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体外诊断

市场调查报告书

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1736919

2026 年至 2032 年体外诊断市场（按产品类型、应用、最终用户和地区）

In Vitro Diagnostics Market By Product Type, By Application, By End-User, And Region For 2026-2032

出版日期: 2025年05月08日 | 出版商:

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

价格

简介目录

体外诊断市场评估 - 2026-2032

体外诊断 (IVD) 市场的发展受到人们对早期疾病检测日益增长的关注的推动，这有助于改善医疗保健效果并降低成本。对早期检测的关注预计将推动市场规模呈指数级增长，到 2024 年将达到 1,089.7 亿美元，到 2032 年将达到 1,633.4 亿美元。

个人化医疗（根据患者个人情况客製化治疗方案）的需求日益增长，也加速了体外诊断（IVD）解决方案的普及。因此，预计个人化医疗的转变将推动市场在2026年至2032年期间以5.19%的复合年增长率成长。

体外诊断市场定义/概述

体外诊断是重要的医疗设备，用于对血液、尿液和组织等生物样本进行诊断检测，以识别和监测各种疾病和健康状况。这些检测在检测感染疾病、自体免疫疾病和其他疾病方面发挥关键作用，并越来越多地用于为个别患者量身定制和优化药物治疗方案。 IVD产业的关键趋势是分子诊断的发展，分子诊断专注于分析遗传物质、蛋白质和其他分子，以高精度诊断和管理疾病。

分子诊断技术，尤其是基因组学和蛋白质组学的进步，已经彻底改变了体外诊断的功能，使其能够检测与特定疾病相关的特定基因突变和生物标记。这一治疗方法的发展使得诊断更加精准、更加个人化，有助于制定个人化治疗方案。分子诊断正在对肿瘤学、感染疾病和遗传性疾病等关键领域的疾病管理产生深远的影响，在这些领域，准确识别疾病标记指南个人化治疗方案。分子诊断在体外诊断领域的持续发展代表着医疗保健领域的突破，它支持更早的诊断、更明智的决策并改善患者的预后。

人口老化和慢性病的增加将如何推动体外诊断市场的成长？

人口老化和慢性病数量的增加正在推动体外诊断市场的成长。世界卫生组织报告称，2020年至2023年间，60岁及以上人口的比例将增加至14亿人。根据联合国《2022年世界人口展望》，到2050年，全球六分之一的人口将达到65岁或以上。这一人群将需要更频繁的诊断检测和疾病监测。美国疾病管制与预防中心报告称，到2022年，每十个美国成年人中就有六个将患有至少一种慢性病。根据国际糖尿病联盟的数据，2021 年全球将有约 5.37 亿成年人罹患糖尿病。美国心臟协会宣布，2021 年 48% 的美国成年人将患有某种形式的心血管疾病。美国食品药物管理局 (FDA) 在 2020 年至 2022 年间核准了120 多种新的体外诊断检测和设备。 2020 年至 2023 年间，就地检验市场将以 15% 的复合年增长率成长。分子诊断市场在疫情期间将成长 30%（2020-2021 年）

根据世界卫生组织估计，2021年全球进行了超过20亿次COVID-19检测。 2022年全球分子诊断市场规模达362亿美元。美国疾病管制与预防中心报告称，COVID-19检测基础设施使其他传染病检查的实验室能力提高了40%。 2021年美国医疗保健支出达4.3兆美元。根据世界卫生组织报告，2020年至2022年，全球医疗保健支出增加了11%。 2020年至2022年，医疗保险在诊断检测方面的支出增加了23%。

高成本的设备和维护成本将如何阻碍体外诊断市场的成长？

高昂的设备和维护成本阻碍了体外诊断市场的成长。 2022 年，高阶分子诊断系统的平均成本为 10 万至 50 万美元。年度维护成本通常占设备初始购买价格的 10% 至 15%。根据 2022 年医疗保健成本分析，小型实验室每年在 IVD 设备维护上的支出约为 15 万至 20 万美元。缺乏技术纯熟劳工也阻碍了市场的成长。美国临床实验室科学学会报告称，2022 年实验室空置率为 7%。根据美国劳工统计局的数据，2022 年将出现约 25,000 名实验室技术人员的短缺。 2021 年，每位临床实验室技术人员的训练费用平均为 4 万至 6 万美元。

严格的监管要求和行业报销挑战构成了市场挑战。根据FDA的报告，2022年体外诊断产品的平均核准时间为9-12个月。 2022年，合规成本成长了25%。 2022年，企业平均每台体外诊断器材的註册申报费用将达到25万至50万美元。 2022年，医疗保险（Medicare）将把某些诊断测试的报销率降低15%至20%。根据CMS的数据，2020年至2022年，临床测试报销额平均下降了10%。 2021年，诊断测试的保险理赔拒赔率与2020年相比增加了23%。

A strong emphasis on early disease detection is a major driver in the in-vitro diagnostics (IVD) market, contributing to improved healthcare outcomes and reduced costs. Thus, the growing emphasis on early detection surged the growth of the market size, surpassing USD 108.97 Billion in 2024 to reach a valuation of USD 163.34 Billion by 2032.

The rising demand for personalized medicine, which tailors treatment to individual patient profiles, has also accelerated the adoption of IVD solutions. Thus, the shift toward personalized care enables the market to grow at a CAGR of 5.19% from 2026 to 2032.

In Vitro Diagnostics Market: Definition/ Overview

In-vitro diagnostics (IVD) are essential medical devices that conduct diagnostic tests on biological samples, including blood, urine, and tissue, to identify and monitor various diseases and health conditions. These tests play a vital role in detecting infectious diseases, autoimmune disorders, and other medical conditions, and they are increasingly used to adjust and optimize drug therapies for individual patients. A significant trend in the IVD industry is the growth of molecular diagnostics, which focuses on analyzing genetic material, proteins, and other molecules to diagnose and manage diseases with high precision.

Advancements in molecular diagnostics, particularly within genomics and proteomics, have transformed IVD capabilities by enabling the detection of specific gene mutations and biomarkers linked to particular diseases. This progress allows for more accurate and tailored diagnoses, leading to the development of personalized treatment plans. Molecular diagnostics has profoundly impacted disease management in critical areas like oncology, infectious diseases, and genetic disorders, where precise identification of disease markers can guide individualized treatment approaches. The ongoing expansion of molecular diagnostics within the IVD field represents a leap forward in healthcare, supporting early diagnosis, informed decision-making, and improved patient outcomes.

How do the Increasing Geriatric Population and Rising Chronic Diseases Surge the Growth of In Vitro Diagnostics Market?

The increasing aging population and growing chronic disorders cases surge the growth of in vitro diagnostics market. The WHO reported that between 2020 and 2023, the proportion of people aged 60+ years increased to 1.4 billion. According to the UN's World Population Prospects 2022, by 2050, 1 in 6 people worldwide will be over 65 years old. This demographic requires more frequent diagnostic testing and disease monitoring. The CDC reported in 2022 that 6 in 10 American adults have at least one chronic disease. Diabetes affected approximately 537 million adults worldwide in 2021 according to the International Diabetes Federation. The American Heart Association stated that 48% of US adults had some form of cardiovascular disease in 2021. The FDA approved over 120 new IVD tests and devices between 2020-2022. The point-of-care testing market saw a 15% CAGR from 2020-2023. Molecular diagnostics segment grew by 30% during the pandemic period (2020-2021)

Over 2 billion COVID-19 tests were performed globally in 2021 according to WHO estimates. The global molecular diagnostics market reached USD 36.2 Billion in 2022. CDC reported that COVID-19 testing infrastructure improved laboratory capabilities for other infectious disease testing by 40%. The US healthcare spending reached USD 4.3 Trillion in 2021. The WHO reported global healthcare spending grew by 11% between 2020 and 2022. Medicare spending on diagnostic testing increased by 23% from 2020 to 2022.

How do the High Costs of Equipment and Maintenance Impede the Growth of In Vitro Diagnostics Market?

The high cost of equipment and maintenance hamper the growth of the in vitro diagnostics market. The average cost of a high-end molecular diagnostic system ranges from $100,000 to $500,000 as of 2022. Annual maintenance costs typically represent 10-15% of the initial equipment purchase price. According to a 2022 healthcare cost analysis, smaller laboratories spend approximately $150,000-$200,000 annually on IVD equipment maintenance. Also, the lack of skilled labor hinders market growth. The American Society for Clinical Laboratory Science reported a 7% vacancy rate for laboratory positions in 2022. According to the Bureau of Labor Statistics, there was a shortage of approximately 25,000 laboratory professionals in 2022. Training costs per laboratory technician averaged $40,000-$60,000 in 2021.

The stringent regulatory requirements and the reimbursement challenges in the industry act as a challenge for the market. FDA reported that the average time for IVD device approval increased to 9-12 months in 2022. Regulatory compliance costs increased by 25% between 2020 and 2022. Companies spent an average of $250,000-$500,000 per IVD device for regulatory submissions in 2022. Medicare reduced reimbursement rates for certain diagnostic tests by 15-20% in 2022. According to CMS data, laboratory test reimbursements decreased by an average of 10% between 2020-2022. Insurance claim denials for diagnostic tests increased by 23% in 2021 compared to 2020

Category-Wise Acumens

How the Precise and Efficient Diagnostic Test Surge the Growth of Reagents & Kits Segment?

The reagents & kits segment dominates the in vitro diagnostics (IVD) market owing to their vital role in performing accurate and efficient diagnostic tests. These products are essential for identifying and measuring biomarkers, pathogens, and other analytes across a range of biological samples, making them indispensable in diagnostics. A notable example of innovation within this segment occurred in February 2022, when Invitae Corporation introduced its CE-IVD-certified cancer testing kits, FusionPlex Dx and LiquidPlex Dx, in Europe. These advanced kits are tailored to enhance precision oncology, enabling more reliable cancer detection and management solutions, which respond to the increasing demand for effective diagnostic tools in the European healthcare market.

With continuous advancements and product launches, the Reagents & Kits segment reinforces its importance within the IVD field. Such innovations drive market growth and support the broader shift toward personalized medicine, which seeks to improve patient outcomes by providing tailored diagnostic and treatment options. By facilitating high-quality diagnostics, reagents and kits contribute significantly to expanding possibilities for individualized patient care, reinforcing their position as a cornerstone in the evolving IVD landscape.

How the Growing Prevalence of Infectious Disease Foster the Growth of Infectious Diseases Segment?

The infectious diseases segment holds a dominant in the in vitro diagnostics (IVD) market, driven by the increasing prevalence of infectious diseases such as HIV, tuberculosis, influenza, and hepatitis. The global demand for early and accurate diagnostics has grown significantly as healthcare systems prioritize rapid identification and treatment of these diseases to prevent widespread transmission. Moreover, the need for swift diagnostics and large-scale screening is amplified by government initiatives focused on controlling outbreaks and reducing disease impact. This focus has bolstered investment and innovation within the infectious disease diagnostics space.

With a particular emphasis on diseases like hepatitis, pneumonia, HIV-AIDS, and tuberculosis. As the incidence of these conditions rises globally, key industry players are accelerating efforts to develop innovative diagnostic systems designed to improve the speed, accuracy, and accessibility of testing. These advancements address the rising infectious disease burden and support effective response measures in urban and remote healthcare settings. As a result, the infectious diseases segment continues to play a pivotal role in the IVD landscape, addressing public health needs and reinforcing its dominance through ongoing technological progress and strategic initiatives.

Country/Region-wise Acumens

How the Substantial Healthcare Expenditure and Robust Infrastructure Surge the Growth of In Vitro Diagnostic Market in North America?

North America substantially dominates the in vitro diagnostic market driven by the high healthcare expenditure & advanced healthcare infrastructure. According to the Centers for Medicare & Medicaid Services, U.S. healthcare spending reached USD 4.3 Trillion in 2021, representing 18.3% of GDP. According to the American Hospital Association, as of 2022, there were over 6,000 hospitals in the U.S. with sophisticated diagnostic laboratories. Canada's healthcare spending exceeded USD 300 Billion in 2021, with significant investments in diagnostic infrastructure.

In addition, the rising prevalence of chronic diseases also contributes to the growth of in vitro diagnostics market. According to the CDC (2022), 6 in 10 Americans live with at least one chronic disease. According to the report of National Diabetes Statistics diabetes affected approximately 37.3 million Americans (11.3% of the population) in 2022. Cancer diagnoses in the U.S. were projected to reach 1.9 million new cases in 2023.

The growing elderly population requiring regular diagnostics propels the adoption of the in vitro diagnostics market in the region. The U.S. population aged 65 and older grew from 54.1 million in 2019 to nearly 57 million in 2021. By 2030, all baby boomers will be 65 or older, expanding the elderly population to 73 million. Medicare spending on clinical laboratory services reached USD 9.2 Billion in 2020.

How Does the High Population in the Region with Disease Burden Accelerate the Growth of the In Vitro Diagnostic Market in the Asia Pacific?

Asia Pacific is anticipated to witness the fastest growth in the in vitro diagnostic market during the forecast period owing to the large population base with a high disease burden. China and India together account for approximately 2.8 billion people (36% of the global population) as of 2022. In 2021, China reported 4.07 million new cancer cases with growing demand for early diagnostics. India recorded over 77 million diabetes cases in 2021, the second highest globally.

In addition, the rising healthcare expenditure & infrastructure development propel the growth of the market. China's healthcare spending reached 7.12 trillion yuan (USD 1.1 Trillion) in 2021, rising 13.5% from 2020. Japan's healthcare expenditure increased to 44.2 trillion yen (USD 333 Billion) in 2021. India allocated USD 10.6 Billion for healthcare infrastructure in the 2022-23 budget, with a significant focus on diagnostic capabilities

Also, the growing aging population & chronic disease management enhance the growth of market growth. According to the Statistics Bureau of Japan. Japan's elderly population (65+ years) reached 29.1% of total population in 2021. South Korea's elderly population is expected to reach 20.3% by 2025. China's 60+ population exceeded 267 million in 2021 (National Bureau of Statistics), creating increased demand for diagnostic services.

Competitive Landscape

The In Vitro Diagnostics (IVD) Market is a highly competitive landscape dominated by a few major players and numerous smaller, specialized companies. Key factors driving competition include technological advancements, regulatory approvals, product innovation, and strategic partnerships.

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 in vitro diagnostics market include:

Abbott Laboratories
Roche Diagnostics
Siemens Healthineers AG
Danaher Corporation
Thermo Fisher Scientific, Inc.
Johnson & Johnson
Becton, Dickinson and Company
Sysmex Corporation
Merck KGaA
bioMerieux

Latest Developments:

In January 2023, Qiagen, a European business, announced the launch of EZ2 Connect MDx IVD, an automated sample platform for diagnostic laboratories.
In September 2022, ADSTEC and its subsidiary ADS Biotec, a market player in automated instrument development, announced that their HANABI Cytogenetic Automation Instruments had received CE marking under the European Union In Vitro Diagnostic Medical Device Directive (IVDD) 98/79/EC.

1 INTRODUCTION OF GLOBAL IN VITRO DIAGNOSTICS 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 IN VITRO DIAGNOSTICS 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 IN VITRO DIAGNOSTICS MARKET, BY PRODUCT TYPE

5.1 Overview
5.2 Reagents & Kits
5.3 Instruments
5.4 Services

6 GLOBAL IN VITRO DIAGNOSTICS MARKET, BY APPLICATION

6.1 Overview
6.2 Infectious Diseases
6.3 Oncology
6.4 Diabetes
6.5 Cardiology

7 GLOBAL IN VITRO DIAGNOSTICS MARKET, BY END-USER

7.1 Overview
7.2 Hospital & Clinics
7.3 Diagnostic Laboratories
7.4 Research Institutes
7.5 Home care settings

8 GLOBAL IN VITRO DIAGNOSTICS 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 and Africa

9 GLOBAL IN VITRO DIAGNOSTICS 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 Roche Diagnostics
- 10.2.1 Overview
- 10.2.2 Financial Performance
- 10.2.3 Product Outlook
- 10.2.4 Key Developments
10.3 Siemens Healthineers 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 Thermo Fisher Scientific, Inc.
- 10.5.1 Overview
- 10.5.2 Financial Performance
- 10.5.3 Product Outlook
- 10.5.4 Key Developments
10.6 Johnson & Johnson
- 10.6.1 Overview
- 10.6.2 Financial Performance
- 10.6.3 Product Outlook
- 10.6.4 Key Developments
10.7 Becton, Dickinson and Company
- 10.7.1 Overview
- 10.7.2 Financial Performance
- 10.7.3 Product Outlook
- 10.7.4 Key Developments
10.8 Sysmex Corporation
- 10.8.1 Overview
- 10.8.2 Financial Performance
- 10.8.3 Product Outlook
- 10.8.4 Key Developments
10.9 Merck KGaA
- 10.9.1 Overview
- 10.9.2 Financial Performance
- 10.9.3 Product Outlook
- 10.9.4 Key Developments
10.10 bioMerieux
- 10.10.1 Overview
- 10.10.2 Financial Performance
- 10.10.3 Product Outlook
- 10.10.4 Key Developments

11 KEY DEVELOPMENTS

11.1 Product Launches/Developments
11.2 Mergers and Acquisitions
11.3 Business Expansions
11.4 Partnerships and Collaborations

12 Appendix

12.1 Related Research

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License/价格

2026 年至 2032 年体外诊断市场（按产品类型、应用、最终用户和地区）

In Vitro Diagnostics Market By Product Type, By Application, By End-User, And Region For 2026-2032

体外诊断市场评估 - 2026-2032

人口老化和慢性病的增加将如何推动体外诊断市场的成长？

高成本的设备和维护成本将如何阻碍体外诊断市场的成长？

目录

第一章：全球体外诊断市场简介

第二章执行摘要

第三章：已验证的市场研究调查方法

第四章 全球体外诊断市场展望

第五章全球体外诊断市场（依产品类型）

第六章全球体外诊断市场（依应用）

第七章全球体外诊断市场（依最终用户）

8. 全球体外诊断市场（按地区）

第九章全球体外诊断市场的竞争格局

第十章 公司简介

第十一章 重大进展

第十二章 附录

In Vitro Diagnostics Market Valuation - 2026-2032