Improved Hemoglobin A1c Tests Support Healthcare Providers in Point-of-Care

The rising prevalence of diabetes mellitus has triggered the need for efficacious diabetes management testing solutions. Due to the growing awareness amongst consumers about the availability of testing options, manufacturers in the hemoglobin A1c testing market are increasing their production capabilities for the development of testing solutions that help track and manage glucose levels. For instance, in June 2019, Abbot - a leading American medical devices and healthcare company, announced the launch of Afinion™ HbA1c Dx assay- a first-of-its-kind, FDA-approved rapid point-of-care test that delivers accurate and precise results for diabetes management.

Other drivers that have catalyzed the need for testing solutions in the hemoglobin A1c testing market are health complications of retinopathy, neuropathy, and cardiovascular diseases due to inefficient management of glucose levels. To comply with the stringent regulations laid down by health commissions, manufacturers in the hemoglobin A1c testing market are investing in research & development to improve the accuracy of commercially-available HbA1c tests.

hemoglobin a1c testing market infographic

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CGM Systems Provide Real-time Data for Type 2 Diabetes Patients

New additions to the point-of-care testing landscape are positively influencing the volume and value growth of the hemoglobin A1c testing market. For instance, the hemoglobin A1c testing market was valued at ~US$ 1 billion in 2018, and is projected to reach a value of ~US$ 2.1 billion by the year 2027. Due to lucrative opportunities for growth in this landscape, manufacturers are introducing testing devices with continuous glucose monitoring (CGM) systems. This innovation has served as a reliable option for type 2 diabetes patients who can easily assess their hemoglobin A1c levels.

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These CGM systems have helped many patients in significantly lowering their HbA1c levels. Companies that have launched these device systems have earned credibility in the hemoglobin A1c testing market, as the health improvements of patients are well-aligned with the criteria laid down by health commissions. Thus, healthcare providers can offer effective diagnosis to patients by obtaining real-time results from the technology.

Home Test Kits and OGTT Provide Reliable Results to Manage Diabetes

Measuring and monitoring glucose levels has certain limitations in the hemoglobin A1c testing landscape. This is because, the test results may vary according to different biological and physiological situations of patients. This has created the demand for improved testing alternatives, where consumers can constantly keep a check on their hemoglobin and glucose levels. To overcome the challenge of constantly-varying test results, manufacturers in the hemoglobin A1c testing market are increasing the availability of home test kits. These home test kits are increasingly gaining the attention of diabetes patients, as they can keep a constant tab on their test results, while sitting at home. With the help of home test kits, consumers can avoid costly visits to clinics and effectively control their glucose levels.

Another challenge that manufacturers face in the hemoglobin A1c testing market is the inefficacy of hemoglobin A1c testing in type 2 diabetes patients. They are overcoming this challenge by recommending the hemoglobin A1c test with the oral glucose tolerance test (OGTT) in order to receive reliable results to assess the risks of pre-diabetes and diabetes.

hemoglobin a1c testing market segmentation

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Analysts’ Viewpoint on Hemoglobin A1c Testing Market

According to Verywell Health magazine, November 2018, home care devices for hemoglobin A1c tests have been found to be reliable, with ~90% correlations done in laboratories. Thus, manufacturers should focus on increasing testing options for home care settings in the hemoglobin A1c testing market.

However, in many cases, the results after hemoglobin A1c testing have not been reliable due to the varying glucose tolerance levels of patients and racial differences. As such, manufacturers can overcome this limitation by introducing home test kits, and recommending the use of these kits with home OGTT to acquire reliable results.

To increase the efficacy of hemoglobin A1c testing, manufacturers recommend that, consumers need to diagnose diabetes with a combination of measurements, and pay close attention to lifestyle choices.

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  • According to the latest report published by Transparency Market Research on the global hemoglobin A1c testing market for the historical year of 2017 and forecast period of 2019 to 2027, increase in the demand for point-of-care testing for the diagnosis of diabetes, high prevalence of diabetes, and launch of automated hemoglobin A1c testing analyzers are expected to boost the growth of the global hemoglobin A1c testing market during the forecast period.
  • The global hemoglobin A1c testing market was valued at ~US$ 1 Bn in 2018, and is expected to expand at a CAGR of ~9% during the forecast period.

Increase in Prevalence of Diabetes: A Key Driver

  • Diabetes is a common health condition among the geriatric population, the prevalence of which is expected to increase over the next few years. This high prevalence of diabetes is expected to drive the growth of the hemoglobin A1c testing market during the forecast period.
  • According to the National Institutes of Health, 8.5% of the people (617 million) across the world were aged 65 years or above in 2016, and this percentage is projected to increase to nearly 17% (1.6 billion) by 2050.
  • In Europe, there has been an exponential increase in the number of patients with diabetes. This can be attributed to obesity, sedentary lifestyle, and unhealthy diet among adults in the region.
  • According to the International Diabetes Federation, over 66 million people had diabetes in Europe in 2017, and the number is likely to rise to 81 million by 2045. There were 7,476,800 cases of diabetes in Germany in 2017. Furthermore, 286,000 children had diabetes in 2017, and each year, 28,600 children are diagnosed with diabetes.
  • These factors have led to the increase in healthcare expenditure, which was US$ 207 Bn in 2017, and is likely to increase to US$ 214 Bn by 2045.

Popularity of Ion-exchange High Performance Liquid Chromatography (HPLC)

  • The ion-exchange high performance liquid chromatography (HPLC) segment dominated the global hemoglobin A1c testing market in 2018, and is expected to account for the largest market share during the forecast period, as this technology is most widely used for hemoglobin A1c testing, and provides accurate HbA1c values in the presence of hemoglobin variants in case of a highly diversified populationHPLC increases the ionic strength of buffer, identifies variants, and consumes less time.
  • Most of the devices available in the market are based on HPLC, and the technology is preferred for hemoglobin A1c testing. HPLC-based hemoglobin A1c testing analyzers can also be used in point-of-care settings, along with laboratories. In December 2015, ARKRAY, Inc. launched a glucose analyzer named 'ADAMS Glucose GA-1172', and a glycohemoglobin analyzer called 'ADAMS A1c HA-8182', to determine blood sugar and hemoglobin A1c levels in patients. The glycohemoglobin analyzer ADAMS A1c HA-8182 is based on HPLC, and provides accurate results.

North America Prominent Hemoglobin A1c Testing Market

  • North America accounted for a major share of the global hemoglobin A1c testing market in 2018, followed by Europe. Increase in the number of point-of-care testing analyzers receiving approval from the Food & Drug Administration (FDA), new product launches, and rise in the adoption of newer technologies for hemoglobin A1c testing are various factors that are expected to drive the hemoglobin A1c testing market in the region.
  • In January 2019, PTS Diagnostics announced that the U.S. Food and Drug Administration (FDA) had cleared a medical device convenience kit that quantitatively measures the percent of glycated hemoglobin, total cholesterol, high-density lipoprotein, triglycerides, and glucose in whole blood.
  • In April 2014, Abbott Laboratories received FDA approval for ARCHITECT Clinical Chemistry Hemoglobin A1c (HbA1c) test to help physicians in diagnosing and monitoring diabetes.
  • In Europe, the hemoglobin A1c testing market is expected to gain traction during the forecast period. The growth of the market in the region can be attributed to the increase in prevalence of diabetes, product approvals in the European Union (EU), and availability of automated hemoglobin A1c analyzers for laboratory settings.
  • In January 2018, Abbott Laboratories received CE approval for new Alinity h-series integrated system for hematology A1c testing. New Alinity h-series has combined features of Alinity hq and Alinity hs.
  • In April 2018, Beckman Coulter obtained CE mark for its DxH 520 hematology analyzer, which is a closed-tube, 5-part differential system for small-volume labs. In April 2018, ABL9 blood analyzers won the 'IF DESIGN AWARD 2018'.
  • The hemoglobin A1c testing market in Asia Pacific is estimated to grow at a faster pace than other regions during the forecast period, due to increase in the number of laboratory testing for diabetes, presence of well-qualified healthcare staff such as diabetologists and clinicians, and growing burden of diabetes.
  • According to the International Diabetes Federation (IDF), approximately 382 million people across the globe are expected to have diabetes by 2035, and of these, 60% will live in Asia and one-third in China.

Global Hemoglobin A1c Testing Market: Competition Landscape

  • Detailed profiles of manufacturers of hemoglobin A1c testing have been provided in the report to evaluate their key product offerings, financials, business strategies, and recent developments.
  • Key players operating in the global hemoglobin A1c testing market include
    • Abbott Laboratories
    • ARKRAY, Inc.
    • Bio-Rad Laboratories, Inc.
    • Polymer Technology Systems, Inc.
    • Danaher Corporation (Beckman Coulter)
    • F. Hoffmann-La Roche Ltd.
    • Menarini Group
    • Sebia
    • Siemens Healthineers
    • Tosoh Corporation
    • Trinity Biotech plc.

Global Hemoglobin A1c Testing Market: Key Developments

Major manufacturers in the global hemoglobin A1c testing market are adopting strategies of collaborations, partnerships, geographical expansion, distribution agreements, and new product development to strengthen their product portfolios and geographic presence in the global market. Key developments in the global hemoglobin A1c testing market are:

  • In December 2018, Arkray, Inc. established the Arkray Middle East Branch in Dubai, the UAE. Lifestyle diseases are on the rise in the Middle East due to rapid economic development in recent years and changes in lifestyle. As per the International Diabetes Federation (IDF), Saudi Arabia, the United Arab Emirates (UAE), Egypt, Bahrain, and Qatar were the top five countries with highest age-adjusted diabetes in 2017.
  • In January 2017, Abbott Laboratories announced the acquisition of St. Jude Medical, Inc., a global medical devices manufacturer. In October 2017, Abbott Laboratories acquired Alere Inc., a diagnostic device and service provider.
  • In October 2018, Beckman Coulter entered into a collaboration with Johns Hopkins Medicine. In June 2018, Beckman Coulter formed a strategic collaboration with the University of California, Irvine. In August 2016, Augusta University's medical center signed a 15-year service agreement with Danaher Corporation, the parent company of Beckman Coulter, to gain access to all diagnostic products and services of Danaher.

In the global hemoglobin A1c testing market report, we have discussed individual strategies, followed by company profiles of the manufacturers of hemoglobin testing devices. The ‘competition landscape’ section is included in the global hemoglobin A1c testing market report to provide readers with a dashboard view of key players operating in the global hemoglobin A1c testing market.

Hemoglobin A1c Testing Market: Scope of the Report

A new study on the global hemoglobin A1c testing market was published by Transparency Market Research (TMR). It presents a wealth of information on the key market dynamics, including the drivers, market trends, and challenges, as well as the structure of the global hemoglobin A1c testing market. TMR’s study offers valuable information about the global hemoglobin A1c testing market, to illustrate how growth will discern during the forecast period of 2019–2027.

Key indicators of market growth, which include Compound Annual Growth Rate (CAGR), are elucidated in TMR’s study in a comprehensive manner. This data can help readers interpret the quantitative growth aspects of the global hemoglobin A1c testing market for the forecast period.

An extensive analysis on leading market players’ business strategies has also been featured in TMR’s study on the global hemoglobin A1c testing market. This can help readers understand principal factors to foresee growth in the global hemoglobin A1c testing market. In this study, readers can also find specific data on the qualitative and quantitative growth avenues for the global hemoglobin A1c testing market, which will guide market players in taking decisions in the future.

Key Questions Answered in TMR’s Hemoglobin A1c Testing Market Study

  • What is the scope of growth of hemoglobin A1c testing companies in the pharmaceutical drugs sector?
  • What will be the Y-o-Y growth of the hemoglobin A1c testing market between 2019 and 2027?
  • What is the influence of changing trends on the global hemoglobin A1c testing market?
  • Will North America continue to remain the most profitable regional market for hemoglobin A1c testing providers?
  • Which factors will impede the growth of the global hemoglobin A1c testing market during the forecast period?
  • Which are the leading companies in the global hemoglobin A1c testing market?

Research Methodology

A unique research methodology has been utilized by TMR to conduct comprehensive research on the growth of the global hemoglobin A1c testing market, and arrive at conclusions on the future growth prospects of the market. This research methodology is a combination of primary and secondary research, which helps analysts warrant the accuracy and reliability of the drawn conclusions.

Secondary resources referred to by analysts during the production of the global hemoglobin A1c testing market report include statistics from company annual reports, SEC filings, company websites, World Bank database, investor presentations, regulatory databases, government publications, and industry white papers. Analysts have also interviewed senior managers, product portfolio managers, CEOs, VPs, and market intelligence managers, who have contributed to the production of TMR’s study on the global hemoglobin A1c testing market as primary sources.

These primary and secondary sources have provided exclusive information during interviews, which serves as a validation from the hemoglobin A1c testing market leaders. Access to an extensive internal repository and external proprietary databases allows for this report to address specific details and questions about the hemoglobin A1c testing market with accuracy. The study has also used the top-down approach to assess numbers for each segment, and the bottom-up approach to counter-validate them. This has helped in making TMR’s estimates on the future prospects of the global hemoglobin A1c testing market more reliable and accurate.

Segmentation of Global Hemoglobin A1c Testing Market

TMR’s study on the global hemoglobin A1c testing market includes information divided into three sections ? by technology, by end user, and by region. Changing industry trends and other crucial market dynamics associated with these three sections of the global hemoglobin A1c testing market have been discussed in detail.

Technology

Ion-Exchange High Performance Liquid Chromatography (HPLC)

Immunoassays

Boronate Affinity Chromatography

Direct Enzymatic Assays

Others

End User

Laboratory Testing

  • Commercial Laboratories
  • Others

Point-of-Care (POC) Testing

  • Hospitals
  • Homecare
  • Clinics
  • Others

Region

North America

Europe

Asia Pacific

Latin America

Middle East & Africa