Hba1c Testing Device Market Size & Share to Surpass $3.03 Billion by 2030 | Vantage Market Research


WASHINGTON, Oct. 30, 2023 (GLOBE NEWSWIRE) -- As per Vantage Market Research, the Global Hba1c Testing Device Market has been significantly growing over the years due to the increasing prevalence of diabetes, raising awareness about diabetes management, and technological advancements in Hba1c Testing Devices.

According to Vantage Market Research, the global Hba1c Testing Device Market is estimated to be valued at USD 3.03 Billion by 2030 and is expected to exhibit a CAGR of 12.9% during the forecast period 2023 to 2030. The global Hba1c Testing Device market grew to USD 1.3 Billion in 2022.

Hba1c Testing Devices are used to measure the average blood glucose levels over some time and are crucial for managing diabetes. These devices come in various types, including handheld glucometers and laboratory-based instruments. They employ different technologies, with handheld devices typically utilizing electrochemical sensors and laboratory instruments using high-performance liquid chromatography (HPLC) or immunoassays. Some machines offer additional functionalities, such as data storage and analysis or connectivity to mobile applications for better diabetes management. Accurate and reliable Hba1c Testing Devices are essential in monitoring the long-term effectiveness of diabetes treatment and making informed health management decisions.

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Key Highlights

  • Increasing the prevalence of diabetes, raising awareness about diabetes management, and technological advancements in Hba1c Testing Devices will bolster market growth.
  • North America accounted for the largest revenue share of 43.2% in 2022.
  • The Asia Pacific region is expected to dominate the market with the largest growth rate during the forecast period.
  • The laboratory Testing Devices segment accounted for the most prominent market growth in 2022 because they are widely used in diagnostic laboratories, hospitals, and clinics due to their accuracy and precision in measuring HbA1c levels.
  • Based on Technology, the Immunoassay segment accounted for the potential market growth in 2022 due to the growing prevalence of diabetes worldwide and the need for efficient and convenient testing solutions.   
  • North America dominates global sales owing to the high prevalence of diabetes in the region and the growing emphasis on early diagnosis and management of the disease.

The market is experiencing significant growth due to the rising prevalence of diabetes and increasing awareness about the importance of glycemic control. Technological advancements have led to the developing of innovative and user-friendly devices, driving market expansion. Additionally, government initiatives to promote early diagnosis and management of diabetes have further propelled market demand. Key players in this market are investing in research and development to introduce new products and gain a competitive edge.

Factors affecting the growth of the Hba1c Testing Device Industry

Several factors can affect the growth of the Hba1c Testing Device industry. Some of these factors include:

  • Increasing prevalence of Diabetes: The upward shift in the majority of Diabetes worldwide is a key factor driving the growth of the Hba1c Testing Device industry. For Example, The International Diabetes Federation estimates that the overall number of patients with Diabetes is predicted to rise to 643 million by the year 2030 and 783 million by 2045, highlighting the need to monitor blood glucose levels using Hba1c Testing Devices regularly.
  • Technological advancements: Technology advancements have significantly improved the accuracy, speed, and ease of use of Hba1c Testing Devices. For example, in 2019, Abbott launched the First-ever Rapid Point-of-Care HbA1c Test to Aid in diagnosing Diabetes.
  • Growing demand for self-monitoring: With the increasing trend of self-management among individuals with Diabetes, there is a rising demand for home-use Hba1c Testing Devices. Know Labs unveiled their latest innovation in 2021, the UBand wristband. This revolutionary device is designed to constantly track blood glucose levels, catering specifically to the needs of diabetic individuals who require regular sugar level monitoring.
  • Favorable reimbursement frameworks: Supportive reimbursement policies and frameworks play a crucial role in adopting Hba1c Testing Devices. Adequate reimbursement for HbA1c testing enables healthcare providers to offer these tests to a broader population, including those with limited financial resources.

Top Companies in The Global Hba1c Testing Device Market

  • Abbott Laboratories (U.S.)
  • ARKRAY Inc. (Japan)
  • Bio-Rad Laboratories Inc. (U.S.)
  • Check Diagnostics GMBH (Germany)
  • Polymer Technology Systems Inc. (U.S.)
  • Danaher Corporation (U.S.)
  • Beckman Coulter (U.S.) F. Hoffmann-La Roche Ltd. (Switzerland)
  • Menarini Group (Italy)
  • Sebia Inc. (U.S.)
  • Siemens Healthcare (Germany)
  • Tosoh Corporation (Japan)
  • Trinity Biotech PLC (Ireland)

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Top Trends in Global Hba1c Testing Device Market

The current trend is moving towards CLIA-waived tests, increasing the demand for CLIA-waived Hba1c Testing Devices. This shift will benefit both manufacturers and customers. Additionally, introducing CLIA-waived POC Hba1c Testing Devices will drive the demand for POC devices. Various studies have shown that the glucose tolerance test is more effective than the hemoglobin A1c blood test. For example, a survey conducted by the City of Hope Diabetes and Metabolism Research Institute in March 2019, which was published at the Endocrine Society's ENDO 2019, found that the hemoglobin A1c blood test missed nearly 73% of individuals with diabetes in comparison to the OGTT Test.

Market Drivers

The global hemoglobin A1c testing devices industry is anticipated to experience major growth due to the rising prevalence of diabetes. North America alone has over 29 million diabetic patients. This number is expected to increase to 34 million by 2027. In 2021, the United States reported more than 26 million diabetes patients. Additionally, there is an increased risk of type II diabetes affecting 541 million adults worldwide, according to the World Health Organization (WHO).

The market growth is also attributed to the growing awareness among patients regarding the importance of early diagnosis and management of diabetes. Furthermore, the rising elderly population is expected to contribute to market growth, with the U.S. Census Bureau projecting a reach of 77 million elderly individuals in the U.S. by 2034. Obesity, a significant factor contributing to diabetes, also drives the demand for Hba1c Testing Devices. The WHO predicts that the world's aging population will reach 2 billion by the year 2050, up from 1 billion in 2020, further propelling market growth.

Market Restraints

The global Hba1c Testing Device market is anticipated to face obstacles to its growth due to the high cost of tests. The laboratory testing process for hemoglobin A1c is expensive and time-consuming, making it difficult for patients to undergo A1C testing. In addition, healthcare professionals tend to rely on blood glucose testing for emergencies. Moreover, low adoption of hemoglobin A1c testing in emerging economies is also expected to aid in market growth.

Market Opportunities

The high prevalence of undiagnosed diabetes in emerging economies is predicted to create lucrative growth opportunities in the market. According to the International Diabetes Federation's data from 2021, nearly half of diabetes patients in Africa and over half in the Asia Pacific region remain undiagnosed. This trend is primarily driven by countries such as India, China, and Indonesia. A study published in Diabetes Care in 2019 revealed that the economic burden of diabetes, including both diagnosed and undiagnosed cases, reached billions of dollars in the United States alone in 2017. Furthermore, introducing cost-effective HbA1c tests and devices will contribute to market growth.

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Recent Development of the Global Hba1c Testing Device Market

  • In March 2023, Abbott received the U.S. FDA approval for its FreeStyle Libre 2 and FreeStyle Libre 3 integrated CGM sensors for integration with automated insulin delivery systems.
  • In February 2023, Dexcom, Inc. received the U.S. CMS approval for coverage for its G7 CGM system.
  • In September 2022, Nemaura Medical Inc. partnered with Eversana to introduce Nemaura's diabetes management system in the U.S.

Report Segmentation of the Global Hba1c Testing Device Market

Test Type Analysis

Laboratory Testing Devices dominated the market with the largest share because they are widely used in diagnostic laboratories, hospitals, and clinics due to their accuracy and precision in measuring HbA1c levels. The global Hba1c Testing Device market is based on test types segmented into laboratory and point-of-care testing devices. These devices are designed to provide rapid and reliable results, making them ideal for large-scale testing. Additionally, laboratory testing devices often have advanced features such as automated sample handling and data management systems, further enhancing their popularity. The dominance of laboratory testing devices in the Hba1c Testing Device market can be attributed to their proven track record and trustworthiness among healthcare professionals.

Technology Analysis

The Immunoassay segment dominated the largest market share. It will dominate in the forecast period because of the growing prevalence of diabetes worldwide and the need for efficient and convenient testing solutions. Immunoassay-based devices offer higher sensitivity and accuracy in measuring glycosylated hemoglobin levels, making them the preferred choice for diagnosing and monitoring diabetes. These devices utilize antibodies to specifically bind to HbA1c and produce a measurable signal, providing precise and reliable results. The global Hba1c Testing Device market is based on the technology analysis segmented into ion-exchange HPLC, immunoassay, boronate affinity chromatography, direct enzymatic assay, and other technologies. Continuous advancements and innovations in immunoassay technology further bolster its market position.

Browse market data Tables and Figures spread through 142 Pages and in-depth TOC on Hba1c Testing Device Market Forecast Report (2023-2030).

Global Hba1c Testing Device Market Segmentation

By Test Type

  • Laboratory Testing Devices
  • Point-of-care Testing Devices

By Technology

  • Ion-Exchange HPLC
  • Immunoassay
  • Boronate Affinity Chromatography
  • Direct Enzymatic Assay
  • Other Technologies

By Region

  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East & Africa

Regional Analysis

Due to a high prevalence of diabetes in the region, along with the presence of advanced medical infrastructure and favorable reimbursement policies, North America held the dominance of the global market share for Hba1c Testing Devices, with a market share of 43.20% in 2022. The United States is a significant market in North America, with a large diabetic population. The country has a well-regulated healthcare system, advanced healthcare facilities, and a high adoption rate of advanced medical technologies. Additionally, favorable reimbursement policies and government initiatives promoting diabetes management contribute to the market growth in this region. Canada is also witnessing significant market growth due to the growing cases of diabetes and rising healthcare expenditure. The Canadian government's focus on improving diabetes management and expanding healthcare access further drives the demand for Hba1c Testing Devices.

The Asia Pacific industry is the most promising due to several possible areas for future expansion. This is attributed to factors such as the rising prevalence of diabetes in countries like India and China, increasing awareness about the importance of early diagnosis and management of diabetes, and implementing government initiatives to control the disease. Additionally, advancements in healthcare infrastructure and the availability of affordable testing devices are driving market growth in the region.

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Scope of the Report:    

Report AttributesDetails
Market Size in 2022USD 1.3 Billion
Revenue Forecast by 2030USD 3.03 Billion
CAGR12.9% from 2023 to 2030
Base Year2022
Forecast Year2023 to 2030
Key PlayersAbbott Laboratories, ARKRAY Inc., Bio-Rad Laboratories Inc., Check Diagnostics GMBH, Polymer Technology Systems Inc., Danaher Corporation, Beckman Coulter, F. Hoffmann-La Roche Ltd., Menarini Group, Sebia Inc., Siemens Healthcare, Tosoh Corporation, Trinity Biotech PLC
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