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體外診斷生技設備

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商品編碼

1738857

化學冷光免疫檢測（CLIA）分析儀市場（按產品類型、應用、技術和地區）2026 年至 2032 年

Chemiluminescence Immunoassay (CLIA) Analyzers Market By Product Type (Benchtop Analyzers, Handheld Analyzers), Application (Infectious Diseases, Oncology), Technology (Sequential Injection, Random Access), & Region for 2026-2032

出版日期: 2025年05月06日 | 出版商:

Verified Market Research | 英文 202 Pages | 商品交期: 2-3個工作天內

價格

簡介目錄

2026-2032 年化學冷光免疫檢測分析 (CLIA) 分析儀市場評估

癌症、心血管疾病和感染疾病等慢性病的發生率不斷上升，推動了化學冷光免疫檢測分析 (CLIA) 分析儀的普及。醫療保健支出的不斷成長，尤其是在發展中地區，也推動了先進診斷設備的購買。預計2024年市場規模將超過65億美元，2032年將達到約98億美元。

此外，各類醫療機構對就地檢驗和快速診斷的需求日益成長，也刺激了化學冷光免疫檢測(CLIA) 分析儀的採用。監管部門的核准以及政府推動先進診斷技術的舉措，也使得該市場在 2026 年至 2032 年期間的複合年成長率達到 5.80%。

化學冷光免疫檢測（CLIA）分析儀市場的定義與概述

化學冷光免疫檢測(CLIA) 分析儀是一種先進的診斷設備，利用化學冷光技術檢測和定量臨床樣本中的多種生物標記。這類分析儀測量化學冷光反應過程中發出的光，在化學發光反應中，酵素或化學基材與目標分析物相互作用，產生可測量的訊號。 CLIA 分析儀以其高靈敏度和特異性以及快速且準確的結果而聞名。

CLIA 分析儀廣泛應用於臨床實驗室的各種診斷應用，包括檢測感染疾病、荷爾蒙水平、癌症生物標記、心臟標記、自體免疫疾病等。它們在常規血液檢測、疾病監測和治療藥物監測中發揮重要作用。此外，CLIA 技術也用於研究環境中的生物標記的發現和檢驗，為疾病機制和潛在治療標靶的發現提供重要見解。

慢性病和感染疾病的日益普及將如何促進化學冷光免疫檢測(CLIA) 分析儀的採用？

化學冷光免疫檢測(CLIA) 分析儀市場正在經歷顯著成長，主要原因是全球美國和感染疾病的盛行率不斷上升。這些先進的診斷工具提供了高靈敏度、特異性和快速的結果，使其成為現代醫療保健環境中必不可少的。根據疾病管制與預防中心 (CDC) 的數據，截至 2024 年 5 月，基於 CLIA 的測試將占美國臨床實驗室診斷的 65%，高於 2022 年的 55%。 2024 年 3 月，世界衛生組織 (WHO) 報告稱，2024 年全球對 CLIA 分析儀的需求將增加 28%，這主要歸因於 CLIA 分析儀在診斷和監測各種疾病（包括癌症和心血管疾病）中的作用。

CLIA 分析儀的技術進步和自動化進一步推動了市場成長。這些改進提高了臨床實驗室的效率、減少了人為錯誤並提高了通量。美國食品藥物管理局(FDA) 於 2024 年核准了15 項新的 CLIA 診斷測試，與前一年同期比較增加了 25%，凸顯了該領域快速的創新步伐。 2024 年 7 月 15 日，西門子 Hertinias 發布了其下一代 CLIA 分析儀，與上一代產品相比，其處理時間加快了 40%，測試選項增加了 30%。此次發布凸顯了 CLIA 技術不斷發展以滿足日益成長的醫療保健需求。

新冠疫情也顯著推動了CLIA分析儀市場的發展，這些系統在大規模檢測工作中發揮關鍵作用。 2024年4月，美國國立衛生研究院(NIH)報告稱，基於CLIA的COVID-19抗體檢測靈敏度高達98%，特異性高達99.5%，優於許多其他檢測方法。這促使CLIA分析儀在臨床和研究領域的應用日益廣泛。

CLIA（化學發光免疫分析）分析儀的高初始成本是否會限制其應用？

化學冷光免疫檢測(CLIA) 分析儀市場的主要限制因素之一是購買和安裝這些先進診斷系統的高初始成本。 CLIA 分析儀需要先進的技術和組件，因此與其他診斷方法相比價格昂貴。對於預算有限的小型臨床實驗室和醫療機構來說，高成本是阻礙其廣泛應用的主要障礙。

CLIA分析儀的操作、校準和維護需要專業知識。由於這些系統的技術複雜性，實驗室需要訓練有素的人員來操作設備、解釋結果並進行日常維護。對此類專業技能的需求可能會增加營運成本，並限制CLIA分析儀在缺乏此類專業知識的環境中的應用。此外，維護和維修成本可能較高，進一步抑制市場成長。

包括CLIA分析儀在內的診斷設備的監管環境非常嚴格，且因地區而異。獲得監管部門的核准既耗時又昂貴，這給製造商帶來了挑戰。此外，使用CLIA分析儀進行診斷測試的報銷政策並不一致，這可能會影響醫療保健提供者的財務可行性。此類監管和報銷挑戰可能會造成不確定性，並限制CLIA技術的採用，減緩市場成長。

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.