U.S. Bleeding Disorder Testing Market Size, Share & Industry Analysis, By Product (Reagents & Consumables and Instruments), By Indication (Hemophilia A, Hemophilia B, Von Willebrand Disease, Idiopathic Thrombocytopenic Purpura, and Others), By End-user (Hospitals & Clinics, Diagnostic Centers, and Others), and Country Forecast, 2024-2032

The U.S. bleeding disorder testing market size was worth USD 23.9 million in 2023 and is projected to grow at a CAGR of 7.0% during the forecast period. 

Bleeding disorders are a group of conditions leading to excessive bleeding due to disruptions in the blood clotting process. These are inherited disorders that occur when the blood lacks certain clotting factors. The increasing incidence of disorders such as hemophilia A, hemophilia B, anemia, liver illnesses, and other blood coagulation problems leads to the rising need for treating bleeding disorders, thereby driving the growth of the bleeding disorder testing market.

• For instance, according to the Centers for Disease Control and Prevention (CDC) data, Hemophilia A affects 1 in 5,000 male births. In addition, every year, around 400 babies are born with hemophilia A. Such statistics are projected to drive the need to treat bleeding disorders, influencing the market growth.

Furthermore, the increasing R&D projects for the treatment of blood disorders, increasing government funds to promote the adoption of bleeding disorders treatments, and rising healthcare expenditure are expected to create numerous growth opportunities for market growth.

The U.S. bleeding disorder testing market size was negatively impacted due to the COVID-19 pandemic in 2020. The increased focus of healthcare workers and hospitals on conducting COVID-19-related tests and procedures led to a decline in testing procedures for other diseases.

U.S. Bleeding Disorder Testing Market Trends

Increasing Implementation of Nanomaterials and Artificial Intelligence in Blood Disorders Testing 

The increasing number of R&D activities by researchers and investments by organizations in the U.S. are resulting in technological advancements in testing for blood disorders. The use of nanotechnology combined with artificial intelligence in various clinical trials for diagnosing bleeding disorders such as tuberculosis (TB), anemia, and Hemophilia is leading to increasing efficiency and accuracy of tests.

• For instance, according to a study published in the Journal of Nature Biomedical Engineering in August 2022, researchers from Tulane University launched a new blood test for children to diagnose tuberculosis (TB) which combines nanotechnology with artificial intelligence. Researchers found that the test was quite efficient and accurate.

Artificial intelligence can potentially analyze chemical and biological data at a quicker pace and with a higher success rate than the human intelligence levels. Such strategic advancements will help deliver promising diagnostics options for patients suffering from bleeding disorders, influencing the U.S. bleeding disorder testing market growth during the forecast period.

U.S. Bleeding Disorder Testing Market Growth Factors

Innovative Product Launches to Boost Market Growth

Continuous efforts by major players in the market and investment in R&D activities are leading to new product launches for bleeding disorder testing kits and instruments.

Furthermore, edge cutting technological developments are projected to influence market growth by 2030. Moreover, the prevalence of bleeding disorders and increasing awareness about the testing methods among the population is anticipated to favor the U.S. bleeding disorder testing market during the forecast period.

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In 2022, nearly 10% of people in the U.S. diagnosed with hemophilia B were four years of age or younger.

RESTRAINING FACTORS

Stringent Regulatory Approval Processes May Hamper Market Growth 

The presence of strict regulatory approval procedures limits the U.S. bleeding disorder testing market. For instance, the development of commercial tests is regulated by the Food and Drug Administration (FDA) considering them as medical devices in the U.S. The collection, preparation, testing, storage, and transport of blood and blood components must undergo all the guidelines issued by the FDA. All clinical laboratory tests are approved by FDA, adding complexity to the market landscape. Moreover, the lack of awareness regarding the technological advancements and processes associated with bleeding testing poses a challenge to the U.S. bleeding disorder testing market size.

U.S. Bleeding Disorder Testing Market Segmentation Analysis

By Product Analysis

Based on product, the market for bleeding disorder testing is segmented into reagents & consumables and instruments.

In 2023, the reagents & consumables segment held a significant U.S. bleeding disorder testing market share owing to numerous product launches, the availability of precise diagnostic kits, and frequent technological advancement in diagnostic technology.

• For instance, in July 2022, Siemens Healthineers announced the launch of advanced technology INNOVANCE VWF (von Willebrand factor) Ac assay. It is a fully automated assay of its kind available to U.S. laboratories for use on the Siemens Healthineers BCS XP System as well as on the Sysmex CS-2500 and CS-5100 hemostasis analyzers. The model provides higher efficiency and high throughput testing. Such product launches provides more reliable diagnosis and improved functionality, hence, projected to propel market growth.

In addition, the instruments segment accounted for a significant CAGR over the forecast period owing to technological advancements leading to improving automation and portable analyzers in this product type.

By Indication Analysis

Based on indication, the market for bleeding disorder testing is classified into hemophilia A, Von Willebrand disease, hemophilia B, idiopathic thrombocytopenic purpura, and others.

In 2023, the hemophilia A segment accounted for a dominant share of the market. The growth is mainly attributed to growing government initiatives for early neonate detection and raising awareness of available diagnostic options.

Furthermore, the idiopathic thrombocytopenic purpura (ITP) segment is anticipated to grow substantially over the forecast period. Factors such as a higher prevalence of idiopathic thrombocytopenic purpura (ITP), significant products catering to the condition, and growing disease awareness among the people are expected to drive market growth.

• For instance, according to the data published by NCBI, the prevalence of idiopathic thrombocytopenic purpura (ITP) is estimated to be 9.5 per 100,000 persons in the U.S. Such instances are projected to drive the adoption of blood disorder testing options, thereby influencing market growth.

By End-user Analysis

Based on end-user, the market is segmented into hospitals & clinics, diagnostic centers, and others.

The hospitals  clinics segment held the highest market share in 2023.  The increasing rate of hospitalizations due to the severity of these diseases is leading to an increased demand for testing instruments and reagents in hospitals and clinics.

In addition, the growing prevalence and diagnosis rate along with the growing healthcare infrastructure is anticipated to augment market growth in the country.

Moreover, diagnostic centers are expected to grow at the fastest growth rate in the near future owing to the availability of precise testing services for a wide range of bleeding disorders.

KEY INDUSTRY PLAYERS

The market is highly fragmented in nature. Some major key players in the market include Siemens Healthcare GmbH, F Hoffmann-La Roche, Sysmex Corporation, and HORIBA, Ltd. The dominance of these companies is mainly attributed to the strong product portfolio and continuous efforts to develop and launch innovative products for blood testing. For instance, in August 2021, Siemens Healthcare GmbH with an agreement with Sysmex Corporation launched Sysmex’s CN-3000 and CN-6000 Hemostasis Systems for mid and high-volume coagulation testing. Some other players, such as Abbott, Beckman Coulter, Inc., Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Novo Nordisk, and others, strive to gain a higher market share by adopting strategic initiatives such as acquisitions, and collaborations.

LIST OF TOP BLEEDING DISORDER TESTING COMPANIES IN U.S./ LIST OF TOP BLEEDING DISORDER TESTING COMPANIES:

• F. Hoffmann-La Roche Ltd. (Switzerland)
• Siemens Healthcare GmbH (Germany)
• HORIBA Ltd. (Japan)
• Sysmex Corporation (Japan)
• Abbott (U.S.)
• Thermo Fisher Scientific Inc. (U.S.)
• Atlas Medical GmbH (Germany)
• HYPHEN BioMed (France)
• Precision Biologics (U.S.)

KEY INDUSTRY DEVELOPMENTS: 

• October 2022 – Siemens Healthcare GmbH announced the launch of ‘von Willebrand factor function test’ for the U.S. laboratories, called the Innovance VWF Ac assay.
• May 2022 - Babson Diagnostics, a science-first health care technology company, and BD (Becton, Dickinson and Company), a worldwide medical technology company announced the expansion of a strategic partnership to advance diagnostic blood collection into new care settings, including at home diagnostic testing.
• March 2021 – ENZYRE BV and Takeda Pharmaceutical Company Limited entered a strategic collaboration to develop assays for diagnosing and monitoring congenital bleeding disorders.

REPORT COVERAGE

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The U.S. bleeding disorder testing market report provides a detailed analysis of the industry. It focuses on key aspects such as product, indication, end-user, leading companies, market dynamics, and competitive landscape. In addition, it includes prevalence of bleeding disorders, new product launches, key industry developments such as mergers, partnerships, & acquisitions, and the impact of COVID-19 on the market. Besides this, the report offers insights into the market trends and highlights key industry dynamics. In addition to the aforementioned factors, it encompasses several factors that have contributed to the growth of the market over recent years.

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