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體外診斷

市場調查報告書

商品編碼

1736919

2026 年至 2032 年體外診斷市場（按產品類型、應用、最終用戶和地區）

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個工作天內

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簡介目錄

體外診斷市場評估 - 2026-2032

體外診斷 (IVD) 市場的發展受到人們對早期疾病檢測日益成長的關注的推動，這有助於改善醫療保健效果並降低成本。對早期檢測的關注預計將推動市場規模呈指數級成長，到 2024 年將達到 1,089.7 億美元，到 2032 年將達到 1,633.4 億美元。

個人化醫療（根據患者個人情況客製化治療方案）的需求日益成長，也加速了體外診斷（IVD）解決方案的普及。因此，預計個人化醫療的轉變將推動市場在2026年至2032年期間以5.19%的複合年成長率成長。

體外診斷市場定義/概述

體外診斷是重要的醫療設備，用於對血液、尿液和組織等生物樣本進行診斷檢測，以識別和監測各種疾病和健康狀況。這些檢測在檢測感染疾病、自體免疫疾病和其他疾病方面發揮關鍵作用，並擴大用於為個別患者量身定做和最佳化藥物治療方案。 IVD產業的關鍵趨勢是分子診斷的發展，分子診斷專注於分析遺傳物質、蛋白質和其他分子，以高精度診斷和管理疾病。

分子診斷技術，尤其是基因組學和蛋白質組學的進步，已經徹底改變了體外診斷的功能，使其能夠檢測與特定疾病相關的特定基因突變和生物標記。這一治療方法的發展使得診斷更加精準、更加個人化，有助於制定個人化治療方案。分子診斷正在對腫瘤學、感染疾病和遺傳性疾病等關鍵領域的疾病管理產生深遠的影響，在這些領域，準確識別疾病標記指南個人化治療方案。分子診斷在體外診斷領域的持續發展代表著醫療保健領域的突破，它支持更早的診斷、更明智的決策並改善患者的預後。

人口老化和慢性病的增加將如何推動體外診斷市場的成長？

人口老化和慢性病數量的增加正在推動體外診斷市場的成長。世界衛生組織報告稱，2020年至2023年間，60歲及以上人口的比例將增加至14億人。根據聯合國《2022年世界人口展望》，到2050年，全球六分之一的人口將達到65歲或以上。這一人群將需要更頻繁的診斷檢測和疾病監測。美國疾病管制與預防中心報告稱，到2022年，每十個美國成年人中就有六個將患有至少一種慢性病。根據國際糖尿病聯盟的數據，2021 年全球將有約 5.37 億成年人罹患糖尿病。美國心臟協會宣布，2021 年 48% 的美國成年人將患有某種形式的心血管疾病。美國食品藥物管理局 (FDA) 在 2020 年至 2022 年間核准了120 多種新的體外診斷檢測和設備。 2020 年至 2023 年間，就地檢驗市場將以 15% 的複合年成長率成長。分子診斷市場在疫情期間將成長 30%（2020-2021 年）

根據世界衛生組織估計，2021年全球進行了超過20億次COVID-19檢測。 2022年全球分子診斷市場規模達362億美元。美國疾病管制與預防中心報告稱，COVID-19檢測基礎設施使其他傳染病檢查的實驗室能力提高了40%。 2021年美國醫療保健支出達4.3兆美元。根據世界衛生組織報告，2020年至2022年，全球醫療保健支出增加了11%。 2020年至2022年，醫療保險在診斷檢測方面的支出增加了23%。

高成本的設備和維護成本將如何阻礙體外診斷市場的成長？

高昂的設備和維護成本阻礙了體外診斷市場的成長。 2022 年，高階分子診斷系統的平均成本為 10 萬至 50 萬美元。年度維護成本通常佔設備初始購買價格的 10% 至 15%。根據 2022 年醫療保健成本分析，小型實驗室每年在 IVD 設備維護上的支出約為 15 萬至 20 萬美元。缺乏技術純熟勞工也阻礙了市場的成長。美國臨床實驗室科學學會報告稱，2022 年實驗室空置率為 7%。根據美國勞工統計局的數據，2022 年將出現約 25,000 名實驗室技術人員的短缺。 2021 年，每位臨床實驗室技術人員的訓練費用平均為 4 萬至 6 萬美元。

嚴格的監管要求和行業報銷挑戰構成了市場挑戰。根據FDA的報告，2022年體外診斷產品的平均核准時間為9-12個月。 2022年，合規成本成長了25%。 2022年，企業平均每台體外診斷器材的註冊申報費用將達到25萬至50萬美元。 2022年，醫療保險（Medicare）將把某些診斷測試的報銷率降低15%至20%。根據CMS的數據，2020年至2022年，臨床測試報銷額平均下降了10%。 2021年，診斷測試的保險理賠拒賠率與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