化学発光免疫測定（CLIA）分析装置市場：製品タイプ、用途、技術、地域別、2026年～2032年

化学発光免疫測定（CLIA）分析装置市場の評価、2026年～2032年

がん、心血管疾患、感染症などの慢性疾患の罹患率の増加が、化学発光免疫測定（CLIA）分析装置の採用を促進しています。特に発展途上地域におけるヘルスケア支出の増加が、高度な診断機器の購入を後押ししており、市場規模は2024年に65億米ドルを突破し、2032年には約98億米ドルに達する見込みです。

これに加えて、さまざまなヘルスケア環境におけるポイントオブケア検査や迅速診断の需要の高まりが、化学発光免疫測定（CLIA）分析装置の採用に拍車をかけています。また、先進的な診断技術を促進する規制当局の承認や政府の取り組みも、2026年から2032年までのCAGR 5.80%での市場成長を可能にしています。

化学発光免疫測定（CLIA）分析装置市場定義/概要

化学発光免疫測定（CLIA）分析装置は、化学発光技術を利用して臨床サンプル中のさまざまな生物学的マーカーを検出・定量する高度な診断装置です。これらの分析計は、酵素または化学基質が標的分析物と相互作用して測定可能なシグナルを生成する化学発光反応中に放出される光を測定します。CLIA分析装置は高感度で特異性が高く、迅速で正確な結果が得られることで知られています。

CLIA分析装置は、感染症、ホルモン値、がんバイオマーカー、心臓マーカー、自己免疫疾患の検出など、さまざまな診断用途に臨床検査室で広く使用されています。日常的な血液検査、疾患モニタリング、治療薬モニタリングにおいて重要な役割を果たしています。さらに、CLIA技術はバイオマーカーの発見と検証のための研究環境でも使用され、疾病メカニズムや潜在的な治療標的に関する重要な洞察を提供しています。

慢性疾患や感染症の有病率の増加は、どのように化学発光免疫測定（CLIA）分析装置の採用を増加させるか？

化学発光免疫測定（CLIA）分析装置市場は、主に慢性疾患と感染症の世界の有病率の増加によって、大きな成長を遂げています。これらの高度な診断ツールは、高感度、特異性、迅速な結果を提供し、現代のヘルスケア環境において不可欠なものとなっています。米国疾病予防管理センター（CDC）によると、2024年5月現在、CLIAに基づく検査は米国における臨床検査診断の65％を占め、2022年の55％から増加しています。世界保健機関（WHO）は2024年3月、CLIA分析装置の世界需要が2024年に28％増加したと報告したが、これは主にがんや心血管障害を含むさまざまな疾患の診断とモニタリングにおけるCLIA分析装置の役割によるものです。

CLIA分析装置の技術的進歩と自動化が市場の成長をさらに促進しています。これらの改良は、臨床検査室における効率の向上、ヒューマンエラーの減少、スループットの向上につながっています。米国食品医薬品局（FDA）は2024年にCLIAに基づく15の新しい診断検査を承認したが、これは前年比25%増であり、この分野における技術革新の急速なペースを浮き彫りにしています。2024年7月15日、シーメンス・ヘルティニアーズは、前モデルと比較して処理時間を40％短縮し、検査メニューを30％増やした次世代CLIA分析装置を発表しました。この発表は、増大するヘルスケア需要に対応するCLIA技術の絶え間ない進化を強調するものです。

COVID-19のパンデミックもCLIA分析装置市場を大きく押し上げ、これらのシステムは大規模な検査活動において重要な役割を果たしています。米国立衛生研究所（NIH）は2024年4月、CLIAベースのCOVID-19抗体検査が感度98％、特異度99.5％を示し、他の多くの検査法を上回ったと報告しました。この結果、臨床と研究の両分野でCLIA分析装置の採用が増加しています。

CLIA（Chemiluminescence Immunoassay）アナライザーの初期コストが高いことは、その応用を抑制するか？

化学発光免疫測定（CLIA）分析装置市場における主な抑制要因の1つは、これらの高度な診断システムの購入とセットアップにかかる初期コストの高さです。CLIA分析装置には高度な技術と部品が必要であるため、他の診断方法と比較して高価です。予算が限られている小規模の臨床検査室やヘルスケア施設では、この高コストが大きな障壁となり、普及の妨げとなります。

CLIA分析装置の操作、校正、保守には専門的な知識が必要です。これらのシステムは技術的に複雑であるため、検査室では機器の取り扱い、結果の解釈、定期的なメンテナンスの実施に訓練を受けた人材が必要となります。このような専門技能の必要性は、運用コストを増加させ、そのような専門知識が容易に得られない環境でのCLIA分析装置の使用を制限する可能性があります。さらに、メンテナンスや修理の費用が高額になり、市場の成長をさらに抑制する可能性があります。

CLIA分析装置を含む診断機器の規制状況は厳しく、地域によって異なります。規制当局の承認取得には時間とコストがかかるため、メーカーにとっては課題となっています。さらに、CLIA分析装置を使用した診断検査に対する償還政策には一貫性がなく、ヘルスケアプロバイダーの財政的な存続に影響を与える可能性があります。このような規制と償還の課題は、不確実性を生み出し、CLIA技術の採用を制限することによって、市場の成長を鈍らせる可能性があります。

目次

第1章 イントロダクション

• 市場の定義
• 市場セグメンテーション
• 調査手法

第2章 エグゼクティブサマリー

• 主な調査結果
• 市場概要
• 市場ハイライト

第3章 市場概要

• 市場規模と成長の可能性
• 市場動向
• 市場促進要因
• 市場抑制要因
• 市場機会
• ポーターのファイブフォース分析

第4章 化学発光免疫測定（CLIA）分析装置市場：製品タイプ別

• ベンチトップ型分析装置
• ハンドヘルド型分析装置
• ポータブル分析装置

第5章 化学発光免疫測定（CLIA）分析装置市場：用途別

• 感染症
• 腫瘍学
• 内分泌学
• 心臓マーカー
• 自己免疫疾患

第6章 化学発光免疫測定（CLIA）分析装置市場：技術別

• シーケンシャルインジェクション
• ランダムアクセス
• バッチ分析装置

第7章 地域別分析

• 北米
• 米国
• カナダ
• メキシコ
• 欧州
• 英国
• ドイツ
• フランス
• イタリア
• アジア太平洋
• 中国
• 日本
• インド
• オーストラリア
• ラテンアメリカ
• ブラジル
• アルゼンチン
• チリ
• 中東・アフリカ
• 南アフリカ
• サウジアラビア
• アラブ首長国連邦

第8章 市場力学

• 市場促進要因
• 市場抑制要因
• 市場機会
• COVID-19の市場への影響

第9章 競合情勢

• 主要企業
• 市場シェア分析

第10章 企業プロファイル

• Abbott Laboratories
• Beckman Coulter（Danaher Corporation）
• Roche Diagnostics
• Siemens Healthineers
• Mindray
• Sysmex Corporation
• DiaSorin S.p.A.
• Fujirebio
• Autobio

第11章 市場の展望と機会

• 新興技術
• 今後の市場動向
• 投資機会

第12章 付録

• 略語リスト
• 出典と参考文献

Chemiluminescence Immunoassay (CLIA) Analyzers Market Valuation - 2026-2032

The increasing incidence of chronic diseases such as cancer, cardiovascular diseases, and infectious diseases is propelling the adoption of chemiluminescence immunoassay (CLIA) analyzers. Rising healthcare spending, particularly in developing regions, supports the acquisition of advanced diagnostic equipment is driving the market size surpass USD 6.5 Billion valued in 2024 to reach a valuation of around USD 9.8 Billion by 2032.

In addition to this, the growing demand for point-of-care testing and rapid diagnostics in various healthcare settings is spurring up the adoption of chemiluminescence immunoassay (CLIA) analyzers. Also, favorable regulatory approvals and government initiatives promoting advanced diagnostic technologies is enabling the market grow at a CAGR of 5.80% from 2026 to 2032.

Chemiluminescence Immunoassay (CLIA) Analyzers Market: Definition/ Overview

Chemiluminescence Immunoassay (CLIA) analyzers are advanced diagnostic instruments that utilize chemiluminescence technology to detect and quantify various biological markers in clinical samples. These analyzers measure the light emitted during a chemiluminescent reaction, which occurs when an enzyme or chemical substrate interacts with the target analyte, producing a measurable signal. CLIA analyzers are known for their high sensitivity, specificity, and ability to deliver rapid and accurate results.

CLIA analyzers are widely used in clinical laboratories for a range of diagnostic applications, including the detection of infectious diseases, hormone levels, cancer biomarkers, cardiac markers, and autoimmune disorders. They play a crucial role in routine blood tests, disease monitoring, and therapeutic drug monitoring. Additionally, CLIA technology is employed in research settings for biomarker discovery and validation, providing critical insights into disease mechanisms and potential therapeutic targets.

How will Rising Prevalence of Chronic and Infectious Diseases Increase Adoption of Chemiluminescence Immunoassay (CLIA) Analyzers?

The chemiluminescence immunoassay (CLIA) analyzers market is experiencing significant growth, driven primarily by the increasing prevalence of chronic and infectious diseases worldwide. These advanced diagnostic tools offer high sensitivity, specificity, and rapid results, making them essential in modern healthcare settings. According to the Centers for Disease Control and Prevention (CDC), as of May 2024, CLIA-based tests accounted for 65% of all laboratory diagnostic procedures in the United States, up from 55% in 2022. The World Health Organization (WHO) reported in March 2024 that global demand for CLIA analyzers increased by 28% in 2024, largely due to their role in diagnosing and monitoring various diseases, including cancer and cardiovascular disorders.

Technological advancements and automation in CLIA analyzers are further propelling market growth. These improvements have led to increased efficiency, reduced human error, and higher throughput in clinical laboratories. The U.S. Food and Drug Administration (FDA) approved 15 new CLIA-based diagnostic tests in 2024, a 25% increase from the previous year, highlighting the rapid pace of innovation in this field. On July 15, 2024, Siemens Healthineers unveiled its next-generation CLIA analyzer, boasting a 40% reduction in processing time and a 30% increase in test menu compared to its predecessor. This launch underscores the continuous evolution of CLIA technology to meet growing healthcare demands.

The COVID-19 pandemic has also significantly boosted the CLIA Analyzers Market, with these systems playing a crucial role in large-scale testing efforts. The National Institutes of Health (NIH) reported in April 2024 that CLIA-based COVID-19 antibody tests showed a sensitivity of 98% and specificity of 99.5%, outperforming many other testing methods. This has led to increased adoption of CLIA analyzers in both clinical and research settings.

Will High Initial Cost of Chemiluminescence Immunoassay (CLIA) Analyzers Restrain Its Application?

One of the primary restraints in the chemiluminescence immunoassay (CLIA) analyzers market is the high initial cost of purchasing and setting up these advanced diagnostic systems. The sophisticated technology and components required for CLIA analyzers make them more expensive compared to other diagnostic methods. This high cost can be a significant barrier for smaller clinical laboratories and healthcare facilities with limited budgets, hindering widespread adoption.

CLIA analyzers require specialized knowledge for operation, calibration, and maintenance. The technical complexity of these systems means that laboratories need trained personnel to handle the equipment, interpret results, and perform regular maintenance. This need for specialized skills can increase operational costs and limit the use of CLIA analyzers in settings where such expertise is not readily available. Additionally, maintenance and repair costs can be high, further restraining market growth.

The regulatory landscape for diagnostic devices, including CLIA analyzers, is stringent and varies across regions. Obtaining regulatory approvals can be time-consuming and costly, posing a challenge for manufacturers. Furthermore, reimbursement policies for diagnostic tests performed using CLIA analyzers can be inconsistent, affecting the financial viability for healthcare providers. These regulatory and reimbursement challenges can slow down market growth by creating uncertainty and limiting the adoption of CLIA technology.

Category-Wise Acumens

Will Rise in Adoption of Benchtop Analyzers Drive Chemiluminescence Immunoassay (CLIA) Analyzers Market?

Benchtop analyzers is emerging as the dominant segment in the chemiluminescence immunoassay (CLIA) analyzers market due to their versatility, compact size, and cost-effectiveness. These analyzers are particularly popular in small to medium-sized laboratories, clinics, and research facilities where space is at a premium. According to the Centers for Medicare & Medicaid Services (CMS), as of June 2024, benchtop CLIA analyzers accounted for 68% of all CLIA analyzers in use across U.S. clinical laboratories. The National Institutes of Health (NIH) reported in April 2024 that benchtop CLIA analyzers showed a 15% increase in adoption rate compared to floor-standing models over the past two years.

The dominance of benchtop analyzers is further reinforced by their improving capabilities and expanding test menus. These compact systems now offer performance comparable to larger analyzers while maintaining a smaller footprint. The Food and Drug Administration (FDA) approved 12 new benchtop CLIA analyzers in 2024, a 33% increase from the previous year, highlighting the rapid innovation in this segment. On July 17, 2024, Siemens Healthineers launched its latest benchtop CLIA analyzer, boasting a 50% smaller footprint than its predecessor while increasing the test menu by 25%. This development underscores the trend towards more powerful yet compact diagnostic solutions

Which Factors Contributing Random Access Segment Dominance in Chemiluminescence Immunoassay (CLIA) Analyzers Market?

The global random access dominating CLIA Analyzers market has seen significant growth in recent years, driven by increasing demand for rapid and accurate diagnostic testing. According to a report by the National Institutes of Health, the market size was valued at approximately USD 1.8 Billion in 2020 and is projected to reach USD 2.9 Billion by 2026, growing at a CAGR of 8.2% during the forecast period. This growth is attributed to the rising prevalence of chronic and infectious diseases, technological advancements in immunoassay techniques, and the growing geriatric population.

Key players in the market include Roche Diagnostics, Abbott Laboratories, Siemens Healthineers, and Beckman Coulter. In March 2024, Roche announced the launch of their new high-throughput CLIA analyzer, the cobas pro integrated solutions, which can perform up to 2,000 tests per hour. This innovation aims to improve laboratory efficiency and reduce turnaround times for critical test results. The U.S. Food and Drug Administration (FDA) reported a 15% increase in CLIA analyzer approvals between 2022 and 2024, indicating a surge in technological advancements and market competition.

The COVID-19 pandemic has further accelerated the adoption of CLIA analyzers, with many laboratories implementing these systems for SARS-CoV-2 antibody testing. A survey conducted by the Centers for Disease Control and Prevention (CDC) in late 2024 found that 78% of clinical laboratories in the United States now use CLIA analyzers for routine testing, up from 65% in 2019. As the healthcare industry continues to prioritize rapid and accurate diagnostics, the Random Access Dominating CLIA Analyzers market is expected to maintain its growth trajectory in the coming years.

Country/Region-wise Acumens

Will Region's Advanced Healthcare Infrastructure in North America Drive Chemiluminescence Immunoassay (CLIA) Analyzers Market Growth?

The North American chemiluminescence immunoassay (CLIA) analyzers market has been experiencing substantial growth, primarily driven by the region's advanced healthcare infrastructure and increasing demand for rapid diagnostic solutions. According to the Centers for Disease Control and Prevention (CDC), as of 2024, approximately 85% of clinical laboratories in the United States utilize CLIA analyzers for various diagnostic tests. The market value in North America reached USD 1.2 Billion in 2022 and is projected to grow at a CAGR of 6.8% from 2024 to 2028, as reported by the National Institutes of Health (NIH).

Key players dominating the North American CLIA Analyzers market include Abbott Laboratories, Beckman Coulter, and Siemens Healthineers. In a recent development, Abbott announced in January 2024 the launch of its next-generation CLIA analyzer, the ARCHITECT i3000SR, which boasts a throughput of up to 450 tests per hour. This launch aims to address the growing demand for high-speed, high-volume testing in large hospitals and reference laboratories. The U.S. Food and Drug Administration (FDA) reported a 20% increase in CLIA analyzer approvals for the North American market between 2021 and 2024, indicating a surge in innovation and competition.

Will Rising Industrialization Enhance Adoption of Chemiluminescence Immunoassay (CLIA) Analyzers in Asia Pacific?

The Asia Pacific Chemiluminescence Immunoassay (CLIA) Analyzers Market is experiencing rapid growth, driven by increasing healthcare expenditure, rising awareness about early disease detection, and improving healthcare infrastructure in developing countries. According to the World Health Organization (WHO), healthcare spending in the Asia Pacific region increased by an average of 6.3% annually between 2018 and 2024. The CLIA Analyzers market in Asia Pacific was valued at USD 980 Million in 2022 and is projected to grow at a CAGR of 9.2% from 2024 to 2028, as reported by the Asia Pacific Medical Technology Association (APACMed).

Key players in the Asia Pacific CLIA Analyzers market include Mindray, Sysmex Corporation, and Shenzhen New Industries Biomedical Engineering Co., Ltd (SNIBE). In a significant development, Mindray launched its new CL-series CLIA analyzer in March 2024, featuring a throughput of up to 300 tests per hour and a menu of over 150 parameters. This launch aims to cater to the growing demand for comprehensive testing solutions in mid-sized hospitals and laboratories across the region. The China Food and Drug Administration (CFDA) reported a 30% increase in CLIA analyzer approvals for the Chinese market between 2022 and 2024, indicating rapid technological advancements and market expansion.

The COVID-19 pandemic has accelerated the adoption of CLIA analyzers in the Asia Pacific region, particularly for large-scale serological testing. A survey conducted by the Asia Pacific Association of Medical Laboratory Scientists (APFCB) in late 2024 found that 68% of surveyed laboratories in the region had invested in new CLIA analyzers since the start of the pandemic.

Competitive Landscape

The chemiluminescence immunoassay (CLIA) analyzers market is a dynamic and competitive space, characterized by a diverse range of players vying for market share. These players are on the run for solidifying their presence through the adoption of strategic plans such as collaborations, mergers, acquisitions, and political support.

The organizations are focusing on innovating their product line to serve the vast population in diverse regions. Some of the prominent players operating in the chemiluminescence immunoassay (CLIA) analyzers market include:

• Roche Diagnostics
• Abbott Laboratories
• Siemens Healthineers
• Danaher Corporation (Beckman Coulter)
• bioMerieux SA
• DiaSorin S.p.A.
• Ortho Clinical Diagnostics
• Thermo Fisher Scientific
• Sysmex Corporation
• Mindray Medical International Limited
• Quidel Corporation
• PerkinElmer, Inc.
• Snibe Diagnostics
• Merck KGaA
• Tosoh Corporation
• Luminex Corporation
• Bio-Rad Laboratories, Inc.
• Hologic, Inc.
• Shenzhen New Industries Biomedical Engineering Co., Ltd. (Snibe)
• Meso Scale Diagnostics, LLC.

Latest Developments

• In December 2024, Siemens Healthineers and Beckman Coulter Diagnostics announced a collaboration to develop a next-generation CLIA analyzer that enhances sensitivity and throughput for routine and specialty assays.
• In March 2024, Abbott Laboratories introduced an advanced CLIA analyzer with enhanced multiplexing capabilities, allowing simultaneous detection of multiple biomarkers from a single sample, improving diagnostic efficiency in clinical settings.

Chemiluminescence Immunoassay (CLIA) Analyzers Market, By Category

• Product Type:
• Benchtop Analyzers
• Handheld Analyzers
• Portable Analyzers
• Application:
• Infectious Diseases
• Oncology
• Endocrinology
• Cardiac Markers
• Autoimmune Diseases
• Technology:
• Sequential Injection
• Random Access
• Batch Analyzers
• Region:
• North America
• Europe
• Asia-Pacific
• South America
• Middle East & Africa

TABLE OF CONTENTS

1. Introduction

• Market Definition
• Market Segmentation
• Research Methodology

2. Executive Summary

• Key Findings
• Market Overview
• Market Highlights

3. Market Overview

• Market Size and Growth Potential
• Market Trends
• Market Drivers
• Market Restraints
• Market Opportunities
• Porter's Five Forces Analysis

4. Chemiluminescence Immunoassay (CLIA) Analyzers Market, By Product Type

• Benchtop Analyzers
• Handheld Analyzers
• Portable Analyzers

5. Chemiluminescence Immunoassay (CLIA) Analyzers Market, By Application

• Infectious Diseases
• Oncology
• Endocrinology
• Cardiac Markers
• Autoimmune Diseases

6. Chemiluminescence Immunoassay (CLIA) Analyzers Market, By Technology

• Sequential Injection
• Random Access
• Batch Analyzers

7. Regional Analysis

• North America
• United States
• Canada
• Mexico
• Europe
• United Kingdom
• Germany
• France
• Italy
• Asia-Pacific
• China
• Japan
• India
• Australia
• Latin America
• Brazil
• Argentina
• Chile
• Middle East and Africa
• South Africa
• Saudi Arabia
• UAE

8. Market Dynamics

• Market Drivers
• Market Restraints
• Market Opportunities
• Impact of COVID-19 on the Market

9. Competitive Landscape

• Key Players
• Market Share Analysis

10. Company Profiles

• Abbott Laboratories
• Beckman Coulter (Danaher Corporation)
• Roche Diagnostics
• Siemens Healthineers
• Mindray
• Sysmex Corporation
• DiaSorin S.p.A.
• Fujirebio
• Autobio

11. Market Outlook and Opportunities

• Emerging Technologies
• Future Market Trends
• Investment Opportunities

12. Appendix

• List of Abbreviations
• Sources and References