Fill finish Manufacturing Market Analysis

Global Fill Finish Manufacturing Market Overview

Fill Finish Manufacturing Market Size was valued at USD 8.37 billion in 2021 and is projected to grow from USD 9.35 billion in 2022 to USD 22.3 billion by 2032, exhibiting a compound annual growth rate (CAGR) of 11% during the forecast period (2023 - 2032). The advancement in fill finish manufacturing techniques growing R&D in pharmaceutical industry are driving market growth.

  Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

Fill Finish Manufacturing Market Trends

• Advancement in fill finish manufacturing techniques to boost market growth

Utilizing isolators and Restricted-access Barrier Systems (RABS), fill finish operations effectively isolate human operators from the fill finish process by establishing sterile manufacturing environments. Barrier isolation systems, which are integrated fill finish machines capable of performing all stages of fill finish processes, are being developed by many equipment manufacturers in the fill finish manufacturing market. The fill finish process is complex and prone to contamination because standalone equipment used in fill finish operations, as opposed to barrier isolation systems, is time- and money-consuming. Many biopharmaceutical companies are implementing isolators or RABS in their drug production facilities due to their advantages.

Moreover, conventional stainless-steel systems need additional cleaning and sterilization (CIP/SIP) in traditional aseptic fill finish processes, whereas a single-use system skips the crucial sterilization steps and speeds up changeovers by streamlining end-of-batch breakdown and decontamination procedures. Single-use fill finish systems are being adopted by numerous pharmaceutical, biopharmaceutical, and contract manufacturing companies, especially for biologics. For instance, the first fully pre-validated, pre-assembled, and pre-sterilized single-use filling system for vials, syringes, cartridge, and ampoule filling is PreVAS (Syntegon Technology GmbH). This is mainly because single-use systems do not require expensive and time-consuming sterilization procedures. Additionally, single-use systems have financial benefits because they require less time to set up and take down, which lowers labor costs. Single-use systems also reduce the need for chemicals and capital expenditures while using less water and energy. The market growth is being positively influenced by the quickening pace of technological advancements in fill finish manufacturing processes.

Fill Finish Manufacturing Market Segment Insights

Fill Finish Manufacturing Product Insights

The Fill Finish Manufacturing Market segmentation, based on product, includes consumables and instruments. The consumables are segmented into prefilled syringes, vials, cartridges, and other consumables including ampoules, bottles, and IV bags among others. Prefilled syringes are further bifurcated into glass prefilled syringes and plastic prefilled syringes. The consumables segment dominated the market in 2021 and is projected to be the fastest growing segment during the forecast period, 2023 to 2032. Prefilled syringes are convenient devices for the drug delivery of parental dosage forms. It reduced the risk of contamination, ease & speed of administration, improved patient compliance, sterility assurance, and elimination the need for overfill of costly therapeutics & consequently reduced waste. The consumables segment held the majority share in 2021 due to the rising adoption of prefilled syringes, wide applications of vials in lyophilization, and surging fill finish outsourcing.

Figure 2: Fill Finish Manufacturing Market, by Product, 2021 & 2030 (USD Billion)

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

September 2022 Becton, Dickinson, and Company launched a next-generation glass prefillable syringe (PFS) to meet the complex and evolving needs of vaccine manufacturing.

October 2021 Aenova Group expand its sterile fill and finish capacity at Latina, Italy with new high-speed flexible line for prefilled syringes and vials. This new area offers capacity for over 180 million prefilled syringes and more than 80 million vials.

Fill Finish Manufacturing Modality Insights

Based on modality, the global fill finish manufacturing industry has been segmented into recombinant proteins, monoclonal antibodies, vaccines, cell therapies, viral gene therapies, non-viral gene therapies, and others. The vaccines are segmented into mRNA, DNA, inactivated, viral vector, live-attenuated, and others including toxoid among others. The monoclonal antibodies segment dominated the market in 2021, while the cell therapies segment is projected to be the fastest growing segment during the forecast period, 2022–2030. The increased market strategic collaborations and new product launches among others are likely to create numerous opportunities for players to gain a competitive edge in the fill finish manufacturing market. For instance, in October 2019, Terumo Corporation (Japan) launched Finia, a fully automated, modular, and functionally closed-fill finish system for cell therapies. This new product eliminates the risk of contamination during manual processing. Thus, such key developments in fill finish manufacturing are projected to drive market growth during the forecast period.

Fill Finish Manufacturing End User Insights

Based on end user, the global fill finish manufacturing industry has been categorized into contract manufacturing organizations, biotechnology & pharmaceutical companies, and others include research & academic institutes among others. The biotechnology & pharmaceutical companies segment accounted for the largest share in 2021 and is anticipated to be the fastest growing for the forecast period 2022-2030. The market growth of the biotechnology and pharmaceutical companies segment is mainly due to the rapidly expanding biotechnology & pharmaceutical industry and the high adoption of superior technologies. Furthermore, biotechnology and pharmaceutical companies are engaging in extensive R&D activities to innovate new drugs and other products, driving growth for this segment. According to BDO USA, LLP (US), in September 2020, R&D spending in the life sciences industry increased by 22% from 2018 to 2019.

Fill Finish Manufacturing Regional Insights

By Region, the study segments the market into North America, Europe, Asia-Pacific, and the Rest of the World. The growth of North America fill finish manufacturing market is extensive research and development activities as well as advanced manufacturing of innovative biopharmaceutical and pharmaceutical products.

Further, the major countries studied are: the U.S., Canada, Germany, France, the UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil.

Figure 3: FILL FINISH MANUFACTURING MARKET SHARE (%) BY REGION 2021

Source: Secondary Research, Primary Research, MRFR Database and Analyst Revie

North America fill finish manufacturing market accounts for the largest market share due to extensive research and development activities, growing investment by global companies, advanced manufacturing of innovative biopharmaceutical and pharmaceutical products. Furthermore, the US fill finish manufacturing market held the largest market share and Canada fill finish manufacturing market accounting for the second largest market in North America.

The Asia-Pacific fill finish manufacturing Market is expected to grow at a highest rate from 2022 to 2030. This is due to increasing investments by CMOs & key biopharmaceutical players, increasing government support, developments in R&D infrastructure in this region. Moreover, the China fill finish manufacturing market held the largest market share, and the Japan fill finish manufacturing market was the fastest growing market in the Asia-Pacific region.

Fill Finish Manufacturing Key Market Players & Competitive Insights

The Fill Finish Manufacturing Market is distinguished by the presence of numerous global, regional, and local players catering to the fill finish manufacturing techniques that are evolving at a rapid pace. Furthermore, the growing R&D in the pharmaceutical industry is further driving the growth of the Fill Finish Manufacturing Market during the forecast period. The major players have adopted a strategy of obtaining regulatory approval from government agencies for their products and signing contracts and agreements to broaden their reach and reduce operational costs. For instance, in February 2022, Thermo Fisher Scientific Inc. and Moderna, Inc. collaborated for large-scale manufacturing in the U.S. of Moderna, Inc.’s COVID-19 vaccine Spikevax and other pipeline investigational mRNA medicines. In this collaboration, Thermo Fisher Scientific Inc. will support Moderna, Inc. in the quick scale-up of aseptic fill finish services and packaging of its COVID-19 vaccine.

The Fill Finish Manufacturing Market is extremely competitive, with players competing, partnering, and investing heavily in research and development to gain a significant market share. The market is moderately fragmented with rising competition, product launches, increasing collaborative partnerships, and other strategic decisions to achieve operational efficiency.

The business model developed by manufacturers in the Fill Finish Manufacturing Market includes manufacturing high-quality fill finish manufacturing products. Mergers and collaborations were also observed to expand the company's product portfolio, as well as introduce new products. The growth of prominent industry players is dependent on various factors, such as market conditions, government support, and industry development. Key manufacturers in the fill finish manufacturing market are focusing on developing products with advanced technologies. It is also projected that increasing government funding for medical education institutes will also boost the market's growth in the upcoming future.

Key Companies in the Fill Finish Manufacturing market includes

• Thermo Fisher Scientific Inc. (US)


• Cytiva (US)


• Fujifilm Holdings Corporation (Japan)


• OPTIMA Packaging Group GmbH (Germany)


• Curia Global, Inc. (US)


• Baxter (US)


• Becton, Dickinson, and Company (US)


• Aenova Group (Germany)


• SGD Pharma (France)


• Groninger & co. GmbH (Germany) among others

Fill Finish Manufacturing Industry Developments

March 2022 SGD Pharma launched an industry first ready-to-use sterile 100 mL moulded glass vials for aseptic fill/finish of parenteral drug products.

February 2022 Thermo Fisher Scientific Inc. and Moderna, Inc. (US) collaborated for large-scale manufacturing in the U.S. of Moderna, Inc.’s COVID-19 vaccine Spikevax and other pipeline investigational mRNA medicines. In this collaboration, Thermo Fisher Scientific Inc. will support Moderna, Inc. in the quick scale-up of aseptic fill finish services and packaging of its COVID-19 vaccine.

February 2021 Cytiva has acquired Vanrx Pharmasystems (Canada), a manufacturer of septic filling machines to fill syringes, vials, and cartridges with reduced risk and increased speed for patients. This acquisition will help the company deliver meaningful solutions for biomanufacturers.

Fill Finish Manufacturing Market Segmentation

Fill Finish Manufacturing Product Outlook

• Consumables
  
  
  
  • Prefilled Syringes
    
    
    
    • Glass Prefilled Syringes
    
    
    • Plastic Prefilled Syringes
    
    
    
    
  
  
  • Vials
    
    
    
    • Glass Vials
    
    
    • Plastic Vials
    
    
    
    
  
  
  • Cartridges
  
  
  • Other
  
  
  
  


• Instruments
  
  
  
  • System Machine
    
    
    
    • Integrated Systems
    
    
    • Standalone Systems
    
    
    
    
  
  
  • Machine Product
    
    
    
    • Automated Machines
    
    
    • Semi-Automated & Manual Machines
    
    
    
    
  
  
  
  

Fill Finish Manufacturing Modality Outlook

• Recombinant Proteins


• Monoclonal Antibodies


• Vaccines
  
  
  
  • mRNA
  
  
  • DNA
  
  
  • Inactivated
  
  
  • Viral Vector
  
  
  • Live-attenuated
  
  
  • Others
  
  
  
  


• Cell Therapies


• Viral Gene Therapies


• Non-Viral Gene Therapies


• Others

Fill Finish Manufacturing End User Outlook

• Contract Manufacturing Organizations


• Biotechnology and Pharmaceutical Companies


• Others

Fill Finish Manufacturing Regional Outlook

• 
  

  North America

  
  
  
  
  • US
  
  
  • Canada
  
  
  
  


• 
  

  Europe

  
  
  
  
  • Germany
  
  
  • France
  
  
  • UK
  
  
  • Italy
  
  
  • Spain
  
  
  • Rest of Europe
  
  
  
  


• 
  

  Asia-Pacific

  
  
  
  
  • China
  
  
  • Japan
  
  
  • India
  
  
  • Australia
  
  
  • South Korea
  
  
  • Australia
  
  
  • Rest of Asia-Pacific
  
  
  
  


• 
  

  Rest of the World

  
  
  
  
  • 
    

    Middle East

    
    
  
  
  • 
    

    Africa

    
    
  
  
  • 
    

    Latin America