Number of pages: 100 | Report Format: PDF | Published date: May 23, 2022
Historical Years – 2021 | Base Year – 2022 | Forecasted Years – 2023-2031
According to the deep-dive market assessment study by Growth Plus Reports, the global HbA1c testing market was valued at US$ 1.51 billion in 2022 and is expected to register a revenue CAGR of 8.1% to reach US$ 3.06 billion by 2031.
HbA1c Testing Market Fundamentals
HbA1c testing, also known as glycated hemoglobin testing, is a diagnostic tool used to measure the average blood glucose levels over a period of approximately 2 to 3 months. HbA1c refers to the hemoglobin molecules in red blood cells that have glucose attached to them. The HbA1c test provides important information about a person's long-term blood glucose control, specifically in the management of diabetes. The HbA1c test reflects the average blood glucose levels over the past 2 to 3 months. It measures the percentage of hemoglobin molecules that have glucose attached to them. HbA1c testing is primarily used in the management of diabetes. It provides an indication of how well an individual's blood glucose levels have been controlled over time.
HbA1c Testing Market Dynamics
The HbA1c testing market is driven by several factors contributing to its growth and expansion. The rising prevalence of diabetes worldwide is a significant driver of the HbA1c testing market. As the number of individuals diagnosed with diabetes continues to grow, the demand for HbA1c testing increases. Regular monitoring of HbA1c levels is essential for effective diabetes management and preventing complications. According to the International Diabetes Federation (IDF), in 2019, approximately 463 million adults (20-79 years old) were living with diabetes worldwide. This number is expected to increase to 700 million by 2045 if current trends continue. Governments, healthcare organizations, and advocacy groups increasingly emphasize diabetes management and prevention. HbA1c testing plays a crucial role in assessing blood glucose control, enabling healthcare providers to develop personalized treatment plans, make necessary adjustments, and provide appropriate interventions to prevent complications. Point-of-care (POC) HbA1c testing has become more accessible and efficient, allowing for immediate results and convenient testing in various healthcare settings, such as clinics, physician offices, and pharmacies. The advancements in POC testing have increased the adoption of HbA1c testing, enabling timely monitoring and intervention. Increased awareness about the importance of regular HbA1c testing for individuals with diabetes has contributed to market growth. Education initiatives by healthcare organizations and patient advocacy groups have highlighted the significance of HbA1c testing in diabetes management, leading to greater demand for testing services. HbA1c testing supports the concept of personalized medicine in diabetes management. By assessing an individual's HbA1c levels, healthcare providers can tailor treatment plans and interventions based on the specific needs of the patient. The shift towards personalized medicine has increased the demand for HbA1c testing as a valuable tool in individualized diabetes care. The growing geriatric population is more prone to developing diabetes and related complications. As the elderly population continues to expand, the demand for HbA1c testing is expected to rise as regular monitoring of blood glucose control becomes even more critical in this demographic.
Genetic variations and altered derivatives of hemoglobin can impact the accuracy of HbA1c. These factors are likely to impede the uptake of HbA1c testing, which is anticipated to impede the expansion of the global market's sales throughout the projected period.
HbA1c Testing Market Ecosystem
The global HbA1c testing market is analyzed from the following perspectives: product, technology, end user, and region.
HbA1c Testing Market by Product
Based on the product, the global HbA1c testing market is segmented into instruments and consumables. The instruments segment is sub-segmented into benchtop devices and handheld devices.
The instruments segment accounts for the largest revenue share of the global HbA1c testing market. This can be ascribed to the rising prevalence of diabetes and the ability of these instruments to provide faster and more accurate results. Benchtop devices are typically larger and more sophisticated, allowing for high accuracy and precision in HbA1c measurements. They are often equipped with advanced technology and robust analytical capabilities, resulting in reliable results. Though, currently the market for hand-held devices for testing is growing rapidly. Handheld devices are user-friendly and require minimal training to operate. They often feature simple interfaces, intuitive controls, and rapid result generation. Abbott's FreeStyle Libre 3 integrated continuous glucose monitoring (iCGM) device was approved by the American Food and Drug Administration (FDA) in April 2023. The portable device, which is the newest member of Abbott's FreeStyle Libre product line, shows real-time glucose readings obtained from a sensor worn on the user's upper arm.
HbA1c Testing Market by Technology
Based on the technology, the global HbA1c testing market is segmented into ion-exchange HPLC, boronate affinity chromatography, turbidimetric inhibition immunoassay, direct enzymatic assay, and other technologies.
The ion-exchange HPLC segment accounts for the largest revenue share of the global HbA1c testing market. This can be attributed to a rise in technology adoption as a result of its benefits, including greater accuracy, enhanced sensitivity, and cost-effectiveness. Ion exchange HPLC systems and reagents for HbA1c testing are widely available in the market. Many clinical laboratories already have the infrastructure and expertise to perform ion exchange HPLC, making it a convenient choice for routine HbA1c testing.
HbA1c Testing Market by End User
Based on the end user, the global HbA1c testing market is segmented into hospitals & clinics, diagnostic laboratories, and home care.
The home care segment is projected to grow fastest during the forecast period. Home care allows patients to perform HbA1c testing in the comfort of their own homes, eliminating the need for frequent visits to healthcare facilities. This convenience is especially beneficial for individuals with limited mobility, elderly patients, and those living in remote areas with limited access to healthcare facilities. The availability of portable and user-friendly HbA1c testing devices has facilitated the growth of home care in the market. Simple HealthKit, in June 2023, teamed up with Walmart to make Simple HealthKit’s at-home HbA1c (Diabetes), Respiratory Wellness, and Sexual Wellness Tests available at Walmart.com.
HbA1c Testing Market by Region
Geographically, the global HbA1c testing market has been segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.
The HbA1c testing market in North America is a significant and growing segment within the healthcare industry. North America has a high prevalence of diabetes, particularly type 2 diabetes. Factors such as sedentary lifestyles, unhealthy diets, and obesity contribute to the increasing incidence of diabetes in the region. In the United States, diabetes affects about 37.3 million individuals or 11.3% of the population. Approximately 28.7 million people, or 28.5% of the population, were expected to have diabetes. The need for regular HbA1c testing to monitor blood glucose control drives the demand for HbA1c testing products and services. North America has a well-developed healthcare infrastructure with advanced medical facilities, a strong network of laboratories, and a high level of awareness about diabetes management. These factors contribute to the availability and accessibility of HbA1c testing services throughout the region. Healthcare providers and organizations in North America significantly emphasize diabetes management and prevention. To evaluate blood glucose control, modify medication, and avoid long-term problems, routine HbA1c testing is regarded as an essential part of diabetes care. The demand for HbA1c testing in the area is influenced by the emphasis on diabetes management. Due to the high prevalence of diabetes, technological improvements, the healthcare system, and the focus on diabetes management, the HbA1c testing market in North America is predicted to keep expanding.
The HbA1c testing market in the Asia Pacific region is experiencing significant growth and presents substantial opportunities. The Asia Pacific region is witnessing a rapid increase in the prevalence of diabetes, driven by factors such as changing lifestyles, urbanization, sedentary habits, and dietary changes. According to American Diabetes Association, more than 60% of the people with diabetes live in Asia, with almost one-half in China and India combined. The Western Pacific, the world’s most populous region, has more than 138.2 million people with diabetes, and the number may rise to 201.8 million by 2035. The rising incidence of diabetes in countries like China, India, and Southeast Asian nations has created a substantial market for HbA1c testing. There is an increasing awareness of diabetes and its management in the Asia Pacific region. Diabetes impedes a tremendous economic burden. According to Lancet Journal 2023, the per-capita economic burden of diabetes would increase from $231 to $414 in China during 2020–2030, with an annual growth rate of 6.02%. Governments, healthcare organizations, and patient advocacy groups are actively promoting diabetes awareness campaigns, educational programs, and initiatives for early detection, prevention, and management of the disease. HbA1c testing plays a crucial role in these efforts, contributing to market growth. The Asia Pacific region has adopted advanced diagnostic technologies, including HbA1c testing methods. Point-of-care testing (POCT) is gaining popularity in the region due to its convenience and rapid results. POCT devices enable on-site HbA1c testing in primary care settings, reducing turnaround time and improving patient management.
HbA1c Testing Market Competitive Landscape
The prominent players operating in the global HbA1c testing market are: -
HbA1c Testing Market Strategic Developments
The glycated hemoglobin or hemoglobin A1c test is a substitute for the HbA1c test. Glycated hemoglobin (HbA1c) testing provides a comprehensive picture of a person's three-month average blood sugar levels.
The revenue CAGR for the HbA1c testing market will be 8.1% during the forecast period.
Abbott Laboratories Inc., Siemens Healthcare Private Limited, Arkray, Inc., Bio-Rad Laboratories, Inc., and F. Hoffmann-La Roche Ltd. are a few of the major players in the global HbA1c testing market.
Asia Pacific is the region with the highest growth rate in the global HbA1c testing market.
The lack of awareness and limited reimbursements in low-income countries are some of the major factors restricting the global HbA1c testing market.
*Insights on financial performance are subject to the availability of information in the public domain