サンプル依頼リスト カート
  • English
  • Korean
  • Traditional Chinese
  • Simplified Chinese
デフォルト表紙
市場調査レポート
商品コード
1560785

体外診断（IVD）の世界市場：2024年～2031年

Global In-Vitro Diagnostics Market - 2024 - 2031

出版日
ページ情報
英文 186 Pages
納期
即日から翌営業日
カスタマイズ可能
適宜更新あり
価格
価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=146.99円
体外診断（IVD）の世界市場：2024年～2031年
出版日: 2024年09月23日
発行: DataM Intelligence
ページ情報: 英文 186 Pages
納期: 即日から翌営業日
GIIご利用のメリット
  • 全表示
  • 概要
  • 目次
概要

レポート概要

体外診断（IVD）の世界市場は、2023年の983億米ドルから2031年には1,457億米ドルに達し、予測期間2024-2031年のCAGRで5.3%の成長が予測されています。

体外診断（IVD）とは、ヒトのサンプルを用いて病気や状態、感染症を検出するための検査分野です。これらの検査は体外で、通常は実験室で、高度な機器と試薬を用いて実施されます。体外診断（IVD）用医薬品は現代医学において極めて重要であり、病気の診断、治療方針の決定、患者の健康状態のモニタリングに重要な情報を提供しています。IVD市場は、技術の進歩、世界人口の高齢化、慢性疾患、個別化医療の需要により急速に成長しています。

市場力学：

促進要因と抑制要因

技術進歩の高まり

技術進歩の高まりは、予測期間中の市場の成長を後押しします。PCRやNGSを含む分子診断は、遺伝性疾患の早期発見を可能にし、診断精度と治療成績を向上させます。ポイントオブケア検査機器は、遠隔地での迅速な診断と治療を可能にします。IVDシステムの自動化とデジタル化により、効率が向上し、人為的ミスが減少し、特に遠隔地においてより正確な結果が得られます。

新規かつ高精度の臨床ラボ検査の導入は、世界中で新規IVD検査の採用を後押ししています。例えば、東レは2023年6月、膵臓がんの診断に使用される東レAPOA2-iTQの製造販売承認を厚生労働省から取得しました。

さらに、2023年3月には、アボット社が米国で新規のラボ用外傷性脳損傷（TBI）血液検査のFDA認可を取得しました。生命を脅かす疾患に対する体外診断（IVD）検査の承認が増加することで、未開拓の市場に新たなビジネスチャンスが生まれると期待されています。

熟練した専門家の不足

世界の体外診断（IVD）市場は、厳しい規制要件、高度な診断技術のコスト高、熟練した専門家の不足など、いくつかの課題に直面しています。これらの要因は、新しい診断製品の参入を遅らせ、医療予算が限られている発展途上国での採用を制限する可能性があります。全体として、これらの要因はIVD市場に参入する企業にとって大きな課題となっています。

市場セグメント分析

体外診断（IVD）の世界市場は、製品タイプ、技術、用途、エンドユーザー、地域によって区分されます。

製品タイプ別では、試薬が体外診断（IVD）市場シェアの約41.3%を占めています。

製品タイプ別では、試薬が約41.3%を占めています。試薬は、体外診断（IVD）において、患者検体中の生物学的マーカーを検出・定量するために不可欠なコンポーネントです。試薬は標的分析物と反応するように設計されており、疾患、状態、感染症の同定と測定を可能にします。試薬は診断検査の正確性と信頼性にとって極めて重要であり、結果の感度と特異性に直接影響します。試薬は、イムノアッセイ、分子診断、臨床化学、血液学など、さまざまな診断アプリケーションで使用されています。個別化医療の成長と迅速な診断により、高品質な試薬の需要が高まっています。

例えば、2023年10月、米国の化学品サプライヤーAlfa Chemistry社は、血液や組織などのサンプルを検査することで検出される疾病の調査を支援するため、生物学的試薬の品揃えを強化し、実験室用のIVD製品3種を発表しました。

市場の地域別シェア

北米は予測期間を通じて市場シェア全体の約38.4%を占めると予測される

北米は、慢性疾患の罹患率の上昇、強力なプレイヤーの存在、新規検査の上市数の増加、政府の資金援助などにより、予測期間を通じて市場全体の約38.4%のシェアを占めると予測されます。

例えば、2023年1月、BDとCerTest Biotecは、米国でMpoxウイルス検出のためのPCR検査について米国FDAからEUAを取得しました。さらに、糖尿病やがんなどの個別化医療のための遺伝子検査に対する要求の高まりが、北米の市場成長を促進すると予想されます。

目次

第1章 調査手法と調査範囲

第2章 定義と概要

第3章 エグゼクティブサマリー

第4章 市場力学

  • 影響要因
    • 促進要因
      • 技術の進歩
      • 慢性疾患の増加
    • 抑制要因
      • 熟練した専門家の不足
    • 機会
    • 影響分析

第5章 産業分析

  • ポーターのファイブフォース分析
  • サプライチェーン分析
  • 価格分析
  • 規制分析
  • 特許分析
  • PESTLE分析
  • SWOT分析
  • DMIオピニオン

第6章 製品タイプ別

  • 機器
  • 試薬
  • ソフトウェア・サービス

第7章 技術別

  • イムノアッセイ
  • POC診断
  • 分子診断
  • 血液学
  • 組織診断
  • 微生物学
  • 自己血糖モニタリング
  • その他

第8章 用途別

  • 感染症
  • 糖尿病
  • がん/腫瘍
  • 心臓病
  • 自己免疫疾患
  • 腎臓病
  • 薬物検査
  • その他

第9章 エンドユーザー別

  • 診断研究所
  • 病院
  • 学術・研究機関
  • その他

第10章 地域別

  • 北米
    • 米国
    • カナダ
    • メキシコ
  • 欧州
    • ドイツ
    • 英国
    • フランス
    • イタリア
    • スペイン
    • その他欧州
  • 南米
    • ブラジル
    • アルゼンチン
    • その他南米
  • アジア太平洋
    • 中国
    • インド
    • 日本
    • 韓国
    • その他アジア太平洋地域
  • 中東・アフリカ

第11章 競合情勢

  • 競合シナリオ
  • 市況/シェア分析
  • M&A分析

第12章 企業プロファイル

  • BioMerieux
    • 会社概要
    • 製品ポートフォリオと説明
    • 財務概要
    • 主な発展
  • Danaher Corporation
  • Roche Diagnostics
  • Becton, Dickinson and Company
  • Bio-Rad Laboratories, Inc.
  • Abbott Laboratories
  • Bayer AG
  • Arkray, Inc
  • Sysmex Corporation
  • Siemens AG

第13章 付録

目次
Product Code: CD1058

Report Overview

Global In Vitro Diagnostics Market reached US$ 98.3 billion in 2023 and is expected to reach US$ 145.7 billion by 2031, growing at a CAGR of 5.3% during the forecast period 2024-2031

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

UK

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

Table of Contents

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)

13. Appendix

  • 13.1. About Us and Services
  • 13.2. Contact Us