InsightAce Analytic Pvt. Ltd. announces the release of the market assessment report on Global Aseptic Fill Finish Market Size, Share & Trends Analysis Report By Molecules (Small Molecules & Biologics), Type of Packaging Containers (Ampoules, Cartridges, Syringes, and Vials), Drug Product Types (Antibodies, Cell Therapies, Gene Therapies, Oligonucleotides, Recombinant Proteins, Vaccines, and Other Products), Target Therapeutic Area (Autoimmune Disorders, Cardiovascular Disorders, Infectious Diseases Oncological Disorders, and Other Disorders), Scale of Operation (Preclinical/Clinical and Commercial), Company Size (Large, Mid-sized, & Small) Market Outlook And Industry Analysis 2031."
Aseptic fill finish services include the precise and sterile filling/sealing of medicinal products into containers such as vials, syringes, ampoules and cartridges. These aseptic conditions during fill and finish operation are important to ensure the safety of the patients and maintain product quality. However, pharmaceutical manufacturers with limited funds and capacity may find it challenging to meet the needs of consumers due to the high cost of specialized equipment and qualified professionals for these jobs. Therefore, many stakeholders outsource their needs by contracting with service providers to ensure the development of quality products. Currently, contract fill-finish services are one of the most commonly outsourced services. Increasing demand for drugs in the global market and the advantages of contract manufacturing in reducing the overall investment in pharmaceutical manufacturing are the main factors boosting business growth. Moreover, the COVID-19 pandemic stimulated the development of COVID-19 vaccines, antiviral drugs, and other related pharmaceutical products. Vaccines & biologics require special manufacturing and fill & finish systems and procedures to maintain product quality and safety. Thus, covid-19 outbreak positively impacted the aseptic fill finish market.
Some of the prominent players in the Aseptic Fill Finish Market are: AbbVie Contract Manufacturing Asymchem Aenova APL BioPharma Solutions BioReliance Boehringer Ingelheim BioXcellence Catalent Biologics Charles River Laboratories CordenPharma Delpharm Fareva Fresenius Kabi Glaxo SmithKline Hetero Drugs Intas Pharmaceuticals Lonza Pierre Fabre Pfizer CentreOne Plastikon Healthcare Patheon PiSA Farmaceutica Recipharm Wacker Biotech Syngene Sharp Services Siegfried Takara Bio WuXi Biologics Wockhardt Other Prominent Players
Market Dynamics:
Drivers: The factors contributing to driving the aseptic fill-finish market are the high demand for outsourcing aseptic fill-finish services, the growing pipeline of drug products, in-house capacity constraints, technological developments, and increased awareness related to the benefits of aseptic fill-finish services.
Many pharma, biopharma, and contract manufacturing organizations have adopted single-use fill-finish systems, specifically for biologics. For example, PreVAS (Syntegon Technology GmbH) is a pre-assembled and pre-sterilized disposable filling system for vials, syringes, cartridges, and ampoules. This is mainly because single-use eliminates the need for expensive and time-consuming sterilization processes.
Challenges: Aseptic fill-finish operations carry more risk than non-sterile processes. They require trained personnel, careful planning, and specialized facilities and equipment to perform the procedure. Maintaining a contamination-free environment is crucial as it can cause financial losses and affect patients' lives. Sterilization of components required for aseptic fill-finishing processes is also an additional step.
Regional Trends: North Americas aseptic fill finish market is projected to hold the second-highest revenue share after Asia Pacific. Factors contributing to this growth are rising demand for diagnostics, increasing pharma & biopharma companies, well-established industrial infrastructure, advancement in medical technologies, increasing collaborations and agreements, and improved developmental capabilities of the contract manufacturing companies in this region.
Key developments in the market: In May 2023, CordenPharma announced its entry into the synthetic Oligonucleotide manufacturing arena in CordenPharma Colorado. With an organic capex investment in Two Phases, the strategic expansion will provide innovative biotech and pharma customers with a fully-integrated API to Drug Product service offering organized under a new Oligonucleotides Platform. In January 2023, CordenPharma announced the signing of a multi-year agreement to manufacture a large-volume peptide at its CordenPharma Colorado facility, including aseptic fill and finish capabilities. In June 2022, Pierre Fabre and Lonza entered into a manufacturing agreement for W0180 Antibody Drug Product. Lonza will provide clinical drug product manufacturing for W0180, discovered by Pierre Fabre targeting solid tumours, from its fill and finish facility in Stein, Switzerland. In March 2021, GlaxoSmithKline offered fill and finish manufacturing capacity to Novavax for the supply of Covid-19 vaccine in the UK. In March 2021, Baxter BioPharma Solutions and Moderna collaborated to offer the fill/finish manufacturing services and supply packaging of the Moderna Covid-19 Vaccine in the U.S.
Market Segments
Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2023 to 2031 based on Type of Molecules Small Molecules Biologics
Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2023 to 2031 based on Type of Packaging Containers Vials Syringes Ampoules Cartridges
Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2023 to 2031 based on Type of Drug Products Vaccines Recombinantn Proteins Antibodies Oligonucleotides Gene Therapies Cell Therapies Other Products
Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2023 to 2031 based on Target Therapeutic Area Autoimmune Disorders Cardiovascular Disorder Infectious Disorders Oncological Disorders Other Disorders
Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2023 to 2031 based on Scale of Operation Preclinical / Clinical Commercial Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2023 to 2031 based on Company Size Large Mid-sized Small
Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2023 to 2031 based on Region North America Europe Asia Pacific Latin America Middle East & Africa
North America Aseptic Fill Finish Market Revenue (US$ Million) by Country, 2023 to 2031 U.S. Canada Europe Aseptic Fill Finish Market Revenue (US$ Million) by Country, 2023 to 2031 Germany France Italy Spain Russia Rest of Europe Asia Pacific Aseptic Fill Finish Market Revenue (US$ Million) by Country, 2023 to 2031 India China Japan South Korea Australia & New Zealand Latin America Aseptic Fill Finish Market Revenue (US$ Million) by Country, 2023 to 2031 Brazil Mexico Rest of Latin America
Middle East & Africa Aseptic Fill Finish Market Revenue (US$ Million) by Country, 2023 to 2031 GCC Countries South Africa Rest of Middle East & Africa
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