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體外診斷

免疫診斷市場規模、佔有率及成長分析（按產品、應用、最終用戶及地區分類）－2026-2033年產業預測

市場調查報告書

商品編碼

1899730

免疫診斷市場規模、佔有率及成長分析（按產品、應用、最終用戶及地區分類）－2026-2033年產業預測

Immunodiagnostics Market Size, Share, and Growth Analysis, By Product (Instruments, Reagents & Consumables), By Application (Infectious Diseases, Oncology & Endocrinology), By End User, By Region -Industry Forecast 2026-2033

出版日期: 2025年12月19日 | 出版商:

SkyQuest | 英文 157 Pages | 商品交期: 3-5個工作天內

價格

簡介目錄

預計到 2024 年，免疫診斷試劑市場規模將達到 251.9 億美元，到 2025 年將達到 262.5 億美元，到 2033 年將達到 364.8 億美元，預測期（2026-2033 年）的複合年成長率為 4.2%。

全球慢性病、感染疾病和自體免疫疾病的增加，推動了對免疫診斷的需求，因為醫療機構更加重視提升診斷能力和早期檢測。這種日益成長的關注度有望為免疫診斷公司創造巨大的機會。診斷技術的創新和個人化醫療的轉變預計將進一步推動需求。此外，居家醫療和遠端醫療的日益普及預計將推動家庭免疫診斷市場的擴張。加上醫療保健成本不斷上漲和人口老化，這些因素為市場相關人員帶來了良好的前景。然而，法規結構不一致、報銷障礙、訓練有素的專業人員短缺、操作流程複雜以及假陽性風險等挑戰可能會阻礙市場的整體擴張。

推動免疫診斷市場發展的因素

全球免疫診斷市場的主要促進因素是慢性病和感染疾病的日益流行，這推動了對精準高效診斷工具的需求。隨著醫療保健系統向預防性和個人化醫療轉型，對可靠診斷方法的需求激增，這些方法能夠識別和監測癌症、自體免疫疾病和感染疾病等疾病。免疫診斷檢測技術的進步，以及人們對這些檢測的認知度和可近性的提高，進一步促進了市場成長。這些因素共同作用，提高了早期診斷和治療的能力，從而改善了患者的預後，並推動了市場擴張。

限制免疫診斷市場發展的因素

全球免疫診斷市場的主要限制因素之一是先進診斷設備和試劑的高成本。安裝和維護先進免疫診斷系統的相關成本可能構成障礙，尤其對於發展中地區的中小型醫療機構和實驗室而言更是如此。這種經濟障礙會限制創新診斷技術的普及，阻礙其廣泛應用。此外，嚴格的產品核可監管要求也減緩了新型免疫診斷解決方案的推出，這給那些希望在不斷變化的競爭格局和醫療需求中拓展市場佔有率的製造商帶來了更多挑戰。

免疫診斷市場趨勢

免疫診斷市場正經歷重大變革，即開發能夠同時檢測多種生物標記的多重檢測技術，從而提高臨床診斷的效率和資源管理水平。這一趨勢的驅動力在於市場對能夠實現快速、準確篩檢的綜合診斷解決方案的需求日益成長。隨著醫療機構尋求透過簡化檢測流程來改善患者預後，在單次檢測中獲取多種健康資訊的能力變得至關重要。專注於這項創新的公司有望憑藉其在不斷發展的免疫診斷解決方案領域的領先地位，獲得競爭優勢。

北美洲
- 美國
- 加拿大
歐洲
- 德國
- 西班牙
- 法國
- 英國
- 義大利
- 其他歐洲地區
亞太地區
- 中國
- 印度
- 日本
- 韓國
- 亞太其他地區
拉丁美洲
- 巴西
- 其他拉丁美洲地區
中東和非洲（MEA）
- 海灣合作理事會國家
- 南非
- 其他中東和非洲地區

競爭格局

前五大公司對比
主要企業的市場定位（2025 年）
主要市場參與者所採取的策略
近期市集活動
主要企業市佔率（2025 年）

主要企業簡介

Abbott（US）
Roche Diagnostics（Switzerland）
DiaSorin（Italy）
Danaher Corporation（US）
QIAGEN（Netherlands）
bioMerieux（France）
Thermo Fisher Scientific（US）
Quest Diagnostics（US）
Siemens Healthineers AG（Germany）
Bio-Rad Laboratories, Inc.（US）
Sysmex Corporation（Japan）
PerkinElmer, Inc.（US）
Agilent Technologies, Inc.（US）
Mindray Medical International Limited（China）
Grifols, SA（Spain）
Becton, Dickinson and Company（BD）（US）
Abcam plc（UK）
Merck KGaA（Germany）
Enzo Biochem, Inc.（US）
Bio-Techne Corporation（US）
Meso Scale Diagnostics, LLC.（US）
GenScript Biotech Corporation（China）
Myriad Genetics, Inc.（US）

簡介目錄

Product Code: SQMIG35A2401

Immunodiagnostics Market size was valued at USD 25.19 Billion in 2024 and is poised to grow from USD 26.25 Billion in 2025 to USD 36.48 Billion by 2033, growing at a CAGR of 4.2% during the forecast period (2026-2033).

The global rise in chronic, infectious, and autoimmune diseases is driving an increased need for immunodiagnostics, as healthcare providers prioritize enhanced diagnostic capabilities and early detection. This growing focus is likely to create significant opportunities for immunodiagnostics companies. Innovations in diagnostic technology and a shift towards personalized medicine are set to further increase demand. Additionally, the increasing trend of home and remote healthcare practices is expected to boost the market for home-based immunodiagnostics. Coupled with heightened healthcare expenditures and a growing elderly population, these factors present promising prospects for market players. However, challenges such as inconsistent regulatory frameworks, reimbursement hurdles, a shortage of trained professionals, complex procedures, and the risk of false positives could hinder overall market expansion.

Top-down and bottom-up approaches were used to estimate and validate the size of the Immunodiagnostics market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Immunodiagnostics Market Segments Analysis

Global Immunodiagnostics Market is segmented by Product, Application, End user, and region. Based on Product, the market is segmented into Instruments, and Reagents & Consumables. Based on Application, the market is segmented intoOncology& Endocrinology, Hepatitis & Retrovirus, Cardiac Markers, Infectious Diseases, and Others. Based on End user, the market is segmented into Clinical Laboratories, Hospitals, Physician's Offices, and Others. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & and Africa.

Driver of the Immunodiagnostics Market

A key market driver for the global immunodiagnostics market is the increasing prevalence of chronic and infectious diseases, which amplifies the demand for accurate and efficient diagnostic tools. As healthcare systems increasingly shift towards preventive care and personalized medicine, the need for reliable diagnostic methods to identify and monitor conditions such as cancer, autoimmune disorders, and infectious diseases has surged. Technological advancements in immunodiagnostic assays, along with the rising awareness and accessibility of these tests, further contribute to market growth. These factors collectively enhance the capacity for early diagnosis and treatment, thereby improving patient outcomes and driving market expansion.

Restraints in the Immunodiagnostics Market

One key market restraint for the global immunodiagnostics market is the high cost of advanced diagnostic equipment and reagents. The expenses associated with acquiring and maintaining sophisticated immunodiagnostic systems can be prohibitive, particularly for small and medium-sized healthcare facilities and laboratories in developing regions. This financial barrier may limit access to innovative diagnostic technologies, hindering widespread adoption and utilization. Furthermore, stringent regulatory requirements for product approval can slow down the introduction of new immunodiagnostic solutions, creating additional challenges for manufacturers aiming to increase market presence amidst rising competition and evolving healthcare needs.

Market Trends of the Immunodiagnostics Market

The immunodiagnostics market is witnessing a significant shift towards the development of multiplex tests, designed to simultaneously detect multiple biomarkers, thereby enhancing efficiency and resource management in clinical diagnostics. This trend is driven by an increasing demand for comprehensive diagnostic solutions that facilitate rapid and accurate screening. As healthcare providers seek to improve patient outcomes through streamlined testing processes, the ability to capture diverse health information in a single assay is becoming paramount. Companies focusing on this innovation are likely to gain competitive advantages, positioning themselves at the forefront of the evolving landscape of immunodiagnostics solutions.

Introduction

Objectives of the Study
Definitions
Market Scope

Research Methodology

Information Procurement
Secondary & Primary Data Sources
Market Size Estimation
Market Assumptions & Limitations

Executive Summary

Market Overview Outlook
Supply Demand Trend Analysis
Segmental Opportunity Analysis

Market Dynamics & Outlook

Market Dynamics
- Drivers
- Opportunities
- Restraints
- Challenges
Porters Analysis
- Competitive rivalry
- Threat of Substitute Products
- Bargaining Power of Buyers
- Threat of New Entrants
- Bargaining Power of Suppliers

Key Market Insights

Technology Analysis
Value Chain Analysis
Ecosystem of the Market
Case study Analysis
Regulatory Landscape
Innovation Matrix
Top Investment Analysis
Key Success Factor
Degree of Competition

Immunodiagnostics Market by Product

Market Overview
Instruments
Reagents & Consumables

Immunodiagnostics Market by Application

Market Overview
Oncology & Endocrinology
Hepatitis & Retrovirus
Cardiac Markers
Infectious Diseases
Others

Immunodiagnostics Market by End user

Market Overview
Clinical Laboratories
Hospitals
Physician's Offices
Online Pharmacies

Immunodiagnostics Market Size by Region

Market Overview
North America
- USA
- Canada
Europe
- Germany
- Spain
- France
- UK
- Italy
- Rest of Europe
Asia Pacific
- China
- India
- Japan
- South Korea
- Rest of Asia-Pacific
Latin America
- Brazil
- Rest of Latin America
Middle East & Africa (MEA)
- GCC Countries
- South Africa
- Rest of MEA

Competitive Landscape

Top 5 Player Comparison
Market Positioning of Key Players, 2025
Strategies Adopted by Key Market Players
Recent Activities in the Market
Key Companies Market Share (%), 2025

Key Company Profiles

Abbott (US)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Roche Diagnostics (Switzerland)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
DiaSorin (Italy)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Danaher Corporation (US)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
QIAGEN (Netherlands)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
bioMerieux (France)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Thermo Fisher Scientific (US)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Quest Diagnostics (US)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Siemens Healthineers AG (Germany)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Bio-Rad Laboratories, Inc. (US)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Sysmex Corporation (Japan)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
PerkinElmer, Inc. (US)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Agilent Technologies, Inc. (US)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Mindray Medical International Limited (China)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Grifols, S.A. (Spain)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Becton, Dickinson and Company (BD) (US)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Abcam plc (UK)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Merck KGaA (Germany)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Enzo Biochem, Inc. (US)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Bio-Techne Corporation (US)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Meso Scale Diagnostics, LLC. (US)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
GenScript Biotech Corporation (China)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Myriad Genetics, Inc. (US)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments