Global HbA1c Testing Device Market - 2022-2029

Market Overview

HbA1c Testing Device Market size was valued at USD1.47 billion in 2021 and is estimated to reach USD 3.29 billion by 2029, growing at a CAGR of 12.6% during the forecast period (2022-2029).

Hemoglobin A1C, also known as HbA1c, is a form of hemoglobin that is bound to glucose. HbA1c blood test is used in many healthcare organizations to test people with type 1 and type 2 diabetes. The level of HBA1c indicates how well diabetes is controlled, which usually is ranged less than 6%. HbA1c test kits allow convenient and semi-quantitative testing of whole blood for HbA1c (glycated hemoglobin).

Market Dynamics

The global HbA1c testing device market is growing due to several factors such as technological advancements in the devices and rising prevalence of diabetes worldwide and government initiatives for awareness and various programs conducted for prevention of diabetes and creating awareness among people.

The rising incidence rate of diabetes globally is expected to drive market growth.

The global HbA1c testing device market is growing owing to the rising incidence rate of diabetes globally. Diabetes is a chronic metabolic condition that occurs when the body cannot produce insulin or use it efficiently, causing glucose to build up in the bloodstream. According to the World Health Organization data (2022), almost 422 million people are suffering from diabetes worldwide, the majority of them are from low to middle income countries, and each year around 1.5 million deaths are caused due to diabetes. Since past few years the number of cases are increasing as well as the prevalence of diabetes is growing continuously.

Also, rising technology advancement in diabetes management devices and the growing awareness of diabetes are expected to boost the HbA1c testing device market's growth. For instance, on 13th March 2020, the Indian Council of Medical Research (ICMR) has developed "SuChek," a 100% indigenous glucometer suitable for diverse climatic conditions, affordable, and validated as per international standards. Another aboriginal device designed as a part of the ICMR study for HbA1c testing is under validation. The Government is also implementing the National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases, and Stroke (NPCDCS), with several objectives of increasing awareness generation for prevention of Non-Communicable Diseases (NCDs), screening, early detection, management, and referral to an appropriate level health facility.

In April 2021, WHO along with Govt. of Canada, launched a new initiative to energise efforts to reduce the risk of diabetes as well as ensure that diabetic patients access affordable and quality treatment globally named as Global Diabetes Compact. These all factors will drive the growth of market in forecast period.

High cost of testing devices is expected to hamper the market growth.

The device's high cost is expected to hamper the global HbA1c testing device market's growth. Limitations of hemoglobin A1c testing is also a limiting factor.

Industry Analysis

The global HbA1c testing device market provides in-depth analysis of the market based on various industry factors such as Porter's Five Forces, Regulatory Analysis, Supply Chain Analysis, Pricing Analysis, Unmet Needs, Product Development.

Segment Analysis

Hand sanitizers segment is expected to hold the largest market share in global HbA1c testing device market

Based on technology, the HbA1c testing device market is segmented into the enzymatic assay, turbidimetric inhibition immunoassay, ion-exchange HPLC, affinity binding chromatography, and others. In 2019, the ion-exchange HPLC segment was estimated to hold the largest market share, owing to its several advantages over other technologies.

Ion-exchange HPLC technology is the most widely used for hemoglobin A1c testing and gives accurate HbA1c values in the presence of hemoglobin variants in the case of a highly diversified population. The HPLC increases the ionic strength of the buffer, consumes less time, and identifies variants. The majority of the hemoglobin A1c testing devices are based on HPLC technology. HPLC-based hemoglobin A1c testing analyzers can also be used in point-of-care settings, along with laboratories. For instance, In Mar 2021, fully automated hemoglobin A1c advanced assay got approved by U.S.FDA and CE certification.

Geographical Analysis

North America region holds the largest market share in the global HbA1c testing device market

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 Centres 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 percentage is expected to increase further during the forecast period.

Also, the rising number of FDA approvals for point-of-care testing analyzers, new product launches, and growing technological advancements in hemoglobin A1c testing is boosting the growth of the market in this region. For instance, in January 2019, PTS Diagnostics received the U.S. Food and Drug Administration (FDA) approval for the medical device convenience kit that quantitatively measures the percent of high-density lipoprotein, glycated hemoglobin, total cholesterol, triglycerides, and glucose in whole blood.

The HbA1c testing market in the Asia Pacific is estimated to grow the fastest. Due to the growing burden of diabetes, the forecast period's growth rate increases the number of laboratory testing for diabetes and well-qualified healthcare staff such as diabetologists and clinicians. For instance, according to the International Diabetes Federation (IDF), around 382 million people worldwide are expected to have diabetes by 2035. Of these, about 60% will live in Asia and one-third in China.

Competitive Landscape

The global HbA1c Testing Device market is competitive, with major players competing and emerging players. Some of the market players include Abbott Laboratories, Arkray, Inc., Danaher Corporation, Siemens Healthcare, Trinity Biotech plc, Alere, Inc., Bio-Rad Laboratories, Inc, and F. Hoffmann-La Roche Ltd.

The key players are adopting various growth strategies such as product launches, acquisitions, and collaborations, contributing to the HbA1c Testing Device market's growth globally. For instance,

• On June 17th, 2019, Abbott launched its Afinion HbA1c Dx assay for use on the Afinion 2 Analyzer and the Afinion AS100 Analyzer. The Afinion HbA1c Dx assay is the first and only rapid point-of-care test cleared by the U.S. Food and Drug Administration (FDA) to aid healthcare professionals in the diagnosis of diabetes and the assessment of patients' risk of developing the condition.
• In Jun 2021, Afinion HbA1c Dx assay developed by Abbott laboratories got approved by the U.S. Food and Drug Administration for point-of-care test. They announced that this product will be available for Afinion 2 analyzer.
• In Sep 2021, Abbott Laboratories partnered with Sanofi in which they will produce diabetes management technology that will be useful for cloud software and insulin titration apps.

Key Companies to Watch

Bio-Rad Laboratory:

Overview: Bio-Rad Laboratories is an American company that develops and manufactures various products with technological advancements for Clinical Diagnostics and Life Science research. It was founded in 1952 and is headquartered in Berkeley, California. This company operates worldwide.

Product Portfolio:

D-10 Hemoglobin Testing System: D-10 instrument gives automated hemoglobin testing in a dense footprint. It combines HbA1c and HbA2/F/A1c testing on single platform, also provides efficient operations for physician clinics and clinical laboratories.

Key Developments: In Mar 2021, Bio-Rad Laboratory revealed its partnership with F. Hoffmann-La Roche AG

The global HbA1c testing device market report would provide an access to an approx. 45+market data table, 40+figures and 180pages.