Pune, Jan. 29, 2025 (GLOBE NEWSWIRE) -- Fill-Finish Manufacturing Market Size & Growth Analysis:
According to SNS Insider, the global Fill-Finish Manufacturing Market size was valued at USD 15.4 billion in 2023 and is projected to reach USD 33.5 billion by 2032, growing at a CAGR of 9.1% from 2024 to 2032
Growth in the global fill-finish manufacturing market is mainly attributed to rising demand for biopharmaceutical products, advancements in manufacturing technologies, and the continuous growth of outsourcing in the pharmaceutical industry.
Market analysis
The global fill-finish manufacturing services market will be driven by increases in chronic diseases as well as improvements in the adoption of biologics and biosimilars. As per the World Health Organization (WHO), chronic diseases account for 71% of all global deaths, around 41 million people each year. The expanding burden associated with the disease is contributing to the development pipeline for additional personalized and potent biological medications, many of which will require advanced fill-finish processes to guarantee product identity, potency, safety, and efficacy. This involves capable manufacturing processes to provide sterile and precise filling for these complex drugs and the rapid deployment of vaccines, monoclonal antibodies, and gene therapies. In addition to this, the increasing demand for personalized medicine and targeted drug delivery systems has created a need for more specialized fill-finish operations.
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Moreover, governmental approaches to stimulate biopharmaceutical development, such as regulatory assistance in the development of vaccines and customized therapies are also aiding the growth in the fill-finish manufacturing market. As an example, the U.S. Food and Drug Administration (FDA) started its opening up biologics initiatives to improve manufacturing quality, which has led to the requirement for fill-finish operations to be of high precision and meet stringent standards. According to the Centers for Disease Control and Prevention (CDC) in the United States, almost 60% of adults have one or more chronic conditions. The widespread occurrence is driving the demand for biologic drugs, the majority of which are developed using advanced fill-finish technologies. With the FDA approving an average of 40 new biologic therapies each year in recent years, fill-finish manufacturing allows these innovative treatments to market.
Key Fill-Finish Manufacturing Companies Profiled
- Becton, Dickinson and Company (BD Hypak™, BD Sterifill)
- Gerresheimer AG (Gx RTF® Vials, Gx Elite Vials)
- West Pharmaceutical Services, Inc. (Daikyo Crystal Zenith®, NovaPure® Stoppers)
- Stevanato Group (EZ-fill® Vials, SG Alba® Syringes)
- Schott AG (SCHOTT EVERIC®, TopLyo®)
- SGD Pharma (Sterinity Vials, Type I Plus)
- Berkshire Sterile Manufacturing (Isolator-Based Filling Line, Lyophilized Vial Solutions)
- OPTIMA packaging group GmbH (Optima H4, Optima VFVM)
- IMA Group (IMA Life Easy Freeze, IMA Life Fillers)
- Recipharm AB (Lyophilized Vials, Aseptic Filling Solutions)
Fill-Finish Manufacturing Market Report Scope
| Report Attributes | Details |
| Market Size in 2023 | US$ 15.4 billion |
| Market Size by 2032 | US$ 33.5 billion |
| CAGR | CAGR of 9.1% From 2024 to 2032 |
| Base Year | 2023 |
| Forecast Period | 2024-2032 |
| Historical Data | 2020-2022 |
| Key Regional Coverage | North America (US, Canada, Mexico), Europe (Eastern Europe [Poland, Romania, Hungary, Turkey, Rest of Eastern Europe] Western Europe] Germany, France, UK, Italy, Spain, Netherlands, Switzerland, Austria, Rest of Western Europe]), Asia Pacific (China, India, Japan, South Korea, Vietnam, Singapore, Australia, Rest of Asia Pacific), Middle East & Africa (Middle East [UAE, Egypt, Saudi Arabia, Qatar, Rest of Middle East]), Africa [Nigeria, South Africa, Rest of Africa], Latin America (Brazil, Argentina, Colombia Rest of Latin America) |
| Key Growth Drivers | Rising Demand for Biopharmaceuticals, Government Initiatives, and Automation in Pharmaceutical Production |
Segment Analysis
By Product Type
The consumables segment accounted for the largest share of the fill-finish manufacturing market in 2023, and this can be attributed to the high demand for consumables owing to the increasing production of biological drugs. This includes vials, prefilled syringes, cartridges, and other primary packaging parts required for drug storage and delivery. Growth in consumables is primarily due to their repetitive utilization and increased inclination towards prefilled syringes and other ready-to-use container formats in the manufacturing of pharmaceuticals.
By Sterilization
In 2023, the aseptic processing segment accounted for the largest market share. Aseptic processing is a vital step during the fill-finish manufacturing process in which drugs should be filled and sealed in a manner that keeps them free from microbial contamination. This process is extensively applied in the biopharmaceutical sector where the requirement for an aseptic environment is essential to prevent the possibility of product contamination while ensuring product quality and efficacy. Aseptic processing will continue to be the most popular sterilization method, as the demand for biologic and other high-value drugs increases. In addition, the coupling of aseptic technology with Robotics and Automation helps perform continuous processes more effectively.
By End User
The global fill-finish manufacturing market dominated by the CMOs segment in 2023. Contract manufacturing organizations (CMOs) are the backbone of the pharmaceutical industry manufacturing ecosystem, providing services from drug development to commercial-scale production. As the demand for outsourced manufacturing services continues to rise, the trend toward more complex biologic drugs further drives the need for fill-finish services from CMOs. CMOs are becoming the go-to for many pharmaceutical companies who want to cut costs, speed up production timelines, and advance their manufacturing capabilities. Additionally, the emergence of biosimilars and gene therapies is expected to further drive the demand for contract manufacturing services in fill-finish operations.
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Fill-Finish Manufacturing Market Segmentation
By Product
- Consumables
- Vials
- Glass Vials
- Plastic Vials
- Pre-Fillable Syringes
- Pre-fillable syringes, by component
- Pre-fillable syringes, by material
- Vial Stoppers
- High compatibility with different drug formulations to augment segment growth
- Cartridges
- Increasing prevalence of diabetes, asthma, and autoimmune disorders to aid market growth
- Other Consumables
- Vials
- Instruments
- System Type
- Integrated systems
- Standalone systems
- Machine Type
- Automated machines
- Semi-automated & manual machines
- System Type
By Sterilization
- Terminal Sterilization
- Aseptic Processing
By End User
- Pharmaceutical & Biopharmaceutical Companies
- Contract Manufacturing Organizations
- Others
Regional Analysis
In 2023, Europe accounted for the largest revenue 35% share of the fill-finish manufacturing market with dominated revenue. The relatively strong position of this region in recent years is due to the presence of a well-developed pharmaceutical industry, strict regulation, and substantial investments in biopharma research and development. There have always been many more fully established pharmaceutical companies and emerging players within the biotech world in Europe, especially Germany, France, and Switzerland. But with this high concentration of manufacturers comes a heavy demand for highly complex fill-finish services.
North America holds a significant market share. The region's market is propelled by the presence of major biopharmaceutical companies, a favorable regulatory environment, and significant government funding for healthcare innovation. The U.S. is the number one market for approvals and consumption of biologic drugs, driving the need for more sophisticated fill-finish capabilities.
Asia-Pacific is anticipated to witness the fastest growth during the forecast period. This rapid expansion can be attributed to increased healthcare spending, expanded biopharmaceutical manufacturing capacity, and increasing adoption of advanced manufacturing technologies. The emergence of countries including China, India, and South Korea as producers of choice with fill-finish investment tour creations are becoming the fast plug-and-play focus of the global pharmaceutical supply chain.
Recent Developments
- In October 2023, Novocol Pharma partnered up with Moderna, Inc. for a long-term agreement for aseptic fill-finish, labeling, and packaging of mRNA respiratory vaccines in Canada. The partnership seeks to bolster local manufacturing capabilities and streamline the production of the mRNA vaccine.
- Datwyler started dispensing RFS combi-seals for cartridges as part of the company's injection devices launch in October 2023. These new seals provide a regulatory requirement, and seal solution for patient safety during drug administration.
- In September 2023, Thermo Fisher Scientific launched new fill-finish systems, claiming the high automation and flexible use of its configurations can help enhance efficiency while minimizing contamination risks in biopharma manufacturing.
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Table of Contents – Major Key Points
1. Introduction
2. Executive Summary
3. Research Methodology
4. Market Dynamics Impact Analysis
5. Statistical Insights and Trends Reporting
6. Competitive Landscape
7. Fill-Finish Manufacturing Market by Product
8. Fill-Finish Manufacturing Market by Sterilization
9. Fill-Finish Manufacturing Market by End User
10. Regional Analysis
11. Company Profiles
12. Use Cases and Best Practices
13. Conclusion
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