한글목차

체외진단(IVD) 부문은 현대 헬스케어의 초석으로, 임상의에게 질병을 발견하고, 건강 상태를 모니터링하며, 정확한 치료 결정을 내릴 수 있는 도구를 제공하고 있습니다.

샘플

헬스케어의 발전과 함께 IVD 시장은 혁신적인 성장세를 보이고 있습니다. 당뇨병, 심혈관질환과 같은 만성질환의 유병률이 증가하고, COVID-19 및 신종 감염병과 같은 전염병의 위협이 지속됨에 따라 혁신적인 진단 솔루션에 대한 수요가 그 어느 때보다 높아지고 있습니다.

본 보고서는 격월간으로 연 6회 발행되며, 각 호는 IVD 산업의 다양한 부문에 특화된 시장 데이터 및 예측, 종합적인 시장 전망, M&A 활동, 산업별, 지역별 동향 등을 정리하고 있습니다.

목차

시장 분석 : 심장 바이오마커 검사

• 심장 바이오마커 개요

시장 전망

• 지역 시장
• 회사개요
  • Abbott Diagnostics
  • Beckman Coulter
  • Siemens
• 벤더 시장 점유율

이그제큐티브 뉴스 브리핑

재무 하이라이트 : BECTON DICKINSON, NATERA

진단 시장 합병, 인수, 파트너십 계약

• 파트너십과 협업
• 합병 및 인수합병

산업별 동향

• 산업별 동향 : COVID-19/독감 최신 정보

지역별 동향

• 멕시코

광범위한 기업 발표

• 공지사항
  • Roche, 질량 분석 시스템 CE 마크 획득
  • QIAGEN, 5개 표적 증후군 패널 FDA 승인 획득
  • Revvity, 무료 테스토스테론 검사에 대한 FDA 승인 획득
  • Spear Bio, FDA 획기적 의료기기 지정 획득
  • Roche, B세포 림프종에 대한 최초의 ISH 검사 승인 발표
  • Roche, FDA로부터 추가 승인 획득

영문목차

The in vitro diagnostics (IVD) sector stands as a cornerstone of modern healthcare, empowering clinicians with the tools to detect diseases, monitor health conditions, and guide precise treatment decisions.

SAMPLE VIEW

As healthcare evolves, the IVD market is poised for transformative growth. With the rising prevalence of chronic conditions such as diabetes and cardiovascular diseases, as well as ongoing threats from infectious diseases like COVID-19 and emerging variants, the demand for innovative diagnostic solutions has never been greater.

"In Vitro Diagnostics Business Outlook" is a bimonthly publication, delivering six issues annually, each dedicated to a different segment of the IVD industry. It provides exclusive insights and data, including:

• Market Data and Forecasts: Detailed growth rates, market size, and market share to identify new opportunities.
• Comprehensive Market View: Coverage of test categories and company profiles.
• M&A Activities: Updates on mergers, acquisitions, partnerships, and collaborations.
• Industry & Region Watch: Tailored strategies based on regional and industry-specific trends.
• News Analysis: In-depth reporting on significant news and events, including exclusive information not readily available elsewhere.

TABLE OF CONTENTS

MARKET ANALYSIS: CARDIAC BIOMARKER TESTING

• OVERVIEW OF CARDIAC BIOMARKERS
• MARKET OUTLOOK
  • Figure: Cardiac Marker Testing Market by End User, 2024-2029 ($ million) (Lab-based, POC-based)
  • Table: Cardiac Marker Diagnostic Sales by End User, 2024-2029 ($ million) (Lab-based, POC-based)
  • Figure: Cardiac Marker Testing Market by End User and Total Value Over Time, 2019-2029 ($ million) (Lab-based, PoC-based)
  • Figure: Cardiac Marker Testing Market, by Marker, 2024 (% Share) (Troponin, BNP, CK-MB, Myoglobin, Other)
• REGIONAL MARKET
  • Table: Cardiac Marker Test Sales Distribution by Global Region, 2024 (%) (Asia Pacific, Europe, North America, RoW)
• COMPANY BRIEFS
  • Abbott Diagnostics
  • Beckman Coulter
  • Siemens
• VENDOR MARKET SHARE
  • Figure: Market Share of Leading Vendors in the Cardiac Marker Segment, by Company, 2024 (%) (Abbott, Danaher, QuidelOrtho, Roche, Siemens, Others)

EXECUTIVE NEWS BRIEFING

• BRIEFS
  • Senseera Closes $7.1 Million in Funding Round
  • Geneoscopy Closes Series C Funding
  • Oxford Cancer Analytics Raises $11 Million in Series A Funding
  • MiRXES Nabs $40 Million in Financing
  • Tethis Nabs Euro-15 Million Funding

FINANCIAL HIGHLIGHTS: BECTON DICKINSON, NATERA

• BECTON DICKINSON REPORTS 4% REVENUE GROWTH IN FISCAL 2024
  • Table: Becton Dickinson Financial Review, by Business Segment, FY 2022-FY 2024 ($ million) (BD Medical, BD Life Sciences, BD Interventional)
  • Figure: Becton Dickinson Business Division Performance, by Business Segment, FY 2022-FY 2024 ($ million) (BD Medical, BD Life Sciences, BD Interventional)
  • Figure: BD Life Sciences Division, Segment Mix, FY 2020 vs. FY 2024 (%) (Integrated Diagnostic Solutions, Biosciences)
  • Figure: Becton Dickinson U.S./International Revenue Distribution, FY 2022-FY 2024 ($ million)
  • Figure: Becton Dickinson Revenue Distribution, by Region, FY 2024 (%) (EMEA, Greater Asia, United States, Other)
• NATERA CONTINUES OVERALL GROWTH TREND WITH PRELIMINARY 2024 RESULTS, EXPECTING A 56% INCREASE OVER 2023
  • Figure: Natera Financial Overview by Quarter, Q1 2023-Q4 2024* ($ million)

DIAGNOSTIC MARKET MERGERS, ACQUISITIONS, AND PARTNERSHIP DEALS

• PARTNERSHIPS AND COLLABORATIONS
• MERGERS AND ACQUISITIONS
  • Table: Recent Diagnostic Market Mergers, Acquisitions, and Partnership Deals, Dec. 2023-Jan. 2025

INDUSTRY WATCH

• INDUSTRY WATCH COVID-19/FLU UPDATE

REGION WATCH

• MEXICO
  • Figure: Mexico GDP, GDP (PPP), and Health Spending, 1990-2020, estimated 2025 ($ billion)
  • Figure: Mexico IVD Market Sales Trends, by Broad IVD Segment, 2016-2024 ($ million) (Clinical Chemistry, Hematology, and Coagulation; Histology; Immunoassays; Microbiology; POC; Others)

BROAD-BASED COMPANY ANNOUNCEMENTS

• ANNOUNCEMENTS
  • Roche Secures CE Marking for Mass Spec System
  • QIAGEN Receives FDA Clearance for Five-Target Syndromic Panel
  • Revvity Secures FDA Clearance for Free Testosterone Test
  • Spear Bio Secures FDA Breakthrough Device Designation
  • Roche Announces Clearance of First ISH Test B-cell Lymphoma
  • Roche Receives Additional FDA Clearance

MARKET ANALYSIS: INFECTIOUS DISEASE TESTING

• OVERVIEW OF INFECTIOUS DISEASE TESTING
• MARKET OUTLOOK
  • Table 1: Global Infectious Disease Testing Market Revenue, by Segment, 2024-2029 ($ million) [Lab-based Immunoassays, Lab-based Molecular, Point-of-Care Tests]
  • Figure 1: Global Infectious Disease Testing Market, by Segment, 2019-2029 ($ million) [Lab-based Immunoassays, Lab-based Molecular, Point-of-Care Tests]
  • Figure 2: Global Infectious Disease Testing Market, Change in Market Performance by Segment, 2023-2024 [Blood Bank Screening, COVID-19, HAIs/Sepsis, Hepatitis, HIV, Respiratory (excl. COVID), Others]
  • Figure 3: Global Infectious Disease Testing Market, by Analyte Target, Distribution of Sales, 2024 [Blood Bank Screening, COVID-19, HAIs/Sepsis, Hepatitis, HIV, Respiratory (excl. COVID), Others]
• REGIONAL MARKET
  • Table 2: Infectious Disease Testing, Distribution by Global Region, 2024 [North America, Europe, Asia Pacific, RoW]
• COMPANY BRIEFS
  • Roche
  • Abbott
  • Danaher
  • Other Participants

EXECUTIVE NEWS BRIEFING

• BRIEFINGS
• Dxcover Limited Raises New Capital
• Cubit Diagnostics Awarded NIH Funding
• CARB-X Funds AstraDx's Neonatal Sepsis Rapid Test
• Freenome Raises Additional $254 Million
• Renovaro Secures $15 Million in New Capital
• Ataraxis AI Secures $20.4 Million in Funding
• MSInsight Nabs €1.6 Million Seed Funding
• C2N Diagnostics Receives $10 Million Investment

FINANCIAL HIGHLIGHTS: GUARDANT HEALTH, ROCHE

• GUARDANT REPORTS STRONG DEMAND – INCREASING REVENUES +31% OVER PREVIOUS YEAR
  • Figure 4: Guardant Health Test Volume, by Segment and Total, Quarterly Q1 2023 through Q4 2024 [Biopharmaceutical Customers, Clinical Customers]
  • Table 3: Guardant Health, by Group Business Revenue, FY 2023 vs FY 2024 ($ million) [Clinical Precision Oncology Testing, Development Services and Other]
  • Figure 5: Guardant Health, by Group Business, FY 2023 vs FY 2024 ($ million) [Clinical Precision Oncology Testing, Development Services and Other]
  • Figure 6: Guardant Health Revenue Performance, by Geographic Region, FY 2023 vs FY 2024 ($ million) [United States, International]
• ROCHE DIAGNOSTIC SALES GROW 4% CER IN 2024 – SUPPORTED BY DEMAND FOR IMMUNODIAGNOSTICS, PATHOLOGY, AND MOLECULAR SOLUTIONS
  • Table 4: Roche, by Group Business, 2024 (CHF MN) [Diagnostic Division, Pharmaceutical Division]
  • Figure 7: Roche Diagnostics, 2024 Product Sales Breakdown, 2024 (CHF MN) [Core Lab, Molecular, Pathology Lab, Point-of-Care]
  • Figure 8: Roche Diagnostic, Segment Distribution, 2024 (%) [Core Lab, Molecular, Pathology Lab, Point-of-Care]
  • Table 5: Roche Diagnostics Division Sales, by Region, 2024 (CHF MN)

DIAGNOSTIC MARKET MERGERS, ACQUISITIONS, AND PARTNERSHIP DEALS

• MERGERS AND ACQUISITIONS
  • Table 6: Recent Diagnostic Market Mergers, Acquisitions, and Partnership Deals, Dec. 2024-March 2025
• PARTNERSHIPS AND COLLABORATIONS

INDUSTRY WATCH

• INDUSTRY WATCH COVID-19/FLU UPDATE

REGION WATCH

• BRAZIL
  • Figure 9: Brazil Short-Term GDP Growth and Inflation Change, 2022-2024, 2025-2026 Projected (%)
  • Figure 10: Brazil General Government Gross Debt as a Percent of GDP, 2000-2020 and 2025 projected (%)
  • Figure 11: Brazil IVD Market Distribution of Sales, by IVD Segment, 2024 (%)

BROAD-BASED COMPANY ANNOUNCEMENTS

• ANNOUNCEMENTS
  • AliveDx Nabs CE Mark for Expanded Autoimmune Menu
  • Beckman Coulter Received FDA Breakthrough Device Designation
  • Beckton Dickinson to Spin Off Bioscience and Diagnostic Business
  • GRAIL Provides Galleri Multi-Cancer Early Detection Test Through Quest
  • Molecular Instruments RNA-ISH Enables Breakthrough LDT
  • Roche Snags FDA Clearance for Preeclampsia Test
  • CytoChip Receives FDA Clearance and CLIA Waiver
  • Cicero Diagnostics Unveiled Endometriosis Detection LDT
  • bioMérieux Secures FDA Clearance for BIOFIRE FILMARRAY GI Panel
  • Beckman Coulter Gains Clearance for its DxC 500i

MARKET ANALYSIS: BLOOD GROUPING/TYPING TESTING

• OVERVIEW OF BLOOD GROUPING/TYPING TESTING
  • Molecular Methods in Blood Typing
  • Discovery of a New Blood Group System

MARKET OUTLOOK: BLOOD GROUPING AND TYPING

• OVERVIEW OF BLOOD GROUPING AND TYPING
  • Regional Market
    • Figure: Blood Grouping/Typing Market, Estimated Revenues, by Global Region, 2019-2029 [Asia Pacific, Europe, North America, Rest of World]
  • Company Briefs
  • Bio-Rad
  • Grifols
  • QuidelOrtho
    • Figure: Global Blood Grouping/Typing Market Share, by Vendor, 2024 (%) [Bio-Rad, Grifols, QuidelOrtho, Others]
  • Werfen/Immucor
  • AliveRx/Quotient

EXECUTIVE NEWS BRIEFING

• BRIEFS
  • Craif Raises $22 Million in Series C Funding
  • Deepull Closes Series C Financing Round
  • Upfront Diagnostics Raises $4.3 million in Funding Round
  • Cizzle Biotechnology Raises £150,000 in Additional Funding
  • Hedera Dx Lands €15 Million in Funding
  • 32 Biosciences Secures $6 Million in Funding

FINANCIAL HIGHLIGHTS: BIOMERIEUX & TRINITY BIOTECH

• bioMerieux Reports Full-Year 2024 Sales of €3,980 Million, Representing 10.3% Organic Growth and Exceeding Expectations
  • Figure: Trinity Biotech Sales, by Business Segment, FY 2023 and FY 2024 ($ thousands) [Clinical Laboratory, Point-of-Care]

DIAGNOSTIC MARKET MERGERS, ACQUISITIONS, AND PARTNERSHIP DEALS

• PARTNERSHIPS AND COLLABORATIONS
• RECENT MERGERS AND ACQUISITIONS
  • Table: Recent Diagnostic Market Mergers, Acquisitions, and Partnership Deals, December 2024-June 2025

INDUSTRY WATCH

• INDUSTRY WATCH COVID-19/FLU UPDATE

REGION WATCH

• CHINA
  • Figure: China Total Health Expenditures, $B and Total Population, 2010-2023
  • Figure: China IVD Market Distribution of Sales, by IVD Segment, 2024 (%)

BROAD-BASED COMPANY ANNOUNCEMENTS

• COMPANY ANNOUNCEMENTS
  • Guardant Health Launches New Hereditary Cancer Test
  • EDX Medical Launches Test for Early Testicular Cancer Detection
  • Lumipulse G pTau 217 β-Amyloid 1-42 Plasma Ratio Receives FDA Clearance
  • Boditech and SphingoTec Launch AFIAS Sphingotest penKid Assay
  • Roche Plans Investment of $550 Million for Indianapolis Diagnostic Site
  • Roche Receives FDA Breakthrough Device Designation
  • DiaSorin Captures FDA Clearance for Multiplex Molecular Panel
  • Nordic Bioscience Launches nordicEndotrophin Assay
  • genedrive Certification of Rapid CYP2C19 ID Kit
  • Predicta Biosciences Launches GenoPredicta Marrow and GenoPredicta Blood
  • Baebies Received FDA Breakthrough Device Designation
  • New Day Diagnostics Launches ColoHealth
  • Randox Received FDA Go-Ahead for ConcizuTrace ELISA
  • LifeLabs Introduces Three Blood-Based Alzheimer's Disease Tests

MARKET ANALYSIS: HISTOLOGY/CYTOLOGY TESTING

• OVERVIEW OF HISTOLOGY/CYTOLOGY TESTING

MARKET OUTLOOK: HISTOLOGY/CYTOLOGY

• OVERVIEW OF HISTOLOGY/CYTOLOGY
  • Table: Histology/Cytology Diagnostic Sales, by Broad Test Category, 2025 ($ million) [Pap Tests, in situ Hybridization, Immunohistochemistry, Traditional Non-Pap Stains, HPV - Amplification/Genome]
  • Figure: Histology/Cytology Diagnostic Market Distribution, by Broad Test Category, 2025 (%) [Pap Tests, in situ Hybridization, Immunohistochemistry, Traditional Non-Pap Stains, HPV - Amplification/Genome]
  • Figure: Evolution of the Histology/Cytology Diagnostic Market, 2020-2030 ($ million) [Pap Tests, in situ Hybridization, Immunohistochemistry, Traditional Non-Pap Stains, HPV - Amplification/Genome]
• REGIONAL MARKET
  • Table: Global Histology/Cytology Sales Distribution, by Region, 2025 (%) [North America, Europe, Asia Pacific, RoW]
• COMPANY BRIEFS
  • Agilent
  • Danaher
  • Hologic
  • Roche

EXECUTIVE NEWS BRIEFING

• BRIEFINGS
  • Visby Medical Raises $55 Million
  • GeneCentric Raises $8 Million in Series C Round
  • Aptitude Medical Systems Secures $9 Million in BARDA Funding
  • Aptitude Medical Systems Secures $8.25 Million in BARDA Funding
  • South Korea's QuantaMatrix Awarded $2.9 Million
  • Cyted Health Raises $44 Million in Series B Financing Round
  • Monod Bio Reaps $1.5 Million Gates Foundation Grant
  • Octave Bioscience Closes $35 Million in Series C Financing

FINANCIAL HIGHLIGHTS: ABBOTT, HORIBA

• ABBOTT LEANS ON DIABETES CARE SEGMENT FOR GROWTH IN 2025
  • Diabetes Care - U.S. Market Performance
  • Diabetes Care - International Market Performance
  • Diagnostic Snapshot
    • Table: Diagnostic Sales, Abbott Laboratories, H1 2024 and 2025 ($ million)
  • Abbott: Total Company Performance
    • Table: Total Sales, Abbott Laboratories, H1 2024 and 2025 ($ million)
  • HORIBA REPORTED YEAR-OVER-YEAR GROWTH IN H1 '25 OF 4.4%, INCREASING BY 6.2 BILLION YEN; EXPECTS 5.6% GROWTH FULL YEAR
    • Figure: Horiba Sales by Business Segment, H1 2024 vs H1 2025 (million Yen) [Energy & Environment, Bio & Healthcare, Materials & Semiconductor]
    • Figure: Horiba H1 2024 & H1 2025 Net Sales, Operating Income, Operating Income Ratio (million Yen)
    • Table: Horiba H1 2024 & H1 2025 Geographic Market Performance (million Yen) [Japan, Asia, Americas, Europe, Total]
    • Figure: Horiba H1 2024/2025 Bio & Healthcare Division, Geographic Market Performance (million Yen) [Japan, Asia, Americas, Europe]

DIAGNOSTIC MARKET MERGERS, ACQUISITIONS, AND PARTNERSHIP DEALS

• PARTNERSHIPS AND COLLABORATIONS
• MERGERS AND ACQUISITIONS
  • Table: Recent Diagnostic Market Mergers, Acquisitions, and Partnership Deals

INDUSTRY WATCH

• INDUSTRY WATCH COVID-19/FLU UPDATE

REGION WATCH

• POLAND
  • Figure: Poland Population Distribution, 2000 through 2100
• Poland: Healthcare Investment and IVD Market Overview
• IVD Market in Poland
  • Figure: Poland - Market Distribution of Broad IVD Segments, 2025 (%) [Immunoassays, Microbiology/Virology, Point-of-Care, Histology/Cytology, Chemistry/Hematology/Coagulation, Other Segments]

BROAD-BASED COMPANY ANNOUNCEMENTS

• ANNOUNCEMENTS
  • Roche Secures CE-IVDR for its HER2 CDx Assay
  • QIAGEN Launches QIAstat -Dx Rise
  • Agilent Receives FDA Approval
  • Pearl Diagnostics Receives FDA Clearance for New Assay
  • Thermo Fisher Captures FDA Approval for NGS-based Companion Diagnostic
  • Hardy Diagnostics Captures FDA Clearance for NG Test
  • Diasorin Captures FDA Clearance for Multiplex Molecular Panel
  • Waters and BD Biosciences & Diagnostics Combine
  • Thermo Fisher Gains NGS Assay Approval
  • EpiCypher Launches Single-Molecule Genomics Assay
  • BioMérieux Secures FDA and CLIA-waiver Clearance
  • Biocartis Captures FDA Approval for CDx