シングルユースアセンブリー市場の評価：製品・ソリューション・用途・エンドユーザー・地域別の機会および予測 (2018-2032年)

世界のシングルユースアセンブリーの市場規模は、予測期間中にCAGR 16.56％で推移し、2024年の43億1,100万米ドルから、2032年には147億3,311万米ドルに成長すると予測されています。

同市場の成長は、医薬品およびバイオ医薬品分野の急速な拡大、バイオ医薬品への投資の増加、新製品および新技術の導入、創薬プロセスの迅速化に向けた取り組みの活発化、感染症の増加といった複数の要因によって後押しされています。同市場は、バイオ医薬品製造やライフサイエンス分野において、あらかじめ組み立てられた使い捨て型の流路システムの利用が広がっていることから、力強い成長を遂げています。これらのアセンブリーは、チューブ、バッグ、フィルター、コネクターなどを含み、高い無菌性、交差汚染リスクの低減、洗浄およびバリデーション工程の不要化といった多くの利点があり、結果として運用効率の向上とコスト削減につながります。また、モノクローナル抗体、ワクチン、細胞・遺伝子治療薬といったバイオ医薬品の製造需要の増加により、これらの製品を製造するためのスケーラブルで柔軟なソリューションが求められており、シングルユースアセンブリーがそのニーズに応えています。技術の進化によって、製品の信頼性、安全性、法規制対応も向上しており、さらに製造各社は環境への影響を低減する目的で持続可能な素材の導入も進めています。規制当局も、シングルユースアセンブリーが高水準の無菌性を確保できることを評価しており、市場の導入拡大を後押ししています。しかし、こうした好調な傾向がある一方で、市場には環境への懸念、サプライチェーンの複雑性、標準化の欠如、専門技術者の必要性といった課題も残されています。

医薬品の市場投入を迅速化しようとする企業の取り組みの高まりは、世界のシングルユースアセンブリー市場における主要なトレンドのひとつです。2024年4月、SaniSure Limitedは、Fill4Sureというカスタム仕様のシングルユース充填アセンブリーを発表しました。これは、医薬品の充填プロセスにおける再現性、安全性、効率性を向上させることを目的としています。この製品には、高性能チューブ、シリコーンオーバーモールディング、低粒子2Dサージバッグ、接着剤・オイル不使用のOEM設計、カスタムニードルなどの特徴があり、コンタミネーションリスクを最小限に抑えることで製品の純度を確保します。これらの高度な機能は、バイオプロセシングやバイオ製造工程の効率化にも貢献し、サプライチェーンの確保や製造能力の拡大を製造業者にもたらします。このようなコスト効率に優れ、かつニーズに応じた設計が可能なアセンブリーは、産業の進化する要件に応える上で、スムーズなスケールアップを実現する手段として大きな役割を果たしています。

バイオ医薬品への投資拡大も、市場の成長を後押しすると期待されています。2024年1月、AbbVie Inc. は、シンガポールのバイオ医薬品製造施設の拡張に2億2,300万米ドルを投資すると発表しました。この拡張は2026年に完了予定で、24,000リットルのバイオ医薬品原薬の製造能力および新たに100名の雇用創出が見込まれています。この投資は、同社のグローバルな製造ネットワークの拡充を支援し、癌領域や免疫領域の開発パイプラインを支えるものとされています。また、シングルユースアセンブリーは、バイオ医薬品の製造工程のさまざまな段階、たとえば中間製品の保管、培地・緩衝液の調製、下流工程処理 (精製など) 、上流工程処理 (培養など) などで使用されており、その重要性は今後さらに高まっていくと見られています。

当レポートでは、世界のシングルユースアセンブリーの市場を調査し、市場の定義と概要、市場規模の推移・予測、各種区分別の詳細分析、産業構造、市場成長への影響因子の分析、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 世界のシングルユースアセンブリー市場の展望

• 市場規模の分析・予測
• 市場シェアの分析・予測
  • 製品別
    • ろ過アセンブリー
    • ボトルアセンブリー
    • バッグアセンブリー
    • チューブアセンブリー
    • 混合システムアセンブリー
    • その他
  • ソリューション別
    • カスタマイズドソリューション
    • 標準ソリューション
  • 用途別
    • ろ過・精製
    • 貯蔵
    • 細胞培養・混合
    • 配合・充填仕上げ
    • サンプリング
    • その他
  • エンドユーザー別
    • バイオ医薬品・製薬会社
    • 学術研究機関
    • CRO・CMO
  • 地域別
    • 北米
    • 南米
    • 欧州
    • アジア太平洋
    • 中東・アフリカ
  • 企業シェア分析 (上位5社およびその他)
• 市場マップ分析

第5章 北米のシングルユースアセンブリー市場の展望

• 市場規模の分析・予測
• 市場シェアの分析・予測
• 国別市場評価
  • カナダ
  • メキシコ

第6章 欧州のシングルユースアセンブリー市場の展望

• 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

第7章 アジア太平洋のシングルユースアセンブリー市場の展望

• 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

第8章 南米のシングルユースアセンブリー市場の展望

• ブラジル
• アルゼンチン

第9章 中東・アフリカのシングルユースアセンブリー市場の展望

• サウジアラビア
• UAE
• 南アフリカ

第10章 需給分析

第11章 バリューチェーン分析

第12章 ポーターのファイブフォース分析

第13章 PESTLE分析

第14章 価格分析

第15章 市場力学

• 市場促進要因
• 市場の課題

第16章 市場動向と発展

第17章 規制枠組みとイノベーション

• 規制当局の承認
• イノベーション/新興技術

第18章 特許の情勢

第19章 ケーススタディ

第20章 競合情勢

• 上位5社の競合マトリックス
• 上位5社のSWOT分析
• 上位10社の情勢
  • Thermo Fisher Scientific Inc.
  • Merck & Co., Inc.
  • Sartorius AG
  • Avantor, Inc.
  • CYTIVA BIOSCIENCE HOLDING LIMITED
  • Parker Hannifin Corporation
  • Corning Incorporated
  • Lonza Group AG
  • Repligen Corporation
  • Meissner Filtration Products, Inc.

第7章 戦略的提言

第8章 調査会社について・免責事項

List of Tables

• Table 1. Single-Use Assemblies Pricing for Major Players (USD, 2024)
• Table 2. Compliance for Single-use Assemblies - International Organisation for Standardization (ISO)
• Table 3. Compliance for Single-use Assemblies - The United States Pharmacopeia (USP)

List of Figures

• Figure 1. Global Single-use Assemblies Market Size, By Value (USD Million), 2018-2032F
• Figure 2. Global Single-use Assemblies Market Size, By Volume (Billion Units), 2018-2032F
• Figure 3. Global Single-use Assemblies Market Share, By Product, By Value, 2018-2032F
• Figure 4. Global Single-use Assemblies Market Share, By Product, By Bag Assemblies, By Value, 2018-2032F
• Figure 5. Global Single-use Assemblies Market Share, By Solution, By Value, 2018-2032F
• Figure 6. Global Single-use Assemblies Market Share, By Application, By Value, 2018-2032F
• Figure 7. Global Single-use Assemblies Market Share, By End-user, By Value, 2018-2032F
• Figure 8. Global Single-use Assemblies Market Share, By Region, By Value, 2018-2032F
• Figure 9. Global Single-use Assemblies Market Share, By Company, By Value, 2024
• Figure 10. Global Single-use Assemblies Market Map, By Product, By Value, 2024
• Figure 11. Global Single-use Assemblies Market Map, By Solution, By Value, 2024
• Figure 12. Global Single-use Assemblies Market Map, By Application, By Value, 2024
• Figure 13. Global Single-use Assemblies Market Map, By End-user, By Value, 2024
• Figure 14. Global Single-use Assemblies Market Map, By Region, By Value, 2024
• Figure 15. Global Single-use Bioreactors Market Map, By Application, By Value, 2024
• Figure 16. Global Single-use Bioreactors Market Map, By End-user, By Value, 2024
• Figure 17. Global Single-use Bioreactors Market Map, By Region, By Value, 2024
• Figure 18. North America Single-use Assemblies Market Size, By Value (USD Million), 2018-2032F
• Figure 19. North America Single-use Assemblies Market Size, By Volume (Billion Units), 2018-2032F
• Figure 20. North America Single-use Assemblies Market Share, By Product, By Value, 2018-2032F
• Figure 21. North America Single-use Assemblies Market Share, By Product, By Bag Assemblies, By Value, 2018-2032F
• Figure 22. North America Single-use Assemblies Market Share, By Solution, By Value, 2018-2032F
• Figure 23. North America Single-use Assemblies Market Share, By Application, By Value, 2018-2032F
• Figure 24. North America Single-use Assemblies Market Share, By End-user, By Value, 2018-2032F
• Figure 25. North America Single-use Assemblies Market Share, By Region, By Value, 2018-2032F
• Figure 26. United States Single-use Assemblies Market Size, By Value (USD Million), 2018-2032F
• Figure 27. United States Single-use Assemblies Market Size, By Volume (Billion Units), 2018-2032F
• Figure 28. United States Single-use Assemblies Market Share, By Product, By Value, 2018-2032F
• Figure 29. United States Single-use Assemblies Market Share, By Product, By Bag Assemblies, By Value, 2018-2032F
• Figure 30. United States Single-use Assemblies Market Share, By Solution, By Value, 2018-2032F
• Figure 31. United States Single-use Assemblies Market Share, By Application, By Value, 2018-2032F
• Figure 32. United States Single-use Assemblies Market Share, By End-user, By Value, 2018-2032F
• Figure 33. Canada Single-use Assemblies Market Size, By Value (USD Million), 2018-2032F
• Figure 34. Canada Single-use Assemblies Market Size, By Volume (Billion Units), 2018-2032F
• Figure 35. Canada Single-use Assemblies Market Share, By Product, By Value, 2018-2032F
• Figure 36. Canada Single-use Assemblies Market Share, By Product, By Bag Assemblies, By Value, 2018-2032F
• Figure 37. Canada Single-use Assemblies Market Share, By Solution, By Value, 2018-2032F
• Figure 38. Canada Single-use Assemblies Market Share, By Application, By Value, 2018-2032F
• Figure 39. Canada Single-use Assemblies Market Share, By End-user, By Value, 2018-2032F
• Figure 40. Mexico Single-use Assemblies Market Size, By Value (USD Million), 2018-2032F
• Figure 41. Mexico Single-use Assemblies Market Size, By Volume (Billion Units), 2018-2032F
• Figure 42. Mexico Single-use Assemblies Market Share, By Product, By Value, 2018-2032F
• Figure 43. Mexico Single-use Assemblies Market Share, By Product, By Bag Assemblies, By Value, 2018-2032F
• Figure 44. Mexico Single-use Assemblies Market Share, By Solution, By Value, 2018-2032F
• Figure 45. Mexico Single-use Assemblies Market Share, By Application, By Value, 2018-2032F
• Figure 46. Mexico Single-use Assemblies Market Share, By End-user, By Value, 2018-2032F
• Figure 47. Europe Single-use Assemblies Market Size, By Value (USD Million), 2018-2032F
• Figure 48. Europe Single-use Assemblies Market Size, By Volume (Billion Units), 2018-2032F
• Figure 49. Europe Single-use Assemblies Market Share, By Product, By Value, 2018-2032F
• Figure 50. Europe Single-use Assemblies Market Share, By Product, By Bag Assemblies, By Value, 2018-2032F
• Figure 51. Europe Single-use Assemblies Market Share, By Solution, By Value, 2018-2032F
• Figure 52. Europe Single-use Assemblies Market Share, By Application, By Value, 2018-2032F
• Figure 53. Europe Single-use Assemblies Market Share, By End-user, By Value, 2018-2032F
• Figure 54. Europe Single-use Assemblies Market Share, By Region, By Value, 2018-2032F
• Figure 55. Germany Single-use Assemblies Market Size, By Value (USD Million), 2018-2032F
• Figure 56. Germany Single-use Assemblies Market Size, By Volume (Billion Units), 2018-2032F
• Figure 57. Germany Single-use Assemblies Market Share, By Product, By Value, 2018-2032F
• Figure 58. Germany Single-use Assemblies Market Share, By Product, By Bag Assemblies, By Value, 2018-2032F
• Figure 59. Germany Single-use Assemblies Market Share, By Solution, By Value, 2018-2032F
• Figure 60. Germany Single-use Assemblies Market Share, By Application, By Value, 2018-2032F
• Figure 61. Germany Single-use Assemblies Market Share, By End-user, By Value, 2018-2032F
• Figure 62. United Kingdom Single-use Assemblies Market Size, By Value (USD Million), 2018-2032F
• Figure 63. United Kingdom Single-use Assemblies Market Size, By Volume (Billion Units), 2018-2032F
• Figure 64. United Kingdom Single-use Assemblies Market Share, By Product, By Value, 2018-2032F
• Figure 65. United Kingdom Single-use Assemblies Market Share, By Product, By Bag Assemblies, By Value, 2018-2032F
• Figure 66. United Kingdom Single-use Assemblies Market Share, By Solution, By Value, 2018-2032F
• Figure 67. United Kingdom Single-use Assemblies Market Share, By Application, By Value, 2018-2032F
• Figure 68. United Kingdom Single-use Assemblies Market Share, By End-user, By Value, 2018-2032F
• Figure 69. France Single-use Assemblies Market Size, By Value (USD Million), 2018-2032F
• Figure 70. France Single-use Assemblies Market Size, By Volume (Billion Units), 2018-2032F
• Figure 71. France Single-use Assemblies Market Share, By Product, By Value, 2018-2032F
• Figure 72. France Single-use Assemblies Market Share, By Product, By Bag Assemblies, By Value, 2018-2032F
• Figure 73. France Single-use Assemblies Market Share, By Solution, By Value, 2018-2032F
• Figure 74. France Single-use Assemblies Market Share, By Application, By Value, 2018-2032F
• Figure 75. France Single-use Assemblies Market Share, By End-user, By Value, 2018-2032F
• Figure 76. Russia Single-use Assemblies Market Size, By Value (USD Million), 2018-2032F
• Figure 77. Russia Single-use Assemblies Market Size, By Volume (Billion Units), 2018-2032F
• Figure 78. Russia Single-use Assemblies Market Share, By Product, By Value, 2018-2032F
• Figure 79. Russia Single-use Assemblies Market Share, By Product, By Bag Assemblies, By Value, 2018-2032F
• Figure 80. Russia Single-use Assemblies Market Share, By Solution, By Value, 2018-2032F
• Figure 81. Russia Single-use Assemblies Market Share, By Application, By Value, 2018-2032F
• Figure 82. Russia Single-use Assemblies Market Share, By End-user, By Value, 2018-2032F
• Figure 83. Italy Single-use Assemblies Market Size, By Value (USD Million), 2018-2032F
• Figure 84. Italy Single-use Assemblies Market Size, By Volume (Billion Units), 2018-2032F
• Figure 85. Italy Single-use Assemblies Market Share, By Product, By Value, 2018-2032F
• Figure 86. Italy Single-use Assemblies Market Share, By Product, By Bag Assemblies, By Value, 2018-2032F
• Figure 87. Italy Single-use Assemblies Market Share, By Solution, By Value, 2018-2032F
• Figure 88. Italy Single-use Assemblies Market Share, By Application, By Value, 2018-2032F
• Figure 89. Italy Single-use Assemblies Market Share, By End-user, By Value, 2018-2032F
• Figure 90. Spain Single-use Assemblies Market Size, By Value (USD Million), 2018-2032F
• Figure 91. Spain Single-use Assemblies Market Size, By Volume (Billion Units), 2018-2032F
• Figure 92. Spain Single-use Assemblies Market Share, By Product, By Value, 2018-2032F
• Figure 93. Spain Single-use Assemblies Market Share, By Product, By Bag Assemblies, By Value, 2018-2032F
• Figure 94. Spain Single-use Assemblies Market Share, By Solution, By Value, 2018-2032F
• Figure 95. Spain Single-use Assemblies Market Share, By Application, By Value, 2018-2032F
• Figure 96. Spain Single-use Assemblies Market Share, By End-user, By Value, 2018-2032F
• Figure 97. Netherlands Single-use Assemblies Market Size, By Value (USD Million), 2018-2032F
• Figure 98. Netherlands Single-use Assemblies Market Size, By Volume (Billion Units), 2018-2032F
• Figure 99. Netherlands Single-use Assemblies Market Share, By Product, By Value, 2018-2032F
• Figure 100. Netherlands Single-use Assemblies Market Share, By Product, By Bag Assemblies, By Value, 2018-2032F
• Figure 101. Netherlands Single-use Assemblies Market Share, By Solution, By Value, 2018-2032F
• Figure 102. Netherlands Single-use Assemblies Market Share, By Application, By Value, 2018-2032F
• Figure 103. Netherlands Single-use Assemblies Market Share, By End-user, By Value, 2018-2032F
• Figure 104. Poland Single-use Assemblies Market Size, By Value (USD Million), 2018-2032F
• Figure 105. Poland Single-use Assemblies Market Size, By Volume (Billion Units), 2018-2032F
• Figure 106. Poland Single-use Assemblies Market Share, By Product, By Value, 2018-2032F
• Figure 107. Poland Single-use Assemblies Market Share, By Product, By Bag Assemblies, By Value, 2018-2032F
• Figure 108. Poland Single-use Assemblies Market Share, By Solution, By Value, 2018-2032F
• Figure 109. Poland Single-use Assemblies Market Share, By Application, By Value, 2018-2032F
• Figure 110. Poland Single-use Assemblies Market Share, By End-user, By Value, 2018-2032F
• Figure 111. Asia-Pacific Single-use Assemblies Market Size, By Value (USD Million), 2018-2032F
• Figure 112. Asia-Pacific Single-use Assemblies Market Size, By Volume (Billion Units), 2018-2032F
• Figure 113. Asia-Pacific Single-use Assemblies Market Share, By Product, By Value, 2018-2032F
• Figure 114. Asia-Pacific Single-use Assemblies Market Share, By Product, By Bag Assemblies, By Value, 2018-2032F
• Figure 115. Asia-Pacific Single-use Assemblies Market Share, By Solution, By Value, 2018-2032F
• Figure 116. Asia-Pacific Single-use Assemblies Market Share, By Application, By Value, 2018-2032F
• Figure 117. Asia-Pacific Single-use Assemblies Market Share, By End-user, By Value, 2018-2032F
• Figure 118. Asia-Pacific Single-use Assemblies Market Share, By Region, By Value, 2018-2032F
• Figure 119. China Single-use Assemblies Market Size, By Value (USD Million), 2018-2032F
• Figure 120. China Single-use Assemblies Market Size, By Volume (Billion Units), 2018-2032F
• Figure 121. China Single-use Assemblies Market Share, By Product, By Value, 2018-2032F
• Figure 122. China Single-use Assemblies Market Share, By Product, By Bag Assemblies, By Value, 2018-2032F
• Figure 123. China Single-use Assemblies Market Share, By Solution, By Value, 2018-2032F
• Figure 124. China Single-use Assemblies Market Share, By Application, By Value, 2018-2032F
• Figure 125. China Single-use Assemblies Market Share, By End-user, By Value, 2018-2032F
• Figure 126. Japan Single-use Assemblies Market Size, By Value (USD Million), 2018-2032F
• Figure 127. Japan Single-use Assemblies Market Size, By Volume (Billion Units), 2018-2032F
• Figure 128. Japan Single-use Assemblies Market Share, By Product, By Value, 2018-2032F
• Figure 129. Japan Single-use Assemblies Market Share, By Product, By Bag Assemblies, By Value, 2018-2032F
• Figure 130. Japan Single-use Assemblies Market Share, By Solution, By Value, 2018-2032F
• Figure 131. Japan Single-use Assemblies Market Share, By Application, By Value, 2018-2032F
• Figure 132. Japan Single-use Assemblies Market Share, By End-user, By Value, 2018-2032F
• Figure 133. India Single-use Assemblies Market Size, By Value (USD Million), 2018-2032F
• Figure 134. India Single-use Assemblies Market Size, By Volume (Billion Units), 2018-2032F
• Figure 135. India Single-use Assemblies Market Share, By Product, By Value, 2018-2032F
• Figure 136. India Single-use Assemblies Market Share, By Product, By Bag Assemblies, By Value, 2018-2032F
• Figure 137. India Single-use Assemblies Market Share, By Solution, By Value, 2018-2032F
• Figure 138. India Single-use Assemblies Market Share, By Application, By Value, 2018-2032F
• Figure 139. India Single-use Assemblies Market Share, By End-user, By Value, 2018-2032F
• Figure 140. South Korea Single-use Assemblies Market Size, By Value (USD Million), 2018-2032F
• Figure 141. South Korea Single-use Assemblies Market Size, By Volume (Billion Units), 2018-2032F
• Figure 142. South Korea Single-use Assemblies Market Share, By Product, By Value, 2018-2032F
• Figure 143. South Korea Single-use Assemblies Market Share, By Product, By Bag Assemblies, By Value, 2018-2032F
• Figure 144. South Korea Single-use Assemblies Market Share, By Solution, By Value, 2018-2032F
• Figure 145. South Korea Single-use Assemblies Market Share, By Application, By Value, 2018-2032F
• Figure 146. South Korea Single-use Assemblies Market Share, By End-user, By Value, 2018-2032F
• Figure 147. Indonesia Single-use Assemblies Market Size, By Value (USD Million), 2018-2032F
• Figure 148. Indonesia Single-use Assemblies Market Size, By Volume (Billion Units), 2018-2032F
• Figure 149. Indonesia Single-use Assemblies Market Share, By Product, By Value, 2018-2032F
• Figure 150. Indonesia Single-use Assemblies Market Share, By Product, By Bag Assemblies, By Value, 2018-2032F
• Figure 151. Indonesia Single-use Assemblies Market Share, By Solution, By Value, 2018-2032F
• Figure 152. Indonesia Single-use Assemblies Market Share, By Application, By Value, 2018-2032F
• Figure 153. Indonesia Single-use Assemblies Market Share, By End-user, By Value, 2018-2032F
• Figure 154. Australia Single-use Assemblies Market Size, By Value (USD Million), 2018-2032F
• Figure 155. Australia Single-use Assemblies Market Size, By Volume (Billion Units), 2018-2032F
• Figure 156. Australia Single-use Assemblies Market Share, By Product, By Value, 2018-2032F
• Figure 157. Australia Single-use Assemblies Market Share, By Product, By Bag Assemblies, By Value, 2018-2032F
• Figure 158. Australia Single-use Assemblies Market Share, By Solution, By Value, 2018-2032F
• Figure 159. Australia Single-use Assemblies Market Share, By Application, By Value, 2018-2032F
• Figure 160. Australia Single-use Assemblies Market Share, By End-user, By Value, 2018-2032F
• Figure 161. Vietnam Single-use Assemblies Market Size, By Value (USD Million), 2018-2032F
• Figure 162. Vietnam Single-use Assemblies Market Size, By Volume (Billion Units), 2018-2032F
• Figure 163. Vietnam Single-use Assemblies Market Share, By Product, By Value, 2018-2032F
• Figure 164. Vietnam Single-use Assemblies Market Share, By Product, By Bag Assemblies, By Value, 2018-2032F
• Figure 165. Vietnam Single-use Assemblies Market Share, By Solution, By Value, 2018-2032F
• Figure 166. Vietnam Single-use Assemblies Market Share, By Application, By Value, 2018-2032F
• Figure 167. Vietnam Single-use Assemblies Market Share, By End-user, By Value, 2018-2032F
• Figure 168. Philippines Single-use Assemblies Market Size, By Value (USD Million), 2018-2032F
• Figure 169. Philippines Single-use Assemblies Market Size, By Volume (Billion Units), 2018-2032F
• Figure 170. Philippines Single-use Assemblies Market Share, By Product, By Value, 2018-2032F
• Figure 171. Philippines Single-use Assemblies Market Share, By Product, By Bag Assemblies, By Value, 2018-2032F
• Figure 172. Philippines Single-use Assemblies Market Share, By Solution, By Value, 2018-2032F
• Figure 173. Philippines Single-use Assemblies Market Share, By Application, By Value, 2018-2032F
• Figure 174. Philippines Single-use Assemblies Market Share, By End-user, By Value, 2018-2032F
• Figure 175. MEA Single-use Assemblies Market Size, By Value (USD Million), 2018-2032F
• Figure 176. MEA Single-use Assemblies Market Size, By Volume (Billion Units), 2018-2032F
• Figure 177. MEA Single-use Assemblies Market Share, By Product, By Value, 2018-2032F
• Figure 178. MEA Single-use Assemblies Market Share, By Product, By Bag Assemblies, By Value, 2018-2032F
• Figure 179. MEA Single-use Assemblies Market Share, By Solution, By Value, 2018-2032F
• Figure 180. MEA Single-use Assemblies Market Share, By Application, By Value, 2018-2032F
• Figure 181. MEA Single-use Assemblies Market Share, By End-user, By Value, 2018-2032F
• Figure 182. MEA Single-use Assemblies Market Share, By Region, By Value, 2018-2032F
• Figure 183. Saudi Arabia Single-use Assemblies Market Size, By Value (USD Million), 2018-2032F
• Figure 184. Saudi Arabia Single-use Assemblies Market Size, By Volume (Billion Units), 2018-2032F
• Figure 185. Saudi Arabia Single-use Assemblies Market Share, By Product, By Value, 2018-2032F
• Figure 186. Saudi Arabia Single-use Assemblies Market Share, By Product, By Bag Assemblies, By Value, 2018-2032F
• Figure 187. Saudi Arabia Single-use Assemblies Market Share, By Solution, By Value, 2018-2032F
• Figure 188. Saudi Arabia Single-use Assemblies Market Share, By Application, By Value, 2018-2032F
• Figure 189. Saudi Arabia Single-use Assemblies Market Share, By End-user, By Value, 2018-2032F
• Figure 190. UAE Single-use Assemblies Market Size, By Value (USD Million), 2018-2032F
• Figure 191. UAE Single-use Assemblies Market Size, By Volume (Billion Units), 2018-2032F
• Figure 192. UAE Single-use Assemblies Market Share, By Product, By Value, 2018-2032F
• Figure 193. UAE Single-use Assemblies Market Share, By Product, By Bag Assemblies, By Value, 2018-2032F
• Figure 194. UAE Single-use Assemblies Market Share, By Solution, By Value, 2018-2032F
• Figure 195. UAE Single-use Assemblies Market Share, By Application, By Value, 2018-2032F
• Figure 196. UAE Single-use Assemblies Market Share, By End-user, By Value, 2018-2032F
• Figure 197. South Africa Single-use Assemblies Market Size, By Value (USD Million), 2018-2032F
• Figure 198. South Africa Single-use Assemblies Market Size, By Volume (Billion Units), 2018-2032F
• Figure 199. South Africa Single-use Assemblies Market Share, By Product, By Value, 2018-2032F
• Figure 200. South Africa Single-use Assemblies Market Share, By Product, By Bag Assemblies, By Value, 2018-2032F
• Figure 201. South Africa Single-use Assemblies Market Share, By Solution, By Value, 2018-2032F
• Figure 202. South Africa Single-use Assemblies Market Share, By Application, By Value, 2018-2032F
• Figure 203. South Africa Single-use Assemblies Market Share, By End-user, By Value, 2018-2032F
• Figure 204. South America Single-use Assemblies Market Size, By Value (USD Million), 2018-2032F
• Figure 205. South America Single-use Assemblies Market Size, By Volume (Billion Units), 2018-2032F
• Figure 206. South America Single-use Assemblies Market Share, By Product, By Value, 2018-2032F
• Figure 207. South America Single-use Assemblies Market Share, By Product, By Bag Assemblies, By Value, 2018-2032F
• Figure 208. South America Single-use Assemblies Market Share, By Solution, By Value, 2018-2032F
• Figure 209. South America Single-use Assemblies Market Share, By Application, By Value, 2018-2032F
• Figure 210. South America Single-use Assemblies Market Share, By End-user, By Value, 2018-2032F
• Figure 211. South America Single-use Assemblies Market Share, By Region, By Value, 2018-2032F
• Figure 212. Brazil Single-use Assemblies Market Size, By Value (USD Million), 2018-2032F
• Figure 213. Brazil Single-use Assemblies Market Size, By Volume (Billion Units), 2018-2032F
• Figure 214. Brazil Single-use Assemblies Market Share, By Product, By Value, 2018-2032F
• Figure 215. Brazil Single-use Assemblies Market Share, By Product, By Bag Assemblies, By Value, 2018-2032F
• Figure 216. Brazil Single-use Assemblies Market Share, By Solution, By Value, 2018-2032F
• Figure 217. Brazil Single-use Assemblies Market Share, By Application, By Value, 2018-2032F
• Figure 218. Brazil Single-use Assemblies Market Share, By End-user, By Value, 2018-2032F
• Figure 219. Argentina Single-use Assemblies Market Size, By Value (USD Million), 2018-2032F
• Figure 220. Argentina Single-use Assemblies Market Size, By Volume (Billion Units), 2018-2032F
• Figure 221. Argentina Single-use Assemblies Market Share, By Product, By Value, 2018-2032F
• Figure 222. Argentina Single-use Assemblies Market Share, By Product, By Bag Assemblies, By Value, 2018-2032F
• Figure 223. Argentina Single-use Assemblies Market Share, By Solution, By Value, 2018-2032F
• Figure 224. Argentina Single-use Assemblies Market Share, By Application, By Value, 2018-2032F
• Figure 225. Argentina Single-use Assemblies Market Share, By End-user, By Value, 2018-2032F

Global single-use assemblies market is projected to witness a CAGR of 16.56% during the forecast period 2025-2032F, growing from USD 4,311.00 million in 2024 to USD 14,733.11 million in 2032F. The market's growth is augmented by the rapid growth of the pharmaceutical and biopharmaceutical sectors, increasing investments towards biologics, the introduction of novel products and technologies, growing efforts to expedite the drug development process, and the increasing prevalence of infectious diseases. The single-use assemblies market is growing strongly due to the growing use of preassembled fluid path systems, disposable in nature, in biopharmaceutical production and life sciences. Assemblies-including tubing, bags, filters, and connectors-have great benefits in terms of better sterility, lowered cross-contamination risk, and avoided cleaning and validation processes, which result in improved operation efficiency and cost savings. The increased demand for the manufacture of biologics such as monoclonal antibodies, vaccines, and cell and gene therapies has escalated the need for scalable and flexible solutions to manufacture these products, and single-use assemblies are addressing that need. Technologies have enhanced reliability, safety, and regulatory support for the product, and market players are incorporating sustainable materials as they focus on reducing the environmental impact related to disposables. Regulatory bodies are favorable owing to the assemblies' capacity to ensure high sterility standards, which further aids in market uptake. Notwithstanding these encouraging trends, the market has challenges such as environmental concern, supply chain complexities, non-standardization, and the requirement for specialized experts.

Rising efforts by companies to expedite drugs to market are among the major global single-use assembly market trends. In April 2024, SaniSure Limited launched Fill4Sure, a custom single-use filling assembly to increase drug product filling processes' repeatability, safety, and efficiency. Features such as high-performance tubing, silicone over-molding, low-particulate 2D surge bags, adhesive and oil-free OEM, and custom-designed needles ensure product purity by minimizing contamination risks. These advanced features also streamline bioprocessing and biomanufacturing processes, aiding the manufacturer in securing supply chains and expanding their capacity. Such cost-efficient and tailor-made efficiencies aid in effortless scaling up to meet the industry's evolving requirements.

Increasing investments in biologics are also expected to aid the market's growth. In January 2024, AbbVie Inc. announced an investment of USD 223 million to expand their Singapore biologics manufacturing facility. The expansion is expected to conclude in 2026 and add 24,000 liters of biologics drug-substance capacity and 100 new jobs. This investment is expected to aid the expansion of the company's manufacturing network globally and support its oncology and immunology pipeline. Additionally, single-use assemblies are used in various stages in the biologics manufacturing sector, including process-intermediate storage, media and buffer preparation, downstream processing, and upstream processing.

Increasing Research and Development Activities Boost Market Demand

The rise in infectious and chronic disease cases in various regions across the globe is propelling the requirement for vaccines, which require single-use assemblies. Due to this, the investments in the production of vaccines are increasing as they aid in reducing the detrimental effects associated with infectious diseases, eradicate major viruses and pathogens, such as smallpox, and decrease child mortality rates. Various government agencies such as the National Institute of Health (NIH), philanthropic foundations and supranational bodies, including the Bill and Melinda Gates Foundation and the European Commission, are also financing vaccine research and development activities. According to estimates from the World Health Organization (WHO), vaccines worth USD 141 million, approximately 16 million doses, were supplied in 2021. These factors boost the demand for single-use assemblies as they offer cost efficiency due to reduced cleaning and downtime and minimize the risk of product loss due to contamination. Another example of growing research and development scenario is reflected by the deal done in January 2025, in which Sartorius extended its collaboration with McMaster University by opening a new bioprocessing automation lab at the university's Faculty of Engineering in Hamilton, Ontario. This state-of-the-art, 1600-square-foot facility aims to advance research and development in biomanufacturing.

Rising Demand for Biopharmaceuticals Propels Demand for Single-Use Assemblies

As the biopharmaceutical sector continues to grow, especially with the rising trend of chronic illnesses like cancer and diabetes and the growth of biologics and biosimilars, there is a growing demand for effective and adaptable manufacturing solutions. According to the American Cancer Society, an estimated 2,041,910 new cases of cancer will be diagnosed in the United States in 2025. Single-use assemblies provide a number of benefits, such as minimized risk of cross-contamination, decreased operational costs, and easier cleaning procedures. These assemblies allow biopharmaceutical firms to automate production and respond to shifting market needs in a timely manner without the extensive cleaning and validation necessary for conventional systems. The flexibility to quickly set up manufacturing arrangements with single-use technologies improves operating efficiency, thus making them more appealing to many biopharmaceutical and pharmaceutical firms.

Surging Demand for Biosimilars and Biologics Supports the Market Growth

The surging demand for biologics and biosimilars is propelling the use of single-use systems in the biopharmaceutical sector. For example, in 2024, 46 biosimilars were approved in Europe and the U.S., reflecting the speedy growth in this industry. With increasing competition for new indications and the introduction of new biosimilars, manufacturers are under increasing pressure to reduce the cost of production. Single-use technology, in addition to continuous upstream processes, have become cost-reducing alternatives, allowing manufacturers to ramp up biomass production as well as increasing overall product yield. This increased uptake of biologics, driven by advances in personalized medicine and demand for more potent medicines, has increased the requirement for quicker and cost-effective production processes. Single-use systems fulfill these requirements by providing higher turn-around, minimizing cleaning and maintenance costs to compensate for marketplace demands. Growing investments into biologics are supporting market growth. AbbVie Inc. announced in January 2024 an investment of USD 223 million to enhance their Singaporean biologics manufacturing plant. The expansion will finish in 2026 and is slated to bring additional 24,000 liters of biologics drug-substance capacity and 100 new employees. This investment is anticipated to contribute to the company's manufacturing footprint expansion worldwide and help its oncology and immunology pipeline. Moreover, single-use assemblies find applications in different stages within the biologics manufacturing industry, such as process-intermediate storage, media and buffer preparation, downstream processing, and upstream processing.

New Product Launches Support Market Growth

Rising efforts to develop novel products that aid in streamlining workflow while allowing for rapid implementation are one of the major factors bolstering the global single-use assemblies market growth. Cytiva introduced Supor Prime filters on June 26, 2024, to enhance high-concentration biologics filtration. Supor Prime is intended for drug developers and improves yields, minimizes blockages, and reduces filtration losses, meeting the growing demand for subcutaneous drugs. The filters accommodate high throughput for feeds up to 220 grams per liter and 30 centipoise viscosity, scaling from clinical to commercial manufacture. Being a green solution, Supor Prime eliminates the use of plastic, cleaning requirements, fluid usage for priming, and CO2 release through enhanced recovery of the product and reduction in upstream manufacturing needs.

Such developments are expected to propel the global single-use assemblies market demand as they allow companies to provide comprehensive solutions tailored to the customer's unique requirements. They also allow for the availability of technologically advanced products and ready-to-implement, affordable, and innovative solutions, thus positively influencing the market's growth.

North America Accounts for Significant Market Share

The market growth in North America is supported by the expansion of the pharmaceutical sector, increasing prevalence of infectious and chronic diseases, and rising emphasis on drug discovery research. Single-use assemblies find applications in patient delivery systems, cell cultivation, lab and drug discovery, and downstream and upstream bioprocessing. The increasing awareness about the various advantages associated with using single-use assemblies as opposed to their counterparts is also supporting the expansion of the market in North America. Traditionally, process equipment is made of stainless steel, among other metals, and has high maintenance and upfront costs.

The rapid growth of the biotechnology industry in the United States is also expected to offer lucrative growth opportunities to the market as single-use assemblies find applications in various biotechnology domains, such as cell and gene therapy. According to estimates from the Council of State Bioscience Associations (CSBA) and Biotechnology Innovation Organization (BIO), the bioscience industry in the United States was valued at USD 2.9 trillion in 2021.

Pharmaceutical and Biopharmaceutical Companies Hold Significant Market Share

The rapid expansion of the pharmaceutical and biopharmaceutical sectors, owing to the increasing prevalence of various chronic and infectious diseases, supports the segment's growth. The increasing investments by major companies in developing new facilities to combat this growing threat bolstered the market's demand. Single-use assemblies reduce the risk of cross-batch and cross-product contamination and provide a smaller manufacturing footprint. Various sterile sectors, including pharmaceutical and biopharmaceutical sectors, have shifted to single-use assemblies and technologies at some time for a few applications, if not all, over the past few years as they aid in improving facility adaptability and flexibility and increase product integrity.

In February 2024, Thermo Fisher Scientific Inc. announced the opening of its new sterile drug facility in Singapore to ensure the delivery of new vaccines and medicines to the Asia Pacific market. The facility has been established with assistance from the Singapore Economic Development Board (EDB) and is in alignment with the efforts of the government to prepare for health emergencies that can emerge in the future. The increasing development of such facilities is expected to propel the requirement for single-use assemblies in the coming years, owing to their various advantages.

Future Market Scenario (2025-2032F)

According to the global single-use assemblies market analysis, the expansion of the pharmaceutical sector, coupled with increasing investments in research and development activities, is expected to bolster the market's demand in the coming years. Features such as reduced environmental impact, faster turnaround and changeover times, high flexibility, and reduced risk of product loss and cross-contamination are expected to propel the utilization of single-use assemblies in the coming years. Continuous efforts of key market players to enhance leak resistance and strength of single-use assemblies are also expected to provide lucrative growth opportunities to the market. Increasing market activity from prominent industry players also secures the robust future growth of market, for instance, in January 2025, Cytiva partnered with Cellular Origins to integrate Cytiva's automated Sefia platform with Cellular Origins' robotics system, Constellation. This collaboration aims to scale cell and gene therapy manufacturing while preserving established processes.

Key Players Landscape and Outlook

New launches by the key market players are bolstering the global single-use assemblies market size. In April 2023, Merck & Co., Inc. launched Ultimus films to provide leak resistance and superior strength in single-use assemblies used in bioprocessing liquid applications. The film is designed using a proprietary woven nylon structure to provide protection against fatigue, tears, leaks, and abrasion, as well as improved resilience and durability and enhanced bag strength. Incorporating woven nylon also provides ease of handling, conformity, and flexibility, which are essential for single-use processing. Such developments are expected to offer lucrative growth opportunities to the market in the coming years as they provide durable and stronger solutions to end-users while minimizing disruptions and increasing operational efficiency.

Watson-Marlow Fluid Technology Solutions (WMFTS) launched a new range of single-use solutions, WMArchitect, in April 2024, aimed at streamlining fluid management in biopharmaceutical manufacturing. The new offering consists of both off-the-shelf and custom single-use assemblies, easing the validation burden and allowing smooth integration into a range of bioprocessing processes. With its open architecture solution, WMArchitect offers flexible system compatibility while ensuring robust regulatory compliance. The answer meets industry priorities, including mitigating cross-contamination risks and inefficiencies of operation, with high-quality ready-to-use assemblies. WMArchitect further optimizes process development by encompassing end-to-end fluid handling applications from upstream processing to finished fill-finish.

In February 2025, Thermo Fisher Scientific Inc. collaborated with the NIH to integrate the Thermo Scientific HyPerforma Enhanced Single-Use Fermentor (eS.U.F.) into vaccine manufacturing processes. This partnership aims to enhance vaccine production efficiency by utilizing single-use technology. In another deal in the same month, Thermo Fisher announced plans to acquire Solventum's Purification and Filtration Business for approximately USD 4.1 billion. This acquisition is expected to complement Thermo Fisher's bioproduction capabilities, particularly in the bioprocessing market.

Table of Contents

1. Research Methodology

2. Project Scope and Definitions

3. Executive Summary

4. Global Single-Use Assemblies Market Outlook, 2018-2032F

• 4.1. Market Size & Forecast
  • 4.1.1. By Value
  • 4.1.2. By Volume
• 4.2. Market Share Analysis & Forecast
  • 4.2.1. By Product
    • 4.2.1.1. Filtration Assemblies
    • 4.2.1.2. Bottle Assemblies
    • 4.2.1.3. Bag Assemblies
      • 4.2.1.3.1. 2D Bag Assemblies
      • 4.2.1.3.2. 3D Bag Assemblies
    • 4.2.1.4. Tubing Assemblies
    • 4.2.1.5. Mixing System Assemblies
    • 4.2.1.6. Others
  • 4.2.2. By Solution
    • 4.2.2.1. Customized Solutions
    • 4.2.2.2. Standard Solutions
  • 4.2.3. By Application
    • 4.2.3.1. Filtration and Purification
    • 4.2.3.2. Storage
    • 4.2.3.3. Cell Culture and Mixing
    • 4.2.3.4. Formulation and Fill-Finish Applications
    • 4.2.3.5. Sampling
    • 4.2.3.6. Others
  • 4.2.4. By End-user
    • 4.2.4.1. Biopharmaceutical and Pharmaceutical Companies
    • 4.2.4.2. Academic and Research Institutes
    • 4.2.4.3. CROs and CMOs
  • 4.2.5. By Region
    • 4.2.5.1. North America
    • 4.2.5.2. South America
    • 4.2.5.3. Europe
    • 4.2.5.4. Asia-Pacific
    • 4.2.5.5. Middle East and Africa
  • 4.2.6. By Company Market Share Analysis (Top 5 Companies and Others - By Value, 2024)
• 4.3. Market Map Analysis, 2024
  • 4.3.1. By Product
  • 4.3.2. By Solution
  • 4.3.3. By Application
  • 4.3.4. By End-user
  • 4.3.5. By Region

5. North America Single-Use Assemblies Market Outlook, 2018-2032F

• 5.1. Market Size Analysis & Forecast
  • 5.1.1. By Value
  • 5.1.2. By Volume
• 5.2. Market Share Analysis & Forecast
  • 5.2.1. By Product
    • 5.2.1.1. Filtration Assemblies
    • 5.2.1.2. Bottle Assemblies
    • 5.2.1.3. Bag Assemblies
      • 5.2.1.3.1. 2D Bag Assemblies
      • 5.2.1.3.2. 3D Bag Assemblies
    • 5.2.1.4. Tubing Assemblies
    • 5.2.1.5. Mixing System Assemblies
    • 5.2.1.6. Others
  • 5.2.2. By Solution
    • 5.2.2.1. Customized Solutions
    • 5.2.2.2. Standard Solutions
  • 5.2.3. By Application
    • 5.2.3.1. Filtration and Purification
    • 5.2.3.2. Storage
    • 5.2.3.3. Cell Culture and Mixing
    • 5.2.3.4. Formulation and Fill-Finish Applications
    • 5.2.3.5. Sampling
    • 5.2.3.6. Others
  • 5.2.4. By End-user
    • 5.2.4.1. Biopharmaceutical and Pharmaceutical Companies
    • 5.2.4.2. Academic and Research Institutes
    • 5.2.4.3. CROs and CMOs
  • 5.2.5. By Country Share
    • 5.2.5.1. United States
    • 5.2.5.2. Canada
    • 5.2.5.3. Mexico
• 5.3. Country Market Assessment
  • 5.3.1. United States Single-Use Assemblies Market Outlook, 2018-2032F*
    • 5.3.1.1. Market Size Analysis & Forecast
      • 5.3.1.1.1. By Value
      • 5.3.1.1.2. By Volume
    • 5.3.1.2. Market Share Analysis & Forecast
      • 5.3.1.2.1. By Product
        • 5.3.1.2.1.1. Filtration Assemblies
        • 5.3.1.2.1.2. Bottle Assemblies
        • 5.3.1.2.1.3. Bag Assemblies
        • 5.3.1.2.1.3.1. 2D Bag Assemblies
        • 5.3.1.2.1.3.2. 3D Bag Assemblies
        • 5.3.1.2.1.4. Tubing Assemblies
        • 5.3.1.2.1.5. Mixing System Assemblies
        • 5.3.1.2.1.6. Others
      • 5.3.1.2.2. By Solution
        • 5.3.1.2.2.1. Customized Solutions
        • 5.3.1.2.2.2. Standard Solutions
      • 5.3.1.2.3. By Application
        • 5.3.1.2.3.1. Filtration and Purification
        • 5.3.1.2.3.2. Storage
        • 5.3.1.2.3.3. Cell Culture and Mixing
        • 5.3.1.2.3.4. Formulation and Fill-Finish Applications
        • 5.3.1.2.3.5. Sampling
        • 5.3.1.2.3.6. Others
      • 5.3.1.2.4. By End-user
        • 5.3.1.2.4.1. Biopharmaceutical and Pharmaceutical Companies
        • 5.3.1.2.4.2. Academic and Research Institutes
        • 5.3.1.2.4.3. CROs and CMOs
  • 5.3.2. Canada
  • 5.3.3. Mexico

All segments will be provided for all regions and countries covered

6. Europe Single-Use Assemblies Market Outlook, 2018-2032F

• 6.1. Germany
• 6.2. France
• 6.3. Italy
• 6.4. United Kingdom
• 6.5. Russia
• 6.6. Netherlands
• 6.7. Spain
• 6.8. Turkey
• 6.9. Poland

7. Asia-Pacific Single-Use Assemblies Market Outlook, 2018-2032F

• 7.1. India
• 7.2. China
• 7.3. Japan
• 7.4. Australia
• 7.5. Vietnam
• 7.6. South Korea
• 7.7. Indonesia
• 7.8. Philippines

8. South America Single-Use Assemblies Market Outlook, 2018-2032F

• 8.1. Brazil
• 8.2. Argentina

9. Middle East and Africa Single-Use Assemblies Market Outlook, 2018-2032F

• 9.1. Saudi Arabia
• 9.2. UAE
• 9.3. South Africa

10. Demand Supply Analysis

11. Value Chain Analysis

12. Porter's Five Forces Analysis

13. PESTLE Analysis

14. Pricing Analysis

15. Market Dynamics

• 15.1. Market Drivers
• 15.2. Market Challenges

16. Market Trends and Developments

17. Regulatory Framework and Innovation

• 17.1. Regulatory Approvals
• 17.2. Innovations/Emerging Technologies

18. Patent Landscape

19. Case Studies

20. Competitive Landscape

• 20.1. Competition Matrix of Top 5 Market Leaders
• 20.2. SWOT Analysis for Top 5 Players
• 20.3. Key Players Landscape for Top 10 Market Players
  • 20.3.1. Thermo Fisher Scientific Inc.
    • 20.3.1.1. Company Details
    • 20.3.1.2. Key Management Personnel
    • 20.3.1.3. Products and Services
    • 20.3.1.4. Financials (As Reported)
    • 20.3.1.5. Key Market Focus and Geographical Presence
    • 20.3.1.6. Recent Developments
  • 20.3.2. Merck & Co., Inc.
  • 20.3.3. Sartorius AG
  • 20.3.4. Avantor, Inc.
  • 20.3.5. CYTIVA BIOSCIENCE HOLDING LIMITED
  • 20.3.6. Parker Hannifin Corporation
  • 20.3.7. Corning Incorporated
  • 20.3.8. Lonza Group AG
  • 20.3.9. Repligen Corporation
  • 20.3.10. Meissner Filtration Products, Inc.

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

7. Strategic Recommendations

8. About Us & Disclaimer