세계의 지질 저하약 시장 규모는 2023년 303억 달러에서 2031년에 384억 7,000만 달러에 달할 것으로 예측되며, 2024-2031년의 예측 기간에 CAGR로 3.03%의 성장이 전망됩니다. 시장은 심장질환의 유병률 증가, 조기 진단 및 적절한 치료 요법에 대한 중요성 증가, 의료 이해 관계자의 심장 건강에 대한 관심과 이 분야에 대한 투자, 규제 정책 개선으로 인해 더 빠른 속도로 확대될 것으로 예상됩니다.
지질 강하제는 혈중 콜레스테롤과 중성지방을 낮추어 심혈관 질환을 예방하고 지질 장애를 관리하는 데 도움이 됩니다. 고지혈증 치료제 또는 고지혈증 치료제로도 알려져 있습니다. 좌식 생활 습관, 건강에 해로운 음식 선택, 스트레스로 인한 심혈관 질환의 유병률 증가가 이러한 약물의 주요 시장 수요로 작용하고 있습니다. 시장 확대의 주요 장애물은 기존 약물의 보급과 새로운 치료 옵션의 채택률의 불일치로 인한 긴장감입니다. 2024년 3월, Esperion Therapeutics, Inc.는 자사의 고지혈증 치료제 NEXLETOL(베메페도산)과 NEXLIZET(베메페도산, 에제티미브)의 적응증 확대가 미국 식품의약국(FDA)으로부터 승인받았다고 밝혔습니다.의 적응증 확대가 미국 식품의약국(USFDA)의 승인을 받았다고 발표했습니다. 이번 승인은 스타틴 사용 여부와 관계없이 1차 예방 및 이차 예방 환자들의 심혈관 위험 감소를 위해 사용할 수 있도록 허용하는 것입니다. 이로써 대상 환자군이 약 7,000만 명으로 확대되어 비스타틴 계열 LDL-C 저감 요법에 큰 진전을 이룰 것으로 기대됩니다.
세계의 지질 저하약 시장에 대해 조사분석했으며, 시장 규모와 예측, 시장 역학, 주요 기업의 상황 등을 제공하고 있습니다.
Global lipid-lowering drugs market is projected to witness a CAGR of 3.03% during the forecast period 2024-2031, growing from USD 30.30 billion in 2023 to USD 38.47 billion in 2031. The market of lipid-lowering drugs is anticipated to expand at a faster pace owing to the rising prevalence of cardiac diseases, the growing emphasis on early diagnosis, and proper treatment regimens, coupled with healthcare stakeholders' attention towards heart health through investment in the field, and improved regulatory policies.
Lipid-lowering drugs help lower cholesterol and triglycerides in the blood, prevent cardiovascular diseases, and manage lipid disorders. They are also known as hyperlipidemia drugs or antihyperlipidemic drugs. The rising prevalence of cardiovascular diseases caused by sedentary lifestyles, unhealthy food choices, and stress is the primary market demand for such drugs. The primary hurdle for the expansion of this market is the tension between the widespread utilization of conventional drugs and novel treatment options owing to a mismatch in the adoption rate. However, the new drugs' regulatory approvals are expected to offer new market opportunities and enable market growth. In March 2024, Esperion Therapeutics, Inc. announced that the USFDA approved expanded labels for its lipid-lowering drugs, NEXLETOL (bempedoic acid) and NEXLIZET (bempedoic acid and ezetimibe). These approvals allow their use for cardiovascular risk reduction in primary and secondary prevention patients, regardless of statin use. It broadens the eligible patient population to approximately 70 million, significantly advancing in non-statin LDL-C lowering therapies.
High Cardiovascular Disease Burden to Boost Demand for Lipid-lowering Drugs
High lipid levels, especially high LDL cholesterol and triglycerides, trigger the development of cardiovascular diseases by promoting atherosclerosis. Hailed by increasing cases of cardiac diseases from lifestyles such as diet, sedentary lifestyle, and obesity, the need for lipid-lowering medications is profoundly greater than ever. Increasing prescriptions for statins and other lipid-modifying therapies to manage cholesterol and attenuate cardiovascular risk is expected to accelerate growth in the market for lipid-lowering drugs. Improvements in treatment options and personalized medicine further drive the ever-growing trend as healthcare providers seek more effective alternatives to combat the growing epidemic of rising lipid levels. For instance, according to an article published in Circulation Journal in June 2024, the prevalence of hypertension is projected to increase from 51.2% in 2020 to 61.0% in 2050. It is estimated that the prevalence of poor diet, inadequate physical activity, and smoking will improve over time, while inadequate sleep will worsen. Additionally, the prevalence of coronary disease, heart failure, stroke, atrial fibrillation, and total cardiovascular disease are expected to increase. Clinical cardiovascular diseases (CVD) are projected to affect 45 million adults, and CVD, including hypertension, will affect more than 184 million adults by 2050, which is more than 61% of the population.
Robust Drug Development Pipeline to Drive Market Growth
A strong drug development pipeline is one of the growth drivers in the market for lipid-lowering drugs. New research and results of clinical trials have led to the arrival of novel therapies answering different types of patient needs, such as genetic lipid disorders and intolerance to traditional statin therapy. Emerging classes of drugs, including PCSK9 inhibitors and other novel agents, provide efficient treatment alternatives. Personalization gets its stronghold in the ready availability of bespoke therapies, supported through genetic profiles, improving patient outcomes and compliance. The greater focus on preventive health care further helps add to the demand for effective solutions to manage lipids, ensuring a strong pipeline converts into significant market growth. For instance, in April 2024, Verve Therapeutics, Inc. announced updates on its PCSK9 program, highlighting the Heart-1 clinical trial of VERVE-101, which showed LDL-C reductions of up to 73%. However, the enrollment was paused due to safety concerns related to a participant. The company will prioritize VERVE-102, which uses a different delivery system and is set to enter the Heart-2 trial in Q2 2024, focusing on lipid-lowering treatments.
Statins and Combinations to Dominate the Lipid-lowering Drugs Market Share
The segment of statins and combinations holds the largest share of the lipid-lowering drugs market as they are proven to be effective and widely used, besides having significant clinical support. Atorvastatin and rosuvastatin are examples of effective statins that decrease the levels of LDL cholesterol and mean a substantial reduction in cardiovascular events. They have a long-proven record and are firmly embedded in preventive medicine. Also, the economic nature of generic statins supports their usability among healthcare providers and patients, enabling access to treatment for a larger population. Moreover, in the context of developing recognition of benefits beyond lipid-lowering, research is still ongoing on the anti-inflammatory properties of statins, making them more appealing. Therefore, with continuous improvement of the formulation and dosage of formulations, the segment of statins remains the core of lipid management by ensuring its dominance in the market for the foreseeable future. As per an article published in August 2024 in the Canadian Journal of Cardiology and several other literary sources, statins are proven to lower LDL-C levels ranging from 20%-60%, positioning them to be highly effective in the lipid-lowering drug category.
North America to Dominate the Lipid-lowering Drugs Market Share
The presence of several key factors, such as the high prevalence of cardiovascular diseases and obesity, leading North America to dominate the market for lipid-lowering drugs. The healthcare infrastructure is well established, with easy access to medical services that ensure timely diagnosis and treatment of hyperlipidemia. There is increased awareness of cardiovascular health among the population, leading to proactive screening and adherence to prescribed therapies. Major pharmaceutical companies in North America are fueling innovation by introducing new lipid-lowering medications. Additional factors favorable to the patient on lipid-lowering drugs are policies and insurance coverage for reimbursement. The regulatory initiatives from the USFDA further strengthen the market growth rate in the region. For instance, in March 2024, Regeneron Pharmaceuticals, Inc. announced that the USFDA extended the approval of Praluent (alirocumab) as an adjunct to diet and other low-density lipoprotein cholesterol (LDL-C) lowering therapies to include pediatric patients aged 8 and older with heterozygous familial hypercholesterolemia (HeFH).
Future Market Scenario (2024 - 2031F)
Recent advancements in the development of lipid-lowering drugs are changing the face of the cardiovascular market. Among these, emerging therapies targeting multiple pathways beyond the usual statins meet major needs in managing dyslipidemia. New molecules, like bempedoic acid and inclisiran, represent novel approaches. Bempedoic acid selectively inhibits cholesterol synthesis in the liver and makes it unable to synthesize cholesterol. In contrast, inclisiran is a siRNA that drastically lowers levels of LDL-C at very infrequent dosing. In addition, drugs targeting ANGPTL3 and ApoC-III for reduction in triglycerides and lipoprotein(a) may further change the management of patients resistant to treatments in use. All these developments are bound to impact market growth as they expand the array of treatments that are being put at the disposal of patients with a high cardiovascular risk profile. The new agents enhance the management of lipids and indicate atherosclerotic event reduction, therefore improving patient compliance and demand on the market.
Key Players Landscape and Outlook
The market players involved in manufacturing lipid-lowering drugs range from local generic drug producers to global pharmaceutical giants fragmenting the market. However, there are many market players, branded drugs, such as Repatha from Amgen Inc., attract a significant market share in terms of revenue. Recent activities in the market include regulatory initiatives, manufacturing collaborations, and acquisitions.
In October 2024, AstraZeneca announced an exclusive license agreement with CSPC Pharmaceutical Group Ltd to fasten the development of YS2302018, a novel lipid-lowering asset targeting lipoprotein(a) CSPC. This collaboration aims to develop therapies that can significantly reduce cardiovascular disease risk associated with elevated lipoprotein(a) levels. The agreement underscores AstraZeneca's commitment to advancing innovative treatments in cardiovascular health, potentially enhancing its portfolio in lipid management.
In May 2024, Click Therapeutics, Inc. announced its expansion into obesity and cardiometabolic diseases through the acquisition of Better Therapeutics, Inc.'s assets, including the FDA-authorized AspyreRx for type 2 diabetes, and the development of candidates, such as BT-002, BT-003, and BT-004, for hyperlipidemia and metabolic dysfunction-associated steatohepatitis (MASH). The focus will be on developing AspyreRx for obesity treatment and optimizing it alongside anti-obesity medications. This initiative aims to enhance patient outcomes and leverage AI-enabled platforms for personalized care in chronic weight management and related conditions.
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Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.