Aseptic Fill Finish Services Market, 2023-2035

Aseptic Fill Finish Services Market, 2023-2035

INTRODUCTION

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.

KEY MARKET INSIGHTS

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.

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, as defined in the below table:

Aseptic Fill finish Services Market: Report Attributes / Market Segmentations

Report Attribute

Details

Forecast Period

2023 – 2035

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 (equivalent to 5 Analyst working days)

PowerPoint Presentation (Complimentary)

Available

Excel Data Packs (Complimentary)

Market Landscape Analysis

Developers Landscape Analysis

Partnership and Collaboration Analysis

Market Forecast and Opportunity Analysis

Source: Roots Analysis

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.

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:

Gregor Kawaletz (Former Chief Commercial Officer, IDT Biologika)

Matt Delaney (Former Vice President Business Development & Marketing, ‎Cytovance Biologics)

Purushottam Singnurkar (Vice President and Head of Formulation Development, Syngene International)

Ales Sima (Head of Business Development, Oncomed Manufacturing)

Amit Chandra (Former Technology Watch Manager, Yposkesi)

Jos Vergeest (International Business Developer, HALIX)

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.

RESEARCH METHODOLOGY

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:

Annual reports

Investor presentations

SEC filings

Industry databases

News releases from company websites

Government policy documents

Industry analysts’ views

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.

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 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.

CHAPTER OUTLINES

Chapter 1 is a preface providing an introduction to the full report, Aseptic Fill finish Services Market, 2023-2035.

Chapter 2 is an executive summary of the key insights captured in our research. It 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.

Chapter 3 provides a general overview of pharmaceuticals and contract manufacturing, which features a detailed discussion on the need for outsourcing within the pharmaceutical industry and key operations outsourced by the biologics and small molecules drug developers, including fill finish. It also provides information on the key considerations for selecting a fill finish service provider, along with the benefits and risks associated with outsourcing fill finish operations.

Chapter 4 includes the overall landscape of aseptic fill finish service providers and analysis based on 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) (ready-to-use vials, ready-to-use cartridges and ready-to-use syringes).

Chapter 5 presents an overall landscape of the companies offering aseptic fill finish services for biopharmaceuticals / biologics, along with analyses based 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) offered (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), type of additional drug product-related service(s) offered (lyophilization, labeling, quality testing, storage and distribution services).

Chapter 6 presents an overall landscape of the companies offering aseptic fill finish services for small molecules, along with analyses based 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).

Chapter 7 includes detailed and tabulated profiles of the key players based in North America. Each profile features a brief overview of the company, its overall contract service offerings highlighting the capabilities of fill finish facilities (if available), financial information (if available), recent developments and an informed future outlook.

Chapter 8 includes detailed and tabulated profiles of the key players based in Europe. Each profile features a brief overview of the company, its overall contract service offerings highlighting the capabilities of fill finish facilities (if available), financial information (if available), recent developments and an informed future outlook.

Chapter 9 includes detailed and tabulated profiles of the key players based in Asia-Pacific. Each profile features a brief overview of the company, its overall contract service offerings highlighting the capabilities of fill finish facilities (if available), financial information (if available), recent developments and an informed future outlook.

Chapter 10 features a detailed analysis of the various partnerships and collaborations that have been inked amongst players since 2013. It includes a brief description of the partnership models (including service agreements, service alliance, 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) involved, type of service(s) offered, type of process(es) involved and type of drug product(s) involved. It also highlights the most active players (in terms of number of partnerships) in the domain.

Chapter 11 presents a comprehensive market forecast analysis, highlighting the likely growth of the aseptic fill finish services market till the year 2035. In order to provide an informed future outlook, our projections have been segmented on the basis of type of molecules (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).

Chapter 12 is a case study focused on use of robotic systems in fill finish operations. It provides a list of equipment used by the service providers (wherever specified) for fill finish operations, highlighting the purpose of robotics in various manufacturing operations. It also includes a list of companies providing robots for applications in pharmaceutical manufacturing.

Chapter 13 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.

Chapter 14 presents the summary of the overall report. The chapter provides the key takeaways from the report and expresses our independent opinion on the aseptic fill finish services market, based on the research and analysis described in the previous chapters.

Chapter 15 contains the transcripts of interviews conducted with representatives from renowned organizations that are engaged in the aseptic contract manufacturing and fill finish domain. In this study, we spoke to Gregor Kawaletz (Chief Commercial Officer, IDT Biologika), Matt Delaney (Vice President Business Development & Marketing, ‎Cytovance Biologics), Purushottam Singnurkar (Research Director and Head of Formulation Development, Syngene International), Ales Sima (Business Development Manager, Oncomed Manufacturing), Amit Chandra (Technology Watch Manager, Yposkesi) and Jos Vergeest (International Business Developer, HALIX).

Chapter 16 is an appendix, which contains tabulated data and numbers for all the figures included in this report.

Chapter 17 is an appendix, which contains a list of companies and organizations mentioned in this report.