2025年體外診斷業務展望（6期 ）

體外診斷（IVD）領域是現代醫療保健的基石，為臨床醫生提供檢測疾病、監測健康狀況和做出有針對性的治療決策的工具。

範例

隨著醫療保健的發展，IVD市場可望實現轉型成長。隨著糖尿病和心血管疾病等慢性病的發病率上升，以及新冠肺炎等傳染病及其變種的持續威脅，對創新診斷解決方案的需求從未如此高漲。

本報告每兩個月出版一次，每年出版六次，每期重點關注 IVD 行業的不同領域，並提供市場資料和預測、全面的市場前景、併購活動、垂直和區域趨勢。

目錄

市場分析：心臟生物標記檢測

• 心臟生物標記概述

市場展望

• 區域市場
• 公司簡介
  • Abbott Diagnostics
  • Beckman Coulter
  • Siemens
• 供應商市場佔有率

執行新聞簡報

財務摘要：BECTON DICKINSON、NATERA

診斷市場合併、收購及合作交易

• 夥伴關係和合作關係
• 合併和收購

產業趨勢

• 產業趨勢：COVID-19/流感最新動態

各地區趨勢

• 墨西哥

大量公司公告

• 公告
  • Roche質譜系統獲得 CE 標誌
  • QIAGEN 的五種針對性綜合徵檢測試劑盒獲得 FDA 批准
  • Revvity 已獲得 FDA 批准提供免費睾酮測試
  • Spear Bio 獲得 FDA 突破性設備認證
  • Roche宣布批准首個 B 細胞淋巴瘤 ISH 檢測
  • Roche獲得 FDA 的額外批准

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