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Hemostasis Diagnostics Market - Growth, Trends, COVID-19 Impact, and Forecasts (2023-2028)

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  • 122 Pages
  • April 2023
  • Region: Global
  • Mordor Intelligence
  • ID: 5529357
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.

Key Market Trends

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.

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.

Competitive Landscape

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.

Additional benefits of purchasing the report:

  • The market estimate (ME) sheet in Excel format
  • 3 months of analyst support

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Table of Contents

1.1 Study Assumptions and Market Definition
1.2 Scope of the Study
4.1 Market Overview
4.2 Market Drivers
4.2.1 Rising Incidences of Blood Clotting Disorders
4.2.2 Technological Advancements for Medical Treatment
4.2.3 Rising Adoption of Automated Hemostasis Equipment
4.3 Market Restraints
4.3.1 Lack of Awareness in Developing Countries
4.3.2 Stringent Government Regulation
4.4 Porter's Five Force Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5 MARKET SEGMENTATION (Market Size by Value - USD million)
5.1 By Product
5.1.1 Laboratory Analyzers Automated Systems Semi-automated Systems Manual Systems
5.1.2 Point-of-Care Testing Systems
5.2 By Test
5.2.1 Activated Partial Thromboplastin Time
5.2.2 D Dimer Test
5.2.3 Fibrinogen Test
5.2.4 Prothrombin Time (PT) Test
5.2.5 Others
5.3 By End User
5.3.1 Hospitals
5.3.2 Diagnostic Centers
5.3.3 Others
5.4 Geography
5.4.1 North America United States Canada Mexico
5.4.2 Europe Germany United Kingdom France Italy Spain Rest of Europe
5.4.3 Asia-Pacific China Japan India Australia South Korea Rest of Asia-Pacific
5.4.4 Middle East and Africa GCC South Africa Rest of Middle East and Africa
5.4.5 South America Brazil Argentina Rest of South America
6.1 Company Profiles
6.1.1 Abbott
6.1.2 Danaher Corporation
6.1.3 F. Hoffmann-La Roche Ltd
6.1.4 Grifols
6.1.5 Werfen
6.1.7 Sysmex Corporation
6.1.8 Siemens Healthineers
6.1.9 Human Diagnostics
6.1.10 GE Healthcare
6.1.11 Bio-Rad Laboratories
6.1.12 Thermo Fisher Scientific, Inc.

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • Abbott
  • Danaher Corporation
  • F. Hoffmann-La Roche Ltd
  • Grifols
  • Werfen
  • Sysmex Corporation
  • Siemens Healthineers
  • Human Diagnostics
  • GE Healthcare
  • Bio-Rad Laboratories
  • Thermo Fisher Scientific, Inc.