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Aseptic Fill Finish Manufacturing Market by Type of Molecule (Small Molecules and Biologics), Type of Packaging Container Offered (Ampoules, Cartridges, Prefilled Syringe and Vials), Type of Drug Product (Antibodies, Cell Therapies, Gene Therapies, Oligonucleotides, Recombinant Proteins, Vaccines and Other Products), Scale of Operation (Preclinical / Clinical and Commercial), Company Size (Large, Mid-sized and Small), Target Therapeutic Area (Autoimmune Disorders, Cardiovascular Disorders, Infectious Diseases Oncological Disorders, and Other Disorders) and Geographical Regions (North America, Europe, Asia Pacific, Middle East and North Africa and Latin America): Industry Trends and Global Forecasts, 2023-2035

March 2023 | 270 pages | ID: A8B098DDB73BEN
Roots Analysis

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The aseptic fill finish market is expected to reach USD 5.4 billion in 2023 anticipated to grow at a CAGR of 9% during the forecast period 2023-2035.

The term 'aseptic fill finish' encapsulates the meticulous and sterile procedure involving the filling and sealing of pharmaceutical products into diverse packaging formats such as vials, prefilled syringes, ampoules, and cartridges. These stringent aseptic conditions are pivotal not only for safeguarding end-user safety but also for maintaining the efficacy and quality of pharmaceuticals. Achieving and maintaining aseptic conditions during fill-finish operations necessitates adept personnel, specialized automated equipment, a carefully constructed clean room environment, and vigilant oversight to uphold the sterility and safety of the final drug product.

However, the substantial costs associated with the specialized equipment and expertise required for fill-finish operations pose challenges for pharmaceutical developers with limited financial resources and production capabilities. As a result, many stakeholders are opting to outsource their fill-finish manufacturing requirements to contract service providers to ensure the production of superior-quality drug products. There exists a multitude of companies specializing in providing services for aseptic fill finish, catering comprehensively to a spectrum of biologics and small molecules. Additionally, there is an escalating demand to augment the capacity for these operations to align with projected needs, prompting service providers to engage in multiple agreements in recent years.

Owing to the consistent endeavors and initiatives undertaken by companies within this sector, the aseptic fill finish manufacturing market is anticipated to experience a consistent and gradual growth trajectory over the forecast period.

Report Coverage
  • An executive summary of the key insights captured in our research. It offers a high-level view on the likely evolution of the aseptic fill finish service providers market in the short to mid-term, and long term.
  • A general overview of pharmaceuticals and contract manufacturing, which features a detailed discussion on the need for outsourcing within the pharmaceutical industry and key operations outsourced by the biologics and small molecules drug developers, including fill / finish. It also provides information on the key considerations for selecting a fill finish service provider, along with the benefits and risks associated with outsourcing fill finish operations.
  • The overall landscape of aseptic fill finish service providers and analysis based on parameters, such as year of establishment, company size (in terms of number of employees), location of headquarters, type of molecule(s) (biologics and small molecules), and type of packaging container(s) (ready-to-use vials, ready-to-use cartridges and ready-to-use syringes).
  • An overall landscape of the companies offering aseptic fill finish services for biopharmaceuticals / biologics, along with analyses based on a number of relevant parameters, such as year of establishment, company size, location of headquarters, location of fill finish facilities, type of packaging container(s) offered, type of biologic(s) manufactured, scale of operation, type of additional drug product-related service(s) offered.
  • Detailed and tabulated profiles of the key players in the small molecules fill finish contract services market in North America, Europe and Asia-Pacific. Each profile features a brief overview of the company, its overall contract service offerings highlighting the capabilities of fill finish facilities (if available), financial information (if available), recent developments and an informed future outlook.
  • A detailed analysis of the various partnerships and collaborations that have been inked amongst players since 2013. It includes a brief description of the partnership models.
  • A comprehensive market forecast analysis, highlighting the likely growth of the aseptic fill finish services market till the year 2035. In order to provide an informed future outlook, our projections have been segmented on the basis of type of molecules (small molecules and biologics), type of packaging container offered (ampoules, cartridges, syringes and vials), type of drug product (antibodies, cell therapies, gene therapies, oligonucleotides, recombinant proteins, vaccines and other drug products), target therapeutic area (autoimmune disorders, oncological disorders, cardiovascular disorders, infectious diseases and other disorders), scale of operation (preclinical / clinical and commercial), company size (large, mid-sized and small), and geography (North America, Europe, Asia-Pacific, Middle East and North Africa, and Latin America).
Key Market Companies
  • AbbVie Contract Manufacturing
  • Asymchem
  • Aenova
  • APL, BioPharma Solutions
  • BioReliance
  • Boehringer Ingelheim BioXcellence
  • Catalent Biologics
  • Charles River Laboratories
  • CordenPharma
  • Delpharm
  • Fareva
  • Fresenius Kabi
  • Glaxo SmithKline
  • Hetero Drugs
  • Intas Pharmaceuticals
  • Lonza
  • Pierre Fabre
  • Pfizer CentreOne
  • Plastikon Healthcare
  • Patheon
  • PiSA Farmaceutica
  • Recipharm
  • Wacker Biotech
  • Syngene
  • Sharp Services
  • Siegfried
  • Takara Bio
  • WuXi Biologics
  • Wockhardt
1. PREFACE
1.1. Chapter Overview
1.2. Key Insights
1.3. Scope of the Report
1.4. Research Methodology
1.5. Frequently Asked Questions
1.6. Chapter Outlines

2. EXECUTIVE SUMMARY

3. INTRODUCTION

3.1. Chapter Overview
3.2. Introduction to Contract Manufacturing
3.3. Commonly Outsourced Operations in Biopharmaceutical Industry
  3.3.1. Aseptic Fill Finish Operations
3.4. Basic Guidelines for Selecting a Fill Finish Service Provider
3.5. Advantages of Outsourcing Fill Finish Operations
3.6. Risks and Challenges Associated with Outsourcing Fill Finish Operations
3.7. Concluding Remarks

4. ASEPTIC FILL FINISH SERVICE PROVIDERS LANDSCAPE

4.1. Chapter Overview
4.2. Aseptic Fill / Finish: Service Providers 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 Type of Molecule(s)
  4.2.5. Analysis by Type of Packaging Container(s) Offered

5. BIOLOGICS FILL FINISH SERVICE PROVIDERS LANDSCAPE

5.1. Chapter Overview
5.2. Biologics Fill Finish: Service Providers Landscape
  5.2.1. Analysis by Year of Establishment
  5.2.2. Analysis by Company Size
  5.2.3. Analysis by Location of Headquarters
  5.2.4. Analysis by Location of Fill Finish Facilities
  5.2.5. Analysis by Type of Packaging Container(s) Offered
  5.2.6. Analysis by Type of Drug Product(s) Involved
  5.2.7. Analysis by Scale of Operation
  5.2.8. Analysis by Additional Drug Product-related Services Offered
  5.2.9. Information on Fill Finish Capacity

6. SMALL MOLECULE FILL FINISH SERVICE PROVIDERS LANDSCAPE

6.1. Chapter Overview
6.2. Small Molecule Fill Finish: Service Providers Landscape
  6.2.1. Analysis by Year of Establishment
  6.2.2. Analysis by Company Size
  6.2.3. Analysis by Location of Headquarters
  6.2.4. Analysis by Location of Fill Finish Facilities
  6.2.5. Analysis by Type of Filling Service(s) Offered
  6.2.6. Analysis by Type of Finishing Service(s) Offered
  6.2.7. Analysis by Type of Packaging Container(s) Offered
  6.2.8. Analysis by Scale of Operation
  6.2.9. Analysis by Type of Dosage Form(s) Filled
  6.2.10. Analysis by Type of Process(es)
  6.2.11. Information on Fill Finish Capacity

7. COMPANY PROFILES: ASEPTIC FILL / FINISH SERVICE PROVIDERS IN NORTH AMERICA

7.1. Chapter Overview
7.2. Companies Offering Aseptic Fill Finish Services for Biologics
  7.2.1. AbbVie Contract Manufacturing
    7.2.1.1. Company Snapshot
    7.2.1.2. Financial Information
    7.2.1.3. Service Portfolio
    7.2.1.4. Fill Finish Services Offered
    7.2.1.5. Recent Developments and Future Outlook
  7.2.2. BioPharma Solutions
    7.2.2.1. Company Snapshot
    7.2.2.2. Financial Information
    7.2.2.3. Service Portfolio
    7.2.2.4. Fill Finish Services Offered
    7.2.2.5. Recent Developments and Future Outlook
  7.2.3. BioReliance
    7.2.3.1. Company Snapshot
    7.2.3.2. Financial Information
    7.2.3.3. Service Portfolio
    7.2.3.4. Fill Finish Services Offered
    7.2.3.5. Recent Developments and Future Outlook
  7.2.4. Catalent Biologics
    7.2.4.1. Company Snapshot
    7.2.4.2. Financial Information
    7.2.4.3. Service Portfolio
    7.2.4.4. Fill Finish Services Offered
    7.2.4.5. Recent Developments and Future Outlook
  7.2.5. Charles River Laboratories
    7.2.5.1. Company Snapshot
    7.2.5.2. Financial Information
    7.2.5.3. Fill Finish Services Offered
    7.2.5.4. Recent Developments and Future Outlook
  7.2.6. Patheon
    7.2.6.1. Company Snapshot
    7.2.6.2. Financial Information
    7.2.6.3. Service Portfolio
    7.2.6.4. Fill Finish Services Offered
    7.2.6.5. Recent Developments and Future Outlook
7.3. Companies Offering Aseptic Fill Finish Services for Small Molecules
    7.3.1.1. Pfizer CentreOne
    7.3.1.2. Company Snapshot
    7.3.1.3. Service Portfolio
    7.3.1.4. Fill Finish Services Offered
    7.3.1.5. Recent Developments and Future Outlook
  7.3.2. Plastikon Healthcare
    7.3.2.1. Company Snapshot
    7.3.2.2. Service Portfolio
    7.3.2.3. Fill Finish Services Offered
    7.3.2.4. Recent Developments and Future Outlook
  7.3.3. Sharp Services
    7.3.3.1. Company Snapshot
    7.3.3.2. Service Portfolio
    7.3.3.3. Fill Finish Services Offered
    7.3.3.4. Recent Developments and Future Outlook

8. COMPANY PROFILES: ASEPTIC FILL FINISH SERVICE PROVIDERS IN EUROPE

8.1. Company Overview
8.2. Companies Offering Aseptic Fill Finish Services for Biologics
  8.2.1. Boehringer Ingelheim BioXcellence
    8.2.1.1. Company Snapshot
    8.2.1.2. Financial Information
    8.2.1.3. Service Portfolio
    8.2.1.4. Fill Finish Services Offered
    8.2.1.5. Recent Developments and Future Outlook
  8.2.2. Fareva
    8.2.2.1. Company Snapshot
    8.2.2.2. Fill Finish Services Offered
    8.2.2.3. Recent Developments and Future Outlook
  8.2.3. GlaxoSmithKline
    8.2.3.1. Company Snapshot
    8.2.3.2. Financial Information
    8.2.3.3. Fill Finish Services Offered
    8.2.3.4. Recent Developments and Future Outlook
  8.2.4. Lonza
    8.2.4.1. Company Snapshot
    8.2.4.2. Financial Information
    8.2.4.3. Service Portfolio
    8.2.4.4. Fill Finish Services Offered
    8.2.4.5. Recent Developments and Future Outlook
  8.2.5. Pierre Fabre
    8.2.5.1. Company Snapshot
    8.2.5.2. Financial Information
    8.2.5.3. Service Portfolio
    8.2.5.4. Fill Finish Services Offered
    8.2.5.5. Recent Developments and Future Outlook
  8.2.6. Wacker Biotech
    8.2.6.1. Company Snapshot
    8.2.6.2. Financial Information
    8.2.6.3. Service Portfolio
  8.2.6. 4. Fill Finish Services Offered
    8.2.6.5. Recent Developments and Future Outlook
8.3. Companies Offering Aseptic Fill Finish Services for Small Molecules
  8.3.1. Aenova
    8.3.1.1. Company Snapshot
    8.3.1.2. Financial Information
    8.3.1.3. Service Portfolio
    8.3.1.4. Fill Finish Services Offered
    8.3.1.5. Recent Developments and Future Outlook
  8.3.2. APL
    8.3.2.1. Company Snapshot
    8.3.2.2. Service Portfolio
    8.3.2.3. Fill Finish Services Offered
    8.3.2.4. Recent Developments and Future Outlook
  8.3.3 CordenPharma
    8.3.3.1. Company Snapshot
    8.3.3.2. Service Portfolio
    8.3.3.3. Fill Finish Services Offered
    8.3.3.4. Recent Developments and Future Outlook
  8.3.4. Delpharm
    8.3.4.1. Company Snapshot
    8.3.4.2. Service Portfolio
    8.3.4.3. Fill Finish Services Offered
    8.3.4.4. Recent Developments and Future Outlook
  8.3.5 PiSA Farmaceutica
    8.3.5.1. Company Snapshot
    8.3.5.2. Service Portfolio
    8.3.5.3. Fill Finish Services Offered
    8.3.5.4. Recent Developments and Future Outlook
8.4 Companies Offering Aseptic Fill Finish Manufacturing for Biologics and Small Molecules
  8.4.1 Fresenius Kabi
    8.4.1.1. Company Snapshot
    8.4.1.2 Financial Information
    8.4.1.3. Service Portfolio
    8.4.1.4. Fill Finish Services Offered
    8.4.1.5. Recent Developments and Future Outlook
  8.4.2 Recipharm
    8.4.2.1. Company Snapshot
    8.4.2.2. Financial Information
    8.4.2.3. Service Portfolio
    8.4.2.4. Fill Finish Services Offered
    8.4.2.5. Recent Developments and Future Outlook

9. COMPANY PROFILES: ASEPTIC FILL FINISH SERVICE PROVIDERS IN ASIA-PACIFIC

9.1 Company Overview
9.2 Companies Offering Aseptic Fill Finish Services for Biologics
  9.2.1 Asymchem
    9.2.1.1. Company Snapshot
    9.2.1.2. Financial Information
    9.2.1.3. Service Portfolio
    9.2.1.4. Fill Finish Services Offered
    9.2.1.5. Recent Developments and Future Outlook
  9.2.2. Samsung Biologics
    9.2.2.1. Company Snapshot
    9.2.2.2. Financial Information
    9.2.2.3. Service Portfolio
    9.2.2.4. Fill Finish Services Offered
    9.2.2.5. Recent Developments and Future Outlook
  9.2.3. Syngene
    9.2.3.1. Company Snapshot
    9.2.3.2. Financial Information
    9.2.3.3. Service Portfolio
    9.2.3.4. Fill Finish Services Offered
    9.2.3.5. Recent Developments and Future Outlook
  9.2.4. Takara Bio
    9.2.4.1. Company Snapshot
    9.2.4.2. Financial Information
    9.2.4.3. Service Portfolio
    9.2.4.4. Fill Finish Services Offered
    9.2.4.5. Recent Developments and Future Outlook
  9.2.5. WuXi Biologics
    9.2.5.1. Company Snapshot
    9.2.5.2. Financial Information
    9.2.5.3. Service Portfolio
    9.2.5.4. Fill Finish Services Offered
    9.2.5.5. Recent Developments and Future Outlook
  9.2.6. Hetero Drugs
    9.2.6.1. Company Snapshot
    9.2.6.2. Fill Finish Services Offered
    9.2.6.3. Recent Developments and Future Outlook
  9.2.7. Intas Pharmaceuticals
    9.2.7.1. Company Snapshot
    9.2.7.2. Fill Finish Services Offered
    9.2.7.3. Recent Developments and Future Outlook
9.3. Companies Offering Aseptic Fill Finish Services for Small Molecules
  9.3.1. Siegfried
    9.3.1.1. Company Snapshot
    9.3.1.2. Financial Information
    9.3.1.3. Service Portfolio
    9.3.1.4. Fill Finish Services Offered
    9.3.1.5. Recent Developments and Future Outlook
  9.3.2. Wockhardt
    9.3.2.1. Company Snapshot
    9.3.2.2. Financial Information
    9.3.2.3. Service Portfolio
    9.3.2.4. Fill Finish Services Offered
    9.3.2.5. Recent Developments and Future Outlook

10. PARTNERSHIPS AND COLLABORATIONS

10.1. Chapter Overview
10.2. Partnership Models
10.3. Aseptic Fill Finish Service Providers: List of Partnerships and Collaborations
  10.3.1. Analysis by Year of Partnership
  10.3.2. Analysis by Type of Partnership
  10.3.3. Analysis by Scale of Operation
  10.3.4. Analysis by Type of Molecule(s) Involved
  10.3.5. Analysis by Type of Service(s) Offered
  10.3.6. Analysis by Type of Process(es) Involved
  10.3.7. Analysis by Type of Drug Product(s) Involved
  10.3.8. Most Active Players: Analysis by Number of Partnerships
  10.3.9. Analysis by Geography
    10.3.9.1. Intercontinental and Intracontinental Agreements

11. MARKET SIZING AND OPPORTUNITY ANALYSIS

11.1. Chapter Overview
11.2. Forecast Methodology
11.3. Overall Aseptic Fill Finish Manufacturing Market, 2023-2035
  11.3.1. Aseptic Fill Finish Services Market: Analysis by Type of Molecule, 2023-2035
  11.3.2. Aseptic Fill Finish Manufacturing Market: Analysis by Type of Packaging Container Offered, 2023-2035
  11.3.3. Aseptic Fill Finish Manufacturing Market: Analysis by Type of Drug Product, 2023-2035
  11.3.4. Aseptic Fill Finish Manufacturing Market: Analysis by Target Therapeutic Area, 2023-2035
  11.3.5. Aseptic Fill Finish Manufacturing Market: Analysis by Scale of Operation, 2023-2035
  11.3.6. Aseptic Fill Finish Manufacturing Market: Analysis by Company Size, 2023-2035
  11.3.7. Aseptic Fill Finish Manufacturing Market: Analysis by Geography, 2023-2035
11.4. Aseptic Fill Finish Manufacturing Market for Biologics, 2023-2035
  11.4.1. Aseptic Fill Finish Manufacturing Market for Biologics: Analysis by Type of Packaging Container Offered, 2023-2035
  11.4.2. Aseptic Fill Finish Manufacturing Market: Analysis by Type of Drug Product, 2023-2035
  11.4.3. Aseptic Fill Finish Manufacturing Market for Biologics: Analysis by Target Therapeutic Area, 2023-2035
  11.4.4. Aseptic Fill Finish Manufacturing Market for Biologics: Analysis by Scale of Operation, 2023-2035
  11.4.5. Aseptic Fill Finish Manufacturing Market for Biologics: Analysis by Company Size, 2023-2035
  11.4.6. Aseptic Fill Finish Manufacturing Market for Biologics: Analysis by Geography, 2023-2035
11.5. Aseptic Fill Finish Manufacturing Market for Small Molecules, 2023-2035
  11.5.1. Aseptic Fill Finish Manufacturing Market for Small Molecules: Analysis by Type of Packaging Container Offered, 2023-2035
  11.5.2. Aseptic Fill Finish Manufacturing Market for Small Molecules: Analysis by Scale of Operation, 2023-2035
  11.5.3. Aseptic Fill Finish Manufacturing Market for Small Molecules: Analysis by Company Size, 2023-2035
  11.5.4. Aseptic Fill Finish Manufacturing Market for Small Molecules: Analysis by Geography, 2023-2035

12. CASE STUDY: ROBOTICS IN PHARMACEUTICAL PACKAGING

12.1. Chapter Overview
12.2. Role of Robotic Systems in Pharmaceutical Industry
12.3. Role of Robotic Systems in Fill / Finish Operation
  12.3.1. Types of Robots Used in Pharmaceutical Operations
  12.3.2. Advantages Associated with Robotic Systems
  12.3.3. Disadvantages Associated with Robotic Systems
  12.4.2. Key Considerations for Selecting a Robotic System
12.3. Contract Service Providers: List of Fill Finish Equipment
12.5. Companies Providing Robots for Use in the Pharmaceutical Industry
12.6. Companies Providing Isolator based Aseptic Filling Systems
12.7. Concluding Remarks

13. CASE STUDY: READY-TO-USE PACKAGING COMPONENTS FOR ASEPTIC FILL FINISH

13.1. Chapter Overview
13.2. Role of Ready-to-Use Packaging Components in Aseptic Fill Finish Operations
  13.2.1. Advantages of Ready to Use Packaging Components
  13.2.2. Disadvantages of Ready to Use Packaging Components
13.3. Companies Providing Ready to Use Packaging Components
13.4. Concluding Remarks

14. CONCLUDING REMARKS

15. EXECUTIVE INSIGHTS

15.1 Chapter Overview
15.2 IDT Biologika
  15.2.1. Company Snapshot
  15.2.1. Interview Transcript: Gregor Kawaletz, Former Chief Commercial Officer
15.3 Cytovance Biologics
  15.3.1. Company Snapshot
  15.3.2. Interview Transcript: Matt Delaney, Former Vice President of Business Development and Marketing
15.4. Syngene
  15.4.1. Company Snapshot
  15.4.2. Interview Transcript: Purushottam Singnurkar, Vice President and Head of Formulation Development
15.5 oncomed manufacturing
  15.5.1. Company Snapshot
  15.5.2. Interview Transcript: Ales Sima, Head of Business Development
15.6 Yposkesi
  15.6.1. Company Snapshot
  15.6.2. Interview Transcript: Amit, Former Technology Watch Manager
15.7 HALIX
  15.7.1. Company Snapshot
  15.7.2. Interview Transcript: Jos Vergeest, International Business Developer

16. APPENDIX 1: TABULATED DATA

17. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS


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