헤모글로빈 A1C 검사 기기 시장 규모는 2024년에 14억 5,000만 달러로 평가되었고, 2026-2032년 CAGR 8.97%로 성장할 전망이며, 2032년에는 28억 9,000만 달러에 이를 것으로 예측됩니다.
헤모글로빈 A1C(HbA1c) 검사 기기는 혈당 측정기와 달리 재택 검사용으로 설계되어 있지 않습니다. 현재 미국에서 입수 가능한 FDA 인가 가정용 A1C 검사 키트는 A1C Now Self-Check Kit뿐입니다. 이것은 가정에서 쉽게 검사할 수 있는 혈당 측정기와는 다릅니다.
A1C 나우 셀프 체크 키트는 손가락을 찌르는 검사로, 약 12분만에 결과가 나옵니다. 그러나 혈액 샘플을 검사 기관에 우편으로 처리해야 하며, 결과는 며칠 후에 도착합니다. 이 검사는 임신 중인 분, 과거 3개월 이내에 수혈을 받은 적이 있는 분, 특정 혈액 질환을 가지고 계신 분에게는 적합하지 않습니다.
헤모글로빈 A1C 검사 기기 시장을 형성하는 주요 시장 역학은 다음과 같습니다.
당뇨병 유병률 상승 : 국제 당뇨병 연합(IDF)에 따르면 세계적으로 당뇨병 환자 수가 급증하고 있습니다. 최신 IDF Diabetes Atlas에서는 2019년에는 4억 6,300만 명의 성인(20-79세)이 당뇨병과 공존하고 있는 것으로 추정하고 있습니다. 이 수는 2045년까지 7억 명으로 증가할 것으로 예측되고 있습니다. 이러한 극적인 증가는 인구 증가, 고령화, 도시화, 가공식품 소비 증가와 운동량 감소 및 라이프 스타일 변화 등 몇 가지 요인에 의한 것입니다. 당뇨병 유병률 상승은 헤모글로빈 A1c 검사 기기 시장의 주요 촉진 요인입니다.
예방 헬슼케어에 대한 주목 향상 : 예방 헬스케어 및 당뇨병 관리에 대한 사람들의 의식 증가는 조기 발견과 개입을 위한 HbA1c 검사 기기의 사용을 촉진하고 있습니다. 정부 기관과 보건 기관은 당뇨병 예방 및 조기 발견의 중요성을 일반 시민에게 계몽하는 캠페인을 전개하고 있습니다. 이러한 캠페인에서는 당뇨병의 위험 인자를 특정해, 발병을 예방 또는 지연시키기 위한 조기 개입을 가능하게 하는 HbA1c 검사의 역할이 강조되는 경우가 많습니다.
포인트 오브 케어 검사(POCT) : POCT 장치의 상승은 클리닉, 약국 또는 집에서 결과를 얻을 수 있으며 HbA1c 검사에 혁명을 일으킬 수 있습니다. 이로 인해 환자는 채혈을 위해 진찰실이나 검사실에 갈 필요가 없어져 검사의 편리성과 접근성이 크게 향상됩니다. POCT 장치는 일반적으로 기존 검사실 기반 분석 장치보다 소형으로 운반할 수 있고 사용하기 쉽습니다. POCT 장치는 기존 검사실 기반 분석 장치보다 훨씬 짧은 시간에 대부분 몇 분 내에 결과를 낼 수 있어 신속한 치료 방침 결정과 조정이 가능합니다.
주요 이슈
HbA1c 검사 기기 및 검사 비용 : HbA1c 검사 기기 및 검사에 드는 비용은 특히 의료 예산이 한정되어 있어 당뇨병 관리에 대한 보험 적용이 불충분한 신흥 국가에서는 일부 환자에게 있어서 큰 장벽이 될 가능성이 있습니다. 따라서 HbA1c 검사 접근성에 격차가 생기고 당뇨병 진단이 늦어지면서 효과적인 질병 관리가 방해받을 수 있습니다.
정확도에 대한 우려 : 정확도가 현저히 향상되었지만 헤모글로빈 변이체 및 특정 약물과 같은 특정 요인으로 인한 간섭 가능성에 대해서는 몇 가지 우려가 남아 있습니다. 그 결과 검사 결과가 부정확해지고 진단이 늦어지거나 불필요한 치료 조정이 이루어질 수 있습니다. 제조업체 각사는, 이러한 간섭 인자의 영향을 최소한으로 억제하기 위해, HbA1c 검사 기기의 정밀도 향상에 끊임없이 임하고 있습니다.
주요 동향
재택 검사에 대한 주목 : 편리하고 이용하기 쉬운 당뇨병 관리에 대한 수요 증가가 재택 A1c 검사 기기의 개발을 뒷받침하고 있습니다. 이러한 검사 기기를 통해 환자는 집에서 편안하게 HbA1c 값을 검사할 수 있게 되어 진찰실이나 검사실에 자주 나갈 필요가 없어집니다. 현재 이용할 수 있는 범위는 한정되어 있지만, 재택 A1c 검사는 향후 몇 년 안에 보급되어 고도화될 것으로 예상됩니다.
당뇨병 관리 시스템과의 통합 : HbA1c 검사 기기를 종합적인 당뇨병 관리 시스템에 통합하는 동향이 있습니다. 이 시스템들은 HbA1c 검사와 혈당 모니터링, 지속 포도당 모니터링(CGM) 기기, 인슐린 펌프, 모바일 앱을 결합한 것입니다. 이 데이터 통합을 통해 환자의 당뇨병 상태를 보다 전체적으로 파악할 수 있고 개인 맞춤형 치료 계획을 세우기 쉬워집니다. 또한 이러한 시스템은 환자에게 실시간 데이터 분석과 피드백을 제공하여 당뇨병 관리에 대해 충분한 정보에 입각한 의사결정을 할 수 있는 힘을 줄 수 있습니다.
Hemoglobin A1C Testing Devices Market size was valued at USD 1.45 Billion in 2024 and is projected to reach USD 2.89 Billion by 2032, growing at a CAGR of 8.97% from 2026 to 2032.
Hemoglobin A1C (HbA1c) testing devices are not designed for home testing, unlike blood glucose meters. There is currently only one FDA-approved home A1C test kit available in the United States, the A1C Now Self-Check Kit. This differs from blood glucose meters, which are readily available for home testing.
The A1C Now Self-Check Kit is a finger prick test that provides results in about 12 minutes. However, it requires that the blood sample be mailed to a lab for processing, and you will receive your results in a few days. This test is not intended for people who are pregnant, have been transfused in the past 3 months, or have certain blood conditions.
The key market dynamics that are shaping the Hemoglobin A1C Testing Devices Market include:
Rising Diabetes Prevalence: Globally, the number of people with diabetes is on a sharp rise, according to the International Diabetes Federation (IDF). In their latest IDF Diabetes Atlas, they estimate that 463 million adults (aged 20-79 years) were living with diabetes in 2019. This number is projected to rise to 700 million by 2045. This dramatic increase is due to several factors, including population growth, aging, urbanization, and lifestyle changes such as increased consumption of processed foods and decreased physical activity. The rising prevalence of diabetes is a major driver of the Hemoglobin A1c Testing Devices Market.
Increased Focus on Preventive Care: Growing public awareness about preventive healthcare and diabetes management is driving the use of HbA1c testing devices for early detection and intervention. Government agencies and health organizations are launching campaigns to educate the public about the importance of diabetes prevention and early detection. These campaigns often highlight the role of HbA1c testing in identifying diabetes risk factors and enabling early intervention to prevent or delay the onset of the disease.
Point-of-Care Testing (POCT): The rise of POCT devices is revolutionizing HbA1c testing by enabling results to be obtained at clinics, pharmacies, or even at home. This eliminates the need for patients to visit a doctor's office or lab for blood draws, significantly improving convenience and access to testing. POCT devices are typically smaller, portable, and easier to use than traditional laboratory-based analyzers. They can provide results in a much shorter timeframe, often within minutes, allowing for quicker treatment decisions and adjustments.
Key Challenges:
Cost of HbA1c Testing Devices and Tests: The cost of HbA1c testing devices and tests can be a significant barrier for some patients, particularly in developing countries where healthcare budgets are limited and insurance coverage for diabetes management may be lacking. This can lead to disparities in access to HbA1c testing, potentially delaying diabetes diagnosis and hindering effective disease management.
Accuracy Concerns: While accuracy has improved significantly, some concerns remain regarding the potential for interference from certain factors such as hemoglobin variants and certain medications. This can lead to inaccurate test results, potentially causing delays in diagnosis or prompting unnecessary treatment adjustments. Manufacturers are constantly working on improving the accuracy of HbA1c testing devices to minimize the impact of these interfering factors.
Key Trends:
Focus on Home Testing: The growing demand for convenient and accessible diabetes management is driving the development of home A1c testing devices. These devices allow patients to test their HbA1c levels in the comfort of their own homes, eliminating the need for frequent visits to a doctor's office or lab. While currently limited in availability, home A1c testing is expected to become more widespread and sophisticated in the coming years.
Integration with Diabetes Management Systems: There's a trend towards integrating HbA1c testing devices with comprehensive diabetes management systems. These systems combine HbA1c testing with blood glucose monitoring, continuous glucose monitoring (CGM) devices, insulin pumps, and mobile apps. This data integration allows for a more holistic view of a patient's diabetes status and facilitates personalized treatment plans. Additionally, these systems can provide real-time data analysis and feedback to patients, empowering them to make informed decisions about their diabetes management.
Here is a more detailed regional analysis of the hemoglobin A1C Testing Devices Market:
Asia Pacific:
According to Verified Market Research, Asia Pacific is estimated to dominate the market over the forecast period. The region has the highest number of people living with diabetes globally, driven by factors like population growth, aging demographics, and increasing urbanization. This large and growing pool of potential patients fuels the demand for HbA1c testing devices.
Economic development in many Asian countries is leading to increased healthcare spending and rising disposable incomes. This creates a more favorable market for innovative medical technologies like HbA1c testing devices.
Many Asian governments are launching initiatives to address the growing burden of diabetes. These initiatives often include promoting early detection and management of diabetes, which can lead to increased adoption of HbA1c testing devices.
Manufacturers are developing more affordable HbA1c testing devices to cater to the price-sensitive markets in Asia Pacific.
Europe:
Europe has a well-established market for Hemoglobin A1c testing devices, with a strong presence of leading manufacturers and a well-developed healthcare infrastructure.
There's a growing emphasis on proactive management of chronic diseases like diabetes across Europe. HbA1c testing plays a crucial role in monitoring blood sugar control and allowing for timely adjustments to treatment plans, contributing to this focus.
Reimbursement policies play a significant role in the European market. Manufacturers need to navigate these policies to ensure that their HbA1c testing devices are covered by healthcare systems, which can influence market adoption.
European healthcare systems prioritize high-quality medical devices. This focus on accuracy and reliability can influence purchasing decisions for HbA1c testing devices.
European healthcare systems prioritize cost-effectiveness. Manufacturers need to balance technological advancements with affordability to ensure their HbA1c testing devices are financially viable for healthcare providers.
North America:
North America is a leader in developing and adopting innovative medical technologies. This trend extends to the Hemoglobin A1c Testing Devices Market, with manufacturers in North America at the forefront of developing new and improved HbA1c testing devices.
North American countries have some of the highest healthcare expenditures globally. This allows for greater investment in new technologies like HbA1c testing devices.
Public health initiatives and campaigns in North America have significantly increased awareness about diabetes and the importance of early detection. This growing awareness fuels the demand for HbA1c testing as a tool for early diagnosis and risk assessment.
The United States, in particular, has one of the highest healthcare expenditures globally. This allows for greater investment in new technologies like HbA1c testing devices, accelerating market growth.
The Global Haemoglobin A1C Testing Devices Market is segmented based on Technology, End-User, Product Type, And Geography.
Based on Technology Type, the market is segmented into High-Performance Liquid Chromatography (HPLC), Immunoassay, Boronate Affinity Chromatography, Direct Enzymatic Assay, and Others. The High-Performance Liquid Chromatography (HPLC) segment is estimated to exhibit the highest growth within the apparel market due to This dominance stems from its exceptional accuracy and reproducibility in measuring HbA1c levels. HPLC separates various blood components based on their unique properties, allowing for precise isolation and quantification of HbA1c. While other technologies may be emerging, HPLC's established performance makes it the current gold standard for HbA1c testing in laboratories.
Based on End users, the market is segmented into Hospitals, Diagnostic Laboratories, Academic & Research Institutes, and Others. The hospital segment is estimated to dominate the apparel market. This is because hospitals manage a high volume of patients, including those with diabetes or at risk of developing it. HbA1c testing plays a crucial role in both diagnosing diabetes and monitoring blood sugar control in hospitalized patients. Additionally, hospitals often have the resources to invest in a wider range of HbA1c testing devices, including advanced laboratory-based analyzers and point-of-care devices for faster results.
Based on the Product type, the market is divided into Bench-top Devices, Point-of-Care (POC) Devices. The bench-top devices segment is estimated to dominate the global market. These are laboratory-based instruments offering high accuracy and throughput, ideal for large-scale processing of blood samples in hospitals and diagnostic labs. However, the market is shifting toward Point-of-Care (POC) devices. These are smaller, portable devices designed for use in clinics, pharmacies, and even at home. POC devices offer faster turnaround times and greater convenience for patients and healthcare providers. As technology advances and affordability improves, POC devices are expected to capture a larger share of the market in the coming years.
Our market analysis also entails a section solely dedicated to such major players wherein our analysts provide an insight into the financial statements of all the major players, along with its product benchmarking and SWOT analysis. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.