In order to meet the anticipated future demand for biologics fill / finish services in the American and European markets, contract service providers based in these regions have made significant investments in accruing additional capacity for drug product manufacturing and fill / finish
-- Chief Commercial Officer, large-sized company
Biologics Fill Finish Manufacturing Market Overview
The biologics fill finish manufacturing market, representing the opportunity for contract manufacturers, is estimated to be USD 4 billion in 2022. The global market size is anticipated to grow at a CAGR of 8.4% during the forecast period. The advent of biologics marked the beginning of a new era in the pharmaceutical industry. Over time, the growing promise of biopharmaceuticals has captured the interest of various industry and academic stakeholders. Currently, more than 200 biologics are commercially available and over 10,000 candidates are under clinical evaluation. With the increasing demand and diversity of biologics, an increase in the demand for production capacity and aseptic fill finish operations has been observed. Fill/finish refers to the process of filling the final drug products in sterile packaging containers (including vials, syringes, ampoules and cartridges).
Of all the steps involved in the production of biologics, fill-finish is amongst the most critical steps and a heavily outsourced operation. In fact, even a minute error 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 risk to the patient’s health. As a result, various stakeholders are turning to contract manufacturing organizations for their fill/finish related requirements and necessary infrastructure, to ensure the development of quality drug products. Driven by the growing demand for biopharmaceuticals, the biologics fill finish manufacturing market is anticipated to witness substantial growth during the forecast period.
Fill Finish Manufacturing Market Key Insights
The Biologics Fill Finish Manufacturing Market (3rd Edition) by Type of Packaging Containers (Ampoules, Cartridges, Syringes and Vials), Type of Biologics (Antibodies, Cell Therapies, Gene Therapies, Oligonucleotides, Recombinant Proteins, Vaccines and Other Biologics), Scale of Operation (Preclinical / Clinical and Commercial), Company Size (Large, Mid-sized and Small), Key Therapeutic Areas (Autoimmune Disorders, Oncological Disorders, Cardiovascular Disorders, Infectious Diseases and Other Disorders), Geographical Regions (North America, Europe, Asia Pacific, Middle East and North Africa and Latin America): Industry Trends and Global Forecasts, 2022-2035 market report features an extensive study of the current market landscape, market size, market forecast and future opportunities associated with the biopharmaceuticals fill finish market, during the given forecast period. The research report highlights efforts of several contract manufacturing organizations engaged in this rapidly emerging segment of the biopharmaceuticals manufacturing industry. Key takeaways of the biologics fill finish manufacturing market are briefly discussed below.
Biologics Fill Finish Manufacturing: Market Landscape of Contract Manufacturing Organizations
With the growing pipeline of biologics, the demand for contract services for development and fill/finish has increased. Currently, close to 180 companies offer fill finish manufacturing services for a wide range of biologics. In terms of geographical presence, we have identified more than 350 fill-finish facilities of these contract manufacturing organizations. Majority of the facilities are located in Europe, followed by North America and Asia Pacific.
Nearly 70% of the companies have the capability to operate at all the scales of operation from preclinical to commercial. Additionally, the companies have capability to work with different types of biologics including peptides, antibodies, vaccines, cell therapy, gene therapy, nucleic acids, plasmid DNA, antibody drug conjugates, biosimilars and others.
Market Trends Analysis: Partnerships by Companies to Fulfil the Growing Demand for Fill-Finish Manufacturing
The biopharmaceutical industry has witnessed substantial number of partnerships and collaborations between drug developers and fill/finish contract manufacturing organizations over the last few years. The COVID 19 pandemic also led to an increase in the demand for fill finish of vaccines, leading to a rise in the number of service agreements. For fulfilling the demand for its COVID vaccine in Europe, Pfizer and BioNTech collaborated with Delpharm, Thermo Fisher Scientific and more companies for fill&finish operations. Similarly, Moderna entered into service agreements with Catalent, ROVI, Thermo Fisher, Recipharm, Samsung Biologics and other companies to fulfill the fill&finish demand for its COVID vaccine. We believe that service providers are likely to continue undertaking similar initiatives in the short-term to consolidate their presence in this field, distinguish themselves from the competition and cater to the diversified needs of their clientele. However, as the demand for fill/finish of pandemic vaccine decreases in the long-term, the contract manufacturing organizations will enter a phase of increased competition.
Global Market Size of Fill Finish Manufacturing for Biopharmaceuticals
The biologics fill finish manufacturing market opportunity for the CMOs is estimated to be USD 4 billion in 2022. With outsourcing being increasingly accepted as a viable / beneficial business model and the anticipated market growth for biologics, the opportunity for fill/finish contract manufacturers is expected to grow at a steady pace over the forecast period. Another key driver for the market growth for outsourcing of fill finish services of biologics is the rise in the number of small biopharmaceutical drug developers. The last few years have seen a rise in the number of investor funded startups for cell and gene therapy. As these drug developers move their products to clinical stages, the demand for outsourcing of biologic manufacturing and fill finish services will witness a healthy market growth.
Europe a Hub for Biologics Fill Finish; North America to be the Fastest Growing Market
Currently, Europe and Asia Pacific capture over 70% share of the overall biologics fill finish manufacturing market. In recent years, demand for fill finish services in Asia Pacific region has observed a tremendous increase. However, in the coming years, owing to the anticipated drug approvals, North America is likely to grow at a much faster rate as compared to other geographies.
Future Outlook: Contract Manufacturers to Undertake Expansions in Order to Fill the Demand Supply Gap
A number of CMO / CDMOs have taken initiatives to expand their existing facilities and incorporate advanced technologies in order to meet the growing demand for fill/finish services, reduce cost of operation / increase efficiency, and comply to evolving safety and regulatory requirements. This market report analyzes the current installed capacity with the contract manufacturers for fill finish of biopharmaceuticals and the demand for commercial biologics till 2035. The current installed capacity is sufficient to meet the industry demand, but based on our data analysis this scenario is likely to change at the earliest by 2027. In order to meet the anticipated demand growth during the forecast period, we expect the contract manufacturers to continue to expand their facilities to strengthen the supply side.
Leading Fill Finish Manufacturing Market Companies Offering Services for Biologics
Examples of key companies engaged in this industry (which have also been profiled in this report) include (in alphabetical order), AbbVie Contract Manufacturing, Asymchem, BioXcellence, BioPharma Solutions, BioReliance, Catalent Biologics, Charles River Laboratories, Fareva, Fresenius Kabi, GlaxoSmithKline, r, Intas Pharmaceuticals, Lonza, Patheon, Pierre Fabre, Recipharm, Samsung Biologics, Syngene, Takara Bio, Wacker Biotech, and WuXi Biologics. This biologics fill finish manufacturing market report includes an easily searchable excel database of all the contract manufacturing organizations that have capability to fill finish biologics worldwide.
Recent Developments in Fill Finish Manufacturing of Biologics
Several recent developments have taken place in the field of fill/finish manufacturing of biologics. We’ve 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 we’ve outlined in our analysis.
- In July 2023, Syngene announced the acquisition of Stelis Biopharma’s biologics manufacturing facility having installed capacity of 20,000 liters.
- In June 2023, Catalent announced the expansion of its integrated development, manufacturing and supply solution, OneBio® Suite across various range of biologic modalities.
- In May 2023, Aurigene Pharmaceutical Services announced the expansion of its biologics CDMO capacity by building a manufacturing facility for therapeutic proteins, antibodies, and viral vectors.
- In May 2023, Thermo Fisher announced the opening of a sterile fill finish facility in Singapore. The facility has a fully automated fill-finish line for small molecules and biologics. It allows the company to conduct end-to-end vaccine manufacturing in Singapore.
- In May 2023, Moderna announced the establishment of a strategic partnership with Novocol. The company mentioned that it will outsource the fill finish operations of vaccines manufactured at Moderna’s Laval-based mRNA facility to latter company.
- In April 2023, Meridian Medical Technologies announced the investment of USD 100 million in order to expand its sterile fill-finish capabilities in Missouri, US. The new facility is anticipated to support company’s sterile fill finish capabilities and increased production of drug-device combination products.
Scope of the Fill Finish Manufacturing Market report
The market research report presents an in-depth analysis of the various firms / contract manufacturing organizations that are engaged in this biologics fill finish manufacturing market, across different segments, as defined in the table below:
Market Size 2022
$ 4 billion
Type of Packing Containers
|Type of Biologics
- Recombinant Proteins
- Gene Therapies
- Cell Therapies
- Other Biologics
Key Geographical Regions
- North America
- Middle East and North Africa
- Latin America
- Preclinical / Clinical
- North America
- Middle East and North Africa
- Latin America
The Fill Finish Manufacturing Market report features an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this industry. Amongst other elements, the market research report includes:
- A summary of the key insights captured in our research, offering a high-level view on the likely evolution of the biologics fill/finish contract manufacturing market in the short to mid-term, and long term.
- A general introduction to biopharmaceuticals and contract manufacturing, featuring a detailed discussion on the need for outsourcing within the biopharmaceutical industry and key operations outsourced by the biologics drug developers, including fill/finish. It also provides information on the key considerations for selecting a fill-finish contract manufacturing organization, along with the benefits and risks associated with outsourcing fill/finish operations.
- A detailed review of the overall landscape of the companies offering biopharmaceuticals fill finish services, 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) 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), type of additional drug product-related service(s) offered (lyophilization, labeling, quality testing, storage and distribution services) and including details relared to companies.
- A detailed competitiveness analysis of the biologics fill/finish contract manufacturing organizations headquartered in different geographies (North America, Europe, Asia-Pacific ad Rest of the World) and offering services across various packaging container(s), based on supplier strength (in terms of years of experience and company size), service strength (considering type of biologic(s) manufactured, scale of operation and type of packaging container(s) used) and service diversity (including number of additional drug product-related service(s) offered and number of facilities).
- Elaborate profiles of key companies based in North America, Europe and Asia Pacific. Each profile provides an overview of the company, business description (information on its service offerings), fill-finish facilities, financial information (if available), details on partnerships, expansions, recent awards and accolades, and an informed future outlook.
- A detailed analysis of the various partnerships and collaborations established by stakeholders in Fill Finish Manufacturing Market since 2013. It includes a brief description of the partnership models (including service agreement, service alliance, product integration agreement and joint venture and acquisition) adopted by stakeholders in the fill-finish manufacturing market. Further, it comprises of analysis based on year of partnership, scale of operation, type of service(s) offered, type of biologic(s) involved, type of process(es) involved and location of the facilities / headquarters. It also highlights the most active companies (in terms of number of partnerships) in the market.
- A detailed analysis of the expansions undertaken by various contract manufacturing organizations to enhance biologics fill/finish capabilities, based on various parameters, including year of expansion, type of expansion, geographical location of the facility, type of packaging container(s) involved, scale of operation (as mentioned in the expansion terms), type of service(s) offered, type of biologic(s) involved, and expansion details (in terms of new area added to the existing facilities). It also highlights the most active companies (in terms of number of instances) in the fill-finish manufacturing market.
- A comprehensive analysis of the global biologics fill&finish capacity, by taking into consideration the container processing capacities of various fill/finish service providers (as available on respective company websites). The global biopharmaceuticals fill/finish capacity has been distributed across number of packaging units, type of packaging container (ampoules, cartridges, syringes and vials), company size of the manufacturer (small, mid-sized and large), scale of operation (preclinical / clinical and commercial) and location of headquarters (North America, Europe, Asia Pacific and Middle East and North Africa) and location of fill/finish facility (North America, Europe, Asia Pacific and Middle East and North Africa and Rest of the World).
- An estimate of the annual demand for fill-finish manufacturing for biologics (in terms of number of units of packaging container), based on various relevant parameters, such as target patient population, dosing frequency, dose strength, type of packaging container and volume of the packaging container of the abovementioned products.
- An analysis on the key performance indicators of service providers based on the information available for top ten biopharmaceutical players on various public platforms, as well as inputs obtained from primary research.
- A regional capability assessment framework, which compares the biologics fill&finish capability across key geographies, based on a number of parameters, such as the number of biologics fill/finish service providers, number of biologics fill/finish facilities, number of biologics fill&finish partnerships inked in that particular geographical region, number of facility expansions and installed biologic fill&finish capacity in that particular geographical region.
- A discussion on the potential growth drivers for the biologics fill finish manufacturing market, takes into consideration the opportunities associated with the growing biopharmaceutical pipeline, increase in outsourcing of fill/finish operations, rising focus on self-administration of drugs / therapies and opportunities in the Asia Pacific region.
- 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 use in manufacturing processes carried in the pharmaceutical industry.
- A case study on the use of ready to use packaging components in the aseptic fill/finish operations. It also provides a list of suppliers providing ready-to-use components.
One of the key objectives of this fill finish manufacturing market report is to estimate the current market size and the future opportunity in the biologics fill-finish manufacturing market over the forecast period. Based on multiple parameters, such as growth of the overall biopharmaceutical market, cost of goods sold, direct manufacturing costs, share of other manufacturing costs and outsourcing trends related to fill/finish operations, we have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the forecast period 2022-2035. 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 packaging containers (ampoules, cartridges, syringes and vials), type of biologics (antibodies, cell therapies, gene therapies, oligonucleotides, recombinant proteins, vaccines and other biologics), key therapeutic areas (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 key geographical regions, (North America, Europe, Asia Pacific, Middle East and North Africa, and Latin America). To account for the uncertainties in the Fill Finish Manufacturing 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 biologics fill finish manufacturing market report are backed by a deep understanding of key insights generated from both secondary and primary research. The perceptions presented in this market analysis were also influenced by discussions held with senior stakeholders in the industry. The market report 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 information forums and primary research discussions. Financial figures mentioned in this market research report are in USD, unless otherwise specified.
Frequently Asked Questions
Question 1: What are fill finish services? Answer:
Fill/finish refers to the process of filling the final drug products in sterile packaging containers (including vials, syringes, ampoules and cartridges) and preparing them for distribution.
Question 2: What is the fill finish process in pharma? Answer:
Fill-finish process includes container preparation, closure preparation, sterilization, filling, capping, sealing and storage.
Question 3: What is the global market size for biologics fill finish manufacturing services? Answer:
The global market size of biologics fill finish manufacturing is estimated to be USD 4 billion in 2022.
Question 4: What is anticipated market growth for biologics fill finish manufacturing services? Answer:
The global biologics fill finish manufacturing market is anticipated to grow at a CAGR of over 8% during the forecast period 2023-2035.
Question 5: Which regional market segment has majority of the biologic fill/finish facilities? Answer:
In terms of number of fill&finish facilities with capability for biologics, Europe is the leading geographical segment with 40% of all the facilities located in the region.
Question 6: In terms of packaging containers, which segment holds the largest market share of biologic fill finish manufacturing market? Answer:
In the year 2022, fill finish of biologics in vials holds the largest market share.
Question 7: Which partnership models are most commonly adopted by stakeholders in this industry? Answer:
In 2022, majority of the partnerships signed between industry stakeholders were service agreements.
Question 8: What types of expansion initiatives are being undertaken by contract manufacturers in the biologics fill finish manufacturing market? Answer:
Post 2019, 54% of the expansions in biologics fill finish manufacturing industry were capacity expansions.
Question 9: Who are the leading contract manufacturing organizations offering biologics fill finish services? Answer:
Some of the leading contract manufacturers engaged in this industry (which have also been profiled in this report) include (in alphabetical order), AbbVie Contract Manufacturing, Asymchem, BioXcellence, BioPharma Solutions, BioReliance, Catalent Biologics, Charles River Laboratories, Fareva, Fresenius Kabi, GlaxoSmithKline, Hetero Drugs, Intas Pharmaceuticals, Lonza, Patheon, Pierre Fabre, Recipharm, Samsung Biologics, Syngene, Takara Bio, Wacker Biotech, and WuXi Biologics.