無菌注射剤受託製造の市場規模、シェア、動向分析レポート：分子タイプ別、投与経路別、治療用途別、最終用途別、地域別、セグメント別予測、2025年～2030年

無菌注射剤受託製造市場の成長と動向：

Grand View Research, Inc.の最新レポートによると、世界の無菌注射剤受託製造市場規模は、2025年から2030年にかけて12.28%のCAGRを記録し、2030年までに319億米ドルに達すると予測されています。

注射剤のパイプラインや承認の増加、生物製剤やバイオシミラーの需要拡大、新規治療薬開発のための研究開発活動への投資増加、細胞・遺伝子治療の需要増加が、無菌注射剤受託製造業界の成長を促進する主な要因です。無菌注射剤の受託製造市場は断片化されており、複数の企業が同様の技術力と加工能力を有しています。

高力価医薬品の管理など独自の能力を持つ受託製造機関（CMO）が業界を支配すると予想されます。欧州と米国には、EUのGMPと米国のFDAの認可を受けた施設を持つ様々な無菌注射剤CMOが存在します。さらに、インドや中国などの新興経済諸国は、予測期間中に有利な成長を遂げると予想されています。これは、これらの国々で注射剤調達サービスの需要が増加しているためです。インドには、EUのGMP/米国FDAの注射剤認証を持つCMOが20社以上あります。インドの無菌注射剤受託製造業界は、製薬大手から新興市場への費用対効果を追求したアウトソーシングサービスの需要が高まっているため、急速に拡大しています。インドの注射剤CMOの大半は地元の需要に応えてきたが、ここ数年で移行が顕著になっています。

COVID-19パンデミックは、無菌注射剤受託製造業界に好影響を与えました。2020年から2021年にかけてCOVID-19ワクチンの需要が大幅に急増したためです。また、同市場の主要プレーヤーは、市場での地位を高めるため、合併、買収、提携といった無機的な戦略イニシアチブを採用しています。さらにここ数年、複数の企業が注射剤受託製造業界への参入に注力しています。例えば、世界の民間投資会社であるブリッジウェスト・グループは、無菌注射剤に特化した新たな開発・製造受託機関（CDMO）施設の立ち上げを発表しました。

無菌注射剤受託製造市場レポートのハイライト

• 分子タイプ別では、大型分子セグメントが2024年に67.07%の最大売上シェアで市場をリードしました。同分野の成長は主に、高分子ベースの治療薬開発に対する受託製造業者の投資の増加、生物製剤注射剤のパイプラインの拡大、バイオシミラーに対する米国FDA承認の顕著な増加によるものです。
• 治療用途別では、がん分野が2024年に28.17%の最大売上シェアで市場をリードしました。がん患者数の増加、研究開発投資の増加、がん治療薬・生物製剤に対する要求の高まりが、同分野の成長を促進する要因のひとつです。
• 投与経路別では、静脈内投与（IV）部門が2024年に30.35%の最大売上シェアで市場をリードしました。複数のヘルスケアシステムが個別化医療にシフトしており、オーダーメイドの静脈内治療の需要を押し上げています。
• 最終用途別では、製薬企業セグメントが2024年に43.48%の最大収益シェアで市場をリードしました。製薬企業は、研究開発などのコアコンピタンスに集中するため、医薬品開発・製造業務を受託製造機関（CMO）に委託するケースが増えています。
• 北米の無菌注射剤受託製造市場は、2024年に42.86%の売上シェアで優位を占める。同地域の成長は、高度なヘルスケアインフラ、研究開発投資の増加、技術開発、大手企業の存在などの要因によるものです。

目次

第1章 調査手法と範囲

第2章 エグゼクティブサマリー

第3章 無菌注射剤受託製造市場の変数、動向、範囲

• 市場系統の見通し
  • 親市場の見通し
  • 関連/付随市場見通し
• 市場力学
  • 市場促進要因分析
  • 市場抑制要因分析
• 無菌注射剤受託製造市場分析ツール
  • 業界分析- ポーターのファイブフォース分析
  • PESTEL分析
  • COVID-19の影響分析

第4章 無菌注射剤受託製造市場：分子タイプの推定・動向分析

• セグメントダッシュボード
• 世界の無菌注射剤受託製造市場分子型の変動分析
• 世界の無菌注射剤受託製造市場規模と動向分析、分子タイプ別、2018～2030年
• 低分子
• 大分子

第5章 無菌注射剤受託製造市場：治療用途の推定・動向分析

• セグメントダッシュボード
• 世界の無菌注射剤受託製造市場における治療用途の変動分析
• 世界の無菌注射剤受託製造市場規模と動向分析、治療用途別、2018～2030年
• がん
• 糖尿病
• 心血管疾患
• 中枢神経系疾患
• 感染症
• 筋骨格
• 抗ウィルス薬
• その他

第6章 無菌注射剤受託製造市場：投与経路の推定・動向分析

• セグメントダッシュボード
• 世界の無菌注射剤受託製造市場の投与経路の変動分析
• 世界の無菌注射剤受託製造市場規模と動向分析、投与経路別、2018～2030年
• 皮下（SC）
• 静脈内（IV）
• 筋肉内（IM）
• その他

第7章 無菌注射剤受託製造市場：最終用途の推定・動向分析

• セグメントダッシュボード
• 世界の無菌注射剤受託製造市場の最終用途変動分析
• 世界の無菌注射剤受託製造市場の規模と動向分析、最終用途別、2018～2030年
• 製薬会社
• バイオ医薬品企業
• その他

第8章 無菌注射剤受託製造市場：地域の推定・動向分析

• 地域別市場シェア分析、2024年および2030年
• 地域市場ダッシュボード
• 市場規模、予測動向分析、2018年から2030年：
• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • 英国
  • ドイツ
  • フランス
  • イタリア
  • スペイン
  • デンマーク
  • ノルウェー
  • スウェーデン
• アジア太平洋
  • 日本
  • 中国
  • インド
  • オーストラリア
  • 韓国
  • タイ
• ラテンアメリカ
  • ブラジル
  • アルゼンチン
• 中東・アフリカ
  • 南アフリカ
  • サウジアラビア
  • アラブ首長国連邦
  • クウェート

第9章 競合情勢

• 企業/競合の分類
• 戦略マッピング
• 企業市況分析、2024年
• 企業プロファイル
  • Baxter
  • Catalent, Inc.
  • Vetter Pharma
  • Recipharm AB
  • Aenova Group
  • Fresenius Kabi AG
  • Unither Pharmaceuticals
  • FAMAR Health Care Services
  • Cipla Inc.
  • NextPharma Technologies

List of Tables

• Table 1. List of Secondary Sources
• Table 2. List of Abbreviations
• Table 3. Global Sterile Injectable Contract Manufacturing, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 4. Global Sterile Injectable Contract Manufacturing, by Molecule Type, 2018 - 2030 (USD Million)
• Table 5. Global Sterile Injectable Contract Manufacturing, by Route of Administration, 2018 - 2030 (USD Million)
• Table 6. Global Sterile Injectable Contract Manufacturing, by End Use, 2018 - 2030 (USD Million)
• Table 7. Global Sterile Injectable Contract Manufacturing, by region, 2018 - 2030 (USD Million)
• Table 8. North America Sterile Injectable Contract Manufacturing, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 9. North America Sterile Injectable Contract Manufacturing, by Molecule Type, 2018 - 2030 (USD Million)
• Table 10. North America Sterile Injectable Contract Manufacturing, by Route of Administration, 2018 - 2030 (USD Million)
• Table 11. North America Sterile Injectable Contract Manufacturing, by End Use, 2018 - 2030 (USD Million)
• Table 12. U.S. Sterile Injectable Contract Manufacturing, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 13. U.S. Sterile Injectable Contract Manufacturing, by Molecule Type, 2018 - 2030 (USD Million)
• Table 14. U.S. Sterile Injectable Contract Manufacturing, by Route of Administration, 2018 - 2030 (USD Million)
• Table 15. Canada Sterile Injectable Contract Manufacturing, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 16. Canada Sterile Injectable Contract Manufacturing, by Molecule Type, 2018 - 2030 (USD Million)
• Table 17. Canada Sterile Injectable Contract Manufacturing, by Route of Administration, 2018 - 2030 (USD Million)
• Table 18. Canada Sterile Injectable Contract Manufacturing, by End Use, 2018 - 2030 (USD Million)
• Table 19. Mexico Sterile Injectable Contract Manufacturing, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 20. Mexico Sterile Injectable Contract Manufacturing, by Molecule Type, 2018 - 2030 (USD Million)
• Table 21. Mexico Sterile Injectable Contract Manufacturing, by Route of Administration, 2018 - 2030 (USD Million)
• Table 22. Mexico Sterile Injectable Contract Manufacturing, by End Use, 2018 - 2030 (USD Million)
• Table 23. Europe Sterile Injectable Contract Manufacturing, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 24. Europe Sterile Injectable Contract Manufacturing, by Molecule Type, 2018 - 2030 (USD Million)
• Table 25. Europe Sterile Injectable Contract Manufacturing, by Route of Administration, 2018 - 2030 (USD Million)
• Table 26. Europe Sterile Injectable Contract Manufacturing, by End Use, 2018 - 2030 (USD Million)
• Table 27. Germany Sterile Injectable Contract Manufacturing, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 28. Germany Sterile Injectable Contract Manufacturing, by Molecule Type, 2018 - 2030 (USD Million)
• Table 29. Germany Sterile Injectable Contract Manufacturing, by Route of Administration, 2018 - 2030 (USD Million)
• Table 30. Germany Sterile Injectable Contract Manufacturing, by End Use, 2018 - 2030 (USD Million)
• Table 31. UK Sterile Injectable Contract Manufacturing, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 32. UK Sterile Injectable Contract Manufacturing, by Molecule Type, 2018 - 2030 (USD Million)
• Table 33. UK Sterile Injectable Contract Manufacturing, by Route of Administration, 2018 - 2030 (USD Million)
• Table 34. UK Sterile Injectable Contract Manufacturing, by End Use, 2018 - 2030 (USD Million)
• Table 35. France Sterile Injectable Contract Manufacturing, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 36. France Sterile Injectable Contract Manufacturing, by Molecule Type, 2018 - 2030 (USD Million)
• Table 37. France Sterile Injectable Contract Manufacturing, by Route of Administration, 2018 - 2030 (USD Million)
• Table 38. France Sterile Injectable Contract Manufacturing, by End Use, 2018 - 2030 (USD Million)
• Table 39. Italy Sterile Injectable Contract Manufacturing, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 40. Italy Sterile Injectable Contract Manufacturing, by Molecule Type, 2018 - 2030 (USD Million)
• Table 41. Italy Sterile Injectable Contract Manufacturing, by Route of Administration, 2018 - 2030 (USD Million)
• Table 42. Italy Sterile Injectable Contract Manufacturing, by End Use, 2018 - 2030 (USD Million)
• Table 43. Spain Sterile Injectable Contract Manufacturing, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 44. Spain Sterile Injectable Contract Manufacturing, by Molecule Type, 2018 - 2030 (USD Million)
• Table 45. Spain Sterile Injectable Contract Manufacturing, by Route of Administration, 2018 - 2030 (USD Million)
• Table 46. Spain Sterile Injectable Contract Manufacturing, by End Use, 2018 - 2030 (USD Million)
• Table 47. Denmark Sterile Injectable Contract Manufacturing, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 48. Denmark Sterile Injectable Contract Manufacturing, by Molecule Type, 2018 - 2030 (USD Million)
• Table 49. Denmark Sterile Injectable Contract Manufacturing, by Route of Administration, 2018 - 2030 (USD Million)
• Table 50. Denmark Sterile Injectable Contract Manufacturing, by End Use, 2018 - 2030 (USD Million)
• Table 51. Norway Sterile Injectable Contract Manufacturing, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 52. Norway Sterile Injectable Contract Manufacturing, by Molecule Type, 2018 - 2030 (USD Million)
• Table 53. Norway Sterile Injectable Contract Manufacturing, by Route of Administration, 2018 - 2030 (USD Million)
• Table 54. Norway Sterile Injectable Contract Manufacturing, by End Use, 2018 - 2030 (USD Million)
• Table 55. Sweden Sterile Injectable Contract Manufacturing, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 56. Sweden Sterile Injectable Contract Manufacturing, by Molecule Type, 2018 - 2030 (USD Million)
• Table 57. Sweden Sterile Injectable Contract Manufacturing, by Route of Administration, 2018 - 2030 (USD Million)
• Table 58. Sweden Sterile Injectable Contract Manufacturing, by End Use, 2018 - 2030 (USD Million)
• Table 59. Asia Pacific Sterile Injectable Contract Manufacturing, by Country, 2018 - 2030 (USD Million)
• Table 60. Asia Pacific Sterile Injectable Contract Manufacturing, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 61. Asia Pacific Sterile Injectable Contract Manufacturing, by Molecule Type, 2018 - 2030 (USD Million)
• Table 62. Asia Pacific Sterile Injectable Contract Manufacturing, by Route of Administration, 2018 - 2030 (USD Million)
• Table 63. Asia Pacific Sterile Injectable Contract Manufacturing, by End Use, 2018 - 2030 (USD Million)
• Table 64. China Sterile Injectable Contract Manufacturing, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 65. China Sterile Injectable Contract Manufacturing, by Molecule Type, 2018 - 2030 (USD Million)
• Table 66. China Sterile Injectable Contract Manufacturing, by Route of Administration, 2018 - 2030 (USD Million)
• Table 67. China Sterile Injectable Contract Manufacturing, by End Use, 2018 - 2030 (USD Million)
• Table 68. Japan Sterile Injectable Contract Manufacturing, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 69. Japan Sterile Injectable Contract Manufacturing, by Molecule Type, 2018 - 2030 (USD Million)
• Table 70. Japan Sterile Injectable Contract Manufacturing, by Route of Administration, 2018 - 2030 (USD Million)
• Table 71. Japan Sterile Injectable Contract Manufacturing, by End Use, 2018 - 2030 (USD Million)
• Table 72. India Sterile Injectable Contract Manufacturing, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 73. India Sterile Injectable Contract Manufacturing, by Molecule Type, 2018 - 2030 (USD Million)
• Table 74. India Sterile Injectable Contract Manufacturing, by Route of Administration, 2018 - 2030 (USD Million)
• Table 75. India Sterile Injectable Contract Manufacturing, by End Use, 2018 - 2030 (USD Million)
• Table 76. South Korea Sterile Injectable Contract Manufacturing, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 77. South Korea Sterile Injectable Contract Manufacturing, by Molecule Type, 2018 - 2030 (USD Million)
• Table 78. South Korea Sterile Injectable Contract Manufacturing, by Route of Administration, 2018 - 2030 (USD Million)
• Table 79. South Korea Sterile Injectable Contract Manufacturing, by End Use, 2018 - 2030 (USD Million)
• Table 80. Australia Sterile Injectable Contract Manufacturing, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 81. Australia Sterile Injectable Contract Manufacturing, by Molecule Type, 2018 - 2030 (USD Million)
• Table 82. Australia Sterile Injectable Contract Manufacturing, by Route of Administration, 2018 - 2030 (USD Million)
• Table 83. Australia Sterile Injectable Contract Manufacturing, by End Use, 2018 - 2030 (USD Million)
• Table 84. Thailand Sterile Injectable Contract Manufacturing, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 85. Thailand Sterile Injectable Contract Manufacturing, by Molecule Type, 2018 - 2030 (USD Million)
• Table 86. Thailand Sterile Injectable Contract Manufacturing, by Route of Administration, 2018 - 2030 (USD Million)
• Table 87. Thailand Sterile Injectable Contract Manufacturing, by End Use, 2018 - 2030 (USD Million)
• Table 88. Latin America Sterile Injectable Contract Manufacturing, by Country, 2018 - 2030 (USD Million)
• Table 89. Latin America Sterile Injectable Contract Manufacturing, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 90. Latin America Sterile Injectable Contract Manufacturing, by Molecule Type, 2018 - 2030 (USD Million)
• Table 91. Latin America Sterile Injectable Contract Manufacturing, by Route of Administration, 2018 - 2030 (USD Million)
• Table 92. Latin America Sterile Injectable Contract Manufacturing, by End Use, 2018 - 2030 (USD Million)
• Table 93. Brazil Sterile Injectable Contract Manufacturing, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 94. Brazil Sterile Injectable Contract Manufacturing, by Molecule Type, 2018 - 2030 (USD Million)
• Table 95. Brazil Sterile Injectable Contract Manufacturing, by Route of Administration, 2018 - 2030 (USD Million)
• Table 96. Brazil Sterile Injectable Contract Manufacturing, by End Use, 2018 - 2030 (USD Million)
• Table 97. Argentina Sterile Injectable Contract Manufacturing, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 98. Argentina Sterile Injectable Contract Manufacturing, by Molecule Type, 2018 - 2030 (USD Million)
• Table 99. Argentina Sterile Injectable Contract Manufacturing, by Route of Administration, 2018 - 2030 (USD Million)
• Table 100. Argentina Sterile Injectable Contract Manufacturing, by End Use, 2018 - 2030 (USD Million)
• Table 101. Middle East & Africa Sterile Injectable Contract Manufacturing, by Country, 2018 - 2030 (USD Million)
• Table 102. Middle East & Africa Sterile Injectable Contract Manufacturing, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 103. Middle East & Africa Sterile Injectable Contract Manufacturing, by Molecule Type, 2018 - 2030 (USD Million)
• Table 104. Middle East & Africa Sterile Injectable Contract Manufacturing, by Route of Administration, 2018 - 2030 (USD Million)
• Table 105. Middle East & Africa Sterile Injectable Contract Manufacturing, by End Use, 2018 - 2030 (USD Million)
• Table 106. South Africa Sterile Injectable Contract Manufacturing, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 107. South Africa Sterile Injectable Contract Manufacturing, by Molecule Type, 2018 - 2030 (USD Million)
• Table 108. South Africa Sterile Injectable Contract Manufacturing, by Route of Administration, 2018 - 2030 (USD Million)
• Table 109. South Africa Sterile Injectable Contract Manufacturing, by End Use, 2018 - 2030 (USD Million)
• Table 110. Saudi Arabia Sterile Injectable Contract Manufacturing, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 111. Saudi Arabia Sterile Injectable Contract Manufacturing, by Molecule Type, 2018 - 2030 (USD Million)
• Table 112. Saudi Arabia Sterile Injectable Contract Manufacturing, by Route of Administration, 2018 - 2030 (USD Million)
• Table 113. Saudi Arabia Sterile Injectable Contract Manufacturing, by End Use, 2018 - 2030 (USD Million)
• Table 114. UAE Sterile Injectable Contract Manufacturing, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 115. UAE Sterile Injectable Contract Manufacturing, by Molecule Type, 2018 - 2030 (USD Million)
• Table 116. UAE Sterile Injectable Contract Manufacturing, by Route of Administration, 2018 - 2030 (USD Million)
• Table 117. UAE Sterile Injectable Contract Manufacturing, by End Use, 2018 - 2030 (USD Million)

List of Figures

• Fig. 1 Sterile Injectable Contract Manufacturing Market segmentation
• Fig. 2 Data analysis models
• Fig. 3 Market formulation and validation
• Fig. 4 Data validating & publishing
• Fig. 5 Market research process
• Fig. 6 Information procurement
• Fig. 7 Primary research
• Fig. 8 Value-chain-based sizing & forecasting
• Fig. 9 QFD modelling for market share assessment
• Fig. 10 Market formulation & validation
• Fig. 11 Commodity flow analysis
• Fig. 12 Market outlook
• Fig. 13 Segment snapshot 1
• Fig. 14 Segment snapshot 2
• Fig. 15 Competitive landscape snapshot
• Fig. 16 Market trends & outlook
• Fig. 17 Porter's five force analysis
• Fig. 18 PESTEL analysis
• Fig. 19 Sterile Injectable Contract Manufacturing Market: Molecule Type outlook key takeaways
• Fig. 20 Sterile Injectable Contract Manufacturing Market: Molecule Type movement analysis
• Fig. 21 Small Molecule estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 22 Large Molecule market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 23 Sterile Injectable Contract Manufacturing Market: Therapeutic Application outlook key takeaways
• Fig. 24 Sterile Injectable Contract Manufacturing Market: Therapeutic Application movement analysis
• Fig. 25 Cancer estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 26 Diabetes estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 27 Cardiovascular Diseases estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 28 Central Nervous Systems Diseases estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 29 Infectious Disorders estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 30 Musculoskeletal estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 31 Anti-Viral estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 32 Others estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 33 Sterile Injectable Contract Manufacturing Market: Route of Administration outlook key takeaways
• Fig. 34 Sterile Injectable Contract Manufacturing Market: Route of Administration movement analysis
• Fig. 35 Subcutaneous (SC) estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 36 Intravenous (IV) estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 37 Intramuscular (IM) estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 38 Others estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 39 Sterile Injectable Contract Manufacturing Market: End Use outlook key takeaways
• Fig. 40 Sterile Injectable Contract Manufacturing Market: End Use movement analysis
• Fig. 41 Pharmaceutical Companies estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 42 Biopharmaceutical Companies estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 43 Others estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 44 Regional marketplace outlook, 2024 & 2030 (USD Million)
• Fig. 45 Regional marketplace: Key takeaways
• Fig. 46 North America Sterile Injectable Contract Manufacturing Market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 47 Key country dynamics
• Fig. 48 US Sterile Injectable Contract Manufacturing Market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 49 Key country dynamics
• Fig. 50 Canada Sterile Injectable Contract Manufacturing Market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 51 Key country dynamics
• Fig. 52 Mexico Sterile Injectable Contract Manufacturing Market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 53 Key country dynamics
• Fig. 54 Europe Sterile Injectable Contract Manufacturing Market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 55 Key country dynamics
• Fig. 56 UK Sterile Injectable Contract Manufacturing Market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 57 Key country dynamics
• Fig. 58 Germany Sterile Injectable Contract Manufacturing Market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 59 Key country dynamics
• Fig. 60 France Sterile Injectable Contract Manufacturing Market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 61 Key country dynamics
• Fig. 62 Spain Sterile Injectable Contract Manufacturing Market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 63 Key country dynamics
• Fig. 64 Italy Sterile Injectable Contract Manufacturing Market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 65 Key country dynamics
• Fig. 66 Denmark Sterile Injectable Contract Manufacturing Market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 67 Key country dynamics
• Fig. 68 Norway Sterile Injectable Contract Manufacturing Market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 69 Key country dynamics
• Fig. 70 Sweden Sterile Injectable Contract Manufacturing Market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 71 Asia Pacific Sterile Injectable Contract Manufacturing Market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 72 Key country dynamics
• Fig. 73 Japan Sterile Injectable Contract Manufacturing Market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 74 Key country dynamics
• Fig. 75 China Sterile Injectable Contract Manufacturing Market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 76 Key country dynamics
• Fig. 77 India Sterile Injectable Contract Manufacturing Market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 78 Key country dynamics
• Fig. 79 Australia Sterile Injectable Contract Manufacturing Market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 80 Key country dynamics
• Fig. 81 South Korea Sterile Injectable Contract Manufacturing Market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 82 Key country dynamics
• Fig. 83 Thailand Sterile Injectable Contract Manufacturing Market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 84 Latin America Sterile Injectable Contract Manufacturing Market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 85 Key country dynamics
• Fig. 86 Brazil Sterile Injectable Contract Manufacturing Market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 87 Key country dynamics
• Fig. 88 Argentina Sterile Injectable Contract Manufacturing Market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 89 MEA Sterile Injectable Contract Manufacturing Market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 90 Key country dynamics
• Fig. 91 South Africa Sterile Injectable Contract Manufacturing Market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 92 Key country dynamics
• Fig. 93 Saudi Arabia Sterile Injectable Contract Manufacturing Market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 94 Key country dynamics
• Fig. 95 UAE Sterile Injectable Contract Manufacturing Market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 96 Key country dynamics
• Fig. 97 Kuwait Sterile Injectable Contract Manufacturing Market estimates and forecasts, 2018 - 2030 (USD Million)
• Fig. 98 Market participant categorization
• Fig. 99 Sterile Injectable Contract Manufacturing Market Position Analysis, 2024
• Fig. 100 Strategic framework

Sterile Injectable Contract Manufacturing Market Growth & Trends:

The global sterile injectable contract manufacturing market size is expected to reach USD 31.9 billion by 2030, registering a CAGR of 12.28% from 2025 to 2030, according to a new report by Grand View Research, Inc. Increasing pipeline and approvals of injectables, growing demand for biologics and biosimilars, rise in investment in research & development activities for the development of novel therapeutics, and increasing demand for cell & gene therapies are the key factors driving the growth of sterile injectable contract manufacturing industry. The market for sterile injectable contract manufacturing is fragmented, with several players having similar technological and processing capabilities.

Contract Manufacturing Organizations (CMOs) with unique capabilities, such as the management of high-potency drugs, are anticipated to dominate the industry. In Europe and the U.S., there are various sterile injectable CMOs with EU GMP and U.S. FDA-approved facilities. Moreover, developing economies such as India and China are anticipated to witness lucrative growth across the forecast period. This is attributable to the increasing demand for injectable sourcing services across these countries. India has over 20 CMOs with EU GMP/U.S. FDA injectable certifications. The Indian sterile injectable contract manufacturing industry is rapidly expanding due to rising demand for outsourcing services from the pharmaceutical giants to emerging markets for cost-effectiveness. Most Indian injectable CMOs have been catering to local demand, but the transition has been evident over the past few years.

The COVID-19 pandemic positively impacted the sterile injectable contract manufacturing industry. This was because of the huge surge in demand for COVID-19 vaccines from 2020 to 2021, as these vaccines are a major part of the injectables industry. In addition, major players in the market are adopting inorganic strategic initiatives such as mergers, acquisitions, and partnerships to enhance their market positions. Furthermore, for the past few years, several companies have focused on penetrating the injectable contract manufacturing industry. For instance, Bridgewest Group, a global private investment firm, announced the launch of a new contract development and manufacturing organization (CDMO) facility focused on sterile injectable drug products.

Sterile Injectable Contract Manufacturing Market Report Highlights:

• Based on molecule type, the large molecule segment led the market with the largest revenue share of 67.07% in 2024. The growth of the segment is mainly due to rising investments by contract manufacturers in developing large molecule-based therapeutics, an expanding pipeline of biologics injectables, and a notable increase in U.S. FDA approvals for biosimilars.
• Based on therapeutic application, the cancer segment led the market with the largest revenue share of 28.17% in 2024. The increasing number of cancer cases, rising R&D investments, and growing requirements for oncology drugs & biologics are some of the factors driving the segment growth.
• Based on route of administration, the intravenous (IV) segment led the market with the largest revenue share of 30.35% in 2024. Several healthcare systems are shifting toward personalized medicine, which is boosting the demand for tailored intravenous therapies.
• Based on end use, the pharmaceutical companies segment led the market with the largest revenue share of 43.48% in 2024. Pharmaceutical companies are increasingly outsourcing their drug development and manufacturing operations to Contract Manufacturing Organizations (CMOs) to focus on their core competencies, such as R&D.
• North America sterile injectable contract manufacturing market dominated with the revenue share of 42.86% in 2024. The growth in the region is attributed to the factors such as to the region's advanced healthcare infrastructure, increasing R&D investment, technological developments, and the presence of major players.

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Market Definitions
  • 1.2.1. Molecule Type Segment
  • 1.2.2. Molecule Therapeutic Application Segment
  • 1.2.3. Route of Administration Segment
  • 1.2.4. End Use Segment
• 1.3. Information analysis
  • 1.3.1. Market formulation & data visualization
• 1.4. Data validation & publishing
• 1.5. Information Procurement
  • 1.5.1. Primary Research
• 1.6. Information or Data Analysis
• 1.7. Market Formulation & Validation
• 1.8. Market Model
• 1.9. Total Market: CAGR Calculation
• 1.10. Objectives

Chapter 2. Executive Summary

• 2.1. Market Outlook
• 2.2. Segment Snapshot
• 2.3. Competitive Landscape Snapshot

Chapter 3. Sterile Injectable Contract Manufacturing Market Variables, Trends & Scope

• 3.1. Market Lineage Outlook
  • 3.1.1. Parent market outlook
  • 3.1.2. Related/ancillary market outlook.
• 3.2. Market Dynamics
  • 3.2.1. Market driver analysis
    • 3.2.1.1. Increasing Pipeline and Approvals of Injectables
    • 3.2.1.2. Growing Demand for Biologics and Biosimilars Significantly Supported Market Growth
    • 3.2.1.3. Rise in Investment Across Research & Development Activities for the Development of Novel Therapeutics
    • 3.2.1.4. Increasing Demand for Cell & Gene Therapies
  • 3.2.2. Market restraint analysis
    • 3.2.2.1. Low Barriers to Market Penetration Have Resulted in Pricing Pressure
    • 3.2.2.2. Challenges Related to Quality Control
• 3.3. Sterile Injectable Contract Manufacturing Market Analysis Tools
  • 3.3.1. Industry Analysis - Porter's
  • 3.3.2. PESTEL Analysis
  • 3.3.3. COVID-19 Impact Analysis

Chapter 4. Sterile Injectable Contract Manufacturing Market: Molecule Type Estimates & Trend Analysis

• 4.1. Segment Dashboard
• 4.2. Global Sterile Injectable Contract Manufacturing Market Molecule Type Movement Analysis
• 4.3. Global Sterile Injectable Contract Manufacturing Market Size & Trend Analysis, by Molecule Type, 2018 to 2030 (USD Million)
• 4.4. Small Molecule
  • 4.4.1. Small molecule market estimates and forecasts, 2018 to 2030 (USD Million)
• 4.5. Large Molecule
  • 4.5.1. Large molecule market estimates and forecasts, 2018 to 2030 (USD Million)

Chapter 5. Sterile Injectable Contract Manufacturing Market: Therapeutic Application Estimates & Trend Analysis

• 5.1. Segment Dashboard
• 5.2. Global Sterile Injectable Contract Manufacturing Market Therapeutic Application Movement Analysis
• 5.3. Global Sterile Injectable Contract Manufacturing Market Size & Trend Analysis, by Therapeutic Application, 2018 to 2030 (USD Million)
• 5.4. Cancer
  • 5.4.1. Cancer market estimates and forecasts, 2018 to 2030 (USD Million)
• 5.5. Diabetes
  • 5.5.1. Diabetes market estimates and forecasts, 2018 to 2030 (USD Million)
• 5.6. Cardiovascular Diseases
  • 5.6.1. Cardiovascular diseases market estimates and forecasts, 2018 to 2030 (USD Million)
• 5.7. Central Nervous Systems Diseases
  • 5.7.1. Central nervous systems diseases market estimates and forecasts, 2018 to 2030 (USD Million)
• 5.8. Infectious Disorders
  • 5.8.1. Infectious disorders market estimates and forecasts, 2018 to 2030 (USD Million)
• 5.9. Musculoskeletal
  • 5.9.1. Musculoskeletal market estimates and forecasts, 2018 to 2030 (USD Million)
• 5.10. Anti-Viral
  • 5.10.1. Anti-Viral market estimates and forecasts, 2018 to 2030 (USD Million)
• 5.11. Others
  • 5.11.1. Others market estimates and forecasts, 2018 to 2030 (USD Million)

Chapter 6. Sterile Injectable Contract Manufacturing Market: Route of Administration Estimates & Trend Analysis

• 6.1. Segment Dashboard
• 6.2. Global Sterile Injectable Contract Manufacturing Market Route of Administration Movement Analysis
• 6.3. Global Sterile Injectable Contract Manufacturing Market Size & Trend Analysis, by Route of Administration, 2018 to 2030 (USD Million)
• 6.4. Subcutaneous (SC)
  • 6.4.1. Subcutaneous (SC) market estimates and forecasts, 2018 to 2030 (USD Million)
• 6.5. Intravenous (IV)
  • 6.5.1. Intravenous (IV) market estimates and forecasts, 2018 to 2030 (USD Million)
• 6.6. Intramuscular (IM)
  • 6.6.1. Intramuscular (IM) market estimates and forecasts, 2018 to 2030 (USD Million)
• 6.7. Others
  • 6.7.1. Others market estimates and forecasts, 2018 to 2030 (USD Million)

Chapter 7. Sterile Injectable Contract Manufacturing Market: End Use Estimates & Trend Analysis

• 7.1. Segment Dashboard
• 7.2. Global Sterile Injectable Contract Manufacturing Market End Use Movement Analysis
• 7.3. Global Sterile Injectable Contract Manufacturing Market Size & Trend Analysis, by End Use, 2018 to 2030 (USD Million)
• 7.4. Pharmaceutical Companies
  • 7.4.1. Pharmaceutical companies market estimates and forecasts, 2018 to 2030 (USD Million)
• 7.5. Biopharmaceutical Companies
  • 7.5.1. Biopharmaceutical companies market estimates and forecasts, 2018 to 2030 (USD Million)
• 7.6. Others
  • 7.6.1. Others market estimates and forecasts, 2018 to 2030 (USD Million)

Chapter 8. Sterile Injectable Contract Manufacturing Market: Regional Estimates & Trend Analysis

• 8.1. Regional Market Share Analysis, 2024 & 2030
• 8.2. Regional Market Dashboard
• 8.3. Market Size, & Forecasts Trend Analysis, 2018 to 2030:
• 8.4. North America
  • 8.4.1. North America Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 8.4.2. U.S.
    • 8.4.2.1. Key country dynamics
    • 8.4.2.2. Competitive scenario
    • 8.4.2.3. Regulatory Landscape
    • 8.4.2.4. U.S. market estimates and forecasts, 2018 to 2030 (USD Million)
  • 8.4.3. Canada
    • 8.4.3.1. Key country dynamics
    • 8.4.3.2. Competitive scenario
    • 8.4.3.3. Regulatory Landscape
    • 8.4.3.4. Canada market estimates and forecasts, 2018 to 2030 (USD Million)
  • 8.4.4. Mexico
    • 8.4.4.1. Key country dynamics
    • 8.4.4.2. Competitive scenario
    • 8.4.4.3. Regulatory Landscape
    • 8.4.4.4. Mexico market estimates and forecasts, 2018 to 2030 (USD Million)
• 8.5. Europe
  • 8.5.1. Europe Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 8.5.2. UK
    • 8.5.2.1. Key country dynamics
    • 8.5.2.2. Competitive scenario
    • 8.5.2.3. Regulatory Landscape
    • 8.5.2.4. UK market estimates and forecasts, 2018 to 2030 (USD Million)
  • 8.5.3. Germany
    • 8.5.3.1. Key country dynamics
    • 8.5.3.2. Competitive scenario
    • 8.5.3.3. Regulatory Landscape
    • 8.5.3.4. Germany market estimates and forecasts, 2018 to 2030 (USD Million)
  • 8.5.4. France
    • 8.5.4.1. Key country dynamics
    • 8.5.4.2. Competitive scenario
    • 8.5.4.3. Regulatory Landscape
    • 8.5.4.4. France market estimates and forecasts, 2018 to 2030 (USD Million)
  • 8.5.5. Italy
    • 8.5.5.1. Key country dynamics
    • 8.5.5.2. Competitive scenario
    • 8.5.5.3. Regulatory Landscape
    • 8.5.5.4. Italy market estimates and forecasts, 2018 to 2030 (USD Million)
  • 8.5.6. Spain
    • 8.5.6.1. Key country dynamics
    • 8.5.6.2. Competitive scenario
    • 8.5.6.3. Regulatory Landscape
    • 8.5.6.4. Spain market estimates and forecasts, 2018 to 2030 (USD Million)
  • 8.5.7. Denmark
    • 8.5.7.1. Key country dynamics
    • 8.5.7.2. Competitive scenario
    • 8.5.7.3. Regulatory Landscape
    • 8.5.7.4. Denmark market estimates and forecasts, 2018 to 2030 (USD Million)
  • 8.5.8. Norway
    • 8.5.8.1. Key country dynamics
    • 8.5.8.2. Competitive scenario
    • 8.5.8.3. Regulatory Landscape
    • 8.5.8.4. Norway market estimates and forecasts, 2018 to 2030 (USD Million)
  • 8.5.9. Sweden
    • 8.5.9.1. Key country dynamics
    • 8.5.9.2. Competitive scenario
    • 8.5.9.3. Regulatory Landscape
    • 8.5.9.4. Sweden market estimates and forecasts, 2018 to 2030 (USD Million)
• 8.6. Asia Pacific
  • 8.6.1. Asia Pacific Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 8.6.2. Japan
    • 8.6.2.1. Key country dynamics
    • 8.6.2.2. Competitive scenario
    • 8.6.2.3. Regulatory Landscape
    • 8.6.2.4. Japan market estimates and forecasts, 2018 to 2030 (USD Million)
  • 8.6.3. China
    • 8.6.3.1. Key country dynamics
    • 8.6.3.2. Competitive scenario
    • 8.6.3.3. Regulatory Landscape
    • 8.6.3.4. China market estimates and forecasts, 2018 to 2030 (USD Million)
  • 8.6.4. India
    • 8.6.4.1. Key country dynamics
    • 8.6.4.2. Competitive scenario
    • 8.6.4.3. Regulatory Landscape
    • 8.6.4.4. India market estimates and forecasts, 2018 to 2030 (USD Million)
  • 8.6.5. Australia
    • 8.6.5.1. Key country dynamics
    • 8.6.5.2. Competitive scenario
    • 8.6.5.3. Regulatory Landscape
    • 8.6.5.4. Australia market estimates and forecasts, 2018 to 2030 (USD Million)
  • 8.6.6. South Korea
    • 8.6.6.1. Key country dynamics
    • 8.6.6.2. Competitive scenario
    • 8.6.6.3. Regulatory Landscape
    • 8.6.6.4. South Korea market estimates and forecasts, 2018 to 2030 (USD Million)
  • 8.6.7. Thailand
    • 8.6.7.1. Key country dynamics
    • 8.6.7.2. Competitive scenario
    • 8.6.7.3. Regulatory Landscape
    • 8.6.7.4. Thailand market estimates and forecasts, 2018 to 2030 (USD Million)
• 8.7. Latin America
  • 8.7.1. Latin America Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 8.7.2. Brazil
    • 8.7.2.1. Key country dynamics
    • 8.7.2.2. Competitive scenario
    • 8.7.2.3. Regulatory Landscape
    • 8.7.2.4. Brazil market estimates and forecasts, 2018 to 2030 (USD Million)
  • 8.7.3. Argentina
    • 8.7.3.1. Key country dynamics
    • 8.7.3.2. Competitive scenario
    • 8.7.3.3. Regulatory Landscape
    • 8.7.3.4. Argentina market estimates and forecasts, 2018 to 2030 (USD Million)
• 8.8. MEA
  • 8.8.1. MEA Market Estimates and Forecasts, 2018 to 2030 (USD Million)
  • 8.8.2. South Africa
    • 8.8.2.1. Key country dynamics
    • 8.8.2.2. Competitive scenario
    • 8.8.2.3. Regulatory Landscape
    • 8.8.2.4. South Africa market estimates and forecasts, 2018 to 2030 (USD Million)
  • 8.8.3. Saudi Arabia
    • 8.8.3.1. Key country dynamics
    • 8.8.3.2. Competitive scenario
    • 8.8.3.3. Regulatory Landscape
    • 8.8.3.4. Saudi Arabia market estimates and forecasts, 2018 to 2030 (USD Million)
  • 8.8.4. UAE
    • 8.8.4.1. Key country dynamics
    • 8.8.4.2. Competitive scenario
    • 8.8.4.3. Regulatory Landscape
    • 8.8.4.4. UAE market estimates and forecasts, 2018 to 2030 (USD Million)
  • 8.8.5. Kuwait
    • 8.8.5.1. Key country dynamics
    • 8.8.5.2. Competitive scenario
    • 8.8.5.3. Regulatory Landscape
    • 8.8.5.4. Kuwait market estimates and forecasts, 2018 to 2030 (USD Million)

Chapter 9. Competitive Landscape

• 9.1. Company/Competition Categorization
• 9.2. Strategy Mapping
• 9.3. Company Market Position Analysis, 2024
• 9.4. Company Profiles/Listing
  • 9.4.1. Baxter
    • 9.4.1.1. Company overview
    • 9.4.1.2. Financial performance
    • 9.4.1.3. Product benchmarking
    • 9.4.1.4. Strategic initiatives
  • 9.4.2. Catalent, Inc.
    • 9.4.2.1. Company overview
    • 9.4.2.2. Financial performance
    • 9.4.2.3. Product benchmarking
    • 9.4.2.4. Strategic initiatives
  • 9.4.3. Vetter Pharma
    • 9.4.3.1. Company overview
    • 9.4.3.2. Financial performance
    • 9.4.3.3. Product benchmarking
    • 9.4.3.4. Strategic initiatives
  • 9.4.4. Recipharm AB
    • 9.4.4.1. Company overview
    • 9.4.4.2. Financial performance
    • 9.4.4.3. Product benchmarking
    • 9.4.4.4. Strategic initiatives
  • 9.4.5. Aenova Group
    • 9.4.5.1. Company overview
    • 9.4.5.2. Financial performance
    • 9.4.5.3. Product benchmarking
    • 9.4.5.4. Strategic initiatives
  • 9.4.6. Fresenius Kabi AG
    • 9.4.6.1. Company overview
    • 9.4.6.2. Financial performance
    • 9.4.6.3. Product benchmarking
    • 9.4.6.4. Strategic initiatives
  • 9.4.7. Unither Pharmaceuticals
    • 9.4.7.1. Company overview
    • 9.4.7.2. Financial performance
    • 9.4.7.3. Product benchmarking
    • 9.4.7.4. Strategic initiatives
  • 9.4.8. FAMAR Health Care Services
    • 9.4.8.1. Company overview
    • 9.4.8.2. Financial performance
    • 9.4.8.3. Product benchmarking
    • 9.4.8.4. Strategic initiatives
  • 9.4.9. Cipla Inc.
    • 9.4.9.1. Company overview
    • 9.4.9.2. Financial performance
    • 9.4.9.3. Product benchmarking
    • 9.4.9.4. Strategic initiatives
  • 9.4.10. NextPharma Technologies
    • 9.4.10.1. Company overview
    • 9.4.10.2. Financial performance
    • 9.4.10.3. Product benchmarking
    • 9.4.10.4. Strategic initiatives