Bleeding Disorder Diagnostics Market by Diagnostic Tests, Indication, End-use

Description

List of Tables

[198 Pages Report] The Bleeding Disorder Diagnostics Market size was estimated at USD 662.87 million in 2023 and expected to reach USD 710.26 million in 2024, at a CAGR 7.60% to reach USD 1,107.09 million by 2030.

Bleeding disorder diagnostics encompass a range of medical tests and procedures used to identify and evaluate the underlying causes of abnormal bleeding. These disorders, which can be either congenital or acquired, affect the blood's ability to coagulate properly, leading to prolonged bleeding even from minor injuries or, in severe cases, spontaneous bleeding without any apparent cause. Diagnostic approaches for bleeding disorders include a combination of clinical assessments and laboratory testing. The goal of these diagnostics is to accurately diagnose the specific type of bleeding disorder, assess its severity, and guide appropriate treatment and management strategies. Accurate diagnosis is crucial for implementing effective treatments and improving the quality of life for individuals with bleeding disorders. The rising prevalence of bleeding disorders worldwide, coupled with a growing awareness among patients about the importance of early diagnosis of these conditions, is bolstering the need for bleeding disorder diagnostics. However, the high cost of advanced diagnostic tests, which may limit their accessibility in low-income regions, and the shortage of skilled professionals in rural and underdeveloped areas pose significant challenges to the widespread adoption of these diagnostic solutions. Despite these challenges, ongoing research and development activities aimed at enhancing diagnostic accuracy and reducing costs offer new growth avenues for improved accessibility and adoption of bleeding disorder diagnostics worldwide.

KEY MARKET STATISTICS
Base Year [2023]	USD 662.87 million
Estimated Year [2024]	USD 710.26 million
Forecast Year [2030]	USD 1,107.09 million
CAGR (%)	7.60%

Diagnostic Tests: Growing importance of genetic testing to identify mutations or abnormalities in specific genes associated with clotting factors

Bleeding time is a traditional diagnostic test designed to evaluate primary hemostasis and assess the duration it takes for blood vessels to cease bleeding after a small incision, typically on the underside of the forearm. It reflects the interaction between platelets and the vascular wall but does not measure clotting factor activity directly. Genetic testing in the context of bleeding disorders involves analyzing an individual's DNA to identify genetic abnormalities or mutations that may lead to a bleeding disorder. These tests are particularly valuable for diagnosing inherited bleeding disorders, including hemophilia A and B, Von Willebrand disease, and other rare clotting factor deficiencies. Genetic tests provide definitive diagnoses, enable carrier testing, offer insights into disease severity, and guide treatment decisions. Platelet aggregation tests are a suite of assays used to evaluate how well platelets, a type of blood cell crucial for clotting, clump together to form a blood clot. These tests assess the function of platelets in response to various aggregating agents such as ADP, collagen, ristocetin, and epinephrine.

Indication: Significant applications of bleeding disorder diagnostics to diagnose different types of VWD

Hemophilia A, also referred to as classical hemophilia, is a genetic disease caused by a deficiency of clotting factor VIII. This condition leads to excessive bleeding following injury or surgery and spontaneous bleeding episodes, notably in muscles and joints. It affects males, being passed on through an X-linked recessive pattern. Hemophilia B, also called Christmas disease, is caused by a deficiency of clotting factor IX. Its clinical manifestations are similar to Hemophilia A, though it is less common. Platelet function disorders are a group of conditions characterized by the inability of platelets to effectively contribute to blood clotting, leading to abnormal bleeding. These disorders can be congenital, such as Glanzmann thrombasthenia or Bernard-Soulier syndrome, or acquired due to other medical conditions or medications. Symptoms include excessive bleeding from wounds, easy bruising, and prolonged bleeding times. Diagnosis of these disorders typically involves platelet count tests, platelet function assays, and bleeding time tests. Von Willebrand Disease (VWD) is one of the common inherited bleeding disorders caused by a dysfunction or deficiency of the von Willebrand factor (VWF), a major protein in blood clot formation. VWD is categorized into three main types based on the quantitative or qualitative defect of VWF. Patients may experience spontaneous bleeding, excessive bleeding during injury or surgical procedures, and heavy menstrual bleeding. Diagnosis of VVD is complex and includes evaluating the patient's bleeding history, VWF antigen tests, and functional assays to assess the activity of VWF and factor VIII.

Regional Insights

In the Americas, particularly in North America, the market for bleeding disorder diagnostics is experiencing robust growth. The United States contributes majorly to this growth with a highly advanced healthcare infrastructure, significant investments in R&D, and a strong presence of major market players. A significant number of hemophilia A & hemophilia B patients and supportive reimbursement policies further fuel the need for bleeding disorder diagnostics in the region. The EMEA region shows a diverse market performance owing to varying economic, healthcare, and regulatory landscapes. Europe maintains a strong market growth with high awareness levels, strong healthcare systems, and significant investments in bleeding disorders diagnostics. However, growth rates in the Middle East and Africa are slower but gradually increasing, driven by efforts to improve healthcare infrastructure and access to diagnostics. The Middle East, in particular, shows promise with rising healthcare expenditure and initiatives to enhance healthcare standards. The APAC region is emerging as a rapidly growing market for bleeding disorder diagnostics, attributed to its large population base, increasing healthcare expenditure, and growing awareness of bleeding disorders. Emerging economies in the region are rapidly adopting bleeding disorder diagnostics solutions owing to their expanding healthcare infrastructure, rise in bleeding disorders, and initiatives by governments to improve healthcare access.

FPNV Positioning Matrix

The FPNV Positioning Matrix is pivotal in evaluating the Bleeding Disorder Diagnostics Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).

Market Share Analysis

The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the Bleeding Disorder Diagnostics Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.

Key Company Profiles

The report delves into recent significant developments in the Bleeding Disorder Diagnostics Market, highlighting leading vendors and their innovative profiles. These include Abbott Laboratories, ARUP Laboratories, Baxter International Inc., Bayer AG, Bio-Rad Laboratories, Inc., Cepheid by Danaher Corporation, CSL Limited, F. Hoffmann-La Roche Ltd., HORIBA, Ltd., Hyphen BioMed by Sysmex Corporation, Laboratory Corporation of America Holdings, Novo Nordisk A/S, Precision BioLogic, rHEALTH, Siemens AG, Takeda Pharmaceutical Company Limited, and Thermo Fisher Scientific Inc..

Market Segmentation & Coverage

This research report categorizes the Bleeding Disorder Diagnostics Market to forecast the revenues and analyze trends in each of the following sub-markets:

Diagnostic Tests
- Bleeding Time
- Genetic Tests
- Platelet Aggregation Tests

Indication
- Hemophilia A & Hemophilia B
- Platelet Function Disorders
- Von Willebrand Disease

End-use
- Diagnostic Laboratories
- Hospitals
- Specialized Clinics

Region
- Americas
  - Argentina
  - Brazil
  - Canada
  - Mexico
  - United States
    - California
    - Florida
    - Illinois
    - New York
    - Ohio
    - Pennsylvania
    - Texas
- Asia-Pacific
  - Australia
  - China
  - India
  - Indonesia
  - Japan
  - Malaysia
  - Philippines
  - Singapore
  - South Korea
  - Taiwan
  - Thailand
  - Vietnam

Europe, Middle East & Africa
- Denmark
- Egypt
- Finland
- France
- Germany
- Israel
- Italy
- Netherlands
- Nigeria
- Norway
- Poland
- Qatar
- Russia
- Saudi Arabia
- South Africa
- Spain
- Sweden
- Switzerland
- Turkey
- United Arab Emirates
- United Kingdom

The report offers valuable insights on the following aspects:

1. Market Penetration: It presents comprehensive information on the market provided by key players.

2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.

3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.

4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.

5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.

The report addresses key questions such as:

1. What is the market size and forecast of the Bleeding Disorder Diagnostics Market?

2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Bleeding Disorder Diagnostics Market?

3. What are the technology trends and regulatory frameworks in the Bleeding Disorder Diagnostics Market?

4. What is the market share of the leading vendors in the Bleeding Disorder Diagnostics Market?

5. Which modes and strategic moves are suitable for entering the Bleeding Disorder Diagnostics Market?

Product Code: MRR-8E373E9E2067

1. Preface

1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Stakeholders

2. Research Methodology

2.1. Define: Research Objective
2.2. Determine: Research Design
2.3. Prepare: Research Instrument
2.4. Collect: Data Source
2.5. Analyze: Data Interpretation
2.6. Formulate: Data Verification
2.7. Publish: Research Report
2.8. Repeat: Report Update

3. Executive Summary

4. Market Overview

5. Market Insights

5.1. Market Dynamics
- 5.1.1. Drivers
  - 5.1.1.1. Increasing prevalence of bleeding disorders
  - 5.1.1.2. Growing awareness and initiatives about bleeding disorders among the general population and healthcare professionals
- 5.1.2. Restraints
  - 5.1.2.1. High costs associated with advanced bleeding disorder diagnostics methods
- 5.1.3. Opportunities
  - 5.1.3.1. Emerging potential of advanced technologies in bleeding disorder diagnostics
  - 5.1.3.2. Growing adoption of point-of-care bleeding disorder testing devices
- 5.1.4. Challenges
  - 5.1.4.1. Regulatory complexities and the dynamic nature of healthcare regulations across different regions
5.2. Market Segmentation Analysis
- 5.2.1. Diagnostic Tests: Growing importance of genetic testing to identify mutations or abnormalities in specific genes associated with clotting factors
- 5.2.2. Indication: Significant applications of bleeding disorder diagnostics to diagnose different types of VWD
5.3. Market Disruption Analysis
5.4. Porter's Five Forces Analysis
- 5.4.1. Threat of New Entrants
- 5.4.2. Threat of Substitutes
- 5.4.3. Bargaining Power of Customers
- 5.4.4. Bargaining Power of Suppliers
- 5.4.5. Industry Rivalry
5.5. Value Chain & Critical Path Analysis
5.6. Pricing Analysis
5.7. Technology Analysis
5.8. Patent Analysis
5.9. Trade Analysis
5.10. Regulatory Framework Analysis

6. Bleeding Disorder Diagnostics Market, by Diagnostic Tests

6.1. Introduction
6.2. Bleeding Time
6.3. Genetic Tests
6.4. Platelet Aggregation Tests

7. Bleeding Disorder Diagnostics Market, by Indication

7.1. Introduction
7.2. Hemophilia A & Hemophilia B
7.3. Platelet Function Disorders
7.4. Von Willebrand Disease

8. Bleeding Disorder Diagnostics Market, by End-use

8.1. Introduction
8.2. Diagnostic Laboratories
8.3. Hospitals
8.4. Specialized Clinics

9. Americas Bleeding Disorder Diagnostics Market

9.1. Introduction
9.2. Argentina
9.3. Brazil
9.4. Canada
9.5. Mexico
9.6. United States

10. Asia-Pacific Bleeding Disorder Diagnostics Market

10.1. Introduction
10.2. Australia
10.3. China
10.4. India
10.5. Indonesia
10.6. Japan
10.7. Malaysia
10.8. Philippines
10.9. Singapore
10.10. South Korea
10.11. Taiwan
10.12. Thailand
10.13. Vietnam

11. Europe, Middle East & Africa Bleeding Disorder Diagnostics Market

11.1. Introduction
11.2. Denmark
11.3. Egypt
11.4. Finland
11.5. France
11.6. Germany
11.7. Israel
11.8. Italy
11.9. Netherlands
11.10. Nigeria
11.11. Norway
11.12. Poland
11.13. Qatar
11.14. Russia
11.15. Saudi Arabia
11.16. South Africa
11.17. Spain
11.18. Sweden
11.19. Switzerland
11.20. Turkey
11.21. United Arab Emirates
11.22. United Kingdom

12. Competitive Landscape

12.1. Market Share Analysis, 2023
12.2. FPNV Positioning Matrix, 2023
12.3. Competitive Scenario Analysis
- 12.3.1. ARUP Laboratories Makes History with Diagnostic Test for Hemophilia A
- 12.3.2. FDA Approves First Gene Therapy for Adults with Severe Hemophilia A
12.4. Strategy Analysis & Recommendation

13. Competitive Portfolio

13.1. Key Company Profiles
13.2. Key Product Portfolio