体外診断市場：製品タイプ別、用途別、エンドユーザー別、地域別、2026～2032年

体外診断市場の評価-2026～2032年

体外診断（IVD）市場は、疾病の早期発見を重視することで、ヘルスケア成果の向上とコスト削減に貢献しています。このため、早期発見が重視されるようになり、市場規模は急拡大し、2024年には1,089億7,000万米ドルを超え、2032年には1,633億4,000万米ドルの評価額に達します。

個々の患者のプロファイルに合わせた治療を行う個別化医療への需要の高まりも、IVDソリューションの採用を加速させています。このように、個別化医療へのシフトにより、市場は2026～2032年にかけてCAGR 5.19%で成長します。

体外診断市場定義/概要

体外診断は、血液、尿、組織などの生体サンプルに対して診断テストを実施し、様々な疾患や健康状態を特定・モニタリングするために不可欠な医療機器です。これらの検査は、感染症、自己免疫疾患、その他の病状を検出する上で重要な役割を果たしており、個々の患者の薬剤療法を調整・最適化するために使用されることが多くなっています。IVD産業における重要な動向は分子診断学の成長です。分子診断学は、遺伝物質、タンパク質、その他の分子を分析し、高精度で病気を診断・管理することに焦点を当てています。

分子診断学、特にゲノミクスとプロテオミクスの進歩は、特定の遺伝子変異や特定の疾患に関連するバイオマーカーの検出を可能にし、体外診断の能力を一変させました。この治療法の開発により、より正確で個人に合わせた診断が可能になり、個別化された治療計画の開発につながります。分子診断学は、腫瘍学、感染症、遺伝性疾患などの重要なセグメントにおける疾病管理に大きな影響を与えており、疾病マーカーの正確な同定は個別化された治療アプローチの指針となります。体外診断のセグメントにおける分子診断の継続的な拡大は、早期診断、十分な情報に基づいた意思決定、患者の転帰の改善をサポートし、ヘルスケアの飛躍的進歩を意味します。

高齢者の増加と慢性疾患の増加は体外診断市場の成長をどのように押し上げるか？

高齢化人口の増加と慢性疾患の増加が体外診断市場の成長を加速させています。WHOは、2020～2023年の間に60歳以上の高齢者の割合が14億人に増加すると報告しています。国連のWorld Population Prospects 2022によると、2050年までに世界の6人に1人が65歳以上になるといいます。この層は、より頻繁な診断検査と疾病モニタリングを必要とします。CDCは2022年、アメリカの成人の10人に6人が少なくとも1つの慢性疾患に罹患していると報告しました。国際糖尿病連合によると、2021年には世界中で約5億3,700万人の成人が糖尿病に罹患しています。米国心臓協会は、2021年には米国成人の48％が何らかの心血管系疾患に罹患していると発表しました。FDAは2020～2022年の間に120以上の新しい体外診断検査と装置を承認しました。ポイントオブケア検査市場は2020～2023年にCAGR15%となりました。分子診断薬セグメントはパンデミック期（2020～2021年）に30%成長

WHOの推定によると、2021年には世界で20億件を超えるCOVID-19検査が実施されました。世界の分子診断市場は2022年に362億米ドルに達しました。CDCの報告によると、COVID-19検査のインフラは他の感染症検査のための検査室の能力を40%向上させました。米国のヘルスケア支出は2021年に4兆3,000億米ドルに達しました。WHOの報告によると、世界のヘルスケア支出は2020～2022年にかけて11%増加しました。メディケアの診断検査への支出は2020～2022年にかけて23%増加しました。

機器とメンテナンスの高コストは体外診断市場の成長をどのように阻害するか？

機器とメンテナンスのコストが高いことが体外診断市場の成長を妨げています。ハイエンド分子診断システムの平均コストは、2022年時点で10万～50万米ドルです。年間保守費用は通常、初期機器購入価格の10～15％を占めます。2022年のヘルスケアコスト分析によると、小規模検査室ではIVD装置のメンテナンスに年間約15万～20万米ドルを費やしています。また、熟練労働者の不足も市場成長の妨げとなっています。米国臨床検査学会は、2022年の検査室の欠員率は7%であると報告しています。労働統計局によると、2022年には約2万5,000人の検査技師が不足するといいます。臨床検査技師一人当たりの訓練費用は、2021年には平均40,000～6万米ドルでした。

産業における厳しい規制要件と償還の課題は、市場課題として作用します。FDAの報告によると、2022年の体外診断の承認にかかる平均期間は9～12ヶ月でした。規制遵守コストは2020～2022年にかけて25%増加しました。企業は2022年にIVD機器1台あたり平均25万～50万米ドルを規制当局への提出に費やします。メディケアは2022年に特定の診断検査の償還率を15～20％引き下げます。CMSのデータによると、臨床検査報酬は2020～2022年にかけて平均10%減少しました。診断検査の保険請求拒否は、2020年と比較して2021年に23％増加しました。

目次

第1章 世界の体外診断市場の導入

• 市場概要
• 調査範囲
• 前提条件

第2章 エグゼクティブサマリー

第3章 VERIFIED MARKET RESEARCHの調査手法

• データマイニング
• バリデーション
• 一次資料
• データソース一覧

第4章 世界の体外診断市場展望

• 概要
• 市場力学
  • 促進要因
  • 抑制要因
  • 機会
• ポーターのファイブフォースモデル
• バリューチェーン分析

第5章 体外診断の世界市場：製品タイプ別

• 概要
• 試薬・キット
• 器具
• サービス

第6章 体外診断の世界市場：用途別

• 概要
• 感染症
• 腫瘍学
• 糖尿病
• 循環器

第7章 体外診断の世界市場：エンドユーザー別

• 概要
• 病院クリニック
• 診断ラボ
• 研究機関
• 在宅医療環境

第8章 体外診断の世界市場：地域別

• 概要
• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • その他の欧州
• アジア太平洋
  • 中国
  • 日本
  • インド
  • その他のアジア太平洋
• その他
  • ラテンアメリカ
  • 中東・アフリカ

第9章 世界の体外診断市場の競合情勢

• 概要
• 各社の市場ランキング
• 主要開発戦略

第10章 企業プロファイル

• Abbott Laboratories
• Roche Diagnostics
• Siemens Healthineers AG
• Danaher Corporation
• Thermo Fisher Scientific, Inc.
• Johnson & Johnson
• Becton, Dickinson and Company
• Sysmex Corporation
• Merck KGaA
• bioMerieux

第11章 主要開発

• 製品上市/開発
• 合併と買収
• 事業拡大
• パートナーシップと提携

第12章 付録

• 関連調査

In Vitro Diagnostics Market Valuation - 2026-2032

A strong emphasis on early disease detection is a major driver in the in-vitro diagnostics (IVD) market, contributing to improved healthcare outcomes and reduced costs. Thus, the growing emphasis on early detection surged the growth of the market size, surpassing USD 108.97 Billion in 2024 to reach a valuation of USD 163.34 Billion by 2032.

The rising demand for personalized medicine, which tailors treatment to individual patient profiles, has also accelerated the adoption of IVD solutions. Thus, the shift toward personalized care enables the market to grow at a CAGR of 5.19% from 2026 to 2032.

In Vitro Diagnostics Market: Definition/ Overview

In-vitro diagnostics (IVD) are essential medical devices that conduct diagnostic tests on biological samples, including blood, urine, and tissue, to identify and monitor various diseases and health conditions. These tests play a vital role in detecting infectious diseases, autoimmune disorders, and other medical conditions, and they are increasingly used to adjust and optimize drug therapies for individual patients. A significant trend in the IVD industry is the growth of molecular diagnostics, which focuses on analyzing genetic material, proteins, and other molecules to diagnose and manage diseases with high precision.

Advancements in molecular diagnostics, particularly within genomics and proteomics, have transformed IVD capabilities by enabling the detection of specific gene mutations and biomarkers linked to particular diseases. This progress allows for more accurate and tailored diagnoses, leading to the development of personalized treatment plans. Molecular diagnostics has profoundly impacted disease management in critical areas like oncology, infectious diseases, and genetic disorders, where precise identification of disease markers can guide individualized treatment approaches. The ongoing expansion of molecular diagnostics within the IVD field represents a leap forward in healthcare, supporting early diagnosis, informed decision-making, and improved patient outcomes.

How do the Increasing Geriatric Population and Rising Chronic Diseases Surge the Growth of In Vitro Diagnostics Market?

The increasing aging population and growing chronic disorders cases surge the growth of in vitro diagnostics market. The WHO reported that between 2020 and 2023, the proportion of people aged 60+ years increased to 1.4 billion. According to the UN's World Population Prospects 2022, by 2050, 1 in 6 people worldwide will be over 65 years old. This demographic requires more frequent diagnostic testing and disease monitoring. The CDC reported in 2022 that 6 in 10 American adults have at least one chronic disease. Diabetes affected approximately 537 million adults worldwide in 2021 according to the International Diabetes Federation. The American Heart Association stated that 48% of US adults had some form of cardiovascular disease in 2021. The FDA approved over 120 new IVD tests and devices between 2020-2022. The point-of-care testing market saw a 15% CAGR from 2020-2023. Molecular diagnostics segment grew by 30% during the pandemic period (2020-2021)

Over 2 billion COVID-19 tests were performed globally in 2021 according to WHO estimates. The global molecular diagnostics market reached USD 36.2 Billion in 2022. CDC reported that COVID-19 testing infrastructure improved laboratory capabilities for other infectious disease testing by 40%. The US healthcare spending reached USD 4.3 Trillion in 2021. The WHO reported global healthcare spending grew by 11% between 2020 and 2022. Medicare spending on diagnostic testing increased by 23% from 2020 to 2022.

How do the High Costs of Equipment and Maintenance Impede the Growth of In Vitro Diagnostics Market?

The high cost of equipment and maintenance hamper the growth of the in vitro diagnostics market. The average cost of a high-end molecular diagnostic system ranges from $100,000 to $500,000 as of 2022. Annual maintenance costs typically represent 10-15% of the initial equipment purchase price. According to a 2022 healthcare cost analysis, smaller laboratories spend approximately $150,000-$200,000 annually on IVD equipment maintenance. Also, the lack of skilled labor hinders market growth. The American Society for Clinical Laboratory Science reported a 7% vacancy rate for laboratory positions in 2022. According to the Bureau of Labor Statistics, there was a shortage of approximately 25,000 laboratory professionals in 2022. Training costs per laboratory technician averaged $40,000-$60,000 in 2021.

The stringent regulatory requirements and the reimbursement challenges in the industry act as a challenge for the market. FDA reported that the average time for IVD device approval increased to 9-12 months in 2022. Regulatory compliance costs increased by 25% between 2020 and 2022. Companies spent an average of $250,000-$500,000 per IVD device for regulatory submissions in 2022. Medicare reduced reimbursement rates for certain diagnostic tests by 15-20% in 2022. According to CMS data, laboratory test reimbursements decreased by an average of 10% between 2020-2022. Insurance claim denials for diagnostic tests increased by 23% in 2021 compared to 2020

Category-Wise Acumens

How the Precise and Efficient Diagnostic Test Surge the Growth of Reagents & Kits Segment?

The reagents & kits segment dominates the in vitro diagnostics (IVD) market owing to their vital role in performing accurate and efficient diagnostic tests. These products are essential for identifying and measuring biomarkers, pathogens, and other analytes across a range of biological samples, making them indispensable in diagnostics. A notable example of innovation within this segment occurred in February 2022, when Invitae Corporation introduced its CE-IVD-certified cancer testing kits, FusionPlex Dx and LiquidPlex Dx, in Europe. These advanced kits are tailored to enhance precision oncology, enabling more reliable cancer detection and management solutions, which respond to the increasing demand for effective diagnostic tools in the European healthcare market.

With continuous advancements and product launches, the Reagents & Kits segment reinforces its importance within the IVD field. Such innovations drive market growth and support the broader shift toward personalized medicine, which seeks to improve patient outcomes by providing tailored diagnostic and treatment options. By facilitating high-quality diagnostics, reagents and kits contribute significantly to expanding possibilities for individualized patient care, reinforcing their position as a cornerstone in the evolving IVD landscape.

How the Growing Prevalence of Infectious Disease Foster the Growth of Infectious Diseases Segment?

The infectious diseases segment holds a dominant in the in vitro diagnostics (IVD) market, driven by the increasing prevalence of infectious diseases such as HIV, tuberculosis, influenza, and hepatitis. The global demand for early and accurate diagnostics has grown significantly as healthcare systems prioritize rapid identification and treatment of these diseases to prevent widespread transmission. Moreover, the need for swift diagnostics and large-scale screening is amplified by government initiatives focused on controlling outbreaks and reducing disease impact. This focus has bolstered investment and innovation within the infectious disease diagnostics space.

With a particular emphasis on diseases like hepatitis, pneumonia, HIV-AIDS, and tuberculosis. As the incidence of these conditions rises globally, key industry players are accelerating efforts to develop innovative diagnostic systems designed to improve the speed, accuracy, and accessibility of testing. These advancements address the rising infectious disease burden and support effective response measures in urban and remote healthcare settings. As a result, the infectious diseases segment continues to play a pivotal role in the IVD landscape, addressing public health needs and reinforcing its dominance through ongoing technological progress and strategic initiatives.

Country/Region-wise Acumens

How the Substantial Healthcare Expenditure and Robust Infrastructure Surge the Growth of In Vitro Diagnostic Market in North America?

North America substantially dominates the in vitro diagnostic market driven by the high healthcare expenditure & advanced healthcare infrastructure. According to the Centers for Medicare & Medicaid Services, U.S. healthcare spending reached USD 4.3 Trillion in 2021, representing 18.3% of GDP. According to the American Hospital Association, as of 2022, there were over 6,000 hospitals in the U.S. with sophisticated diagnostic laboratories. Canada's healthcare spending exceeded USD 300 Billion in 2021, with significant investments in diagnostic infrastructure.

In addition, the rising prevalence of chronic diseases also contributes to the growth of in vitro diagnostics market. According to the CDC (2022), 6 in 10 Americans live with at least one chronic disease. According to the report of National Diabetes Statistics diabetes affected approximately 37.3 million Americans (11.3% of the population) in 2022. Cancer diagnoses in the U.S. were projected to reach 1.9 million new cases in 2023.

The growing elderly population requiring regular diagnostics propels the adoption of the in vitro diagnostics market in the region. The U.S. population aged 65 and older grew from 54.1 million in 2019 to nearly 57 million in 2021. By 2030, all baby boomers will be 65 or older, expanding the elderly population to 73 million. Medicare spending on clinical laboratory services reached USD 9.2 Billion in 2020.

How Does the High Population in the Region with Disease Burden Accelerate the Growth of the In Vitro Diagnostic Market in the Asia Pacific?

Asia Pacific is anticipated to witness the fastest growth in the in vitro diagnostic market during the forecast period owing to the large population base with a high disease burden. China and India together account for approximately 2.8 billion people (36% of the global population) as of 2022. In 2021, China reported 4.07 million new cancer cases with growing demand for early diagnostics. India recorded over 77 million diabetes cases in 2021, the second highest globally.

In addition, the rising healthcare expenditure & infrastructure development propel the growth of the market. China's healthcare spending reached 7.12 trillion yuan (USD 1.1 Trillion) in 2021, rising 13.5% from 2020. Japan's healthcare expenditure increased to 44.2 trillion yen (USD 333 Billion) in 2021. India allocated USD 10.6 Billion for healthcare infrastructure in the 2022-23 budget, with a significant focus on diagnostic capabilities

Also, the growing aging population & chronic disease management enhance the growth of market growth. According to the Statistics Bureau of Japan. Japan's elderly population (65+ years) reached 29.1% of total population in 2021. South Korea's elderly population is expected to reach 20.3% by 2025. China's 60+ population exceeded 267 million in 2021 (National Bureau of Statistics), creating increased demand for diagnostic services.

Competitive Landscape

The In Vitro Diagnostics (IVD) Market is a highly competitive landscape dominated by a few major players and numerous smaller, specialized companies. Key factors driving competition include technological advancements, regulatory approvals, product innovation, and strategic partnerships.

The organizations are focusing on innovating their product line to serve the vast population in diverse regions. Some of the prominent players operating in the in vitro diagnostics market include:

• Abbott Laboratories
• Roche Diagnostics
• Siemens Healthineers AG
• Danaher Corporation
• Thermo Fisher Scientific, Inc.
• Johnson & Johnson
• Becton, Dickinson and Company
• Sysmex Corporation
• Merck KGaA
• bioMerieux

Latest Developments:

• In January 2023, Qiagen, a European business, announced the launch of EZ2 Connect MDx IVD, an automated sample platform for diagnostic laboratories.
• In September 2022, ADSTEC and its subsidiary ADS Biotec, a market player in automated instrument development, announced that their HANABI Cytogenetic Automation Instruments had received CE marking under the European Union In Vitro Diagnostic Medical Device Directive (IVDD) 98/79/EC.

In Vitro Diagnostics Market, By Category

• Product Type:
• Reagents & Kits
• Instruments
• Services
• Application:
• Infectious Diseases
• Oncology
• Diabetes
• Cardiology
• End-User:
• Hospital & Clinics
• Diagnostic Laboratories
• Research Institutes
• Home care settings
• Region:
• North America
• Europe
• Asia-Pacific
• South America
• Middle East & Africa

TABLE OF CONTENTS

1 INTRODUCTION OF GLOBAL IN VITRO DIAGNOSTICS MARKET

• 1.1 Overview of the Market
• 1.2 Scope of Report
• 1.3 Assumptions

2 EXECUTIVE SUMMARY

3 RESEARCH METHODOLOGY OF VERIFIED MARKET RESEARCH

• 3.1 Data Mining
• 3.2 Validation
• 3.3 Primary Interviews
• 3.4 List of Data Sources

4 GLOBAL IN VITRO DIAGNOSTICS MARKET OUTLOOK

• 4.1 Overview
• 4.2 Market Dynamics
  • 4.2.1 Drivers
  • 4.2.2 Restraints
  • 4.2.3 Opportunities
• 4.3 Porters Five Force Model
• 4.4 Value Chain Analysis

5 GLOBAL IN VITRO DIAGNOSTICS MARKET, BY PRODUCT TYPE

• 5.1 Overview
• 5.2 Reagents & Kits
• 5.3 Instruments
• 5.4 Services

6 GLOBAL IN VITRO DIAGNOSTICS MARKET, BY APPLICATION

• 6.1 Overview
• 6.2 Infectious Diseases
• 6.3 Oncology
• 6.4 Diabetes
• 6.5 Cardiology

7 GLOBAL IN VITRO DIAGNOSTICS MARKET, BY END-USER

• 7.1 Overview
• 7.2 Hospital & Clinics
• 7.3 Diagnostic Laboratories
• 7.4 Research Institutes
• 7.5 Home care settings

8 GLOBAL IN VITRO DIAGNOSTICS MARKET, BY GEOGRAPHY

• 8.1 Overview
• 8.2 North America
  • 8.2.1 U.S.
  • 8.2.2 Canada
  • 8.2.3 Mexico
• 8.3 Europe
  • 8.3.1 Germany
  • 8.3.2 U.K.
  • 8.3.3 France
  • 8.3.4 Rest of Europe
• 8.4 Asia Pacific
  • 8.4.1 China
  • 8.4.2 Japan
  • 8.4.3 India
  • 8.4.4 Rest of Asia Pacific
• 8.5 Rest of the World
  • 8.5.1 Latin America
  • 8.5.2 Middle East and Africa

9 GLOBAL IN VITRO DIAGNOSTICS MARKET COMPETITIVE LANDSCAPE

• 9.1 Overview
• 9.2 Company Market Ranking
• 9.3 Key Development Strategies

10 COMPANY PROFILES

• 10.1 Abbott Laboratories
  • 10.1.1 Overview
  • 10.1.2 Financial Performance
  • 10.1.3 Product Outlook
  • 10.1.4 Key Developments
• 10.2 Roche Diagnostics
  • 10.2.1 Overview
  • 10.2.2 Financial Performance
  • 10.2.3 Product Outlook
  • 10.2.4 Key Developments
• 10.3 Siemens Healthineers AG
  • 10.3.1 Overview
  • 10.3.2 Financial Performance
  • 10.3.3 Product Outlook
  • 10.3.4 Key Developments
• 10.4 Danaher Corporation
  • 10.4.1 Overview
  • 10.4.2 Financial Performance
  • 10.4.3 Product Outlook
  • 10.4.4 Key Developments
• 10.5 Thermo Fisher Scientific, Inc.
  • 10.5.1 Overview
  • 10.5.2 Financial Performance
  • 10.5.3 Product Outlook
  • 10.5.4 Key Developments
• 10.6 Johnson & Johnson
  • 10.6.1 Overview
  • 10.6.2 Financial Performance
  • 10.6.3 Product Outlook
  • 10.6.4 Key Developments
• 10.7 Becton, Dickinson and Company
  • 10.7.1 Overview
  • 10.7.2 Financial Performance
  • 10.7.3 Product Outlook
  • 10.7.4 Key Developments
• 10.8 Sysmex Corporation
  • 10.8.1 Overview
  • 10.8.2 Financial Performance
  • 10.8.3 Product Outlook
  • 10.8.4 Key Developments
• 10.9 Merck KGaA
  • 10.9.1 Overview
  • 10.9.2 Financial Performance
  • 10.9.3 Product Outlook
  • 10.9.4 Key Developments
• 10.10 bioMerieux
  • 10.10.1 Overview
  • 10.10.2 Financial Performance
  • 10.10.3 Product Outlook
  • 10.10.4 Key Developments

11 KEY DEVELOPMENTS

• 11.1 Product Launches/Developments
• 11.2 Mergers and Acquisitions
• 11.3 Business Expansions
• 11.4 Partnerships and Collaborations

12 Appendix

• 12.1 Related Research