Pharmaceutical Aseptic Fill & Finish CMO Market Size, Share, Growth, and Industry Growth By Type (Ampoule Filling Services, Vial Filling Services, Prefilled Syringes Filling Services, and Others) By Application (Vaccines, Biologics and Biosimilars, Generics, and Patented Small Molecules), Regional Insights, and Forecast From 2023 To 2031

Updated On: 04 September 2023

Pharmaceutical Aseptic Fill & Finish CMO Market REPORT OVERVIEW

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The global pharmaceutical aseptic fill & finish CMO market size was USD 2229.7 million in 2021 and market is projected to touch USD 6619.96 million by 2031, exhibiting with a growing compound annual growth rate (CAGR) of 11.4% during the forecast period.

The final production phase in the total drug manufacturing process is fill-finish. It follows upstream bioprocessing, which is the synthesis of an active participant by cultured cells or fermenting. It also happens after downstream filtration. Fill-finish is a rather mature industrial activity that focuses on product composition and packing efficiency. Fill-finishing includes complex mechanical engineering filling, fluid and solid pouring, and closing systems, considerably more than bioprocessing.

The section where a sterile medicine is transmitted from a filling needle to a sterile container, generally a vial or prefilled syringe, is known as aseptic fill-finish. Except for sterile lyophilization, the closure of a container usually occurs after the fill-finish. It is an important aspect of the market.

COVID-19 Impact: Increasing R&D Activities for Vaccine Formulation to Bolster Market Progress

The COVID-19 pandemic has provided various possibilities for the pharmaceutical aseptic fill & finish CMO industry to boost their R&D for coronavirus vaccine formulation. Clinical trial manufacturing provided various options for contract manufacturing organizations (CMOs), thereby benefiting the market during the pandemic. There is a huge pipeline of pharmaceuticals, and both small and mega corporations outsource pipeline advancement to partners. The pandemic has also freed up internal capacity at big pharma. Some companies, such as Pfizer, have outsourced numerous internally created pharmaceuticals to contract manufacturing organizations.

However, due to drug shortages caused by COVID-19, the stock availability of vaccines is projected to be limited in the immediate term. Supply from Chinese industrial facilities have been severely decreased since the implementation of lockdowns. The biggest impact has been the inability of several usual workforces to return to work, resulting in unrealized efficiency at several levels of the pharmaceutical sector.

LATEST TRENDS

"Developments in Fill Finish Process to Bolster Market Progress"

Fill-finish is one of the most important aspects of biopharmaceutical manufacturing. Any errors in this process result in contamination, poor packing, or miss-formulation. IT has a significant impact on product failure, safety concerns, and the loss of valuable products. Fill-Finish activities are primarily mechanical, comprising the manipulation, movement, and packaging of solid and liquid dosage forms.

Fill-finish processing occurs only after upstream bioprocessing, fermentation, or cell culture synthesis of the active component and downstream purification. At the end of the development phase, tried-and-true methods are more likely to be used. Due to innovation, risk issues such as regulatory work and cost can be incorporated into bioprocess operations. It includes the mixing, formulating, or preparation of other active agents into their final form, such as lyophilized or liquid powder, sealing and filling of the final containers, mostly made of plastic. These factors are likely to bolster pharmaceutical aseptic fill & finish CMO market development. 

Pharmaceutical Aseptic Fill & Finish CMO Market Segmentation

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• By Type Analysis

By type, the market is segmented into ampoule filling services, vial filling services, prefilled syringes filling services, and others.

The vial filling services segment is expected to lead market share. The expanding demand for syringes, the global usage of vials in lyophilization, and the growing use of disposable packaging for biologics contribute to this segment's rapid growth. The prevalence of diabetes is likely to grow, and new product launches are expected to move the segment forward. These factors are likely to influence the growth of the pharmaceutical aseptic fill & finish CMO market. 

• By Application Analysis

Based on application, the market is classified into vaccines, biologics and biosimilars, generics, and patented small molecules.

The vaccine segment is expected to be the leader because the pandemic has opened up several opportunities for pharmaceutical and biopharmaceutical companies to expand their coronavirus vaccine R&D. Additionally, the rising demand for high-quality components in the fill-finish process is expected to boost pharmaceutical aseptic fill & finish CMO industry progress. 

DRIVING FACTORS

"Increasing R&D Investments to Facilitate Industry Progress"

Research and development are some of the most important investment areas in the pharmaceutical and biotech industries. Companies focus heavily on research and development to improve drugs available at lower costs. Companies have a strong competitive advantage in the pharmaceutical and biotechnology industry since price and function are the major competing elements. Some pharmaceutical companies' R&D departments were compacted due to the emergence of CRO players, particularly those operating on a small scale. As more clinical research organizations (CROs) began to offer research services at a reasonable price, in-house pharmaceutical R&D departments were forced to compete. Rather than taking full responsibility for R&D activities, manufacturers frequently collaborate with drug development companies. Because of new pharma collaborations, CROs gain valuable knowledge and skills, which benefits them to gain more clients. These factors can influence the growth of the pharmaceutical aseptic fill & finish CMO market during the upcoming years. 

"Rising Adoption of Outsourcing Fill-Finish Services to Magnify Market Growth"

Fill-and-finish contract services are still one of the most widely outsourced services presently. Almost every pharmaceutical and biotechnology company outsources some or all of their fill-and-finish requirements. A virtual start-up company hires a pharmaceutical aseptic fill & finish CMO because it lacks both volume and the resources to develop capacity. Large enterprises with in-house fill-and-finish capacity outsource at least some of their fill-and-finish needs to reduce supply chain risks.

The capacity of a CMO can be used for a variety of reasons, including unexpected demand, second-source regulations, and improved size-to-need matching. When a company's in-house capacity is insufficient to generate fresh items or formats, it will turn to a CMO. Specialized capabilities, such as lyophilization, prefilled syringes and cartridges, and innovative therapies, may necessitate specialized products that are more cost-effective to outsource. These factors are likely to drive the pharmaceutical aseptic fill & finish CMO market growth. 

RESTRAINING FACTORS

"Process Failure and Cost of Production to Impede Market Progress"

Failures in the fill-finish step can introduce microbial contamination and cause problems with formulation and dosage. Expenses in the laboratory are high during the production cycle, storage, transportation, and maintenance charges, limitations imposed by governments and non-profit groups on the use of plastics may propel market progress. However, manufacturers' constant efforts and investments in R&D activities are projected to soon reduce the consequences of these restraints in the pharmaceutical aseptic fill & finish CMO industry.

Pharmaceutical Aseptic Fill & Finish CMO Market REGIONAL INSIGHTS

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"Presence of a Developed Digital Infrastructure to Bolster Growth in North America"

Regionally, the market is grouped into North America, Europe, Asia-Pacific, and the rest of the world. 

North America is likely to dominate the pharmaceutical aseptic fill & finish CMO market share because of the large number of pharmaceutical companies with large production capacity in this region. North America holds a significant market share in the fill-finish manufacturing sector. Furthermore, the rising focus on improved biopharmaceutical goods, the advent of the biosimilar industry, and the patent expiration of biologic products contribute to the overall regional market's growth.

Asia-Pacific is the second-largest market shareholder globally, owing to general growth in the biopharmaceutical industry. Factors such as increased investments by CMOs, significant biopharmaceutical businesses, increased government support, advances in R&D infrastructure, and expertise and academic excellence in the region contribute to the pharmaceutical aseptic fill & finish CMO industry growth.

In Europe, the European Union's high position in this industry can be attributed to a greater focus on biosimilar research due to the patent expiration of important biologics products. Furthermore, well-established medication reimbursement systems have increased the demand for biologics among patients by making them more affordable to consume. Biopharmaceutical companies have increased production volumes and expanded production facilities to meet consumers’ demand.

KEY INDUSTRY PLAYERS

"Major Players are Acquiring Start-Ups and Expanding Consumer Base to Improve Market Position"

Several main companies in the pharmaceutical aseptic fill & finish CMO industry are very competitive. Furthermore, the market is currently dominated by a few significant competitors in terms of market share. These market-leading companies are diversifying their consumer base by expanding into new countries. These businesses are relying on strategic collaboration activities to grow their market share and profit margins. To improve their product capabilities, industry players are also acquiring start-ups focusing on enterprise network equipment technologies.

List of Market Players Profiled

• Baxter BioPharma Solutions (U.S.)
• Boehringer Ingelheim (Germany)
• Vetter Pharma (Germany)
• Fresenius Kabi (Germany)
• Pfizer CentreOne (New York)
• Aenova (Germany)
• WuXi Biologics (China)
• Jubilant HollisterStier (U.S.)
• Bushu Pharmaceuticals (Japan)
• LSNE Contract Manufacturing (U.S.)
• Ajinomoto Bio-Pharma Services (U.S.)
• CMIC CMO (Japan)
• TAIYO Pharma Tech Co., Ltd. (Japan)
• HALIX (U.K.)
• Cognate BioServices (U.S.)
• Afton Scientific (U.S.)
• Novasep (France)
• Emergent Biosolutions (U.S.)
• Seikagaku (Japan)
• Jiangshu YAOHAI Bio-Pharmaceutical (China)
• Akron Biotech (U.S.)
• Symbiosis Pharmaceutical Services (U.K.)

INDUSTRY DEVELOPMENT

• May 2020: Ajinomoto Bio-Pharma Services (CMO player) announced that it had signed a manufacturing services agreement with CytoDyn Inc. For the supply of the investigational new drug leronlimab (PRO 140), which is currently being studied in clinical trial protocols for mild-to-moderately ill and severely ill COVID-19 patients.

REPORT COVERAGE

The research covers various topics, including demand, product development, revenue generation, and sterile vial sales across regions. Considering sales during the forecast period, an optimistic and cautious scenario has been used to fully estimate the pharmaceutical aseptic fill & finish CMO sector. The survey also takes into account price point comparisons by region with the global average price.