DUBLIN--(
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)--The
"Biologics Fill Finish Services Market by Type of Packaging Containers, Type of Biologics, Scale of Operation, Company Size, Key Therapeutic Areas, Geographical Regions: Industry Trends and Global Forecasts, 2022-2035"
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Biologics Fill / Finish Services Market Industry Trends and Global Forecasts report features an extensive study on the biologics fill / finish service providers. The study features an in-depth analysis, highlighting the diverse capabilities of stakeholders engaged in this domain.
The advent of biologics marked the beginning of a new era in the pharmaceutical industry. Over time, the growing promise of biopharmaceuticals has captured the interest of various industry and academic stakeholders. Currently, more than 200 biologics are commercially available and over 10,000 candidates are under clinical evaluation.
With the increasing demand and diversity of biologics, an increase in the demand for production capacity and aseptic fill / finish operations has been observed. Aseptic fill / finish refers to the process of filling the final drug products in sterile packaging containers (including vials, syringes, ampoules and cartridges).
Of all the steps involved in the production of biologics, fill / finish is amongst the most critical steps and a heavily outsourced operation. In fact, even a minute error during the fill / finish process can lead to microbial contamination, which can subsequently result in the loss of drug product, production delays and, most importantly, pose risk to the patient's health.
As a result, various stakeholders are turning to contract service providers for their fill / finish related requirements and necessary infrastructure, to ensure the development of quality drug products.
With the growing pipeline of biologics, the demand for contract services for biologics development and biologics fill / finish has increased. Currently, close to 180 companies offer biologics fill / finish services.
These stakeholders have taken several initiatives to expand their existing facilities and incorporate advanced technologies in order to meet the growing demand for fill / finish services, reduce cost of operation / increase efficiency, and comply to evolving safety and regulatory requirements.
Additionally, the biopharmaceutical industry has witnessed substantial number of partnerships and collaborations between drug developers and fill / finish biopharmaceuticals service providers over the last few years. We believe that service providers are likely to continue undertaking similar initiatives to consolidate their presence in this field, distinguish themselves from the competition and cater to the diversified needs of their clientele.
With outsourcing being increasingly accepted as a viable / beneficial business model and the anticipated growth in the biologics market, the opportunity for fill / finish biopharmaceuticals service providers is expected to grow at a steady pace over the coming years.
One of the key objectives of this report was to estimate the current market size and the future opportunity in the biologics fill / finish services market over the coming 13 years.
Based on multiple parameters, such as growth of the overall biopharmaceutical market, cost of goods sold, direct manufacturing costs, share of other manufacturing costs and outsourcing trends related to fill / finish operations, we have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2022-2035.
The report features detailed transcripts of interviews held with the following industry and non-industry players:
Gregor Kawaletz (Chief Commercial Officer, IDT Biologika)
Matt Delaney (Vice President Business Development & Marketing, (Cytovance Biologics)
Purushottam Singnurkar (Research Director and Head of Formulation Development, Syngene International)
Ales Sima (Business Development Manager, Oncomed Manufacturing)
Amit Chandra (Technology Watch Manager, Yposkesi)
Jos Vergeest (International Business Developer, HALIX)
Frequently Asked Questions
What is fill finish?
Who are the key players offering biologics fill / finish services?
Where are biologics fill / finish facilities located?
What is the market share of ampoules, cartridges, vials, and syringes in fill / finsih?
What types of expansion initiatives are being undertaken by players in this domain?
What is the current demand for biologics fill / finish services?
What is the current and future market size for biologics fill / finish services?
Key Topics Covered:
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
3.6. 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
5. COMPANY COMPETITIVENESS ANALYSIS
5.1. Chapter Overview
5.2. Methodology and Key Parameters
5.3. Biologics Fill / Finish 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 Service Providers in Europe
5.5. Biologics Fill / Finish Service Providers in Asia-Pacific and Rest of the World
6. BIOLOGICS FILL / FINISH SERVICE PROVIDERS 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
6.4. BioReliance
6.5. Catalent Biologics
6.6. Patheon
6.7. Charles River Laboratories
7. BIOLOGICS FILL / FINISH SERVICE PROVIDERS IN EUROPE
7.1. Chapter Overview
7.2. Boehringer Ingelheim BioXcellence
7.3. Lonza
7.4. Pierre Fabre
7.5. Recipharm
7.6. Wacker Biotech
7.7. Fareva
7.8. Fresenius Kabi
7.9. Glaxo SmithKline
8. BIOLOGICS FILL / FINISH SERVICE PROVIDERS IN ASIA-PACIFIC
8.1. Chapter Overview
8.2. Asymchem
8.3. Samsung Biologics
8.4. Syngene
8.5. Takara Bio
8.6. WuXi Biologics
8.7. Hetero Drugs
8.8. Intas Pharmaceuticals
9. PARTNERSHIPS AND COLLABORATIONS
9.1. Chapter Overview
9.2. Partnership Models
9.3. Biologics Fill / Finish Service Providers: List of Partnerships and Collaborations
10. RECENT EXPANSIONS
10.1. Chapter Overview
10.2. Biologics Fill / Finish Service Providers: Recent Expansions
11. CAPACITY ANALYSIS
11.1. Chapter Overview
11.2. Assumptions and Methodology
11.3. Global Fill / Finish Capacity (by Number of Units Filled)
11.4. Global Fill / Finish Capacity (by Fill Volume)
11.5. Global Fill / Finish Capacity for Ampoules (by Number of Units Filled)
11.6. Global Fill / Finish Capacity for Ampoules (by Fill Volume)
11.7. Global Fill / Finish Capacity for Cartridges (by Number of Units Filled)
11.8. Global Fill / Finish Capacity for Cartridges (by Fill Volume)
11.9. Global Fill / Finish Capacity for Syringes (by Number of Units Filled)
11.10. Global Fill / Finish Capacity for Syringes (by Fill Volume)
11.11. Global Fill / Finish Capacity for Vials (by Number of Units Filled)
11.12. Global Fill / Finish Capacity for Vials (by Fill Volume)
11.13. Conclusion
12. DEMAND ANALYSIS
12.1. Chapter Overview
12.2. Assumptions and Methodology
12.3. Global Demand for Biologics Fill / Finish Services
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
13.2.2. Process and Capability-related Indicators
13.2.3. Market Reputation-related Indicators
13.2.4. Other Important Performance Indicators
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. Concluding Remarks
15. MARKET SIZING AND OPPORTUNITY ANALYSIS
15.1. Chapter Overview
15.2. Forecast Methodology
15.3. Overall Biologics Fill / Finish Services Market, 2022-2035
15.4. Biologics Fill / Finish Services Market for Ampoules, 2022-2035
15.5. Biologics Fill / Finish Services Market for Cartridges, 2022-2035
15.6. Biologics Fill / Finish Services Market for Syringes, 2022-2035
15.7. Biologics Fill / Finish Services Market for Vials, 2022-2035
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
17.4. 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
18.3. Companies Providing Ready-to-Use Packaging Components
18.4. Conclusion
19. CONCLUDING REMARKS
20. EXECUTIVE INSIGHTS
20.1 Chapter Overview
20.2 IDT Biologika
20.3 Cytovance Biologics
20.4. Syngene
20.5 oncomed manufacturing
20.6 Yposkesi
20.7 HALIX
21. APPENDIX 1: TABULATED DATA
22. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS
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