生物製剤の充填仕上げ製造市場（第3版）：包装容器の種類（アンプル、カートリッジ、シリンジ、バイアル）、生物製剤の種類（抗体、細胞治療薬、遺伝子治療薬、オリゴヌクレオチド、組換えタンパク質、ワクチン、その他の生物製剤）、事業規模（前臨床/臨床、商業）別、企業規模（大規模、中規模、小規模）、主要治療領域（自己免疫疾患、がん疾患、心血管疾患、感染症、その他の疾患）、地域（北米、欧州、アジア太平洋地域、中東・北アフリカ、中南米）：業界動向と世界予測、2022-2035年

Biologics Fill Finish Manufacturing Market (3rd Edition) by Type of Packaging Containers (Ampoules, Cartridges, Syringes and Vials), Type of Biologics (Antibodies, Cell Therapies, Gene Therapies, Oligonucleotides, Recombinant Proteins, Vaccines and Other Biologics), Scale of Operation (Preclinical / Clinical and Commercial), Company Size (Large, Mid-sized and Small), Key Therapeutic Areas (Autoimmune Disorders, Oncological Disorders, Cardiovascular Disorders, Infectious Diseases and Other Disorders), Geographical Regions (North America, Europe, Asia Pacific, Middle East and North Africa and Latin America): Industry Trends and Global Forecasts, 2022-2035

生物製剤の充填仕上げ製造市場は、2022年までに40億米ドルに達すると予想され、予測期間2022-2035年の年平均成長率は8.4%と予測されている。生物製剤の台頭は、医薬品セクターにおける大きな変革を意味する。... もっと見る

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サマリー

生物製剤の充填仕上げ製造市場は、2022年までに40億米ドルに達すると予想され、予測期間2022-2035年の年平均成長率は8.4%と予測されている。

生物製剤の台頭は、医薬品セクターにおける大きな変革を意味する。バイオ医薬品の可能性の高まりは、幅広い業界関係者や学術機関を惹きつけている。現在、市場には200を超える商業的に入手可能な生物製剤があり、1万を超える候補が臨床評価を受けている。このように拡大する生物製剤の状況は、需要の増大と多様性と共に、生産能力の拡大と無菌充填・仕上げ工程に対する要求の大幅な増加をもたらしている。

充填/仕上げ作業は、最終医薬品をバイアル、シリンジ、アンプル、カートリッジなどの無菌容器に包装する上で極めて重要である。生物製剤の製造における様々な手順の中でも、充填・仕上げは極めて重要な工程であり、多くの場合、外注されています。

充填／仕上げの段階で小さなミスがあっても、微生物汚染につながる可能性があり、医薬品の損失、製造の遅延、そして最も重要なことですが、患者の健康を危険にさらすことにつながります。その結果、多くの関係者が、高品質の医薬品の開発と供給を保証するために、充填／仕上げ作業に関する専門知識と必要なインフラを備えた製造受託機関にますます期待を寄せるようになっています。

バイオ医薬品に対する需要の高まりに後押しされ、生物製剤の充填・仕上げ製造市場は当面大きな成長を遂げると予想される。

レポート対象範囲
 生物製剤の充填仕上げ製造市場を調査し、包装容器の種類、生物製剤の分類、事業規模、企業規模、主要治療分野、地域別に分類しています。
 当市場の成長に影響を与える要因（促進要因、阻害要因、機会、課題など）について分析しています。
 当レポートでは、市場内の潜在的な優位性と障壁をステークホルダー向けに評価し、主要市場プレイヤーの競争環境に関する洞察を提供しています。
 市場収益予測は、主要5地域のセグメントについて提供しています。
 包括的な調査は、バイオ医薬品と受託製造の紹介から始まり、業界がアウトソーシング、特に充填・仕上げなどの業務に依存していることを強調しています。充填・仕上げの受託製造組織を選択する際の留意点を概説し、関連するメリットとリスクを詳述しています。
 バイオ医薬品の充填／仕上げサービスを提供する企業について詳細な評価を行い、設立年、企業規模、所在地、利用する包装容器、製造する生物製剤の種類、業務規模、医薬品関連の追加サービスなどのパラメータを分析している。
 分析は様々な地域の充填/仕上げ受託メーカー間の競争環境にも及び、包装容器に関するサプライヤーとサービスの強み、多様性、規模を評価している。
 北米、欧州、アジア太平洋地域の主要企業のプロフィールは、サービス、施設、財務データ、パートナーシップ、拡大、称賛、将来の見通しに関する洞察を提供する。さらに、2013年以降の業界パートナーシップを精査し、パートナーシップモデル、性質、範囲、市場における活発な企業を検証しています。
 生物製剤の充填/仕上げ能力を強化するために製造委託先が採用した拡大戦略については、年、タイプ、所在地、提供サービス、関与する生物製剤などのパラメータを考慮しながら分析し、最も活発な企業を強調しています。
 さらなる分析として、世界の生物製剤の充填／仕上げ能力、包装単位、企業規模、事業規模、本社所在地の分布を包括的に評価している。本レポートでは、関連パラメータに基づき、充填・仕上げ製造の年間需要を推計している。
 サービスプロバイダーの主要業績指標、地域別能力評価フレームワーク、潜在的な市場成長促進要因の調査。ケーススタディでは、無菌充填／仕上げ作業におけるロボットシステムの使用や、すぐに使える包装部品の採用に焦点を当て、使用機器や関連業界のサプライヤーについて詳述しています。

主要市場企業
 AbbVie Contract Manufacturing
 バイオファーマ・ソリューションズ
 バイオリライアンス
 キャタレント・バイオロジクス
 パセオン
 チャールズ・リバー・ラボラトリーズ
 ベーリンガーインゲルハイムバイオエクセレンス
 ロンザ
 ピエール・ファーブル
 レシファーム
 ワッカーバイオテック
 ファレバ
 フレゼニウス・カビ
 グラクソ・スミスクライン
 アシムケム
 サムスンバイオロジクス
 シンジェン
 タカラバイオ
 呉西生物製剤
 ヘテロドラッグス
 インタス・ファーマシューティカルズ

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1 PREFACE
1.1. Scope of the Report
1.2. Market Segmentation
1.3. Research Methodology
1.4. Key Questions Answered
1.5. Chapter Outlines
2 EXECUTIVE SUMMARY
3 INTRODUCTION
3.1. Chapter Overview
3.2. Introduction to Biologics
3.3. Need for Outsourcing Biologics-related Operations
3.4. Introduction to Contract Manufacturing
3.5. Commonly Outsourced Operations in the Biopharmaceutical Industry
3.5.1. Biologics Fill/Finish Operations
3.6. Basic Guidelines for Selecting a Fill/Finish Service Provider
3.7. Advantages of Outsourcing Fill/Finish Operations
3.8. Risks and Challenges of Outsourcing Fill/Finish Operations
4 BIOLOGICS FILL/FINISH SERVICE PROVIDERS: MARKET LANDSCAPE
4.1. Chapter Overview
4.2. Biologics Fill/Finish Service Providers: Overall Market Landscape
4.2.1. Analysis by Year of Establishment
4.2.2. Analysis by Company Size
4.2.3. Analysis by Location of Headquarters
4.2.4. Analysis by Location of Fill-Finish Facilities
4.2.5. Analysis by Type of Packaging Container(s) Used
4.2.6. Analysis by Type of Biologic(s) Manufactured
4.2.7. Analysis by Scale of Operation
4.2.8. Analysis by Additional Drug Product-related Services Offered
4.2.9. Biologics Fill/Finish Service Providers: Information on Fill-Finish Capacity
5 COMPANY COMPETITIVENESS ANALYSIS
5.1. Chapter Overview
5.2. Methodology and Key Parameters
5.3. Biologics Fill Finish Manufacturing Service Providers in North America
5.3.1. Players Offering Services for Ampoules
5.3.2. Players Offering Services for Cartridges
5.3.3. Players Offering Services for Syringes
5.3.4. Players Offering Services for Vials
5.4. Biologics Fill Finish Manufacturing Service Providers in Europe
5.4.1. Players Offering Services for Ampoules
5.4.2. Players Offering Services for Cartridges
5.4.3. Players Offering Services for Syringes
5.4.4. Players Offering Services for Vials
5.5. Biologics Fill Finish Manufacturing Service Providers in Asia Pacific and Rest of the World
5.5.1. Players Offering Services for Ampoules
5.5.2. Players Offering Services for Cartridges
5.5.3. Players Offering Services for Syringes
5.5.4. Players Offering Services for Vials
6 BIOLOGICS FILL FINISH CONTRACT MANUFACTURING COMPANIES IN NORTH AMERICA
6.1. Chapter Overview
6.2. AbbVie Contract Manufacturing
6.2.1. Company Overview
6.2.2. Service Portfolio
6.2.3. Financial Information
6.2.4. Recent Developments and Future Outlook
6.3. BioPharma Solutions
6.3.1. Company Overview
6.3.2. Service Portfolio
6.3.3. Recent Developments and Future Outlook
6.4. BioReliance
6.4.1. Company Overview
6.4.2. Service Portfolio
6.4.3. Financial Information
6.4.4. Recent Developments and Future Outlook
6.5. Catalent Biologics
6.5.1. Company Overview
6.5.2. Service Portfolio
6.5.3. Financial Information
6.5.4. Recent Developments and Future Outlook
6.6. Patheon
6.6.1. Company Overview
6.6.2. Service Portfolio
6.6.3. Financial Information
6.6.4. Recent Developments and Future Outlook
6.7. Charles River Laboratories
6.7.1. Company Overview
6.7.2. Fill / Finish Related Services
6.7.3. Financial Information
6.7.4. Recent Developments and Future Outlook
7 BIOLOGICS FILL FINISH CONTRACT MANUFACTURING COMPANIES IN EUROPE
7.1. Chapter Overview
7.2. Boehringer Ingelheim BioXcellence
7.2.1. Company Overview
7.2.2. Service Portfolio
7.2.3. Financial Information
7.2.4. Recent Developments and Future Outlook
7.3. Lonza
7.3.1. Company Overview
7.3.2. Service Portfolio
7.3.3. Financial Information
7.3.4. Recent Developments and Future Outlook
7.4. Pierre Fabre
7.4.1. Company Overview
7.4.2. Service Portfolio
7.4.3. Financial Information
7.4.4. Recent Developments and Future Outlook
7.5. Recipharm
7.5.1. Company Overview
7.5.2. Service Portfolio
7.5.3. Financial Information
7.5.4. Recent Developments and Future Outlook
7.6. Wacker Biotech
7.6.1. Company Overview
7.6.2. Service Portfolio
7.6.3. Financial Information
7.6.4. Recent Developments and Future Outlook
7.7. Fareva
7.7.1. Company Overview
7.7.2. Fill / Finish Related Services
7.7.3. Recent Developments and Future Outlook
7.8. Fresenius Kabi
7.8.1. Company Overview
7.8.2. Fill / Finish Related Services
7.8.3. Financial Information
7.8.4. Recent Developments and Future Outlook
7.9. GlaxoSmithKline
7.9.1. Company Overview
7.9.2. Fill / Finish Related Services
7.9.3. Financial Information
7.9.4. Recent Developments and Future Outlook
8 BIOLOGICS FILL FINISH CONTRACT MANUFACTURING COMPANIES IN ASIA PACIFIC
8.1. Chapter Overview
8.2. Asymchem
8.2.1. Company Overview
8.2.2. Service Portfolio
8.2.3. Financial Information
8.2.4. Recent Developments and Future Outlook
8.3. Samsung Biologics
8.3.1. Company Overview
8.3.2. Service Portfolio
8.3.3. Financial Information
8.3.4. Recent Developments and Future Outlook
8.4. Syngene
8.4.1. Company Overview
8.4.2. Service Portfolio
8.4.3. Financial Information
8.4.4. Recent Developments and Future Outlook
8.5. Takara Bio
8.5.1. Company Overview
8.5.2. Service Portfolio
8.5.3. Financial Information
8.5.4. Recent Developments and Future Outlook
8.6. WuXi Biologics
8.6.1. Company Overview
8.6.2. Service Portfolio
8.6.3. Financial Information
8.6.4. Recent Developments and Future Outlook
8.7. Hetero Drugs
8.7.1. Company Overview
8.7.2. Fill / Finish Related Services
8.7.3. Recent Developments and Future Outlook
8.8. Intas Pharmaceuticals
8.8.1. Company Overview
8.8.2. Fill / Finish Related Services
8.8.3. Recent Developments and Future Outlook
9 PARTNERSHIPS AND COLLABORATIONS
9.1. Chapter Overview
9.2. Partnership Models
9.3. Biologics Fill / Finish Service Providers: List of Partnerships and Collaborations
9.3.1. Analysis by Year of Partnership
9.3.2. Analysis by Type of Partnership
9.3.3. Analysis by Scale of Operation
9.3.4. Analysis by Type of Service(s) Offered
9.3.5. Analysis by Type of Process(es)
9.3.6. Analysis by Type of Biologic(s) Involved
9.3.7. Most Active Players: Analysis by Number of Partnerships
9.3.8. Analysis by Geographical Region
9.3.8.1. Intercontinental and Intracontinental Agreements
10 RECENT EXPANSIONS
10.1. Chapter Overview
10.2. Biologics Fill/Finish Service Providers: Recent Expansions
10.2.1. Analysis by Year of Expansion
10.2.2. Analysis by Type of Expansion
10.2.3. Analysis by Type of Packaging Container(s) Used
10.2.4. Analysis by Type of Service(s) Offered
10.2.5. Analysis by Type of Biologic(s) Involved and Scale of Operation
10.2.7. Most Active Players: Analysis by Number of Service(s) Offered
10.2.8. Analysis by Geographical Region
10.2.9. Expansions in North America: Analysis by Type of Service(s) Offered and Type of
Biologic(s) Involved
10.2.10. Expansions in Europe: Analysis by Type of Service(s) Offered and Type of Biologic(s) Involved
10.2.11. Expansions in Asia Pacific: Analysis by Type of Service(s) Offered and Type of Biologic(s) Involved
11 CAPACITY ANALYSIS
11.1. Chapter Overview
11.2. Assumptions and Methodology
11.3. Global Fill Finish Capacity (by Number of Units Filled)
11.3.1. Analysis by Type of Packaging Container
11.3.2. Analysis by Company Size
11.3.3. Analysis by Scale of Operation
11.3.4. Analysis by Location of Headquarters
11.3.5. Analysis by Location of Fill/Finish Facilities
11.4. Global Fill Finish Capacity (by Fill Volume)
11.4.1. Analysis by Type of Packaging Container
11.4.2. Analysis by Company Size
11.4.3. Analysis by Scale of Operation
11.4.4. Analysis by Location of Headquarters
11.4.5. Analysis by Location of Fill/Finish Facilities
11.5. Global Fill Finish Capacity for Ampoules (by Number of Units Filled)
11.5.1 Analysis by Company Size
11.5.2 Analysis by Scale of Operation
11.5.3. Analysis by Location of Headquarters
11.5.4 Analysis by Location of Fill/Finish Facilities
11.6. Global Fill Finish Capacity for Ampoules (by Fill Volume)
11.6.1. Analysis by Company Size
11.6.2. Analysis by Scale of Operation
11.6.3. Analysis by Location of Headquarters
11.6.4. Analysis by Location of Fill/Finish Facilities
11.7. Global Fill Finish Capacity for Cartridges (by Number of Units Filled)
11.7.1. Analysis by Company Size
11.7.2. Analysis by Scale of Operation
11.7.3. Analysis by Location of Headquarters
11.7.4. Analysis by Location of Fill/Finish Facilities
11.8. Global Fill Finish Capacity for Cartridges (by Fill Volume)
11.8.1. Analysis by Company Size
11.8.2. Analysis by Scale of Operation
11.8.3. Analysis by Location of Headquarters
11.8.4. Analysis by Location of Fill/Finish Facilities
11.9. Global Fill Finish Capacity for Syringes (by Number of Units Filled)
11.9.1 Analysis by Company Size
11.9.2 Analysis by Scale of Operation
11.9.3. Analysis by Location of Headquarters
11.9.4 Analysis by Location of Fill/Finish Facilities
11.10. Global Fill Finish Capacity for Syringes (by Fill Volume)
11.10.1. Analysis by Company Size
11.10.2. Analysis by Scale of Operation
11.10.3. Analysis by Location of Headquarters
11.10.4. Analysis by Location of Fill/Finish Facilities
11.11. Global Fill Finish Capacity for Vials (by Number of Units Filled)
11.11.1 Analysis by Company Size
11.11.2 Analysis by Scale of Operation
11.11.3. Analysis by Location of Headquarters
11.11.4. Analysis by Location of Fill/Finish Facilities
11.12. Global Fill Finish Capacity for Vials (by Fill Volume)
11.12.1. Analysis by Company Size
11.12.2. Analysis by Scale of Operation
11.12.3. Analysis by Location of Headquarters
11.12.4. Analysis by Location of Fill/Finish Facilities
11.13. Conclusion
12 DEMAND ANALYSIS
12.1. Chapter Overview
12.2. Assumptions and Methodology
12.3. Global Demand for Biologics Fill Finish Services
12.3.1. Analysis by Type of Packaging Container
12.3.2. Analysis by Type of Biologic
12.3.3. Analysis by Therapeutic Area
12.3.4. Analysis by Scale of Operation
12.3.5. Analysis by Company Size
12.3.6. Analysis by Geographical Location
12.4. Demand and Supply Analysis
13 KEY PERFORMANCE INDICATORS FOR BIOLOGIC MANUFACTURING AND FILL/FINISH
13.1. Chapter Overview
13.2. Biologics Manufacturing and Fill/Finish: Key Performance Indicators
13.2.1. Financial Indicators
13.2.1.1. Big Pharma Perspective
13.2.1.2. Contract Manufacturers’ Perspective
13.2.2. Process and Capability-related Indicators
13.2.2.1. Big Pharma Perspective
13.2.2.2. Contract Manufacturers’ Perspective
13.2.3. Market Reputation-related Indicators
13.2.3.1. Big Pharma Perspective
13.2.3.2. Contract Manufacturers’ Perspective
13.2.4. Other Important Performance Indicators
13.3.5. Conclusion
14 REGIONAL CAPABILITY ASSESSMENT
14.1. Chapter Overview
14.2. Assumptions and Key Parameters
14.3. Biologics Fill/Finish Capabilities in North America
14.4. Biologics Fill/Finish Capabilities in Europe
14.5. Biologics Fill/Finish Capabilities in Asia Pacific and Rest of the World
14.6. Regional Analysis of Installed Biologics Fill Finish Capacity
14.7.
15 MARKET SIZING AND OPPORTUNITY ANALYSIS
15.1. Chapter Overview
15.2. Forecast Methodology
15.3. Overall Biologics Fill Finish Manufacturing Market, 2022-2035
15.3.1. Biologics Fill Finish Manufacturing Market, 2022-2035: Distribution by Type of Packaging Container
15.3.2. Biologics Fill Finish Manufacturing Market, 2022-2035: Distribution by Type of Biologic
15.3.3. Biologics Fill Finish Manufacturing Market, 2022-2035: Distribution by Therapeutic Area
15.3.4. Biologics Fill Finish Manufacturing Market, 2022-2035: Distribution by Scale of Operation
15.3.5. Biologics Fill Finish Manufacturing Market, 2022-2035: Distribution by Company Size
15.3.6. Biologics Fill Finish Manufacturing Market, 2022-2035: Distribution by Geographical Region
15.3.5.1 Biologics Fill Finish Manufacturing Market in North America, 2022-2035: Distribution by Countries
15.3.5.2. Biologics Fill Finish Manufacturing Market in North America, 2022-2035: Distribution by Type of Packaging Container
15.3.5.3. Biologics Fill Finish Manufacturing Market in North America, 2022-2035: Distribution by Type of Biologic
15.3.5.4. Biologics Fill Finish Manufacturing Market in North America, 2022-2035: Distribution by Therapeutic Area
15.3.5.5. Biologics Fill Finish Manufacturing Market in North America, 2022-2035: Distribution by Scale of Operation
15.3.5.6. Biologics Fill Finish Manufacturing Market in North America, 2022-2035: Distribution by Company Size
15.3.5.7. Biologics Fill Finish Manufacturing Market in Europe, 2022-2035: Distribution by Countries
15.3.5.8. Biologics Fill Finish Manufacturing Market in Europe, 2022-2035: Distribution by Type of Packaging Container
15.3.5.9. Biologics Fill Finish Manufacturing Market in Europe, 2022-2035: Distribution by Type of Biologic
15.3.5.10. Biologics Fill Finish Manufacturing Market in Europe, 2022-2035: Distribution by Therapeutic Area
15.3.5.11. Biologics Fill Finish Manufacturing Market in Europe, 2022-2035: Distribution by Scale of Operation
15.3.5.12. Biologics Fill Finish Manufacturing Market in Europe, 2022-2035: Distribution by Company Size
15.3.5.13. Biologics Fill Finish Manufacturing Market in Asia Pacific, 2022-2035: Distribution by Countries
15.3.5.14. Biologics Fill Finish Manufacturing Market in Asia Pacific, 2022-2035: Distribution by Type of Packaging Container
15.3.5.15. Biologics Fill Finish Manufacturing Market in Asia Pacific, 2022-2035: Distribution by Type of Biologic
15.3.5.16. Biologics Fill Finish Manufacturing Market in Asia Pacific, 2022-2035: Distribution by Therapeutic Area
15.3.5.17. Biologics Fill Finish Manufacturing Market in Asia Pacific, 2022-2035: Distribution by Scale of Operation
15.3.5.18. Biologics Fill Finish Manufacturing Market in Asia Pacific, 2022-2035: Distribution by Company Size
15.3.5.19. Biologics Fill Finish Manufacturing Market in Middle East and North Africa, 2022-2035: Distribution by Countries
15.3.5.20. Biologics Fill Finish Manufacturing Market in Middle East and North Africa, 2022-2035: Distribution by Type of Packaging Container
15.3.5.21. Biologics Fill Finish Manufacturing Market in Middle East and North Africa, 2022-2035: Distribution by Type of Biologic
15.3.5.22. Biologics Fill Finish Manufacturing Market in Middle East and North Africa, 2022-2035: Distribution by Therapeutic Area
15.3.5.23. Biologics Fill Finish Manufacturing Market in Middle East and North Africa, 2022-2035: Distribution by Scale of Operation
15.3.5.24. Biologics Fill Finish Manufacturing Market in Middle East and North Africa, 2022-2035: Distribution by Company Size
15.3.5.25. Biologics Fill Finish Manufacturing Market in Latin America and Rest of the World, 2022-2035: Distribution by Countries
15.3.5.26. Biologics Fill Finish Manufacturing Market in Latin America and Rest of the World, 2022-2035: Distribution by Type of Packaging Container
15.3.5.27. Biologics Fill Finish Manufacturing Market in Latin America and Rest of the World, 2022-2035: Distribution by Type of Biologic
15.3.5.28. Biologics Fill Finish Manufacturing Market in Latin America and Rest of the World, 2022-2035: Distribution by Therapeutic Area
15.3.5.29. Biologics Fill Finish Manufacturing Market in Latin America and Rest of the World, 2022-2035: Distribution by Scale of Operation
15.3.5.30. Biologics Fill Finish Manufacturing Market in Latin America and Rest of the World, 2022-2035: Distribution by Company Size
15.4. Biologics Fill Finish Manufacturing Market for Ampoules, 2022-2035
15.4.1. Biologics Fill Finish Manufacturing Market for Ampoules, 2022-2035: Distribution by Type of Biologic
15.4.2. Biologics Fill Finish Manufacturing Market for Ampoules, 2022-2035: Distribution by Therapeutic Area
15.4.3. Biologics Fill Finish Manufacturing Market for Ampoules, 2022-2035: Distribution by Scale of Operation
15.4.4. Biologics Fill Finish Manufacturing Market for Ampoules, 2022-2035: Distribution by Company Size
15.4.5. Biologics Fill Finish Manufacturing Market for Ampoules, 2022-2035: Distribution by Geographical Region
15.4.4.1. Biologics Fill Finish Manufacturing Market for Ampoules in North America, 2022-2035: Distribution by Type of Biologic
15.4.4.2. Biologics Fill Finish Manufacturing Market for Ampoules in North America, 2022-2035: Distribution by Therapeutic Area
15.4.4.3. Biologics Fill Finish Manufacturing Market for Ampoules in North America, 2022-2035: Distribution by Scale of Operation
15.4.4.4. Biologics Fill Finish Manufacturing Market for Ampoules in North America, 2022-2035: Distribution by Company Size
15.4.4.5. Biologics Fill Finish Manufacturing Market for Ampoules in Europe, 2022-2035: Distribution by Type of Biologic
15.4.4.6. Biologics Fill Finish Manufacturing Market for Ampoules in Europe, 2022-2035: Distribution by Therapeutic Area
15.4.4.7. Biologics Fill Finish Manufacturing Market for Ampoules in Europe, 2022-2035: Distribution by Scale of Operation
15.4.4.8. Biologics Fill Finish Manufacturing Market for Ampoules in Europe, 2022-2035: Distribution by Company Size
15.4.4.9. Biologics Fill Finish Manufacturing Market for Ampoules in Asia Pacific, 2022-2035: Distribution by Type of Biologic
15.4.4.10. Biologics Fill Finish Manufacturing Market for Ampoules in Asia Pacific, 2022-2035: Distribution by Therapeutic Area
15.4.4.11. Biologics Fill Finish Manufacturing Market for Ampoules in Asia Pacific, 2022-2035: Distribution by Scale of Operation
15.4.4.12. Biologics Fill Finish Manufacturing Market for Ampoules in Asia Pacific, 2022-2035: Distribution by Company Size
15.4.4.13. Biologics Fill Finish Manufacturing Market for Ampoules in Middle East and North Africa, 2022-2035: Distribution by Type of Biologic
15.4.4.14. Biologics Fill Finish Manufacturing Market for Ampoules in Middle East and North Africa, 2022-2035: Distribution by Therapeutic Area
15.4.4.15. Biologics Fill Finish Manufacturing Market for Ampoules in Middle East and North Africa, 2022-2035: Distribution by Scale of Operation
15.4.4.16. Biologics Fill Finish Manufacturing Market for Ampoules in Middle East and North Africa, 2022-2035: Distribution by Company Size
15.4.4.17. Biologics Fill Finish Manufacturing Market for Ampoules in Latin America and Rest of the World, 2022-2035: Distribution by Type of Biologic
15.4.4.18. Biologics Fill Finish Manufacturing Market for Ampoules in Latin America and Rest of the World, 2022-2035: Distribution by Therapeutic Area
15.4.4.19. Biologics Fill Finish Manufacturing Market for Ampoules in Latin America and Rest of the World, 2022-2035: Distribution by Scale of Operation
15.4.4.20. Biologics Fill Finish Manufacturing Market for Ampoules in Latin America and Rest of the World, 2022-2035: Distribution by Company Size
15.5. Biologics Fill Finish Manufacturing Market for Cartridges, 2022-2035
15.5.1. Biologics Fill Finish Manufacturing Market for Cartridges, 2022-2035: Distribution by Type of Biologic
15.5.2. Biologics Fill Finish Manufacturing Market for Cartridges, 2022-2035: Distribution by Therapeutic Area
15.5.3. Biologics Fill Finish Manufacturing Market for Cartridges, 2022-2035: Distribution by Scale of Operation
15.5.4. Biologics Fill Finish Manufacturing Market for Cartridges, 2022-2035: Distribution by Company Size
15.5.5. Biologics Fill Finish Manufacturing Market for Cartridges, 2022-2035: Distribution by Geographical Region
15.5.4.1. Biologics Fill Finish Manufacturing Market for Cartridges in North America, 2022-2035: Distribution by Type of Biologic
15.5.4.2. Biologics Fill Finish Manufacturing Market for Cartridges in North America, 2022-2035: Distribution by Therapeutic Area
15.5.4.3. Biologics Fill Finish Manufacturing Market for Cartridges in North America, 2022-2035: Distribution by Scale of Operation
15.5.4.4. Biologics Fill Finish Manufacturing Market for Cartridges in North America, 2022-2035: Distribution by Company Size
15.5.4.5. Biologics Fill Finish Manufacturing Market for Cartridges in Europe, 2022-2035: Distribution by Type of Biologic
15.5.4.6. Biologics Fill Finish Manufacturing Market for Cartridges in Europe, 2022-2035: Distribution by Therapeutic Area
15.5.4.7. Biologics Fill Finish Manufacturing Market for Cartridges in Europe, 2022-2035: Distribution by Scale of Operation
15.5.4.8. Biologics Fill Finish Manufacturing Market for Cartridges in Europe, 2022-2035: Distribution by Company Size
15.5.4.9. Biologics Fill Finish Manufacturing Market for Cartridges in Asia Pacific, 2022-2035: Distribution by Type of Biologic
15.5.4.10. Biologics Fill Finish Manufacturing Market for Cartridges in Asia Pacific, 2022-2035: Distribution by Therapeutic Area
15.5.4.11. Biologics Fill Finish Manufacturing Market for Cartridges in Asia Pacific, 2022-2035: Distribution by Scale of Operation
15.5.4.12. Biologics Fill Finish Manufacturing Market for Cartridges in Asia Pacific, 2022-2035: Distribution by Company Size
15.5.4.13. Biologics Fill Finish Manufacturing Market for Cartridges in Middle East and North Africa, 2022-2035: Distribution by Type of Biologic
15.5.4.14. Biologics Fill Finish Manufacturing Market for Cartridges in Middle East and North Africa, 2022-2035: Distribution by Therapeutic Area
15.5.4.15. Biologics Fill Finish Manufacturing Market for Cartridges in Middle East and North Africa, 2022-2035: Distribution by Scale of Operation
15.5.4.16. Biologics Fill Finish Manufacturing Market for Cartridges in Middle East and North Africa, 2022-2035: Distribution by Company Size
15.5.4.17. Biologics Fill Finish Manufacturing Market for Cartridges in Latin America and Rest of the World, 2022-2035: Distribution by Type of Biologic
15.5.4.18. Biologics Fill Finish Manufacturing Market for Cartridges in Latin America and Rest of the World, 2022-2035: Distribution by Therapeutic Area
15.5.4.19. Biologics Fill Finish Manufacturing Market for Cartridges in Latin America and Rest of the World, 2022-2035: Distribution by Scale of Operation
15.5.4.20. Biologics Fill Finish Manufacturing Market for Cartridges in Latin America and Rest of the World, 2022-2035: Distribution by Company Size
15.6. Biologics Fill Finish Manufacturing Market for Syringes, 2022-2035
15.6.1. Biologics Fill Finish Manufacturing Market for Syringes, 2022-2035: Distribution by Type of Biologic
15.6.2. Biologics Fill Finish Manufacturing Market for Syringes, 2022-2035: Distribution by Therapeutic Area
15.6.3. Biologics Fill Finish Manufacturing Market for Syringes, 2022-2035: Distribution by Scale of Operation
15.6.4. Biologics Fill Finish Manufacturing Market for Syringes, 2022-2035: Distribution by Company Size
15.6.5. Biologics Fill Finish Manufacturing Market for Syringes, 2022-2035: Distribution by Geographical Region
15.6.4.1. Biologics Fill Finish Manufacturing Market for Syringes in North America, 2022-2035: Distribution by Type of Biologic
15.6.4.2. Biologics Fill Finish Manufacturing Market for Syringes in North America, 2022-2035: Distribution by Therapeutic Area
15.6.4.3. Biologics Fill Finish Manufacturing Market for Syringes in North America, 2022-2035: Distribution by Scale of Operation
15.6.4.4. Biologics Fill Finish Manufacturing Market for Syringes in North America, 2022-2035: Distribution by Company Size
15.6.4.5. Biologics Fill Finish Manufacturing Market for Syringes in Europe, 2022-2035: Distribution by Type of Biologic
15.6.4.6. Biologics Fill Finish Manufacturing Market for Syringes in Europe, 2022-2035: Distribution by Therapeutic Area
15.6.4.7. Biologics Fill Finish Manufacturing Market for Syringes in Europe, 2022-2035: Distribution by Scale of Operation
15.6.4.8. Biologics Fill Finish Manufacturing Market for Syringes in Europe, 2022-2035: Distribution by Company Size
15.6.4.9. Biologics Fill Finish Manufacturing Market for Syringes in Asia Pacific, 2022-2035: Distribution by Type of Biologic
15.6.4.10. Biologics Fill Finish Manufacturing Market for Syringes in Asia Pacific, 2022-2035: Distribution by Therapeutic Area
15.6.4.11. Biologics Fill Finish Manufacturing Market for Syringes in Asia Pacific, 2022-2035: Distribution by Scale of Operation
15.6.4.12. Biologics Fill Finish Manufacturing Market for Syringes in Asia Pacific, 2022-2035: Distribution by Company Size
15.6.4.13. Biologics Fill Finish Manufacturing Market for Syringes in Middle East and North Africa, 2022-2035: Distribution by Type of Biologic
15.6.4.14. Biologics Fill Finish Manufacturing Market for Syringes in Middle East and North Africa, 2022-2035: Distribution by Therapeutic Area
15.6.4.15. Biologics Fill Finish Manufacturing Market for Syringes in Middle East and North Africa, 2022-2035: Distribution by Scale of Operation
15.6.4.16. Biologics Fill Finish Manufacturing Market for Syringes in Middle East and North Africa, 2022-2035: Distribution by Company Size
15.6.4.17. Biologics Fill Finish Manufacturing Market for Syringes in Latin America and Rest of the World, 2022-2035: Distribution by Type of Biologic
15.6.4.18. Biologics Fill Finish Manufacturing Market for Syringes in Latin America and Rest of the World, 2022-2035: Distribution by Therapeutic Area
15.6.4.19. Biologics Fill Finish Manufacturing Market for Syringes in Latin America and Rest of the World, 2022-2035: Distribution by Scale of Operation
15.6.4.20. Biologics Fill Finish Manufacturing Market for Syringes in Latin America and Rest of the World, 2022-2035: Distribution by Company Size
15.7. Biologics Fill Finish Manufacturing Market for Vials, 2022-2035
15.7.1. Biologics Fill Finish Manufacturing Market for Vials, 2022-2035: Distribution by Type of Biologic
15.7.2. Biologics Fill Finish Manufacturing Market for Vials, 2022-2035: Distribution by Therapeutic Area
15.7.3. Biologics Fill Finish Manufacturing Market for Vials, 2022-2035: Distribution by Scale of Operation
15.7.4. Biologics Fill Finish Manufacturing Market for Vials, 2022-2035: Distribution by Company Size
15.7.5. Biologics Fill Finish Manufacturing Market for Vials, 2022-2035: Distribution by Geographical Region
15.7.4.1. Biologics Fill Finish Manufacturing Market for Vials in North America, 2022-2035: Distribution by Type of Biologic
15.7.4.2. Biologics Fill Finish Manufacturing Market for Vials in North America, 2022-2035: Distribution by Therapeutic Area
15.7.4.3. Biologics Fill Finish Manufacturing Market for Vials in North America, 2022-2035: Distribution by Scale of Operation
15.7.4.4. Biologics Fill Finish Manufacturing Market for Vials in North America, 2022-2035: Distribution by Company Size
15.7.4.5. Biologics Fill Finish Manufacturing Market for Vials in Europe, 2022-2035: Distribution by Type of Biologic
15.7.4.6. Biologics Fill Finish Manufacturing Market for Vials in Europe, 2022-2035: Distribution by Therapeutic Area
15.7.4.7. Biologics Fill Finish Manufacturing Market for Vials in Europe, 2022-2035: Distribution by Scale of Operation
15.7.4.8. Biologics Fill Finish Manufacturing Market for Vials in Europe, 2022-2035: Distribution by Company Size
15.7.4.9. Biologics Fill Finish Manufacturing Market for Vials in Asia Pacific, 2022-2035: Distribution by Type of Biologic 15.7.4.10.
15.7.4.11. Biologics Fill Finish Manufacturing Market for Vials in Asia Pacific, 2022-2035: Distribution by Scale of Operation
15.7.4.12. Biologics Fill Finish Manufacturing Market for Vials in Asia Pacific, 2022-2035: Distribution by Company Size
15.7.4.13. Biologics Fill Finish Manufacturing Market for Vials in Middle East and North Africa, 2022-2035: Distribution by Type of Biologic
15.7.4.14. Biologics Fill Finish Manufacturing Market for Vials in Middle East and North Africa, 2022-2035: Distribution by Therapeutic Area
15.7.4.15. Biologics Fill Finish Manufacturing Market for Vials in Middle East and North Africa, 2022-2035: Distribution by Scale of Operation
15.7.4.16. Biologics Fill Finish Manufacturing Market for Vials in Middle East and North Africa, 2022-2035: Distribution by Company Size
15.7.4.17. Biologics Fill Finish Manufacturing Market for Vials in Latin America and Rest of the World, 2022-2035: Distribution by Type of Biologic
15.7.4.18. Biologics Fill Finish Manufacturing Market for Vials in Latin America and Rest of the World, 2022-2035: Distribution by Therapeutic Area
15.7.4.19. Biologics Fill Finish Manufacturing Market for Vials in Latin America and Rest of the World, 2022-2035: Distribution by Scale of Operation
15.7.4.20. Biologics Fill Finish Manufacturing Market for Vials in Latin America and Rest of the World, 2022-2035: Distribution by Company Size
16 FUTURE GROWTH OPPORTUNITIES
16.1. Chapter Overview
16.2. Growing Biopharmaceutical Pipeline
16.3. Increase in Outsourcing of Fill/Finish Activities
16.4. Rising Focus on Self-Administration of Drugs
16.5. Advances in Aseptic Fill/Finish Technologies
16.6. Growing Opportunities in the Asia Pacific Region
17 CASE STUDY: ROBOTIC SYSTEMS IN FILL/FINISH OPERATIONS
17.1. Chapter Overview
17.2. Contract Service Providers: List of Fill/Finish Equipment
17.3. Role of Robotic Systems in Fill/Finish Operations
17.3.1. Types of Robots Used in Pharmaceutical Operations
17.3.2. Key Considerations for Selecting a Robotic System
17.3.3. Advantages of Robotic Systems
17.3.4. Disadvantages of Robotic Systems
17.4. Companies Providing Robots for Use in the Pharmaceutical Industry
17.5. Companies Providing Isolator-based Aseptic Filling Systems
17.6. Concluding Remarks

18 CASE STUDY: READY TO USE PACKAGING COMPONENTS FOR ASEPTIC FILL FINISH
18.1. Chapter Overview
18.2. Role of Ready to Use Packaging Components in Aseptic Fill Finish Operations
18.2.1. Advantages of Ready to Use Packaging Components
18.2.2. Disadvantages of Ready to Use Packaging Components
18.3. Companies Providing Ready to Use Packaging Components
18.4. Conclusion
19 CONCLUDING REMARKS
20 EXECUTIVE INSIGHTS
20.1 Chapter Overview
20.2 IDT Biologika
20.2.1. Company Snapshot
20.2.1. Interview Transcript: Gregor Kawaletz, Chief Commercial Officer
20.3 Cytovance Biologics
20.3.1. Company Snapshot
20.3.2. Interview Transcript: Matt Delaney, Vice President of Business Development and Marketing
20.4. Syngene
20.4.1. Company Snapshot
20.4.2. Interview Transcript: Purushottam Singnurkar, Research Director and Head of Formulation Development
20.5 oncomed manufacturing
20.5.1. Company Snapshot
20.5.2. Interview Transcript: Ales Sima, Business Development Manager
20.6 Yposkesi
20.6.1. Company Snapshot
20.6.2. Interview Transcript: Amit, Technology Watch Manager
20.7 HALIX
20.7.1. Company Snapshot
20.7.2. Interview Transcript: Jos Vergeest, International Business Developer
21 APPENDIX 1: TABULATED DATA
22 APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

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Table of Contents

Summary

The biologics fill finish manufacturing market is expected to reach USD 4 billion by 2022 and is anticipated to grow at a CAGR of 8.4% during the forecast period 2022-2035

The rise of biologics marks a significant transformation within the pharmaceutical sector. The increasing potential of biopharmaceuticals has attracted a wide range of industry stakeholders and academic institutions. Currently, the market offers over 200 commercially accessible biologics, with more than 10,000 candidates undergoing clinical assessment. This expanding landscape of biologics, along with growing demand and diversity, has led to a significant increase in the requirement for expanded production capacity and aseptic fill-finish processes.

Fill/finish operations are crucial in packaging final drug products into sterile containers such as vials, syringes, ampoules, and cartridges. Among the various procedures in biologics production, fill-finish represents a pivotal step, often outsourced extensively.

Even a small mistake during the fill/finish stage can result in microbial contamination, leading to potential loss of drug products, production delays, and most importantly, endangering patient well-being. As a result, numerous stakeholders are increasingly looking to contract manufacturing organizations for their expertise in fill/finish operations and necessary infrastructure to ensure the development and delivery of high-quality drug products.

Driven by the escalating demand for biopharmaceuticals, the biologics fill-finish manufacturing market is anticipated to undergo significant growth in the foreseeable future.

Report Coverage
 The report conducts an examination of the biological fill finish manufacturing market, categorizing it by packaging container types, biologics classifications, operational scales, company sizes, key therapeutic sectors, and geographical regions.
 An analysis is performed on the factors—such as drivers, restraints, opportunities, and challenges—that impact the growth of this market.
 The report evaluates the potential advantages and barriers within the market for stakeholders, providing insights into the competitive landscape for leading market players.
 Market revenue forecasts are provided for segments across five major regions.
 A comprehensive study begins with an introduction to biopharmaceuticals and contract manufacturing, emphasizing the industry's reliance on outsourcing, specifically in operations like fill/finish. Considerations for selecting a fill-finish contract manufacturing organization are outlined, detailing associated benefits and risks.
 Detailed assessments are conducted on companies offering biopharmaceuticals fill/finish services, analyzing parameters including establishment year, company size, location, packaging containers utilized, types of biologics produced, operational scales, and additional drug product-related services.
 The analysis extends to the competitive landscape among fill/finish contract manufacturers across various geographies, evaluating supplier and service strengths, diversity, and scale concerning packaging containers.
 Profiles of key companies in North America, Europe, and Asia Pacific provide insights into their services, facilities, financial data, partnerships, expansions, accolades, and future outlooks. Additionally, industry partnerships since 2013 are scrutinized, examining partnership models, nature, scope, and active companies in the market.
 Expansion strategies adopted by contract manufacturing organizations to enhance biologics fill/finish capabilities are analyzed, considering parameters such as year, type, location, services offered, and biologics involved, highlighting the most active companies.
 Further analysis involves a comprehensive assessment of global biologics fill/finish capacity, distribution across packaging units, company sizes, operational scales, and headquarters locations. The report estimates annual demand for fill-finish manufacturing based on relevant parameters.
 Exploration of key performance indicators of service providers, a regional capability assessment framework, and potential market growth drivers. Case studies focus on the use of robotic systems and the adoption of ready-to-use packaging components in aseptic fill/finish operations, detailing equipment used and relevant industry suppliers.

Key Market Companies
 AbbVie Contract Manufacturing
 BioPharma Solutions
 BioReliance
 Catalent Biologics
 Patheon
 Charles River Laboratories
 Boehringer Ingelheim BioXcellence
 Lonza
 Pierre Fabre
 Recipharm
 Wacker Biotech
 Fareva
 Fresenius Kabi
 GlaxoSmithKline
 Asymchem
 Samsung Biologics
 Syngene
 Takara Bio
 WuXi Biologics
 Hetero Drugs
 Intas Pharmaceuticals

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