DUBLIN--(BUSINESS WIRE)--The "Fill Finish Pharmaceutical Contract Manufacturing Market Industry Trends and Global Forecasts to 2035: Distribution by Type of Fill Finish Service Offered, Type of FDF, API Potency, Type of Primary Packaging Container, Scale of Operation and Leading Players" report has been added to ResearchAndMarkets.com's offering.
The Fill Finish Pharmaceutical Contract Manufacturing Market is valued at USD 7.2 billion in 2024, growing at a CAGR of 4.8% during the forecast period till 2035.
The fill-finish process for small molecules represents the final step in downstream product processing, where the formulated drug is combined with essential excipients and stabilizers. The bulk purified formulation is then transferred into pre-sterilized containers, such as glass vials, prefilled syringes, cartridges, or ampoules for inspection, labeling, and packaging. Recent studies show that small molecule drugs constitute nearly 90% of the current therapeutics pipeline. In 2023, 61% of the 55 FDA-approved drugs were small molecules, reflecting a steady rise from 56% in 2021 and 57% in 2022.
Sterile fill-finish is recognized as one of the most critical steps in pharmaceutical production. Aseptic conditions during this stage are essential for ensuring both product quality and patient safety, as well as maintaining the pharmacological effectiveness of the drug. However, the fill-finish process for novel small molecule formulations requires specialized equipment and expertise, driving up production costs. This increase in capital expenditure presents challenges for drug developers with limited resources, pushing many to outsource manufacturing operations to contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs).
The growing pipeline of small molecule drugs, their increasing complexity, and the need for specialized expertise is driving demand for fill-finish services in the pharmaceutical industry. Additionally, with a stronger emphasis on quality and multi-product strategies, the adoption of advanced technologies, such as artificial intelligence and robotics, is expected to fuel further investment in this area, promoting growth in the fill-finish pharmaceutical contract manufacturing market.
Key Benefits of Buying this Report
- The report offers valuable insights into revenue estimation for both the overall market and its sub-segments, in order to empower market leaders and newcomers with critical information requisite for establishing their footprint in the industry.
- The report can be utilized by stakeholders to enhance their understanding of the competitive landscape, allowing for improved business positioning and more effective go-to-market strategies.
- The report provides stakeholders with a comprehensive view on the Fill Finish Pharmaceutical Contract Manufacturing Market, covering essential information on significant market drivers, barriers, opportunities, and challenges.
Key Companies Profiled in the Finish Pharmaceutical Contract Manufacturing Market include:
- Alcami
- Amanta Healthcare
- Aurigene Pharmaceutical Services
- Batterjee Pharma
- Burrard Pharmaceuticals
- Curida
- Eriochem
- Fresenius Kabi
- GlaxoSmithKline
- Nextar Chempharma Solutions
- Pfizer CentreOne
- Plastikon Healthcare
- Procaps
- Recipharm
- ROMMELAG CMO
- Sharp
- Sypharma
- Teva Pharmaceuticals
- WuXi AppTec
Key Topics Covered:
1. PREFACE
2. RESEARCH METHODOLOGY
3. MARKET DYNAMICS
4. ECONOMIC AND OTHER PROJECT SPECIFIC CONSIDERATIONS
4.1. Chapter Overview
4.2. Market Dynamics
5. EXECUTIVE SUMMARY
6. INTRODUCTION
6.1. Chapter Overview
6.2. Introduction to Fill / Finish Services for Small Molecules
6.3. Need for Outsourcing Small Molecules-related Operations
6.4. Role of Contract Manufacturers in the Small Molecules Industry
6.5. Key Considerations while selecting a Fill / Finish Service Provider
6.6. Advantages of Outsourcing Fill / Finish Services
6.7. Risks and Challenges of Outsourcing Fill / Finish Operations
6.8. Future Perspectives
7. MARKET LANDSCAPE
7.1. Chapter Overview
7.2. Small Molecules Fill / Finish Service Providers: Overall Market Landscape
8. COMPANY PROFILES: SERVICE PROVIDERS IN NORTH AMERICA
8.1. Chapter Overview
8.2. Leading Small Molecules Fill / Finish Service Providers based in North America
8.2.1. Alcami
8.2.2. Pfizer CentreOne
8.2.3. Sharp Services
8.3. Other Leading Small Molecules Fill / Finish Service Providers based in North America
8.3.1. Burrard Pharmaceuticals
8.3.2. Plastikon Healthcare
9. COMPANY PROFILES: SERVICE PROVIDERS IN EUROPE
9.1. Chapter Overview
9.2. Leading Small Molecules Fill / Finish Service Providers based in Europe
9.2.1. Fresenius Kabi
9.2.2. GlaxoSmithKline
9.2.3. Recipharm
9.3. Other Leading Small Molecules Fill / Finish Service Providers based in Europe
9.3.1. Curida
9.3.2. ROMMELAG CMO
10. COMPANY PROFILES: SERVICE PROVIDERS IN ASIA-PACIFIC
10.1. Chapter Overview
10.2. Leading Small Molecules Fill / Finish Service Providers based in Asia-Pacific
10.2.1. Aurigene Pharmaceutical Services
10.2.2. Sypharma
10.2.3. WuXi AppTec
10.3. Other Small Molecules Fill / Finish Service Providers based in Asia-Pacific
10.3.1. Amanta Healthcare
11. COMPANY PROFILES: SERVICE PROVIDERS IN THE REST OF THE WORLD
11.1. Chapter Overview
11.2. Leading Small Molecules Fill / Finish Service Providers based in the Rest of the World
11.2.1. Eriochem
11.2.2. Teva Pharmaceutical Industries
11.3. Other Small Molecules Fill / Finish Service Providers based in Rest of the World
11.3.1. Batterjee Pharma
11.3.2. Procaps
12. COMPANY COMPETITIVENESS ANALYSIS
12.1. Chapter Overview
12.2. Assumptions and Key Parameters
12.3. Methodology
12.4. Small Molecules Fill / Finish Service Providers based in North America
12.5. Small Molecules Fill / Finish Service Providers based in Europe
12.6. Small Molecules Fill / Finish Service Providers based in Asia-Pacific and Rest of the World
13. CAPACITY ANALYSIS
13.1. Chapter Overview
13.2. Global Annual Small Molecules Fill / Finish Capacity for Ampoules (Number of Units)
13.3. Global Annual Small Molecules Fill / Finish Capacity for Cartridges (Number of Units)
13.4. Global Annual Small Molecules Fill / Finish Capacity for Prefilled Syringes (Number of Units)
13.5. Global Annual Small Molecules Fill / Finish Capacity for Vials (Number of Units)
14. CASE STUDY: ROBOTIC SYSTEMS IN FILL / FINISH OPERATIONS
14.1. Chapter Overview
14.2. Role of Robotic Systems in Fill / Finish Operations
14.3. Companies Providing Robots for use in the Pharmaceutical Industry
14.4. Companies Providing Isolator-based Aseptic Filling Systems
14.5. Small Molecules Fill / Finish Service Providers: List of Equipment Used
14.6. Concluding Remarks
15. CASE STUDY: READY-TO-USE PACKAGING COMPONENTS FOR ASEPTIC FILL / FINISH
15.1. Chapter Overview
15.2. Role of Ready-to-Use Packaging Components in Aseptic Fill / Finish Operations
15.2.1. Advantages of Ready-to-Use Packaging Components
15.2.2. Disadvantages of Ready-to-Use Packaging Components
15.3. Companies Providing Ready-to-Use Packaging Components
15.4. Concluding Remarks
16. MARKET IMPACT ANALYSIS: DRIVERS, RESTRAINTS, OPPORTUNITIES AND CHALLENGES
16.1. Chapter Overview
16.2. Market Drivers
16.3. Market Restraints
16.4. Market Opportunities
16.5. Market Challenges
16.6. Conclusion
17. GLOBAL PHARMACEUTICAL FILL / FINISH MANUFACTURING MARKET
17.1. Chapter Overview
17.2. Assumptions and Methodology
17.3. Global Pharmaceutical Fill / Finish Manufacturing Market, till 2035
17.3.1. Scenario Analysis
17.3.1.1. Conservative Scenario
17.3.1.2. Optimistic Scenario
17.4. Key Market Segmentations
18. PHARMACEUTICAL FILL / FINISH MANUFACTURING MARKET, BY TYPE OF FILL / FINISH SERVICE OFFERED
18.1. Chapter Overview
18.2. Assumptions and Methodology
18.3. Pharmaceutical Fill / Finish Manufacturing Market: Distribution by Type of Fill / Finish Service Offered, 2019, Current Year and 2035
18.3.1. Pharmaceutical Fill / Finish Manufacturing Market for Terminal Sterilization, till 2035
18.3.2. Pharmaceutical Fill / Finish Manufacturing Market for Aseptic Filling, till 2035
18.3.3. Pharmaceutical Fill / Finish Manufacturing Market for Blow-Fill-Seal, till 2035
18.4. Pharmaceutical Fill / Finish Manufacturing Market, by Type of Fill / Finish Services Offered: Market Dynamics Assessment
18.4.1. Penetration-Growth (P-G) Matrix
18.4.2. Data Triangulation and Validation
19. PHARMACEUTICAL FILL / FINISH MANUFACTURING MARKET, BY TYPE OF FDF
19.1. Chapter Overview
19.2. Assumptions and Methodology
19.3. Pharmaceutical Fill / Finish Manufacturing Market: Distribution by Type of FDF, 2019, Current Year and 2035
19.3.1. Pharmaceutical Fill / Finish Manufacturing Market for Generic FDF, till 2035
19.3.2. Pharmaceutical Fill / Finish Manufacturing Market for Originator FDF, till 2035
19.4. Pharmaceutical Fill / Finish Manufacturing Market, by Type of FDF: Market Dynamics Assessment
19.4.1. Penetration-Growth (P-G) Matrix
19.4.2. Data Triangulation and Validation
20. PHARMACEUTICAL FILL / FINISH MANUFACTURING MARKET, BY API POTENCY
20.1. Chapter Overview
20.2. Assumptions and Methodology
20.3. Pharmaceutical Fill / Finish Manufacturing Market: Distribution by API Potency, 2019, Current Year and 2035
20.4. Pharmaceutical Fill / Finish Manufacturing Market, by API Potency: Market Dynamics Assessment
21. PHARMACEUTICAL FILL / FINISH MANUFACTURING MARKET, BY TYPE OF PRIMARY PACKAGING CONTAINER
21.1. Chapter Overview
21.2. Assumptions and Methodology
21.3. Pharmaceutical Fill / Finish Manufacturing Market: Distribution by Type of Primary Packaging Container, 2019, Current Year and 2035
21.4. Pharmaceutical Fill / Finish Manufacturing Market, by Type of Primary Packaging Container: Market Dynamics Assessment
22. PHARMACEUTICAL FILL / FINISH MANUFACTURING MARKET, BY SCALE OF OPERATION
22.1. Chapter Overview
22.2. Assumptions and Methodology
22.3. Pharmaceutical Fill / Finish Manufacturing Market: Distribution by Scale of Operation, 2019, Current Year and 2035
22.4. Pharmaceutical Fill / Finish Manufacturing Market, by Scale of Operation: Market Dynamics Assessment
23. PHARMACEUTICAL FILL / FINISH MANUFACTURING MARKET, BY COMPANY SIZE
23.1. Chapter Overview
23.2. Assumptions and Methodology
23.3. Pharmaceutical Fill / Finish Manufacturing Market: Distribution by Company Size, 2019, Current Year and 2035
23.4. Pharmaceutical Fill / Finish Manufacturing Market, by Company Size: Market Dynamics Assessment
24. PHARMACEUTICAL FILL / FINISH MANUFACTURING MARKET, BY GEOGRAPHICAL REGIONS
24.1. Chapter Overview
24.2. Assumptions and Methodology
24.3. Pharmaceutical Fill / Finish Manufacturing Market: Distribution by Geographical Regions, 2019, Current Year and 2035
24.4. Pharmaceutical Fill / Finish Manufacturing Market, by Geographical Regions: Market Dynamics Assessment
25. PHARMACEUTICAL FILL / FINISH MANUFACTURING MARKET, BY LEADING PLAYERS
25.1. Chapter Overview
25.2. Leading Industry Players
26. CONCLUSION
27. EXECUTIVE INSIGHT
27.1 Chapter Overview
27.2. Bushu Pharmaceuticals
27.2.1. Company Snapshot
27.2.2. Interview Transcript: Tomoya Sato, Senior Executive Director, Global Sales and Marketing
28. APPENDIX I: TABULATED DATA
29. APPENDIX II: LIST OF COMPANIES AND ORGANIZATIONS
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