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全球体外临床测试设备市场 - 2024-2031

Global In Vitro Clinical Test Equipment Market - 2024-2031

出版日期: 2024年12月04日 | 出版商:

DataM Intelligence | 英文 184 Pages | 商品交期: 最快1-2个工作天内

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简介目录

概述

2023年，全球体外临床测试设备市场规模达795亿美元，预估至2031年将达1,206.2亿美元，2024-2031年预测期间复合年增长率为5.35%。

体外临床测试设备是指一种不同但特定的医疗设备类别，用于执行不涉及人类受试者的测试，并且主要在实验室中进行。此外，这些设备对于处理各种样本（包括血液、尿液、唾液或组织）以用于诊断、预后、治疗反应评估甚至疾病追踪的目的非常重要。

传统的体外临床测试设备几乎没有变化；然而，现代技术采用了自动化、人工智慧和连接等技术，使其成为更有效、更精确、更能适应医疗保健和研究需求以及大规模测试的技术。

市场动态：

驱动程式和限制

慢性病和传染病的盛行率不断上升

世界各地慢性病和传染病负担的不断增加是鼓励采用体外临床测试设备的主要因素之一。糖尿病、心臟病和癌症等慢性疾病需要定期观察和准确的诊断测试，以便制定最佳的治疗方案。

例如，根据世界卫生组织（WHO）报告，2022年，新诊断出近190亿癌症病例，五年内患病病例达535亿。肺癌发生人数为 24.8 亿，其次是乳癌，为 22.9 亿人。国际癌症研究机构预测，癌症发生率到2025 年将达到213 亿，到2030 年将达到241 亿。随着早期检测和诊断（包括先进的肿瘤分析技术）的进步，乳癌正在成为全球负担最重的癌症。

同时，COVID-19、流感和任何其他新产生的病原体等传染病增加了对快速有效的诊断机器的需求，以控制疫情并遏制其传播。包括分子诊断和免疫测定在内的便携式诊断测试设备也可透过提供更可靠、快速和非侵入性的诊断测试解决方案来支援公共卫生和疾病管理。

临床检测设备成本高

设备的高成本是体外临床测试设备产业发展的主要缺点之一。这些设备通常包括先进的诊断机器，例如分子或血液分析仪、自动化系统和免疫分析设备，所有这些设备由于其复杂性、技术精度以及监管机构所需的认证而需要高资本。

这些高昂的成本对于一些医疗保健提供者、实验室或最近发展的国家来说是相当不利的，因为其中一些没有必要的初始投资资本。除此之外，与这些仪器相关的备件、持续校准和日常费用也增加了成本问题。由于这种成本障碍，先进诊断方法的使用往往变得遥不可及，在欠发达或发展中地区更是如此，导致体内测试解决方案市场增长缓慢，并导致体外测试替代方案的采用率较低。

In vitro clinical test equipment denotes a different but specific category of medical equipment which is utilized in performing , tests that do not involve human subjects and are also mainly performed in a laboratory. Moreover these devices are of a great importance in the processing of various specimens including blood, urine, saliva, or tissue for the purposes of diagnosing, prognosis, treatment response assessment, or even follow-up of diseases.

The traditional in vitro clinical test equipment underwent little to no changes; however, the modern one embraces technology such as automation, artificial intelligence, and connectivity which makes it a more effective, precise, adaptable to healthcare and research demands, and mass testing technique.

Market Dynamics: Drivers & Restraints

Growing Prevalence of Chronic and Infectious Diseases

The rising burden of chronic as well as infectious diseases across the world is amongst the leading factors that encourage the uptake of in vitro clinical test equipment. Chronic ailments like diabetes, heart diseases, and cancer necessitate periodical observation as well as accurate diagnostic tests so as to formulate the best treatment procedures.

For instance, according to World Health Organization (WHO) reported that in 2022, nearly 19 billion new cancer cases were diagnosed, with 53.5 billion prevalent cases in the 5-year period. Lung cancer accounted for 2.48 billion incident cases, followed by breast cancer with 2.29 billion. The International Agency for Research on Cancer projected that cancer incidence cases will reach 21.3 billion in 2025 and 24.1 billion in 2030. Breast cancer is becoming the most burdening cancer globally, with advances in early detection and diagnosis, including advanced tumor profiling technologies, paving the way for a projected 2.7 billion incidence cases in 2030.

At the same time, communicable diseases such as COVID-19, influenza, and any other newly coined pathogens have increased the demand for quick and effective diagnosis machinery in order to control the outbreaks and curb their spread. Portable diagnostic testing devices including molecular diagnostics and immunoassays are also available to support public health and disease management by offering more reliable, rapid, and non-invasive diagnostic testing solutions.

High Cost of the Clinical Test Equipments

The high cost involved with the equipment serves as one of the primary drawbacks in the enhancement of the in vitro clinical test equipment sector. This equipment often comprises advanced diagnostic machines such as molecular or hematology analyzers, automated systems, and immunoassay equipment, all of which demand a high capital due to their complex nature, technological precisions, and the certifications needed from regulating bodies.

These high costs are quite detrimental to some health care providers, laboratories or countries with recent developments, as some of them do not have the necessary capital for the initial investment. Apart from that, the spare parts, continuous calibration, and day-to-day expenses associated with these instruments increase the cost problemati. Due to this cost hurdle, use of advanced diagnostic methods often becomes out of reach, more so is in under developed or developing regions causing slow growth in the market for in vivo test solutions and resulting in low uptake of in vitro testing alternatives.

Segment Analysis

The global In vitro clinical test equipment market is segmented based on product type, technology, application, end user, and region.

Product Type:

Analyzers segment is expected to dominate the In vitro clinical test equipment market share

The analyzers segment holds a major portion of the In vitro clinical test equipment market share and is expected to continue to hold a significant portion of the In vitro clinical test equipment market share during the forecast period.

Analyzers are crucial tools in the global in vitro clinical test equipment market, aiding in the diagnosis and monitoring of various diseases and health conditions. They process biological samples like blood, urine, and tissues to detect biomarkers, pathogens, or abnormalities. Modern analyzers offer high throughput, reduce human error, and improve laboratory workflow efficiency. They are essential in managing chronic diseases, detecting infections, and monitoring treatment effectiveness, driving their adoption in hospitals, diagnostic labs, and research settings. Their versatility and ability to provide rapid results make analyzers a cornerstone of the in vitro diagnostic landscape.

For instance, in January 2024, HORIBA Medical has introduced the HELO 2.0 high throughput automated hematology platform, CE-IVDR approved and pending US FDA approval. This new generation high-end hematology range, designed in consultation with customers, offers a flexible, efficient, and scalable modular solution for mid to large-scale laboratories, offering a flexible and efficient solution for high throughput automated hematology.

Molecular Diagnostics segment is the fastest-growing segment in the In vitro clinical test equipment market share

The molecular diagnostics segment is the fastest-growing segment in the In vitro clinical test equipment market share and is expected to hold the market share over the forecast period.

The molecular diagnostics segment is a significant player in the global in vitro clinical test equipment market due to its ability to provide accurate, rapid, and sensitive disease detection at genetic and molecular levels. This includes advanced technologies like PCR, NGS, and molecular assays, which are crucial for detecting infectious diseases, genetic disorders, and cancer biomarkers. The demand for personalized medicine and precision diagnostics is driving the expansion of molecular diagnostics, enabling targeted therapies based on individual genetic profiles. The increasing prevalence of infectious diseases, like COVID-19, has further accelerated the need for molecular diagnostic tools. The segment continues to grow with continuous technological advancements enhancing the accuracy, efficiency, and affordability of in vitro clinical tests.

For instance, in April 2023, ELITech Group has announced the launch of a new high-throughput sample-to-result instrument for molecular diagnostics. The company, which introduced the ELITe InGenius in 2016, has since expanded its menu to over 50 CE-IVD parameters and validated over 20 sample matrices. BeGenius, launched in 2021, is designed for laboratories requiring higher throughput. Over 1100 instruments have been installed globally, and ELITech MDx is committed to transitioning its entire portfolio of CE-IVD parameters to IVDR.

Geographical Analysis

North America is expected to hold a significant position in the In vitro Clinical Test Equipment market share

North America holds a substantial position in the In vitro Clinical Test Equipment market and is expected to hold most of the market share due to the advanced healthcare infrastructure, high healthcare spending, and a strong emphasis on research and development. The US, with its leading medical device manufacturers, research institutions, and hospitals, drives demand for advanced diagnostic technologies. The region's regulatory environment and strict quality standards by agencies like the FDA ensure high-quality in vitro diagnostic equipment.

Moreover, the rising prevalence of chronic diseases, personalized medicine, early detection, and prevention also contribute to the expanding use of in vitro diagnostic tools in North America. The ongoing efforts to combat infectious diseases like COVID-19 further emphasize the importance of molecular diagnostics and in vitro testing solutions, making the North American market a vital hub for innovation and growth.

For instance, in November 2024, Veracyte has signed a multi-year agreement with Illumina to develop and offer high-performing molecular tests as decentralized in vitro diagnostic (IVD) tests on Illumina's NextSeq 550Dx next-generation sequencing instrument. This is part of Veracyte's expanded, multi-platform IVD approach, which includes qPCR, and aims to make its tests available to more patients globally.

Europe is growing at the fastest pace in the In vitro Clinical Test Equipment market

Europe holds the fastest pace in the In vitro Clinical Test Equipment market and is expected to hold most of the market share due to the increasing prevalence of chronic diseases, well-established healthcare infrastructure, significant investments in research and development, and a strong regulatory framework. This has led to increased demand for advanced diagnostic tools, boosting market confidence and adoption. The aging population in many European countries also intensifies the need for efficient and early diagnostic methods. The presence of leading medical device industry players and high awareness and healthcare expenditure continue to fuel market growth in this region.

Competitive Landscape

The major global players in the In vitro clinical test equipment market include Abbott Laboratories, Roche Diagnostics, Thermo Fisher Scientific, Siemens Healthineers, Danaher Corporation (Beckman Coulter, Cepheid), Mindray Bio-Medical Electronics Co., Ltd, Trivitron Healthcare, GenScript and among others.

Emerging Players

The emerging players in the In vitro clinical test equipment market include PerkinElmer Inc, Agilent Technologies, Inc, Sysmex Corporation and among others.

Key Developments

In September 2023, NeoDx Biotech Labs has introduced a Real-time PCR-Technology-based in vitro diagnostic kit for Ankylosing Spondylitis, enhancing healthcare services' testing capabilities. The kit, HLA-B27 RT-PCR detection kit for Exon 2/Exon 3, detects Human Leukocyte Antigen B27 in whole blood, a key factor in inflammatory disorders like Ankylosing Spondylitis, Psoriasis, Inflammatory Bowel Disease, and Reactive Arthritis, aiding early diagnosis and treatment.

Why Purchase the Report?

To visualize the global In vitro clinical test equipment market segmentation based on product type, technology, application, end user and region and 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 clinical test equipment market with all segments.
PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
Product mapping is available in excel consisting of key products of all the major players.

The global In vitro clinical test equipment market report would provide approximately 70 tables, 65 figures, and 184 pages.

Target Audience 2023

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 Technology
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. Growing Prevalence of Chronic and Infectious Diseases
4.2. Restraints
4.3. Opportunity
- 4.3.1. 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

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. Analyzers*
- 6.2.1. Introduction
- 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
6.3. Consumables
6.4. Software and Services

7. By Technology

7.1. Introduction
- 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 7.1.2. Market Attractiveness Index, By Technology
7.2. Clinical Chemistry*
- 7.2.1. Introduction
- 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
7.3. Molecular Diagnostics
7.4. Immunoassays
7.5. Point-of-Care Testing (POCT)
7.6. 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 Disease Testing*
- 8.2.1. Introduction
- 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
8.3. Cancer Diagnostics
8.4. Cardiology Testing
8.5. Endocrinology Testing
8.6. Nephrology Testing
8.7. 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. Hospitals and Clinics*
- 9.2.1. Introduction
- 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
9.3. Diagnostic Laboratories
9.4. Academic and Research Institutes
9.5. Homecare Settings
9.6. 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 Technology
- 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. 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 Technology
- 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. U.K.
  - 10.3.7.3. France
  - 10.3.7.4. Spain
  - 10.3.7.5. Italy
  - 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 Technology
- 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 Technology
- 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 Technology
- 10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.6.6. 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. Abbott Laboratories*
- 12.1.1. Company Overview
- 12.1.2. Product Portfolio and Description
- 12.1.3. Financial Overview
- 12.1.4. Key Developments
12.2. Roche Diagnostics
12.3. Thermo Fisher Scientific
12.4. Siemens Healthineers
12.5. Danaher Corporation (Beckman Coulter, Cepheid)
12.6. Mindray Bio-Medical Electronics Co., Ltd
12.7. Trivitron Healthcare
12.8. GenScript

LIST NOT EXHAUSTIVE