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시장보고서
상품코드
2128003
출혈성 질환 검사 시장 : 규모, 점유율, 성장, 산업 분석, 지역별 동향 및 예측(2026-2034년)Bleeding Disorder Testing Market Size, Share, Growth, Global Industry Analysis, Regional Insights and Forecast to 2026-2034 |
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출혈성 질환 검사 시장의 성장 요인
세계 출혈성 질환 검사 시장은 2025년에 1억 980만 달러 규모에 달하고, 2026년 1억 1,839만 달러에서 2034년에는 2억 2,220만 달러로 성장할 것으로 예측 기간 동안 연평균 성장률(CAGR) 8.19%를 나타낼 것으로 전망됩니다. 2025년에는 선진적인 의료 인프라, 진단 기술의 보급, 그리고 유전성 출혈성 질환에 대한 인식 제고에 힘입어 유럽이 40.25%라는 최대 시장 점유율을 차지했습니다.
A형 혈우병, B형 혈우병, 폰 빌레브란트병, 특발성 혈소판 감소성 자반증 등의 출혈성 질환은 심각한 합병증을 예방하기 위해 조기 진단이 필요합니다. 이러한 질환의 유병률 증가와 더불어 임상 검사 진단 기술의 발전이 맞물리면서 전 세계적으로 전문적인 검사 솔루션에 대한 수요가 견인되고 있습니다. 자동 분석기, 시약, AI를 활용한 진단 플랫폼의 지속적인 개선이 시장 확대를 더욱 뒷받침하고 있습니다.
시장 동향
인공지능(AI)과 첨단 진단 기술의 통합이 시장 성장을 주도
출혈성 질환 검사 시장에서는 인공지능(AI), 머신러닝(ML) 및 자동화 검사 시스템의 통합을 통해 급속한 기술 혁신이 진행되고 있습니다. AI를 활용한 진단 플랫폼은 검사 시간을 단축하고 인적 오류를 줄이면서 질환 감지 정확도를 높이고 있습니다. 또한, 나노기술에 기반한 진단 기술과 고처리량 분석 장치의 혁신으로 인해, 검사실에서는 더욱 신속하고 신뢰성 높은 응고 검사를 실시할 수 있게 되었습니다.
주요 제조업체들도 병원 및 검사실의 워크플로우 효율화를 도모하기 위해 첨단 지혈 분석 장치와 자동화 진단 솔루션을 도입하고 있습니다.
시장 성장 촉진요인
출혈성 질환 유병률 상승이 검사 수요를 견인
유전성 출혈성 질환의 발생률 증가는 여전히 이 시장의 가장 강력한 성장 요인 중 하나입니다. 전 세계 의료 기관에 따르면, 인식 제고와 선별 검사 프로그램의 개선으로 인해 혈우병 및 폰 빌레브란트병으로 진단받는 환자 수는 계속 증가하고 있습니다. 정부, 의료 기관, 환자 지원 단체는 인식 제고 캠페인과 최신 임상 지침을 통해 조기 진단을 적극적으로 추진하고 있습니다.
특히 신흥 경제국에서의 의료 인프라 투자 확대에 힘입어 진단 검사 서비스에 대한 접근성이 더욱 확대되고 있습니다.
시장 확장을 뒷받침하는 지속적인 제품 혁신
각 진단 기기 제조업체들은 첨단 응고 분석기, 검사 키트, 소모품을 시장에 출시하기 위해 연구 개발에 막대한 투자를 하고 있습니다. 자동화 기술, 휴대용 진단 기기, 디지털 검사실 솔루션을 통해 검사 효율이 향상되는 동시에 운영 비용이 절감되고 있습니다. 또한, 진단 기기 제조업체와 의료 서비스 제공업체 간의 전략적 제휴도 제품 출시를 가속화하고 시장 내 영향력을 확대되고 있습니다.
시장 제약 요인
신흥 경제국에서의 검사 보급률 저하가 성장을 제약
인지도는 높아지고 있지만, 많은 개발도상국에서는 의료 인프라의 미비, 보험 환급 정책의 제한, 검사 시설의 부족으로 인해 진단 서비스 보급률은 여전히 낮은 수준에 머물러 있습니다. 또한, 첨단 검사 장비 및 시약에 드는 높은 비용도 자원이 제한적인 헬스케어 시스템에서의 도입을 방해하고 있습니다. 게다가, 국제 진단 지침에 대한 준수 수준이 일관되지 않은 점도 일부 신흥 시장에서 여전히 큰 과제로 남아 있습니다.
지역별 분석
유럽
유럽은 2025년에 4,420만 달러 시장 규모를 기록하며 계속해서 최대 지역 시장으로 자리매김할 것이며, 2026년에는 4,775만 달러에 달할 것으로 예측됩니다. 잘 갖춰진 의료 인프라, 확립된 진단 지침, 그리고 출혈성 질환 유병률 증가가 계속해서 이 지역의 성장을 뒷받침하고 있습니다. 영국 시장은 2026년에 1,624만 달러에 달할 것으로 예측되며, 독일 시장은 707만 달러에 달할 것으로 전망됩니다.
북미
북미 시장은 2025년에 3,187만 달러 시장 규모를 기록하며, 2026년에는 3,413만 달러에 달할 것으로 전망됩니다. 규제 당국의 승인 증가, 자동화 검사 기술의 확산, 그리고 인식 제고 프로그램의 확충이 이 지역 수요를 견인하고 있습니다. 미국 시장은 2026년에 2,898만 달러에 달할 것으로 전망됩니다.
기타 지역
기타 지역 시장은 2025년에 690만 달러를 차지하며, 2026년에는 730만 달러로 성장할 것으로 전망됩니다. 아시아태평양, 중동 및 기타 신흥 지역의 의료 인프라 개선, 진단 역량 확대, 인식 제고 활동 증가가 시장 성장을 뒷받침하고 있습니다. 2026년에는 중국이 1,742만 달러, 일본이 385만 달러, 인도가 306만 달러에 달할 것으로 예측됩니다.
목차
제1장 서론
제2장 주요 요약
제3장 시장 역학
제4장 주요 인사이트
제5장 세계의 출혈성 질환 검사 시장 분석, 인사이트 및 예측(2021-2034년)
제6장 북미의 출혈성 질환 검사 시장 분석, 인사이트 및 예측(2021-2034년)
제7장 유럽의 출혈성 질환 검사 시장 분석, 인사이트 및 예측(2021-2034년)
제8장 아시아태평양의 출혈성 질환 검사 시장 분석, 인사이트 및 예측(2021-2034년)
제9장 기타 지역의 출혈성 질환 검사 시장 분석, 인사이트 및 예측(2021-2034년)
제10장 경쟁 분석
JHS 26.09.17Growth Factors of bleeding disorders testing Market
The global bleeding disorders testing market was valued at USD 109.8 million in 2025 and is projected to grow from USD 118.39 million in 2026 to USD 222.20 million by 2034, registering a CAGR of 8.19% during the forecast period. Europe accounted for the largest market share of 40.25% in 2025, supported by advanced healthcare infrastructure, strong diagnostic adoption, and increasing awareness of inherited bleeding disorders.
Bleeding disorders, including hemophilia A, hemophilia B, Von Willebrand disease, and idiopathic thrombocytopenic purpura, require timely diagnosis to prevent severe complications. The growing prevalence of these disorders, coupled with technological advancements in laboratory diagnostics, is driving the demand for specialized testing solutions worldwide. Continuous improvements in automated analyzers, reagents, and AI-assisted diagnostic platforms are further strengthening market expansion.
Market Trends
Integration of Artificial Intelligence and Advanced Diagnostic Technologies Driving Market Growth
The bleeding disorders testing market is witnessing rapid technological transformation with the integration of artificial intelligence (AI), machine learning (ML), and automated laboratory systems. AI-powered diagnostic platforms improve the accuracy of disease detection while reducing testing time and human errors. Additionally, innovations in nanotechnology-based diagnostics and high-throughput analyzers are enabling laboratories to perform faster and more reliable coagulation testing.
Leading manufacturers are also introducing advanced hemostasis analyzers and automated diagnostic solutions to enhance workflow efficiency in hospitals and diagnostic laboratories.
Market Drivers
Rising Prevalence of Bleeding Disorders Boosting Testing Demand
The increasing incidence of inherited bleeding disorders remains one of the strongest growth drivers for the market. According to global healthcare organizations, the number of diagnosed patients with hemophilia and Von Willebrand disease continues to rise due to improved awareness and better screening programs. Governments, healthcare organizations, and patient advocacy groups are actively promoting early diagnosis through awareness campaigns and updated clinical guidelines.
Growing investments in healthcare infrastructure, particularly across emerging economies, are further expanding access to diagnostic testing services.
Continuous Product Innovation Supporting Market Expansion
Diagnostic manufacturers are investing significantly in research and development to introduce advanced coagulation analyzers, testing kits, and consumables. Automation technologies, portable diagnostic devices, and digital laboratory solutions are improving testing efficiency while reducing operational costs. Strategic collaborations between diagnostic companies and healthcare providers are also accelerating product commercialization and expanding market reach.
Market Restraints
Limited Testing Penetration in Emerging Economies Restrains Growth
Despite increasing awareness, many developing countries continue to experience low diagnostic penetration due to inadequate healthcare infrastructure, limited reimbursement policies, and insufficient laboratory facilities. High costs associated with advanced testing instruments and reagents also restrict adoption in resource-constrained healthcare systems. In addition, inconsistent adherence to international diagnostic guidelines remains a major challenge in several emerging markets.
Segment Analysis
By Product Type
Based on product type, the market is segmented into reagents & consumables and instruments.
The reagents & consumables segment is expected to dominate the market with a 69.34% share in 2026, supported by increasing testing volumes and continuous demand for diagnostic consumables across laboratories. Meanwhile, the instruments segment is projected to witness steady growth due to increasing adoption of automated coagulation analyzers and technological advancements.
By Indication
Based on indication, the market includes hemophilia A, Von Willebrand disease, hemophilia B, idiopathic thrombocytopenic purpura, and others.
The hemophilia A segment is projected to account for the largest market share of 46.19% in 2026, driven by its relatively higher prevalence and growing awareness regarding early diagnosis. Increasing adoption of advanced coagulation testing technologies is also supporting growth across other disease segments.
By End User
Based on end user, the market is categorized into hospitals & clinics, diagnostic centers, and others.
The hospitals & clinics segment is expected to dominate the market with a 60.31% share in 2026, owing to increasing patient admissions, wider availability of diagnostic facilities, and growing implementation of advanced laboratory equipment. Diagnostic centers are anticipated to register the fastest growth during the forecast period due to rising outpatient diagnostic services and technological advancements.
Regional Analysis
Europe
Europe remained the leading regional market with a value of USD 44.2 million in 2025 and is expected to reach USD 47.75 million in 2026. Strong healthcare infrastructure, established diagnostic guidelines, and increasing prevalence of bleeding disorders continue to support regional growth. The U.K. market is projected to reach USD 16.24 million in 2026, while Germany is expected to reach USD 7.07 million.
North America
North America generated USD 31.87 million in 2025 and is projected to reach USD 34.13 million in 2026. Rising regulatory approvals, growing adoption of automated testing technologies, and increasing awareness programs are driving regional demand. The U.S. market is expected to reach USD 28.98 million in 2026.
Rest of the World
The Rest of the World market accounted for USD 6.9 million in 2025 and is projected to grow to USD 7.3 million in 2026. Improving healthcare infrastructure, expanding diagnostic capabilities, and increasing awareness initiatives across Asia Pacific, the Middle East, and other emerging regions are supporting market growth. China is expected to reach USD 17.42 million, Japan USD 3.85 million, and India USD 3.06 million in 2026.
Competitive Landscape
The global bleeding disorders testing market is moderately fragmented, with leading companies focusing on product innovation, automation, strategic partnerships, and regional expansion. Continuous investments in research and development are helping manufacturers strengthen their diagnostic portfolios and improve testing efficiency.
Major companies operating in the market include F. Hoffmann-La Roche Ltd., Siemens Healthcare GmbH, HORIBA Ltd., Sysmex Corporation, Abbott, Thermo Fisher Scientific Inc., Atlas Medical GmbH, HYPHEN BioMed, and Precision Biologics.
Key Industry Developments
- July 2022: HORIBA Ltd. expanded its Yumizen H500 and H550 hematology product family with enhanced performance and new features.
- February 2022: Sysmex Corporation established Sysmex LLC in Saudi Arabia to strengthen its hematology and hemostasis business.
- November 2021: Precision BioLogic introduced CRYOcheck Factor VIII Deficient Plasma with VWF across several international markets.
- August 2021: Siemens Healthcare GmbH launched Sysmex CN-3000 and CN-6000 Hemostasis Systems for medium- and high-volume coagulation testing.
- March 2021: F. Hoffmann-La Roche introduced eight new Cobas Pro integrated solution configurations to improve laboratory throughput and testing efficiency.
Conclusion
The global bleeding disorders testing market is expected to witness strong growth through 2034, supported by the increasing prevalence of inherited bleeding disorders, growing awareness regarding early diagnosis, and continuous technological advancements in diagnostic testing. Rising adoption of automated analyzers, AI-powered diagnostic platforms, and advanced coagulation testing systems will further accelerate market expansion. As healthcare infrastructure continues to improve across both developed and emerging economies, demand for accurate, efficient, and accessible bleeding disorder testing solutions is expected to remain robust throughout the forecast period.
Segmentation By Product Type
- Reagents & Consumables
- Instruments
By Indication
- Hemophilia A
- Hemophilia B
- Von Willebrand Disease
- Idiopathic Thrombocytopenic Purpura
- Others
By End-user
- Hospitals & Clinics
- Diagnostic Centers
- Others
By Geography
- North America (U.S. and Canada)
- Europe (U.K., Germany, France, Italy, Spain, Scandinavia, and the Rest of Europe)
- Asia Pacific (Japan, China, India, Australia, Southeast Asia, and the Rest of Asia Pacific)
- Rest of the World
Table of Content
1. Introduction
- 1.1. Research Scope
- 1.2. Market Segmentation
- 1.3. Research Methodology
- 1.4. Definitions and Assumptions
2. Executive Summary
3. Market Dynamics
- 3.1. Market Drivers
- 3.2. Market Restraints
- 3.3. Market Opportunities
- 3.4. Market Trends
4. Key Insights
- 4.1. Prevalence of Bleeding Disorders, by Key Countries, 2025
- 4.2. New Product Launches, By Key Players
- 4.3. Technological Advancements in the Global Bleeding Disorders Testing Market
- 4.4. Impact of COVID-19 on the Market
5. Global Bleeding Disorders Testing Market Analysis, Insights and Forecast, 2021-2034
- 5.1. Market Analysis, Insights and Forecast - By Product Type
- 5.1.1. Reagents & Consumables
- 5.1.2. Instruments
- 5.2. Market Analysis, Insights and Forecast - By Indication
- 5.2.1. Hemophilia A
- 5.2.2. Hemophilia B
- 5.2.3. Von Willebrand Disease
- 5.2.4. Idiopathic Thrombocytopenic Purpura (ITP)
- 5.2.5. Others
- 5.3. Market Analysis, Insights and Forecast - By End-user
- 5.3.1. Hospitals & Clinics
- 5.3.2. Diagnostic Centers
- 5.3.3. Others
- 5.4. Market Analysis, Insights and Forecast - By Region
- 5.4.1. North America
- 5.4.2. Europe
- 5.4.3. Asia Pacific
- 5.4.4. Rest of the World
6. North America Bleeding Disorders Testing Market Analysis, Insights and Forecast, 2021-2034
- 6.1. Market Analysis, Insights and Forecast - By Product Type
- 6.1.1. Reagents & Consumables
- 6.1.2. Instruments
- 6.2. Market Analysis, Insights and Forecast - By Indication
- 6.2.1. Hemophilia A
- 6.2.2. Hemophilia B
- 6.2.3. Von Willebrand Disease
- 6.2.4. Idiopathic Thrombocytopenic Purpura (ITP)
- 6.2.5. Others
- 6.3. Market Analysis, Insights and Forecast - By End-user
- 6.3.1. Hospitals & Clinics
- 6.3.2. Diagnostic Centers
- 6.3.3. Others
- 6.4. Market Analysis, Insights and Forecast - By Country
- 6.4.1. U.S.
- 6.4.2. Canada
7. Europe Bleeding Disorders Testing Market Analysis, Insights and Forecast, 2021-2034
- 7.1. Market Analysis, Insights and Forecast - By Product Type
- 7.1.1. Reagents & Consumables
- 7.1.2. Instruments
- 7.2. Market Analysis, Insights and Forecast - By Indication
- 7.2.1. Hemophilia A
- 7.2.2. Hemophilia B
- 7.2.3. Von Willebrand Disease
- 7.2.4. Idiopathic Thrombocytopenic Purpura (ITP)
- 7.2.5. Others
- 7.3. Market Analysis, Insights and Forecast - By End-user
- 7.3.1. Hospitals & Clinics
- 7.3.2. Diagnostic Centers
- 7.3.3. Others
- 7.4. Market Analysis, Insights and Forecast - By Country/ Sub-region
- 7.4.1. U.K
- 7.4.2. Germany
- 7.4.3. France
- 7.4.4. Spain
- 7.4.5. Italy
- 7.4.6. Scandinavia
- 7.4.7. Rest of Europe
8. Asia Pacific Bleeding Disorders Testing Market Analysis, Insights and Forecast, 2021-2034
- 8.1. Market Analysis, Insights and Forecast - By Product Type
- 8.1.1. Reagents & Consumables
- 8.1.2. Instruments
- 8.2. Market Analysis, Insights and Forecast - By Indication
- 8.2.1. Hemophilia A
- 8.2.2. Hemophilia B
- 8.2.3. Von Willebrand Disease
- 8.2.4. Idiopathic Thrombocytopenic Purpura (ITP)
- 8.2.5. Others
- 8.3. Market Analysis, Insights and Forecast - By End-user
- 8.3.1. Hospitals & Clinics
- 8.3.2. Diagnostic Centers
- 8.3.3. Others
- 8.4. Market Analysis, Insights and Forecast - By Country/ Sub-region
- 8.4.1. Japan
- 8.4.2. China
- 8.4.3. India
- 8.4.4. Australia
- 8.4.5. Southeast Asia
- 8.4.6. Rest of Asia Pacific
9. Rest of the World Bleeding Disorders Testing Market Analysis, Insights and Forecast, 2021-2034
- 9.1. Market Analysis, Insights and Forecast - By Product Type
- 9.1.1. Reagents & Consumables
- 9.1.2. Instruments
- 9.2. Market Analysis, Insights and Forecast - By Indication
- 9.2.1. Hemophilia A
- 9.2.2. Hemophilia B
- 9.2.3. Von Willebrand Disease
- 9.2.4. Idiopathic Thrombocytopenic Purpura (ITP)
- 9.2.5. Others
- 9.3. Market Analysis, Insights and Forecast - By End-user
- 9.3.1. Hospitals & Clinics
- 9.3.2. Diagnostic Centers
- 9.3.3. Others
10. Competitive Analysis
- 10.1. Global Market Share Analysis (2025)
- 10.2. Company Profiles
- 10.2.1. Siemens Healthcare GmbH
- 10.2.1.1. Overview
- 10.2.1.2. Product
- 10.2.1.3. SWOT Analysis
- 10.2.1.4. Recent Developments
- 10.2.1.5. Strategies
- 10.2.1.6. financials (Based on Availability)
- 10.2.2. F. Hoffmann-La Roche Ltd.
- 10.2.2.1. Overview
- 10.2.2.2. Product
- 10.2.2.3. SWOT Analysis
- 10.2.2.4. Recent Developments
- 10.2.2.5. Strategies
- 10.2.2.6. financials (Based on Availability)
- 10.2.3. Thermo Fisher Scientific Inc.
- 10.2.3.1. Overview
- 10.2.3.2. Product
- 10.2.3.3. SWOT Analysis
- 10.2.3.4. Recent Developments
- 10.2.3.5. Strategies
- 10.2.3.6. financials (Based on Availability)
- 10.2.4. Abbott Laboratories
- 10.2.4.1. Overview
- 10.2.4.2. Product
- 10.2.4.3. SWOT Analysis
- 10.2.4.4. Recent Developments
- 10.2.4.5. Strategies
- 10.2.4.6. financials (Based on Availability)
- 10.2.5. Atlas Medical GmbH
- 10.2.5.1. Overview
- 10.2.5.2. Product
- 10.2.5.3. SWOT Analysis
- 10.2.5.4. Recent Developments
- 10.2.5.5. Strategies
- 10.2.5.6. financials (Based on Availability)
- 10.2.6. HORIBA, Ltd.
- 10.2.6.1. Overview
- 10.2.6.2. Product
- 10.2.6.3. SWOT Analysis
- 10.2.6.4. Recent Developments
- 10.2.6.5. Strategies
- 10.2.6.6. financials (Based on Availability)
- 10.2.7. Sysmex Corporation
- 10.2.7.1. Overview
- 10.2.7.2. Product
- 10.2.7.3. SWOT Analysis
- 10.2.7.4. Recent Developments
- 10.2.7.5. Strategies
- 10.2.7.6. financials (Based on Availability)
- 10.2.8. HYPHEN BioMed
- 10.2.8.1. Overview
- 10.2.8.2. Product
- 10.2.8.3. SWOT Analysis
- 10.2.8.4. Recent Developments
- 10.2.8.5. Strategies
- 10.2.8.6. financials (Based on Availability)
- 10.2.9. Precision BioLogic Incorporated
- 10.2.9.1. Overview
- 10.2.9.2. Product
- 10.2.9.3. SWOT Analysis
- 10.2.9.4. Recent Developments
- 10.2.9.5. Strategies
- 10.2.9.6. financials (Based on Availability)
- 10.2.10. Other Players
- 10.2.1. Siemens Healthcare GmbH
