it from interacting with LDL receptors in the liver, allowing more LDL receptors to remain on the surface of liver cells. This increases the ability of the liver to remove LDL-C from the bloodstream, significantly lowering LDL-C levels by 50-60%. PCSK9 inhibitors are recommended as adjunct to diet and maximally tolerated statin therapy for patients who require additional lowering of LDL-C.  

The PCSK9 inhibitors market is estimated to be valued at USD 2.44 Bn in 2024 and is expected to reach USD 6 Bn by 2031, growing at a compound annual growth rate (CAGR) of 16.2% from 2024 to 2031.


Key Takeaways

Key players operating in the PCSK9 Inhibitors market are Amgen, Sanofi, Novartis. Amgen's Repatha was one of the first approved PCSK9 inhibitors in 2015.

The growing prevalence of cardiovascular diseases across the world is a major factor driving the demand for PCSK9 Inhibitors. As per WHO, cardiovascular diseases are the number 1 cause of death globally, taking an estimated 17.9 million lives each year.

Technological advancements like new drug delivery mechanisms are helping to improve treatment efficacy and compliance rates for PCSK9 inhibitor drugs. Biologics manufacturers are developing more patient-friendly delivery options like auto-injectors to provide convenient home administration.

Market Trends

Increasing use of combination therapies: Recent clinical trials showed that combining PCSK9 inhibitors with other lipid-lowering drugs provides additional benefits. This has led to their increased use along with statins and Ezetimibe.

Focus on real-world evidence: Manufacturers are conducting extensive real-world studies to establish effectiveness and safety of PCSK9 inhibitors in various patient subgroups treated in real clinical practice. This helps expand the eligible patient population.

Market Opportunities

Emerging markets: Countries like China and India with huge cardiovascular disease burden offer significant growth opportunities for PCSK9 inhibitors owing to increasing healthcare spending capability.

Reduced prices: Expected loss of patents during 2023-25 period will enable introduction of lower-cost biosimilars and increase affordability of PCSK9 therapy in developing regions. This will help tap into the vast unmet need.

Impact of COVID-19 on PCSK9 Inhibitors Market Growth

The outbreak of COVID-19 pandemic has significantly impacted the growth of PCSK9 inhibitors market globally. During the initial phase of pandemic, the demand for PCSK9 inhibitors like alirocumab and evolocumab witnessed a decline as many patients avoided healthcare facilities due to the risk of virus exposure. Furthermore, manufacturing and supply chain disruptions hampered their production and distribution.

However, as the pandemic continued, the vulnerable patients suffering from cardiovascular diseases and other co-morbid conditions continued their treatment to manage cholesterol levels and reduce complications. The healthcare providers adopted telemedicine practices to help high-risk cardiovascular patients with remote monitoring and prescription refills. The pharmaceutical firms also implemented strategies like home delivery services to ensure an uninterrupted supply of essential drugs.

With the ongoing mass vaccination drives and gradual resumption of regular healthcare services, the market is expected to regain its pre-pandemic growth levels in the coming years. The key players are focusing on strengthening the supply infrastructure and digital healthcare systems to deal with any future emergencies. There is an increased focus on research related to vaccines, testing, and therapeutics for COVID-19 patients with cardiovascular conditions requiring lipid-lowering therapies.

Geographical Regions with Highest Market Concentration

The United States represents the largest market for PCSK9 inhibitors globally, accounting for over 60% of the total revenue. With a high prevalence of hypercholesterolemia and cardiovascular diseases, the US witnesses huge demand for potent lipid-lowering medications. Europe is the second major region concentrated with this market, majorly driven by markets of Germany, France, Italy, and the UK.

Fastest Growing Regional Market

The Asia Pacific region has emerged as the fastest growing market for PCSK9 inhibitors market in recent years. Factors such as increasing healthcare expenditures, growing geriatric population, and rising prevalence of cardiovascular disease risk factors are fueling the market growth. Additionally, improved access to diagnosis and treatment, coupled with presence of less stringent regulations compared to developed markets, provides impetus to market expansion. China and Japan individually account for over 30% of APAC's PCSK9 inhibitors market owing to their large patient pools and enhancing healthcare infrastructure.

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Ravina Pandya, Content Writer, has a strong foothold in the market research industry. She specializes in writing well-researched articles from different industries, including food and beverages, information and technology, healthcare, chemical and materials, etc.

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