ヘモグロビンA1C検査装置の世界市場規模：技術別、エンドユーザー別、製品タイプ別、地域範囲別および予測

ヘモグロビンA1C検査装置の市場規模と予測

ヘモグロビンA1C検査装置市場規模は、2024年に14億5,000万米ドルと評価され、2026～2032年にかけてCAGR 8.97%で成長し、2032年には28億9,000万米ドルに達すると予測されます。

ヘモグロビンA1C（HbA1c）検査装置は、血糖値測定器とは異なり、在宅検査用に設計されていないです。現在米国で入手可能なFDA認可の家庭用A1C検査キットは、A1C Now Self-Check Kitのみです。これは、家庭で簡単に検査できる血糖測定器とは異なります。

A1Cナウセルフチェック・キットは指を刺す検査で、約12分で結果が出る。ただし、血液サンプルを検査機関に郵送して処理する必要があり、結果は数日後に届きます。この検査は、妊娠中の方、過去3ヶ月以内に輸血を受けたことのある方、特定の血液疾患をお持ちの方には適していません。

ヘモグロビンA1C検査装置の世界市場力学

ヘモグロビンA1C検査装置市場を形成している主要市場力学は以下の通りです。

主要市場促進要因

糖尿病有病率の上昇：国際糖尿病連合（IDF）によると、世界的に糖尿病患者数が急増しています。最新のIDF Diabetes Atlasでは、2019年には4億6,300万人の成人（20～79歳）が糖尿病と共存していると推定しています。この数は2045年までに7億人に増加すると予測されています。この劇的な増加は、人口増加、高齢化、都市化、加工食品の消費の増加や運動量の減少などのライフスタイルの変化など、いくつかの要因によるものです。糖尿病有病率の上昇は、ヘモグロビンA1c検査装置市場の主要促進要因です。

予防医療への注目の高まり：予防ヘルスケアと糖尿病管理に対する人々の意識の高まりが、早期発見と介入のためのHbA1c検査装置の使用を促進しています。政府機関や保健機関は、糖尿病予防と早期発見の重要性を一般市民に啓蒙するキャンペーンを展開しています。こうしたキャンペーンでは、糖尿病の危険因子を特定し、発症を予防または遅らせるための早期介入を可能にするHbA1c検査の役割が強調されることが多いです。

ポイントオブケア検査（POCT）：POCT装置の台頭は、クリニック、薬局、あるいは自宅で結果を得ることを可能にし、HbA1c検査に革命をもたらしています。これにより、患者は採血のために診察室や検査室に出向く必要がなくなり、検査の利便性とアクセスが大幅に向上します。POCT装置は一般的に、従来型検査室ベースの分析装置よりも小型で持ち運びができ、使いやすいです。POCT装置は、従来型検査室ベースの分析装置よりもはるかに短時間で、多くの場合数分以内に結果を出すことができるため、迅速な治療方針の決定や調整が可能になります。

主要課題

HbA1c検査装置と検査のコスト：HbA1c検査装置や検査にかかる費用は、特に医療予算が限られており、糖尿病管理に対する保険適用が不十分な新興諸国では、一部の患者にとって大きな障壁となる可能性があります。そのため、HbA1c検査へのアクセスに格差が生じ、糖尿病の診断が遅れ、効果的な疾病管理が妨げられる可能性があります。

精度に関する懸念：精度は著しく向上しているが、ヘモグロビンの変異体や特定の薬剤などの特定の要因による干渉の可能性については、いくつかの懸念が残っています。その結果、検査結果が不正確になり、診断が遅れたり、不必要な治療調整が行われたりする可能性があります。メーカー各社は、こうした干渉因子の影響を最小限に抑えるため、HbA1c検査装置の精度向上に絶えず取り組んでいます。

主要動向

在宅検査への注目：便利で利用しやすい糖尿病管理に対する需要の高まりが、在宅A1c検査装置の開発を後押ししています。これらの検査装置により、患者は自宅で快適にHbA1c値を検査できるようになり、診察室や検査室に頻繁に出向く必要がなくなります。現在、利用できる範囲は限られているが、在宅A1c検査は今後数年のうちに普及し、高度化すると予想されます。

糖尿病管理システムとの統合：HbA1c検査装置を包括的な糖尿病管理システムに統合する動向があります。これらのシステムは、HbA1c検査と血糖モニタリング、持続グルコースモニタリング（CGM）装置、インスリンポンプ、モバイルアプリを組み合わせたものです。このデータ統合により、患者の糖尿病状態をより全体的に把握することができ、個人に合わせた治療計画が立てやすくなります。さらに、これらのシステムは、患者にリアルタイムのデータ分析とフィードバックを提供し、糖尿病管理について十分な情報に基づいた意思決定を行う力を与えることができます。

目次

第1章 ヘモグロビンA1C検査装置の世界市場導入

• 市場概要
• 調査範囲
• 前提条件

第2章 エグゼクティブサマリー

第3章 VERIFIED MARKET RESEARCHの調査手法

• データマイニング
• バリデーション
• 一次資料
• データソース一覧

第4章 ヘモグロビンA1C検査装置の世界市場展望

• 概要
• 市場力学
  • 促進要因
  • 抑制要因
  • 機会
• ポーターのファイブフォースモデル
• バリューチェーン分析

第5章 ヘモグロビンA1C検査装置の世界市場：技術別

• 概要
• 高速液体クロマトグラフィー（HPLC）
• イムノアッセイ
• ボロネートアフィニティークロマトグラフィー
• 直接酵素測定法
• その他

第6章 ヘモグロビンA1C検査装置の世界市場：エンドユーザー別

• 概要
• 病院
• 診断ラボ
• 学術・研究機関
• その他

第7章 ヘモグロビンA1C検査装置の世界市場：製品タイプ別

• 概要
• ベンチトップ型装置
• ポイントオブケア（POC）装置

第8章 ヘモグロビンA1C検査装置の世界市場：地域別

• 概要
• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • その他の欧州
• アジア太平洋
  • 中国
  • 日本
  • インド
  • その他のアジア太平洋
• その他
  • ラテンアメリカ
  • 中東・アフリカ

第9章 世界のヘモグロビンA1C検査装置市場の競合情勢

• 概要
• 各社の市場ランキング
• 主要開発戦略

第10章 企業プロファイル

• Abbott Laboratories
• Siemens Healthineers
• F. Hoffmann-La Roche AG
• Danaher Corporation
• Bio-Rad Laboratories Inc.
• Sebia
• ARKRAY, Inc.
• Trinity BIoTech

第11章 付録

• 関連調査

Hemoglobin A1C Testing Devices Market Size And Forecast

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.

Global Hemoglobin A1C Testing Devices Market Dynamics

The key market dynamics that are shaping the Hemoglobin A1C Testing Devices Market include:

Key Market Drivers

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.

Global Hemoglobin A1C Testing Devices Market Regional Analysis

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.

Global Hemoglobin A1C Testing Devices Market: Segmentation Analysis

The Global Haemoglobin A1C Testing Devices Market is segmented based on Technology, End-User, Product Type, And Geography.

Haemoglobin A1C Testing Devices Market, By Technology

• High-Performance Liquid Chromatography (HPLC)
• Immunoassay
• Boronate Affinity Chromatography
• Direct Enzymatic Assay
• Others

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.

Haemoglobin A1C Testing Devices Market, By End-User

• Hospitals
• Diagnostic Laboratories
• Academic & Research Institutes
• Others

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.

Haemoglobin A1C Testing Devices Market, By Product Type

• Bench-top Devices
• Point-of-Care (POC) Devices

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.

Key Players

• The "Hemoglobin A1C Testing Devices Market" study report will provide valuable insight with an emphasis on the global market. The major players in the market are Abbott Laboratories, Siemens Healthineers, F. Hoffmann-La Roche AG, Danaher Corporation, Bio-Rad Laboratories, Inc., Sebia, Tosoh Bioscience, ARKRAY, Inc., and Trinity Biotech.

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.

• Hemoglobin A1C Testing Devices Market Recent Developments
• In 2024, Trivitron Healthcare introduced the NANO H5 and NANO H110, which are advanced HPLC-based diagnostic solutions for HbA1c testing that provide results in about 130 seconds.
• In 2024, Abbott Laboratories offers the Afinion(TM) HbA1c Dx assay, a point-of-care device that delivers rapid and accurate results

TABLE OF CONTENTS

1 INTRODUCTION OF GLOBAL HEMOGLOBIN A1C TESTING DEVICES MARKET

• 1.1 Overview of the Market
• 1.2 Scope of Report
• 1.3 Assumptions

2 EXECUTIVE SUMMARY

3 RESEARCH METHODOLOGY OF VERIFIED MARKET RESEARCH

• 3.1 Data Mining
• 3.2 Validation
• 3.3 Primary Interviews
• 3.4 List of Data Sources

4 GLOBAL HEMOGLOBIN A1C TESTING DEVICES MARKET OUTLOOK

• 4.1 Overview
• 4.2 Market Dynamics
  • 4.2.1 Drivers
  • 4.2.2 Restraints
  • 4.2.3 Opportunities
• 4.3 Porters Five Force Model
• 4.4 Value Chain Analysis

5 GLOBAL HEMOGLOBIN A1C TESTING DEVICES MARKET, BY TECHNOLOGY

• 5.1 Overview
• 5.2 High-Performance Liquid Chromatography (HPLC)
• 5.3 Immunoassay
• 5.4 Boronate Affinity Chromatography
• 5.5 Direct Enzymatic Assay
• 5.6 Others

6 GLOBAL HEMOGLOBIN A1C TESTING DEVICES MARKET, BY END-USER

• 6.1 Overview
• 6.2 Hospitals
• 6.3 Diagnostic Laboratories
• 6.4 Academic & Research Institutes
• 6.5 Others

7 GLOBAL HEMOGLOBIN A1C TESTING DEVICES MARKET, BY PRODUCT TYPE

• 7.1 Overview
• 7.2 Bench-top Devices
• 7.3 Point-of-Care (POC) Devices

8 GLOBAL HEMOGLOBIN A1C TESTING DEVICES MARKET, BY GEOGRAPHY

• 8.1 Overview
• 8.2 North America
  • 8.2.1 U.S.
  • 8.2.2 Canada
  • 8.2.3 Mexico
• 8.3 Europe
  • 8.3.1 Germany
  • 8.3.2 U.K.
  • 8.3.3 France
  • 8.3.4 Rest of Europe
• 8.4 Asia Pacific
  • 8.4.1 China
  • 8.4.2 Japan
  • 8.4.3 India
  • 8.4.4 Rest of Asia Pacific
• 8.5 Rest of the World
  • 8.5.1 Latin America
  • 8.5.2 Middle East & Africa

9 GLOBAL HEMOGLOBIN A1C TESTING DEVICES MARKET COMPETITIVE LANDSCAPE

• 9.1 Overview
• 9.2 Company Market Ranking
• 9.3 Key Development Strategies

10 COMPANY PROFILES

• 10.1 Abbott Laboratories
  • 10.1.1 Overview
  • 10.1.2 Financial Performance
  • 10.1.3 Product Outlook
  • 10.1.4 Key Developments
• 10.2 Siemens Healthineers
  • 10.2.1 Overview
  • 10.2.2 Financial Performance
  • 10.2.3 Product Outlook
  • 10.2.4 Key Developments
• 10.3 F. Hoffmann-La Roche AG
  • 10.3.1 Overview
  • 10.3.2 Financial Performance
  • 10.3.3 Product Outlook
  • 10.3.4 Key Developments
• 10.4 Danaher Corporation
  • 10.4.1 Overview
  • 10.4.2 Financial Performance
  • 10.4.3 Product Outlook
  • 10.4.4 Key Developments
• 10.5 Bio-Rad Laboratories Inc.
  • 10.5.1 Overview
  • 10.5.2 Financial Performance
  • 10.5.3 Product Outlook
  • 10.5.4 Key Developments
• 10.6 Sebia
  • 10.6.1 Overview
  • 10.6.2 Financial Performance
  • 10.6.3 Product Outlook
  • 10.6.4 Key Developments
• 10.7 ARKRAY, Inc.
  • 10.7.1 Overview
  • 10.7.2 Financial Performance
  • 10.7.3 Product Outlook
  • 10.7.4 Key Developments
• 10.8 Trinity Biotech
  • 10.8.1 Overview
  • 10.8.2 Financial Performance
  • 10.8.3 Product Outlook
  • 10.8.4 Key Developments

11 Appendix

• 11.1 Related Research