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.
Key Market Trends
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.
Competitive Landscape
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).
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Table of Contents
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- 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
- Syntegon Technology GmbH (Robert Bosch GmbH)
Methodology
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