세계의 출혈성 질환 검사 시장 예측 : 제품별, 적응증별, 검사 유형별, 최종 사용자별, 지역별 분석(-2032년)

According to Stratistics MRC, the Global Bleeding Disorders Testing Market is accounted for $113.3 billion in 2025 and is expected to reach $209.8 billion by 2032 growing at a CAGR of 9.2% during the forecast period. Bleeding disorders testing refers to a group of laboratory tests used to diagnose conditions that affect the blood's ability to clot properly. These disorders can lead to excessive bleeding or bruising, even from minor injuries. Common tests include complete blood count (CBC), prothrombin time (PT), activated partial thromboplastin time (aPTT), platelet function tests, and specific factor assays. Testing helps identify inherited conditions like hemophilia and von Willebrand disease, or acquired issues such as vitamin K deficiency or liver disease. Accurate diagnosis through bleeding disorders testing is crucial for guiding treatment and preventing complications related to uncontrolled bleeding or clotting abnormalities.

According to the National Hemophilia Foundation, Von Willebrand disease is the most common bleeding disorder, affecting approximately 1 in every 100 people or up to 1% of the U.S. population.

Market Dynamics:

Driver:

Increasing Prevalence of Bleeding Disorders

The increasing prevalence of bleeding disorders, such as hemophilia and von Willebrand disease, is driving significant growth in the bleeding disorders testing market. As awareness rises and diagnosis becomes more critical for effective treatment, demand for accurate and early testing solutions has surged. This trend is encouraging technological advancements and expanded healthcare investments, particularly in developing regions. Overall, the rising patient pool is positively impacting market expansion, fostering innovation and improved accessibility to diagnostic tools worldwide.

Restraint:

High Costs of Diagnostic Tests

High costs of diagnostic tests for bleeding disorders negatively impact accessibility, limiting testing to only well-funded healthcare settings. This reduces early detection and treatment opportunities, leading to poor patient outcomes. Additionally, it strains healthcare systems, especially in low-income regions, where affordability is a major barrier. The financial burden may discourage timely diagnosis, prolonging patient suffering and increasing long-term healthcare costs. Thus, it limits the market expansion.

Opportunity:

Technological Advancements in Diagnostic Tools

Technological advancements in diagnostic tools have significantly improved the bleeding disorders testing market by enhancing accuracy, speed, and accessibility. Innovations like next-generation sequencing, point-of-care testing, and AI-driven analytics enable earlier detection and more personalized treatment plans. These advancements not only increase diagnostic precision but also reduce testing costs and improve patient outcomes. With more efficient and reliable tools, healthcare providers can offer better care, driving growth and expansion in the bleeding disorders testing market.

Threat:

Regulatory Challenges

Regulatory hurdles in the bleeding disorders testing industry can cause delays in the approval of new diagnostic technologies, impeding innovation and limiting patient access to improved diagnostics. Tight rules might make operations more expensive, which would affect affordability. Furthermore, different regulatory restrictions in different regions might make it more difficult for businesses to enter the market, which can slow down the availability of products and lower the overall efficacy of therapies for bleeding disorders. This makes it more difficult to provide prompt, efficient care.

Covid-19 Impact

The COVID-19 pandemic significantly disrupted the bleeding disorder testing market. Routine diagnostic procedures declined due to lockdowns, patient hesitancy, and healthcare system reallocation towards COVID-19 care. This led to reduced testing for conditions like hemophilia and Von Willebrand disease. Additionally, supply chain disruptions and resource constraints further impacted testing availability. However, the market is recovering, driven by increasing bleeding disorder prevalence and advancements in diagnostic technologies.

The diagnostic laboratories segment is expected to be the largest during the forecast period

The diagnostic laboratories segment is expected to account for the largest market share during the forecast period as these laboratories enable early detection and effective management of bleeding disorders. Their integration of cutting-edge technologies, such as genetic testing and coagulation analyzers, enhances diagnostic precision and patient outcomes. Moreover, increasing collaborations with healthcare providers and growing awareness about bleeding disorders continue to expand market reach, solidifying diagnostic laboratories as a cornerstone of market development.

The prothrombin time (PT) segment is expected to have the highest CAGR during the forecast period

Over the forecast period, the prothrombin time (PT) segment is predicted to witness the highest growth rate because it makes it possible to precisely evaluate clotting function, which is essential for identifying a number of bleeding conditions. PT testing improves early diagnosis and treatment by detecting diseases such as hemophilia, vitamin K insufficiency, and liver disorders. PT testing's function in customized treatment and precise diagnosis supports the growing market, encouraging innovation and enhancing patient outcomes as knowledge and accessibility to healthcare increase.

Region with largest share:

During the forecast period, the Asia Pacific region is expected to hold the largest market share because of growing awareness, better healthcare infrastructure, and developments in diagnostic technologies. Market expansion has been positively impacted by the increasing prevalence of bleeding disorders as well as a growing emphasis on early diagnosis and individualized treatment. Furthermore, the region's market is expanding favorably due to the growing use of cutting-edge testing techniques and government programs to improve access to healthcare.

Region with highest CAGR:

Over the forecast period, the North America region is anticipated to exhibit the highest CAGR, owing to increased awareness and early diagnosis of bleeding disorders such as hemophilia. Advancements in testing technologies, along with the rising demand for personalized treatment, are further fueling market expansion. Additionally, supportive healthcare policies, improved accessibility to diagnostic tests, and a growing focus on patient-centered care contribute to a positive impact, enhancing patient outcomes and fostering continued growth in the region's healthcare sector.

Key players in the market

Some of the key players profiled in the Bleeding Disorders Testing Market include Siemens Healthineers, F. Hoffmann-La Roche Ltd., Abbott Laboratories, Sysmex Corporation, HORIBA Ltd., Thermo Fisher Scientific Inc., Bio-Rad Laboratories, Inc., Grifols S.A., Danaher Corporation, Helena Laboratories Corporation, DiaPharma Group Inc., Atlas Medical GmbH, Hyphen BioMed, Precision BioLogic Incorporated, Trinity Biotech plc, Sekisui Diagnostics LLC, Takeda Pharmaceutical Company Limited, Nihon Kohden Corporation and Novo Nordisk A/S.

Key Developments:

In May 2025, Cadrenal Therapeutics has entered into a collaboration agreement with Abbott to support the pivotal TECarfarin Anticoagulation and Hemocompatibility with Left Ventricular Assist Devices (TECH-LVAD) trial. This trial aims to evaluate the efficacy and safety of tecarfarin, a new oral vitamin K antagonist (VKA), in patients with implanted HeartMate 3(TM) left ventricular assist devices (LVADs).

In December 2024, Abbott Laboratories and DexCom have resolved all their ongoing patent disputes concerning continuous glucose monitoring (CGM) devices. This settlement, announced on December 23, 2024, includes the dismissal of all pending legal cases worldwide and prohibits both companies from initiating any patent, trade dress, or design rights litigation against each other for the next decade.

Products Covered:

• Reagents
• Consumables
• Instruments
• Accessories

Indications Covered:

• Hemophilia A
• Hemophilia B
• Von Willebrand Disease
• Idiopathic Thrombocytopenic Purpura
• Other Indications

Test Types Covered:

• Complete Blood Count (CBC)
• Prothrombin Time (PT)
• Activated Partial Thromboplastin Time (aPTT)
• Fibrinogen Test
• Genetic Testing
• Platelet Function Tests
• Other Test Types

End Users Covered:

• Hospitals
• Diagnostic Laboratories
• Ambulatory Surgical Centers
• Academic and Research Institutes
• specialty clinics
• Other End Users

Regions Covered:

• North America
  • US
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • Italy
  • France
  • Spain
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • New Zealand
  • South Korea
  • Rest of Asia Pacific
• South America
  • Argentina
  • Brazil
  • Chile
  • Rest of South America
• Middle East & Africa
  • Saudi Arabia
  • UAE
  • Qatar
  • South Africa
  • Rest of Middle East & Africa

What our report offers:

• Market share assessments for the regional and country-level segments
• Strategic recommendations for the new entrants
• Covers Market data for the years 2022, 2023, 2024, 2026, and 2030
• Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
• Strategic recommendations in key business segments based on the market estimations
• Competitive landscaping mapping the key common trends
• Company profiling with detailed strategies, financials, and recent developments
• Supply chain trends mapping the latest technological advancements

Free Customization Offerings:

All the customers of this report will be entitled to receive one of the following free customization options:

• Company Profiling
  • Comprehensive profiling of additional market players (up to 3)
  • SWOT Analysis of key players (up to 3)
• Regional Segmentation
  • Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
• Competitive Benchmarking
  • Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances

Table of Contents

1 Executive Summary

2 Preface

• 2.1 Abstract
• 2.2 Stake Holders
• 2.3 Research Scope
• 2.4 Research Methodology
  • 2.4.1 Data Mining
  • 2.4.2 Data Analysis
  • 2.4.3 Data Validation
  • 2.4.4 Research Approach
• 2.5 Research Sources
  • 2.5.1 Primary Research Sources
  • 2.5.2 Secondary Research Sources
  • 2.5.3 Assumptions

3 Market Trend Analysis

• 3.1 Introduction
• 3.2 Drivers
• 3.3 Restraints
• 3.4 Opportunities
• 3.5 Threats
• 3.6 Product Analysis
• 3.7 End User Analysis
• 3.8 Emerging Markets
• 3.9 Impact of Covid-19

4 Porters Five Force Analysis

• 4.1 Bargaining power of suppliers
• 4.2 Bargaining power of buyers
• 4.3 Threat of substitutes
• 4.4 Threat of new entrants
• 4.5 Competitive rivalry

5 Global Bleeding Disorders Testing Market, By Product

• 5.1 Introduction
• 5.2 Reagents
• 5.3 Consumables
• 5.4 Instruments
• 5.5 Accessories

6 Global Bleeding Disorders Testing Market, By Indication

• 6.1 Introduction
• 6.2 Hemophilia A
• 6.3 Hemophilia B
• 6.4 Von Willebrand Disease
• 6.5 Idiopathic Thrombocytopenic Purpura
• 6.6 Other Indications

7 Global Bleeding Disorders Testing Market, By Test Type

• 7.1 Introduction
• 7.2 Complete Blood Count (CBC)
• 7.3 Prothrombin Time (PT)
• 7.4 Activated Partial Thromboplastin Time (aPTT)
• 7.5 Fibrinogen Test
• 7.6 Genetic Testing
• 7.7 Platelet Function Tests
• 7.8 Other Test Types

8 Global Bleeding Disorders Testing Market, By End User

• 8.1 Introduction
• 8.2 Hospitals
• 8.3 Diagnostic Laboratories
• 8.4 Ambulatory Surgical Centers
• 8.5 Academic and Research Institutes
• 8.6 specialty clinics
• 8.7 Other End Users

9 Global Bleeding Disorders Testing Market, By Geography

• 9.1 Introduction
• 9.2 North America
  • 9.2.1 US
  • 9.2.2 Canada
  • 9.2.3 Mexico
• 9.3 Europe
  • 9.3.1 Germany
  • 9.3.2 UK
  • 9.3.3 Italy
  • 9.3.4 France
  • 9.3.5 Spain
  • 9.3.6 Rest of Europe
• 9.4 Asia Pacific
  • 9.4.1 Japan
  • 9.4.2 China
  • 9.4.3 India
  • 9.4.4 Australia
  • 9.4.5 New Zealand
  • 9.4.6 South Korea
  • 9.4.7 Rest of Asia Pacific
• 9.5 South America
  • 9.5.1 Argentina
  • 9.5.2 Brazil
  • 9.5.3 Chile
  • 9.5.4 Rest of South America
• 9.6 Middle East & Africa
  • 9.6.1 Saudi Arabia
  • 9.6.2 UAE
  • 9.6.3 Qatar
  • 9.6.4 South Africa
  • 9.6.5 Rest of Middle East & Africa

10 Key Developments

• 10.1 Agreements, Partnerships, Collaborations and Joint Ventures
• 10.2 Acquisitions & Mergers
• 10.3 New Product Launch
• 10.4 Expansions
• 10.5 Other Key Strategies

11 Company Profiling

• 11.1 Siemens Healthineers
• 11.2 F. Hoffmann-La Roche Ltd.
• 11.3 Abbott Laboratories
• 11.4 Sysmex Corporation
• 11.5 HORIBA Ltd.
• 11.6 Thermo Fisher Scientific Inc.
• 11.7 Bio-Rad Laboratories, Inc.
• 11.8 Grifols S.A.
• 11.9 Danaher Corporation
• 11.10 Helena Laboratories Corporation
• 11.11 DiaPharma Group Inc.
• 11.12 Atlas Medical GmbH
• 11.13 Hyphen BioMed
• 11.14 Precision BioLogic Incorporated
• 11.15 Trinity Biotech plc
• 11.16 Sekisui Diagnostics LLC
• 11.17 Takeda Pharmaceutical Company Limited
• 11.18 Nihon Kohden Corporation
• 11.19 Novo Nordisk A/S