体外診断用AIの世界市場の評価：コンポーネントタイプ別、技術別、用途別、エンドユーザー別、地域別、機会、予測（2017年～2031年）

世界の体外診断用AIの市場規模は、予測期間中にCAGR 26.56％で成長し、2023年の6億4,944万米ドルから、2031年には42億7,475万米ドルに成長すると予測されています。

体外診断用AIの市場は、正確で迅速な診断に対する需要の高まり、AIや機械学習における技術的進歩、データ分析能力の向上、規制当局の支援、データ駆動型の疾患予後の重視の高まりなどの要因によってプラスの影響を受けています。放射線科患者の画像診断手順の自動化とデジタル化も、診断精度を向上させ放射線科医の作業負荷を軽減するAIベースのツールの必要性を促進し、市場の成長をさらに高めています。

正確で迅速な診断への需要の高まり

正確で迅速な診断に対する需要の高まりは、体外診断用AIの統合に大きな影響を与えています。AIは診断精度、効率、患者の転帰を向上させることで、体外診断に革命をもたらしています。ビッグデータの導入と技術の進歩は、体外診断用AIの応用機会を促進し、医療診断、モニタリング、治療の意思決定の改善につながります。機械学習アルゴリズムによってヒューマンエラーを排除するAIのユニークな能力は、正確で迅速な診断を可能にし、市場のさらなる拡大につながります。主要企業は、診断プロセスを迅速化し、信頼性の高い結果を提供するために革新的な製品に投資しています。

機械学習アルゴリズムの進歩

ヘルスケア業界は、体外診断のための機械学習アルゴリズムの進歩によって急速な変貌を遂げつつあります。AIによるラボ分析、癌診断のためのディープラーニング、スマート診断システムなどが注目すべき発展として現れています。クラウドコンピューティングとAIにおけるこれらのイノベーションは、医療の意思決定を劇的に改善する可能性を秘めています。さまざまな疾患に対する大規模臨床試験を通じて検証されたAI連動型のユニバーサル診断システムは、もっとも有望なアプリケーションのひとつです。細胞ベースの腫瘍学的検査、臨床判断支援、反射検査、エラー検出、画像解析におけるAIの統合は、ラボ環境とヘルスケア業界に大きな変化をもたらすと期待されています。

AIベースの体外診断ソリューションに対する規制当局の焦点

AIベースの体外診断ソリューションの安全性と有効性を確保するためには、規制当局のサポートが不可欠です。世界の多くの当局が法規制面での支援イニシアチブを実施しており、体外診断市場におけるAIの成長にさらに貢献しています。

当レポートでは、世界の体外診断用AIの市場を調査し、市場の定義と概要、市場規模の推移・予測、各種区分・地域別の詳細分析、産業構造、市場成長への影響因子の分析、ケーススタディ、競合情勢、主要企業のプロファイルなどをまとめています。

目次

第1章 調査手法

第2章 プロジェクトの範囲と定義

第3章 エグゼクティブサマリー

第4章 世界の体外診断用AI市場の展望

• 市場規模・予測
• コンポーネントタイプ別
  • ソフトウェア
  • サービス
  • ハードウェア
• 技術別
  • 機械学習
  • 自然言語処理
  • コンテキストアウェアコンピューティング
  • コンピュータビジョン
  • その他
• 用途別
  • 癌
  • 糖尿病
  • 感染症
  • 心臓血管
  • その他
• エンドユーザー別
  • 病院
  • 画像診断センター
  • 病理学センター
  • その他
• 地域別
  • 北米
  • 欧州
  • アジア太平洋
  • 南米
  • 中東・アフリカ
• 企業別市場シェア

第5章 世界の体外診断用AI市場の展望：地域別

• 北米
• 欧州
• アジア太平洋
• 南米
• 中東・アフリカ

第6章 市場マッピング

• コンポーネントタイプ別
• 技術別
• 用途
• エンドユーザー別
• 地域別

第7章 マクロ環境と産業構造

• 需給分析
• 輸出入分析
• バリューチェーン分析
• PESTEL分析
• ポーターのファイブフォース分析

第8章 市場力学

• 成長促進要因
• 成長抑制要因（課題、抑制要因）

第9章 規制の枠組みとイノベーション

• 特許情勢
• 規制当局の承認
• イノベーション/最新技術

第10章 主要企業の情勢

• 市場リーダー上位5社の競合マトリックス
• 市場リーダー上位5社の市場収益分析
• M&A・ジョイントベンチャー (該当する場合)
• SWOT分析 (参入5社)

第11章 価格分析

第12章 ケーススタディ

第13章 主要企業の見通し

• Alphabet Inc.
• Siemens Healthineers AG
• Microsoft Corporation
• Koninklijke Philips N.V.
• GE Healthcare Technologies Inc
• F. Hoffmann-La Roche AG
• Abbott Laboratories Inc.
• Hologic, Inc.
• Ibex Medical Analytics Ltd.
• Danaher Corporation

第14章 戦略的提言

第15章 当社について・免責事項

List of Tables

• Table 1. Pricing Analysis of Products from Key Players
• Table 2. Competition Matrix of Top 5 Market Leaders
• Table 3. Mergers & Acquisitions/ Joint Ventures (If Applicable)
• Table 4. About Us - Regions and Countries Where We Have Executed Client Projects

List of Figures

• Figure 1. Global AI in In-vitro Diagnostics Market, By Value, In USD Million, 2017-2031F
• Figure 2. Global AI in In-vitro Diagnostics Market Share (%), By Component Type, 2017-2031F
• Figure 3. Global AI in In-vitro Diagnostics Market Share (%), By Technology, 2017-2031F
• Figure 4. Global AI in In-vitro Diagnostics Market Share (%), By Application, 2017-2031F
• Figure 5. Global AI in In-vitro Diagnostics Market Share (%), By End-user, 2017-2031F
• Figure 6. Global AI in In-vitro Diagnostics Market Share (%), By Region, 2017-2031F
• Figure 7. North America AI in In-vitro Diagnostics Market, By Value, In USD Million, 2017-2031F
• Figure 8. North America AI in In-vitro Diagnostics Market Share (%), By Component Type, 2017-2031F
• Figure 9. North America AI in In-vitro Diagnostics Market Share (%), By Technology, 2017-2031F
• Figure 10. North America AI in In-vitro Diagnostics Market Share (%), By Application, 2017-2031F
• Figure 11. North America AI in In-vitro Diagnostics Market Share (%), By End-user, 2017-2031F
• Figure 12. North America AI in In-vitro Diagnostics Market Share (%), By Country, 2017-2031F
• Figure 13. United States AI in In-vitro Diagnostics Market, By Value, In USD Million, 2017-2031F
• Figure 14. United States AI in In-vitro Diagnostics Market Share (%), By Component Type, 2017-2031F
• Figure 15. United States AI in In-vitro Diagnostics Market Share (%), By Technology, 2017-2031F
• Figure 16. United States AI in In-vitro Diagnostics Market Share (%), By Application, 2017-2031F
• Figure 17. United States AI in In-vitro Diagnostics Market Share (%), By End-user, 2017-2031F
• Figure 18. Canada AI in In-vitro Diagnostics Market, By Value, In USD Million, 2017-2031F
• Figure 19. Canada AI in In-vitro Diagnostics Market Share (%), By Component Type, 2017-2031F
• Figure 20. Canada AI in In-vitro Diagnostics Market Share (%), By Technology, 2017-2031F
• Figure 21. Canada AI in In-vitro Diagnostics Market Share (%), By Application, 2017-2031F
• Figure 22. Canada AI in In-vitro Diagnostics Market Share (%), By End-user, 2017-2031F
• Figure 23. Mexico AI in In-vitro Diagnostics Market, By Value, In USD Million, 2017-2031F
• Figure 24. Mexico AI in In-vitro Diagnostics Market Share (%), By Component Type, 2017-2031F
• Figure 25. Mexico AI in In-vitro Diagnostics Market Share (%), By Technology, 2017-2031F
• Figure 26. Mexico AI in In-vitro Diagnostics Market Share (%), By Application, 2017-2031F
• Figure 27. Mexico AI in In-vitro Diagnostics Market Share (%), By End-user, 2017-2031F
• Figure 28. Europe AI in In-vitro Diagnostics Market, By Value, In USD Million, 2017-2031F
• Figure 29. Europe AI in In-vitro Diagnostics Market Share (%), By Component Type, 2017-2031F
• Figure 30. Europe AI in In-vitro Diagnostics Market Share (%), By Technology, 2017-2031F
• Figure 31. Europe AI in In-vitro Diagnostics Market Share (%), By Application, 2017-2031F
• Figure 32. Europe AI in In-vitro Diagnostics Market Share (%), By End-user, 2017-2031F
• Figure 33. Europe AI in In-vitro Diagnostics Market Share (%), By Country, 2017-2031F
• Figure 34. Germany AI in In-vitro Diagnostics Market, By Value, In USD Million, 2017-2031F
• Figure 35. Germany AI in In-vitro Diagnostics Market Share (%), By Component Type, 2017-2031F
• Figure 36. Germany AI in In-vitro Diagnostics Market Share (%), By Technology, 2017-2031F
• Figure 37. Germany AI in In-vitro Diagnostics Market Share (%), By Application, 2017-2031F
• Figure 38. Germany AI in In-vitro Diagnostics Market Share (%), By End-user, 2017-2031F
• Figure 39. France AI in In-vitro Diagnostics Market, By Value, In USD Million, 2017-2031F
• Figure 40. France AI in In-vitro Diagnostics Market Share (%), By Component Type, 2017-2031F
• Figure 41. France AI in In-vitro Diagnostics Market Share (%), By Technology, 2017-2031F
• Figure 42. France AI in In-vitro Diagnostics Market Share (%), By Application, 2017-2031F
• Figure 43. France AI in In-vitro Diagnostics Market Share (%), By End-user, 2017-2031F
• Figure 44. Italy AI in In-vitro Diagnostics Market, By Value, In USD Million, 2017-2031F
• Figure 45. Italy AI in In-vitro Diagnostics Market Share (%), By Component Type, 2017-2031F
• Figure 46. Italy AI in In-vitro Diagnostics Market Share (%), By Technology, 2017-2031F
• Figure 47. Italy AI in In-vitro Diagnostics Market Share (%), By Application, 2017-2031F
• Figure 48. Italy AI in In-vitro Diagnostics Market Share (%), By End-user, 2017-2031F
• Figure 49. United Kingdom AI in In-vitro Diagnostics Market, By Value, In USD Million, 2017-2031F
• Figure 50. United Kingdom AI in In-vitro Diagnostics Market Share (%), By Component Type, 2017-2031F
• Figure 51. United Kingdom AI in In-vitro Diagnostics Market Share (%), By Technology, 2017-2031F
• Figure 52. United Kingdom AI in In-vitro Diagnostics Market Share (%), By Application, 2017-2031F
• Figure 53. United Kingdom AI in In-vitro Diagnostics Market Share (%), By End-user, 2017-2031F
• Figure 54. Russia AI in In-vitro Diagnostics Market, By Value, In USD Million, 2017-2031F
• Figure 55. Russia AI in In-vitro Diagnostics Market Share (%), By Component Type, 2017-2031F
• Figure 56. Russia AI in In-vitro Diagnostics Market Share (%), By Technology, 2017-2031F
• Figure 57. Russia AI in In-vitro Diagnostics Market Share (%), By Application, 2017-2031F
• Figure 58. Russia AI in In-vitro Diagnostics Market Share (%), By End-user, 2017-2031F
• Figure 59. Netherlands AI in In-vitro Diagnostics Market, By Value, In USD Million, 2017-2031F
• Figure 60. Netherlands AI in In-vitro Diagnostics Market Share (%), By Component Type, 2017-2031F
• Figure 61. Netherlands AI in In-vitro Diagnostics Market Share (%), By Technology, 2017-2031F
• Figure 62. Netherlands AI in In-vitro Diagnostics Market Share (%), By Application, 2017-2031F
• Figure 63. Netherlands AI in In-vitro Diagnostics Market Share (%), By End-user, 2017-2031F
• Figure 64. Spain AI in In-vitro Diagnostics Market, By Value, In USD Million, 2017-2031F
• Figure 65. Spain AI in In-vitro Diagnostics Market Share (%), By Component Type, 2017-2031F
• Figure 66. Spain AI in In-vitro Diagnostics Market Share (%), By Technology, 2017-2031F
• Figure 67. Spain AI in In-vitro Diagnostics Market Share (%), By Application, 2017-2031F
• Figure 68. Spain AI in In-vitro Diagnostics Market Share (%), By End-user, 2017-2031F
• Figure 69. Turkey AI in In-vitro Diagnostics Market, By Value, In USD Million, 2017-2031F
• Figure 70. Turkey AI in In-vitro Diagnostics Market Share (%), By Component Type, 2017-2031F
• Figure 71. Turkey AI in In-vitro Diagnostics Market Share (%), By Technology, 2017-2031F
• Figure 72. Turkey AI in In-vitro Diagnostics Market Share (%), By Application, 2017-2031F
• Figure 73. Turkey AI in In-vitro Diagnostics Market Share (%), By End-user, 2017-2031F
• Figure 74. Poland AI in In-vitro Diagnostics Market, By Value, In USD Million, 2017-2031F
• Figure 75. Poland AI in In-vitro Diagnostics Market Share (%), By Component Type, 2017-2031F
• Figure 76. Poland AI in In-vitro Diagnostics Market Share (%), By Technology, 2017-2031F
• Figure 77. Poland AI in In-vitro Diagnostics Market Share (%), By Application, 2017-2031F
• Figure 78. Poland AI in In-vitro Diagnostics Market Share (%), By End-user, 2017-2031F
• Figure 79. South America AI in In-vitro Diagnostics Market, By Value, In USD Million, 2017-2031F
• Figure 80. South America AI in In-vitro Diagnostics Market Share (%), By Component Type, 2017-2031F
• Figure 81. South America AI in In-vitro Diagnostics Market Share (%), By Technology, 2017-2031F
• Figure 82. South America AI in In-vitro Diagnostics Market Share (%), By Application, 2017-2031F
• Figure 83. South America AI in In-vitro Diagnostics Market Share (%), By End-user, 2017-2031F
• Figure 84. South America AI in In-vitro Diagnostics Market Share (%), By Country, 2017-2031F
• Figure 85. Brazil AI in In-vitro Diagnostics Market, By Value, In USD Million, 2017-2031F
• Figure 86. Brazil AI in In-vitro Diagnostics Market Share (%), By Component Type, 2017-2031F
• Figure 87. Brazil AI in In-vitro Diagnostics Market Share (%), By Technology, 2017-2031F
• Figure 88. Brazil AI in In-vitro Diagnostics Market Share (%), By Application, 2017-2031F
• Figure 89. Brazil AI in In-vitro Diagnostics Market Share (%), By End-user, 2017-2031F
• Figure 90. Argentina AI in In-vitro Diagnostics Market, By Value, In USD Million, 2017-2031F
• Figure 91. Argentina AI in In-vitro Diagnostics Market Share (%), By Component Type, 2017-2031F
• Figure 92. Argentina AI in In-vitro Diagnostics Market Share (%), By Technology, 2017-2031F
• Figure 93. Argentina AI in In-vitro Diagnostics Market Share (%), By Application, 2017-2031F
• Figure 94. Argentina AI in In-vitro Diagnostics Market Share (%), By End-user, 2017-2031F
• Figure 95. Asia-Pacific AI in In-vitro Diagnostics Market, By Value, In USD Million, 2017-2031F
• Figure 96. Asia-Pacific AI in In-vitro Diagnostics Market Share (%), By Component Type, 2017-2031F
• Figure 97. Asia-Pacific AI in In-vitro Diagnostics Market Share (%), By Technology, 2017-2031F
• Figure 98. Asia-Pacific AI in In-vitro Diagnostics Market Share (%), By Application, 2017-2031F
• Figure 99. Asia-Pacific AI in In-vitro Diagnostics Market Share (%), By End-user, 2017-2031F
• Figure 100. Asia-Pacific AI in In-vitro Diagnostics Market Share (%), By Country, 2017-2031F
• Figure 101. India AI in In-vitro Diagnostics Market, By Value, In USD Million, 2017-2031F
• Figure 102. India AI in In-vitro Diagnostics Market Share (%), By Component Type, 2017-2031F
• Figure 103. India AI in In-vitro Diagnostics Market Share (%), By Technology, 2017-2031F
• Figure 104. India AI in In-vitro Diagnostics Market Share (%), By Application, 2017-2031F
• Figure 105. India AI in In-vitro Diagnostics Market Share (%), By End-user, 2017-2031F
• Figure 106. China AI in In-vitro Diagnostics Market, By Value, In USD Million, 2017-2031F
• Figure 107. China AI in In-vitro Diagnostics Market Share (%), By Component Type, 2017-2031F
• Figure 108. China AI in In-vitro Diagnostics Market Share (%), By Technology, 2017-2031F
• Figure 109. China AI in In-vitro Diagnostics Market Share (%), By Application, 2017-2031F
• Figure 110. China AI in In-vitro Diagnostics Market Share (%), By End-user, 2017-2031F
• Figure 111. Japan AI in In-vitro Diagnostics Market, By Value, In USD Million, 2017-2031F
• Figure 112. Japan AI in In-vitro Diagnostics Market Share (%), By Component Type, 2017-2031F
• Figure 113. Japan AI in In-vitro Diagnostics Market Share (%), By Technology, 2017-2031F
• Figure 114. Japan AI in In-vitro Diagnostics Market Share (%), By Application, 2017-2031F
• Figure 115. Japan AI in In-vitro Diagnostics Market Share (%), By End-user, 2017-2031F
• Figure 116. Australia AI in In-vitro Diagnostics Market, By Value, In USD Million, 2017-2031F
• Figure 117. Australia AI in In-vitro Diagnostics Market Share (%), By Component Type, 2017-2031F
• Figure 118. Australia AI in In-vitro Diagnostics Market Share (%), By Technology, 2017-2031F
• Figure 119. Australia AI in In-vitro Diagnostics Market Share (%), By Application, 2017-2031F
• Figure 120. Australia AI in In-vitro Diagnostics Market Share (%), By End-user, 2017-2031F
• Figure 121. Vietnam AI in In-vitro Diagnostics Market, By Value, In USD Million, 2017-2031F
• Figure 122. Vietnam AI in In-vitro Diagnostics Market Share (%), By Component Type, 2017-2031F
• Figure 123. Vietnam AI in In-vitro Diagnostics Market Share (%), By Technology, 2017-2031F
• Figure 124. Vietnam AI in In-vitro Diagnostics Market Share (%), By Application, 2017-2031F
• Figure 125. Vietnam AI in In-vitro Diagnostics Market Share (%), By End-user, 2017-2031F
• Figure 126. South Korea AI in In-vitro Diagnostics Market, By Value, In USD Million, 2017-2031F
• Figure 127. South Korea AI in In-vitro Diagnostics Market Share (%), By Component Type, 2017-2031F
• Figure 128. South Korea AI in In-vitro Diagnostics Market Share (%), By Technology, 2017-2031F
• Figure 129. South Korea AI in In-vitro Diagnostics Market Share (%), By Application, 2017-2031F
• Figure 130. South Korea AI in In-vitro Diagnostics Market Share (%), By End-user, 2017-2031F
• Figure 131. Indonesia AI in In-vitro Diagnostics Market, By Value, In USD Million, 2017-2031F
• Figure 132. Indonesia AI in In-vitro Diagnostics Market Share (%), By Component Type, 2017-2031F
• Figure 133. Indonesia AI in In-vitro Diagnostics Market Share (%), By Technology, 2017-2031F
• Figure 134. Indonesia AI in In-vitro Diagnostics Market Share (%), By Application, 2017-2031F
• Figure 135. Indonesia AI in In-vitro Diagnostics Market Share (%), By End-user, 2017-2031F
• Figure 136. Philippines AI in In-vitro Diagnostics Market, By Value, In USD Million, 2017-2031F
• Figure 137. Philippines AI in In-vitro Diagnostics Market Share (%), By Component Type, 2017-2031F
• Figure 138. Philippines AI in In-vitro Diagnostics Market Share (%), By Technology, 2017-2031F
• Figure 139. Philippines AI in In-vitro Diagnostics Market Share (%), By Application, 2017-2031F
• Figure 140. Philippines AI in In-vitro Diagnostics Market Share (%), By End-user, 2017-2031F
• Figure 141. Middle East & Africa AI in In-vitro Diagnostics Market, By Value, In USD Million, 2017-2031F
• Figure 142. Middle East & Africa AI in In-vitro Diagnostics Market Share (%), By Component Type, 2017-2031F
• Figure 143. Middle East & Africa AI in In-vitro Diagnostics Market Share (%), By Technology, 2017-2031F
• Figure 144. Middle East & Africa AI in In-vitro Diagnostics Market Share (%), By Application, 2017-2031F
• Figure 145. Middle East & Africa AI in In-vitro Diagnostics Market Share (%), By End-user, 2017-2031F
• Figure 146. Middle East & Africa AI in In-vitro Diagnostics Market Share (%), By Country, 2017-2031F
• Figure 147. Saudi Arabia AI in In-vitro Diagnostics Market, By Value, In USD Million, 2017-2031F
• Figure 148. Saudi Arabia AI in In-vitro Diagnostics Market Share (%), By Component Type, 2017-2031F
• Figure 149. Saudi Arabia AI in In-vitro Diagnostics Market Share (%), By Technology, 2017-2031F
• Figure 150. Saudi Arabia AI in In-vitro Diagnostics Market Share (%), By Application, 2017-2031F
• Figure 151. Saudi Arabia AI in In-vitro Diagnostics Market Share (%), By End-user, 2017-2031F
• Figure 152. UAE AI in In-vitro Diagnostics Market, By Value, In USD Million, 2017-2031F
• Figure 153. UAE AI in In-vitro Diagnostics Market Share (%), By Component Type, 2017-2031F
• Figure 154. UAE AI in In-vitro Diagnostics Market Share (%), By Technology, 2017-2031F
• Figure 155. UAE AI in In-vitro Diagnostics Market Share (%), By Application, 2017-2031F
• Figure 156. UAE AI in In-vitro Diagnostics Market Share (%), By End-user, 2017-2031F
• Figure 157. South Africa AI in In-vitro Diagnostics Market, By Value, In USD Million, 2017-2031F
• Figure 158. South Africa AI in In-vitro Diagnostics Market Share (%), By Component Type, 2017-2031F
• Figure 159. South Africa AI in In-vitro Diagnostics Market Share (%), By Technology, 2017-2031F
• Figure 160. South Africa AI in In-vitro Diagnostics Market Share (%), By Application, 2017-2031F
• Figure 161. South Africa AI in In-vitro Diagnostics Market Share (%), By End-user, 2017-2031F
• Figure 162. By Component Type Map-Market Size (USD Million) & Growth Rate (%), 2023
• Figure 163. By Technology Map-Market Size (USD Million) & Growth Rate (%), 2023
• Figure 164. By Application Map-Market Size (USD Million) & Growth Rate (%), 2023
• Figure 165. By End-user Map-Market Size (USD Million) & Growth Rate (%), 2023
• Figure 166. By Region Map-Market Size (USD Million) & Growth Rate (%), 2023

The global AI in in-vitro diagnostics market is projected to witness a CAGR of 26.56% during the forecast period 2024-2031, growing from USD 649.44 million in 2023 to USD 4274.75 million in 2031. AI in in-vitro diagnostics market is positively influenced by factors like growing demand for accurate and rapid diagnostics, technical advancements in AI and machine learning, improved data analytics capabilities, regulatory support, and growing emphasis on data-driven prognosis of diseases. The automation and digitization of radiology patient imaging procedures drive the need for AI-based tools to improve diagnostic accuracy and reduce radiologist workload, further enhancing the market growth.

However, inadequate AI workforce and ambiguous regulatory guidelines for medical software across different countries, concerns around data security and privacy, data bias, and limitation of reagent-based assays in IVD techniques are some of the challenges in AI in in-vitro diagnostic market.

For instance, in October 2023, Roche announced a collaboration with Ibex and Amazon Web Services to enhance the adoption of AI-enabled digital pathology solutions for improving cancer diagnoses. Under this collaboration, Roche's Navify Digital Pathology software platform is offering Ibex's Artificial Intelligence (AI) algorithms for the diagnosis of breast and prostate cancer and this solution runs on Amazon Web Services.

Growing Demand for Accurate and Rapid Diagnostics

The growing demand for accurate and rapid diagnostics is significantly impacting the integration of AI in in-vitro diagnostics. AI is revolutionizing the in-vitro diagnostics landscape by enhancing diagnostic accuracy, efficiency, and patient outcomes. The influx of big data and technological advances are driving opportunities for the application of AI in in-vitro diagnostics, leading to improvements in medical diagnostics, monitoring, and treatment decision-making. The unique capability of AI to eliminate human errors through machine learning algorithms enables accurate and rapid diagnostics, leading to further expansion of the market. Key players invest in innovative products to speed up the diagnostic process and provide reliable results.

For instance, in February 2023, Cardio Diagnostics Holdings announced the launch of PrecisionCHD, an integrated epigenetic-genetic blood test for early detection of coronary heart diseases. PrecisionCHD is anticipated to detect coronary heart disease with greater than 75% sensitivity in both men and women. It utilizes DNA methylation and single nucleotide polymorphism biomarkers alongside AI algorithms for precision diagnostics.

Advancements in Machine Learning Algorithms

The healthcare industry is undergoing rapid transformation with the advancements in machine learning algorithms for in-vitro diagnostics. AI-assisted laboratory analysis, deep learning for cancer diagnosis, and smart diagnostic systems are some notable developments that have emerged. These innovations in cloud computing and AI have the potential to drastically improve healthcare decision-making. AI-linked universal diagnostic systems validated through large clinical trials for various diseases are some of the most promising applications. The integration of AI in cell-based oncology tests, clinical decision support, reflex testing, error detection, and imaging analysis is expected to bring about significant changes in the laboratory landscape and the healthcare industry. Ultimately, this will make healthcare more efficient and effective, further strengthening the market.

In August 2023, Celegence launched CAPTIS Copilot, which is a cutting-edge document automation and literature review solution for the life sciences industry. This enterprise cloud-based platform is designed specifically for the device and diagnostic industry and uses pre-trained large language models (LLM) and Reinforcement Learning from Human Feedback (RLHF). CAPTIS Copilot is a cloud-based solution that significantly enhances the ability of device and IVD manufacturers to increase innovation. It also empowers clinical, regulatory, and medical writing teams to be more efficient and productive with their time.

Regulatory Emphasis on AI-based In-vitro Diagnostics Solutions

Regulatory support is crucial for ensuring the safety and effectiveness of AI-based in-vitro diagnostics solutions. The U.S. Food and Drug Administration (FDA) regulates AI-driven medical products, including in-vitro diagnostic devices. In the European Union, the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) have been updated to include a classification system that specifies the regulatory pathways for in-vitro diagnostic devices, including those utilizing AI. Many other authorities worldwide are also implementing similar regulatory support initiatives, further contributing to AI's growth in the in-vitro diagnostics market.

For instance, in May 2023, Tempus received United States FDA approval for its xT CDx, a next-generation sequencing-based in vitro diagnostic device. xT CDx is a 648-gene next-generation sequencing test for solid tumor profiling, including microsatellite instability status and companion diagnostic claims for colorectal cancer patients.

Dominance of Software Segment

Component-wise, the major revenue in AI in in-vitro diagnostics market is mainly driven by software components. AI-based algorithm-based software is incorporated into the equipment used for in-vitro diagnostics, such as PCR instruments, NGS equipment, and others. The software component holds a major share in the AI-based diagnostics market due to its ability to improve diagnostic accuracy, efficiency, and quality and its rapid penetration rates in the healthcare sector. The increasing demand for AI-powered software tools and cloud-based solutions and the growing number of AI-based diagnostic startups and investments in the field drive this.

For instance, in March 2023, Visiopharm, a renowned provider of AI-powered precision pathology software, introduced a new and advanced Ki67 algorithm that offers diagnostic decision support to pathologists. The algorithm has received clearance under the European In-Vitro Diagnostic Regulations (IVDR) and is entirely automated, making it easy for pathologists to become fully productive without requiring manual steps.

Cancer Application Segment Dominates the Market

Cancer is the primary area where AI-based diagnostic solutions are being developed. This is because AI has the potential to significantly improve the accuracy, speed, and reliability of cancer diagnosis, prognosis, and treatment. AI-based tools have shown promising results in various aspects of oncology, such as risk assessment, early diagnosis, patient prognosis estimation, and treatment selection. Moreover, AI technology has gone beyond diagnosing cancer and has been able to provide precise grading of in situ carcinomas and more, which has led to better cancer care for patients.

In February 2023, Ibex Medical Analytics (Ibex) announced that its Galen Prostate solution received the CE mark under the In Vitro Diagnostic Medical Devices Regulation (IVDR) for assisting pathologists in the primary diagnosis of prostate biopsies. It is the first standalone AI-based cancer diagnostics product certified under the IVDR.

North America Dominates the Market

North America dominates the AI in in-vitro diagnostics market with a high revenue share due to the higher AI implementation rate in the medical industry. However, a study conducted by Pew Research Center found that 60% of Americans would be uncomfortable with their healthcare provider relying on AI. Despite this, physicians and medical students in the USA have shown a high acceptance of clinical AI. AI-based in-vitro diagnostics solutions allow practitioners to receive clean data quickly, leading to more accurate diagnoses and cutting annual US healthcare costs, further expanding the market growth. FDA approvals play a significant role in the dominance of the North America region.

For instance, in November 2023, Lunit announced that it had got FDA approval for an AI-powered Lunit INSIGHT DBT solution. The solution is designed to analyze images generated by 3D Breast Tomosynthesis (DBT) equipment, which provides a quick and precise breast cancer diagnosis compared to traditional 2D mammography screenings.

Future Market Scenario (2024 - 2031F)

Growing demand for rapid and precise diagnostic solutions drives the growth of the AI in in-vitro diagnostics market.

Advancements in machine learning algorithms to manage predictive and diagnostic data have significantly contributed to the drastic growth of AI in in-vitro diagnostics market.

Cancer application segment is anticipated to dominate the AI in in-vitro diagnostics market due to the emergence of large number of AI-based diagnostics solutions in recent times.

Regulatory support for ensuring the safety and efficacy of AI-based in-vitro diagnostics solutions has brought lucrative growth in the market.

Key Players Landscape and Outlook

The key participants in the AI in in-vitro diagnostics market include Alphabet Inc., Siemens Healthineers AG, Microsoft Corporation, Koninklijke Philips N.V., and GE Healthcare Technologies Inc. These companies contribute to the growth and development of the AI in in-vitro diagnostics market through technological innovations, strategic partnerships, and market expansion. Many startups are coming with innovative products and large-cap players are acquiring them for market expansion.

In August 2023, Huma partnered with Google to use its generative AI technology 'Med-PaLM 2' to streamline its disease-management digital product, a SaMD platform. The partnership aims to use Google's generative AI platform for automating clinical summary reports from incoming data.

In April 2023, Canon Medical announced the complete acquisition of Minaris Medical. Through this acquisition, canon aims to expand its in-vitro diagnostics offerings. Minaris Medical is a leading provider of in-vitro diagnostic reagents and automated analyzer systems. Canon Medical has diagnostic imaging as its core business and with this acquisition, it can effectively expand its business in the in-vitro diagnostics segment.

Table of Contents

1. Research Methodology

2. Project Scope & Definitions

3. Executive Summary

4. Global AI in In-vitro Diagnostics Market Outlook, 2017-2031F

• 4.1. Market Size & Forecast
  • 4.1.1. By Value
• 4.2. By Component Type
  • 4.2.1. Software
  • 4.2.2. Services
  • 4.2.3. Hardware
• 4.3. By Technology
  • 4.3.1. Machine Learning
  • 4.3.2. Natural Language Processing
  • 4.3.3. Context-Aware Computing
  • 4.3.4. Computer Vision
  • 4.3.5. Others
• 4.4. By Application
  • 4.4.1. Cancer
  • 4.4.2. Diabetes
  • 4.4.3. Infectious Diseases
  • 4.4.4. Cardiovascular
  • 4.4.5. Others
• 4.5. By End-user
  • 4.5.1. Hospitals
  • 4.5.2. Diagnostic Imaging Centers
  • 4.5.3. Pathology Centers
  • 4.5.4. Others
• 4.6. By Region
  • 4.6.1. North America
  • 4.6.2. Europe
  • 4.6.3. Asia-Pacific
  • 4.6.4. South America
  • 4.6.5. Middle East and Africa
• 4.7. By Company Market Share (%), 2023

5. Global AI in In-vitro Diagnostics Market Outlook, By Region, 2017-2031F

• 5.1. North America*
  • 5.1.1. Market Size & Forecast
    • 5.1.1.1. By Value
  • 5.1.2. By Component Type
    • 5.1.2.1. Software
    • 5.1.2.2. Services
    • 5.1.2.3. Hardware
  • 5.1.3. By Technology
    • 5.1.3.1. Machine Learning
    • 5.1.3.2. Natural Language Processing
    • 5.1.3.3. Context-Aware Computing
    • 5.1.3.4. Computer Vision
    • 5.1.3.5. Others
  • 5.1.4. By Application
    • 5.1.4.1. Cancer
    • 5.1.4.2. Diabetes
    • 5.1.4.3. Infectious Diseases
    • 5.1.4.4. Cardiovascular
    • 5.1.4.5. Others
  • 5.1.5. By End-user
    • 5.1.5.1. Hospitals
    • 5.1.5.2. Diagnostic Imaging Centers
    • 5.1.5.3. Pathology Centers
    • 5.1.5.4. Others
  • 5.1.6. United States*
    • 5.1.6.1. Market Size & Forecast
    • 5.1.6.1.1. By Value
    • 5.1.6.2. By Component Type
    • 5.1.6.2.1. Software
    • 5.1.6.2.2. Services
    • 5.1.6.2.3. Hardware
    • 5.1.6.3. By Technology
    • 5.1.6.3.1. Machine Learning
    • 5.1.6.3.2. Natural Language Processing
    • 5.1.6.3.3. Context-Aware Computing
    • 5.1.6.3.4. Computer Vision
    • 5.1.6.3.5. Others
    • 5.1.6.4. By Application
    • 5.1.6.4.1. Cancer
    • 5.1.6.4.2. Diabetes
    • 5.1.6.4.3. Infectious Diseases
    • 5.1.6.4.4. Cardiovascular
    • 5.1.6.4.5. Others
    • 5.1.6.5. By End-user
    • 5.1.6.5.1. Hospitals
    • 5.1.6.5.2. Diagnostic Imaging Centers
    • 5.1.6.5.3. Pathology Centers
    • 5.1.6.5.4. Others
  • 5.1.7. Canada
  • 5.1.8. Mexico

All segments will be provided for all regions and countries covered

• 5.2. Europe
  • 5.2.1. Germany
  • 5.2.2. France
  • 5.2.3. United Kingdom
  • 5.2.4. Italy
  • 5.2.5. Spain
  • 5.2.6. Turkey
  • 5.2.7. Russia
  • 5.2.8. Netherlands
  • 5.2.9. Poland
• 5.3. Asia-Pacific
  • 5.3.1. China
  • 5.3.2. India
  • 5.3.3. Japan
  • 5.3.4. South Korea
  • 5.3.5. Australia
  • 5.3.6. Vietnam
  • 5.3.7. Indonesia
  • 5.3.8. Philippines
• 5.4. South America
  • 5.4.1. Brazil
  • 5.4.2. Argentina
• 5.5. Middle East & Africa
  • 5.5.1. Saudi Arabia
  • 5.5.2. UAE
  • 5.5.3. South Africa

6. Market Mapping, 2023

• 6.1. By Component Type
• 6.2. By Technology
• 6.3. By Application
• 6.4. By End-user
• 6.5. By Region

7. Macro Environment and Industry Structure

• 7.1. Demand Supply Analysis
• 7.2. Import Export Analysis
• 7.3. Value Chain Analysis
• 7.4. PESTEL Analysis
  • 7.4.1. Political Factors
  • 7.4.2. Economic System
  • 7.4.3. Social Implications
  • 7.4.4. Technological Advancements
  • 7.4.5. Environmental Impacts
  • 7.4.6. Legal Compliances and Regulatory Policies (Statutory Bodies Included)
• 7.5. Porter's Five Forces Analysis
  • 7.5.1. Supplier Power
  • 7.5.2. Buyer Power
  • 7.5.3. Substitution Threat
  • 7.5.4. Threat from New Entrant
  • 7.5.5. Competitive Rivalry

8. Market Dynamics

• 8.1. Growth Drivers
• 8.2. Growth Inhibitors (Challenges and Restraints)

9. Regulatory Framework and Innovation

• 9.1. Patent Landscape
• 9.2. Regulatory Approvals
• 9.3. Innovations/Emerging Technologies

10. Key Players Landscape

• 10.1. Competition Matrix of Top Five Market Leaders
• 10.2. Market Revenue Analysis of Top Five Market Leaders (in %, 2023)
• 10.3. Mergers and Acquisitions/Joint Ventures (If Applicable)
• 10.4. SWOT Analysis (For Five Market Players)

11. Pricing Analysis

12. Case Studies

13. Key Players Outlook

• 13.1. Alphabet Inc.
  • 13.1.1. Company Details
  • 13.1.2. Key Management Personnel
  • 13.1.3. Products & Services
  • 13.1.4. Financials (As reported)
  • 13.1.5. Key Market Focus & Geographical Presence
  • 13.1.6. Recent Developments
• 13.2. Siemens Healthineers AG
• 13.3. Microsoft Corporation
• 13.4. Koninklijke Philips N.V.
• 13.5. GE Healthcare Technologies Inc
• 13.6. F. Hoffmann-La Roche AG
• 13.7. Abbott Laboratories Inc.
• 13.8. Hologic, Inc.
• 13.9. Ibex Medical Analytics Ltd.
• 13.10. Danaher Corporation

Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.

14. Strategic Recommendations

15. About Us & Disclaimer