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Bleeding Disorder Testing Market Size, Share & COVID-19 Impact Analysis, By Product Type (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 Regional Forecast, 2022-2029

Region : Global | Format: PDF | Report ID: FBI106908

 

KEY MARKET INSIGHTS

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The global bleeding disorder testing market size was valued at USD 82.6 million in 2021. The market is projected to grow from USD 88.5 million in 2022 to USD 149.6 million by 2029, exhibiting a CAGR of 7.8% during the forecast period. The global COVID-19 pandemic has been unprecedented and staggering, with bleeding disorder testing experiencing lower-than-anticipated demand across all regions compared to pre-pandemic levels. Based on our analysis, the global market recorded a decline of 6.1% in 2020 as compared to 2019.


Bleeding disorders are a group of conditions that result when the blood clotting process is disrupted leading to excessive bleeding. These disorders are almost always inherited and they result when the blood lacks certain clotting factors. The market for bleeding disorder testing has grown and developed in recent years to meet the rising demand. The major factor contributing to the growth of the market is the rising prevalence of bleeding disorders such as hemophilia A, hemophilia B, Von Willebrand disease, and others among the population.


Moreover, the development of testing instruments and integration of Artificial Intelligence (AI) and Machine Learning (ML) by leading market players has emerged as an important contributing factor.



  • For instance, 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.

  • For instance, in March 2021, F. Hoffmann-La Roche Ltd. launched eight new configurations for Cobas pro integrated solutions with an aim to maximize throughput and increase testing efficiency.


COVID-19 IMPACT


Market Growth Limited Due to Reduced Number of Testing among the Population amid COVID-19


The COVID-19 impact on the market was negative due to significant decrease in the number of patient visits during the lockdown. The COVID-19 restrictions imposed by the governments of different countries led to a reduced number of diagnostic procedures for hemophilia A, B, and other diseases. Additionally, the increased focus of healthcare providers and diagnostic centers to conduct higher number of tests and procedures related to the COVID-19 led to a reduced number of testing and procedures for other disorders. This along with the fear of contracting infection among the bleeding disorder patients was one of the factors that resulted in lower number of testing for these disorders among the population.


The market players witnessed a significant decline in revenue generated during 2020. For instance, F Hoffmann-La Roche Ltd. registered a decline of 5.1% in the revenues generated in 2020 as compared to the previous year. The decline in the revenue was due to the reduced number of routine blood tests and testing for disorders such as hemophilia A, B, Von Willebrand disease, and others owing to the COVID-19 pandemic.


However, the growing prevalence of bleeding disorder globally, along with the increasing diagnosis rate and treatment, is creating demand for testing of these disorders among the patient population. Thus, the increased demand for these tests during 2021 helped companies recover and witness growth in the revenue generated. Additionally, the higher number of approvals and launches of products in various countries is expected to spur the bleeding disorder testing market growth during the forecast period.


LATEST TRENDS 


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Increasing Implementation of Artificial Intelligence and Nanomaterials in Testing and Diagnosis to Augment Market Growth 


The increasing R&D activities and investments by various foundations, national, and international organizations are resulting in technological advancements in the field of diagnosis of blood disorders. One of the trends in the market is the use of artificial intelligence in the diagnosis of disorders, which is anticipated to propel the market growth.


The use of machine learning in various clinical trials for the diagnosis of bleeding disorder such as Hemophilia is leading to an increasing efficiency and accuracy.



  • According to a 2022 article published by the National Center for Biotechnology Information (NCBI), the utilization of artificial intelligence in Hemophilia is in its early phases owing to its several advantages such as prediction of severity of Hemophilia A, improved recognition of mutated gene causing the disease, and others.


The rising awareness regarding the disorders among the population and technological advancements and innovations by various foundations in developed as well as emerging countries are some of the attributable factors responsible for the rising number of testing globally.



  • According to a 2021 news release by Novo Nordisk Hemophilia Foundation, the project for the development of an AI chatbot for Hemophilia in several African countries was approved in April 2021. The chatbot will be integrated into web-based mobile phones for early diagnosis and care for Hemophilia.


Additionally, there is a rising number of clinical studies using nano diagnostics for the detection of bleeding disorder owing to their increasing potential. Thus, rising advancements in technology are resulting in increasing applications of artificial intelligence, machine learning, and nanoparticles in the diagnosis and testing of bleeding disorders such as hemophilia and others.


DRIVING FACTORS


Rising Prevalence and Diagnosis of Bleeding Disorder among General Population to Anticipate the Market Growth


The rising prevalence of disorders, such as Hemophilia A, B, idiopathic thrombocytopenic purpura, and others, among the population is increasing in both developed and emerging regions owing to various genetic factors. This is resulting in a higher patient population suffering from bleeding disorder.



  • According to a 2020 annual global survey conducted by the World Federation of Hemophilia, the total number of patients suffering from bleeding disorder increased from around 287,066 in 2015 to 393,658 in 2020. This increase is attributable to the rise in the diagnosis rate of the disorder among the population.


Also, increasing efforts and initiatives by healthcare organizations and other foundations are resulting in rising awareness among the general population regarding these disorders, available testing, and treatment options.



  • In January 2021, clinical practice guidelines on the diagnosis and management of Von Willebrand Disease were updated by the collaborative efforts of the National Hemophilia Foundation (NHF), the American Society of Hematology (ASH), World Federation of Hemophilia, and the International Society on Thrombosis and Hemostasis (ISTH).


Also, the rising number of treatment centers that provide training and education about the disorders, diagnosis, and treatment to the patients suffering from bleeding disorders such as Hemophilia, Von Willebrand Disease, and others is also contributing to the higher rate of diagnosis. The above mentioned factors along with increasing healthcare infrastructure in the emerging regions is projected to fuel the market growth during the forecast period.


Recent Product Approvals along with Presence of Robust Pipeline to Accelerate the Market Growth


There is increasing research and development activities by the market players owing to rising prevalence of bleeding disorder and demand for testing procedures. Also, increasing research activity is an important factor leading to advancements and innovations in the test kits and instruments for the diagnosis of bleeding disorders such as Hemophilia A, Hemophilia B, Von Willebrand Disease, and others.



  • In August 2021, rHEALTH in partnership with a global biopharmaceutical company developed a highly accurate, fingerstick-based approach to measure thrombocytopenia (low platelet counts).


Moreover, continuous efforts of the major players in the market and investment in research and development activities are resulting in a higher number of launches of bleeding disorder testing kits and instruments.



  • In July 2022, HORIBA Medical launched new products in its Yumizen H500 and H550 hematology product family with enhanced performance, new features, and increased benefits.


Thus, all these factors are resulting in higher rates of diagnosis among the population especially in developed regions, which is expected to propel the growth of the market during the forecast period.


RESTRAINING FACTORS


Low Adherence to Guidelines and Low Penetration of Testing in Emerging Countries to Restrict the Market Growth


There are various organizations in the developed countries such as the United States, the U.K., and others establishing national guidelines for diagnosis and management of bleeding disorder. This is a primary factor leading to higher rate of diagnosis and proper management of these disorders in the region.


On the other hand, emerging countries with comparatively lower adherence to the guidelines for the diagnosis and testing are resulting in lower penetration of testing and diagnosis of these conditions in the region.



  • According to the 2020 global annual report published by the World Federation of Hemophilia, the number of surveys to identify patients with Hemophilia and other bleeding disorder conducted in the UAE, Kuwait, and other Middle East countries is one. This indicated lower focus on diagnosis and penetration of testing in these countries as compared to developed countries.


The lower focus of the national organizations and other institutions in emerging countries toward increasing the awareness regarding these conditions and management of these disorders is resulting in lower penetration of testing among the population.


Along with these, the procurement of reagents and instruments in regions such as Africa and others owing to the high cost is one of the challenges that is limiting the early diagnosis and proper care of patients suffering from bleeding disorder.


SEGMENTATION


By Product Type Analysis


Increasing Penetration of Testing Procedures to Augment the Reagents & Consumables Segment Share


On the basis of product type, the market is segmented into reagents & consumables and instruments. The increasing rate of testing, owing to developing healthcare infrastructure and healthcare access in emerging regions also attributes to the growth of the reagents & consumables segment. The increasing incidence of bleeding disorder among the population along with the rising awareness regarding the bleeding disorder testing options is leading to an increased demand for bleeding disorder testing instruments globally.



  • According to a 2020 report published by the Centers for Disease Control and Prevention (CDC), the prevalence of hemophilia A and B in the U.S. is estimated to be 1 in 5,617 male births and 1 in 19,283 males births, respectively.


Moreover, advancements in technology leading to improving automation and portable analyzers are anticipated to further aid the increasing adoption of these instruments in clinical laboratories.


By Indication Analysis


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Hemophilia A Segment Growth to be Driven by Rising Disease Prevalence


On the basis of indication, the market is subdivided into hemophilia A, Von Willebrand disease, hemophilia B, idiopathic thrombocytopenic purpura, and others.


The rising prevalence of bleeding disorders such as Hemophilia A & B is leading to an increased patient population among all regions. This, coupled with rising awareness of diagnostic options available, is resulting in a higher rate of diagnosis.



  • For instance, according to the 2020 annual global survey conducted by the World Federation of Hemophilia, the number of people with Hemophilia was 209,614, which represents around 60.4% of the people affected by bleeding disorder.


The government bodies and other healthcare organizations are increasing their focus and efforts to develop guidelines for diagnosis and management of bleeding disorders such as Von Willebrand disease. This, along with rising prevalence of the disorder among the population, is anticipated to fuel the segmental growth.


The rising advancements in the technology and increasing number of launches of hematology and hemostasis analyzers are leading to higher adoption of analyzers and other instruments across the laboratories globally. This is a crucial factor that is anticipated to propel the testing of indications such as idiopathic thrombocytopenic purpura and others during the forecast period.


By End-user Analysis


Rising Rate of Diagnosis of Bleeding Disorder Among the Population to Fuel the Diagnostic Centers Segment


On the basis of end-user, the market is segmented into hospitals & clinics, diagnostic centers, and others. The rising awareness among the population regarding bleeding disorder along with the rising prevalence of the disorders is leading to a higher rate of diagnosis among the population. Also, the increasing technological advancements and rising number of launches of portable analyzers and software are contributing to the rising rate of testing in diagnostic centers.



  • In March 2021, F. Hoffmann-La Roche launched Cobas pure integrated solutions in countries accepting the CE mark with an aim to simplify the diagnostic procedures in small to medium sized labs with automation technology.


On the other hand, the increasing hospitalization rate due to the severity of these disorders is leading to an increased demand for testing instruments and reagents in hospitals and clinics. Thus, the increasing prevalence, diagnosis rate, and growing healthcare infrastructure in the regions are anticipated to augment the market.


REGIONAL INSIGHTS


Europe Bleeding Disorder Testing Market Size, 2021 (USD Million)

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On the basis of region, Europe held a dominating share and is expected to register a higher growth rate due to factors such as increasing prevalence of bleeding disorder in the U.K., Germany, and other countries. The rising number of patient population along with rising adherence to the guidelines for diagnosis of these disorders is driving the market growth.   



  • For instance, according to the 2020 report published by the World Federation of Hemophilia, there were in total 11,183 people with Von Willebrand disease in the U.K. among the study countries in 2020.


On the other hand, increasing number of regulatory approvals and launches of testing instruments and devices in the U.S. and Canada is anticipated to increase the bleeding disorder testing market share of North America during the forecast period.



  • In March 2019, HemoSonics, LLC received de novo marketing authorization by the FDA for its Quantra Hemostasis Analyzer platform and QPLus cartridge for the commercial availability in the U.S.


The improving healthcare infrastructure in emerging countries, such as China, Japan, Australia, and other countries, and increasing awareness and diagnosis rate of bleeding disorder testing are some of the major factors that are anticipated to fuel the market growth in Asia Pacific, the Middle East, and other regions.



  • In 2019, CSL, in collaboration with the National Foundation of Hemophilia, hosted a Hemophilia Health Care Hackathon in Japan. The event was aimed to increase the awareness of hemophilia among the patient and to increase the testing rates and efficiency of treatment.


KEY INDUSTRY PLAYERS


Leading Companies Develop a Strong Portfolio of Bleeding Disorder Testing Instruments & Consumables to Secure Competitive Edge


The global bleeding disorder testing market is fragmented, with many players operating in the market. Sysmex Corporation, Siemens Healthcare GmbH, F Hoffmann-La Roche, and HORIBA, Ltd. are some of the major companies.


The strong product portfolio of bleeding disorder testing products, strategic partnerships with other regional market players, and continuous efforts to develop and launch innovative products to strengthen its portfolio are some of the factors attributable to the dominance of these players in the market.



  • In August 2021, Siemens Healthcare GmbH as per its agreement with Sysmex Corporation launched Sysmex’s CN-3000 and CN-6000 Hemostasis Systems for mid and high-volume coagulation testing.


Also, companies, such as Beckman Coulter, Inc., Abbott, Shenzhen Mindray Bio-Medical Electronics Co., Ltd., and others, with their increasing focus on product approvals and launches is one of the important factors contributing to the rising market share of these players.


Precision BioLogic Incorporated, Diapharma, Boule, Atlas Medical GmbH, and others are some of the market players that are emerging in the market. The rising prevalence of bleeding disorder along with awareness is resulting in emphasis of market players to launch products and strengthen their presence.



  • In January 2020, Precision BioLOgic Incorporated received the authorization to commercialize the CRYOcheck Chromogenic Factor VIII assay in Australia, New Zealand, Canada, and the European Union.


Thus, the increasing focus on product approvals, launches, mergers and acquisitions, among the market players is anticipated to create growth opportunities for the emerging players and spur the market growth.


LIST OF KEY COMPANIES PROFILED:



KEY INDUSTRY DEVELOPMENTS:



  • July 2022 - HORIBA, Ltd. launched new products in its Yumizen H500 and H550 hematology product family with enhanced performance, new features, and increased benefits.

  • February 2022 - Sysmex Corporation established a new subsidiary, Sysmex LLC, in Saudi Arabia with an aim to reinforce its sales and services structure in Saudi Arabia. The new subsidiary will focus on strengthening its hematology, hemostasis, and urinalysis markets.

  • November 2021 – Precision BioLogic Incorporated launched a new CRYOcheck Factor VIII Deficient Plasma with VWF. The product was rolled out in Canada, the European Union, New Zealand, and Australia.

  • August 2021 - Siemens Healthcare GmbH as per its agreement with Sysmex Corporation launched Sysmex’s CN-3000 and CN-6000 Hemostasis Systems for mid and high-volume coagulation testing.

  • March 2021 - F. Hoffmann-La Roche Ltd. rolled out eight new configurations. Intended at maximizing throughput and increasing testing efficiency, the new configurations were launched for Cobas pro integrated solutions.


REPORT COVERAGE


An Infographic Representation of Bleeding Disorder Testing Market

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The market research report provides a detailed market analysis. It focuses on key aspects such as disease indication, end user, leading companies, competitive landscape. Besides this, it offers insights into the market trends, impact of COVID-19, and prevalence of bleeding disorder, among other key insights. In addition to the factors mentioned above, the report encompasses several factors that have contributed to the growth rate of the market in recent years.


Report Scope & Segmentation






















































  ATTRIBUTE



  DETAILS



Study Period



2018-2029



Base Year



2021



Estimated Year



2022



Forecast Period



2022-2029



Historical Period



2018-2020



Unit



Value (USD million)



Segmentation



By Product Type, Indication, End-user, and Region



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



Frequently Asked Questions

Fortune Business Insights says that the global market stood at USD 82.6 million in 2021 and is projected to reach USD 149.6 million by 2029.

In 2021, the market value stood at USD 33.1 million.

The market will exhibit steady growth at a CAGR of 7.8% during the forecast period (2022-2029).

By indication, Hemophilia A segment will lead the market.

The rising prevalence of bleeding disorder among the general population, recent product approvals with the presence of robust pipelines, and increasing penetration of these testing among the patient population, especially in developed countries, are the key drivers of the market.

Sysmex Corporation, Siemens Healthcare GmbH, F. Hoffmann-La Roche Ltd., and HORIBA Ltd. are the major players in the market.

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