Summary

Overview
Global HbA1c Testing Market reached US$ XX million in 2023 and is expected to reach US$XXmillion by 2031, growing at a CAGR of XX% during the forecast period 2024-2031.
HbA1c testing products are diagnostic tools designed for the measurement of hemoglobin A1c levels in blood samples. Hemoglobin A1c (HbA1c) is a form of hemoglobin that reflects average blood glucose levels over a period of approximately 2-3 months. HbA1c testing is commonly used in the management and monitoring of diabetes. These testing kits typically include the necessary components for collecting a blood sample and conducting the analysis to quantify the percentage of hemoglobin A1c in the blood.
Elevated HbA1c levels are indicative of poor blood glucose control, which increases the risk of diabetes-related complications such as cardiovascular disease, kidney problems, and nerve damage. Regular HbA1c testing allows for the early identification of individuals at risk, enabling proactive interventions to prevent complications. HbA1c testing helps set realistic and personalized glycemic control goals for individuals with diabetes. The results provide a basis for patient education, empowering individuals to make informed decisions about their lifestyle, medication adherence, and overall diabetes management.
Market Dynamics: Drivers
Increasing the availability of home diagnostic tests
The increasing popularity and adoption of home HbA1c testing products can be attributed to several factors, reflecting the broader trends in healthcare and patient preferences. For instance, home care diagnostic tests provide individuals with the ability to monitor specific health parameters without the need for a visit to a healthcare facility. This aligns with the broader trend of consumer-centric healthcare. The COVID-19 pandemic has accelerated the adoption of home care diagnostic tests, particularly for infectious diseases. The need for decentralized testing and reducing the risk of exposure in healthcare settings has driven demand for home-based testing solutions.
Additionally, the rise of product launhes also helps to accelerates the market. For instance, in May 2022, OmegaQuant had introduced the HbA1cblood sugar at-home testing kit, enabling users to test their hemoglobin A1c level to metabolize glucose, according to a press release. Typically, HbA1c testing requires a blood draw and lab analysis, but OmegaQuant’s HbA1c test allows for a simple finger stick so users can take the test on their own time and at their convenience, at home.
Furthermore, in May 2022, Labcorp screening for diabetes easier with the an at-home collection kit through Labcorp OnDemand that measures hemoglobin A1c (HbA1c) from a small blood sample. The Weavr Velvet device separates plasma and red blood cells, which allows a more in-depth, complex analysis of the sample. Thus above factors helps to boost the market growth.
Market Dynamics: Restraints
High cost of the kits
The cost of HbA1c testing kits can impact their accessibility for individuals, particularly in regions with limited financial resources. In some cases, patients may find it challenging to afford regular testing, leading to delayed or infrequent monitoring of their diabetes. Healthcare systems may face budget constraints, especially in resource-limited settings.
The cost of purchasing and maintaining HbA1c testing equipment can strain healthcare budgets, limiting the widespread availability of these kits in certain regions. Accessibility to HbA1c testing kits may be influenced by insurance coverage. In regions where insurance coverage is limited or where certain populations have inadequate insurance, individuals may face barriers to accessing these kits due to high out-of-pocket expenses.
Companies often invest in marketing and sales efforts to promote and sell their HbA1c testing kits. These expenses, including advertising, distribution networks, and sales personnel, are factored into the overall cost structure. For instance, the A1CNow Self Check HbA1c Test Kit preice ranges in between $64.95-$72.33. Thus due to the high cost of the testing kits will restrain the market growth.
Segment Analysis
The global HbA1c testing Market is segmented based on product type, technology, end user and region.
The kits segment from the product type segment accounted for approximately 39.7% of HbA1c Testing type share
HbA1c testing provides a measure of average blood glucose levels over the past 2-3 months. This gives healthcare professionals a comprehensive view of a patient's long-term glucose control, as opposed to self-monitoring of blood glucose levels, which provides snapshots of current levels. HbA1c testing is one of the diagnostic tools for diabetes. It helps identify individuals with elevated average blood glucose levels over an extended period, aiding in the diagnosis of diabetes and prediabetes.
The demand for point-of-care testing is on the rise, driven by the need for faster results and increased convenience. Companies may launch HbA1c testing kits designed for use at the point of care, allowing for quicker assessments and immediate treatment adjustments. For instance, in October 2023, Healthyr, continuied to take action toward reinventing patient care with the launch of their six at-home tests currently available at Walmart. The six at-home tests include Healthyr's General Health Test, Cholesterol Test, HbA1c + Glucose Test, Thyroid Test, Cholesterol and Blood Sugar Test, and STI Test.
Additionally, in February 2023, Hurdle, a diagnostics-as-a-service company launched an at-home Hemoglobin A1c (HbA1c) Test that enables adult consumers to take a simple at-home blood sample to screen and monitor for diabetes. The developed by leading scientists, Hurdle’s testing technology offers leading accuracy and reliability and operates in partnership with labs that hold themselves to the highest testing standards. Thus above factors helps to accelerates the segment growth.
Geographical Analysis
North America accounted for approximately 32.4% of the market share in 2022
North America is dominating the global HbA1c testing device market accounted for the largest market share, owing to rising incidences of diabetes. The United States is one of the top five countries with the highest diabetic population. The country has close to 100 million adults, diabetic and pre-diabetic. In 2021, according to the Centers for Disease Control and Prevention (CDC), more than 30 million people in the United States have diabetes. More than 84 million U.S. adults (over a third) have pre-diabetes. Diabetes is the 7th leading cause of death in the United States.
Type 2 diabetes accounts for about 90% to 95% of all diagnosed cases of diabetes; type 1 diabetes accounts for about 5%. The market growth of diabetic devices is directly proportional to the increasing diabetic population in the country. In the last 20 years, the number of adults diagnosed with diabetes has more than doubled as the American population has aged and become more overweight or obese. In the United States, 30% of the population lives with obesity, 7.5% of those have diabetes, and this rise of diseases helps to raise market growth in the region.
Market Segmentation
By Product Type
• Kits
• Reagents
By Technology
• Immunoassay
• High-performance liquid chromatography (HPLC)
• Boronate affinity Chromatography
• Enzymatic assays
By End User
• Diagnostics Laboratories
• Hospitals
• Others
By Region
• North America
o U.S.
o Canada
o Mexico
• Europe
o Germany
o UK
o France
o Italy
o Spain
o Rest of Europe
• South America
o Brazil
o Argentina
o Rest of South America
• Asia-Pacific
o China
o India
o Japan
o Australia
o Rest of Asia-Pacific
• Middle East and Africa
Competitive Landscape
The major global players in the market include Abbott Laboratories, Arkray, Inc, Bio-Rad Laboratories Inc, EKF Diagnostics Holdings Plc, Siemens Healthineers, PTS Diagnostics, Inc, Getein Biotech, Inc, Thermo Fisher Scientific Inc., Roche Diagnostics Corporation, Meril Life Sciences Pvt. Ltd among others.
Key Developments
• In April 2023, Abbott, Siemens Healthineers, i-SENS Partner With FIND to Improve Access to HbA1c Tests that will be used to reduce diabetes underdiagnosis in low- and middle-income countries. The global diagnostics access organization said the three firms have agreed to offer at a discount point-of-care HbA1c testing kits that provide a patient's average blood sugar concentration over two to three months. The agreement involves Abbott's Afinion, Siemens Healthineers' DCA Vantage, and i-SENS' A1Care tests.
• In March 2022, LumiraDx Limited, a next-generation point of care diagnostics company, its HbA1c test had achieved CE Marking. Used with the LumiraDx Platform, the test provides results in under seven minutes from sample application for the monitoring of individuals with diabetes, and as an aid in screening and identifying patients who may be at risk for developing diabetes, all at the point of
Why Purchase the Report?
• To visualize the global HbA1c testing market segmentation based on product type, technology, end user, and regionas well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development.
• Excel data sheet with numerous data points of HbA1c testing market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.
The global HbA1c testing market report would provide approximately 64tables, 61figures and 186pages.
Target Audience 2023
• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies

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Table of Contents

1. Methodology and Scope
1.1. Research Methodology
1.2. Research Objective and Scope of the Report
2. Definition and Overview
3. Executive Summary
3.1. Snippet by Product Type
3.2. Snippet by Technology
3.3. Snippet by End User
3.4. Snippet by Region
4. Dynamics
4.1. Impacting Factors
4.1.1. Drivers
4.1.1.1. The global increase in the prevalence of diabetes
4.1.1.2. Increasing the availability of home diagnostic tests
4.1.2. Restraints
4.1.2.1. High cost of the kits
4.1.2.2. XX
4.1.3. Opportunity
4.1.4. Impact Analysis
5. Industry Analysis
5.1. Porter's Five Force Analysis
5.2. Supply Chain Analysis
5.3. Pricing Analysis
5.4. Regulatory Analysis
5.5. Patent Analysis
5.6. SWOT Analysis
5.7. DMI Opinion
6. COVID-19 Analysis
6.1. Analysis of COVID-19
6.1.1. Scenario Before COVID
6.1.2. Scenario During COVID
6.1.3. Scenario Post COVID
6.2. Pricing Dynamics Amid COVID-19
6.3. Demand-Supply Spectrum
6.4. Government Initiatives Related to the Market During Pandemic
6.5. Manufacturers Strategic Initiatives
6.6. Conclusion
7. By Product Type
7.1. Introduction
7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
7.1.2. Market Attractiveness Index, By Product Type
7.2. Kits *
7.2.1. Introduction
7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
7.3. Reagents
8. By Technology
8.1. Introduction
8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
8.1.2. Market Attractiveness Index, By Technology
8.2. Immunoassay *
8.2.1. Introduction
8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
8.3. High-performance liquid chromatography (HPLC)
8.4. Boronate affinity Chromatography
8.5. Enzymatic assays
9. By End User
9.1. Introduction
9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
9.1.2. Market Attractiveness Index, By End User
9.2. Diagnostics Laboratories *
9.2.1. Introduction
9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
9.3. Hospitals
9.4. Others
10. By Region
10.1. Introduction
10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
10.1.2. Market Attractiveness Index, By Region
10.2. North America
10.2.1. Introduction
10.2.2. Key Region-Specific Dynamics
10.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
10.2.6.1. U.S.
10.2.6.2. Canada
10.2.6.3. Mexico
10.3. Europe
10.3.1. Introduction
10.3.2. Key Region-Specific Dynamics
10.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
10.3.6.1. Germany
10.3.6.2. UK
10.3.6.3. France
10.3.6.4. Italy
10.3.6.5. Spain
10.3.6.6. Rest of Europe
10.4. South America
10.4.1. Introduction
10.4.2. Key Region-Specific Dynamics
10.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
10.4.6.1. Brazil
10.4.6.2. Argentina
10.4.6.3. Rest of South America
10.5. Asia-Pacific
10.5.1. Introduction
10.5.2. Key Region-Specific Dynamics
10.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
10.5.6.1. China
10.5.6.2. India
10.5.6.3. Japan
10.5.6.4. Australia
10.5.6.5. Rest of Asia-Pacific
10.6. Middle East and Africa
10.6.1. Introduction
10.6.2. Key Region-Specific Dynamics
10.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
11. Competitive Landscape
11.1. Competitive Scenario
11.2. Market Positioning/Share Analysis
11.3. Mergers and Acquisitions Analysis
12. Company Profiles
12.1. Abbott Laboratories*
12.1.1. Company Overview
12.1.2. Product Portfolio and Description
12.1.3. Financial Overview
12.1.4. Key Developments
12.2. Arkray, Inc
12.3. Bio-Rad Laboratories Inc
12.4. EKF Diagnostics Holdings Plc
12.5. Siemens Healthineers
12.6. PTS Diagnostics, Inc
12.7. Getein Biotech, Inc
12.8. Thermo Fisher Scientific Inc.
12.9. Roche Diagnostics Corporation
12.10. Meril Life Sciences Pvt. Ltd.
LIST NOT EXHAUSTIVE
13. Appendix
13.1. About Us and Services
13.2. Contact Us