Aseptic Fill Finish Manufacturing Market

Aseptic Fill Finish Manufacturing 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

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Aseptic Fill Finish Manufacturing Market Overview

The global aseptic fill finish manufacturing market size is estimated to grow from USD 5.4 billion in 2023 to USD 15 billion by 2035, representing a CAGR of 9% during the forecast period 2023-2035. Aseptic fill finish refers to accurate and sterile fill finish / sealing of drug products into packaging containers, such as vials, prefilled 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 manufacturing requires skilled personnel, specialized automated equipment, clean room 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 fill-finish 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 manufacturing 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 companies in this industry, the aseptic fill finish manufacturing market is anticipated to grow at a steady pace, over the forecast period.

The image provides context of aseptic fill / finish market. The growing concern to maintain pharmacological efficacy and product quality, to ensure patient’s safety, has led to a greater focus on the need for aseptic fill / finish; drug developers prefer to outsource these operations to benefit from the expertise of service providers This image provides list of biologics fill / finish service providers. Over 175 companies claim to offer fill / finish services for various types of biopharmaceutical drug products; the growth initiatives, in this segment, are being led by large and mid-sized players The image provides details on the current biologics fill / finish service providers market landscape. More than 70% of the service providers offer fill / finish for proteins and peptides; in addition, ~80% of the players have the required capabilities to carry out lyophilization operations

Aseptic Fill Finish Manufacturing Market Key Insights

The Aseptic Fill Finish Manufacturing Market by Type of Molecule (Small Molecules and Biologics), Type of Packaging Container Offered (Ampoules, Cartridges, Prefilled Syringe 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, market size and future opportunity for the aseptic fill finish service providers. Some of the key takeaways from the market report are mentioned below.

Growing Demand for Aseptic Fill Finish Services

Aseptic fill finish is a critical step in the production of drugs, as it involves the aseptic fill and finish of therapeutic products into containers. In fact, even a minute error during the fill finish manufacturing 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. ,  

Fill Finish CMO: 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 sterile fill finish operations. However, extensive capital investment and complex infrastructure is necessary for carrying out in-house fill&finish 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 sterile fill finish operations to service providers, which have the required fill finish  facility and specialized equipment to ensure the quality of end products.  With the growing demand for biologics and the advent of new generation of complex biologics and ATMPs, the aseptic fill finish manufacturing market for the contract manufacturers will continue to witness healthy market growth over the forecast period.

Sterile Fill Finish: Key Drivers of the Aseptic Fill Finish Manufacturing 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 such as pharmaceutical vials and prefilled syringe. Additionally, various recent developments in this segment of the pharmaceutical industry indicate that service providers are actively upgrading their sterile fill finish capabilities and infrastructure to accommodate the current and anticipated demand for aseptic fill finish services.

Aseptic Fill Finish Manufacturing: Overall Market Size is Anticipated to Increase at CAGR of ~9%

Driven by the growing pipeline of pharmaceutical and biopharmaceutical drug products, as well as the rising demand for contract manufacturing in this sector, the aseptic fill finish manufacturing market is anticipated to grow at a CAGR of 9%, during the forecast period. Specifically, in terms of type of packaging container, the highest market share is anticipated to be captured by vials and prefilled syringe. In addition, at present, a major proportion of the market is represented by players based in North America and Europe. However, over the forecast period, Asia Pacific market is anticipated to grow at a higher CAGR.

Key Companies in the Aseptic Fill Finish Manufacturing Market

Examples of key companies engaged in offering sterile 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. This market report includes an easily searchable excel database of all the aseptic fill finish CMO worldwide.

Recent Developments in Aseptic Fill Finish Market

Several recent developments have taken place in the field of aseptic fill finish market. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.

  • In June 2023, WuXi announced the expansion of its capacity for drug substance and drug product in Germany. 
  • In May 2023, Moderna collaborated with Novocol Pharma in order to perform aseptic fill-finish, labelling and packaging of mRNA respiratory vaccines in Canada.
This image provides list of small molecules fill / finish service providers.Around 125 industry players offer fill / finish services for various types of small molecule drug products, across different scales of operation This infographic looks at the current small molecules fill / finish service providers market landscape.Leveraging their expertise, 85% stakeholders extend services for labelling and packaging, both for clinical and commercial scale operations This image looks at the trend of partnerships and collaboration agreements signed by companies providing services related to aseptic fill / finish. In order to expand their aseptic fill / finish service portfolios and gain access to emerging technologies, companies are actively entering into strategic partnerships

Scope of the Aseptic Fill Finish Manufacturing Market Report

The market report presents an in-depth analysis of the various firms / organizations that are engaged in this industry, across different segments, as defined in the below table:

Market Outlook / Report Segments

Key Data Points Report Insights & Segments

Base Year

2022

Forecast Period 2023-2035
Historical Period

2018-2022

Market Size 2023 $5.4 billion
CAGR 2023-2035 ~9%
Type of Molecules Small Molecules, Biologics
Type of Packaging Containers Offered Vials, Syringes, Ampoules, Cartridges
Type of Drug Products Vaccine, Recombinant Proteins, Antibodies, Oligonucleotides, Gene Therapies, Cell Therapies, Other Products
Target Therapeutic Area Autoimmune Disorders, Cardiovascular Disorders , Infectious Disorders, Oncological Disorders , Other Disorders
Scale of Operation Preclinical / Clinical, Commercial
Company Size Large, Mid-sized, Small
Geography North America, Europe, Asia Pacific, Middle East and North Africa, Latin America
Key Companies Profiled

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 

(Full list of 235+ companies captured in the market landscape analysis of the report) 
 

Customization Scope 15% Free Customization Option
PowerPoint Presentation (Complimentary) Available
Excel Data Packs (Complimentary) Market Landscape Analysis, Developers Landscape Analysis, Partnership and Collaboration Analysis, Market Forecast and Opportunity Analysis

The market report also presents an in-depth analysis of various stakeholders contributing to the aseptic fill finish manufacturing market growth, highlighting their capabilities across different geographies. Amongst other elements, the market report includes :

  • A summary of the key insights derived from our research, which offers a high-level view on the likely evolution of the fill finish CMO 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 CMO, along with the advantages and risks posed by outsourcing fill&finish operations.
  • A detailed assessment of the overall landscape of sterile 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 prefilled syringe 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 manufacturuing facility, type of packaging container(s) used (ampoules, cartridges,prefilled syringe 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 manufactruing facility, type of filling service(s) offered (aseptic filling, terminal sterilization and blow fill seal services), type of finishing service(s) offered (inspection and labelling and packaging), type of packaging container(s) offered (ampoules, cartridges, prefilled syringe and vials),  scale of operation (preclinical, clinical and commercial), types of dosage forms filled (solid, liquids, lyophilized products / powders and semi-solids), type of process(es) (automated and manual / semi-automated).
  • Tabulated profiles of key companies based in North America, Europe and Asia Pacific. Each profile provides a company snapshot, along with information on its services offered, fill-finish manufactruing facility, financial information (if available), recent developments and an informed future outlook. 
  • A detailed analysis of the various partnerships and collaborations established by contract manufacturing organizations in aseptic fill finish manufacturing market, 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 service providers in this market. 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 companies (in terms of number of partnerships) in the industry.  
  • A case study focused on use of robotic systems in aseptic fill and 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.

One of the key objectives of this market report was to estimate the current market size and future opportunities in the aseptic fill finish manufacturing market, over the forecast period. We have provided an informed estimate of the likely evolution of the aseptic fill finish manufacturing market in the short to mid-term and long term, for the forecast period. 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, prefilled syringe 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 growth 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 market 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:

  • Former Chief Commercial Officer, Germany based Large Company
  • Former Vice President Business Development & Marketing, ‎US based Mid-sized Company
  • Vice President and Head of Formulation Development, India based Large Company
  • Head of Business Development, Czech Republic based Small Company
  • Former Technology Watch Manager, France based Mid-sized Company
  • International Business Developer, Netherlands based Mid-sized Company

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.

This image provides details on aseptic fill / finish market size. The aseptic fill / finish services market is likely to grow at a CAGR of ~11%, till 2035; this opportunity is expected to be well distributed across different types of molecules, packaging containers and drug products The image provides segmentaion of aseptic fill / finish market market. In the long-term, the US (~30%) is likely to significantly contribute towards the market growth, followed by Asia-Pacific countries; specifically, within Europe, Germany and France are like to account for ~5% market share, each  

Frequently Asked Questions

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 4: 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 5: 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 6: 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 7: 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 8: 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 9: 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.

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