출혈성 질환 검사 시장 : 규모, 점유율, 성장률, 산업 분석, 유형별, 용도별, 지역별 고찰, 예측(2026-2034년)

Growth 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 to USD 118.39 million in 2026, reaching USD 223.38 million by 2034, exhibiting a CAGR of 8.26% during 2026-2034. Europe dominated the global market with a 40.25% share in 2025, supported by strong diagnostic infrastructure and high disease awareness.

Bleeding disorders are inherited or acquired conditions that impair the body's ability to clot blood properly, resulting in prolonged or excessive bleeding. Common conditions include Hemophilia A, Hemophilia B, Von Willebrand Disease (VWD), and idiopathic thrombocytopenic purpura (ITP). The increasing prevalence of these disorders, along with technological advancements in diagnostic platforms, is driving market expansion.

Market Overview

The growth of the bleeding disorders testing market is primarily fueled by rising diagnosis rates and improved access to healthcare services globally. According to the World Federation of Hemophilia, the number of diagnosed bleeding disorder cases increased significantly between 2015 and 2020, highlighting growing awareness and screening efforts.

Technological advancements, including automation in coagulation analyzers, artificial intelligence (AI), machine learning (ML), and nano-diagnostics, are transforming testing procedures. For example, Roche launched expanded configurations for its Cobas pro integrated solutions to improve throughput and efficiency, supporting increased diagnostic demand.

COVID-19 Impact

The COVID-19 pandemic negatively affected the market in 2020 due to reduced hospital visits and postponement of routine diagnostic procedures. Testing for hemophilia, Von Willebrand disease, and related conditions declined as healthcare systems prioritized COVID-19 testing.

Major companies experienced temporary revenue declines. However, recovery began in 2021 and 2022 as routine healthcare services resumed. Increased diagnosis rates and new product approvals are expected to sustain steady growth from 2025 onward.

Market Trends

Integration of Artificial Intelligence in Diagnostics

The implementation of AI and ML in coagulation testing is an emerging trend. AI is being explored for predicting hemophilia severity, identifying gene mutations, and enhancing early diagnosis accuracy. Additionally, nano-diagnostic technologies are being studied for improved sensitivity in detecting clotting abnormalities.

Growing R&D investments and digital health integration are expected to accelerate innovation in testing instruments and software platforms during the forecast period.

Market Growth Drivers

Rising Prevalence and Diagnosis Rates

The increasing global prevalence of bleeding disorders is a key growth driver. Hemophilia A remains the most common severe inherited bleeding disorder, accounting for a substantial portion of diagnosed cases worldwide. Updated clinical guidelines and awareness campaigns by organizations such as the National Hemophilia Foundation and the World Federation of Hemophilia are promoting early diagnosis.

Improved healthcare infrastructure in emerging economies is also contributing to higher testing volumes.

Increasing R&D and Product Launches

Continuous product innovation is strengthening market growth. Companies are developing advanced hemostasis analyzers and reagent kits to improve efficiency and automation in laboratories. Government-backed initiatives and philanthropic funding programs aimed at rare blood disorders are further accelerating diagnostic advancements.

Market Restraints

Despite strong growth prospects, the market faces challenges such as low testing penetration in emerging countries, limited adherence to diagnostic guidelines, and high costs of advanced instruments and reagents. In regions with limited healthcare funding, early diagnosis remains a challenge, restricting market expansion.

Segmentation Analysis

By Product Type

The market is segmented into reagents & consumables and instruments.

• Reagents & consumables held the largest share (69.34% in 2026) and are expected to grow at the fastest rate due to increasing testing frequency and recurring demand.
• The instruments segment is projected to grow steadily, supported by automation and technological advancements in coagulation analyzers.

By Indication

The market is segmented into Hemophilia A, Von Willebrand Disease, Hemophilia B, ITP, and others.

• Hemophilia A dominated the market in 2026 with a 46.19% share, driven by high disease prevalence and increased screening.
• Von Willebrand disease represents a significant segment due to its relatively higher occurrence globally.

By End-user

The market is categorized into hospitals & clinics, diagnostic centers, and others.

• Hospitals & clinics accounted for 60.31% of the market in 2026, owing to higher patient inflow and established laboratory facilities.
• Diagnostic centers are expected to witness the highest CAGR due to rising adoption of automated analyzers.

Regional Insights

Europe

Europe led the market with a valuation of USD 44.2 million in 2025 and USD 47.75 million in 2026. The region benefits from strong regulatory frameworks, high awareness levels, and established diagnostic guidelines.

North America

North America is projected to witness significant growth, supported by regulatory approvals and product launches. The U.S. market is valued at USD 28.98 million in 2026.

Asia Pacific and Rest of the World

Emerging economies such as China, Japan, and India are expanding healthcare infrastructure and increasing rare disease awareness. China's market is valued at USD 17.42 million in 2026, while Japan and India are valued at USD 3.85 million and USD 3.06 million in 2026, respectively.

Competitive Landscape

The market is fragmented with key players including F. Hoffmann-La Roche Ltd., Siemens Healthcare GmbH, Sysmex Corporation, HORIBA Ltd., Abbott, Thermo Fisher Scientific Inc., Atlas Medical GmbH, HYPHEN BioMed, and Precision Biologics.

Companies are focusing on product approvals, strategic collaborations, mergers & acquisitions, and expansion of diagnostic portfolios to strengthen their competitive position.

Conclusion

The global bleeding disorders testing market is poised for steady expansion, growing from USD 109.8 million in 2025 to USD 223.38 million by 2034, at a CAGR of 8.26%. Growth is driven by increasing disease prevalence, rising diagnosis rates, technological advancements in coagulation testing, and expanding healthcare infrastructure. Europe currently leads the market, while North America and Asia Pacific are expected to witness substantial growth. Despite challenges such as limited testing penetration in emerging regions, ongoing innovation and awareness initiatives will continue to support long-term market growth through 2034.

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