The World Market for HbA1c Testing: Trends, Technologies, and Growth Opportunities, 2025
1990년대 이후 HbA1c 검사는 당뇨병 환자의 장기적인 혈당 조절을 모니터링하는 데 있어 매우 중요하며, 진단을 위한 포도당 검사를 보완하는 역할을 해왔습니다. 최근 연구에 따르면, 특히 공복혈당(FBG) 검사와 함께 사용할 경우, HbA1c 검사가 당뇨병 검진 및 환자 모니터링에 유용하다는 것이 강조되고 있습니다. 이 보고서는 실험실 기반 및 현장 검사(lab-based and point-of-care) HbA1c 검사 기기를 모두 포괄하며, 세계 관점과 특정 지역 분석을 제공합니다.
HbA1c 검사 업계는 상환 승인, 단체 구매 조직 및 정부의 가격 협상 등 고유한 과제에 직면해 있습니다. 기술 혁신과 시장 성공을 위해서는 지속적인 R&D 투자가 필수적입니다. 이러한 어려움에도 불구하고, HbA1c 검사 산업은 세계 인구의 고령화와 신흥 시장에서의 의료비 지출 증가로 인한 혜택을 누리고 있습니다.
표면화학, 나노기술, 분석과학의 발전으로 보다 편리하고 정확하며 비침습적인 HbA1c 측정이 가능해질 것으로 예상됩니다. 당뇨병 관리를 위한 심도 있는 기계학습 알고리즘과 모바일 앱의 통합은 입원을 줄이고 환자 결과를 개선할 수 있는 새로운 헬스케어 혁신의 시대를 열게 될 것입니다.
이 보고서는 세계 HbA1c 검사 시장을 조사하여 HbA1c의 총 시장 가치, 검사 용도별, 기술별, 시장 진입 기업별 부문을 조사했습니다. 상세한 기업 개요을 통해 경쟁적인 인사이트를 제공합니다. 시장 데이터는 2024년을 기준 연도로 하는 제조업체 수준 세계 시장을 반영하고 있습니다. 인구 동향, 기술 혁신, 세계 시장 확대를 배경으로 2024년부터 2029년까지 연평균 성장률(CAGR)을 예측하고, 2024년 경쟁 분석과 지역별 분석도 수록하고 있습니다.
목차
제1장 주요 요약
제2장 소개
- 개요
- 진단
- 분류
- 임신
- 기타
- 위험요인
- 당뇨병 인구통계
- 국제 통계
- 미국의 유병률
- 미국의 발생률
- 미국의 사망자수
- 미국 비용
- HbA1c
제3장 HbA1c 검사, 장소별
- 소개
- 시험실에서의 HbA1c 검사
- POC에서의 HbA1c 검사
- HbA1c 검사 장소별 시장
제4장 HbA1c 검사 시장, 기술 플랫폼별
- 개요
- 크로마토그래피
- 고속 액체 크로마토그래피(HPLC)
- 보로네이트 친화성
- 면역측정
- 효소법과 마이크로 광학법
- 기타
- 기술별 시장
제5장 HbA1c 검사 시장 개요와 경쟁
- 세계의 HbA1c 시장 전체
- 국가별 시장 분석
- 북미
- 유럽
- 아시아태평양
- 라틴아메리카
- 기타
- 경쟁 분석
제6장 HbA1c 검사 시장 과제와 동향
- WHO 필수 IVD 리스트
- 글리코 알부민 검사
- 변경 보고
- PAMA 과제
- A1c의 인종적 차이
- 원격의료
- LDT 업데이트
- 메디케어와 HbA1c 검사
- IT와 AI
- 당뇨병과 고령화 사회
- 고령화의 영향
- 헬스케어 효율
- 당뇨병 합병증
- 규제상 문제
- 치과의원에서의 HbA1c 검사
제7장 HbA1c 검사 시장 기업 개요
- 소개
- Abbott
- A. Menarini Diagnostics, S.r.l.
- ARKRAY, Inc
- Beckman Coulter/Danaher
- Bio-Rad
- DiaSys Diagnostics Systems GmbH
- Diazyme Laboratories, Inc
- EKF Diagnostics Holdings Plc
- HemoCue/Danaher
- HUMAN Diagnostics
- OSANG Healthcare Co, Ltd
- PTS Diagnostics, Inc
- QuidelOrtho Corporation
- Roche Diagnostics Corporation
- Sebia
- Sekisui Diagnostics, LLC
- Siemens Healthineers GmbH
- Tosoh Bioscience, LLC
- Trinity Biotech
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Kalorama Information's "The World Market for HbA1c Testing: Trends, Technologies, and Growth Opportunities, 2025" provides a comprehensive analysis of the global HbA1c testing market, highlighting key trends, technological advancements, and growth opportunities. This report delves into the geographical distribution, demographic influences, and critical market issues shaping the industry. It offers a detailed examination of market values, regional dynamics, and competitive landscapes, with insights into leading providers.
Since the 1990s, HbA1c testing has been pivotal in monitoring long-term glycemic control in diabetics, complementing glucose tests for diagnosis. Recent research underscores the HbA1c test's utility in diabetes screening and patient monitoring, especially when combined with fasting blood glucose (FBG) tests. The report covers both lab-based and point-of-care HbA1c test devices, providing a global perspective with specific regional analyses.
The market summary includes total HbA1c market values, segmented by test usage, technology, and market participation. Detailed company profiles offer competitive insights. The report's data is derived from extensive primary and secondary research, including interviews with over 20 industry experts, healthcare providers, and government officials. Additional insights were gathered from company representatives, ensuring a robust and accurate market overview.
Market data reflects the world market at the manufacturers' level, with 2024 as the base year. Compound annual growth rates (CAGRs) are projected for the 2024-2029 period, supported by demographic trends, technological innovations, and global market expansion. Competitive analysis and regional breakdowns for 2024 are also provided.
The HbA1c testing industry faces unique challenges, including reimbursement approvals and price negotiations by group purchasing organizations and governments. Continuous R&D investments are crucial for innovation and market success. Despite these challenges, the industry benefits from an aging global population and increased healthcare spending in emerging markets. The report highlights the potential for new competitors, investors, and venture capitalists in the HbA1c testing market.
Advancements in surface chemistry, nanotechnology, and analytical sciences are expected to yield more convenient, accurate, and non-invasive HbA1c assays. The integration of deep machine learning algorithms and mobile apps for diabetes management promises to reduce hospitalizations and improve patient outcomes, heralding a new era of healthcare innovation.
Table of Contents
Chapter 1: Executive Summary
- Introduction
- Scope and Methodology
- Market Summary
- Table 1-1: Global HbA1c Testing Market Analysis, 2024-2029 ($ million)
- Figure 1-1: Global HbA1c Testing Market, 2024-2029 ($ million)
- Market Segmentation
- Issues and Trends Affecting the HbA1c Testing Market
- Competitive Analysis
Chapter 2: Introduction
- Overview
- Diagnosis
- Type 1
- Type 2
- Classification
- Type 1
- Type 2
- Gestational
- Other
- Risk Factors
- Demographics of Diabetes
- International Statistics
- US Prevalence
- US Incidence
- US Deaths
- US Cost
- HbA1c
Chapter 3: HbA1c Testing by Setting
- Introduction
- Laboratory-based HbA1c Testing
- POC HbA1c Testing
- Market by HbA1c Testing Setting
- Table 3-1: Global l HbA1c Test Sales Market and Distribution by Setting, 2024-2029 ($ million) estimated [HbA1c Lab and HbA1c POC]
- Table 3-2: Selected POC Professional HbA1c Products
- Table 3-3: Selected POC Self-Testing HbA1c Products
Chapter 4: HbA1c Testing Market by Technology Platforms
- Overview
- Chromatography
- High-Performance Liquid Chromatography (HPLC)
- Boronate Affinity
- Immunoassay
- Enzymatic and Micro-optical Methods
- Others
- Market by Technology
- Table 4-1: Global HbA1c Test Sales Market and Distribution by Technology Platform, 2024-2029 ($ million) estimated [Enzymatic/MODM, HPLC, Immunoassay, Others]
- Figure 4-1: Global HbA1c Test Sales Market by Technology Platform, 2024-2029 ($ million) estimated (Enzymatic/MODM, HPLC, Immunoassay, Others)
- Figure 4-2: Global HbA1c Test Distribution by Technology Platform, 2024 (%) (Enzymatic/MODM, HPLC, Immunoassay, Others)
Chapter 5: HbA1c Testing Market Summary and Competitive
- Total Global HbA1c Market
- Table 5-1: Global HbA1c Testing Market Analysis, 2024-2029 ($ million)
- Figure 5-1: Global HbA1c Testing Market Analysis, 2024-2029 ($ million)
- Market Analysis by Country
- Table 5-2: Global HbA1c Testing Market by Region, Revenues and % Market, 2024-2029 ($ million) estimated [Asia Pacific, Europe, Latin America, North America, ROW]
- Figure 5-2: Global HbA1c Testing Market by Region, 2024-2029 ($ million) estimated (Asia Pacific, Europe, Latin America, North America, ROW)
- Figure 5-3: Global HbA1c Testing Market Share, by Region, 2024 (%) (Asia Pacific, Europe, Latin America, North America, ROW)
- North America
- Table 5-3: North America HbA1c Testing Market Analysis, 2024-2029 ($ million)
- Europe
- Table 5-4: Europe HbA1c Testing Market Analysis, 2024-2029 ($ million)
- Germany
- France
- Italy
- United Kingdom
- Spain
- Figure 5-4: Europe HbA1c Testing Percentage Participation, by Country, 2024 (%) (France, German, Italy, Spain, United Kingdom, Rest of Europe)
- Asia Pacific
- Table 5-5: Asia Pacific HbA1c Testing Market Analysis, 2024-2029 ($ million)
- Japan
- China
- India
- Figure 5-5: Asia Pacific HbA1c Testing Percentage Participation, by Country 2024 (%) (Australia, China, India, Japan, South Korea, Rest of Asia Pacific)
- Latin America
- Table 5-6: Latin America HbA1c Testing Market Analysis, 2024-2029 ($ million)
- Figure 5-6: Latin America HbA1c Testing Percentage Participation, by Country, 2024 (%) (Brazil, Chile, Columbia, Mexico, Rest of Latin America)
- Rest of World
- Table 5-7: Rest of World HbA1c Testing Market Analysis, 2024-2029 ($ million)
- Competitive Analysis
- Table 5-8: Global HbA1c Testing Market Estimated Revenues and Market Share of Leading Suppliers, 2024 ($ million) [Abbott, Bio-Rad, Danaher (HemoCue and Beckman Coulter), Roche, Siemens Healthineers, Others]
- Figure 5-7: Global HbA1c Testing Market Estimated Revenues, Leading Suppliers, 2024 ($ million) [Abbott, Bio-Rad, Danaher (HemoCue and Beckman Coulter), Roche, Siemens Healthineers, Others]
- Figure 5-8: Global HbA1c Testing Market Share of Leading Suppliers, 2024 (%) [Abbott, Bio-Rad, Danaher (HemoCue and Beckman Coulter), Roche, Siemens Healthineers, Others]
Chapter 6: Issues and Trends in the HbA1c Testing Market
- WHO Essential IVD List
- Table 6-1: WHO Model List of Essential In Vitro Diagnostics (EDL)
- Glycated Albumin Test
- Reporting Changes
- The Challenge of PAMA
- Racial Differences in A1c
- Telemedicine
- LDT Update
- Medicare and HbA1c Testing
- IT and AI
- Diabetes and the Aging World
- Impact of Aging Populations
- Figure 6-1: Global Population Trends, Total Population vs. Age 65+ Population, 2000-2050
- Healthcare Efficiency
- Diabetes Complications
- Regulatory Issues
- Table 6-2: Routine Chemistry CLIA Regulations Acceptable Limits (AP) Changes 2025
- Dental Office HbA1c Testing
Chapter 7: HbA1c Testing Market Company Profiles
- Introduction
- Abbott
- Table 7-1: Abbott Corporate Summary
- Company Overview
- Products
- Performance Review
- Table 7-2: Abbott Revenues, 2020-2024 ($ million)
- A. Menarini Diagnostics, S.r.l.
- Table 7-3: A. Menarini Diagnostics Corporate Summary
- Company Overview
- Products
- ARKRAY, Inc
- Table 7-4: ARKRAY Corporate Summary
- Company Overview
- Products
- Beckman Coulter/Danaher
- Table 7-5: Beckman Coulter Corporate Summary
- Company Overview
- Products
- Bio-Rad
- Table 7-6: Bio-Rad Corporate Summary
- Company Overview
- Products
- Financial Performance
- Table 7-7: Bio-Rad Corporation Revenue, 2020-2024 ($ million)
- DiaSys Diagnostics Systems GmbH
- Table 7-8: DiaSys Diagnostics Systems Corporate Summary
- Company Overview
- Products
- Diazyme Laboratories, Inc.
- Table 7-9: Diazyme Laboratories Corporate Summary
- Company Overview
- Products
- EKF Diagnostics Holdings Plc
- Table 7-10: EKF Diagnostics Corporate Summary
- Company Overview
- Products
- HemoCue/Danaher
- Table 7-11: HemoCue Corporate Summary
- Company Overview
- Products
- HUMAN Diagnostics.
- Table 7-12: HUMAN Diagnostics Corporate Summary
- Company Overview
- Products
- OSANG Healthcare Co, Ltd
- Table 7-13: OSANG Healthcare Corporate Summary
- Company Overview
- Products
- PTS Diagnostics, Inc
- Table 7-14: PTS Diagnostics Corporate Summary
- Company Overview
- Products
- QuidelOrtho Corporation
- Table 7-15: QuidelOrtho Corporate Summary
- Company Overview
- Products
- Performance Review
- Table 7-16: QuidelOrtho Revenues, 2020-2024 ($ million)
- Roche Diagnostics Corporation
- Table 7-17: Roche Diagnostics Corporate Summary
- Company Overview
- Products
- Performance Review
- Table 7-18: Roche Diagnostics, 2020-2024 (CHF millions)
- Sebia
- Table 7-19: Sebia Corporate Summary
- Company Overview
- Products
- Sekisui Diagnostics, LLC
- Table 7-20: Sekisui Diagnostics Corporate Summary
- Company Overview
- Products
- Siemens Healthineers GmbH
- Table 7-21: Siemens Healthineers Corporate Summary
- Company Overview
- Products
- Performance Review
- Table 7-22: Siemens Healthineers, 2020-2024 (Euro-million)
- Tosoh Bioscience, LLC
- Table 7-23: Tosoh Bioscience Corporate Summary
- Company Overview
- Products
- Trinity Biotech
- Table 7-24: Trinity Biotech Corporate Summary
- Company Overview
- Products
