ASEPTIC FILL FINISH MANUFACTURING MARKET: OVERVIEW
As per Roots Analysis, the global aseptic fill finish manufacturing market is estimated to grow from USD 5.4 billion in the current year to USD 15 billion by 2035, at a CAGR of 9% during the forecast period, till 2035.
The market sizing and opportunity analysis has been segmented across the following parameters:
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
Key Geographical Regions
- North America
- Europe
- Asia-Pacific
- Middle East and North Africa
- Latin America
ASEPTIC FILL FINISH MANUFACTURING MARKET: GROWTH AND TRENDS
Fill / finish is the final step in the downstream processing of a product, wherein the purified bulk formulation of the drug product is mixed with the necessary excipients and stabilizers and formulated and aliquoted into the appropriate dosage forms for clinical use or commercial distribution. These operations are usually carried out under aseptic conditions and are mostly automated. It is worth mentioning that aseptic fill finish manufacturing requires specialized automated equipment, clean room setup, skilled personnel, and continuous supervision to maintain the sterility and safety of the final drug product. Given the challenges associated with improper filling of drugs and to ensure the quality of end-products, innovators have developed a preference for outsourcing their aseptic fill / finish operations to contract service providers. Presently, contract fill-and-finish services are among the most outsourced services in the pharmaceutical domain. Driven by the growing trend of outsourcing, the opportunity within the aseptic fill / finish services market is anticipated to increase at a steady pace in the foreseen future.
ASEPTIC FILL FINISH MANUFACTURING MARKET: KEY INSIGHTS
The report delves into the current state of the aseptic fill finish manufacturing market and identifies potential growth opportunities within the industry. Some key findings from the report include:
- 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.
- 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.
- Around 125 industry players offer fill / finish services for various types of small molecule drug products, across different scales of operation.
- Leveraging their expertise, 85% of stakeholders extend services for labelling and packaging, both for clinical and commercial scale operations.
- In order to expand their aseptic fill / finish service portfolios and gain access to emerging technologies, companies are actively entering into strategic partnerships.
- 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.
- 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 likely to account for ~5% market share, each.
ASEPTIC FILL FINISH MANUFACTURING MARKET: KEY SEGMENTS
Currently, Biologics Occupy the Largest Share of the Aseptic Fill Finish Manufacturing Market
Based on the type of molecule, the market is segmented into small molecules and biologics. At present, the biologic segment holds the maximum share of the aseptic fill finish manufacturing market. This trend is unlikely to change in the near future.
Syringes is the Fastest Growing Segment of the Aseptic Fill Finish Manufacturing Market
Based on the type of packaging container, the market is segmented into vials, syringes, ampoules, cartridges. Currently, vials hold the maximum share of the aseptic fill finish manufacturing market. It is worth highlighting that aseptic fill finish manufacturing market for syringes is likely to grow at a relatively higher CAGR.
Antibodies are Likely to Dominate the Aseptic Fill Finish Manufacturing Market During the Forecast Period
Based on the type of drug products, the market is segmented into vaccines, recombinant proteins, antibodies, oligonucleotides, gene therapies, cell therapies, other products. At present, antibodies hold the maximum share of the aseptic fill finish manufacturing market. This trend is likely to remain the same in the forthcoming years.
Oncological Disorders Account for the Largest Share of the Aseptic Fill Finish Manufacturing Market
Based on the therapeutic area, the market is segmented into autoimmune disorders, cardiovascular disorders, infectious disorders, oncological disorders, other disorders. While oncological disorders account for a relatively higher market share, it is worth highlighting that the autoimmune disorders segment is expected to witness substantial market growth in the coming years.
Based on the Scale of Operation, Commercial Scale is Likely to Dominate the Aseptic Fill Finish Manufacturing Market During the Forecast Period
Based on the scale of operation, the market is segmented into preclinical / clinical and commercial scale. Whilst commercial scale manufacturing will be the primary driver of the overall market, it is worth highlighting that the aseptic fill finish manufacturing market at preclinical / clinical scale is likely to grow at a relatively higher CAGR.
Large Companies Segment is the Fastest Growing Segment of the Aseptic Fill Finish Manufacturing Market During the Forecast Period
Based on the company size, the market is segmented into large, mid-sized and small companies. At present, large companies hold the maximum share of the aseptic fill finish manufacturing market. It is worth highlighting that the aseptic fill finish manufacturing market for small companies is likely to grow at a relatively higher CAGR.
North America Accounts for the Largest Share of the Market
Based on key geographical regions, the market is segmented into North America, Europe, Asia-Pacific and Rest of the World. Majority share is expected to be captured by players based in North America. It is worth highlighting that, over the years, the market in Asia-Pacific is expected to grow at a higher CAGR.
Example Players in the Aseptic Fill Finish Manufacturing Market
- 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
Primary Research Overview
The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders. The research report features detailed transcripts of interviews held with the following industry stakeholders:
- Former Chief Commercial Officer, IDT Biologika
- Former Vice President of Business Development and Marketing, Cytovance Biologics
- Vice President and Head of Formulation Development, Syngene
- Head of Business Development, oncomed manufacturing
- Former Technology Watch Manager, Yposkesi
- International Business Developer, HALIX
ASEPTIC FILL FINISH MANUFACTURING MARKET: RESEARCH COVERAGE
- Market Sizing and Opportunity Analysis: The report features an in-depth analysis of the aseptic fill / finish manufacturing market, focusing on key market segments, including [A] type of molecule, [B] type of packaging container offered, [C] type of drug product, [D] scale of operation, [E] company size, [F] target therapeutic area and [G] key geographical regions.
- Market Landscape 1: A comprehensive evaluation of sterile fill / finish service providers, considering various parameters, such as [A] year of establishment, [B] company size (in terms of number of employees), [C] location of headquarters, [D] type of molecule(s) and [E] type of packaging container(s) offered.
- Market Landscape 2: A comprehensive evaluation of companies offering aseptic fill / finish services for biologics, considering various parameters, such as [A] year of establishment, [B] company size, [C] location of headquarters, [D] location of fill / finish manufacturing facility, [E] type of packaging container(s) used, [F] type of biologic(s) manufactured, [G] scale of operation and [H] type of additional drug product-related service(s) offered.
- Market Landscape 3: A comprehensive evaluation of companies offering aseptic fill / finish services for small molecules, considering various parameters, such as [A] year of establishment, [B] company size, [C] location of headquarters, [D] location of fill finish manufacturing facility, [E] type of filling service(s) offered, [F] type of finishing service(s) offered, [G] type of packaging container(s) offered, [H] scale of operation, [I] types of dosage forms filled and [J] type of process(es).
- Company Profiles: In-depth profiles of key aseptic fill / finish service providers based in North America, Europe and Asia Pacific, focusing on [A] company overviews, [B] service portfolio, [C] fill-finish manufacturing facility, [D] financial information (if available), [E] recent developments and [F] an informed future outlook.
- Partnerships and Collaborations: An analysis of partnerships established in this sector based on multiple relevant parameters, such as [A] year of partnership, [B] type of partnership, [C] scale of operation, [D] type of molecule(s), [E] type of service(s) offered, [F] type of process(es) involved, [G] type of drug product(s) filled and [H] most active companies (in terms of number of partnerships) in the industry.
- Case Study 1: A general discussion on the use of robotic systems in aseptic fill and finish operations. It provides a list of equipment used by fill / finish service providers, highlighting the purpose of robotics in various manufacturing operations. Additionally, it includes a list of companies offering robots for use in the manufacturing processes which are carried out in the pharmaceutical sector.
- Case Study 2: A general discussion on the use of ready-to-use packaging components in aseptic fill / finish operations. It also includes information related to the advantages and disadvantages of ready-to-use packaging components, along with a list of suppliers providing these components.
KEY QUESTIONS ANSWERED IN THIS REPORT
- How many companies are currently engaged in this market?
- Which are the leading companies in this market?
- What kind of partnership models are commonly adopted by industry stakeholders?
- What factors are likely to influence the evolution of this market?
- What is the current and future market size?
- What is the CAGR of this market?
- How is the current and future market opportunity likely to be distributed across key market segments?
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