세계의 PCSK9 저해제 시장 보고서(2025년)
PCSK9 Inhibitor Global Market Report 2025
상품코드 : 1810993
리서치사 : The Business Research Company
발행일 : On Demand Report
페이지 정보 : 영문 250 Pages
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한글목차

PCSK9 저해제 시장 규모는 향후 수년간 비약적인 성장이 전망됩니다. 2029년에는 CAGR 20.6%로 68억 7,000만 달러로 성장합니다. 예측 기간 중의 성장은 병용요법 채택 증가, 고위험군 환자의 저비중 지단백 콜레스테롤 감소에 대한 관심 증가, 차세대 PCSK9 억제제 파이프라인 확대, 신흥 시장에서의 보급 확대, 심혈관 질환 예방을 위한 헬스케어 구상 증가 등에 기인할 것으로 보입니다. 이 기간 중 예상되는 주요 동향으로는 리보핵산 기반 PCSK9 치료제의 발전, 환자 순응도를 높이는 전달 메커니즘의 개선, 혁신적인 지질 관리 플랫폼의 통합, 디지털 건강 모니터링 툴의 발전, 첨단 바이오마커 기반 치료 접근법 개발 등이 있습니다.

고지혈증 유병률 증가는 향후 수년간 PCSK9 억제제 시장의 성장을 촉진할 것으로 예측됩니다. 고지혈증은 혈중 콜레스테롤, 중성지방 등 지질 농도가 높아져 심혈관 질환의 위험이 높아지는 질환입니다. 고지혈증은 혈중 콜레스테롤, 중성지방 등 지질 농도가 높아져 심혈관 질환의 위험을 높이는 질환입니다. PCSK9 억제제는 혈류에서 과도한 LDL 콜레스테롤을 제거하는 간 기능을 향상시키고 지질 프로파일을 개선하여 고지혈증 관리에 도움을 줄 수 있습니다. 예를 들어 2024년 12월 영국의 Office for Health Improvement and Disparities는 2023년 영국에서 약 188만 명(3%)이 선천성 심장병(CHD) 진단을 받았다고 보고했습니다. 또한 호주 통계청은 2023년 12월 고콜레스테롤 비율이 18-34세 1.1%에서 75세 이상 29.0%로 급증할 것으로 전망하고 있습니다. 이처럼 고지혈증 유병률 증가는 PCSK9 억제제 시장 확대에 박차를 가하고 있습니다.

PCSK9 억제제 시장의 주요 기업은 고위험 심혈관 환자의 LDL 콜레스테롤 수치를 영구적으로 낮추는 장기적 또는 일회성 솔루션을 제공하기 위해 생체내 유전자 치료와 같은 최첨단 치료법을 개발하고 있습니다. In vivo 유전자 치료는 환자의 체내에 유전물질을 직접 주입하여 표적 세포내 결함 유전자를 교정 또는 대체함으로써 질병의 발생원에서 치료 효과를 창출합니다. 예를 들어 2025년 4월 미국 임상 단계 기업인 Verve Therapeutics는 VERVE-102의 Heart-2 Phase 1b 임상 1b 시험에서 유망 초기 결과를 얻었다고 발표했습니다. 이 시험은 LDL 콜레스테롤의 대폭적이고 지속적인 감소가 필요한 질환인 이형접합 가족성 고콜레스테롤혈증(HeFH)과 조기 관상동맥질환(CAD) 환자에 초점을 맞췄습니다. VERVE-102의 단회 투여는 PCSK9 단백질과 LDL-C 수치를 용량 의존적으로 감소시켰으며, 0.6mg/kg 투여군에서는 평균 53%의 LDL 콜레스테롤 감소를 경험했고, 일부 환자는 69%까지 감소했습니다. 이러한 결과는 VERVE-102가 매우 효과적인 콜레스테롤 저하 치료제로서의 가능성을 보여줍니다.

목차

제1장 개요

제2장 시장의 특징

제3장 시장 동향과 전략

제4장 시장 : 금리, 인플레이션, 지정학, 무역 전쟁과 관세 및 Covid와 회복이 시장에 미치는 영향을 포함한 거시경제 시나리오

제5장 세계의 성장 분석과 전략 분석 프레임워크

제6장 시장 세분화

제7장 지역별·국가별 분석

제8장 아시아태평양 시장

제9장 중국 시장

제10장 인도 시장

제11장 일본 시장

제12장 호주 시장

제13장 인도네시아 시장

제14장 한국 시장

제15장 서유럽 시장

제16장 영국 시장

제17장 독일 시장

제18장 프랑스 시장

제19장 이탈리아 시장

제20장 스페인 시장

제21장 동유럽 시장

제22장 러시아 시장

제23장 북미 시장

제24장 미국 시장

제25장 캐나다 시장

제26장 남미 시장

제27장 브라질 시장

제28장 중동 시장

제29장 아프리카 시장

제30장 경쟁 구도와 기업 개요

제31장 기타 대기업과 혁신적 기업

제32장 세계의 시장 경쟁 벤치마킹과 대시보드

제33장 주요 합병과 인수

제34장 최근 시장 동향

제35장 시장 잠재력이 높은 국가, 부문, 전략

제36장 부록

KSA
영문 목차

영문목차

PCSK9 inhibitors are medications that lower LDL cholesterol by preventing the PCSK9 protein from breaking down LDL receptors on liver cells. By blocking PCSK9, these inhibitors improve the liver's capacity to clear low-density lipoprotein cholesterol, thus reducing blood cholesterol levels and lowering the risk of cardiovascular diseases.

The primary types of PCSK9 inhibitor drugs include alirocumab, evolocumab, inclisiran, bococizumab, and others. Alirocumab is a fully human monoclonal antibody that inhibits PCSK9 to reduce LDL cholesterol levels in patients with hypercholesterolemia. The various routes of administration include oral, subcutaneous injection, and intravenous injection. The modalities are categorized into fully humanized monoclonal antibodies and small interfering RNA (siRNA). These drugs have multiple applications, such as treating hypercholesterolemia, hyperlipidemia, preventing cardiovascular disease, and familial hypercholesterolemia, and are distributed through hospitals, specialty clinics, retail pharmacies, and online pharmacies.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report's Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The sudden escalation of U.S. tariffs and the consequent trade frictions in spring 2025 are severely impacting the pharmaceutical companies contend with tariffs on APIs, glass vials, and lab equipment inputs with few alternative sources. Generic drug makers, operating on razor-thin margins, are especially vulnerable, with some reducing production of low-profit medicines. Biotech firms face delays in clinical trials due to tariff-related shortages of specialized reagents. In response, the industry is expanding API production in India and Europe, increasing inventory stockpiles, and pushing for trade exemptions for essential medicines.

The PCSK9 inhibitors market research report is one of a series of new reports from The Business Research Company that provides PCSK9 inhibitors market statistics, including the PCSK9 inhibitors industry global market size, regional shares, competitors with the PCSK9 inhibitors market share, detailed PCSK9 inhibitors market segments, market trends, and opportunities, and any further data you may need to thrive in the PCSK9 inhibitors industry. This PCSK9 inhibitors market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.

The PCSK9 inhibitor market size has grown exponentially in recent years. It will grow from $2.68 billion in 2024 to $3.24 billion in 2025 at a compound annual growth rate (CAGR) of 20.9%. The growth observed during the historic period can be attributed to an increasing geriatric population, heightened research and development investments in lipid-lowering therapies, a rise in FDA approvals for PCSK9 inhibitors, expanding strategic collaborations, and growing demand for personalized medicine in cardiovascular care.

The PCSK9 inhibitor market size is expected to see exponential growth in the next few years. It will grow to $6.87 billion in 2029 at a compound annual growth rate (CAGR) of 20.6%. The growth during the forecast period can be attributed to the increasing adoption of combination therapies, a rising focus on lowering low-density lipoprotein cholesterol in high-risk patients, an expanding pipeline of next-generation PCSK9 inhibitors, greater penetration in emerging markets, and growing healthcare initiatives aimed at cardiovascular disease prevention. Major trends expected in this period include advancements in ribonucleic acid-based PCSK9 therapies, improved delivery mechanisms to enhance patient compliance, integration of innovative lipid management platforms, progress in digital health monitoring tools, and the development of advanced biomarker-driven treatment approaches.

The rising prevalence of hyperlipidemia is expected to drive the growth of the PCSK9 inhibitor market in the coming years. Hyperlipidemia is a condition marked by elevated levels of lipids, such as cholesterol and triglycerides, in the blood, which increases the risk of cardiovascular diseases. This increase in prevalence is largely attributed to aging populations, as cholesterol levels typically rise significantly after age 45. PCSK9 inhibitors assist in managing hyperlipidemia by boosting the liver's capacity to remove excess LDL cholesterol from the bloodstream, improving lipid profiles. For example, in December 2024, the Office for Health Improvement and Disparities in the UK reported that about 1.88 million people (3%) in England were diagnosed with congenital heart disease (CHD) in 2023. Additionally, the Australian Bureau of Statistics noted in December 2023 that high cholesterol rates sharply rise from 1.1% among individuals aged 18-34 to 29.0% in those aged 75 and older. Thus, the growing prevalence of hyperlipidemia is fueling expansion in the PCSK9 inhibitor market.

Key players in the PCSK9 inhibitor market are developing cutting-edge treatments like in vivo gene therapy to offer long-lasting or one-time solutions that permanently reduce LDL cholesterol levels in high-risk cardiovascular patients. In vivo gene therapy involves directly delivering genetic material into the patient's body to modify or replace defective genes within targeted cells, producing therapeutic effects at the disease source. For instance, in April 2025, Verve Therapeutics Inc., a US-based clinical-stage company, announced promising early results from its Heart-2 Phase 1b trial of VERVE-102. This trial focuses on patients with heterozygous familial hypercholesterolemia (HeFH) and premature coronary artery disease (CAD), conditions that require significant and sustained LDL cholesterol reduction. A single dose of VERVE-102 produced dose-dependent reductions in PCSK9 protein and LDL-C levels, with the 0.6 mg/kg group experiencing an average LDL cholesterol decrease of 53%, and some patients achieving up to 69% reduction. These outcomes demonstrate VERVE-102's potential as a highly effective cholesterol-lowering therapy.

In March 2024, Lib Therapeutics, a US-based biopharmaceutical company, partnered with Hasten Biopharmaceuticals to commercialize the PCSK9 inhibitor LIB003 in China. This collaboration aims to speed up the clinical development and regulatory approval of lerodalcibep in China by utilizing Hasten Biopharmaceuticals' expertise in the country's regulatory environment and market conditions, thereby advancing a new treatment option for patients with hypercholesterolemia. Hasten Biopharmaceuticals Co., Ltd. is a China-based firm specializing in clinical development, drug manufacturing, and progressing the clinical trial application for lerodalcibep.

Major players in the pcsk9 inhibitor market are Merck & Co. Inc., Sanofi S.A, AstraZeneca plc, Novartis AG, Amgen Inc., Regeneron Pharmaceuticals Inc., Astellas Pharma Inc., Dr. Reddy's Laboratories Ltd., Alnylam Pharmaceuticals Inc., Ionis Pharmaceuticals Inc., Innovent Biologics Inc., Shanghai Junshi Biosciences Co. Ltd., Akeso Inc., Verve Therapeutics Inc., LIB Therapeutics LLC, CiVi Biopharma Inc., CVI Pharmaceuticals Ltd., Vaxxinity Inc., Jiangsu Hengrui Pharmaceuticals Co. Ltd., Shenyang Xinlitai Pharmaceutical Co. Ltd.

North America was the largest region in the PCSK9 inhibitor market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in PCSK9 inhibitor report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.

The countries covered in the PCSK9 inhibitor market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The PCSK9 inhibitor market consists of sales of monoclonal antibodies, sirna therapies, small molecule inhibitors, and peptide-based inhibitors. Values in this market are 'factory gate' values, that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values and are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

PCSK9 Inhibitor Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.

This report focuses on pcsk9 inhibitor market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.

Reasons to Purchase

Where is the largest and fastest growing market for pcsk9 inhibitor ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The pcsk9 inhibitor market global report from the Business Research Company answers all these questions and many more.

The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.

The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.

Scope

Table of Contents

1. Executive Summary

2. PCSK9 Inhibitor Market Characteristics

3. PCSK9 Inhibitor Market Trends And Strategies

4. PCSK9 Inhibitor Market - Macro Economic Scenario Including The Impact Of Interest Rates, Inflation, Geopolitics, Trade Wars and Tariffs, And Covid And Recovery On The Market

5. Global PCSK9 Inhibitor Growth Analysis And Strategic Analysis Framework

6. PCSK9 Inhibitor Market Segmentation

7. PCSK9 Inhibitor Market Regional And Country Analysis

8. Asia-Pacific PCSK9 Inhibitor Market

9. China PCSK9 Inhibitor Market

10. India PCSK9 Inhibitor Market

11. Japan PCSK9 Inhibitor Market

12. Australia PCSK9 Inhibitor Market

13. Indonesia PCSK9 Inhibitor Market

14. South Korea PCSK9 Inhibitor Market

15. Western Europe PCSK9 Inhibitor Market

16. UK PCSK9 Inhibitor Market

17. Germany PCSK9 Inhibitor Market

18. France PCSK9 Inhibitor Market

19. Italy PCSK9 Inhibitor Market

20. Spain PCSK9 Inhibitor Market

21. Eastern Europe PCSK9 Inhibitor Market

22. Russia PCSK9 Inhibitor Market

23. North America PCSK9 Inhibitor Market

24. USA PCSK9 Inhibitor Market

25. Canada PCSK9 Inhibitor Market

26. South America PCSK9 Inhibitor Market

27. Brazil PCSK9 Inhibitor Market

28. Middle East PCSK9 Inhibitor Market

29. Africa PCSK9 Inhibitor Market

30. PCSK9 Inhibitor Market Competitive Landscape And Company Profiles

31. PCSK9 Inhibitor Market Other Major And Innovative Companies

32. Global PCSK9 Inhibitor Market Competitive Benchmarking And Dashboard

33. Key Mergers And Acquisitions In The PCSK9 Inhibitor Market

34. Recent Developments In The PCSK9 Inhibitor Market

35. PCSK9 Inhibitor Market High Potential Countries, Segments and Strategies

36. Appendix

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