Aseptic formulation processing is the manipulation of sterile active pharmaceutical ingredient (APIs) or pharmaceutical product in a carefully controlled environment using aseptic technique in order to produce a sterile end product. Aseptic formulation processing is a risk management program that ensures the pharmaceutical product’s safety and integrity by confirming the transfer of formulation ingredients with high potency without any chance of contamination in the pre-sterilized vials or containers. Maintaining a controlled environment is vital in aseptic formulation processing as the quality of the final product and sterility of the manufacturing procedure is maintained due to the sterile environment. The environmental conditions required for aseptic processing is maintained by sterile air supply through laminar air flow machines in the aseptic formulation processing facilities. During the process of packaging of the final product, technical measures should be taken such as handling sterile materials in a controlled environment in order to control microbial and particulate contamination to acceptable levels. This process is done manually or with the help of automated aseptic filling devices. However, for improving the aseptic formulation processing procedures in the pharmaceutical industry, the Parenteral Drug Association (PDA) published its aseptic validation technical report in 1981. After that several regulatory authorities published guidelines for aseptic processing of pharmaceutical products.
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Aseptic Formulation Processing Market: Drivers and Restraints
The aseptic formulation processing is a challenging process as transferring the material from one process to another, without operating error and manual contamination poses a high risk to the finished pharmaceutical product. This has fuelled the demand for aseptic filling devices which has further boosted the growth of aseptic formulation processing market. In addition, regulatory agencies across the globe are developing and enforcing stringent requirements for environmental and process control for aseptic formulation processing. These factors are creating interest in advanced aseptic technologies that further raises the demand for superior contamination control devices. Growing awareness about using highly integrated sterile devices and the development of new therapeutic drugs is expected to drive the aseptic formulation processing market. Increase in pharmaceutical supplies and improved sanitary packaging method are some of the major driving factors of the aseptic formulation processing market. However, the high cost of the service cost due to high maintenance cleanrooms, aseptic areas, and formulation filling equipment are likely to hamper the growth of aseptic formulation processing market.
Aseptic Formulation Processing Market: Overview
The global market for aseptic formulation processing is expected to experience exponential growth due to technological advancements and increasing product penetration in the market. Among technology segment, automated technology type is expected to grow with the highest CAGR in the aseptic formulation processing market over the forecast period owing to the added benefits like time reduction in packaging, less manual error. Pharmaceutical companies in the end users segment are expected to generate maximum revenue due to increasing adoption of the aseptic formulation processing in pharmaceutical companies during the forecast years. Due to improved GMP (Good manufacturing practices) and stringent regulations the adoption rate of this aseptic formulation processing devices by end users, aseptic formulation processing are estimated to be fastest growing market from 2018 to 2028.
Aseptic Formulation Processing Market: Regional Outlook
North America is expected to be the leader in global aseptic formulation processing market due to better availability of resources and presence of established pharmaceutical companies. The Asia Pacific aseptic formulation processing market is projected to be the fastest-growing market for global aseptic formulation processing, owing to its increasing out sourcing of pharmaceutical industry and CRO’s contract research organizations in the region. Europe is expected to take the second largest market share in the global aseptic formulation processing market throughout the forecast period. Middle East & Africa aseptic formulation processing market is expected to witness slow growth due to lack of technological reach.
Aseptic Formulation Processing Market: Key Players
Some of the major players identified in the global aseptic formulation processing market are Robert Bosch Packaging Technology GmbH, E.I. Du Pont De Nemours and Co, JBT Corporation, Kwang Dah Enterprises Co. Ltd., SHIBUYA CORPORATION, ITECO srl, Greatview Aseptic Packaging Co., Ltd, Powder Systems Limited and GEA Group among others.
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