IVD品質管理の世界市場の評価：検体別、製品別、用途別、技法別、エンドユーザー別、地域別、機会、予測（2017年～2031年）

世界のIVD品質管理の市場規模は、2023年の13億2,000万米ドルから2031年に19億1,000万米ドルに達すると予測され、予測期間の2024年～2031年にCAGRで4.77%の成長が見込まれます。さまざまな要因が市場を形成しており、これには革新的な新製品の開発への注力や、先進技術の統合の進行、免疫測定製品への需要の増加、データ管理ソリューションの普及、北米の優位性などが含まれます。

イノベーションの促進や新製品の開発など、複数の要因が世界のIVD品質管理市場をコントロールしています。メーカーは常に、手術効率、患者の安全性、入手性を向上させる、より優れた使い捨て手術器具を新たに開発しようとしています。そのためには、変化する医療現場の需要を満たすために、最先端のコンポーネント、スタイル、機能を調査する必要があります。世界のIVD品質管理市場は、AI、データ管理システム、自動化などの最先端技術を統合しています。これらの技術開発により、診断検査における品質管理作業の精度、有効性、アクセシビリティが向上しています。

世界のIVD品質管理市場は、免疫測定/免疫化学セグメントが優位に立つと予測されます。これは、免疫測定検査の種類が増え、標的の同定と定量を迅速、簡便、正確に行えるようになったためです。データ管理システムはデータの保存、処理、報告をより効率的にするため、世界のIVD品質管理産業でますます普及しています。これらの技術はデータの完全性を促進し、全体的な業務効率を高め、検査室の品質管理作業を簡素化します。

例えば、臨床診断製品とライフサイエンス研究の世界的リーダーであるBio-Rad Laboratories, Inc.は、基礎研究、トランスレーショナルリサーチ、プロセス開発、品質管理におけるポリメラーゼ連鎖反応（PCR）の利用を容易にすることを目的としたPTC Tempo 48/48およびPTC Tempo 384 Thermal Cyclerの導入を2023年9月に発表しました。Bio-Radの伝統的なPCRヒートサイクラーの最新モデルがPTC Tempo 48/48とPTC Tempo 384 Thermal Cyclerです。PTC Tempo Thermal Cyclerは、アップデートされたユーザーフレンドリーなインターフェースと、BR.ioクラウドプラットフォーム上でデータをモニターしプロトコル管理を合理化する機能を含む、適合性のある接続オプションで設計されています。

市場におけるPCR検査の開発への注目の高まり

世界のIVD品質管理市場では、PCR検査の開発への注目が高まっています。ポリメラーゼ連鎖反応の利用と手法は、ここ数年でさまざまな臨床分野で作成、改良され、採用されています。これらの新しいPCR法に向けた品質基準の作成は、結果が臨床的意思決定に影響を与えるあらゆる「インハウス」アッセイの場合と同様に、GLP（Good Laboratory Practice）および国内（外）のガイドラインの両方に準拠するために必要でした。品質基準はELISAや培養ベースのアッセイのような「古典的」診断検査に向けて以前から確立されており、継続的に開発および改良されている新しいPCRベースのアッセイについても、品質保証と品質管理の両方について確立された推奨事項があります。

例えば、GENE-UP BREWPRO Yeast Slurry（YS）は、体外診断薬の世界的リーダーであるbioMerieux, Inc.が2024年5月に発表した新しい診断品質管理PCR検査です。その目的は、原料酵母と酵母増殖中の不純物を正確に特定し、最高水準の発酵を保証することです。White Labsとのパートナーシップにより開発されたこのソリューションは、酵母スラリー用に特別に設計されたターゲットと、より高い感度で最適化されたサンプル前処理を備えています。現在の醸造産業の品質管理検査キットは、酵母スラリーそのものではなく、最終製品に含まれる可能性のあるスポイラーを特定するために作られています。

当レポートでは、世界のIVD品質管理市場について調査分析し、市場規模と予測、市場力学、主要企業の情勢と見通しなどを提供しています。

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IVD品質管理市場の見通し（2017年～2031年）

• 市場規模と予測
  • 金額
  • 数量
• 検体別
  • 血漿
  • 全血
  • 尿
• 製品別
  • 品質管理製品
  • データ管理ソリューション
  • 品質評価サービス
• 用途別
  • 腫瘍
  • 心臓
  • 神経
  • 感染症
  • 自己免疫疾患
  • その他
• 技法別
  • 分子診断
  • 凝固/止血
  • 血液学
  • 微生物学
  • 免疫化学/免疫測定
  • 臨床化学/生化学
  • その他
• エンドユーザー別
  • 病院、診療所
  • 診断検査室
  • IVDメーカー
  • CRO
  • その他
• 地域別
  • 北米
  • 欧州
  • アジア太平洋
  • 南米
  • 中東・アフリカ
• 市場シェア：企業別（2023年）

第5章 世界のIVD品質管理市場の見通し：地域別（2017年～2031年）

• 北米
  • 市場規模と予測
  • 検体別
  • 製品別
  • 用途別
  • 技法別
  • エンドユーザー別
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • フランス
  • イタリア
  • 英国
  • ロシア
  • オランダ
  • スペイン
  • トルコ
  • ポーランド
• アジア太平洋
  • インド
  • 中国
  • 日本
  • オーストラリア
  • ベトナム
  • 韓国
  • インドネシア
  • フィリピン
• 南米
  • ブラジル
  • アルゼンチン
• 中東・アフリカ
  • サウジアラビア
  • アラブ首長国連邦
  • 南アフリカ

第6章 市場マッピング（2023年）

• 検体別
• 製品別
• 用途別
• 技法別
• 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
• 輸入輸出分析
• 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 規制枠組みとイノベーション

• 臨床試験
• 特許情勢
• 規制当局の承認
• イノベーション/新技術

第10章 主要企業の情勢

• マーケットリーダー上位5社の競合マトリクス
• マーケットリーダー上位5社の市場収益の分析（2023年）
• 合併と買収/合弁事業（該当する場合）
• SWOT分析（市場企業5社）
• 特許分析（該当する場合）

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

• Bio-Rad Laboratories, Inc.
• Danaher Corporation
• Thermo Fisher Scientific, Inc.
• QuidelOrtho Corporation
• Siemens Healthineers AG
• LGC Group
• Randox Laboratories Ltd.
• Microbiologics, Inc.
• Streck LLC
• SERO AS

第14章 戦略的推奨

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 IVD Quality Control Market, By Value, In USD Billion, 2017-2031F
• Figure 2. Global IVD Quality Control Market, By Volume, In Million Units, 2017-2031F
• Figure 3. Global IVD Quality Control Market Share (%), By Source, 2017-2031F
• Figure 4. Global IVD Quality Control Market Share (%), By Product, 2017-2031F
• Figure 5. Global IVD Quality Control Market Share (%), By Application, 2017-2031F
• Figure 6. Global IVD Quality Control Market Share (%), By Technique, 2017-2031F
• Figure 7. Global IVD Quality Control Market Share (%), By End-user, 2017-2031F
• Figure 8. Global IVD Quality Control Market Share (%), By Region, 2017-2031F
• Figure 9. North America IVD Quality Control Market, By Value, In USD Billion, 2017-2031F
• Figure 10. North America IVD Quality Control Market, By Volume, In Million Units, 2017-2031F
• Figure 11. North America IVD Quality Control Market Share (%), By Source, 2017-2031F
• Figure 12. North America IVD Quality Control Market Share (%), By Product, 2017-2031F
• Figure 13. North America IVD Quality Control Market Share (%), By Application, 2017-2031F
• Figure 14. North America IVD Quality Control Market Share (%), By Technique, 2017-2031F
• Figure 15. North America IVD Quality Control Market Share (%), By End-user, 2017-2031F
• Figure 16. North America IVD Quality Control Market Share (%), By Country, 2017-2031F
• Figure 17. United States IVD Quality Control Market, By Value, In USD Billion, 2017-2031F
• Figure 18. United States IVD Quality Control Market, By Volume, In Million Units, 2017-2031F
• Figure 19. United States IVD Quality Control Market Share (%), By Source, 2017-2031F
• Figure 20. United States IVD Quality Control Market Share (%), By Product, 2017-2031F
• Figure 21. United States IVD Quality Control Market Share (%), By Application, 2017-2031F
• Figure 22. United States IVD Quality Control Market Share (%), By Technique, 2017-2031F
• Figure 23. United States IVD Quality Control Market Share (%), By End-user, 2017-2031F
• Figure 24. Canada IVD Quality Control Market, By Value, In USD Billion, 2017-2031F
• Figure 25. Canada IVD Quality Control Market, By Volume, In Million Units, 2017-2031F
• Figure 26. Canada IVD Quality Control Market Share (%), By Source, 2017-2031F
• Figure 27. Canada IVD Quality Control Market Share (%), By Product, 2017-2031F
• Figure 28. Canada IVD Quality Control Market Share (%), By Application, 2017-2031F
• Figure 29. Canada IVD Quality Control Market Share (%), By Technique, 2017-2031F
• Figure 30. Canada IVD Quality Control Market Share (%), By End-user, 2017-2031F
• Figure 31. Mexico IVD Quality Control Market, By Value, In USD Billion, 2017-2031F
• Figure 32. Mexico IVD Quality Control Market, By Volume, In Million Units, 2017-2031F
• Figure 33. Mexico IVD Quality Control Market Share (%), By Source, 2017-2031F
• Figure 34. Mexico IVD Quality Control Market Share (%), By Product, 2017-2031F
• Figure 35. Mexico IVD Quality Control Market Share (%), By Application, 2017-2031F
• Figure 36. Mexico IVD Quality Control Market Share (%), By Technique, 2017-2031F
• Figure 37. Mexico IVD Quality Control Market Share (%), By End-user, 2017-2031F
• Figure 38. Europe IVD Quality Control Market, By Value, In USD Billion, 2017-2031F
• Figure 39. Europe IVD Quality Control Market, By Volume, In Million Units, 2017-2031F
• Figure 40. Europe IVD Quality Control Market Share (%), By Source, 2017-2031F
• Figure 41. Europe IVD Quality Control Market Share (%), By Product, 2017-2031F
• Figure 42. Europe IVD Quality Control Market Share (%), By Application, 2017-2031F
• Figure 43. Europe IVD Quality Control Market Share (%), By Technique, 2017-2031F
• Figure 44. Europe IVD Quality Control Market Share (%), By End-user, 2017-2031F
• Figure 45. Europe IVD Quality Control Market Share (%), By Country, 2017-2031F
• Figure 46. Germany IVD Quality Control Market, By Value, In USD Billion, 2017-2031F
• Figure 47. Germany IVD Quality Control Market, By Volume, In Million Units, 2017-2031F
• Figure 48. Germany IVD Quality Control Market Share (%), By Source, 2017-2031F
• Figure 49. Germany IVD Quality Control Market Share (%), By Product, 2017-2031F
• Figure 50. Germany IVD Quality Control Market Share (%), By Application, 2017-2031F
• Figure 51. Germany IVD Quality Control Market Share (%), By Technique, 2017-2031F
• Figure 52. Germany IVD Quality Control Market Share (%), By End-user, 2017-2031F
• Figure 53. France IVD Quality Control Market, By Value, In USD Billion, 2017-2031F
• Figure 54. France IVD Quality Control Market, By Volume, In Million Units, 2017-2031F
• Figure 55. France IVD Quality Control Market Share (%), By Source, 2017-2031F
• Figure 56. France IVD Quality Control Market Share (%), By Product, 2017-2031F
• Figure 57. France IVD Quality Control Market Share (%), By Application, 2017-2031F
• Figure 58. France IVD Quality Control Market Share (%), By Technique, 2017-2031F
• Figure 59. France IVD Quality Control Market Share (%), By End-user, 2017-2031F
• Figure 60. Italy IVD Quality Control Market, By Value, In USD Billion, 2017-2031F
• Figure 61. Italy IVD Quality Control Market, By Volume, In Million Units, 2017-2031F
• Figure 62. Italy IVD Quality Control Market Share (%), By Source, 2017-2031F
• Figure 63. Italy IVD Quality Control Market Share (%), By Product, 2017-2031F
• Figure 64. Italy IVD Quality Control Market Share (%), By Application, 2017-2031F
• Figure 65. Italy IVD Quality Control Market Share (%), By Technique, 2017-2031F
• Figure 66. Italy IVD Quality Control Market Share (%), By End-user, 2017-2031F
• Figure 67. United Kingdom IVD Quality Control Market, By Value, In USD Billion, 2017-2031F
• Figure 68. United Kingdom IVD Quality Control Market, By Volume, In Million Units, 2017-2031F
• Figure 69. United Kingdom IVD Quality Control Market Share (%), By Source, 2017-2031F
• Figure 70. United Kingdom IVD Quality Control Market Share (%), By Product, 2017-2031F
• Figure 71. United Kingdom IVD Quality Control Market Share (%), By Application, 2017-2031F
• Figure 72. United Kingdom IVD Quality Control Market Share (%), By Technique, 2017-2031F
• Figure 73. United Kingdom IVD Quality Control Market Share (%), By End-user, 2017-2031F
• Figure 74. Russia IVD Quality Control Market, By Value, In USD Billion, 2017-2031F
• Figure 75. Russia IVD Quality Control Market, By Volume, In Million Units, 2017-2031F
• Figure 76. Russia IVD Quality Control Market Share (%), By Source, 2017-2031F
• Figure 77. Russia IVD Quality Control Market Share (%), By Product, 2017-2031F
• Figure 78. Russia IVD Quality Control Market Share (%), By Application, 2017-2031F
• Figure 79. Russia IVD Quality Control Market Share (%), By Technique, 2017-2031F
• Figure 80. Russia IVD Quality Control Market Share (%), By End-user, 2017-2031F
• Figure 81. Netherlands IVD Quality Control Market, By Value, In USD Billion, 2017-2031F
• Figure 82. Netherlands IVD Quality Control Market, By Volume, In Million Units, 2017-2031F
• Figure 83. Netherlands IVD Quality Control Market Share (%), By Source, 2017-2031F
• Figure 84. Netherlands IVD Quality Control Market Share (%), By Product, 2017-2031F
• Figure 85. Netherlands IVD Quality Control Market Share (%), By Application, 2017-2031F
• Figure 86. Netherlands IVD Quality Control Market Share (%), By Technique, 2017-2031F
• Figure 87. Netherlands IVD Quality Control Market Share (%), By End-user, 2017-2031F
• Figure 88. Spain IVD Quality Control Market, By Value, In USD Billion, 2017-2031F
• Figure 89. Spain IVD Quality Control Market, By Volume, In Million Units, 2017-2031F
• Figure 90. Spain IVD Quality Control Market Share (%), By Source, 2017-2031F
• Figure 91. Spain IVD Quality Control Market Share (%), By Product, 2017-2031F
• Figure 92. Spain IVD Quality Control Market Share (%), By Application, 2017-2031F
• Figure 93. Spain IVD Quality Control Market Share (%), By Technique, 2017-2031F
• Figure 94. Spain IVD Quality Control Market Share (%), By End-user, 2017-2031F
• Figure 95. Turkey IVD Quality Control Market, By Value, In USD Billion, 2017-2031F
• Figure 96. Turkey IVD Quality Control Market, By Volume, In Million Units, 2017-2031F
• Figure 97. Turkey IVD Quality Control Market Share (%), By Source, 2017-2031F
• Figure 98. Turkey IVD Quality Control Market Share (%), By Product, 2017-2031F
• Figure 99. Turkey IVD Quality Control Market Share (%), By Application, 2017-2031F
• Figure 100. Turkey IVD Quality Control Market Share (%), By Technique, 2017-2031F
• Figure 101. Turkey IVD Quality Control Market Share (%), By End-user, 2017-2031F
• Figure 102. Poland IVD Quality Control Market, By Value, In USD Billion, 2017-2031F
• Figure 103. Poland IVD Quality Control Market, By Volume, In Million Units, 2017-2031F
• Figure 104. Poland IVD Quality Control Market Share (%), By Source, 2017-2031F
• Figure 105. Poland IVD Quality Control Market Share (%), By Product, 2017-2031F
• Figure 106. Poland IVD Quality Control Market Share (%), By Application, 2017-2031F
• Figure 107. Poland IVD Quality Control Market Share (%), By Technique, 2017-2031F
• Figure 108. Poland IVD Quality Control Market Share (%), By End-user, 2017-2031F
• Figure 109. South America IVD Quality Control Market, By Value, In USD Billion, 2017-2031F
• Figure 110. South America IVD Quality Control Market, By Volume, In Million Units, 2017-2031F
• Figure 111. South America IVD Quality Control Market Share (%), By Source, 2017-2031F
• Figure 112. South America IVD Quality Control Market Share (%), By Product, 2017-2031F
• Figure 113. South America IVD Quality Control Market Share (%), By Application, 2017-2031F
• Figure 114. South America IVD Quality Control Market Share (%), By Technique, 2017-2031F
• Figure 115. South America IVD Quality Control Market Share (%), By End-user, 2017-2031F
• Figure 116. South America IVD Quality Control Market Share (%), By Country, 2017-2031F
• Figure 117. Brazil IVD Quality Control Market, By Value, In USD Billion, 2017-2031F
• Figure 118. Brazil IVD Quality Control Market, By Volume, In Million Units, 2017-2031F
• Figure 119. Brazil IVD Quality Control Market Share (%), By Source, 2017-2031F
• Figure 120. Brazil IVD Quality Control Market Share (%), By Product, 2017-2031F
• Figure 121. Brazil IVD Quality Control Market Share (%), By Application, 2017-2031F
• Figure 122. Brazil IVD Quality Control Market Share (%), By Technique, 2017-2031F
• Figure 123. Brazil IVD Quality Control Market Share (%), By End-user, 2017-2031F
• Figure 124. Argentina IVD Quality Control Market, By Value, In USD Billion, 2017-2031F
• Figure 125. Argentina IVD Quality Control Market, By Volume, In Million Units, 2017-2031F
• Figure 126. Argentina IVD Quality Control Market Share (%), By Source, 2017-2031F
• Figure 127. Argentina IVD Quality Control Market Share (%), By Product, 2017-2031F
• Figure 128. Argentina IVD Quality Control Market Share (%), By Application, 2017-2031F
• Figure 129. Argentina IVD Quality Control Market Share (%), By Technique, 2017-2031F
• Figure 130. Argentina IVD Quality Control Market Share (%), By End-user, 2017-2031F
• Figure 131. Asia-Pacific IVD Quality Control Market, By Value, In USD Billion, 2017-2031F
• Figure 132. Asia-Pacific IVD Quality Control Market, By Volume, In Million Units, 2017-2031F
• Figure 133. Asia-Pacific IVD Quality Control Market Share (%), By Source, 2017-2031F
• Figure 134. Asia-Pacific IVD Quality Control Market Share (%), By Product, 2017-2031F
• Figure 135. Asia-Pacific IVD Quality Control Market Share (%), By Application, 2017-2031F
• Figure 136. Asia-Pacific IVD Quality Control Market Share (%), By Technique, 2017-2031F
• Figure 137. Asia- Pacific IVD Quality Control Market Share (%), By End-user, 2017-2031F
• Figure 138. Asia-Pacific IVD Quality Control Market Share (%), By Country, 2017-2031F
• Figure 139. India IVD Quality Control Market, By Value, In USD Billion, 2017-2031F
• Figure 140. India IVD Quality Control Market, By Volume, In Million Units, 2017-2031F
• Figure 141. India IVD Quality Control Market Share (%), By Source, 2017-2031F
• Figure 142. India IVD Quality Control Market Share (%), By Product, 2017-2031F
• Figure 143. India IVD Quality Control Market Share (%), By Application, 2017-2031F
• Figure 144. India IVD Quality Control Market Share (%), By Technique, 2017-2031F
• Figure 145. India IVD Quality Control Market Share (%), By End-user, 2017-2031F
• Figure 146. China IVD Quality Control Market, By Value, In USD Billion, 2017-2031F
• Figure 147. China IVD Quality Control Market, By Volume, In Million Units, 2017-2031F
• Figure 148. China IVD Quality Control Market Share (%), By Source, 2017-2031F
• Figure 149. China IVD Quality Control Market Share (%), By Product, 2017-2031F
• Figure 150. China IVD Quality Control Market Share (%), By Application, 2017-2031F
• Figure 151. China IVD Quality Control Market Share (%), By Technique, 2017-2031F
• Figure 152. China IVD Quality Control Market Share (%), By End-user, 2017-2031F
• Figure 153. Japan IVD Quality Control Market, By Value, In USD Billion, 2017-2031F
• Figure 154. Japan IVD Quality Control Market, By Volume, In Million Units, 2017-2031F
• Figure 155. Japan IVD Quality Control Market Share (%), By Source, 2017-2031F
• Figure 156. Japan IVD Quality Control Market Share (%), By Product, 2017-2031F
• Figure 157. Japan IVD Quality Control Market Share (%), By Application, 2017-2031F
• Figure 158. Japan IVD Quality Control Market Share (%), By Technique, 2017-2031F
• Figure 159. Japan IVD Quality Control Market Share (%), By End-user, 2017-2031F
• Figure 160. Australia IVD Quality Control Market, By Value, In USD Billion, 2017-2031F
• Figure 161. Australia IVD Quality Control Market, By Volume, In Million Units, 2017-2031F
• Figure 162. Australia IVD Quality Control Market Share (%), By Source, 2017-2031F
• Figure 163. Australia IVD Quality Control Market Share (%), By Product, 2017-2031F
• Figure 164. Australia IVD Quality Control Market Share (%), By Application, 2017-2031F
• Figure 165. Australia IVD Quality Control Market Share (%), By Technique, 2017-2031F
• Figure 166. Australia IVD Quality Control Market Share (%), By End-user, 2017-2031F
• Figure 167. Vietnam IVD Quality Control Market, By Value, In USD Billion, 2017-2031F
• Figure 168. Vietnam IVD Quality Control Market, By Volume, In Million Units, 2017-2031F
• Figure 169. Vietnam IVD Quality Control Market Share (%), By Source, 2017-2031F
• Figure 170. Vietnam IVD Quality Control Market Share (%), By Product, 2017-2031F
• Figure 171. Vietnam IVD Quality Control Market Share (%), By Application, 2017-2031F
• Figure 172. Vietnam IVD Quality Control Market Share (%), By Technique, 2017-2031F
• Figure 173. Vietnam IVD Quality Control Market Share (%), By End-user, 2017-2031F
• Figure 174. South Korea IVD Quality Control Market, By Value, In USD Billion, 2017-2031F
• Figure 175. South Korea IVD Quality Control Market, By Volume, In Million Units, 2017-2031F
• Figure 176. South Korea IVD Quality Control Market Share (%), By Source, 2017-2031F
• Figure 177. South Korea IVD Quality Control Market Share (%), By Product, 2017-2031F
• Figure 178. South Korea IVD Quality Control Market Share (%), By Application, 2017-2031F
• Figure 179. South Korea IVD Quality Control Market Share (%), By Technique, 2017-2031F
• Figure 180. South Korea IVD Quality Control Market Share (%), By End-user, 2017-2031F
• Figure 181. Indonesia IVD Quality Control Market, By Value, In USD Billion, 2017-2031F
• Figure 182. Indonesia IVD Quality Control Market, By Volume, In Million Units, 2017-2031F
• Figure 183. Indonesia IVD Quality Control Market Share (%), By Source, 2017-2031F
• Figure 184. Indonesia IVD Quality Control Market Share (%), By Product, 2017-2031F
• Figure 185. Indonesia IVD Quality Control Market Share (%), By Application, 2017-2031F
• Figure 186. Indonesia IVD Quality Control Market Share (%), By Technique, 2017-2031F
• Figure 187. Indonesia IVD Quality Control Market Share (%), By End-user, 2017-2031F
• Figure 188. Philippines IVD Quality Control Market, By Value, In USD Billion, 2017-2031F
• Figure 189. Philippines IVD Quality Control Market, By Volume, In Million Units, 2017-2031F
• Figure 190. Philippines IVD Quality Control Market Share (%), By Source, 2017-2031F
• Figure 191. Philippines IVD Quality Control Market Share (%), By Product, 2017-2031F
• Figure 192. Philippines IVD Quality Control Market Share (%), By Application, 2017-2031F
• Figure 193. Philippines IVD Quality Control Market Share (%), By Technique, 2017-2031F
• Figure 194. Philippines IVD Quality Control Market Share (%), By End-user, 2017-2031F
• Figure 195. Middle East & Africa IVD Quality Control Market, By Value, In USD Billion, 2017-2031F
• Figure 196. Middle East & Africa IVD Quality Control Market, By Volume, In Million Units, 2017-2031F
• Figure 197. Middle East & Africa IVD Quality Control Market Share (%), By Source, 2017-2031F
• Figure 198. Middle East & Africa IVD Quality Control Market Share (%), By Product, 2017-2031F
• Figure 199. Middle East & Africa IVD Quality Control Market Share (%), By Application, 2017-2031F
• Figure 200. Middle East & Africa IVD Quality Control Market Share (%), By Technique, 2017-2031F
• Figure 201. Middle East & Africa IVD Quality Control Market Share (%), By End-user, 2017-2031F
• Figure 202. Middle East & Africa IVD Quality Control Market Share (%), By Country, 2017-2031F
• Figure 203. Saudi Arabia IVD Quality Control Market, By Value, In USD Billion, 2017-2031F
• Figure 204. Saudi Arabia IVD Quality Control Market, By Volume, In Million Units, 2017-2031F
• Figure 205. Saudi Arabia IVD Quality Control Market Share (%), By Source, 2017-2031F
• Figure 206. Saudi Arabia IVD Quality Control Market Share (%), By Product, 2017-2031F
• Figure 207. Saudi Arabia IVD Quality Control Market Share (%), By Application, 2017-2031F
• Figure 208. Saudi Arabia IVD Quality Control Market Share (%), By Technique, 2017-2031F
• Figure 209. Saudi Arabia IVD Quality Control Market Share (%), By End-user, 2017-2031F
• Figure 210. UAE IVD Quality Control Market, By Value, In USD Billion, 2017-2031F
• Figure 211. UAE IVD Quality Control Market, By Volume, In Million Units, 2017-2031F
• Figure 212. UAE IVD Quality Control Market Share (%), By Source, 2017-2031F
• Figure 213. UAE IVD Quality Control Market Share (%), By Product, 2017-2031F
• Figure 214. UAE IVD Quality Control Market Share (%), By Application, 2017-2031F
• Figure 215. UAE IVD Quality Control Market Share (%), By Technique, 2017-2031F
• Figure 216. UAE IVD Quality Control Market Share (%), By End-user, 2017-2031F
• Figure 217. South Africa IVD Quality Control Market, By Value, In USD Billion, 2017-2031F
• Figure 218. South Africa IVD Quality Control Market, By Volume, In Million Units, 2017-2031F
• Figure 219. South Africa IVD Quality Control Market Share (%), By Source, 2017-2031F
• Figure 220. South Africa IVD Quality Control Market Share (%), By Product, 2017-2031F
• Figure 221. South Africa IVD Quality Control Market Share (%), By Application, 2017-2031F
• Figure 222. South Africa IVD Quality Control Market Share (%), By Technique, 2017-2031F
• Figure 223. South Africa IVD Quality Control Market Share (%), By End-user, 2017-2031F
• Figure 224. By Source Map-Market Size (USD Billion) & Growth Rate (%), 2023
• Figure 225. By Product Map-Market Size (USD Billion) & Growth Rate (%), 2023
• Figure 226. By Application Map-Market Size (USD Billion) & Growth Rate (%), 2023
• Figure 227. By Technique Map-Market Size (USD Billion) & Growth Rate (%), 2023
• Figure 228. By End-user Map-Market Size (USD Billion) & Growth Rate (%), 2023
• Figure 229. By Region Map-Market Size (USD Billion) & Growth Rate (%), 2023

Global IVD quality control market is projected to witness a CAGR of 4.77% during the forecast period 2024-2031F, growing from USD 1.32 billion in 2023 to USD 1.91 billion in 2031F. Various factors shape the global IVD quality control market, including an increased focus on developing new and innovative products, increased integration of advanced technologies, rise in demand for immunoassay products, increased popularity of data management solutions, and dominance of North America.

Several factors are controlling the global IVD quality control market, including fostering innovations and developing new products. Manufacturers are always trying to create new and better disposable surgical instruments that will increase surgical efficiency, patient safety, and affordability. This requires investigating cutting-edge components, styles, and features to satisfy the changing demands of the medical field. The global IVD quality control market is integrating cutting-edge technology, including artificial intelligence, data management systems, and automation. These technological developments enhance the precision, effectiveness, and accessibility of quality control procedures in diagnostic testing.

The global IVD quality control market is anticipated to be dominated by the immunoassay/immunochemistry segment. This is because an increasing variety of immunoassay tests are available, which offer quick, easy, and precise findings for target identification and quantification. Since they make data storage, processing, and reporting more efficient, data management systems are becoming increasingly popular in the global IVD quality control industry. These technologies facilitate data integrity, increase overall operational efficiency, and simplify quality control procedures for laboratories.

For example, a global leader in clinical diagnostic products and life science research, Bio-Rad Laboratories, Inc., announced in September 2023 the introduction of its PTC Tempo 48/48 and PTC Tempo 384 Thermal Cyclers, intended to facilitate polymerase chain reaction (PCR) applications in basic and translational research, process development, and quality control. The newest models in Bio-Rad's traditional PCR heat cyclers lineup are the PTC Tempo 48/48 and PTC Tempo 384 Thermal Cyclers. The PTC Tempo Thermal Cyclers are designed with an updated, user-friendly interface and adaptable connectivity options, including the ability to monitor data on the BR.io cloud platform to streamline protocol administration.

Increased Focus on Developing PCR Tests in the Market

The global IVD quality control market is witnessing an increased focus on the development of PCR tests. Applications and methods for polymerase chain reaction have been created, refined, and employed in the last several years for a variety of clinical fields. The creation of quality standards for these new PCR methods has been necessary to comply with both good laboratory practice (GLP) and (inter)national guidelines, as is the case with any "in-house" assay whose results impact clinical decision-making. Quality standards have previously been established for "classical" diagnostic tests like ELISAs and culture-based assays, and there are also established recommendations for both quality assurance and quality control for new PCR-based assays that are constantly being developed and improved.

For example, the GENE-UP BREWPRO Yeast Slurry (YS) is a novel diagnostic quality control PCR test that was introduced in May 2024 by bioMerieux, Inc., a global leader in in vitro diagnostics. Its purpose is to precisely identify impurities in raw yeast materials and yeast propagations to guarantee fermentation of the highest caliber. The solution, which was created in partnership with White Labs, has specialized targets designed specifically for yeast slurries and an optimized sample prep with higher sensitivity. Present-day brewing industry quality control test kits are made to identify possible spoilers in the final product rather than in the yeast slurries themselves.

Increased Integration of Advanced Technologies is Driving the Market

Innovation is essential for improving quality control, and the tremendous transition in the diagnostics industry is bolstering the growth of the global IVD quality control market. The diagnosis procedure is being completely transformed by cutting-edge technology, including automation, machine learning, and artificial intelligence. These developments have the potential to increase the precision, effectiveness, and dependability of quality control procedures, producing test results that are more reliable and consistent. The diagnostics industry's quality control procedures have seen a substantial transformation because of the incorporation of Internet of Things (IoT) technologies. Diagnostic tools with IoT capabilities may continually track several variables, including equipment performance, humidity, and temperature. Proactive quality control procedures are made possible by the quick detection of any deviations from ideal operating conditions made possible by this real-time data collection.

For example, Bio-Rad Laboratories Inc. revealed in August 2023 that they will leverage AWS Systems Manager to build an Internet of Things device that will enhance their Next-Generation Quality Control Informatics Solution. AWS Systems Manager is a comprehensive and secure resource management tool that can be used in hybrid and multi-cloud scenarios. Without requiring any extra IT support, it connects to the instrument, the lab information system, middleware, and other software through an edge device that serves as a bridge between the lab and the cloud.

The Rise in Demand for Immunoassay Products is Boosting Market Growth

Immunoassay products are an important part of the global IVD quality control market. IVD kits and reagent variance are evaluated and tracked using immunoassay-based quality control tools. Any variations in performance can be found and fixed by comparing several IVD products to standardized immunoassay controls. Immunoassay-based quality control products can be used to identify the cause of problems in diagnostic testing. Potential causes of error, such as reagent quality, instrument performance, or operator technique, can be found and fixed by comparing results from control samples to predicted values.

For instance, Siemens Healthineers AG introduced Atellica CI Analyzer, a small testing equipment designed to address lab problems, in July 2023. With its unique features, the Atellica CI Analyzer is carefully built to maximize downtime and boost lab productivity and profitability. Labs can provide more consistent sample turnaround times thanks to automated maintenance and quality control scheduling, micro-volume aspiration, and random-access sampling. The independence of the immunoassay and chemistry engines ensures that throughput is unaffected if one of them needs to stop.

Data Management Solutions are Popular in the Market

Data management solutions offer a centralized platform for storing, organizing, and managing all data about quality control procedures in the IVD industry. In this way, a single source for quality control data is produced, incorporating information from several diagnostic devices, laboratory information systems (LIS), and other locations. Data management systems offer safe data storage, access controls, and audit trails to guarantee the accuracy and traceability of quality control data. Real-time monitoring of quality control parameters, including test results, reagent stability, and equipment performance, can be facilitated by data management solutions. All these factors make data management solutions an important factor driving the growth of the global IVD quality control market.

For instance, with the introduction of new waters_connect for IVD and QUAN Review Application in May 2024, Waters Corporation simplified the clinical data review process. ExceptionFocused Review (xfR) enables users to quickly identify and address errors that require attention. Its key features include reducing data review time by up to 50% (in comparison to Waters TargetLyn Software) and providing a one-screen dashboard that summarizes key parameters like standards, calibration, and quality control, all grouped for a streamlined view.

North America is Dominating the IVD Quality Control Market

The global IVD quality control market is dominated by North American nations, especially the United States, for several important reasons, including the existence of several accredited clinical laboratories. The United States boasts a well-respected healthcare system and many accredited clinical laboratories that follow tight quality control guidelines. The healthcare systems in North America have embraced cutting-edge diagnostic technologies like immunoassays and molecular diagnostics with great speed. The requirement for quality control procedures to guarantee the precision and dependability of test results has increased because of the growing usage of these technologies.

For example, Next Gen Diagnostics announced on June 11, 2024, that it would open its first laboratory in the United States in Cambridge, Massachusetts. The facility will offer United States' customers and partners fully integrated, affordable bacterial sequencing and bioinformatics services. This ability is enhanced by NGD's best-in-class fully automated bioinformatics, which offers comprehensive analysis of cohort phylogeny, resistance elements, and phenotype, delivered and visualized in a robust user interface, as well as quality control and relatedness determination validated in several publications.

Future Market Scenario (2024-2031F)

The global IVD quality control market is expected to see a rise in demand for multi-analyte controls, which contain numerous analytes of interest.

Point-of-care testing adoption in the global IVD quality control market is motivated by the need for quick, easy-to-use, and trustworthy diagnostic tools that improve patient outcomes and expedite processes.

It is anticipated that the increased focus on developing environmentally friendly and sustainable products will drive the growth of the global IVD quality control market.

In the global IVD quality control market, companion diagnostics, which direct the use of particular treatment products, are becoming increasingly popular.

Key Players Landscape and Outlook

Many major companies in the global IVD quality control market are forming alliances to expand in the industry. Major players can build more sophisticated and comprehensive quality control products by collaborating with other businesses to make use of complementary skills, technology, and resources. Through alliances, prominent players can better serve the different needs of the diagnostics industry by broadening the scope of their quality control solutions and diversifying their product portfolios. Investing heavily in R&D and obtaining regulatory licenses is necessary to develop products with quality control.

For example, top AI software provider Bioz, Inc., dedicated to scientific research, announced in January 2024 that it has partnered with top worldwide diagnostics provider Randox Laboratories Ltd. The organization, which is well-known for its creative research and development, provides a wide range of superior goods and services, such as quality controls, toxicology solutions, modern diagnostic devices, and clinical chemistry reagents. Using this creative partnership, Bioz has integrated Bioz Badges as dynamic, real-time widgets into the product pages of Randox Laboratories' website. These widgets offer real-time scientific application data, including excerpts from peer-reviewed scientific articles that are specifically connected to the use of the product. This collaboration aims to help academics make evidence-based decisions by raising exposure and brand awareness.

Table of Contents

1. Research Methodology

2. Project Scope and Definitions

3. Executive Summary

4. Global IVD Quality Control Market Outlook, 2017-2031F

• 4.1. Market Size & Forecast
  • 4.1.1. By Value
  • 4.1.2. By Volume
• 4.2. By Product
  • 4.2.1. By Source
    • 4.2.1.1. Plasma
    • 4.2.1.2. Whole Blood
    • 4.2.1.3. Urine
  • 4.2.2. Quality Control Products
    • 4.2.2.1. By Function
      • 4.2.2.1.1. Instrument-Specific Controls
      • 4.2.2.1.2. Independent Controls
    • 4.2.2.2. By Type
      • 4.2.2.2.1. Serum/Plasma-based Controls
      • 4.2.2.2.2. Whole Blood-based Controls
      • 4.2.2.2.3. Urine-based Controls
      • 4.2.2.2.4. Others
  • 4.2.3. Data Management Solutions
  • 4.2.4. Quality Assessment Services
• 4.3. By Application
  • 4.3.1. Oncology
  • 4.3.2. Cardiology
  • 4.3.3. Neurology
  • 4.3.4. Infectious Diseases
  • 4.3.5. Autoimmune Disorders
  • 4.3.6. Others
• 4.4. By Technique
  • 4.4.1. Molecular Diagnostics
  • 4.4.2. Coagulation/Hemostasis
  • 4.4.3. Hematology
  • 4.4.4. Microbiology
  • 4.4.5. Immunochemistry/Immunoassay
  • 4.4.6. Clinical Chemistry/Biochemistry
  • 4.4.7. Others
• 4.5. By End-user
  • 4.5.1. Hospitals and Clinics
  • 4.5.2. Diagnostic Laboratories
  • 4.5.3. IVD Manufacturers
  • 4.5.4. CROs
  • 4.5.5. 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 IVD Quality Control Market Outlook, By Region, 2017-2031F

• 5.1. North America*
  • 5.1.1. Market Size & Forecast
    • 5.1.1.1. By Value
    • 5.1.1.2. By Volume
  • 5.1.2. By Source
    • 5.1.2.1. Plasma
    • 5.1.2.2. Whole Blood
    • 5.1.2.3. Urine
  • 5.1.3. By Product
    • 5.1.3.1. Quality Control Products
      • 5.1.3.1.1. By Function
        • 5.1.3.1.1.1. Instrument-Specific Controls
        • 5.1.3.1.1.2. Independent Controls
      • 5.1.3.1.2. By Type
        • 5.1.3.1.2.1. Serum/Plasma-based Controls
        • 5.1.3.1.2.2. Whole Blood-based Controls
        • 5.1.3.1.2.3. Urine-based Controls
        • 5.1.3.1.2.4. Others
    • 5.1.3.2. Data Management Solutions
    • 5.1.3.3. Quality Assessment Services
  • 5.1.4. By Application
    • 5.1.4.1. Oncology
    • 5.1.4.2. Cardiology
    • 5.1.4.3. Neurology
    • 5.1.4.4. Infectious Diseases
    • 5.1.4.5. Autoimmune Disorders
    • 5.1.4.6. Others
  • 5.1.5. By Technique
    • 5.1.5.1. Molecular Diagnostics
    • 5.1.5.2. Coagulation/Hemostasis
    • 5.1.5.3. Hematology
    • 5.1.5.4. Microbiology
    • 5.1.5.5. Immunochemistry/Immunoassay
    • 5.1.5.6. Clinical Chemistry/Biochemistry
    • 5.1.5.7. Others
  • 5.1.6. By End-user
    • 5.1.6.1. Hospitals and Clinics
    • 5.1.6.2. Diagnostic Laboratories
    • 5.1.6.3. IVD Manufacturers
    • 5.1.6.4. CROs
    • 5.1.6.5. Others
  • 5.1.7. United States*
    • 5.1.7.1. Market Size & Forecast
      • 5.1.7.1.1. By Value
      • 5.1.7.1.2. By Volume
    • 5.1.7.2. By Source
      • 5.1.7.2.1. Plasma
      • 5.1.7.2.2. Whole Blood
      • 5.1.7.2.3. Urine
    • 5.1.7.3. By Product
      • 5.1.7.3.1. Quality Control Products
        • 5.1.7.3.1.1. By Function
        • 5.1.7.3.1.1.1. Instrument-Specific Controls
        • 5.1.7.3.1.1.2. Independent Controls
      • 5.1.7.3.2. By Type
        • 5.1.7.3.2.1.1. Serum/Plasma-based Controls
        • 5.1.7.3.2.1.2. Whole Blood-based Controls
        • 5.1.7.3.2.1.3. Urine-based Controls
        • 5.1.7.3.2.1.4. Others
      • 5.1.7.3.3. Data Management Solutions
      • 5.1.7.3.4. Quality Assessment Services
    • 5.1.7.4. By Application
      • 5.1.7.4.1. Oncology
      • 5.1.7.4.2. Cardiology
      • 5.1.7.4.3. Neurology
      • 5.1.7.4.4. Infectious Diseases
      • 5.1.7.4.5. Autoimmune Disorders
      • 5.1.7.4.6. Others
    • 5.1.7.5. By Technique
      • 5.1.7.5.1. Molecular Diagnostics
      • 5.1.7.5.2. Coagulation/Hemostasis
      • 5.1.7.5.3. Hematology
      • 5.1.7.5.4. Microbiology
      • 5.1.7.5.5. Immunochemistry/Immunoassay
      • 5.1.7.5.6. Clinical Chemistry/Biochemistry
      • 5.1.7.5.7. Others
    • 5.1.7.6. By End-user
      • 5.1.7.6.1. Hospitals and Clinics
      • 5.1.7.6.2. Diagnostic Laboratories
      • 5.1.7.6.3. IVD Manufacturers
      • 5.1.7.6.4. CROs
      • 5.1.7.6.5. Others
  • 5.1.8. Canada
  • 5.1.9. 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. Italy
  • 5.2.4. United Kingdom
  • 5.2.5. Russia
  • 5.2.6. Netherlands
  • 5.2.7. Spain
  • 5.2.8. Turkey
  • 5.2.9. Poland
• 5.3. Asia-Pacific
  • 5.3.1. India
  • 5.3.2. China
  • 5.3.3. Japan
  • 5.3.4. Australia
  • 5.3.5. Vietnam
  • 5.3.6. South Korea
  • 5.3.7. Indonesia
  • 5.3.8. Philippines
• 5.4. South America
  • 5.4.1. Brazil
  • 5.4.2. Argentina
• 5.5. Middle East and Africa
  • 5.5.1. Saudi Arabia
  • 5.5.2. UAE
  • 5.5.3. South Africa

6. Market Mapping, 2023

• 6.1. By Source
• 6.2. By Product
• 6.3. By Application
• 6.4. By Technique
• 6.5. By End-user
• 6.6. 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. Clinical Trials
• 9.2. Patent Landscape
• 9.3. Regulatory Approvals
• 9.4. 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 (By Value, 2023)
• 10.3. Mergers and Acquisitions/Joint Ventures (If Applicable)
• 10.4. SWOT Analysis (For Five Market Players)
• 10.5. Patent Analysis (If Applicable)

11. Pricing Analysis

12. Case Studies

13. Key Players Outlook

• 13.1. Bio-Rad Laboratories, Inc.
  • 13.1.1. Company Details
  • 13.1.2. Key Management Personnel
  • 13.1.3. Products and Services
  • 13.1.4. Financials (As Reported)
  • 13.1.5. Key Market Focus and Geographical Presence
  • 13.1.6. Recent Developments
• 13.2. Danaher Corporation
• 13.3. Thermo Fisher Scientific, Inc.
• 13.4. QuidelOrtho Corporation
• 13.5. Siemens Healthineers AG
• 13.6. LGC Group
• 13.7. Randox Laboratories Ltd.
• 13.8. Microbiologics, Inc.
• 13.9. Streck LLC
• 13.10. SERO AS

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