PUBLISHER: Roots Analysis | PRODUCT CODE: 1250131
PUBLISHER: Roots Analysis | PRODUCT CODE: 1250131
Aseptic fill finish refers to accurate and sterile filling / sealing of drug products into packaging containers, such as vials, syringes, ampoules and cartridges. These aseptic conditions during fill finish operations are not only essential for ensuring end-user's safety, but also maintaining pharmacological efficacy and product quality. 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 services for aseptic fill finish of a wide range of biologics and small molecules. 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.
The Aseptic Fill Finish Services Market by Type of Molecule (Small Molecules and Biologics), Type of Packaging Container Offered (Ampoules, Cartridges, Syringes and Vials), Type of Drug Product (Antibodies, Cell Therapies, Gene Therapies, Oligonucleotides, Recombinant Proteins, Vaccines and Other Products), Scale of Operation (Preclinical / Clinical and Commercial), Company Size (Large, Mid-sized and Small), Target Therapeutic Area (Autoimmune Disorders, Cardiovascular Disorders, Infectious Diseases Oncological Disorders, and Other Disorders) and Geographical Regions (North America, Europe, Asia Pacific, Middle East and North Africa and Latin America): Industry Trends and Global Forecasts, 2023-2035 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.
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.
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:
One of the key objectives of this report was to estimate the current market size and future opportunities in the aseptic fill finish services market, over the coming 12 years. We have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2023-2035. In order to provide a detailed future outlook, year-wise projections of the current and future opportunity have been further segmented on the basis of type of molecule (small molecules and biologics), type of packaging container offered (ampoules, cartridges, syringes and vials), type of drug product (antibodies, cell therapies, gene therapies, oligonucleotides, recombinant proteins, vaccines and other drug products), target therapeutic area (autoimmune disorders, oncological disorders, cardiovascular disorders, infectious diseases and other disorders), scale of operation (preclinical / clinical and commercial), company size (large, mid-sized and small) and geography, (North America, Europe, Asia-Pacific, Middle East and North Africa, and Latin America). To account for uncertainties in the market and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market's evolution.
The opinions and insights presented in this report are backed by our understanding of key data generated from both secondary and primary research. The perceptions presented in this study were also influenced by our discussions with senior stakeholders in the industry. The report further features detailed transcripts of interviews held with the following industry and non-industry players:
All actual figures have been sourced and analyzed from publicly available forums and primary research discussions. It is important to highlight that, financial figures mentioned in this report are in USD, unless otherwise specified.
The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews / surveys with the domain experts (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Wherever possible, the available data has been checked for accuracy from multiple sources of information.
The secondary sources of information include:
While the focus has been on forecasting the market till 2035, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our understanding of the relevant markets, and knowledge gathered from various secondary and primary sources of information.
Question 1: What is the aseptic fill finish?
Answer: Fill finish is the last step in the aseptic manufacturing process, where drug products are filled and packaged in various packaging containers, such as vials, syringes, ampoules and cartridges, under sterile conditions. Further, the process is carried out in a controlled cleanroom environment, which has low levels of particulate matter and microorganisms to prevent microbial contamination. It is worth mentioning that fill finish is a complex and highly regulated process, to ensure the safety and efficacy of these drug products, as any contamination could lead to serious health risks for patients.
Question 2: What are the requirements and considerations for aseptic fill finish operation?
Answer: Aseptic filling process requires close coordination and complex interactions between supporting personnel and key operational equipment, sterilized drug product, cleanroom and other supporting facilities, and ancillary materials.
Question 3: 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).
Question 3: 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.
Question 4: 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.
Question 5: 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.
Question 6: 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.
Question 7: 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.
Question 8: 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.