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体外诊断

市场调查报告书

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1560785

全球体外诊断市场 - 2024 - 2031

Global In-Vitro Diagnostics Market - 2024 - 2031

出版日期: 2024年09月23日 | 出版商:

DataM Intelligence | 英文 186 Pages | 商品交期: 最快1-2个工作天内

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简介目录

报告概述

2023年全球体外诊断市场规模达983亿美元，预估至2031年将达1,457亿美元，2024-2031年预测期间复合年增长率为5.3%

体外诊断 (IVD) 是一个使用人类样本检测疾病、病症或感染的测试领域。这些测试是在体外进行的，通常是在实验室环境中，使用先进的仪器和试剂。 IVD 在现代医学中至关重要，为疾病诊断、治疗决策和监测患者健康状况提供关键资讯。由于技术进步、全球人口老化、慢性病和个人化医疗需求，IVD 市场正在快速成长。

市场动态：

驱动程式和限制

科技进步的崛起

技术进步的兴起有助于市场在预测期内成长。包括 PCR 和 NGS 在内的分子诊断可以实现早期遗传疾病检测，提高诊断准确性和治疗效果。现场护理测试设备可以在远端环境中实现更快的诊断和治疗。 IVD 系统的自动化和数位化提高了效率，减少了人为错误，并提供了更准确的结果，尤其是在远端设定中。

新型且高度准确的临床实验室测试的引入正在推动新型 IVD 测试在全球范围内的采用。例如，2023 年 6 月，东丽工业公司用于诊断胰臟癌的东丽 APOA2-iTQ 获得了日本厚生劳动省的上市许可。

此外，2023 年3 月，雅培(Abbott) 的新型实验室创伤性脑损伤(TBI) 血液检测获得了美国FDA 的批准。尚未开发的市场创造新的机会。

缺乏熟练的专业人员

全球体外诊断市场面临多项挑战，包括严格的监管要求、先进诊断技术的高成本以及熟练专业人员的缺乏。这些因素可能会延迟新诊断产品的进入，并限制其在医疗保健预算有限的发展中国家的采用。总体而言，这些因素为 IVD 市场营运公司带来了重大挑战。

细分市场分析

全球体外诊断市场根据产品类型、技术、应用、最终用户和地区进行细分。

该产品类型细分市场的试剂约占体外诊断市场份额的41.3%

产品类型细分市场的试剂占比约41.3%。试剂是体外诊断中检测和量化患者样本中生物标记的重要组成部分。它们旨在与目标分析物发生反应，从而能够识别和测量疾病、病症或感染。试剂对于诊断检测的准确性和可靠性至关重要，直接影响结果的敏感性和特异性。它们用于各种诊断应用，包括免疫测定、分子诊断、临床化学和血液学。由于个人化医疗的发展和快速诊断，对高品质试剂的需求不断增加。

例如，2023 年 10 月，美国化学品供应商 Alfa Chemistry 推出了三种实验室使用的 IVD 产品，扩大了其生物试剂的范围，以帮助研究透过血液或组织等样本检测发现的疾病。

市场地域占有率

预计北美在整个预测期内将占据总市场份额的 38.4% 左右

由于慢性病发病率上升、强大参与者的存在、新测试启动数量的增加以及政府的支持性资金，预计北美在整个预测期内将占据约 38.4% 的市场份额。

例如，2023 年 1 月，BD 和 CerTest Biotec 获得了美国 FDA 的 EUA，用于在美国进行 Mpox 病毒检测的 PCR 检测。预计将推动北美市场的成长。

In Vitro Diagnostics (IVD) is a field of tests used to detect diseases, conditions, or infections using human samples. These tests are conducted outside the body, typically in laboratory settings, using advanced instruments and reagents. IVD is crucial in modern medicine, providing critical information for disease diagnosis, treatment decisions, and monitoring patient health. The market for IVD is rapidly growing due to technological advancements, an aging global population, chronic diseases, and personalized medicine demand.

Market Dynamics: Drivers & Restraints

Rise in technological advancements

The rise in technological advancements help the market to grow during the forecast period. Molecular diagnostics, including PCR and NGS, enable early genetic disease detection, improving diagnosis accuracy and treatment outcomes. Point-of-care testing devices enable faster diagnosis and treatment in remote settings. Automation and digitalization in IVD systems improve efficiency, reduce human error, and provide more accurate results, especially in remote settings.

The introduction of novel and highly accurate clinical laboratory tests is boosting the adoption of novel IVD tests worldwide. For instance, in June 2023, Toray Industries, Inc. received marketing approval from Japan's Ministry of Health, Labour and Welfare for its Toray APOA2-iTQ used to diagnose pancreatic cancer.

Moreover, in March 2023, Abbott received U.S. FDA clearance for its novel laboratory Traumatic Brain Injury (TBI) blood test in the U.S. Increasing approvals of IVD tests for life-threatening diseases are expected to create new opportunities in the untapped market.

Lack of skilled professionals

The global in vitro diagnostics market faces several challenges, including stringent regulatory requirements, high costs of advanced diagnostic technologies, and a lack of skilled professionals. These factors can delay the entry of new diagnostic products and limit their adoption in developing countries with limited healthcare budgets. Overall, these factors pose significant challenges for companies operating in the IVD market.

Market Segment Analysis

The global in vitro diagnostics market is segmented based on product type, technique, application, end-user, and region.

The reagents from the product type segment accounted for approximately 41.3% of the in vitro diagnostics market share

The reagents from the product type segment accounted for approximately 41.3%. Reagents are essential components in in vitro diagnostics for detecting and quantifying biological markers in patient samples. They are designed to react with target analytes, enabling the identification and measurement of diseases, conditions, or infections. Reagents are crucial for the accuracy and reliability of diagnostic tests, directly affecting the sensitivity and specificity of results. They are used in various diagnostic applications, including immunoassays, molecular diagnostics, clinical chemistry, and hematology. The demand for high-quality reagents has increased due to personalized medicine growth and rapid diagnostics.

For instance, in October 2023, US-based chemical supplier Alfa Chemistry introduced three IVD products for laboratory use, enhancing its range of biological reagents, to aid in research on diseases detected through tests on samples like blood or tissue.

Market Geographical Share

North America is estimated to hold about 38.4% of the total market share throughout the forecast period

North America is estimated to hold about 38.4% of the total market share throughout the forecast period due rising incidence of chronic diseases, the presence of strong players, the increasing number of novel test launches, and supportive government funding.

For instance, in January 2023, BD and CerTest Biotec received EUA from the U.S. FDA for a PCR test for Mpox virus detection in the U.S. Moreover, the increasing requirement for genetic testing for personalized health care, such as that for diabetes and cancer, is expected to drive market growth in North America.

Market Segmentation

By-Product Type

Instruments

Reagents

Software and Services

By Technique

Immunoassays

POC diagnostics

Molecular diagnostics

Hematology

Tissue diagnostics

Microbiology

Self-Blood-Glucose Monitoring

Others

By Application

Infectious Diseases

Diabetes

Cancer/Oncology

Cardiology

Autoimmune Diseases

Nephrology

Drug Testing

Others

By End User

Diagnostic Laboratories

Hospitals

Academics and Research Institutes

Others

By Region

North America

The U.S.

Canada

Mexico

Europe

Germany

France

Italy

Spain

Rest of Europe

South America

Brazil

Argentina

Rest of South America

Asia-Pacific

China

India

Japan

South Korea

Rest of Asia-Pacific

Middle East and Africa

Market Competitive Landscape

The major global players in the market include BioMerieux, Danaher Corporation, Roche Diagnostics, Becton, Dickinson and Company, Bio-Rad Laboratories, Inc., Abbott Laboratories, Bayer AG, Arkray, Inc., Sysmex Corporation, Siemens AG among others.

Key Developments

In January 2024, ELITech Group proudly announces the introduction of the GI Bacterial PLUS ELITe MGB Kit, a robust addition to its diagnostic portfolio. Tailored specifically for diagnosing gastrointestinal bacterial infections, the in vitro assay exclusively targets major bacterial pathogens including Campylobacter spp.

In September 2023, NeoDx Biotech Labs, a Bengaluru-based startup launched a Real-time PCR-Technology-based in vitro diagnostic (IVD) kit for Ankylosing Spondylitis & empowered healthcare services to improve their testing capabilities.

Why Purchase the Report?

To visualize the global in vitro diagnostics market segmentation based on product type, technique, application, end-user, and region as well as understand key commercial assets and players.

Identify commercial opportunities by analyzing trends and co-development.

Excel data sheet with numerous data points of the in vitro diagnostics market level with all segments.

PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.

Product mapping available as excel consisting of key products of all the major players.

The global in vitro diagnostics market report would provide approximately 64 tables, 61 figures, and 186 pages.

Target Audience 2024

Manufacturers/ Buyers

Industry Investors/Investment Bankers

Research Professionals

Emerging Companies

1. Methodology and Scope

1.1. Research Methodology
1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

3.1. Snippet by Product Type
3.2. Snippet by Technique
3.3. Snippet by Application
3.4. Snippet by End User
3.5. Snippet by Region

4. Dynamics

4.1. Impacting Factors
- 4.1.1. Drivers
  - 4.1.1.1. Rise in technological advancements
  - 4.1.1.2. Rise in the prevalence of chronic diseases
- 4.1.2. Restraints
  - 4.1.2.1. Lack of skilled professionals
- 4.1.3. Opportunity
- 4.1.4. Impact Analysis

5. Industry Analysis

5.1. Porter's Five Force Analysis
5.2. Supply Chain Analysis
5.3. Pricing Analysis
5.4. Regulatory Analysis
5.5. Patent Analysis
5.6. PESTLE Analysis
5.7. SWOT Analysis
5.8. DMI Opinion

6. By Product Type

6.1. Introduction
- 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 6.1.2. Market Attractiveness Index, By Product Type
6.2. Instruments*
- 6.2.1. Introduction
6.3. Reagents
6.4. Software and Services

7. By Technique

7.1. Introduction
- 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technique
7.2. Market Attractiveness Index, By Technique
7.3. Immunoassays*
- 7.3.1. Introduction
- 7.3.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
7.4. POC diagnostics
7.5. Molecular diagnostics
7.6. Hematology
7.7. Tissue diagnostics
7.8. Microbiology
7.9. Self-Blood-Glucose Monitoring
7.10. Others

8. By Application

8.1. Introduction
- 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 8.1.2. Market Attractiveness Index, By Application
8.2. Infectious Diseases*
- 8.2.1. Introduction
8.3. Diabetes
8.4. Cancer/Oncology
8.5. Cardiology
8.6. Autoimmune Diseases
8.7. Nephrology
8.8. Drug Testing
8.9. Others

9. By End User

9.1. Introduction
- 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
- 9.1.2. Market Attractiveness Index, By End User
9.2. Diagnostic Laboratories*
- 9.2.1. Introduction
- 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
9.3. Hospitals
9.4. Academics and Research Institutes
9.5. Others

10. By Region

10.1. Introduction
- 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
- 10.1.2. Market Attractiveness Index, By Region
10.2. North America
- 10.2.1. Introduction
- 10.2.2. Key Region-Specific Dynamics
- 10.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technique
- 10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
- 10.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.2.7.1. The U.S.
  - 10.2.7.2. Canada
  - 10.2.7.3. Mexico
10.3. Europe
- 10.3.1. Introduction
- 10.3.2. Key Region-Specific Dynamics
- 10.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technique
- 10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
- 10.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.3.7.1. Germany
  - 10.3.7.2. UK
  - 10.3.7.3. France
  - 10.3.7.4. Italy
  - 10.3.7.5. Spain
  - 10.3.7.6. Rest of Europe
10.4. South America
- 10.4.1. Introduction
- 10.4.2. Key Region-Specific Dynamics
- 10.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technique
- 10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
- 10.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.4.7.1. Brazil
  - 10.4.7.2. Argentina
  - 10.4.7.3. Rest of South America
10.5. Asia-Pacific
- 10.5.1. Introduction
- 10.5.2. Key Region-Specific Dynamics
- 10.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technique
- 10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
- 10.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.5.7.1. China
  - 10.5.7.2. India
  - 10.5.7.3. Japan
  - 10.5.7.4. South Korea
  - 10.5.7.5. Rest of Asia-Pacific
10.6. Middle East and Africa
- 10.6.1. Introduction
- 10.6.2. Key Region-Specific Dynamics
- 10.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technique
- 10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
10.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User

11. Competitive Landscape

11.1. Competitive Scenario
11.2. Market Positioning/Share Analysis
11.3. Mergers and Acquisitions Analysis

12. Company Profiles

12.1. BioMerieux*
- 12.1.1. Company Overview
- 12.1.2. Product Portfolio and Description
- 12.1.3. Financial Overview
- 12.1.4. Key Developments
12.2. Danaher Corporation
12.3. Roche Diagnostics
12.4. Becton, Dickinson and Company
12.5. Bio-Rad Laboratories, Inc.
12.6. Abbott Laboratories
12.7. Bayer AG
12.8. Arkray, Inc
12.9. Sysmex Corporation
12.10. Siemens AG (*LIST NOT EXHAUSTIVE)