Dublin, April 11, 2023 (GLOBE NEWSWIRE) -- The "Aseptic Fill Finish Market by Type of Molecule, Type of Packaging Container Offered, Type of Drug Product, Scale of Operation, Company Size, Target Therapeutic Area and Geographical Regions: Industry Trends and Global Forecasts, 2023-2035" report has been added to ResearchAndMarkets.com's offering.
The report features an extensive study of the current market landscape and future opportunity for the aseptic fill finish service providers. The report answers many key questions related to this domain.
It is worth noting that aseptic fill finish operations require skilled personnel, specialized automated equipment, cleanroom setup and continuous supervision to maintain the sterility and safety of the final drug product.
However, given the high cost of specialized equipment and affiliated expertise required for such operations, it is difficult for a drug developer with limited finances and capacity constraints to meet the needs of their clientele.
As a result, various stakeholders are outsourcing their fill finish related needs to contract service providers, in order to ensure the development of quality drug products. In fact, a number of companies are involved in offering biologics fill finish services and small molecule fill finish services. Additionally, there is a need for expanding the capacity to meet the anticipated demand for such operations.
For this purpose, service providers have inked several agreements over the last few years. Driven by the consistent initiatives being undertaken by players in this domain, the aseptic fill finish services market is anticipated to grow at a steady pace, over the coming years.
Key Market Insights
Growing Demand for Aseptic Fill Finish Services
Aseptic fill finish is a critical step in the production of drugs, as it involves the aseptic filling and packaging of therapeutic products into containers. In fact, even a minute error during the aseptic filling process can lead to microbial contamination, posing a considerable risk to the patient's health. Therefore, aseptic fill finish operations need to be performed under controlled environmental conditions, in order to minimize the exposure of drug product to factors that could negatively impact its stability and efficacy. This, in turn, helps in extending the shelf life of a drug product. It is also worth mentioning that, in recent years, many players are carrying out fill finish operations using automated equipment, without any manual intervention. This practice is believed to enhance the production efficiency, minimize downtime, reduce waste production, as well as increase the overall productivity. ,
Need for Outsourcing Aseptic Fill Finish Operations
The growing demand for pharmaceutical and biopharmaceutical drug products has created a need for higher capacity for production of therapies and their corresponding aseptic fill finish operations. However, extensive capital investment and complex infrastructure is necessary for carrying out in-house filling of biologics and small molecules.
In addition, mishandling of drug product during the fill finish process can lead to microbial contamination, which can subsequently result in the loss of drug product, production delays and most importantly, pose a risk to the patient's health. These aforementioned challenges have prompted pharmaceutical drug developers to outsource their fill finish operations to service providers, which have the required aseptic facilities and specialized equipment to ensure the quality of end products.
Key Drivers of the Aseptic Fill Finish Services Market
At present, the rising demand for outsourcing of aseptic fill finish services is driven by multiple factors, such as growing pipeline of drug products, stringent regulatory requirements, in-house capacity constraints, technological advancements and increased awareness related to the benefits of aseptic fill finish services.
Current Market Landscape of Aseptic Fill finish Service Providers
The current market landscape features the presence of over 235 aseptic fill finish service providers, spread across the globe. Overall, the market seems to be well-fragmented, featuring the presence of large, mid-sized and small companies, which have the required expertise to offer aseptic fill finish services across different types of packaging containers.
Additionally, various recent developments in this segment of the pharmaceutical industry indicate that service providers are actively upgrading their sterile pharmaceutical manufacturing capabilities and infrastructure to accommodate the current and anticipated demand for aseptic fill finish services.
Overall Size of the Aseptic Fill Finish Services Market
Driven by the growing pipeline of pharmaceutical and biopharmaceutical drug products, as well as the rising demand for contract services in this sector, the aseptic fill finish market is anticipated to grow at a compound annual growth rate (CAGR) of 7%, during the period 2023-2035.
Specifically, in terms of type of packaging container, the highest share of the market is anticipated to be captured by vials and prefilled syringes. In addition, at present, a major proportion of the market is represented by players based in North America and Europe.
Key Players in the Aseptic Fill Finish Services Market
Examples of key players engaged in offering aseptic fill finish services for biologics and small molecules include (which have been captured in this report) Aenova, AbbVie Contract Manufacturing, APL, Asymchem, 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, Patheon, Pfizer CentreOne, Plastikon Healthcare, PiSA Farmaceutica, Recipharm, Sharp Services, Wacker Biotech, Syngene, Takara Bio, WuXi Biologics, Siegfried and Wockhardt.
Scope of the Report
The study presents an in-depth analysis of the various firms / organizations that are engaged in this domain, across different segments.
The study also presents an in-depth analysis of various stakeholders engaged in this domain, highlighting their capabilities across different geographies. Following are some of the key focus areas and topics elaborated in this report:
- A summary of the key insights derived from our research, which offers a high-level view on the likely evolution of the aseptic fill finish service providers market in the short to mid-term, and long term.
- A general introduction to pharmaceuticals and contract manufacturing, which features a detailed discussion on the need for outsourcing within the pharmaceutical industry and key operations outsourced by biologic and small molecule drug developers, including fill finish. It also provides information on the key considerations for selecting a fill finish service provider, along with the advantages and risks posed by outsourcing fill finish operations.
- A detailed assessment of the overall landscape of aseptic fill finish service providers, along with information on several relevant parameters, such as year of establishment, company size (in terms of number of employees), location of headquarters, type of molecule(s) (biologics and small molecules) and type of packaging container(s) offered (ready-to-use cartridges, ready-to-use syringes and ready-to-use vials).
- A review of the overall landscape of companies offering aseptic fill finish services for biologics, along with analyses on a number of relevant parameters, such as year of establishment, company size, location of headquarters, location of fill finish facilities, type of packaging container(s) used (ampoules, cartridges, syringes and vials), type of biologic(s) manufactured (antibody drug conjugates, antibodies, biosimilars, cell therapies, gene therapies, oligonucleotides, peptides / proteins, vaccines, viral products, and others), scale of operation (preclinical, clinical and commercial) and type of additional drug product-related service(s) offered (lyophilization, labeling, quality testing, storage and distribution services).
- A detailed assessment of the overall market landscape of the companies offering aseptic fill finish services for small molecules, along with analyses on a number of relevant parameters, such as year of establishment, company size, location of headquarters, location of fill finish facilities, type of filling service(s) offered (aseptic filling, terminal streilization and blow-filling-seal), type of finishing service(s) offered (inspection and labelling and packaging), type of packaging container(s) offered (ampoules, cartridges, syringes and vials), scale of operation (preclinical, clinical and commercial), type of dosage form(s) filled (solid, liquids, lyophilized products / powders and semi-solids), type of process(es) (automated and manual / semi-automated).
- Tabulated profiles of key players based in North America, Europe and Asia-Pacific. Each profile provides an overview of the company, along with information on its service portfolio, fill finish facilities, financial information (if available), recent developments and an informed future outlook.
- A detailed analysis of the various partnerships and collaborations established by stakeholders in this domain, since 2013. It includes a brief description of different agreement models (including service agreements, service alliances, product integration agreements, joint ventures and acquisitions) adopted by stakeholders in this domain. Further, it comprises of analysis based on year of partnership, type of partnership, scale of operation, type of molecule(s), type of service(s) offered, type of process(es) involved, and type of drug product(s) filled. It also highlights the most active players (in terms of number of partnerships) in the domain.
- A case study focused on use of robotic systems in fill finish operations. It provides a list of equipment used by fill finish service providers (wherever specified), highlighting the purpose of robotics in various manufacturing operations. It also includes a list of companies offering robots for use in the manufacturing processes which are carried in the pharmaceutical sector.
- A case study on use of ready-to-use packaging components in aseptic fill finish operations. The chapter also provides information related to the advantages and disadvantages of ready-to-use packaging components, along with a list of suppliers providing these components.
Frequently Asked Questions
How many players are providing aseptic fill finish services?
Answer: Presently, more than 235 companies offer aseptic fill finish and other related services (such as aseptic filling, terminal sterilization and blow-fill-seal).
What are the latest trends in aseptic fill finish services market?
Answer: Aseptic fill finish market is evolving to meet the growing demands of the pharmaceutical and biopharmaceutical industry. Advanced technologies, such as robotics and single-use systems are being adopted to improve the accuracy, efficiency and safety of aseptic fill finish procedures.
In fact, single-use technology reduces the risk of cross-contamination and need for cleaning validation. Further, automated aseptic filling systems reduce the human interference and can meet various operational requirements, from loading of raw material to cleaning of the equipment. This, in turn, can improve the consistency and quality of the final product.
What is the growth rate of aseptic fill finish services market?
Answer: The global aseptic fill finish services market is expected to grow at a CAGR of 7%, during the period 2023-2035.
Which region captures the largest share of the aseptic fill finish services market?
Answer: Currently, Europe contributes to more than 35% share of the overall market. Further, Asia-Pacific is likely to grow at a relatively faster pace, during the forecast period.
Which segment, in terms of type of molecule, currently accounts for the largest share of the aseptic fill finish services market?
Answer: The small molecules segment currently holds the largest share (68%) in the overall aseptic fill finish services market. This trend is unlikely to change during the forecast period.
Which types of packaging containers are most widely used in the aseptic fill finish services market?
Answer: Presently, the vials (67%) account for the largest share in the global aseptic fill finish services market.
What type of partnerships are taking place in the aseptic fill finish services market?
Answer: At present, service agreements represent the most preferred type of partnership model adopted by stakeholders in this domain. This is followed by acquisitions and service alliances.
For more information about this report visit https://www.researchandmarkets.com/r/10vf7s
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