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體外診斷

市場調查報告書

商品編碼

1560785

全球體外診斷市場 - 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個工作天內

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簡介目錄

報告概述

2023年全球體外診斷市場規模達983億美元，預估至2031年將達1,457億美元，2024-2031年預測期間複合年成長率為5.3%

體外診斷 (IVD) 是一個使用人類樣本檢測疾病、病症或感染的測試領域。這些測試是在體外進行的，通常是在實驗室環境中，使用先進的儀器和試劑。 IVD 在現代醫學中至關重要，為疾病診斷、治療決策和監測患者健康狀況提供關鍵資訊。由於技術進步、全球人口老化、慢性病和個人化醫療需求，IVD 市場正在快速成長。

市場動態：

驅動程式和限制

科技進步的崛起

技術進步的興起有助於市場在預測期內成長。包括 PCR 和 NGS 在內的分子診斷可以實現早期遺傳疾病檢測，提高診斷準確性和治療效果。現場護理測試設備可以在遠端環境中實現更快的診斷和治療。 IVD 系統的自動化和數位化提高了效率，減少了人為錯誤，並提供了更準確的結果，尤其是在遠端設定中。

新型且高度準確的臨床實驗室測試的引入正在推動新型 IVD 測試在全球範圍內的採用。例如，2023 年 6 月，東麗工業公司用於診斷胰臟癌的東麗 APOA2-iTQ 獲得了日本厚生勞動省的上市許可。

此外，2023 年3 月，雅培(Abbott) 的新型實驗室創傷性腦損傷(TBI) 血液檢測獲得了美國FDA 的批准。尚未開發的市場創造新的機會。

缺乏熟練的專業人員

全球體外診斷市場面臨多項挑戰，包括嚴格的監管要求、先進診斷技術的高成本以及熟練專業人員的缺乏。這些因素可能會延遲新診斷產品的進入，並限制其在醫療保健預算有限的發展中國家的採用。總體而言，這些因素為 IVD 市場營運公司帶來了重大挑戰。

細分市場分析

全球體外診斷市場根據產品類型、技術、應用、最終用戶和地區進行細分。

該產品類型細分市場的試劑約佔體外診斷市場佔有率的41.3%

產品類型細分市場的試劑佔比約41.3%。試劑是體外診斷中檢測和量化患者樣本中生物標記的重要組成部分。它們旨在與目標分析物發生反應，從而能夠識別和測量疾病、病症或感染。試劑對於診斷檢測的準確性和可靠性至關重要，直接影響結果的敏感性和特異性。它們用於各種診斷應用，包括免疫測定、分子診斷、臨床化學和血液學。由於個人化醫療的發展和快速診斷，對高品質試劑的需求不斷增加。

例如，2023 年 10 月，美國化學品供應商 Alfa Chemistry 推出了三種實驗室使用的 IVD 產品，擴大了其生物試劑的範圍，以幫助研究透過血液或組織等樣本檢測發現的疾病。

市場地域佔有率

預計北美在整個預測期內將佔據總市場佔有率的 38.4% 左右

由於慢性病發病率上升、強大參與者的存在、新測試啟動數量的增加以及政府的支持性資金，預計北美在整個預測期內將佔據約 38.4% 的市場佔有率。

例如，2023 年 1 月，BD 和 CerTest Biotec 獲得了美國 FDA 的 EUA，用於在美國進行 Mpox 病毒檢測的 PCR 檢測。預計將推動北美市場的成長。

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)