Drivers: Rising technological advancements in fill-finish manufacturing processes
Technological advancements in aseptic fill-finish operations involve the usage of isolators and restricted-access barrier systems (RABS), which create robust sterile manufacturing environments that effectively separate human operators from the fill-finish process. Many equipment manufacturers in the fill finish manufacturing market are focusing on the development of barrier isolation systems, which are integrated fill-finish machines capable of carrying out all stages of fill-finish processes.
In contrast to barrier isolation systems, standalone equipment used in fill-finish operations is both time-consuming and expensive, thus making the entire process complex and prone to contamination. The SA25 aseptic filling workcell by Vanrx Pharma is an example of an isolated system. Owing to the benefits of isolators or RABS, many biopharmaceutical companies are adopting these machines in drug production facilities.
Restraints: High costs associated with isolators and RABs
RABS and isolators have advanced features and functionalities. The equipment provides an enclosed environment, which reduces the risk of contamination. RABS and isolators are expensive as compared to standalone systems. The average price of RABS and isolators is around USD 4.0 million to USD 8.0 million, which is high for standalone systems.
This severely limits the accessibility of small businesses. In underdeveloped or developing countries, the adoption of isolators and RABS is very low as compared to standalone systems. Standalone systems are still used in small pharmaceutical and biopharmaceutical companies, R&D laboratories, and academic institutes.
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Global Leading Companies:
The major players in the global fill-finish manufacturing market include Syntegon Technology GmbH (Germany), I.M.A. (Industria Macchine Automatiche) S.p.A. (Italy), Becton, Dickson and Company (US), Stevanato Group (Italy), West Pharmaceutical Services, Inc. (US), OPTIMA Packaging Group GmbH (Germany), Bausch+Strobel (Germany), Groninger & Co. GmbH (Germany), and Gerresheimer AG (Germany).
Growth Strategies Adopted by Leading Players:
These players have adopted various growth strategies such as product launches, acquisitions, agreements, and partnerships to increase their presence in the global fill-finish manufacturing industry.
Recent Developments:
# In 2022, BD entered into an agreement with Mitsubishi Gas Chemical Company to investigate the further development of OXYCAPT, an innovation from MGC that integrates the best of plastic and glass for plastic syringes.
# In 2021, West Pharmaceutical introduced the DeltaCube Modeling Platform and NovaGuard SA Pro Safety System for 0.5 mL standard glass syringes at Interphex.
Syntegon Technology GmbH (Germany) is a leading player in the global fill-finish manufacturing market. The company focuses on product innovation to strengthen its position in the market. The company offers an broad product portfolio in the market through its machinery systems segment, which includes a wide range of automated standalone machines, integrated systems, and barrier systems such as isolator systems and RABS.
I.M.A. (Industria Macchine Automatiche) S.p.A. (Italy) is a leading player in the global fill-finish manufacturing market. IMA is one of the leading manufacturers of automated machines for the processing and packaging of pharmaceuticals, cosmetics, tea, food, and coffee. The company operates through three business segments—Pharmaceutical; Tobacco Packaging; Tea, Food, & Others. Through its Pharmaceutical segment, IMA deals with the production of machines for processing and packaging of capsules; filling liquid and powdered products in bottles and vials; and tube filling and other pharmaceutical operations. In 2021, BC partners have acquired IMA group and now working under them.
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Geographical Growth Scenario:
Europe accounted for the largest share of the fill-finish manufacturing market.
Europe accounted for the largest share of the market among all the regions. Factors such as well-established reimbursement systems for drugs have further enhanced the demand for biologics among patients by making them affordable to consume, and to fulfill this, biopharmaceutical companies have increased their production volumes and expand production capacities and increasing focus on the development of biosimilar due to the patent expiry of key biologics products.
