全球體外診斷檢測市場（第19版）

全球體外診斷（IVD）市場正進入穩定且強勁的成長期，其成長動力並非源自於突破性平台的湧現，而是策略性的產品組合重組、數位整合和選擇性創新。 Kalorama Information 出版的第19版「全球體外診斷（IVD）市場報告」檢驗了行業相關人員如何應對競爭壓力、成本限制和不斷變化的醫療保健需求，並為2030年前的永續成長做好準備。

戰略重點領域的轉變

自第 18 版發布以來，Kalorama Information 已確定體外診斷 (IVD) 行業以下三個重點領域：

• 投資組合拓展
• 客製化
• 每月健康

第十九版的一項調查顯示，企業優先考慮的是擴大產品組合和測試項目，而不是投資全新的平台或顛覆性設備。這種轉變反映的是策略調整，而非放棄創新。

將投資組合擴張作為核心成長策略

投資組合的擴張受到多種因素的驅動，這些因素已成為關鍵的成長機制：

• 擴展現有平台上的檢查選單
• 進入鄰近病害區域
• 越來越依賴收購和業務重組來擴大投資組合。

具體例子包括旨在擴大癌症診斷產品組合的收購，以及旨在重新聚焦現有產品組合中高附加價值領域的公司重組工作。

新產品不斷湧入市場，尤其是在蛋白質等特定成長領域。然而，新平台的整體普及速度仍然有限​​。

創新路徑和夥伴關係模式

雖然顛覆性平台創新目前受到限制，但在幾個關鍵技術領域，有意義的創新仍在繼續：

• 分子診斷
• 伴隨診斷
• 即時分子診斷
• 數位病理學
• 人工智慧輔助診斷

尤其值得注意的是，企業越來越依賴收購和合作來獲取創新，而不是只依賴內部研發。

數位健康的角色日益擴大

數位醫療正成為競爭差異化的核心要素，並正經歷以下發展階段：

• 連接性
• 資料管理
• 人工智慧

這些功能使企業能夠過渡到整合解決方案模式，從而支援經常性收入來源，加強客戶關係，並在競爭激烈的市場中實現差異化。

市場成長前景及各細分市場趨勢

根據 Kalorama Information 的分析，預計在整個預測期內將逐年穩定成長，但不同細分市場的表現將有顯著差異。

細分市場趨勢

• 常規檢測領域預計將保持平穩或適度成長。
• 預計成長率高的細分市場將跑贏市場平均。

需求流行病學因素

全球慢性病負擔日益加重，尤其是單一患者罹患多種慢性病的比例不斷上升，推動了對體外診斷醫療器材 (IVD) 的持續需求。

主要指標如下：

• 大約 40% 的美國人和 33% 的世界人口患有至少一種慢性疾病。
• 美國約有 20% 的成年人患有兩種或兩種以上的慢性疾病。

高血壓、慢性肺部疾病、氣喘、心臟病和癌症等疾病的併發會加劇以下因素：

• 醫療服務使用量增加
• 延長護理週期和延長治療計劃
• 居家診斷的需求日益成長

這些趨勢持續推動所有醫療機構中體外診斷檢測數量的增加。

未來5到10年，Kalorama Information預測體外診斷（IVD）產品市場將逐步轉型。主要成長促進因素如下：

• 全球老化
• 疾病負擔加重
• 國際醫療基礎設施的擴張

這些因素並不能完全消除財政或政策上的不利因素，但預計可以抵消這些不利因素。

報告範圍和調查方法

• 該研究涵蓋全球體外診斷 (IVD) 市場，包括 2025 年至 2030 年的預測（以美元計）。
• 市場規模是根據製造商的銷售收入計算的，而不是根據零售價格或兌換價格計算的。
• 按測試類別進行細分分析，並在可能的情況下按分析物進行細分分析。
• 我們專注於公司發展趨勢、財務績效和供應商活動。
• 我們認知到所有市場規模和預測數據都是估計值，可能會因市場狀況、貿易政策和已公佈的企業收益的變化而波動。

本報告的專門章節檢驗了人工智慧、次世代定序、基因編輯和微生物組研究的長期趨勢。

對產業相關人員的價值

第19版為企業主管、行銷負責人和策略決策者提供以下內容：

• 清楚闡述投資重點如何重塑體外診斷產業
• 洞察哪些細分市場和技術可能表現優於其他市場和技術。
• 在財政、監管和政策不確定性背景下評估成長機會的背景

本報告結合行業專業知識、廣泛的二手研究以及對市場參與企業的訪談，對體外診斷 (IVD) 市場的發展方向以及企業應如何定位自身以有效競爭進行了基於證據和透明的評估。

第1章摘要整理

第2章：引言

• 體外診斷狀況
• 範圍
• 每版註釋
  • 優先領域的變化
• 報告設計
• PAMA 和 CMS
• 體外診斷市場細分市場分析
• 頂級供應商和利基公司
• 介紹
• 頂級公司概覽
• Abbott Diagnostics
• Roche Diagnostics
• Danaher Corporation
• Cepheid
• Radiometer
• Beckman Coulter
• Thermo Fisher Scientific
• Dexcom
• Siemens Healthineers
• Illumina
• Exact Sciences
• Sysmex Corporation
• Becton Dickinson & Co
• QuidelOrtho Corporation
• Werfen
• Natera
• Mindray
• Hologic
• Agilent
• Bio-Rad Laboratories
• QIAGEN NV
• Revvity
• Overview of Selected Second-Tier Companies
• Diasorin Group
• Bruker/CALID Group
• Guardant Health
• Myriad Genetics
• Grifols SA
• Diagnostica Stago
• BGI Genomics
• Sekisui Diagnostics
• ARKAY
• GeneDx
• Fujirebio
• Fulgent Genetics
• Seegene
• Horiba
• Randox
• Eiken Chemical Co
• Nihon Kohden
• Meridian
• Menarini Diagnostics
• Haemonetics

第3章：體外診斷市場全球展望

• 範圍
• 概述
• 同時的威脅：慢性威脅和急性威脅
• 全球體外診斷市場未來趨勢預測
• 世界人口與老化
• 人員縮減
• 世界衛生組織基本體外診斷醫療器材清單
• 慢性病增多
• COVID-19
• 新興市場和新興國家
• 全球體外診斷市場規模及預測
• 美國體外診斷市場
• PAMA 和報銷制度的變更
• CARES 法對 PAMA 的影響
• 維持測試服務存取的方法（SALSA）
• LDT 更新
• 為末期腎功能衰竭患者提供全面的保險支付
• 進階臨床測試（ADLT）
• 精準醫療和NGS
• 歐洲體外診斷市場
• 歐盟法規
• 歐洲精準醫療
• Brexit
• 日本
• 東歐：一個正在崛起的地區
• 中國：體外診斷市場現狀
• 中國的臨床檢測市場
• 中國的數量導向型採購
• 印度：人口與機會
• 印度臨床檢測市場
• 體外診斷醫療器材法規
• 印度的「無印度宣傳活動」
• 其他亞洲國家
• 巴西
• 疾病趨勢
• 巴西臨床檢測市場
• 體外診斷醫療器材法規
• 墨西哥
• 俄羅斯聯邦
• 加拿大
• 新興市場
  • 沙烏地阿拉伯體外診斷市場
  • 南非體外診斷市場
  • 韓國體外診斷市場
  • 土耳其的體外診斷市場
  • 阿拉伯聯合大公國體外診斷市場
  • 其他值得關注的市場
  • 智利
  • 哥倫比亞
  • 印尼
  • 馬來西亞
  • 秘魯
  • 菲律賓
  • 波蘭
  • 羅馬尼亞
  • 泰國
  • 越南
• 各國體外診斷市場機遇

第4章：公司和產業的趨勢

• 範圍
• 每版注記
• 無國界的先進醫療
• 中國市場最新資訊
• 消費者基因檢測服務
• 疾病的基因檢測
• 基因組檢測
• 基因編輯
• CRISPR作為診斷工具
• CRISPR技術與食品業
• 微生物組
• 次世代定序
• 液態生物檢體
• 品質保證
• 產品新聞
• 已獲市場核准的產品
• 微生物學中的液態生物檢體
• 2022年至2025年液態生物檢體相關企業
• 液態生物檢體的未來
• 資訊科技與人工智慧的進步
• 人工智慧在臨床環境中的應用
• 人工智慧醫生的應用
• 監管途徑
• 產品舉措
• 人工智慧在液態生物檢體中的應用
• 人工智慧在解讀液態生物檢體中的作用
• 與產業領導者合作
• 正在研發或近期推出的新型液態生物檢體/人工智慧產品
• 未來趨勢
• 外泌體定序
• 免疫檢測中生物素檢測的干擾誤差
• 臨床應用和液態切片
• 創傷性腦損傷和IVD
• 個人化醫療
• 伴隨診斷
• 遠端醫療
• 區塊鏈
• 藥物濫用
• 生物標記與藥物濫用
• 濫用藥物的臨床檢測
• 尿
• 血
• 口服
• 頭髮
• 唾液檢測
• 呼吸檢測的進步
• 微型醫院的潛力
• 氣候變遷與感染疾病
• 回扣計劃
• 早期發現膿毒症
• 醫療診斷和3D列印
• 人員短缺
• 針對性檢測

第5章：照護現場偵測（POC​​）

• 範圍
• 概述與趨勢
• POC產業促進因素
• 以患者為中心的促進者
• 醫療保健駕駛人
• 技術加速因素
• 經濟的驅動力
• 其他促進因素
• POC業
• 監管挑戰
• 有色人種專業人士
• 市售自測
• 驗孕棒/不孕症檢測盒
• 大腸直腸癌篩檢
• 血脂檢測
• 藥物濫用檢測
• 產品
• 快速照護現場傳染病檢查
• 產品
• 愛滋病毒和肝炎檢測與監測
• 結核
• 熱帶疾病和被忽視的疾病
• 呼吸系統疾病
• 敗血症和院內感染
• 性健康
• 萊姆病
• COVID-19
• 市場規模和成長
• 臨床用非處方藥和專業人員免疫檢測方法
• 妊娠測試
• 心血管診斷
• 藥物濫用/治療性藥物監測
• 糖尿病檢測 -血糖值測量
• 利用資訊科技支援糖尿病管理
• 糖尿病市場分析
• POC葡萄糖競爭物質
• 血糖值自我監測
• 非侵入式偵測設備
• 持續血糖監測
• 由專家進行血糖值檢測
• 糖尿病檢測 - 糖化血紅素
• 糖尿病的基因和其他標記物
• 關鍵概念驗證測試參與者

第6章核心實驗室

• 範圍
• 核心實驗室概覽與發展趨勢
• 連接性
• 化學測試概述
• 實驗室自動化
• 市場分析
• 快速反應系統
• 重症監護分析
• 尿液檢查
• 化學測試的商業性前景

第7章免疫檢測

• 範圍
• 概述與趨勢
• 免疫檢測技術不斷發展。
• 質譜分析
• 免疫測量
• 市場分析
• 成熟檢測片段
• 甲狀腺功能
• 治療藥物監測
• 維生素D
• 貧血
• 毒理學/日間操作
• 過敏
• 生長免疫測定
• 蛋白質
• 腫瘤標記
• 心臟標記物
• 自體免疫
• 類風濕性關節炎
• 胃腸道疾病
• 移植管理
• 女性健康
• 阿茲海默症和多發性硬化症
• 創傷性腦損傷
• 其他免疫檢測
• 創新性的概念驗證
• 免疫檢測的商業性前景

第8章 分子檢測

• 範圍
• 概述
• 樣品製備和品管
• 分子演化
• 外泌體定序分析
• 液態生物檢體
• 代謝體學學分析
• 資訊科技
• 人工智慧（AI）
• 法醫學研究—新的可能性
• 測試平台
• 主要參與者
• 市場分析
• 腫瘤學
• 遺傳性疾病、血栓症相關單核苷酸多態性及其他疾病
• 阿茲海默症和失智症
• 心血管疾病
• 憂鬱症和精神障礙
• 產前和新生兒篩檢
• 移植診斷
• 女性健康
• 分子檢測的商業性前景

第9章 血液學

• 範圍
• 血液學概論及發展趨勢
• 數位影像分析
• 數位演化
• 品管測量程序
• 臨床檢查室的血液學檢測
• 區域檢查室血液學檢測與設備市場
• 分散式血液檢測
• 照護端的血紅素/血球比容值
• 市場分析：主要供應商
• 血液檢測的商業性前景

第10章 凝血

• 範圍
• 血液凝固檢驗及免疫組織化學檢測概述及發展趨勢
  • COVID-19
  • 直介面服抗凝血劑（DOACs）
  • D-二聚體
  • 市場分析
  • 實驗室檢測
  • 高凝血狀態的遺傳標記
  • 主要供應商：實驗室系統
  • 分散血液凝固檢驗- 專業人士適用
  • 分散式血液凝固檢驗-OTC
  • 血小板檢測
  • 主要供應商：POC SYSTEMS
  • 血液凝固檢驗的商業市場

第11章 微生物學與病毒學

• 範圍
• 感染疾病的真正影響
• 微生物的抗生素抗藥性－臨床試驗的作用
• 快速識別
• 傳統微生物學及其局限性
• 新微生物學—創新
  • 液態微生物學與自動化創新
  • 血液培養後的微生物鑑定
  • 利用PCR和其他核酸增幅檢查（NAAT）傳染病檢查
  • 與微生物組相關的微生物檢測
  • Illumina
  • Bio-Rad
  • QIAGEN
  • Luminex (Diasorin)
  • inBiome BV
  • DNA Genotek
  • Thermo Fisher Scientific
  • 其他
• 基於次世代定序的微生物學方法
• 綜合症/多項檢查
• 感染疾病的威脅及其嚴重後果
• 蜱傳疾病（TBD）
• 結核病和其他感染疾病
• 恰加斯病
• 登革熱
• 伊波拉出血熱
• 屈公病
• 中東呼吸道症候群冠狀病毒（MERS-CoV）
• 馬爾堡
• SARS-CoV-2（COVID-19）
• 猴痘
• 市場分析
• 市場分析－傳統微生物鑑定和抗菌藥物敏感性測試
• 常規ID/AST
• 血液培養
• 顯色介質
• 從培養基中收集的菌落進行快速檢測。
• 補給品
• 市場分析—微生物免疫檢測
• 微生物學免疫檢測的進展
• 肝炎檢測
• 敗血症
• HIV免疫檢測測定
• 性行為感染傳染病（STD）
• 火炬
• 萊姆病
• 市場分析—分子微生物學
• 實驗室自動化與分子診斷
• 分子呼吸道傳染病檢查
• 三大呼吸道疾病：流感、鏈球菌感染疾病及呼吸道合胞呼吸道融合病毒（RSV）感染疾病。
• 性行為感染感染的分子檢測
• 分子肝炎檢測
• 分子生物 HIV 檢測
• 院內感染（HAI）的分子檢測
• 問題評估：醫院感染統計數據
• 困難梭狀芽孢桿菌
• MRSA
• 結核病分子檢測
• 分子微生物學檢測的局限性
• 快速微生物檢測
• 質譜分析
• 微生物學的未來前景

第12章 血庫服務

• 範圍
• 概述
• 全球血液採集現狀
• 世界血液安全
• 茲卡病毒
• 血液及血液成分的採集
• 重新評估輸血
• 血型鑑定及血型分類市場
• 人工血型鑑定方法
• 自動化血型鑑定和篩檢方法
• 分子生物學方法
• 打字機市場規模及成長
• 血型檢測市場（按地區分類）
• 血液檢測市場
• 預防細菌感染
• 免疫檢測
• 核酸檢測（NAT）
• 市場規模和成長
• 血液檢測市場（按地區分類）

第13章 組織學與細胞學

• 範圍
• 概述
• 專題
• 組織學自動化
• 進階分析解決方案
• HPV體外診斷檢測正逐漸成為主流。
• 市場分析
• 整體市場
• 區域市場分析
• 傳統染色
• 子宮頸抹片檢查
• 免疫組織化學和原位雜合反應
• 藥物診斷組織學
• 數位影像處理和計算病理學
• 循環性腫瘤細胞
• 流式細胞技術
• 組織學和細胞學檢測的商業性前景

第14章 公司簡介：第一層

• 範圍
• ABBOTT DIAGNOSTICS
• AGILENT TECHNOLOGIES
• BECKMAN COULTER / DANAHER
• Beckman Coulter Life Sciences
• BECTON, DICKINSON AND COMPANY (BD)
• BIOMERIEUX INC.
• BIO-RAD LABORATORIES, INC.
• BRUKER CORPORATION
• CEPHEID / DANAHER
• DANAHER CORPORATION
• HOLOGIC, INC.
• ILLUMINA
• LEICA BIOSYSTEMS/DANAHER
• NATERA
• QIAGEN
• QUIDELORTHO CORPORATION
• RADIOMETER A/S / DANAHER
• ROCHE TISSUE DIAGNOSTICS
• SIEMENS HEALTHINEERS (SIEMENS)
• SYSMEX CORPORATION
• THERMO FISHER SCIENTIFIC INC.
• WERFEN

第15章 公司簡介：第二層

• 範圍
• ARKRAY
• BGI GENOMICS (FORMERLY BEIJING GENOME INSTITUTE)
• MGI Tech Co., Limited, China
• BIOCARTIS
• DIAGNOSTICA STAGO SAS
• DIASORIN SPA
• EIKEN CHEMICAL CO., LTD
• FUJIREBIO DIAGNOSTICS, INC.
• FULGENT GENETICS, INC
• GENEDX
• GRIFOLS SA
• GUARDANT HEALTH, INC.
• HAEMONETICS
• HORIBA
• MENARINI DIAGNOSTICS
• MERIDIAN BIOSCIENCE, INC.
• MINDRAY - SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
• MYRIAD GENETICS, INC.
• ORASURE TECHNOLOGIES, INC.
• RANDOX LABORATORIES LTD.
• SEEGENE, INC.
• SEKISUI DIAGNOSTICS LLC
• VERACYTE, INC.

第16章 公司簡介：專業血庫公司

• 範圍
• ALIVEDX
• CERUS CORPORATION

第17章 公司簡介：CoreLab 及其他公司

• 範圍
• SCIEX PTE LTD.
• 糖尿病
• 分子
• EKF DIAGNOSTICS HOLDINGS PLC
• SHIMADZU SCIENTIFIC INSTRUMENTS
• SNIBE CO. LTD. (SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO. LTD.)
• TOSOH BIOSCIENCE
• TRINITY BIOTECH PLC

第18章 公司簡介：CTC 和液態切片檢測提供商

• 範圍
• EPIC SCIENCES
• FOUNDATION MEDICINE, INC.
• NEOGENOMICS

第19章 公司簡介：專業公司

• 範圍
• ASCENSIA DIABETES CARE HOLDINGS AG
• INSULET CORPORATION
• MEDTRONIC PLC
• VERILY LIFE SCIENCES LLC

第20章 公司簡介：血液學（細胞分析）和凝血專科診所

• 範圍
• CELLAVISION AB
• MASIMO CORPORATION
• NOVA BIOMEDICAL CORPORATION (NOVA)

第21章 公司簡介：病理專科

• 範圍
• AMOY DIAGNOSTICS CO. LTD.
• APPLIED SPECTRAL IMAGING INC. (ASI)
• VISIOPHARM

第22章 公司簡介：專業免疫檢測公司

• 範圍
• BIOHIT HEALTHCARE
• BIOMERICA INC.
• BIO-TECHNE CORPORATION
• EUROBIO SCIENTIFIC
• EUROIMMUN AG (REVVITY)
• INOVA DIAGNOSTICS, INC.
• VOLITIONRX LIMITED

第23章 公司簡介：微生物學專家

• 範圍
• ADVANCED BIOLOGICAL LABORATORIES, SA (ABL)
• ALTONA DIAGNOSTICS
• ARCDIA INTERNATIONAL OY LTD.
• COPAN ITALIA SPA AND COPAN DIAGNOSTICS, INC.
• GENETIC ANALYSIS AS
• Q-LINEA AB

第24章 公司簡介：專業分子檢測公司

• 範圍
• PACIFIC BIOSCIENCES OF CALIFORNIA, INC. (PACBIO)
• STANDARD BIOTOOLS

第25章 公司簡介：就地檢驗的專業公司

• 範圍
• ABINGDON HEALTH LTD.
• BINX HEALTH
• CHEMBIO DIAGNOSTIC SYSTEMS, INC.
• GENEDRIVE PLC (FORMERLY EPISTEM HOLDINGS)
• MEDMIRA, INC.

第26章 公司簡介：提供產前檢測服務的公司

• 範圍
• BERRY GENOMICS CO. LTD.
• INEX INNOVATE
• OXFORD GENE TECHNOLOGY
• YOURGENE HEALTH

第27章 公司簡介：品管與樣品製備專家

• 範圍
• AGENA BIOSCIENCE, INC.
• BIOTYPE DIAGNOSTIC GMBH
• INCELLDX
• LGC SERACARE LIFE SCIENCES, INC.
• PREANALYTIX GMBH
• PRECIPIO, INC.
• QUANTERIX CORPORATION
• STRECK INC.

第28章 測試服務供應商

• 範圍
• AGENDIA BV
• AMBRY GENETICS
• ARUP LABORATORIES
• ASPIRA 女性健康
• BLUEPRINT GENETICS OY
• BOSTON HEART DIAGNOSTICS
• CAREDX, INC.
• PREDICTIVE ONCOLOGY
• LABCORP, LABORATORY CORPORATION OF AMERICA
• MAYO CLINIC LABORATORIES
• MDXHEALTH SA
• OPKO DIAGNOSTICS/OPKO HEALTH
• QUEST DIAGNOSTICS
• SONIC HEALTHCARE

The global in vitro diagnostics (IVD) market is entering a period of measured but positive growth, shaped less by disruptive platform launches and more by strategic portfolio realignment, digital integration, and selective innovation. Kalorama Information’s 19th Edition of The Worldwide Market for In Vitro Diagnostic (IVD) Tests examines how industry participants are navigating competitive pressures, cost constraints, and evolving healthcare needs while positioning for sustainable growth through 2030.

Shifting Areas of Strategic Focus

Since publication of the 18th Edition, Kalorama Information has identified three dominant areas of concentration across the IVD industry:

• Portfolio expansion
• Customization
• Digital health

Research conducted for the 19th Edition indicates that companies are prioritizing portfolio and menu expansion over investment in entirely new platforms or disruptive instrumentation. This evolution reflects a strategic shift rather than a retreat from innovation.

Portfolio Expansion as a Core Growth Strategy

Portfolio expansion has emerged as the primary mechanism for growth, driven by several factors:

• Expansion of test menus on existing platforms
• Entry into adjacent disease areas
• Increased reliance on acquisitions and restructuring to strengthen portfolio breadth

Examples include acquisitions aimed at expanding cancer diagnostics portfolios and corporate restructuring efforts designed to refocus on high value strengths within existing portfolios.

New products continue to enter the market, particularly in select growth areas such as proteins. However, the overall pace of new platform introductions remains limited.

Innovation Pathways and Partnership Models

While disruptive platform innovation is currently constrained, meaningful innovation continues across several key technology areas:

• Molecular diagnostics
• Companion diagnostics
• Point of care (POC) molecular diagnostics
• Digital pathology
• AI driven diagnostics

Notably, companies are increasingly acquiring or partnering to access innovation rather than relying solely on internal development.

The Expanding Role of Digital Health

Digital health is becoming a central element of competitive differentiation, advancing through:

• Connectivity
• Data management
• Artificial intelligence

These capabilities are enabling companies to move toward integrated solution models that support recurring revenue streams, strengthen customer relationships, and enhance differentiation in a crowded marketplace.

Market Growth Outlook and Segment Performance

Kalorama Information’s analysis points to incremental annual growth across the forecast period, though performance will vary widely by segment.

Segment Dynamics

• Routine testing areas may see flat or modest growth
• Higher growth segments are expected to outperform the market average

Epidemiological Drivers of Demand

At the foundation of sustained IVD demand is the growing global burden of chronic disease, particularly the prevalence of multiple chronic conditions within individual patients.

Key indicators include:

• Approximately 40% of Americans and 33% of the global population live with at least one chronic condition
• Nearly 20% of U.S. adults live with two or more chronic conditions

The co occurrence of conditions such as hypertension, chronic lung disease, asthma, heart disease, and cancer drives:

• Increased healthcare utilization
• Longer care cycles or extended treatment plans
• Rising demand for home based diagnostics

These trends continue to fuel IVD test volume growth across care settings.

Over the next five to ten years, Kalorama Information anticipates moderate, gradual shifts in IVD product markets. Growth will be driven primarily by:

• An aging global population
• Rising disease burden
• Expansion of international healthcare infrastructure

These forces are expected to offset, though not eliminate, fiscal and policy related headwinds.

Report Scope and Methodology

• Global IVD market coverage with forecasts for 2025–2030, presented in U.S. dollars
• Market size based on manufacturer revenues, not retail or reimbursement pricing
• Segment analysis by test category and, where possible, analyte
• Emphasis on corporate developments, financial performance, and vendor activity
• Recognition that all market values and forecasts are estimates, subject to evolving market conditions, trade policies, and reported company revenues

Long term trends including artificial intelligence, next generation sequencing, gene editing, and microbiome research are examined in dedicated sections of the report.

Value to Industry Stakeholders

This 19th Edition provides senior executives, marketers, and strategic decision makers with:

• A clear view of how investment priorities are reshaping the IVD industry
• Insight into which segments and technologies are positioned to outperform
• Context for evaluating growth opportunities amid fiscal, regulatory, and policy uncertainty

By combining industry expertise, extensive secondary research, and interviews with market participants, the report delivers a grounded, transparent assessment of where the IVD market is headed and how companies can position themselves to compete effectively.

CHAPTER 1: EXECUTIVE SUMMARY

• ABOUT KALORAMA INFORMATION
• OVERVIEW
  • Figure 1-1: Worldwide IVD Market Sales, 2020, 2025, and 2030 ($ billion)
  • Figure 1-2: COVID-19 IVD Market, Share by Segment, 2025 (%) [Immunoassay Lab-Based, Molecular Dx Lab-Based, Point-of-Care]
• SCOPE AND METHODOLOGY
• SIZE AND GROWTH OF THE MARKET
  • Table 1-1: Global In Vitro Diagnostic (IVD) Sales, by Product Segment, 2025-2030 ($ million) [Blood Bank Molecular; Blood Bank Screening; Drugs of Abuse; Blood Grouping/Typing; Circulating Tumor Cells; Clinical Chemistry; Coagulation; Histology/Cytology; Continuous Glucose; Diabetes HbA1c Immunoassays, Lab-Based; Hematology; HPV, Molecular; Immunoassays - Infectious Disease; Immunoassays - Other; Mass Spectrometry; Microbiology (ID/AST); Molecular Microbiology; Nucleic Acid Assays; POC, OTC Diabetes; POC, OTC Other; POC, Professional; Other]
• MARKET HIGHLIGHTS
• MARKET ASSUMPTIONS
  • Table 1-2: IVD Market Assumptions 2025 Outlook
• COMPETITIVE PICTURE IN IVD
• FINDING WHAT YOU ARE LOOKING FOR IN THE 19TH EDITION
  • Table 1-3: Finding What You Are Looking For in the 19th Edition

CHAPTER 2: INTRODUCTION

• IVD LANDSCAPE
• SCOPE
• Edition-Specific Notes
  • Shifting Areas of Concentration
• Report Design
• PAMA AND CMS
• MARKET ANALYSIS OF IVD MARKET SEGMENTS
  • Table 2-1: Global In Vitro Diagnostic (IVD) Sales, by Product Segment, 2025-2030 ($ million) (%) [Blood Bank Molecular; Blood Bank Screening; Drugs of Abuse; Blood Grouping/Typing; Circulating Tumor Cells; Clinical Chemistry; Coagulation; Histology/Cytology; Continuous Glucose; COVID-19 Dx; Diabetes HbA1c Immunoassays, Lab-Based; Hematology; HPV, Molecular; Immunoassays - Infectious Disease; Immunoassays - Other; Mass Spectrometry; Microbiology (ID/AST); Molecular Microbiology; POC, OTC Diabetes; POC, OTC Other; POC, Professional; Other]
  • Table 2-2: Additional Global In Vitro Diagnostic (IVD) Markets of Interest (Not in Totals), Sales by Product Segment, 2025-2030 ($ million) (%) [Clinical Sequencing; Drugs of Abuse, Criminal; Drugs of Abuse, Employment (non IVD); DTC Genetic Testing; Flow Cytometry; Prenatal Test Services]
• TOP SUPPLIERS AND NICHE PLAYERS
• Introduction
• Overview of the Top Tier Companies
  • Table 2-3: Clinical Diagnostic Revenues of Selected Top 20 IVD Companies, 2024 and 2025 ($ million)
• Abbott Diagnostics
• Roche Diagnostics
• Danaher Corporation
• Cepheid
• Radiometer
• Beckman Coulter
• Thermo Fisher Scientific
• Dexcom
• Siemens Healthineers
  bioMérieux
• Illumina
• Exact Sciences
• Sysmex Corporation
• Becton Dickinson & Co
• QuidelOrtho Corporation
• Werfen
• Natera
• Mindray
• Hologic
• Agilent
• Bio-Rad Laboratories
• QIAGEN N.V.
• Revvity
• Overview of Selected Second-Tier Companies
  • Table 2-4: Revenues of Selected Top 20 Niche IVD Players, 2024 and estimated 2025 ($ million)
  • Figure 2-1: Top Tier Market Distribution, 2024 and estimated 2025 (%)
• Diasorin Group
• Bruker/CALID Group
• Guardant Health
• Myriad Genetics
• Grifols S.A.
• Diagnostica Stago
• BGI Genomics
• Sekisui Diagnostics
• ARKAY
• GeneDx
• Fujirebio
• Fulgent Genetics
• Seegene
• Horiba
• Randox
• Eiken Chemical Co
• Nihon Kohden
• Meridian
• Menarini Diagnostics
• Haemonetics
• IVD COMPANIES MERGERS & ACQUISITIONS
  • Table 2-5: Selected IVD Mergers and Acquisitions, 2023-2026 (first half)
• COLLABORATION, PARTNERSHIP, ALLIANCE AGREEMENTS
• TEST SERVICES
  • Figure 2-2: Clinical Laboratory Test Service Market Forecasted Growth, by Segment, 2024-2029 (%)
  • Table 2-6: Global Lab Market Segmentation, 2024 ($ billion) [Hospital and Acute Care Labs, Independent Labs, Physician Office Labs]
  • Table 2-7: Total Revenues for Leading U.S.-based Reference Labs, 2023-2025 ($ million)
• HISTORICAL IVD MARKET VS TODAY
• In the Beginning to Now
  • Figure 2-3: Share of Global IVD Market, by Segment, 2000 and 2025 Compared (%) [Blood Banking (imm & typing); Clinical Chemistry; Coagulation; Hematology; Immunoassays; Microbiology [ID/AST]; Molecular; POC – Other; Histology/Cytology; POC Diabetes; Others]
• Future
• Next-Generation Sequencing
• Cancer Testing (Liquid Biopsy)
• Companion Diagnostics

CHAPTER 3: THE GLOBAL PICTURE FOR IN VITRO DIAGNOSTIC MARKETS

• SCOPE
• OVERVIEW
• Simultaneous Threats: Chronic and Acute
• Expected World IVD Market Developments
• GLOBAL POPULATION AND AGING
  • Figure 3-1: Global Fertility Rate vs. Population Size, 1950-2050 (billion)
  • Figure 3-2: Global Population Distribution, 2025
  • Table 3-1: Elderly Support Ratio in Various Countries, 2010 and 2050 [Australia; Brazil; Canada; China; China, Hong Kong SAR; France; Germany; India; Italy; Japan; Mexico; Saudi Arabia; Singapore; South Africa; Spain; Turkey; United Kingdom; United States; World]
• Workforce Reduction
• WHO ESSENTIAL IVD LIST
  • Table 3-2: WHO Model List of Essential In Vitro Diagnostics (EDL)
• Increase in Chronic Diseases
  • Figure 3-3: Leading Causes of Death Globally, 2021* (number of deaths in millions)
• COVID-19
  • Table 3-3: Selected Molecular EUA Tests for COVID-19, 2024-July 2025
  • Table 3-4: Selected Antigen Immunoassay Tests for SARS-CoV-2, 2024-2025
• EMERGING AND EMERGED MARKETS
  • Table 3-5: Developed/Developing Economies, UN Classification* Table, 2025
  • Figure 3-4: Developed vs. Developing IVD Market Shares, 2025 and Projected 2030 (%)
  • Table 3-6: Countries To Watch for IVD Opportunities, by Total Population and Percent Urban, 2025 [Australia; Brazil; China; France; Germany; Hungary; India; Mexico; Netherlands; Poland; Romania; Saudi Arabia; South Africa; South Korea; Sweden; Switzerland, Turkey; United Kingdom; United States]
• SIZE AND FORECAST FOR THE GLOBAL IVD MARKET
  • Table 3-7: Global In Vitro Diagnostic Market, Major Country/Region Markets, 2025 and 2030 ($ million) [Australia; Brazil; Canada; China; Eastern Europe; EU 15/W. Europe; India; Japan; Mexico; Peru; Russia; Saudi Arabia; South Africa; South Korea; Turkey; UAE; United States; Vietnam; Rest of World]
  • Table 3-8: Global In Vitro Diagnostic Market, Regional Markets, 2025 and 2030 ($ million) [Africa, Asia Pacific, Europe, Latin America, Middle East, North America]
  • Table 3-9: Global In Vitro Diagnostic Market, YOY Growth, by Segment, 2024-2025 (%) [Blood Bank Molecular; Blood Bank Screening – Immunoassays; Blood Grouping/Typing; Clinical Chemistry; Coagulation (PT/INR, Molecular); D-dimer; Diabetes HbA1c, Lab; Drugs of Abuse; Hematology - Core Lab; Histology/Cytology; Immunoassays - Infectious Disease; Immunoassays - Other Immunos; Mass Spectrometry (Micro/Non-Micro); Microbiology (ID/AST); Microbiology (Molecular); NAAT – Oncology; NAAT – Genetic/Inherited; POC, OTC Glucose OTC; POC Continuous Glucose; POC, OTC Other; POC, Professional/Hospital]
  • Table 3-10: Global In Vitro Diagnostic Market, Regional Markets, 2024-2025 YOY Change (%) [Africa, Asia Pacific, Europe, Latin America, Middle East, North America]
• THE IVD MARKET IN THE UNITED STATES
  • Table 3-11: United States IVD Market Share, by Segment, 2025 (%) [Blood Grouping; Clinical Chemistry; Coagulation; Hematology; Histology; Immunoassay Infectious Disease; Immunoassay Other; Microbiology ID/AST; Microbiology Molecular; Nucleic Acid Assays; POC Diabetes; POC Other; Others]
• PAMA and Reimbursement Changes
• Impact of CARES Act on PAMA
  • Table 3-12: Proposed Clinical Diagnostic Laboratory Test (CDLT) Rates, 2020-2027
• Saving Access to Laboratory Service Act (SALSA)
• LDT Update
• Bundled Insurance Payments for ESRD Patients
  • Table 3-13: Laboratory Tests Subject to ESRD Consolidated Billing
• Advanced Laboratory Tests (ADLT)
  • Table 3-14: List of Approved ADLTs, March 2026
• Precision Medicine and NGS
• IVD Market in Europe
  • Figure 3-5: International Monetary Fund Inflation Map, Global 2024
  • Table 3-15: Western European IVD Market, by Country, 2025 ($ million, estimated) [Austria; Belgium; Denmark; Finland; France; Germany; Greece; Ireland; Italy; Luxembourg; Netherlands; Norway; Portugal; Spain; Sweden; Switzerland; UK]
• EU Regulation
  • Table 3-16: IVD Market Per Capita, Europe, 2025 Estimates [Bulgaria; Croatia; Czech Republic; France; Germany; Greece; Hungary; Italy; Lithuania; Netherlands; Poland; Romania; Russia; Serbia; Slovakia; Slovenia; Spain; Sweden; Switzerland; Ukraine; UK]
• Precision Medicine in Europe
• Brexit
• JAPAN
  • Table 3-17: Japan IVD Market, Share by Segment, 2025 (%) [Clinical Chemistry; Coagulation; Hematology; Histology; Immunoassay Infectious Disease; Immunoassay Other; Microbiology ID/AST; Microbiology Molecular; POC Diabetes; POC Other; Others]
• EASTERN EUROPE: GROWTH REGION
  • Table 3-18: Eastern European IVD Market, by Country, 2025 ($ million) [Bulgaria; Croatia; Czech Republic; Hungary; Poland; Romania; Slovakia; Slovenia; Ukraine; Other]
  • Figure 3-6: Eastern Europe IVD Market, by Country, 2025 ($ million) [Bulgaria; Croatia; Czech Republic; Hungary; Poland; Romania; Slovakia; Slovenia; Ukraine; Other]
• CHINA: CURRENT IVD MARKET
  • Table 3-19: China IVD Market, Share by Segment, 2025 (%) [Blood Bank Screening; Clinical Chemistry; Coagulation; Hematology; Histology; Immunoassay Infectious Disease; Immunoassay Other; Microbiology ID/AST; Microbiology Molecular; POC Diabetes; POC Other; Others]
  • Table 3-20: Total Midyear Population, by Broad Age Group: China, 2010-2050 (million persons)
• Clinical Laboratory Market in China
• Volume-Based Procurement in China
• INDIA: POPULATION AND OPPORTUNITY
  • Table 3-21: India IVD Market, Share by Segment, 2025 (%) [Clinical Chemistry, Hematology, Coagulation; Histology/Cytology; Immunoassays; Microbiology/Virology; POC Glucose; POC Other; Others]
• Clinical Laboratory Market in India
• IVD Regulation
• India’s Mukt Bharat Campaign
• REST OF ASIA
  • Table 3-22: Asia Pacific Region IVD Market, by Country, 2025 ($ million) [Australia; China; India; Indonesia; Japan; Malaysia; Philippines; Singapore; South Korea; Thailand; Vietnam]
• BRAZIL
  • Table 3-23: Brazil IVD Market, by Broad Segment, 2025 (%) [Core Lab; Histology; Immunoassays; Microbiology/Virology; Point-of-Care - glucose; Point-of-Care - other]
• Disease Trends
• Clinical Laboratory Market in Brazil
• IVD Regulation
• MEXICO
  • Table 3-24: Mexico IVD Market, by Broad Segment, 2025 (%) [Clinical Chemistry, Hematology, Coagulation; Histology; Immunoassays; Microbiology; Point-of-Care; Others]
• THE RUSSIAN FEDERATION
• CANADA
• EMERGING MARKETS
  • Saudi Arabia IVD Market
  • South Africa IVD Market
  • South Korea IVD Market
  • Turkey IVD Market
  • United Arab Emirates (UAE) IVD Market
  • Other Markets to Watch
  • Chile
  • Colombia
  • Indonesia
  • Malaysia
  • Peru
  • Philippines
  • Poland
  • Romania
  • Thailand
  • Vietnam
• IVD MARKET OPPORTUNITY BY COUNTRY
  • Table 3-25: IVD Market Opportunity, by Country (2025 Market Rank, Country CAGR 2025-2030) (%)

CHAPTER 4: COMPANY AND INDUSTRY TRENDS

• SCOPE
• EDITION-SPECIFIC NOTES
• Advanced Medicine Without Borders
  • Table 4-1: Key Emerging IVD Markets, 2020-2025 ($ million)
• China Market Update
• Direct to Consumer Genetic Test Services
• Genetic Testing in Disease
• Genomic Testing
• GENE EDITING
  • Table 4-2: Selected Gene Editing / CRISPR Innovations
• CRISPR as a Diagnostic Tool
• CRISPR and the Food Industry
• MICROBIOME
  • Table 4-3: Selected Microbiome Test Innovations
• NEXT-GENERATION SEQUENCING
  • Table 4-4: Selected Clinical NGS Platforms on the Market
• Liquid Biopsy
• Quality Assurance
• Product News
• Market Cleared Products
• Liquid Biopsy in Microbiology
• Liquid Biopsy Companies in 2022-2025
• The Future for Liquid Biopsy
• INFORMATION TECHNOLOGY ADVANCES AND ARTIFICIAL INTELLIGENCE
• AI in Clinical Practice
  • Table 4-5: Selected AI Market Cleared Tests
• AI Physician Usage
• The Regulatory Pathway
• Product Initiatives
  • Table 4-6: Selected AI Product Initiatives in Development and Collaborations
• AI in Liquid Biopsy
• Role of AI in Liquid Biopsy Interpretation
• Industry Leaders and Initiatives
• New Liquid Biopsy / AI Products in Development or Recently Launched
  • Table 4-7: Selected AI/Liquid Biopsy Initiatives
• Future Trends
• EXOSOME SEQUENCING
• BIOTIN INTERFERENCE IN IMMUNOASSAY DETECTION ERRORS
  • Table 4-8: Biotin-free Offerings Currently on the Market
  • Table 4-9: Biotin Interference with Troponin Lab Tests – Assays Subject to Biotin Interference
• Clinical Applications and Liquid Biopsy
• TRAUMATIC BRAIN INJURY AND IVD
• PERSONALIZED MEDICINE
• Companion Diagnostics
  • Table 4-10: Selected FDA Approved Companion Diagnostics 2025
• TELEHEALTH
• BLOCKCHAIN
• SUBSTANCE ABUSE
• Biomarkers and Substance Abuse
• Clinical Laboratory Testing for Drugs of Abuse
  • Table 4-11: Global Drug Abuse Statistics
• Urine
• Blood
• Oral
• Hair
• SALIVA TESTING
• BREATH TEST ADVANCES
  • Table 4-12: Selected Disease Markers in Exhaled Breath
• MICRO-HOSPITAL OPPORTUNITIES
• CLIMATE CHANGE AND INFECTIOUS DISEASE
• KICKBACK SCHEMES
• EARLY SEPSIS DETECTION
• MEDICAL DIAGNOSTICS AND 3D PRINTING
• STAFFING SHORTAGES
• TARGETED TESTING

CHAPTER 5: POINT-OF-CARE (POC) TESTS

• SCOPE
• OVERVIEW AND TRENDS
• POC INDUSTRY DRIVERS
• Patient-focused drivers
• Medical/Healthcare-related drivers
• Technology drivers
• Economic drivers
• Other drivers
• POC INDUSTRY CHALLENGES
• REGULATORY CHALLENGES
• PROFESSIONAL POC
  • Table 5-1: Worldwide Professional POC Test Sales, by Category, 2025 -2030 ($ million) [Cardiac Markers; Cholesterol; Coagulation; Critical Care POC; Drugs of Abuse; Fecal Occult Blood; Fertility; Glucose; HbA1c POC; Hematology; Infectious Diseases; Urinalysis; Others]
  • Table 5-2: Selected Professional POC Test Innovations (excluding COVID-19 testing)
• OTC SELF TESTING
  • Table 5-3: Worldwide POC Self-Test Sales, by Category, 2025-2030($ million) [Cholesterol; Coagulation; Drugs of Abuse; Fecal Occult Blood; Glucose, Continuous; Glucose, Self; H. pylori; HIV; Other Infectious Disease (inc. COVID-19); Pregnancy; Urinalysis; Other (TSH, Allergy, Autoimmune, etc.)]
• PREGNANCY/FERTILITY TESTS
  • Table 5-4: POC Pregnancy and Fertility Test Market Distribution, by End User, 2025 (%) [OTC, PRO]
  • Table 5-5: Pregnancy/Fertility POC Test Sales Distribution, by Global Region, 2025 (%) [Europe; Japan; United States; Rest of World]
• COLON CANCER SCREENING
  • Table 5-6: Selected POC Colon Cancer Tests
  • Table 5-7: Colon Cancer POC Test Sales Distribution, by Global Region, 2025 (%) [Europe; Japan; United States; Rest of World]
• LIPID TESTING
  • Table 5-8: Lipid POC Test Sales Distribution, by Global Region, 2025 (%) [Europe; Japan; United States; Rest of World]
• DRUGS OF ABUSE TESTING
  • Table 5-9: POC Drugs of Abuse Test Sales Distribution, by Setting, 2025 (%) [Criminal Justice; Critical Care - Traditional POC; Employment Screening]
• Products
  • Table 5-10: Drugs of Abuse Tests on the Market
  • Table 5-11: Drugs of Abuse POC Test Sales Distribution, by Global Region, 2025 (%) [Europe; Japan; United States; Rest of World]
• RAPID AND POC INFECTIOUS DISEASE TESTING
  • Table 5-12: Innovations in Molecular POC Infectious Disease Diagnostics
• Products
  • Table 5-13: POC Infectious Disease Test Summary by Disease and Technology
• HIV and Hepatitis Testing and Monitoring
• Tuberculosis
• Tropical and Neglected Diseases
• Respiratory Diseases
• Sepsis and Nosocomial Disease
• Sexual Health
• Lyme Disease
• COVID-19
• MARKET SIZE AND GROWTH
• Point-of-Care OTC and Professional Use Immunoassays
  • Table 5-14: Global POC Immunoassay Sales Distribution, by Region, 2025 (%) [Europe; Japan; United States; Rest of World]
  • Table 5-15: Global POC Immunoassay Test Sales, by Test Category, 2025-2030 ($ million) [OTC/Self Tests (Drugs of Abuse; H. pylori; HIV; Infectious Disease/COVID-19; Pregnancy/Ovulation; Other) and Professional POC (Cardiac Markers; Drugs of Abuse; HbA1c; Infectious Disease/COVID-19; Pregnancy; Other)]
  • Table 5-16: Selected Self-Test Immunoassay Innovations
• Pregnancy Testing
• Cardiovascular Diagnostics
• Drugs of Abuse/Therapeutic Drug Monitoring
  • Table 5-17: Infectious Disease POC Test Demand, by Type, 2025 (%) [C. difficile; COVID-19; E. coli; H. pylori; Hepatitis; HIV; Home Test/OTC; Influenza; Malaria; Other respiratory; STD; Others]
  • Table 5-18: Infectious Disease POC Test Sales Distribution, by Global Region, 2025 (%) [Europe; Japan; United States; Rest of World]
• DIABETES TESTING – BLOOD GLUCOSE MONITORING
  • Table 5-19: Glucose POC Test Sales Distribution, by Global Region, 2025 (%) [Europe; Japan; United States; Rest of World]
  • Figure 5-1: POC Glucose Testing Market Growth, by Category, 2025-2030 (%) [Continuous; HbA1c POC, Professional; OTC; Professional]
• IT to Aid Diabetes Management
  • Table 5-20: Selected Apps and Glucose Management IT
• Diabetes Market Analysis
  • Table 5-21: Global Diabetes Sales, by Test Category, 2025-2030 ($ million) [Glucose OTC; Glucose, continuous; HbA1c Lab; HbA1c POC]
• POC Glucose Competitors
  • Table 5-22: Top Three POC Test Vendors, by Glucose Test Revenues, 2025 ($ million)
• Blood Glucose Self-Testing
  • Table 5-23: Selected Glucose Self-Test Meter Innovations
• Non-invasive Testing Devices
  • Table 5-24: Selected Noninvasive Glucose Monitoring Devices
• Continuous Glucose Monitoring
  • Table 5-25: Selected Continuous Blood Glucose System Developments
• Blood Glucose Testing by Professionals
  • Table 5-26: Selected Innovations in Hospital-based Glucose Monitoring
• Diabetes Testing – Glycated Hemoglobin
  • Table 5-27: Global HbA1c Test Sales Market and Distribution, by Setting, 2025-2030 ($ million) [HbA1c Lab; HbA1c POC]
  • Table 5-28: Selected POC HbA1c Devices
• Genes and Other Markers of Diabetes
  • Table 5-29: Selected POC Diabetes Monitoring Tests
• THE MAJOR POC TEST PLAYERS
  • Table 5-30: POC Test Revenues of Selected IVD Companies, 2025 ($ million)

CHAPTER 6: THE CORE LAB

• SCOPE
• CORE LAB OVERVIEW AND TRENDS
  • Table 6-1: Selected Analytes for the Core Lab
• CONNECTIVITY
• OVERVIEW OF CHEMISTRY TESTS
• Lab Automation
• MARKET ANALYSIS
  • Table 6-2: Global Lab-based Clinical Chemistry Sales, by Test Category, 2025-2030 ($ million) [Blood Gases; General Chemistries; Urinalysis]
  • Table 6-3: Global Clinical Chemistry Sales Distribution, by Region, 2025 (%) [Asia Pacific; Europe; North America; Rest of World]
  • Table 6-4: Selected Major Clinical Chemistry Companies, by Sales, 2025 ($ million, estimated)
  • Table 6-5: Selected Clinical Chemistry Innovations
• Rapid Response Systems
  • Table 6-6: Selected Major Whole Blood Chemistry Analyzers
• Critical Care Analysis
  • Table 6-7: Blood Gas, Electrolyte, and Critical Care Instrument Market, by End User, 2025 and 2030 ($ million) [Lab-based; POC-based]
  • Table 6-8: Blood Gas, Electrolyte, and Critical Care Market Leaders, 2025 (% distribution of total sales, including POC)
• Urinalysis
  • Table 6-9: Urinalysis Market, by End User, 2025 and 2030 ($ million) [Lab-based, POC-based]
  • Table 6-10: Urinalysis Systems (including POC) Market Leaders, 2025 (% distribution of total sales, estimated)
  • Table 6-11: Selected Urinalysis Innovations
• THE COMMERCIAL OUTLOOK FOR CHEMISTRY TESTS

CHAPTER 7: IMMUNOASSAYS

• SCOPE
• OVERVIEW AND TRENDS
• Immunoassay Technology Continues to Evolve
  • Table 7-1: Selected Immunoassay Technologies
• Mass Spectrometry
  • Table 7-2: Selected Innovation in Mass Spectrometry for Routine Analyses
• Radioimmunoassays
• MARKET ANALYSIS
  • Table 7-3: Global Lab-based Immunoassay Sales (excluding infectious disease and blood screening), by Analyte Type, 2025-2030 ($ million) [Allergy; Anemia; Autoimmune; Cardiac Markers; Diabetes/HbA1c; Drug of Abuse; Fertility; Proteins; Therapeutic Drugs; Thyroid; Tumor Markers; Vitamin D; Others]
  • Table 7-4: Global Immunoassay (excluding infectious disease and blood screening) Sales Distribution, by Region, 2025 (%) [Asia Pacific, Europe, Japan, North America, Rest of World]
  • Table 7-5: IVD Quality Control (immunoassay/molecular) Market, 2025 ($ million, estimated)
  • Table 7-6: Selected Immunoassay Quality Control Products
  • Table 7-7: Revenues of Leading Lab-based Immunoassay Vendors, 2024-2025 ($ million)
• MATURE ASSAY SEGMENT
• Thyroid Function
• Therapeutic Drug Monitoring
• Vitamin D
  • Table 7-8: Selected Vitamin D Immunoassays
• Anemia
• Toxicology/DAU
• Allergy
• GROWTH IMMUNOASSAYS
• Proteins
  • Figure 7-1: Other Proteins, by Percent of Total, 2025 (%)
• Tumor Markers
  • Table 7-9: Selected Tumor Marker Innovations
• Cardiac Markers
  • Table 7-10: Regional Cardiac Marker Immunoassay Market Share, by Country, 2025 (%) [EU Countries; Japan; Latin America; Middle East; North America; Rest of Asia Pacific; Rest of Europe; Rest of World]
  • Table 7-11: Selected Cardiac Marker Innovations
• Autoimmune
  • Table 7-12: Selected Autoimmune Test Innovations
• Rheumatoid Arthritis
  • Table 7-13: Selected Arthritis Immunoassay Innovations
• Gastrointestinal Disorders
  • Table 7-14: Selected Inflammatory Bowel Disease Test Innovations
• Transplant Management
  • Table 7-15: Selected Immunoassays for Transplant Medicine
• Women’s Health
  • Table 7-16: Selected Women’s Health Innovations
• Alzheimer’s Disease and Multiple Sclerosis
  • Table 7-17: Selected Innovations for Alzheimer’s Disease Immunoassays
• Traumatic Brain Injury
• Other Immunoassays
  • Figure 7-2: Other Select Immunoassays, by Percent of Total Immunoassays, 2025 (%) [Bone Marker; Endocrine/Adrenal; Radioimmunoassays; Others]
  • Table 7-18: Selected Immunoassay Innovations
• INNOVATING POC
  • Table 7-19: Selected POC Test Innovations
  • Table 7-20: Selected POC Immunoassay Test Platforms
• THE COMMERCIAL OUTLOOK FOR IMMUNOASSAYS

CHAPTER 8: MOLECULAR ASSAYS

• SCOPE
• OVERVIEW
  • Table 8-1: Common Next Generation Molecular Test Traits
• SAMPLE PREPARATION AND QUALITY CONTROL
  • Table 8-2: Selected Molecular Test Sample Preparation and QC Innovations
• MOLECULAR EVOLUTION
• Exosome Sequencing
  • Table 8-3: Selected Exosome Test Innovations
• Liquid Biopsy
  • Table 8-4: Selected Liquid Biopsy Innovations
• Metabolomic Profiling
• Information Technology
  • Table 8-5: Selected IT Innovations in Molecular Diagnostics
• Artificial Intelligence (AI)
• Forensic Studies – An Emerging Opportunity
  • Table 8-6: Selected Innovations in Forensic DNA Testing
• Test Platforms
  • Table 8-7: Key Molecular Technologies and Major Players
  • Table 8-8: Selected Molecular Test Platform Innovations
• MAJOR PLAYERS
  • Table 8-9: Molecular Test Revenues of Selected IVD Vendors, 2022, 2023, 2024, and estimated 2025 ($ million)
• MARKET ANALYSIS
  • Table 8-10: Global Genomic, HLA, NIPT, and Oncology Molecular Test Sales, by Type with NIPT, 2025-2030 ($ million)
• Oncology
  • Table 8-11: Global Molecular Cancer Test Sales Distribution, by Region, 2025 (%) [Asia Pacific; Europe; North America; Rest of World]
  • Table 8-12: Selected Molecular Tumor Marker Test Innovations
• Inherited/Genetic Diseases, Thrombophilia SNPs and Other Disorders
  • Table 8-13: Most Frequently Requested Genetic Tests
  • Table 8-14: Global Molecular Thrombophilia Assay Sales Distribution, by Region, 2025 (%) [Asia Pacific; Europe; North America; Rest of World]
• Alzheimer’s Disease and Dementia
• Cardiovascular Disease
  • Table 8-15: Selected Genomic Tests for Inherited Diseases
• Depression and Psychiatric Disorders
• Prenatal and Newborn Testing
  • Table 8-16: Global Prenatal Test Sales Distribution, by Region, 2025 (%) [Asia Pacific; Europe; North America; Rest of World]
  • Table 8-17: Selected Prenatal Services Provided
  • Table 8-18: Selected Molecular Tests for Prenatal Analysis
• Transplant Diagnostics
  • Table 8-19: Global Molecular HLA Testing Sales Distribution, by Region, 2025 (%) [Asia Pacific; Europe; North America; Rest of World]
  • Figure 8-1: Global Transplant Rate, by Region, 2024
  • Table 8-20: Selected Innovations of Molecular Transplant Diagnostics
• Women’s Health
• THE COMMERCIAL OUTLOOK FOR MOLECULAR TESTS

CHAPTER 9: HEMATOLOGY

• SCOPE
• OVERVIEW OF HEMATOLOGY AND TRENDS
  • Table 9-1: Hematology Analyzer Distribution of Sales, by Menu Capability, 2025 estimated (%)
  • Table 9-2: Lab-based Hematology Sales, by Analyte Average Annual Distribution, 2025 (%)
• Digital Image Analysis
  • Table 9-3: Selected Hematology Image Analysis Innovations
• Digital Evolution
• Quality Control Measurement Programs
  • Table 9-4: Selected Quality Control Hematology FDA Registrations, 2024
• LABORATORY-BASED HEMATOLOGY TESTING
  • Table 9-5: Selected Hematology Innovations
  • Table 9-6: Global Laboratory-based Hematology Test and Instrument Market, 2025 and 2030 ($ million)
• Regional Laboratory-based Hematology Test and Instrument Market
  • Table 9-7: Global Laboratory-based Hematology Test and Instrument Market, by Region, 2025 (%) [Asia Pacific; Europe; North America; Rest of World]
• DECENTRALIZED HEMATOLOGY TESTING
• Hemoglobin/Hematocrit at the POC
  • Table 9-8: POC Hematology Distribution, by Specialty, 2025 (%) [Hematocrit/Hemoglobin vs. Other Routine Hematology (WBC, Erythrocyte, Platelet)]
  • Table 9-9: Selected POC Hemoglobin and Hematocrit Systems
  • Table 9-10: Selected POC Hematology Analyzer Systems
  • Table 9-11: Decentralized Hematology Test and Instrument Market, by Type, 2025 and 2030 ($ million) [Instruments, Lab-Style; Handheld Devices]
• MARKET ANALYSIS: LEADING SUPPLIERS
  • Table 9-12: Top Hematology Company Revenues (Laboratory and POC), 2025 ($ million)
  • Figure 9-1: Market Share for Top Hematology Companies (Laboratory and POC), 2025 (%)
  • Table 9-13: Global Hematology (Laboratory-based and POC) Sales Distribution, by Region, 2025 (%) [Asia Pacific; Europe; North America; Rest of World]
• THE COMMERCIAL OUTLOOK FOR HEMATOLOGY TESTS

CHAPTER 10: COAGULATION

• SCOPE
• OVERVIEW AND TRENDS OF COAGULATION AND IMMUNOHEMATOLOGY TESTS
  • COVID-19
  • Direct Oral Anticoagulants (DOACs)
  • D-dimer
    • Table 10-1: Global D-dimer Sales Distribution, by Region, 2025 (%) [Asia Pacific; Europe; North America; Rest of World]
  • MARKET ANALYSIS
    • Table 10-2: Global Coagulation Sales, by Segment, 2025-2030 ($ million) [D-dimer; Molecular; Professional POC; Professional Self; PT/INR Labs]
    • Table 10-3: Global Coagulation Test and Instrument Market, by Region, 2025 (%) [Asia Pacific; Europe; North America; Rest of World]
  • LAB-BASED TESTING
    • Table 10-4: Selected Lab-based Coagulation Innovations
  • Genetic Markers of Hypercoagulopathies
    • Table 10-5: Related CMS Codes for Reimbursement National Limits, Molecular, 2025
    • Table 10-6: Global Molecular - Thrombophilia SNP Sales Distribution, by Region, 2025 (%) [Asia Pacific; Europe; North America; Rest of World]
    • Table 10-7: Selected Molecular Coagulation Test Innovations
  • LEADING SUPPLIERS: LABORATORY SYSTEMS
    • Table 10-8: Top Coagulation Company Market Share Laboratory-based, 2025 (%)
  • DECENTRALIZED COAGULATION TESTING – PROFESSIONAL USE
  • Decentralized Coagulation Testing – OTC
    • Table 10-9: Selected POC Coagulation Test Innovations
  • Platelet Testing
    • Table 10-10: Selected Platelet Activity Test Innovations
  • LEADING SUPPLIERS: POC SYSTEMS
    • Table 10-11: Top Coagulation Company Revenues, POC, 2025 ($ million, estimated)
  • THE COMMERCIAL MARKET FOR COAGULATION TESTS
    • Table 10-12: Major Anticoagulants Uses and Tests

CHAPTER 11: MICROBIOLOGY AND VIROLOGY

• SCOPE
• THE REAL IMPACT OF INFECTIONS
  • Herpes and Alzheimer’s Disease
  • Ebola and Cancer
  • HIV and Cancer
  • H pylori and Cancer
  • Bacteria and Parkinson's
  • HPV and Cancer
• MICROBIAL ANTIBIOTIC RESISTANCE – THE ROLE OF CLINICAL TESTS
  • Fast Identification
    • Table 11-1: Selected Companies Developing Faster Identification, Some Also with Antimicrobial Susceptibility/Resistance Tests
  • TRADITIONAL MICROBIOLOGY AND ITS LIMITS
  • THE NEW MICROBIOLOGY - INNOVATIONS
    • Liquid Based Microbiology and Automation Innovations
    • Post-Blood Culture Microbial ID
    • PCR and Other NAAT-Based Tests for Infectious Diseases
      • Table 11-2: Selected Nucleic Acid Amplification Test and Other Molecular Companies in Microbiology
    • Microbiome-Related Microbiology Tests
    • Illumina
    • Bio-Rad
    • QIAGEN
    • Luminex (Diasorin)
    • inBiome BV
    • DNA Genotek
    • Thermo Fisher Scientific
    • Others
    • Next-Generation Sequencing-Based Microbiology Approaches
      • Table 11-3: Selected Companies Applying DNA/RNA Sequencing to Microbiology
    • Syndromic/Multiplex Testing
  • HIGH-CONSEQUENCE INFECTIOUS DISEASE THREATS
    • Table 11-4: Selected Companies Marketing Products Addressing High-Consequence Infectious Disease Threats
  • Tickborne Diseases (TBDs)
  • TB and Other Infectious Diseases
  • Chagas
  • Dengue
  • Ebola
  • Chikungunya
  • Middle East Respiratory Syndrome-Coronavirus (MERS-CoV)
  • Marburg
  • SARS-CoV-2 (COVID-19)
  • Monkeypox
• MARKET ANALYSIS
  • Table 11-5: Global Microbiology Sales Distribution, by Region, 2025 (%) [Asia Pacific; Europe; North America; Rest of World]
• MARKET ANALYSIS - TRADITIONAL MICROBIOLOGY ID/AST
  • Table 11-6: Global Microbiology ID/AST Market, by Segment, 2025-2030 ($ million) [Blood Culture; Chromogenic Media; ID/AST Auto; ID/AST Panels; Rapid Microbiology]
  • Table 11-7: Global ID/AST Testing Sales Distribution, by Region, 2025 (%) [Asia Pacific; Europe; North America; Rest of World]
• Traditional ID/AST
  • Table 11-8: Global ID/AST Testing, Distribution by Systems, (%) [Auto, Panel]
• Blood Culture
  • Table 11-9: Selected Advanced Techniques in Positive Blood Culture
• Chromogenic Media
• Rapid Tests Performed on Colonies from Culture Media
• Supplies

• MARKET ANALYSIS - MICROBIOLOGY IMMUNOASSAYS
  • Improvements in Microbiology Immunoassays
    • Figure 11-1: Immunoassay Respiratory Testing, by Target Pathogens, 2025 (%) [Multi-Target, Single-Target]
    • Table 11-10: Selected Infectious Disease Immunoassay Innovations
    • Table 11-11: Global Clinical Laboratory-Based Microbiology/Infectious Disease Immunoassay Market, by Pathogen, 2025($ million) [HAIs/Sepsis; Hepatitis; HIV; Lyme Disease; Mycology; Parasitology; Respiratory; STDs; ToRCH; Other]
    • Table 11-12: Global Laboratory-Based Microbiology/Infectious Disease Immunoassay Market Distribution, by Region, 2025 (%) [Asia Pacific; Europe; North America; Rest of World]
  • Hepatitis Testing
  • Sepsis
    • Figure 11-2: Global Lab-based Microbiology Immunoassay Sepsis Market Distribution, by Type, 2025 (%) [PCT, Traditional]
  • HIV Immunoassay Testing
    • Table 11-13: Selected HIV Assays
  • Sexually Transmitted Diseases (STDs)
  • ToRCH
  • Lyme Disease
• MARKET ANALYSIS - MOLECULAR MICROBIOLOGY
  • Table 11-14: Global Molecular Microbiology Sales Distribution by Region, 2025 (%) [Asia Pacific, Europe, North America, RoW]
  • Table 11-15: Global Molecular Microbiology Market, by Pathogen/Disease Indication, 2025-2030 ($ million) [Blood Bank Screening; GC/Chlamydia; HAI; Hepatitis; HIV; Mycobacteria/TB; Organism ID; Respiratory; Others]
• Lab Automation and Molecular Diagnostics
  • Table 11-16: Selected Automated Molecular Test Instrument Platforms
• Molecular Respiratory Infection Testing
• The Respiratory Trio – Flu, Strep, RSV
  • Figure 11-3: Molecular Respiratory Testing, by Target Pathogens, 2025 (%) [Multi-Target, Single-Target]
• Molecular Testing for Sexually Transmitted Diseases
• Molecular Hepatitis Testing
• Molecular HIV Testing
  • Table 11-17: Innovations in Molecular POC Diagnostics for HIV
• Molecular Tests for Hospital-Acquired Infections (HAIs)
  • Table 11-18: Frequency of the Most Common Nosocomial Infections
• Assessing the Problem: Nosocomial Infection Statistics
• Clostridium Difficile
• MRSA
• Molecular TB Testing
• Limitations of Molecular Microbiology Testing

• RAPID MICROBIOLOGY TESTS
  • Table 11-19: Global Rapid Microbiology Testing Market, Sales Distribution, by Pathogen, 2025 (%) [C. Difficile; COVID-19; E. coli; H. pylori; Hepatitis; HIV; Influenza; Malaria; Other respiratory; STD; Other]
  • Figure 11-4: Rapid Infectious Disease Test Sales, by Respiratory/Non-respiratory Segments, 2025 (%)
  • Figure 11-5: Rapid Respiratory Testing, by Target Pathogens, 2025 (%) [Multi-Target, Single-Test]
• MASS SPECTROMETRY
  • Table 11-20: Selected Companies Marketing Mass Spectrometers and/or Assays for the Clinical Laboratory [CE-Marked and/or 510(k) cleared]
• THE FUTURE OUTLOOK FOR MICROBIOLOGY

CHAPTER 12: BLOOD BANKING SERVICES

• SCOPE
• OVERVIEW
• The Current Status of Global Blood Collection
• GLOBAL BLOOD SAFETY
  • Table 12-1: Laboratory Screening of Blood Donations for Transfusion-Transmissible Infections, Number of Countries [Chagas; HBV; HCV; HIV; HTLV I/II1; Malaria; Syphilis]
  • Table 12-2: Prevalence of TTIs in Blood Donations [Median (Interquartile range)], by Income Group
• Zika Virus
• Blood and Component Collection
  • Table 12-3: Blood Component Usage for Selected Conditions
• Reevaluating Blood Transfusions
  • Table 12-4: Impact of Alloimmunization (% of Patients Screening Positive for One or More Antibodies)
• BLOOD TYPING AND GROUPING MARKET
• Manual Blood Typing Methods
• Automated Blood Typing and Screening Methods
• Molecular Methods
  • Table 12-5: Selected Blood Typing and Grouping Innovations
• Size and Growth of Typing Markets
  • Table 12-6: Global Blood Typing Market, 2025-2030 ($ million)
• Blood Typing Market by Geography
  • Table 12-7: Global Blood Typing Sales Distribution, by Region, 2025 (%) [Asia Pacific; Europe; North America; Rest of World]
• BLOOD TESTING MARKET
  • Table 12-8: Selected Blood Testing Innovations
• Preventing Bacterial Infections
• Immunoassays
• Nucleic Acid Testing (NAT)
• Size and Growth of the Market
  • Table 12-9: Global Blood Banking Diagnostics Market, 2025-2030 ($ million) [Immunoassay Screen; NAT Screens]
• Blood Testing Market by Geography
  • Table 12-10: Global Blood Testing Market, by Geography, 2025 (%) [Asia Pacific; Europe; North America; Rest of World]

THE COMMERCIAL OUTLOOK FOR BLOOD BANKING TESTING

CHAPTER 13: HISTOLOGY AND CYTOLOGY

• SCOPE
• OVERVIEW
• SPECIAL TOPICS
• Histology Automation
  • Table 13-1: Selected Histology Lab Automation
  • Table 13-2: Histology Information Technology Tools
• Advanced Analysis Solutions
  • Table 13-3: Selected Advanced Histology Techniques
• HPV IVD Testing Becomes Main Stream
  • Table 13-4: Global HPV Test Sales Distribution, by Region, 2025 (%) [Asia Pacific; Europe; North America; Rest of World]
  • Table 13-5: Selected HPV Test Innovations
• MARKET ANALYSIS
• Total Market
  • Table 13-6: Global Histology/Cytology Sales, by Type, 2025-2030 ($ million) [HPV; Immunohistochemistry; in situ hybridization; Pap Tests; traditional non-Pap stains]
• Regional Market Analysis
  • Table 13-7: Global Histology/Cytology Sales Distribution, by Region, 2025 (%) [Asia Pacific; Europe; North America; Rest of World]
  • Table 13-8: Revenues of the Major Histology Companies, 2018-2025 ($ million, estimated)
• Traditional Stains
  • Table 13-9: Selected Vendors of Traditional Histology Stains
• Pap Testing
  • Table 13-10: Primary and Secondary Prevention of Cervical Cancer, Screening Responses, by Country, 2021
  • Table 13-11: Three approaches to cervical cancer screening and future tests
• Immunohistochemistry and In Situ Hybridization
  • Table 13-12: Selected In Situ Hybridization-based Tests
  • Table 13-13: Selected IHC Test Innovations
• Pharmacodiagnostic Histology
  • Table 13-14: Major Pharmacodiagnostic Markers
  • Table 13-15: Selected Pharmacodiagnostic Histology Tests
• Digital Imaging and Computational Pathology
  • Table 13-16: Selected Digital Pathology Image Capture and Viewing Solutions
  • Table 13-17: Selected Digital Imaging Innovations
• Circulating Tumor Cells
  • Table 13-18: Innovations in CTC Technology
• Flow Cytometry
• THE COMMERCIAL OUTLOOK FOR HISTOLOGY AND CYTOLOGY TESTS

CHAPTER 14: COMPANY PROFILES: THE TOP TIER

• SCOPE
• ABBOTT DIAGNOSTICS
  • Table 14-1: Abbott Diagnostics Revenue History, 2023-2025 ($ million)
  • Table 14-2: Abbott Diagnostic Revenues, by Segment, 2023-2025 ($ million, estimated)
• Core Lab
• Hematology
• Blood Banking
• Infectious Diseases – Molecular
• Diabetes
• HIV Point of Care
  i-STAT Business
• AGILENT TECHNOLOGIES
  • Table 14-3: Agilent Revenue History, 2023-2025 ($ million)
• Genomics
• Cytogenetic Analysis
• Sequencing
• CRISPR
• Flow Cytometry
• Companion Diagnostics - Dako
• Digital Pathology
• BECKMAN COULTER / DANAHER
• Hematology
• Hematology IT
• Clinical Chemistry
• Immunoassays
• Microbiology
• IT Clinical
• Flow Cytometry
• Blood Banking
• Beckman Coulter Life Sciences
• BECTON, DICKINSON AND COMPANY (BD)
  • Table 14-4: BD Revenue History, 2023-2025 ($ million, estimated) FYE Sept 30
• Cytology
• Molecular Microbiology
• Traditional Microbiology - ID/AST
• Blood Culture
• Hospital Acquired Infections
• Blood Collection
• Mass Spectrometry
• Flow Cytometry
• Immunoassay
• BIOMÉRIEUX INC.
  • Table 14-5: bioMérieux Revenue History, 2023-2025 (€ million)
• Traditional Microbiology
• Blood Culture
• Immunoassays
• Mass Spectrometry
• BIOFIRE Diagnostics Business
• Expansion
• BIO-RAD LABORATORIES, INC.
  • Table 14-6: Bio-Rad Revenue History, 2023-2025 ($ million, estimated)
• Quality Control
• Blood Bank
• Diabetes
• Immunoassays
• Liquid Biopsy
• Droplet Digital PCR
• Sequencing
• BRUKER CORPORATION
  • Table 14-7: Bruker Revenue History Product Revenue, 2023-2025 ($ million)
• Acquisitions and Collaborations
• Mass Spectrometry
• Microbiology
• Molecular PCR
• CEPHEID / DANAHER
• GeneXpert/ Xpress Line
• Tuberculosis
• Microbiology
• POC Testing
• Cancer
• DANAHER CORPORATION
  • Table 14-8: Danaher Revenue History, Diagnostics Segment, 2023-2025 ($ million, estimated)
• DEXCOM
  • Table 14-9: Dexcom Revenue History, 2023-2025 ($ million)
• EXACT SCIENCES
  • Table 14-10: Exact Sciences Revenue History, 2023-2025 ($ million)
• HOLOGIC, INC.
  • Table 14-11: Hologic Revenue History, Diagnostic Product Revenue, 2023-2025 ($ million)
• PANTHER Molecular System
• Sexually Transmitted Infections
• Infectious Diseases
• PANTHER Fusion
• Cytology
• ILLUMINA
  • Table 14-12: Illumina Revenue History, 2023-2025 ($ million, not all revenues are for clinical products and services; estimated)
• China
• LEICA BIOSYSTEMS/DANAHER
• Digital Pathology
• Tissue Staining
• Lab Systems
• NATERA
  • Table 14-13: Natera Revenue History, 2023-2025 ($ million)
• QIAGEN
  • Table 14-14: QIAGEN Revenue History, 2023-2025 ($ million)
• Tuberculosis.
• Molecular Expansion
• Precision Medicine / Companion Diagnostics
• Molecular Microbiology
• Prenatal Testing
• Next-Generation Sequencing
• Liquid Biopsy
• Cervical Cancer
• Expansion
• QUIDELORTHO CORPORATION
  • Table 14-15: QuidelOrtho Revenue History, 2023-2025 ($ million)
  • Table 14-16: QuidelOrtho Diagnostic Revenues, by Segment, 2023-2025 ($ million, estimated)
• Immunoassays
• Rapid Immunoassays
• The Solana Business
• Blood Bank
• RADIOMETER A/S / DANAHER
• Critical Care
• Immunoassays
• HemoCue
• Transcutaneous Monitoring
• REVVITY
  • Table 14-17: Revvity Revenue History, 2023-2025 ($ million, estimated)
• ROCHE DIAGNOSTICS
  • Table 14-18: Roche Revenue History, 2023-2025 (CHF million)
  • Table 14-19: Roche Diagnostic Revenues, by Segment, 2023-2025 (CHF million)
• Hematology
• Immunoassays
• HIV
• Molecular Expansion
• Core Molecular
• Digital PCR
• Diabetes Care
• Coagulation
  cobas Liat System – POC
• HPV
• Blood Bank
• Transplant Medicine
• Sequencing and Mass Spectrometry
• Cancer Companion Testing
• Information Technology
• ROCHE TISSUE DIAGNOSTICS
• Immunohistochemistry - IHC
• Cervical Cancer Screening
• Companion Diagnostics
• SIEMENS HEALTHINEERS (SIEMENS)
  • Table 14-20: Siemens Healthineers Revenue History, 2023-2025 (€ million)
• Core Lab
• Lab Automation
• Immunoassays
• Hematology
• Urinalysis
• Molecular
• Sequencing with Artificial Intelligence
• Acute Care – POC
• POC Connectivity
• Business Expansion
• SYSMEX CORPORATION
  • Table 14-21: Sysmex Revenue History, 2023-2025 (billions of Yen) FYE March 31
• Hematology
• Coagulation
• Urinalysis
• Immunoassays
• Lab Information System
• Flow Cytometry
• Precision Medicine / Companion Test Diagnostics
• Liquid Biopsy
• Sysmex Inostics
• Forging New Markets
• THERMO FISHER SCIENTIFIC INC.
  • Table 14-22: Thermo Fisher Revenue History, Clinical Diagnostics, 2023-2025 ($ million)
• Immunoassays
• Microbiology
• Molecular Test Business
• Next-Generation Sequencing
  qPCR
• Oncology Companion Diagnostics
• Transplant Medicine
• Mass Spectrometry
• WERFEN
  • Table 14-23: Werfen Recent Revenue History, 2023-2025 (€ billion)

CHAPTER 15: COMPANY PROFILES: THE SECOND TIER

• SCOPE
• ARKRAY
• Dry Chemistry / Immunoassays
• Urinalysis
• BGI GENOMICS (FORMERLY BEIJING GENOME INSTITUTE)
• MGI Tech Co., Limited, China
• Prenatal Testing
• Test Services
• Whole Genome Sequencing (WGS)
• NGS Sequencing
• BIOCARTIS
• DIAGNOSTICA STAGO S.A.S.
• DIASORIN S.P.A
• POC
• Immunoassays
• Molecular
• Molecular Oncology
• EIKEN CHEMICAL CO., LTD
• FUJIREBIO DIAGNOSTICS, INC.
• FULGENT GENETICS, INC
• GENEDX
• GRIFOLS S.A.
• Blood Transfusion Business
• ABO Blood Typing
• Molecular ABO Blood Typing
• Immunoassays
• GUARDANT HEALTH, INC.
• HAEMONETICS
• HORIBA
• MENARINI DIAGNOSTICS
• MERIDIAN BIOSCIENCE, INC.
• MINDRAY - SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
• MYRIAD GENETICS, INC.
• ORASURE TECHNOLOGIES, INC.
• RANDOX LABORATORIES LTD.
• Clinical Chemistries
• POC and Rapid
• Companion Diagnostics
• Controls
• Evidence Series - Multistat Biochip Analyzers
• Molecular
• SEEGENE, INC.
• SEKISUI DIAGNOSTICS LLC
• VERACYTE, INC.

CHAPTER 16: COMPANY PROFILES: BLOOD BANK SPECIALISTS

• SCOPE
• ALIVEDX
• CERUS CORPORATION

CHAPTER 17: COMPANY PROFILES: CORE LAB AND OTHER COMPANIES

• SCOPE
• SCIEX PTE LTD.
• Diabetes
• Molecular
• EKF DIAGNOSTICS HOLDINGS PLC
• SHIMADZU SCIENTIFIC INSTRUMENTS
• SNIBE CO. LTD. (SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO. LTD.)
• TOSOH BIOSCIENCE
• TRINITY BIOTECH PLC

CHAPTER 18: COMPANY PROFILES: CTC & LIQUID BIOPSY TEST PROVIDERS

• SCOPE
• EPIC SCIENCES
• FOUNDATION MEDICINE, INC.
• NEOGENOMICS

CHAPTER 19: COMPANY PROFILES: SPECIALISTS

• SCOPE
• ASCENSIA DIABETES CARE HOLDINGS AG
• INSULET CORPORATION
• MEDTRONIC PLC
• VERILY LIFE SCIENCES LLC

CHAPTER 20: COMPANY PROFILES: HEMATOLOGY (CELL ANALYSIS) AND COAGULATION SPECIALISTS

• SCOPE
• CELLAVISION AB
• MASIMO CORPORATION
• NOVA BIOMEDICAL CORPORATION (NOVA)

CHAPTER 21: COMPANY PROFILES: HISTOPATHOLOGY SPECIALISTS

• SCOPE
• AMOY DIAGNOSTICS CO. LTD.
• APPLIED SPECTRAL IMAGING INC. (ASI)
• VISIOPHARM

CHAPTER 22: COMPANY PROFILES: IMMUNOASSAY SPECIALISTS

• SCOPE
• BIOHIT HEALTHCARE
• BIOMERICA INC.
• BIO-TECHNE CORPORATION
• EUROBIO SCIENTIFIC
• EUROIMMUN AG (REVVITY)
• INOVA DIAGNOSTICS, INC.
• VOLITIONRX LIMITED

CHAPTER 23: COMPANY PROFILES: MICROBIOLOGY SPECIALISTS

• SCOPE
• ADVANCED BIOLOGICAL LABORATORIES, S.A. (ABL)
• ALTONA DIAGNOSTICS
• ARCDIA INTERNATIONAL OY LTD.
• COPAN ITALIA S.P.A. AND COPAN DIAGNOSTICS, INC.
• GENETIC ANALYSIS AS
• Q-LINEA AB

CHAPTER 24: COMPANY PROFILES: MOLECULAR TEST SPECIALISTS

• SCOPE
• PACIFIC BIOSCIENCES OF CALIFORNIA, INC. (PACBIO)
• STANDARD BIOTOOLS

CHAPTER 25: COMPANY PROFILES: POINT OF CARE TEST SPECIALISTS

• SCOPE
• ABINGDON HEALTH LTD.
• BINX HEALTH
• CHEMBIO DIAGNOSTIC SYSTEMS, INC.
• GENEDRIVE PLC (FORMERLY EPISTEM HOLDINGS)
• MEDMIRA, INC.

CHAPTER 26: COMPANY PROFILES: PRENATAL TEST SERVICE PROVIDERS

• SCOPE
• BERRY GENOMICS CO. LTD.
• INEX INNOVATE
• OXFORD GENE TECHNOLOGY
• YOURGENE HEALTH

CHAPTER 27: COMPANY PROFILES: QUALITY CONTROL & SAMPLE PRETREATMENT SPECIALISTS

• SCOPE
• AGENA BIOSCIENCE, INC.
• BIOTYPE DIAGNOSTIC GMBH
• INCELLDX
• LGC SERACARE LIFE SCIENCES, INC.
• PREANALYTIX GMBH
• PRECIPIO, INC.
• QUANTERIX CORPORATION
• STRECK INC.

CHAPTER 28: TEST SERVICE PROVIDERS

• SCOPE
• AGENDIA BV
• AMBRY GENETICS
• ARUP LABORATORIES
• ASPIRA WOMEN’S HEALTH
• BLUEPRINT GENETICS OY
• BOSTON HEART DIAGNOSTICS
• CAREDX, INC.
• PREDICTIVE ONCOLOGY
• LABCORP, LABORATORY CORPORATION OF AMERICA
• MAYO CLINIC LABORATORIES
• MDXHEALTH SA
• OPKO DIAGNOSTICS/OPKO HEALTH
• QUEST DIAGNOSTICS
• SONIC HEALTHCARE