Fill Finish Manufacturing Market Size
Study Period | 2019 - 2029 |
Base Year For Estimation | 2023 |
Forecast Data Period | 2024 - 2029 |
CAGR | 8.70 % |
Fastest Growing Market | Asia Pacific |
Largest Market | North America |
Major Players*Disclaimer: Major Players sorted in no particular order |
Fill Finish Manufacturing Market Analysis
The Fill Finish Manufacturing Market is expected to register a CAGR of 8.7% during the forecast period. Fill finish manufacturing is defined as an introduction of a drug product into a container or delivery system (and subsequent packaging) under aseptic conditions which is essential to ensure the safety and efficacy of the product. Some of the challenges to fill finish manufacturing processes include maintaining sterility of components, production and equipment areas. The fill finish process involves introduction of a drug product in any form such as powder, solution, suspension in containers such as syringes, vials, cartridges, etc. For a typical biopharmaceutical, the fill finish step involves the thawing of the frozen product solution, pH buffering agent preparations and finally filling the solution into vials or syringes. In the case of sensitive products like proteins, the vials are often freeze-dried (lyophilized) in order to increase the shelf-life period. Most of the biopharmaceutical products are fragile in nature like proteins and have several stability problems during pharmaceutical processing and filling, in addition, biological drugs are prone to the contamination that could lead to huge economic losses for the manufacturers. The fill and finish process provides advanced aseptic solutions to prevent contamination of biopharmaceutical products.
According to the Food and Drug Administration (FDA), it has approved 1,171 generic drugs in the year 2019, breaking its previous record of 971 in the year 2018. Technological advancements related to fill finish manufacturing products and the launch of new drugs and therapeutics are the key driving factors in fill finish manufacturing market.
Fill Finish Manufacturing Market Trends
This section covers the major market trends shaping the Fill Finish Manufacturing Market according to our research experts:
Consumables segment is Expected to Hold a Major Market Share in the Fill Finish Manufacturing Market
Consumables segment is categorized into cartridges, prefillable syringes, vials, and other consumables such as ampoules, bottles, bags, and single-use systems. Prefilled syringes are highly preferred due to ease of administration, safe, biologically sterile, time and accuracy benefits. As per Congressional Research Service, the use of biologics and spending on these products has been increasing, for example, the United States has spent totaled 120.1 billion dollars on biologics in the year 2017, about 12.5% increase compare to the year 2016.
Consumables segment hold a significant market share in the fill finish manufacturing market and is anticipated to show similar trend over the forecast period due to high replacement rate compared to instruments, shelf life of consumables is less and required in large quantity. Rising adoption of prefilled syringes, wide applications of vials in lyophilization and increasing fill finish outsourcing are the key driving factors in the consumables segment.
North America is Expected to Hold a Significant Share in the Market and Expected to do Same in the Forecast Period
North America is expected to hold a major market share in the fill finish manufacturing market due to the presence of a number of pharmaceutical and biopharmaceutical companies with large production capacities in this region. North America holds a significant market share in the fill finish manufacturing market and is anticipated to show a similar trend over the forecast period. Furthermore, the growing emphasis on superior biopharmaceutical products, the emergence of the biosimilar market and patent expiry of biologic products is also fueling the growth of the overall regional market to a large extent.
Fill Finish Manufacturing Industry Overview
The Fill Finish Manufacturing Market is moderately competitive and consists of several major players. In terms of market share, few of the major players are currently dominating the market. Some of the companies which are currently dominating the market are Becton, Dickinson and Company, Optima, West Pharmaceutical Services, Inc, IMA S.P.A, Groninger & Co GmbH, Schott AG, Nipro Medical Corporation, Gerresheimer AG, Piramal Pharma Solutions and Syntegon Technology GmbH (Robert Bosch GmbH).
Fill Finish Manufacturing Market Leaders
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Becton, Dickinson and Company
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Optima
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West Pharmaceutical Services, Inc
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IMA S.P.A
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Groninger & Co GmbH
*Disclaimer: Major Players sorted in no particular order
Fill Finish Manufacturing Market Report - Table of Contents
1. INTRODUCTION
- 1.1 Study Assumptions
- 1.2 Scope of the Study
2. RESEARCH METHODOLOGY
3. EXECUTIVE SUMMARY
4. MARKET DYNAMICS
- 4.1 Market Overview
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4.2 Market Drivers
- 4.2.1 Technological Advancement in Fill Finish Products
- 4.2.2 Rise in Fill Finish Outsourcing
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4.3 Market Restraints
- 4.3.1 Stringent Regulatory Issues
- 4.3.2 High Production Costs
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4.4 Porter's Five Force Analysis
- 4.4.1 Threat of New Entrants
- 4.4.2 Bargaining Power of Buyers/Consumers
- 4.4.3 Bargaining Power of Suppliers
- 4.4.4 Threat of Substitute Products
- 4.4.5 Intensity of Competitive Rivalry
5. MARKET SEGMENTATION
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5.1 By Product Type
- 5.1.1 Consumables
- 5.1.1.1 Prefillable Syringes
- 5.1.1.2 Cartridges
- 5.1.1.3 Vials
- 5.1.1.4 Other Consumables
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5.2 By End User
- 5.2.1 Contract Manufacturing Organizations
- 5.2.2 Pharmaceutical and Biotechnology Industries
- 5.2.3 Others
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5.3 Geography
- 5.3.1 North America
- 5.3.1.1 United States
- 5.3.1.2 Canada
- 5.3.1.3 Mexico
- 5.3.2 Europe
- 5.3.2.1 Germany
- 5.3.2.2 United Kingdom
- 5.3.2.3 France
- 5.3.2.4 Italy
- 5.3.2.5 Spain
- 5.3.2.6 Rest of Europe
- 5.3.3 Asia-Pacific
- 5.3.3.1 China
- 5.3.3.2 Japan
- 5.3.3.3 India
- 5.3.3.4 Australia
- 5.3.3.5 South Korea
- 5.3.3.6 Rest of Asia-Pacific
- 5.3.4 Middle-East and Africa
- 5.3.4.1 GCC
- 5.3.4.2 South Africa
- 5.3.4.3 Rest of Middle-East and Africa
- 5.3.5 South America
- 5.3.5.1 Brazil
- 5.3.5.2 Argentina
- 5.3.5.3 Rest of South America
6. COMPETITIVE LANDSCAPE
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6.1 Company Profiles
- 6.1.1 Becton, Dickinson and Company
- 6.1.2 Optima
- 6.1.3 West Pharmaceutical Services, Inc
- 6.1.4 IMA S.P.A
- 6.1.5 Groninger & Co GmbH
- 6.1.6 Schott AG
- 6.1.7 Nipro Medical Corporation
- 6.1.8 Gerresheimer AG
- 6.1.9 Piramal Pharma Solutions
- 6.1.10 Syntegon Technology GmbH (Robert Bosch GmbH)
- *List Not Exhaustive
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
** Subject To AvailablityFill Finish Manufacturing Industry Segmentation
Fill finish manufacturing is defined as an introduction of a drug product into a container or delivery system (and subsequent packaging) under aseptic conditions which is essential to ensure safety and efficacy of the product. Fill Finish Manufacturing Market is segmented By Product Type, By End User and Geography.
By Product Type | Consumables | Prefillable Syringes |
Cartridges | ||
Vials | ||
Other Consumables | ||
By End User | Contract Manufacturing Organizations | |
Pharmaceutical and Biotechnology Industries | ||
Others | ||
Geography | North America | United States |
Canada | ||
Mexico | ||
Geography | Europe | Germany |
United Kingdom | ||
France | ||
Italy | ||
Spain | ||
Rest of Europe | ||
Geography | Asia-Pacific | China |
Japan | ||
India | ||
Australia | ||
South Korea | ||
Rest of Asia-Pacific | ||
Geography | Middle-East and Africa | GCC |
South Africa | ||
Rest of Middle-East and Africa | ||
Geography | South America | Brazil |
Argentina | ||
Rest of South America |
Fill Finish Manufacturing Market Research FAQs
What is the current Fill Finish Manufacturing Market size?
The Fill Finish Manufacturing Market is projected to register a CAGR of 8.70% during the forecast period (2024-2029)
Who are the key players in Fill Finish Manufacturing Market?
Becton, Dickinson and Company, Optima, West Pharmaceutical Services, Inc, IMA S.P.A and Groninger & Co GmbH are the major companies operating in the Fill Finish Manufacturing Market.
Which is the fastest growing region in Fill Finish Manufacturing Market?
Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2024-2029).
Which region has the biggest share in Fill Finish Manufacturing Market?
In 2024, the North America accounts for the largest market share in Fill Finish Manufacturing Market.
What years does this Fill Finish Manufacturing Market cover?
The report covers the Fill Finish Manufacturing Market historical market size for years: 2019, 2020, 2021, 2022 and 2023. The report also forecasts the Fill Finish Manufacturing Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.
What are the key considerations for choosing a fill-finish manufacturer?
The key considerations for choosing a fill-finish manufacturer are a) Expertise b) Regulatory compliance c) Capacity for your needs
Fill Finish Manufacturing Industry Report
The global fill finish manufacturing market is poised for significant growth, primarily driven by the rising demand for biologics and vaccines. Key factors fueling this growth include technological advancements such as automated and robotic fill-finish systems, which enhance operational efficiencies and reduce contamination risks, vital for biologics production. The shift toward biologics and biosimilars is escalating the need for advanced fill finish services, with consumables like pre-filled syringes and vials dominating due to their crucial role in maintaining sterility and dosage accuracy. The adoption of Contract Manufacturing Organizations (CMOs) is surging, attributed to their cost efficiencies and focus on core competencies. Geographically, North America and Europe lead due to advanced healthcare infrastructures and stringent regulatory frameworks, while Asia Pacific is the fastest-growing region, spurred by increases in healthcare spending and biopharmaceutical development. The market is also marked by strategic collaborations and technological integrations that improve the scalability and efficiency of fill finish processes, ensuring the efficacy and safety of final pharmaceutical products. For detailed market insights and forecasts, a comprehensive analysis is available from Mordor Intelligence™. Get a sample of this industry analysis as a free report PDF download.