Hemostasis Diagnostics Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029)

The report covers Hemostasis Diagnostics Market Trends and the market is segmented by Product (Laboratory Analyzers, and Point-of-Care Testing Systems), Test (Activated Partial, Thromboplastin Time, D Dimer Test, Fibrinogen Test, Prothrombin Time (PT) Test, and Other Tests), End-Use (Hospitals, Diagnostic Centers, and Others) and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The market provides the value (in USD million) for the above-mentioned segments.

Hemostasis Diagnostics Market Size

Hemostasis Diagnostics Market Summary
Study Period 2019 - 2029
Base Year For Estimation 2023
CAGR 8.10 %
Fastest Growing Market Asia Pacific
Largest Market North America
Market Concentration Low

Major Players

Hemostasis Diagnostics Market Major Players

*Disclaimer: Major Players sorted in no particular order

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Hemostasis Diagnostics Market Analysis

The hemostasis diagnostics market is expected to grow at a CAGR of 8.1% over the forecast period.

COVID-19 had a significant impact on the studied market owing to the high utility of point-of-care diagnostic tests and various hemostasis tests in COVID-19-admitted patients with other comorbidities like diabetes or cardiovascular diseases. For instance, according to a research article published in the PLOS One Journal in October 2021, elevated D-dimer is used to predict the severity of SARS-CoV2 infection. Hence, 129 patients underwent a D-Dimer assessment following COVID-19 recovery. D-dimer elevation was found in 15% and was significantly more common in patients who had experienced a severe COVID-19 infection that had required hospitalization compared to patients with mild disease. Therefore, growth was observed in the utility of hemostasis diagnostics during the pandemic. In the current scenario, the hemostasis diagnostics market is growing because of the rising number of surgical procedures which require these tests as a routine assessment of the preoperative patient hence market is expected to show a stable growth rate during the forecast period.

In addition, the rising incidences of blood clotting disorders, technological advancements for medical treatment, and rising adoption of automated hemostasis equipment are actively affecting the growth of the studied market.

As per a World Bleeding Disorders Registry 2021 report, the survey of 37 countries reported 9,414 people with hemophilia as of December 2021, the high prevalence was reported in South-East Asia with 2,828 affected individuals, followed by Eastern Mediterranean and Africa with 2,418 and 1,027 individuals. Out of the total cases, 7,943 were of hemophilia A and 1,428 were of hemophilia B. As hemostasis diagnostics is crucial in detecting various types of hemophilia, the market is expected to grow with the high burden of cases.

Furthermore, an article published in eJIFCC in June 2021 stated that in most developing countries, point-of-care technology is delivered in remote locations or physicians' chambers or hospital setups of emergency rooms, operation theaters, and ICUs. It is applied for therapeutic aid, preventive measures (for targeted screening in high-risk groups), or surveillance measures (monitoring of routine blood parameters). The rising demand of point-of-care testing and other diagnostic tests for hemostatis diagnostics is further projected to propel the market growth.

Also, initiatives undertaken by market players to advance the development of hemostasis diagnostics leading to product launches, and partnerships are contributing to the market growth. For instance, in February 2021, Sysmex Corporation and Siemens Healthcare Diagnostics Inc. extended their strategic agreement to work together on global supply, distribution, and sales and service for hemostasis products through at least 2023. The partnership enabled one of the largest portfolio of hemostasis systems and reagents in the world to continue to be available to laboratory customers worldwide.

Therefore, owing to the aforesaid factors such as high burden of hemophilia worldwide, research studies for the advancement in hemostatis diagnostics and strategic initiatives by market players to strengthen their market position, the studied market is anticipated to witness growth over the analysis period. However, a lack of awareness regarding hemostasis disorders in underdeveloped regions and stringent government regulations may restrict the market.

Hemostasis Diagnostics Market Trends

This section covers the major market trends shaping the Hemostasis Diagnostics Market according to our research experts:

The Point-of-Care Testing Systems Segment is Expected to Hold a Significant Market Share Over The Forecast Period.

The point-of-care (POC) testing system segment is expected to hold a significant market share over the forecast period. Point-of-care testing is vital in emergency departments, intensive care units, and operating rooms as the results are on the spot. The segment is expected to grow owing to technological advancement coupled with the introduction of cost-effective and high-quality medical solutions.

Leukemia is also associated with hemostatic complications which often require the usage of POC diagnostics for better management of the diseases. According to the American Cancer Society, Cancer Statistics 2022, out of the total new cancer cases, leukemia was estimated with 60,650 new cases in the United States in 2022. In addition, as per Leukemia Foundation 2022 update, it is expected that 19,403 Australians will be newly diagnosed with a blood cancer such as leukemia, lymphoma, and myeloma in 2022. This is equivalent to 53 people per day or one person every 27 minutes. The same source stated that 135,000 people were living with blood cancer in Australia in 2022, and more than 275,000 Australians are expected to be living with blood cancer by 2035. Thus, the high burden of leukemia worldwide is also projected to boost the market growth

Acute bleeding requires fast and targeted therapy. Hence, knowledge of the patient's potential to form a clot is crucial. An article published in Practical Laboratory Journal in May 2021 stated that Point-of-care testing (POCT) provides fast and reliable information on coagulation. The results of the article indicated that POCT is a suitable method for emergency diagnosis and can be used as prognostic diagnostic elements in haemotherapy algorithms to initiate targeted haemotherapy at an early point in time. Thus, the rising demand for rapid diagnostics is expected to propel the segment growth during the forecast period.

Furthermore, various market players are engaged in strategic initiatives such as research and development to develop an innovative POC testing system which is also contributing to the segment growth. For instance, in January 2022, Werfen received 510 (k) clearance from the US FDA for its GEM Hemochron 100 whole-blood hemostasis testing system. The system uses Hemochron technology and provides activated clotting time (ACT) results in a few minutes. This POC testing modality enhances patient outcomes in the cardiovascular operating room and other acute care settings. Owing to the advantages offered by point-of-care, the segment is expected to propel during the forecast period.

Therefore, owing to the aforesaid factors such as high burden of leukemia and growing demand for point-of-care testing for leukemia and other types of blood cancer and technological advancements in the POC testing is expected to propel the segment growth during the forecast period.

Estimated Number of New Leukemia Cases (in Thousand), By Type, United States, 2022

The North America is Expected to Hold a Significant Market Share Over The Forecast Period

North America is expected to hold a significant market share mainly because of the high adoption of advanced automated analyzers, the presence of a large patient pool, high prevalence of blood clot disorders is aggressively propelling the demand for hemostasis diagnosis.

According to a review article published in January 2021 in Pharmacoeconomics Open Journal, point-of-care testing (POCT) is a crucial diagnostic technology for optimal patient care and advantageous for different applications such as monitoring, screening, and diagnosis in several settings. POCT is also used for out-of-hospital monitoring of the International Normalized Ratio in patients receiving a vitamin K antagonist like warfarin. The vast utility of point-of-care testing used for hemostasis diagnostics is expected to propel its demand in the region during the forecast period.

The collaboration between a government organization and a market player is also contributing to market growth. For instance, in October 2022, the Canadian Hemophilia Society and Bayer ADVANCE Canada Research Program initiated the applications for market players to engage in research activities to identify and research key issues in the aging hemophilia population. The main goal of this program is to offer one or two USD 30,000 to a maximum of USD 60,000 research grants for one year. The partnership between government bodies and market players for engaging healthcare researchers and professionals for research related to hemophilia is expected to augment the utility of hemostasis diagnostics and propel the market growth in the region.

Additionally, the strategic initiatives adopted by market players in hemostasis diagnostics are also contributing to the market growth. For instance, in August 2021, Siemens Healthineers launched Sysmex's CN-3000 and CN-6000 Hemostasis Systems for mid and high-volume coagulation testing following the expansion of the partnership of both companies in February 2021. Such partnerships and product launch in expected to strengthen the market position and also augment the market growth in the region during the forecast period.

Therefore, owing to the above-mentioned factors such as rising funding by government bodies for research in hemophilia diagnostics and company initiatives in the region, the growth of the studied market is anticipated in the North America Region.

Hemostasis Diagnostics Market - Growth Rate by Region

Hemostasis Diagnostics Industry Overview

The hemostasis diagnostics market is fragmented in nature due to the presence of many companies operating globally as well as regionally. The competitive landscape includes an analysis of a few international as well as local companies which hold a significant or major market share. Some market players are Abbott, Sysmex Corporation, Thermo Fisher Scientific Inc, F. Hoffmann-La Roche Ltd, Danaher Corporation, and Nihon Kohden Corporation. 

Hemostasis Diagnostics Market Leaders

  1. Abbott

  2. Thermo Fisher Scientific, Inc.

  3. F. Hoffmann-La Roche Ltd

  4. Nihon Kohden Corporation

  5. Siemens Healthineers

*Disclaimer: Major Players sorted in no particular order

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Hemostasis Diagnostics Market News

  • In December 2022, HemoSonics received 510 (k) market clearance for its Quantra Hemostasis System with QStat Cartridge from the US FDA. The company stated that the QStat Cartridge assay increases Quantra's overall diagnostic capabilities. The new next-generation whole-blood hemostasis system covers the widest variety of clinical indications of any point-of-care hemostasis analyzer in the United States.
  • In November 2022, a Dutch company, Enzyre, which is developing ambulant diagnostic technology for blood coagulation testing, successfully raised USD 11.9 million (EUR 12 million) in series A funding to help hemophilia patients test from home

Hemostasis Diagnostics Market Report - Table of Contents

  1. 1. INTRODUCTION

    1. 1.1 Study Assumptions and Market Definition

    2. 1.2 Scope of the Study

  2. 2. RESEARCH METHODOLOGY

  3. 3. EXECUTIVE SUMMARY

  4. 4. MARKET DYNAMICS

    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 Rising Incidences of Blood Clotting Disorders

      2. 4.2.2 Technological Advancements for Medical Treatment

      3. 4.2.3 Rising Adoption of Automated Hemostasis Equipment

    3. 4.3 Market Restraints

      1. 4.3.1 Lack of Awareness in Developing Countries

      2. 4.3.2 Stringent Government Regulation

    4. 4.4 Porter's Five Force Analysis

      1. 4.4.1 Threat of New Entrants

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Bargaining Power of Suppliers

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry

  5. 5. MARKET SEGMENTATION (Market Size by Value - USD million)

    1. 5.1 By Product

      1. 5.1.1 Laboratory Analyzers

        1. 5.1.1.1 Automated Systems

        2. 5.1.1.2 Semi-automated Systems

        3. 5.1.1.3 Manual Systems

      2. 5.1.2 Point-of-Care Testing Systems

    2. 5.2 By Test

      1. 5.2.1 Activated Partial Thromboplastin Time

      2. 5.2.2 D Dimer Test

      3. 5.2.3 Fibrinogen Test

      4. 5.2.4 Prothrombin Time (PT) Test

      5. 5.2.5 Others

    3. 5.3 By End User

      1. 5.3.1 Hospitals

      2. 5.3.2 Diagnostic Centers

      3. 5.3.3 Others

    4. 5.4 Geography

      1. 5.4.1 North America

        1. 5.4.1.1 United States

        2. 5.4.1.2 Canada

        3. 5.4.1.3 Mexico

      2. 5.4.2 Europe

        1. 5.4.2.1 Germany

        2. 5.4.2.2 United Kingdom

        3. 5.4.2.3 France

        4. 5.4.2.4 Italy

        5. 5.4.2.5 Spain

        6. 5.4.2.6 Rest of Europe

      3. 5.4.3 Asia-Pacific

        1. 5.4.3.1 China

        2. 5.4.3.2 Japan

        3. 5.4.3.3 India

        4. 5.4.3.4 Australia

        5. 5.4.3.5 South Korea

        6. 5.4.3.6 Rest of Asia-Pacific

      4. 5.4.4 Middle East and Africa

        1. 5.4.4.1 GCC

        2. 5.4.4.2 South Africa

        3. 5.4.4.3 Rest of Middle East and Africa

      5. 5.4.5 South America

        1. 5.4.5.1 Brazil

        2. 5.4.5.2 Argentina

        3. 5.4.5.3 Rest of South America

  6. 6. COMPETITIVE LANDSCAPE

    1. 6.1 Company Profiles

      1. 6.1.1 Abbott

      2. 6.1.2 Danaher Corporation

      3. 6.1.3 F. Hoffmann-La Roche Ltd

      4. 6.1.4 Grifols

      5. 6.1.5 Werfen

      6. 6.1.6 NIHON KOHDEN CORPORATION

      7. 6.1.7 Sysmex Corporation

      8. 6.1.8 Siemens Healthineers

      9. 6.1.9 Human Diagnostics

      10. 6.1.10 GE Healthcare

      11. 6.1.11 Bio-Rad Laboratories

      12. 6.1.12 Thermo Fisher Scientific, Inc.

    2. *List Not Exhaustive
  7. 7. MARKET OPPORTUNITIES AND FUTURE TRENDS

**Subject to Availability
**Competitive Landscape Covers - Business Overview, Financials, Products and Strategies, and Recent Developments
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Hemostasis Diagnostics Industry Segmentation

As per the scope of the report, hemostasis diagnostics are those devices that help in the identification of hemostatic defects which leads to excessive bleeding. Hemostasis is a mechanism followed by the body after getting injured, it slows down blood loss and stops blood flow. Hemostasis helps in the diagnosis of the actual cause of these disorders with history and helps in the treatment. The Market is Segmented By Product (Laboratory Analyzers (Automated Systems, Semi-automated Systems, and Manual Systems), Point-of-Care Testing Systems), Test (Activated Partial, Thromboplastin Time, D Dimer Test, Fibrinogen Test, Prothrombin Time (PT) Test, and Other Tests), End-Use (Hospitals, Diagnostic Centers, and Others) and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The market report also covers the estimated market sizes and trends for 17 different countries across major regions, globally. The report offers the value (in USD million) for the above segments.

By Product
Laboratory Analyzers
Automated Systems
Semi-automated Systems
Manual Systems
Point-of-Care Testing Systems
By Test
Activated Partial Thromboplastin Time
D Dimer Test
Fibrinogen Test
Prothrombin Time (PT) Test
Others
By End User
Hospitals
Diagnostic Centers
Others
Geography
North America
United States
Canada
Mexico
Europe
Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific
China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle East and Africa
GCC
South Africa
Rest of Middle East and Africa
South America
Brazil
Argentina
Rest of South America
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Hemostasis Diagnostics Market Research FAQs

The Hemostasis Diagnostics Market is projected to register a CAGR of 8.10% during the forecast period (2024-2029)

Abbott, Thermo Fisher Scientific, Inc., F. Hoffmann-La Roche Ltd , Nihon Kohden Corporation and Siemens Healthineers are the major companies operating in the Hemostasis Diagnostics Market.

Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2024-2029).

In 2024, the North America accounts for the largest market share in Hemostasis Diagnostics Market.

The report covers the Hemostasis Diagnostics Market historical market size for years: 2019, 2020, 2021, 2022 and 2023. The report also forecasts the Hemostasis Diagnostics Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.

Hemostasis Diagnostics Industry Report

Statistics for the 2024 Hemostasis Diagnostics market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Hemostasis Diagnostics analysis includes a market forecast outlook 2029 and historical overview. Get a sample of this industry analysis as a free report PDF download.

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Hemostasis Diagnostics Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029)