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体外診断薬（IVD）の世界市場-2024～2031年

Global In-vitro diagnostics (IVDs) Market - 2024-2031

出版日
ページ情報
英文 176 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=145.63円
体外診断薬（IVD）の世界市場-2024～2031年
出版日: 2024年12月04日
発行: DataM Intelligence
ページ情報: 英文 176 Pages
納期: 即日から翌営業日
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  • 概要
  • 目次
概要

概要

体外診断薬（IVD）の世界市場は、2023年に862億米ドルに達し、2031年には1,398億3,000万米ドルに達すると予測され、予測期間2024年にはCAGR 6.9%で成長する見込みです。

体外診断薬（IVD）は、血液、尿、組織などの人体サンプルに対して実施される様々な医療検査を包括する広義の用語です。これらの検査は、病気の診断、健康状態のモニタリング、治療方針の決定に役立つことを目的としています。体外診断用医薬品には、検体の検査を容易にし、患者の健康状態に関する重要な情報を提供する試薬、器具、ソフトウェアシステムなどの幅広い機器が含まれます。FDAによると、体外診断用医薬品は現代医療に不可欠なツールであり、医療の専門家が病気を早期に発見し、治療の成功を評価し、患者のケアをよりよく管理することを可能にします。

慢性疾患の有病率の増加は、予測期間中の市場を牽引する要因です。例えば、汎米保健機構（Pan American Health Organization）によると、世界全体では、新たに2,000万人ががんと診断され、1,000万人ががんで死亡すると予想されています。今後20年間で、がんの負担は60％近く増加し、医療システム、個人、地域社会にさらなる負担を強いることになります。

市場力学：

促進要因と抑制要因

慢性疾患の増加

慢性疾患の有病率の増加は、世界の体外診断薬（IVD）市場の成長における重要な要因になると予想されます。慢性疾患の有病率の増加は、世界の体外診断薬（IVD）産業を牽引する重要な促進要因です。糖尿病、心血管疾患、がんはますます蔓延しており、早期発見と管理のためのより優れた診断技術が求められています。これらの疾患は継続的なモニタリングと治療が必要であるため、体外診断用医薬品（IVD）検査の需要が増加しています。高齢者は慢性疾患にかかりやすく、その結果、定期的な健康診断や診断検査の需要が高まるからです。

例えば、米国国立衛生研究所によると、2023年には米国で新たに195万8310人のがん患者が発生し、60万9820人が死亡すると予想されています。前立腺がんの罹患率は、20年間減少してきたが、2014～2019年にかけて毎年3％上昇し、新たに9万9,000人の症例が追加される結果となりました。年間がん罹患率は男女10万人当たり440.5人です（2017～2021年の症例別の）。がん死亡率（がん死亡率）は、年間男女10万人当たり146.0人（2018～2022年の死亡別の）。2024年には、0歳から19歳までの小児と青年1万4,910人ががんと診断され、1,590人が死亡すると予測されています。

さらに、国立衛生研究所によると、2型糖尿病患者は約4億6,200万人で、これは世界人口の6.28％に相当します。例えば、米国疾病予防管理センターによると、米国の人口の11.6％を占める全年齢の約3,840万人が糖尿病と診断されています。歳以上の成人では、この数字は3,810万人に上り、米国成人の14.7％を占めています。

厳しい規制要件

厳しい規制要件などの要因が、世界の体外診断薬（IVD）市場を阻害すると予想されます。厳しい規制要件は、欧州の体外診断用医療機器規制（IVDR）のような新たな法規制がもたらす合併症のために、世界の体外診断用医薬品（IVD）市場を大きく阻害すると予想されます。例えば、2022年5月に施行されたIVDRは、性能評価と市販後調査のより厳格な基準を設定することで、体外診断用医薬品の規制状況を一変させました。多くの体外診断用医薬品は、以前は適合を自己宣言することができましたが、IVDRはこれらの機器のかなりの割合を審査するようノーティファイド・オーガニゼーションに求めています。

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
      • 慢性疾患の増加
    • 抑制要因
      • 厳格な規制要件
    • 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
  • 償還分析
  • 特許分析
  • SWOT分析
  • DMIの見解

第6章 製品・サービス別

  • 機器
  • キット
  • ソフトウェア

第7章 技術別

  • 免疫測定
  • 血液検査
  • 尿検査

第8章 サンプル別

  • 血液
  • 唾液
  • 尿
  • その他

第9章 検査タイプ別

  • 臨床検査
  • ポイントオブケア検査

第10章 用途別

  • 腫瘍学
  • 自己免疫疾患
  • 感染症
  • その他

第11章 エンドユーザー別

  • 病院とクリニック
  • 診断センター
  • 学術研究機関

第12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
    • その他の欧州
  • 南米
    • ブラジル
    • アルゼンチン
    • その他の南米
  • アジア太平洋
    • 中国
    • インド
    • 日本
    • 韓国
    • その他のアジア太平洋
  • 中東・アフリカ

第13章 競合情勢

  • 競合シナリオ
  • 市況・シェア分析
  • M&A分析

第14章 企業プロファイル

  • F. Hoffmann-La Roche Ltd
  • Abbott
  • Hologic, Inc
  • Danaher Corporation
  • Bio-Rad Laboratories, Inc
  • Revvity
  • Siemens Healthcare Private Limited
  • Thermo Fisher Scientific Inc.
  • Illumina, Inc.
  • Sysmex Corporation

第15章 付録

目次
Product Code: PH1058

Overview

The global in-vitro diagnostics (IVDs) market reached US$ 86.2 billion in 2023 and is expected to reach US$ 139.83 billion by 2031, growing at a CAGR of 6.9% during the forecast period 2024-2031.

In vitro diagnostics (IVDs) is a broad term encompassing a variety of medical tests performed on human body samples such as blood, urine, and tissue. These tests are intended to help diagnose diseases, monitor health conditions, and guide treatment decisions. IVDs include a wide range of devices, such as reagents, tools, and software systems that make it easier to examine specimens and offer crucial information about a patient's health. According to the FDA, IVDs are vital tools in modern medicine, enabling healthcare practitioners to detect diseases early, assess the success of treatments, and better manage patient care.

The increasing prevalence of chronic diseases is the driving factor that drives the market over the forecast period. For instance, according to the Pan American Health Organization, globally, there were an expected 20 million new cancer diagnoses and 10 million cancer deaths. Over the next two decades, the cancer burden will rise by almost 60%, putting a further burden on healthcare systems, individuals, and communities.

Market Dynamics: Drivers & Restraints

Increasing prevalence of chronic diseases

The increasing prevalence of chronic diseases is expected to be a significant factor in the growth of the global in-vitro diagnostics (IVDs) market. The growing prevalence of chronic diseases is a significant driver driving the global in-vitro diagnostics (IVD) industry. Diabetes, cardiovascular disease, and cancer are growing increasingly prevalent, demanding better diagnostic technologies for early detection and management. As these disorders necessitate continual monitoring and treatment, the demand for IVD tests has increased. The aging population exacerbates this tendency, since older people are more susceptible to chronic illnesses, resulting in an increased demand for regular health checkups and diagnostic testing.

For instance, according to the National Institute of Health, in 2023, the United States is expected to see 1,958,310 new cancer cases and 609,820 cancer deaths. Prostate cancer incidence climbed by 3% every year from 2014 to 2019, after two decades of reduction, resulting in an additional 99,000 new cases. The annual cancer incidence rate is 440.5 per 100,000 men and women (based on cases from 2017 to 2021). The cancer death rate (cancer mortality) is 146.0 per 100,000 men and women annually (based on deaths from 2018-2022). In 2024, a projected 14,910 children and adolescents between the ages of 0 and 19 will be diagnosed with cancer, with 1,590 deaths from the condition.

Moreover, according to the National Institute of Health, approximately 462 million individuals were affected by type 2 diabetes corresponding to 6.28% of the world's population. For instance, according to the Centers for Disease Control and Prevention, approximately 38.4 million individuals of all ages, representing 11.6% of the U.S. population, were diagnosed with diabetes. Among adults aged 18 and older, this figure rose to 38.1 million, accounting for 14.7% of all U.S. adults.

Stringent Regulatory Requirements

Factors such as stringent regulatory requirements associated are expected to hamper the global in-vitro diagnostics (IVDs) market. Stringent regulatory requirements are expected to severely impede the global in-vitro diagnostics (IVD) market, owing mostly to the complications brought by new legislation such as the In Vitro Diagnostic Medical Device Regulation (IVDR) in Europe. For instance, the IVDR, which went into effect in May 2022, changed the regulatory landscape for IVDs by establishing more stringent standards for performance evaluation and post-market surveillance. Many IVDs could previously self-declare compliance, however, the IVDR requires notified organizations to review a significant percentage of these devices.

Segment Analysis

The global in-vitro diagnostics (IVDs) market is segmented based on product and service, technology, specimen, test type, application, end-user, and region.

Oncology segment is expected to dominate the global in-vitro diagnostics (IVDs) market share

The oncology category is expected to dominate the global in-vitro diagnostics (IVDs) market due to a number of compelling factors, the most prominent of which is the global increase in cancer incidence. Cancer is still one of the top causes of illness and mortality worldwide, with millions of new cases diagnosed each year. This increased frequency has created a greater demand for reliable diagnostic techniques that can aid in early detection and treatment outcomes. One of the primary causes of this expansion is the emphasis on early cancer detection, which increases the likelihood of successful treatment. Healthcare providers and groups are becoming more vocal about frequent screening and diagnostic testing, especially among high-risk populations.

The increasing prevalence of cancer is one of the major reasons making oncology the dominant segment. For instance, according to the World Health Organization (WHO), cancer diagnoses are predicted to exceed 22 million by 2023 and in the case of breast cancer, 1 in 12 women will be diagnosed with breast cancer in their lifetime and 1 in 71 women die of it. underscoring the critical need for better therapeutic strategies.

Geographical Analysis

North America is expected to hold a significant position in the global in-vitro diagnostics (IVDs) market share

North America is expected to hold a significant portion of the global in-vitro diagnostics (IVDs) market. North America is expected to have a significant part in the worldwide in-vitro diagnostics (IVDs) market, owing to its advanced healthcare infrastructure, high prevalence of chronic diseases, and presence of major diagnostic businesses. The region's solid healthcare system, which includes vast laboratory networks and powerful diagnostic technology, makes it easier for breakthrough IVD solutions to be widely adopted. This infrastructure not only supports a large volume of diagnostic testing but also allows for the rapid introduction of new technologies into clinical practice.

The rising prevalence of chronic diseases such as diabetes, cardiovascular disease, and cancer is fueling the need for IVDs in North America. For instance, according to an article published by the National Institute of Health, in 2024, 2,001,140 new cancer cases and 611,720 cancer deaths are projected to occur in the United States. Cancer mortality continued to decline through 2021, averting over 4 million deaths since 1991 because of reductions in smoking, earlier detection for some cancers, and improved treatment options in both adjuvant and metastatic settings. However, these gains are threatened by increasing incidence for 6 of the top 10 cancers.

Asia Pacific is growing at the fastest pace in the global in-vitro diagnostics (IVDs) market

Asia Pacific is experiencing the fastest growth in global in-vitro diagnostics (IVDs) owing to the increasing incidence of chronic diseases and technological advancements in the region. For instance, according to the National Institute of Health, the expected number of cancer cases in India for 2022 is 14,61,427 (crude rate: 100.4 per 100,000). In India, one out of every nine people is likely to develop cancer over his or her lifetime. Males and females were most likely to develop lung and breast cancer, respectively.

Competitive Landscape

The major global players in the global in-vitro diagnostics (IVDs) market include F. Hoffmann-La Roche Ltd, Abbott, Hologic, Inc., Danaher Corporation, Bio-Rad Laboratories, Inc., Revvity, Siemens Healthcare Private Limited, Thermo Fisher Scientific Inc., Illumina, Inc., and Sysmex Corporation among others.

Emerging Players

Genomtec, QuantiLight, and GeneSys Bio among others

Key Developments

  • In August 2024, InBios International Inc., a leading developer and manufacturer of diagnostic tests for emerging infectious diseases and biothreats announced the launching of a new in vitro serological ELISA kit for presumptive clinical laboratory diagnosis of Strongyloides infection that offers results in under 75 minutes.
  • In December 2023, Thermo Fisher Scientific announced the launch of a nucleic acid purification instrument and kit for automated viral and bacterial respiratory testing. The KingFisher Apex Dx system automates the extraction of up to 24 or 96 DNA, RNA, protein, or cell samples and transitions from clinical research to diagnostics by offering research use only (RUO) and in vitro diagnostics (IVD) software modes.

Why Purchase the Report?

  • Pipeline & Innovations: Reviews ongoing clinical trials, product pipelines, and forecasts upcoming advancements in medical devices and pharmaceuticals.
  • Product Performance & Market Positioning: Analyzes product performance, market positioning, and growth potential to optimize strategies.
  • Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.
  • Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
  • Market Updates & Industry Changes: Covers recent regulatory changes, new policies, and emerging technologies.
  • Competitive Strategies: Analyzes competitor strategies, market share, and emerging players.
  • Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.
  • Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.
  • Regional Growth & Investment: Highlights high-growth regions and investment opportunities.
  • Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient product delivery.
  • Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.
  • Post-market Surveillance: Uses post-market data to enhance product safety and access.
  • Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

The global in-vitro diagnostics (IVDs) market report would provide approximately 53 tables, 47 figures, and 176 pages.

Target Audience 2023

  • Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
  • Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
  • Technology & Innovation: AI/Robotics Providers, R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.
  • Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.
  • Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.
  • Supply Chain: Distribution and Supply Chain Managers.
  • Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.
  • Academic & Research: Academic Institutions.

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 and Service
  • 3.2. Snippet by Technology
  • 3.3. Snippet by Specimen
  • 3.4. Snippet by Test Type
  • 3.5. Snippet by Application
  • 3.6. Snippet by Region

4. Dynamics

  • 4.1. Impacting Factors
    • 4.1.1. Drivers
      • 4.1.1.1. Increasing Prevalence of Chronic Diseases
    • 4.1.2. Restraints
      • 4.1.2.1. Stringent Regulatory Requirements
    • 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. Reimbursement Analysis
  • 5.6. Patent Analysis
  • 5.7. SWOT Analysis
  • 5.8. DMI Opinion

6. By Product and Service

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

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. Immunoassay*
    • 7.2.1. Introduction
    • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 7.3. Hematology
  • 7.4. Urinalysis

8. By Specimen

  • 8.1. Introduction
    • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Specimen
    • 8.1.2. Market Attractiveness Index, By Specimen
  • 8.2. Blood*
    • 8.2.1. Introduction
    • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 8.3. Saliva
  • 8.4. Urine
  • 8.5. Others

9. By Test Type

  • 9.1. Introduction
    • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test Type
    • 9.1.2. Market Attractiveness Index, By Test Type
  • 9.2. Laboratory Tests*
    • 9.2.1. Introduction
    • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 9.3. Point-of-Care Tests

10. By Application

  • 10.1. Introduction
    • 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 10.1.2. Market Attractiveness Index, By Application
  • 10.2. Oncology*
    • 10.2.1. Introduction
    • 10.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 10.3. Autoimmune Diseases
  • 10.4. Infectious Diseases
  • 10.5. Others

11. By End-User

  • 11.1. Introduction
    • 11.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
    • 11.1.2. Market Attractiveness Index, By End-User
  • 11.2. Hospitals and Clinics*
    • 11.2.1. Introduction
    • 11.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 11.3. Diagnostic Centers
  • 11.4. Academic and Research Institutes

12. By Region

  • 12.1. Introduction
    • 12.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
    • 12.1.2. Market Attractiveness Index, By Region
  • 12.2. North America
    • 12.2.1. Introduction
    • 12.2.2. Key Region-Specific Dynamics
    • 12.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product and Service
    • 12.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
    • 12.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Specimen
    • 12.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test Type
    • 12.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 12.2.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
    • 12.2.9. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 12.2.9.1. The U.S.
      • 12.2.9.2. Canada
      • 12.2.9.3. Mexico
  • 12.3. Europe
    • 12.3.1. Introduction
    • 12.3.2. Key Region-Specific Dynamics
    • 12.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
    • 12.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Specimen
    • 12.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test Type
    • 12.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 12.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
    • 12.3.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 12.3.8.1. Germany
      • 12.3.8.2. UK
      • 12.3.8.3. France
      • 12.3.8.4. Italy
      • 12.3.8.5. Spain
      • 12.3.8.6. Rest of Europe
  • 12.4. South America
    • 12.4.1. Introduction
    • 12.4.2. Key Region-Specific Dynamics
    • 12.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
    • 12.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Specimen
    • 12.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test Type
    • 12.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 12.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
    • 12.4.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 12.4.8.1. Brazil
      • 12.4.8.2. Argentina
      • 12.4.8.3. Rest of South America
  • 12.5. Asia-Pacific
    • 12.5.1. Introduction
    • 12.5.2. Key Region-Specific Dynamics
    • 12.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
    • 12.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Specimen
    • 12.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test Type
    • 12.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 12.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
    • 12.5.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 12.5.8.1. China
      • 12.5.8.2. India
      • 12.5.8.3. Japan
      • 12.5.8.4. South Korea
      • 12.5.8.5. Rest of Asia-Pacific
  • 12.6. Middle East and Africa
    • 12.6.1. Introduction
    • 12.6.2. Key Region-Specific Dynamics
    • 12.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
    • 12.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Specimen
    • 12.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test Type
    • 12.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 12.6.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User

13. Competitive Landscape

  • 13.1. Competitive Scenario
  • 13.2. Market Positioning/Share Analysis
  • 13.3. Mergers and Acquisitions Analysis

14. Company Profiles

  • 14.1. F. Hoffmann-La Roche Ltd*
    • 14.1.1. Company Overview
    • 14.1.2. Product Portfolio and Description
    • 14.1.3. Financial Overview
    • 14.1.4. Key Developments
  • 14.2. Abbott
  • 14.3. Hologic, Inc
  • 14.4. Danaher Corporation
  • 14.5. Bio-Rad Laboratories, Inc
  • 14.6. Revvity
  • 14.7. Siemens Healthcare Private Limited
  • 14.8. Thermo Fisher Scientific Inc.
  • 14.9. Illumina, Inc.
  • 14.10. Sysmex Corporation

LIST NOT EXHAUSTIVE

15. Appendix

  • 15.1. About Us and Services
  • 15.2. Contact Us