Global Pharmaceutical Aseptic Fill - Finish CMO Market Research Report 2022 (Status and Outlook)-official website

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Report Overview:

In pharmaceutical manufacturing, fill-finish operations are critical, since fill-finish is the last step before a product is packaged and ultimately delivered to the patient. By the time a drug reaches this stage, the drug product is highly valuable, as it has already been through labour- and cost-intensive production stages, including upstream processing, cell culture or fermentation and downstream purification. Failures in the integrity of the fill-finish stage can introduce microbial contamination and generate issues with formulation and doing.

The adoption of single-use or single-use equipment is the overarching trend in filling services. The use of aseptic kits in final filling services including single-use techniques can significantly reduce the risk of cross-contamination and reduce cleaning requirements. The use of facilities geared toward multi-product usage is one of the current trends across the industry. Additionally, manufacturers are actively developing fully automated, state-of-the-art filling-finishing packages to reduce the risks associated with operator involvement.

The global Pharmaceutical Aseptic Fill & Finish CMO market size is projected to reach US$ 6822.33 Million by 2029 from US$ 4936.96 million in 2022 at a CAGR of 5.97% during 2023-2029. Rising demand to reduce overall investment in drug development, filling Technological advancements in packing operation processes and increasing demand for outsourcing of fill-finish services will be the core drivers driving the growth of the Pharmaceutical Aseptic Fill & Finish CMO market.

The accuracy and success rate of drug filling plays an important role in reducing the overall cost of drug development. Some active pharmaceutical ingredients have strong efficacy and high cost, and the handling and filling of pharmaceutical powders such as active pharmaceutical ingredients in clinical development must be cautious. At the same time, the filling of biological products is an important link in the production process. Its production process is very complicated and unstable, so it is not suitable for terminal sterilization, and it needs to be sterilized during filter filling.

While traditional stainless steel systems require additional cleaning and sterilization (CP/SP) in traditional aseptic filling processes, single-use systems eliminate the critical sterilization step and further shorten the time by simplifying end-of-batch breakdown Changeover times and purge operations. Many pharmaceutical, biopharmaceutical and contract manufacturing organizations are adopting single-use fill-finish systems, especially for biologics. Technological advancements in aseptic fill operations involve the use of isolators and restricted access barrier systems (RABS), which create robust aseptic manufacturing environments that effectively separate operators from the fill completion process. Disposable systems also offer economic advantages, such as significantly less installation and clean-up time, which reduces labor costs. Single-use systems also help reduce capital costs and chemicals used while minimizing utilities and water. The increasing pace of technological advancements in the filling-finishing manufacturing process is actively driving the market growth.

Due to complex production and limited resources, it is common for the entire pharmaceutical industry to partner with CDMOs. The CDMO assists in the development and manufacture of aseptically filled finished products. Companies often consider outsourcing the filling and finishing of biopharmaceuticals to a CMO for production capacity or specialized manufacturing capabilities. The growing popularity of contract manufacturing organizations (CMOs) among various biotechnology companies is also considered to be a significant factor driving the market growth.

In addition, the growing demand for Pharmaceutical Aseptic Fill & Finish CMO in emerging markets will also become an important reason for the expansion of the entire Pharmaceutical Aseptic Fill & Finish CMO market. Emerging markets such as India and China will provide lucrative opportunities for the players in this market. At the same time, the COVID-19 pandemic has spurred the development of COVID-19 vaccines, antibody therapies, antiviral drugs, and various other related pharmaceutical products. The pandemic has severely affected countries such as Brazil, India, the United States, and major European countries, increasing the demand for biopharmaceutical products, thereby boosting pharmaceutical production. Vaccines and biologics require special manufacturing and filling equipment and procedures to ensure product quality and safety, which requires advanced analytical capabilities and adaptable aseptic filling techniques. This has also become the driving force for market development.

Segment by Type, the Pharmaceutical Aseptic Fill & Finish CMO can be split into Glass Vials, Disposable Syringes, etc. Glass Vials type occupies the highest market share, reaching 39.66% in 2021. Most biological products and vaccines are packed in glass vials to ensure extreme safety and avoid leakage. The Prefilled Syringes market is expected to register the fastest CAGR of 7.32% during the forecast period. Prefilled syringes are a well-established drug delivery technology for novel complex biologics and traditional small molecule drugs. They offer several advantages over other container types, such as reduced medication errors, fast and safe dosing and preparation, longer storage times, and lower risk of spillage, all of which contribute to development costs and reduced batch sizes . Hence, the segment is poised to witness considerable growth throughout the forecast period owing to the aforementioned factors.

According to application scenarios, pharmaceutical aseptic filling can be divided into vaccines, biological products and biosimilars, generic drugs and other sectors. In 2021, the vaccine segment has the highest market share, already reaching 38.85%, and will maintain this position during the forecast period. In addition, the market size of Biologics and Biosimilar and Generics will maintain a compound growth rate of more than 6.5%.

On basis of geography, the Pharmaceutical Aseptic Fill & Finish CMO market is segmented into North America, Europe, Asia-Pacific, South America, Middle East and Africa, etc. Asia-Pacific is the most important market for Pharmaceutical Aseptic Fill & Finish CMO, and in In 2021, it has already occupied more than 40% of the market share. During the forecast period, the Asia-Pacific market will continue to expand at the highest CAGR of 8.11%. This is mainly attributed to low labor and raw material costs, increasing research activities, favorable government support, and technological integration and advancement. Meanwhile, increasing number of CMOs expanding in the region and numerous bottling facilities under construction are also driving the market expansion. For example, Thermo Fisher will increase its aseptic filling capabilities with a new facility in Singapore. The facility will then initially provide a high-speed sterilization line approved for live viruses, which must first be filled with large-scale expertise in Singapore, before providing the additional capability of standard filling/finishing.

Currently, the concentration in the Pharmaceutical Aseptic Fill & Finish CMO market is low. According to our calculations, the two concentration indicators CR5 and HHI used to measure the market are 50.74% and 6.71% respectively, showing a relatively low level of concentration in 2022. In 2023, we expect the market concentration to decrease. More than 130 companies are actively providing aseptic fill/seal services for small molecules. Recently, many of the service providers mentioned above have also formed strategic alliances and/or acquired other players to further enhance their respective service offerings. This trend is also likely to continue for the foreseeable future. Key players in the market include Baxter Pharmaceutical Solutions LLC, Fresenius Kabi, Pfizer CentreOne, AbbVie, Vetter Pharma, Jubilant HollisterStier LLC, Ajinomoto Bio-Pharma Services, GRAM (Grand River Aseptic Manufacturing), Boehringer Ingelheim, WuXi Services, PCI, Pharma Aenova, TAIYO Pharma Tech Co.,Ltd., CMIC HOLDINGS Co., Ltd., Emergent BioSolutions, Bushu Pharmaceuticals, Novasep, HALIX, Symbiosis Pharmaceutical Services, Afton Scientific, Jiangsu Yaohai Bio-Pharmaceutical, Seikagaku, Techdow, Akron Biotech.

This report provides a deep insight into the global Pharmaceutical Aseptic Fill & Finish CMO market covering all its essential aspects. This ranges from a macro overview of the market to micro details of the market size, competitive landscape, development trend, niche market, key market drivers and challenges, SWOT analysis, value chain analysis, etc.

The analysis helps reader to shape the competition within the industries and strategies for the competitive environment in order to enhance the potential profit. Furthermore, it provides a simple framework for evaluating and accessing the position of the business organization. The report structure also focuses on the competitive landscape of the Global Pharmaceutical Aseptic Fill & Finish CMO Market, this report introduces in detail the market share, market performance, product situation, operation situation, etc. of the main players, which helps the readers in the industry to identify the main competitors and deeply understand the competition pattern of the market.

In a word, this report is a must-read for industry players, investors, researchers, consultants, business strategists, and all those who have any kind of stake or are planning to foray into the Pharmaceutical Aseptic Fill & Finish CMO market in any manner.

Global Pharmaceutical Aseptic Fill & Finish CMO Market: Market Segmentation Analysis

The research report includes specific segments by region (country), manufacturers, Type, and Application. Market segmentation creates subsets of a market based on product type, end-user or application, Geographic, and other factors. By understanding the market segments, the decision-maker can leverage this targeting in the product, sales, and marketing strategies. Market segments can power your product development cycles by informing how you create product offerings for different segments.