無菌注射剤受託製造市場規模、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、2023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2030年までに319億2,000万米ドルに達し、2023年から2030年までのCAGRは12.1%で成長すると推定されています。

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す主な要因となっています。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ハイライト

• 2022年には大型分子セグメントが61.3%の最大シェアを占める。このセグメントの成長を牽引しているのは、細胞・遺伝子治療、RNA治療など、大型分子の大部分を占める大型分子ベースの治療薬に対する需要の増加です。
• 治療用途別では、がん分野が2022年に28.5%の最大シェアを占めました。このセグメントのシェア拡大は、主に抗がん剤ベースの注射治療薬に対する需要の増加によるものです。
• 皮下（SC）セグメントは、予測期間中に12.6％の最速CAGRを記録すると予測されています。これは、ワクチン、成長ホルモン、インスリンの投与に関連する利点により、SC注射剤の需要が世界的に高いためです。
• 新規無菌注射剤の開発に投資するバイオ製薬企業が増加しているため、予測期間中のCAGRはバイオ製薬企業が12.4%と最も高くなると予想されます。
• アジア太平洋地域は予測期間中に13.1%という高いCAGRを記録すると予測されています。この高成長は主に、インドや中国などの新興経済諸国に製造業務をアウトソーシングする欧米の製薬企業の増加によるものです。

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、動向および範囲

• 市場系統の見通し
  • 親市場の見通し
  • 関連/付随市場の見通し
• 市場力学
  • 市場促進要因の分析
  • 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- ポーターズ
  • PESTEL分析
  • COVID-19感染症の影響分析

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

• 無菌注射剤受託製造市場、分子タイプ別：セグメントダッシュボード
• 無菌注射剤受託製造市場、分子タイプ別：変動分析
  • 低分子
  • 高分子

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

• 無菌注射剤受託製造市場、治療用途別：セグメントダッシュボード
• 無菌注射剤受託製造市場、治療用途別：変動分析
  • がん
  • 糖尿病
  • 心血管疾患
  • 中枢神経系疾患
  • 感染症
  • 筋骨格系
  • 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

• 無菌注射剤受託製造市場、投与経路別：セグメントダッシュボード
• 無菌注射剤受託製造市場、投与経路別：変動分析
  • 皮下（SC）
  • 静脈内投与（IV）
  • 筋肉内（IM）
  • その他

第7章 無菌注射剤受託製造市場：最終用途推定・動向分析

• 無菌注射剤受託製造市場、最終用途別：セグメントダッシュボード
• 無菌注射剤受託製造市場、最終用途別：変動分析
  • 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：地域推定・動向分析

• 地域市場シェア分析、2022年および2030年
• 地域市場ダッシュボード
• 世界の地域市場のスナップショット
• 北米
  • 市場推計・予測、2018～2030年
  • 米国
  • カナダ
• 欧州
  • 英国
  • ドイツ
  • フランス
  • イタリア
  • スペイン
  • デンマーク
  • スウェーデン
  • ノルウェー
• アジア太平洋地域
  • 日本
  • インド
  • 中国
  • 韓国
  • オーストラリア
  • タイ
• ラテンアメリカ
  • ブラジル
  • メキシコ
  • 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

• 市場参入企業の分類
  • イノベーター
  • マーケットリーダー
  • 新興プレイヤー
  • 企業の市場シェア分析、2022年
• 企業プロファイル
  • Baxter
  • Catalent, Inc
  • Vetter Pharma
  • Recipharm AB
  • Aenova Group
  • Fresenius Kabi
  • Unither Pharmaceuticals
  • Famar
  • Cipla Inc.
  • NextPharma Technologies

List of Tables

• Table 1 List of secondary sources
• Table 2 List of Abbreviations
• Table 3 North America Sterile Injectable Contract Manufacturing market, by region, 2018 - 2030 (USD Million)
• Table 4 North America Sterile Injectable Contract Manufacturing market, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 5 North America Sterile Injectable Contract Manufacturing market, by Molecule Type, 2018 - 2030 (USD Million)
• Table 6 North America Sterile Injectable Contract Manufacturing market, by Route of Administration, 2018 - 2030 (USD Million)
• Table 7 North America Sterile Injectable Contract Manufacturing market, by End-use, 2018 - 2030 (USD Million)
• Table 8 U.S. Sterile Injectable Contract Manufacturing market, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 9 U.S. Sterile Injectable Contract Manufacturing market, by Molecule Type, 2018 - 2030 (USD Million)
• Table 10 U.S. Sterile Injectable Contract Manufacturing market, by Route of Administration, 2018 - 2030 (USD Million)
• Table 11 U.S. Sterile Injectable Contract Manufacturing market, by End-use, 2018 - 2030 (USD Million)
• Table 12 Canada Sterile Injectable Contract Manufacturing market, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 13 Canada Sterile Injectable Contract Manufacturing market, by Molecule Type, 2018 - 2030 (USD Million)
• Table 14 Canada Sterile Injectable Contract Manufacturing market, by Route of Administration, 2018 - 2030 (USD Million)
• Table 15 Canada Sterile Injectable Contract Manufacturing market, by End-use, 2018 - 2030 (USD Million)
• Table 16 Europe Sterile Injectable Contract Manufacturing market, by region, 2018 - 2030 (USD Million)
• Table 17 Europe Sterile Injectable Contract Manufacturing market, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 18 Europe Sterile Injectable Contract Manufacturing market, by Molecule Type, 2018 - 2030 (USD Million)
• Table 19 Europe Sterile Injectable Contract Manufacturing market, by Route of Administration, 2018 - 2030 (USD Million)
• Table 20 Europe Sterile Injectable Contract Manufacturing market, by End-use, 2018 - 2030 (USD Million)
• Table 21 UK Sterile Injectable Contract Manufacturing market, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 22 UK Sterile Injectable Contract Manufacturing market, by Molecule Type, 2018 - 2030 (USD Million)
• Table 23 UK Sterile Injectable Contract Manufacturing market, by Route of Administration, 2018 - 2030 (USD Million)
• Table 24 UK Sterile Injectable Contract Manufacturing market, by End-use, 2018 - 2030 (USD Million)
• Table 25 Germany Sterile Injectable Contract Manufacturing market, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 26 Germany Sterile Injectable Contract Manufacturing market, by Molecule Type, 2018 - 2030 (USD Million)
• Table 27 Germany Sterile Injectable Contract Manufacturing market, by Route of Administration, 2018 - 2030 (USD Million)
• Table 28 Germany Sterile Injectable Contract Manufacturing market, by End-use, 2018 - 2030 (USD Million)
• Table 29 France Sterile Injectable Contract Manufacturing market, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 30 France Sterile Injectable Contract Manufacturing market, by Molecule Type, 2018 - 2030 (USD Million)
• Table 31 France Sterile Injectable Contract Manufacturing market, by Route of Administration, 2018 - 2030 (USD Million)
• Table 32 France Sterile Injectable Contract Manufacturing market, by End-use, 2018 - 2030 (USD Million)
• Table 33 Italy Sterile Injectable Contract Manufacturing market, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 34 Italy Sterile Injectable Contract Manufacturing market, by Molecule Type, 2018 - 2030 (USD Million)
• Table 35 Italy Sterile Injectable Contract Manufacturing market, by Route of Administration, 2018 - 2030 (USD Million)
• Table 36 Italy Sterile Injectable Contract Manufacturing market, by End-use, 2018 - 2030 (USD Million)
• Table 37 Spain Sterile Injectable Contract Manufacturing market, by Therapeutic Application type, 2018 - 2030 (USD Million)
• Table 38 Spain Sterile Injectable Contract Manufacturing market, by Molecule Type, 2018 - 2030 (USD Million)
• Table 39 Spain Sterile Injectable Contract Manufacturing market, by Route of Administration, 2018 - 2030 (USD Million)
• Table 40 Spain Sterile Injectable Contract Manufacturing market, by End-use, 2018 - 2030 (USD Million)
• Table 41 Denmark Sterile Injectable Contract Manufacturing market, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 42 Denmark Sterile Injectable Contract Manufacturing market, by Molecule Type, 2018 - 2030 (USD Million)
• Table 43 Denmark Sterile Injectable Contract Manufacturing market, by Route of Administration, 2018 - 2030 (USD Million)
• Table 44 Denmark Sterile Injectable Contract Manufacturing market, by End-use, 2018 - 2030 (USD Million)
• Table 45 Sweden Sterile Injectable Contract Manufacturing market, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 46 Sweden Sterile Injectable Contract Manufacturing market, by Molecule Type, 2018 - 2030 (USD Million)
• Table 47 Sweden Sterile Injectable Contract Manufacturing market, by Route of Administration, 2018 - 2030 (USD Million)
• Table 48 Sweden Sterile Injectable Contract Manufacturing market, by End-use, 2018 - 2030 (USD Million)
• Table 49 Norway Sterile Injectable Contract Manufacturing market, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 50 Norway Sterile Injectable Contract Manufacturing market, by Molecule Type, 2018 - 2030 (USD Million)
• Table 51 Norway Sterile Injectable Contract Manufacturing market, by Route of Administration, 2018 - 2030 (USD Million)
• Table 52 Norway Sterile Injectable Contract Manufacturing market, by End-use, 2018 - 2030 (USD Million)
• Table 53 Asia Pacific Sterile Injectable Contract Manufacturing market, by region, 2018 - 2030 (USD Million)
• Table 54 Asia Pacific Sterile Injectable Contract Manufacturing market, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 55 Asia Pacific Sterile Injectable Contract Manufacturing market, by Molecule Type, 2018 - 2030 (USD Million)
• Table 56 Asia Pacific Sterile Injectable Contract Manufacturing market, by Route of Administration, 2018 - 2030 (USD Million)
• Table 57 Asia Pacific Sterile Injectable Contract Manufacturing market, by End-use, 2018 - 2030 (USD Million)
• Table 58 China Sterile Injectable Contract Manufacturing market, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 59 China Sterile Injectable Contract Manufacturing market, by Molecule Type, 2018 - 2030 (USD Million)
• Table 60 China Sterile Injectable Contract Manufacturing market, by Route of Administration, 2018 - 2030 (USD Million)
• Table 61 China Sterile Injectable Contract Manufacturing market, by End-use, 2018 - 2030 (USD Million)
• Table 62 Japan Sterile Injectable Contract Manufacturing market, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 63 Japan Sterile Injectable Contract Manufacturing market, by Molecule Type, 2018 - 2030 (USD Million)
• Table 64 Japan Sterile Injectable Contract Manufacturing market, by Route of Administration, 2018 - 2030 (USD Million)
• Table 65 Japan Sterile Injectable Contract Manufacturing market, by End-use, 2018 - 2030 (USD Million)
• Table 66 India Sterile Injectable Contract Manufacturing market, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 67 India Sterile Injectable Contract Manufacturing market, by Molecule Type, 2018 - 2030 (USD Million)
• Table 68 India Sterile Injectable Contract Manufacturing market, by Route of Administration, 2018 - 2030 (USD Million)
• Table 69 India Sterile Injectable Contract Manufacturing market, by End-use, 2018 - 2030 (USD Million)
• Table 70 Australia Sterile Injectable Contract Manufacturing market, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 71 Australia Sterile Injectable Contract Manufacturing market, by Molecule Type, 2018 - 2030 (USD Million)
• Table 72 Australia Sterile Injectable Contract Manufacturing market, by Route of Administration, 2018 - 2030 (USD Million)
• Table 73 Australia Sterile Injectable Contract Manufacturing market, by End-use, 2018 - 2030 (USD Million)
• Table 74 South Korea Sterile Injectable Contract Manufacturing market, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 75 South Korea Sterile Injectable Contract Manufacturing market, by Molecule Type, 2018 - 2030 (USD Million)
• Table 76 South Korea Sterile Injectable Contract Manufacturing market, by Route of Administration, 2018 - 2030 (USD Million)
• Table 77 South Korea Sterile Injectable Contract Manufacturing market, by End-use, 2018 - 2030 (USD Million)
• Table 78 Thailand Sterile Injectable Contract Manufacturing market, by Molecule Type, 2018 - 2030 (USD Million)
• Table 79 Thailand Sterile Injectable Contract Manufacturing market, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 80 Thailand Sterile Injectable Contract Manufacturing market, by Route of Administration, 2018 - 2030 (USD Million)
• Table 81 Thailand Sterile Injectable Contract Manufacturing market, by End-use, 2018 - 2030 (USD Million)
• Table 82 Latin America Sterile Injectable Contract Manufacturing market, by region, 2018 - 2030 (USD Million)
• Table 83 Latin America Sterile Injectable Contract Manufacturing market, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 84 Latin America Sterile Injectable Contract Manufacturing market, by Molecule Type, 2018 - 2030 (USD Million)
• Table 85 Latin America Sterile Injectable Contract Manufacturing market, by Route of Administration, 2018 - 2030 (USD Million)
• Table 86 Latin America Sterile Injectable Contract Manufacturing market, by End-use, 2018 - 2030 (USD Million)
• Table 87 Brazil Sterile Injectable Contract Manufacturing market, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 88 Brazil Sterile Injectable Contract Manufacturing market, by Molecule Type, 2018 - 2030 (USD Million)
• Table 89 Brazil Sterile Injectable Contract Manufacturing market, by Route of Administration, 2018 - 2030 (USD Million)
• Table 90 Brazil Sterile Injectable Contract Manufacturing market, by End-use, 2018 - 2030 (USD Million)
• Table 91 Mexico Sterile Injectable Contract Manufacturing market, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 92 Mexico Sterile Injectable Contract Manufacturing market, by Molecule Type, 2018 - 2030 (USD Million)
• Table 93 Mexico Sterile Injectable Contract Manufacturing market, by Route of Administration, 2018 - 2030 (USD Million)
• Table 94 Mexico Sterile Injectable Contract Manufacturing market, by End-use, 2018 - 2030 (USD Million)
• Table 95 Argentina Sterile Injectable Contract Manufacturing market, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 96 Argentina Sterile Injectable Contract Manufacturing market, by Molecule Type, 2018 - 2030 (USD Million)
• Table 97 Argentina Sterile Injectable Contract Manufacturing market, by Route of Administration, 2018 - 2030 (USD Million)
• Table 98 Argentina Sterile Injectable Contract Manufacturing market, by End-use, 2018 - 2030 (USD Million)
• Table 99 Middle East and Africa Sterile Injectable Contract Manufacturing market, by region, 2018 - 2030 (USD Million)
• Table 100 Middle East and Africa Sterile Injectable Contract Manufacturing market, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 101 Middle East and Africa Sterile Injectable Contract Manufacturing market, by Molecule Type, 2018 - 2030 (USD Million)
• Table 102 Middle East and Africa Sterile Injectable Contract Manufacturing market, by Route of Administration, 2018 - 2030 (USD Million)
• Table 103 Middle East & Africa Sterile Injectable Contract Manufacturing market, by End-use, 2018 - 2030 (USD Million)
• Table 104 South Africa Sterile Injectable Contract Manufacturing market, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 105 South Africa Sterile Injectable Contract Manufacturing market, by Molecule Type, 2018 - 2030 (USD Million)
• Table 106 South Africa Sterile Injectable Contract Manufacturing market, by Route of Administration, 2018 - 2030 (USD Million)
• Table 107 South Africa Sterile Injectable Contract Manufacturing market, by End-use, 2018 - 2030 (USD Million)
• Table 108 Saudi Arabia Sterile Injectable Contract Manufacturing market, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 109 Saudi Arabia Sterile Injectable Contract Manufacturing market, by Molecule Type, 2018 - 2030 (USD Million)
• Table 110 Saudi Arabia Sterile Injectable Contract Manufacturing market, by Route of Administration, 2018 - 2030 (USD Million)
• Table 111 Saudi Arabia Sterile Injectable Contract Manufacturing market, by End-use, 2018 - 2030 (USD Million)
• Table 112 UAE Sterile Injectable Contract Manufacturing market, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 113 UAE Sterile Injectable Contract Manufacturing market, by Molecule Type, 2018 - 2030 (USD Million)
• Table 114 UAE Sterile Injectable Contract Manufacturing market, by Route of Administration, 2018 - 2030 (USD Million)
• Table 115 UAE Sterile Injectable Contract Manufacturing market, by End-use, 2018 - 2030 (USD Million)
• Table 116 Kuwait Sterile Injectable Contract Manufacturing market, by Therapeutic Application, 2018 - 2030 (USD Million)
• Table 117 Kuwait Sterile Injectable Contract Manufacturing market, by Molecule Type, 2018 - 2030 (USD Million)
• Table 118 Kuwait Sterile Injectable Contract Manufacturing market, by Route of Administration, 2018 - 2030 (USD Million)
• Table 119 Kuwait Sterile Injectable Contract Manufacturing market, by End-use, 2018 - 2030 (USD Million)

List of Figures

• Fig. 1 Market research process
• Fig. 2 Information procurement
• Fig. 3 Market research approaches
• Fig. 4 QFD modeling for market share assessment
• Fig. 5 Market formulation & validation
• Fig. 6 Commodity flow analysis
• Fig. 7 Primary research pattern
• Fig. 8 Primary interviews in North America
• Fig. 9 Primary interviews in Europe
• Fig. 10 Primary interviews in Asia Pacific
• Fig. 11 Primary interviews in Latin America
• Fig. 12 Primary interviews in MEA
• Fig. 13 Market Snapshot
• Fig. 14 Segment Snapshot
• Fig. 15 Segment Snapshot
• Fig. 16 Competitive Landscape Snapshot
• Fig. 17 Sterile Injectable Contract Manufacturing market segmentation
• Fig. 18 Parent market outlook (2022)
• Fig. 19 Related/ancillary market outlook (2022)
• Fig. 20 Market driver relevance analysis (Current & future impact)
• Fig. 21 Current shared services and outsourcing usage levels
• Fig. 22 Market restraint relevance analysis (Current & future impact)
• Fig. 23 Porter's five forces analysis
• Fig. 24 SWOT analysis, by a factor (political & legal, economic and technological)
• Fig. 25 Sterile Injectable Contract Manufacturing Market Molecule Type outlook: Segment dashboard
• Fig. 26 Sterile Injectable Contract Manufacturing: Molecule Type movement analysis
• Fig. 27 Small Molecule market, 2018 - 2030 (USD Million)
• Fig. 28 Large Molecule market, 2018 - 2030 (USD Million)
• Fig. 29 Sterile Injectable Contract Manufacturing Market Therapeutic Application outlook: Segment dashboard
• Fig. 30 Sterile Injectable Contract Manufacturing: Therapeutic Application type movement analysis
• Fig. 31 Cancer market, 2018 - 2030 (USD Million)
• Fig. 32 Diabetes market, 2018 - 2030 (USD Million)
• Fig. 33 Cardiovascular Diseases market, 2018 - 2030 (USD Million)
• Fig. 34 Central Nervous System Diseases market, 2018 - 2030 (USD Million)
• Fig. 35 Infectious Disorders market, 2018 - 2030 (USD Million)
• Fig. 36 Musculoskeletal market, 2018 - 2030 (USD Million)
• Fig. 37 Anti-Viral market, 2018 - 2030 (USD Million)
• Fig. 38 Others market, 2018 - 2030 (USD Million)
• Fig. 39 Sterile Injectable Contract Manufacturing market Route of Administration outlook: Segment dashboard
• Fig. 40 Sterile Injectable Contract Manufacturing market: Route of Administration movement analysis
• Fig. 41 Subcutaneous (SC) market, 2018 - 2030 (USD Million)
• Fig. 42 Intravenous (IV) market, 2018 - 2030 (USD Million)
• Fig. 43 Intramuscular (IM) market, 2018 - 2030 (USD Million)
• Fig. 44 Regional marketplace: Segment dashboard
• Fig. 45 Regional outlook, 2022 & 2030
• Fig. 46 North America market, 2018 - 2030 (USD Million)
• Fig. 47 U.S. market, 2018 - 2030 (USD Million)
• Fig. 48 Canada market, 2018 - 2030 (USD Million)
• Fig. 49 Europe market, 2018 - 2030 (USD Million)
• Fig. 50 Germany market, 2018 - 2030 (USD Million)
• Fig. 51 UK market, 2018 - 2030 (USD Million)
• Fig. 52 France market, 2018 - 2030 (USD Million)
• Fig. 53 Italy market, 2018 - 2030 (USD Million)
• Fig. 54 Spain market, 2018 - 2030 (USD Million)
• Fig. 55 Denmark market, 2018 - 2030(USD Million)
• Fig. 56 Sweden market, 2018 - 2030 (USD Million)
• Fig. 57 Norway market, 2018 - 2030 (USD Million)
• Fig. 58 Asia Pacific market, 2018 - 2030 (USD Million)
• Fig. 59 China market, 2018 - 2030 (USD Million)
• Fig. 60 Japan market, 2018 - 2030 (USD Million)
• Fig. 61 India market, 2018 - 2030 (USD Million)
• Fig. 62 Australia market, 2018 - 2030 (USD Million)
• Fig. 63 South Korea market, 2018 - 2030 (USD Million)
• Fig. 64 Latin America market, 2018 - 2030 (USD Million)
• Fig. 65 Brazil market, 2018 - 2030 (USD Million)
• Fig. 66 Mexico market, 2018 - 2030 (USD Million)
• Fig. 67 Argentina market, 2018 - 2030 (USD Million)
• Fig. 68 Middle East & Africa market, 2018 - 2030 (USD Million)
• Fig. 69 South Africa market, 2018 - 2030 (USD Million)
• Fig. 70 Saudi Arabia market, 2018 - 2030 (USD Million)
• Fig. 71 UAE market, 2018 - 2030 (USD Million)
• Fig. 72 Kuwait market, 2018 - 2030 (USD Million)

Sterile Injectable Contract Manufacturing Market Growth & Trends

The global sterile injectable contract manufacturing market size is estimated to reach USD 31.92 billion by 2030, growing at a CAGR of 12.1% from 2023 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

• The large molecule segment accounted for the largest share of 61.3% in 2022. The segment's growth is driven by increasing demand for large molecule-based therapeutics such as cell & gene therapy, RNA therapy, etc., which constitute a vast portion of large molecules
• Based on therapeutic application, the cancer segment accounted for the largest share of 28.5% in 2022. The growth in the share of this segment is majorly due to the increasing demand for anti-cancer-based injectable therapeutics
• The Subcutaneous (SC) segment is anticipated to register the fastest CAGR of 12.6% during the forecast period. This is because of the high demand for SC injectables globally, owing to their associated benefits while administering vaccines, growth hormones, and insulin
• Biopharmaceutical companies are anticipated to witness the highest CAGR of 12.4% over the forecast period due to the increasing number of biopharmaceutical companies investing in developing novel sterile injectables
• Asia Pacific is anticipated to witness the highest CAGR of 13.1% during the forecast period. This high growth is primarily due to the increasing number of Western pharmaceutical companies outsourcing their manufacturing activities to developing economies such as India and China

Table of Contents

Chapter 1. Research Methodology and Scope

• 1.1. Market Segmentation & Scope
  • 1.1.1. Segment Definitions
  • 1.1.2. Molecule Type
  • 1.1.3. Therapeutic Application
  • 1.1.4. Route of Administration
  • 1.1.5. End-use
• 1.2. Regional Scope
• 1.3. Estimates And Forecast Timeline
• 1.4. Objectives
  • 1.4.1. Objective - 1
  • 1.4.2. Objective - 2
  • 1.4.3. Objective - 3
• 1.5. Research Methodology
• 1.6. Information Procurement
  • 1.6.1. Purchased Database
  • 1.6.2. GVR's Internal Database
  • 1.6.3. Secondary Sources
  • 1.6.4. Primary Research
• 1.7. Information Or Data Analysis
  • 1.7.1. Data Analysis Models
• 1.8. Market Formulation & Validation
• 1.9. Model Details
  • 1.9.1. Commodity Flow Analysis
  • 1.9.2. Parent Market Analysis
• 1.10. List Of Secondary Sources
• 1.11. List Of Abbreviations

Chapter 2. Executive Summary

• 2.1. Market Outlook
• 2.2. Segment Outlook
• 2.3. Competitive Insights

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
    • 3.3.1.1. Supplier Power
    • 3.3.1.2. Buyer Power
    • 3.3.1.3. Substitution Threat
    • 3.3.1.4. Threat Of New Entrant
    • 3.3.1.5. Competitive Rivalry
  • 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. Sterile Injectable Contract Manufacturing Market, By Molecule Type: Segment Dashboard
• 4.2. Sterile Injectable Contract Manufacturing Market, By Molecule Type: Movement Analysis
• 4.3. Sterile Injectable Contract Manufacturing Market Estimates & Forecasts, By Molecule Type, 2018 - 2030
  • 4.3.1. Small Molecule
    • 4.3.1.1. Small Molecule Sterile Injectable Contract Manufacturing Market, 2018 to 2030 (USD Million)
  • 4.3.2. Large Molecule
    • 4.3.2.1. Large Molecule Sterile Injectable Contract Manufacturing Market, 2018 to 2030 (USD Million)

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

• 5.1. Sterile Injectable Contract Manufacturing Market, By Therapeutic Application: Segment Dashboard
• 5.2. Sterile Injectable Contract Manufacturing Market, By Therapeutic Application: Movement Analysis
• 5.3. Sterile Injectable Contract Manufacturing Market Estimates & Forecasts, By Therapeutic Application, 2018 - 2030
  • 5.3.1. Cancer
    • 5.3.1.1. Cancer Sterile Injectable Contract Manufacturing Market, 2018 to 2030 (USD Million)
  • 5.3.2. Diabetes
    • 5.3.2.1. Diabetes Sterile Injectable Contract Manufacturing Market, 2018 to 2030 (USD Million)
  • 5.3.3. Cardiovascular Diseases
    • 5.3.3.1. Cardiovascular Diseases Sterile Injectable Contract Manufacturing Market, 2018 to 2030 (USD Million)
  • 5.3.4. Central Nervous System Diseases
    • 5.3.4.1. Central Nervous System Diseases Sterile Injectable Contract Manufacturing Market, 2018 to 2030 (USD Million)
  • 5.3.5. Infectious Disorders
    • 5.3.5.1. Infectious Disorders Sterile Injectable Contract Manufacturing Market, 2018 to 2030 (USD Million)
  • 5.3.6. Musculoskeletal
    • 5.3.6.1. Musculoskeletal Sterile Injectable Contract Manufacturing Market, 2018 to 2030 (USD Million)
  • 5.3.7. Anti-Viral
    • 5.3.7.1. Anti-Viral Sterile Injectable Contract Manufacturing Market, 2018 to 2030 (USD Million)
  • 5.3.8. Others
    • 5.3.8.1. Others Sterile Injectable Contract Manufacturing Market, 2018 to 2030 (USD Million)

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

• 6.1. Sterile Injectable Contract Manufacturing Market, By Route of Administration: Segment Dashboard
• 6.2. Sterile Injectable Contract Manufacturing Market, By Route of Administration: Movement Analysis
• 6.3. Sterile Injectable Contract Manufacturing Market Estimates & Forecasts, By Route of Administration, 2018 - 2030
  • 6.3.1. Subcutaneous (SC)
    • 6.3.1.1. Subcutaneous (SC) Sterile Injectable Contract Manufacturing Market 2018 to 2030 (USD Million)
  • 6.3.2. Intravenous (IV)
    • 6.3.2.1. Intravenous (IV) Sterile Injectable Contract Manufacturing Market 2018 to 2030 (USD Million)
  • 6.3.3. Intramuscular (IM)
    • 6.3.3.1. Intramuscular (IM) Sterile Injectable Contract Manufacturing Market 2018 to 2030 (USD Million)
  • 6.3.4. Others
    • 6.3.4.1. Others Sterile Injectable Contract Manufacturing Market 2018 to 2030 (USD Million)

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

• 7.1. Sterile Injectable Contract Manufacturing Market, By End-use: Segment Dashboard
• 7.2. Sterile Injectable Contract Manufacturing Market, By End-use: Movement Analysis
• 7.3. Sterile Injectable Contract Manufacturing Market Estimates & Forecasts, By End-use, 2018 - 2030
  • 7.3.1. Pharmaceutical Companies
    • 7.3.1.1. Pharmaceutical Companies Sterile Injectable Contract Manufacturing Market 2018 to 2030 (USD Million)
  • 7.3.2. Biopharmaceutical Companies
    • 7.3.2.1. Biopharmaceutical Companies Sterile Injectable Contract Manufacturing Market 2018 to 2030 (USD Million)
  • 7.3.3. Others
    • 7.3.3.1. Others Sterile Injectable Contract Manufacturing Market 2018 to 2030 (USD Million)

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

• 8.1. Regional Market Share Analysis, 2022 & 2030
• 8.2. Regional Market Dashboard
• 8.3. Global Regional Market Snapshot
• 8.4. North America
  • 8.4.1. Market Estimates and Forecast, 2018 - 2030 (Revenue, 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 Framework
    • 8.4.2.4. U.S. Market Estimates and Forecasts, 2018 - 2030
  • 8.4.3. Canada
    • 8.4.3.1. Key Country Dynamics
    • 8.4.3.2. Competitive Scenario
    • 8.4.3.3. Regulatory Framework
    • 8.4.3.4. Canada Market Estimates and Forecasts, 2018 - 2030
• 8.5. Europe
  • 8.5.1. UK
    • 8.5.1.1. Key Country Dynamics
    • 8.5.1.2. Competitive Scenario
    • 8.5.1.3. Regulatory Framework
    • 8.5.1.4. UK Market Estimates and Forecasts, 2018 - 2030
  • 8.5.2. Germany
    • 8.5.2.1. Key Country Dynamics
    • 8.5.2.2. Competitive Scenario
    • 8.5.2.3. Regulatory Framework
    • 8.5.2.4. Germany Market Estimates and Forecasts, 2018 - 2030
  • 8.5.3. France
    • 8.5.3.1. Key Country Dynamics
    • 8.5.3.2. Competitive Scenario
    • 8.5.3.3. Regulatory Framework
    • 8.5.3.4. France Market Estimates and Forecasts, 2018 - 2030
  • 8.5.4. Italy
    • 8.5.4.1. Key Country Dynamics
    • 8.5.4.2. Competitive Scenario
    • 8.5.4.3. Regulatory Framework
    • 8.5.4.4. Italy Market Estimates and Forecasts, 2018 - 2030
  • 8.5.5. Spain
    • 8.5.5.1. Key Country Dynamics
    • 8.5.5.2. Competitive Scenario
    • 8.5.5.3. Regulatory Framework
    • 8.5.5.4. Spain Market Estimates and Forecasts, 2018 - 2030
  • 8.5.6. Denmark
    • 8.5.6.1. Key Country Dynamics
    • 8.5.6.2. Competitive Scenario
    • 8.5.6.3. Regulatory Framework
    • 8.5.6.4. Denmark Market Estimates and Forecasts, 2018 - 2030
  • 8.5.7. Sweden
    • 8.5.7.1. Key Country Dynamics
    • 8.5.7.2. Competitive Scenario
    • 8.5.7.3. Regulatory Framework
    • 8.5.7.4. Sweden Market Estimates and Forecasts, 2018 - 2030
  • 8.5.8. Norway
    • 8.5.8.1. Key Country Dynamics
    • 8.5.8.2. Competitive Scenario
    • 8.5.8.3. Regulatory Framework
    • 8.5.8.4. Norway Market Estimates and Forecasts, 2018 - 2030
• 8.6. Asia Pacific
  • 8.6.1. Japan
    • 8.6.1.1. Key Country Dynamics
    • 8.6.1.2. Competitive Scenario
    • 8.6.1.3. Regulatory Framework
    • 8.6.1.4. Japan Market Estimates and Forecasts, 2018 - 2030
  • 8.6.2. India
    • 8.6.2.1. Key Country Dynamics
    • 8.6.2.2. Competitive Scenario
    • 8.6.2.3. Regulatory Framework
    • 8.6.2.4. India Market Estimates and Forecasts, 2018 - 2030
  • 8.6.3. China
    • 8.6.3.1. Key Country Dynamics
    • 8.6.3.2. Competitive Scenario
    • 8.6.3.3. Regulatory Framework
    • 8.6.3.4. China Market Estimates and Forecasts, 2018 - 2030
  • 8.6.4. South Korea
    • 8.6.4.1. Key Country Dynamics
    • 8.6.4.2. Competitive Scenario
    • 8.6.4.3. Regulatory Framework
    • 8.6.4.4. South Korea Market Estimates and Forecasts, 2018 - 2030
  • 8.6.5. Australia
    • 8.6.5.1. Key Country Dynamics
    • 8.6.5.2. Competitive Scenario
    • 8.6.5.3. Regulatory Framework
    • 8.6.5.4. Australia Market Estimates and Forecasts, 2018 - 2030
  • 8.6.6. Thailand
    • 8.6.6.1. Key Country Dynamics
    • 8.6.6.2. Competitive Scenario
    • 8.6.6.3. Regulatory Framework
    • 8.6.6.4. Thailand Market Estimates and Forecasts, 2018 - 2030
• 8.7. Latin America
  • 8.7.1. Brazil
    • 8.7.1.1. Key Country Dynamics
    • 8.7.1.2. Competitive Scenario
    • 8.7.1.3. Regulatory Framework
    • 8.7.1.4. Brazil Market Estimates and Forecasts, 2018 - 2030
  • 8.7.2. Mexico
    • 8.7.2.1. Key Country Dynamics
    • 8.7.2.2. Competitive Scenario
    • 8.7.2.3. Regulatory Framework
    • 8.7.2.4. Mexico Market Estimates and Forecasts, 2018 - 2030
  • 8.7.3. Argentina
    • 8.7.3.1. Key Country Dynamics
    • 8.7.3.2. Competitive Scenario
    • 8.7.3.3. Regulatory Framework
    • 8.7.3.4. Argentina Market Estimates and Forecasts, 2018 - 2030
• 8.8. MEA
  • 8.8.1. South Africa
    • 8.8.1.1. Key Country Dynamics
    • 8.8.1.2. Competitive Scenario
    • 8.8.1.3. Regulatory Framework
    • 8.8.1.4. South Africa Market Estimates and Forecasts, 2018 - 2030
  • 8.8.2. Saudi Arabia
    • 8.8.2.1. Key Country Dynamics
    • 8.8.2.2. Competitive Scenario
    • 8.8.2.3. Regulatory Framework
    • 8.8.2.4. Saudi Arabia Market Estimates and Forecasts, 2018 - 2030
  • 8.8.3. UAE
    • 8.8.3.1. Key Country Dynamics
    • 8.8.3.2. Competitive Scenario
    • 8.8.3.3. Regulatory Framework
    • 8.8.3.4. UAE Market Estimates and Forecasts, 2018 - 2030
  • 8.8.4. Kuwait
    • 8.8.4.1. Key Country Dynamics
    • 8.8.4.2. Competitive Scenario
    • 8.8.4.3. Regulatory Framework
    • 8.8.4.4. Kuwait Market Estimates and Forecasts, 2018 - 2030

Chapter 9. Competitive Landscape

• 9.1. Market Participant Categorization
  • 9.1.1. Innovators
  • 9.1.2. Market Leaders
  • 9.1.3. Emerging Players
  • 9.1.4. Company Market Share Analysis, 2022
• 9.2. Company Profiles
  • 9.2.1. Baxter
    • 9.2.1.1. Company Overview
    • 9.2.1.2. Financial Performance
    • 9.2.1.3. Service Benchmarking
    • 9.2.1.4. Strategic Initiatives
  • 9.2.2. Catalent, Inc
    • 9.2.2.1. Company Overview
    • 9.2.2.2. Financial Performance
    • 9.2.2.3. Service Benchmarking
    • 9.2.2.4. Strategic Initiatives
  • 9.2.3. Vetter Pharma
    • 9.2.3.1. Company Overview
    • 9.2.3.2. Financial Performance
    • 9.2.3.3. Service Benchmarking
    • 9.2.3.4. Strategic Initiatives
  • 9.2.4. Recipharm AB
    • 9.2.4.1. Company Overview
    • 9.2.4.2. Financial Performance
    • 9.2.4.3. Service Benchmarking
    • 9.2.4.4. Strategic Initiatives
  • 9.2.5. Aenova Group
    • 9.2.5.1. Company Overview
    • 9.2.5.2. Financial Performance
    • 9.2.5.3. Service Benchmarking
    • 9.2.5.4. Strategic Initiatives
  • 9.2.6. Fresenius Kabi
    • 9.2.6.1. Company Overview
    • 9.2.6.2. Financial Performance
    • 9.2.6.3. Service Benchmarking
    • 9.2.6.4. Strategic Initiatives
  • 9.2.7. Unither Pharmaceuticals
    • 9.2.7.1. Company Overview
    • 9.2.7.2. Financial Performance
    • 9.2.7.3. Service Benchmarking
    • 9.2.7.4. Strategic Initiatives
  • 9.2.8. Famar
    • 9.2.8.1. Company Overview
    • 9.2.8.2. Financial Performance
    • 9.2.8.3. Service Benchmarking
    • 9.2.8.4. Strategic Initiatives
  • 9.2.9. Cipla Inc.
    • 9.2.9.1. Company Overview
    • 9.2.9.2. Financial Performance
    • 9.2.9.3. Service Benchmarking
    • 9.2.9.4. Strategic Initiatives
  • 9.2.10. NextPharma Technologies
    • 9.2.10.1. Company Overview
    • 9.2.10.2. Financial Performance
    • 9.2.10.3. Service Benchmarking
    • 9.2.10.4. Strategic Initiatives