Biologics Fill Finish Manufacturing Market

Biologics Fill Finish Manufacturing Market (4th Edition): Industry Trends and Global Forecasts, Till 2035 - Type of Primary Packaging Container (Ampoules, Cartridges, Syringes and Vials), Type of Biologic Manufactured (Antibodies, Cell Therapies, Gene Therapies, Oligonucleotides, Recombinant Proteins, Vaccines and Other Biologics), Scale of Operation (Preclinical / Clinical and Commercial), Therapeutic Area (Autoimmune Disorders, Cardiovascular Disorders, Infectious Diseases, Metabolic Disorders, Oncological Disorders and Other Disorders), End-users (Pharmaceutical / Biopharmaceutical Companies and Contract Manufacturing Organizations / Others), Type of Player (Industry and Non-Industry), Company Size (Small, Mid-sized and Large) and Key Geographical Regions (North America (US, Canada and Mexico), Europe (Austria, France, Germany, Italy, Spain, Switzerland, UK and Rest of Europe), Asia-Pacific (China, India, Japan, South Korea and Rest of Asia-Pacific) and Rest of the World (Argentina, Brazil, Iran, Israel and Other Countries).

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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 global biologics fill finish manufacturing market is estimated to grow from $5.3 billion in 2024 to $11.6 billion by 2035, representing a CAGR of 7.4% during the forecast period 2024-2035. The new research study consists of industry trends, detailed market analysis, key market insights, market impact analysis, market forecast and opportunity analysis. The growth in the opportunity for fill finish contract manufacturers over the next decade is likely to be the result of the anticipated rise in the demand for biologic drugs.

Biologics Fill Finish Manufacturing Market Type of Primary Packaging Container, 2024-2035 (USD Billion)

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Biologics represents a revolutionary class of medicine that has marked the beginning of a new era in the pharmaceutical industry. Over time, these large molecules have proven to be a promising therapeutic modality in the treatment of a myriad of chronic and hard-to-treat disorders, including autoimmune disorders, infectious diseases, genetic disorders, oncological disorders and rare diseases. Unlike small molecules, biologics, such as antibodies, cellular therapies and therapeutic proteins are complex molecules that are designed to precisely target specific biomarkers associated with the disease pathways.

The biologics manufacturing is a complex and highly demanding process as they tend to be highly sensitive to various environmental conditions, including light, temperature, pH and oxygen levels, owing to the fact that they are derived from living cells. As a result, they require sophisticated manufacturing capabilities, including fermentation, aseptic fill finish, adequate storage with controlled temperatures and analytical testing to produce quality drug products. Additionally, the fill finish of biologics is a critical step in the production of biopharmaceuticals, as it requires well-defined handling protocols to ensure the sterility of the product while filling into the final packaging containers. Any discrepancies encountered at this stage of manufacturing can lead to microbial contamination, subsequently resulting in loss of product, long development timelines and substantial financial burden on the drug developers, owing to the high cost of cell-derived raw materials.

As a result, an increasing number of drug developers are relying on biologics contract manufacturing and development organizations to outsource their fill finish operations. It is worth highlighting that approximately 75% of the drug developers prefer to outsource fill finish activities of biological drug products. Moreover, the fill finish manufacturing companies possess the necessary capabilities and state-of-the-art facilities with clean rooms that are essential for minimizing the risk of contamination while reducing the percentage of product loss during the sterile fill finish of biologics.

Further, the recent technological advancements, such as automation, robotics and incorporation of artificial intelligence has empowered fill finish companies to enhance their biologics fill finish services in order to ensure precise and accurate filling processes. Such high-caliber services are enabling the drug developers to redirect their financial investment towards the development of novel molecules while entrusting the final steps of their drug substances manufacturing to third party service providers. Driven by the growing demand for biologics along with the technological advancements in fill finish operations, the biologics fill finish manufacturing market is anticipated to witness substantial market growth, during the forecast period.

Biologics Fill Finish Manufacturing Market Share Insights

The market research report presents an in-depth analysis of the various fill finish manufacturing companies in the biologics fill finish industry, across different segments, as defined in the table below: 

Biologics Fill Finish Manufacturing Market: Report Attribute / Market Segmentations

Key Report Attribute Details
Historical Trend 2018-2023
Base Year 2023
Forecast Period 2024-2035
Market Size 2024 $ 5.3 Billion
Growth Rate CAGR of 7.4% from 2024 to 2035
Type of Primary Packaging Container
  • Ampoules
  • Cartridges
  • Syringes
  • Vials
Type of Biologic Manufactured
  • Antibodies
  • Cell Therapies
  • Gene Therapies
  • Oligonucleotides
  • Recombinant Proteins
  • Vaccines
  • Other Biologics
Scale of Operation
  • Preclinical / Clinical
  • Commercial
Therapeutic Area
  • Autoimmune Disorders
  • Cardiovascular Disorders
  • Infectious Diseases
  • Metabolic Disorders
  • Oncological Disorders 
  • Other Disorders
End Users
  • Pharmaceutical / Biopharmaceutical Companies
  • Contract Manufacturing Organizations / Others
Type of Player
  • Industry
  • Non-Industry
Company Size
  • Small
  • Mid-sized
  • Large
Key Geographical Regions
  • North America (US, Canada and Mexico)
  • Europe (Austria, France, Germany, Italy, Spain, Switzerland, UK and Rest of Europe)
  • Asia-Pacific (China, India, Japan, South Korea and Rest of Asia-Pacific)
  • Rest of the World (Argentina, Brazil, Iran, Israel and Other Countries)
Key Companies Profiled
  • AbbVie Contract Manufacturing
  • Asymchem
  • Boehringer Ingelheim BioXcellence
  • Catalent Biologics
  • Charles River
  • Elements Material Technology
  • Evonik
  • Fareva
  • Fresenius Kabi
  • GSK
  • Hetero
  • Lonza
  • Patheon pharma services
  • Pierre Fabre
  • Recipharm
  • Sandoz
  • Syngene
  • WACKER
  • WuXi Biologics

(Full list of ~240 companies captured is available in the report) 

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  • Market Landscape Analysis
  • Capacity Analysis
  • Demand Analysis
  • Market Sizing and Opportunity Analysis

One of the key objectives of this market report was to estimate the current market size, opportunity and the future growth potential of the biologics fill finish manufacturing market, over the forecast period. Based on multiple parameters, likely adoption trends and through primary validations, we have provided an informed estimate on the market evolution during the forecast period, 2024-2035. 

The market report also features the likely distribution of the current and forecasted opportunity across various segments, such as type of primary packaging container (ampoules, cartridges, syringes and vials), type of biologic manufactured (antibodies, cell therapies, gene therapies, oligonucleotides, recombinant proteins, vaccines and other biologics), scale of operation (preclinical / clinical and commercial), therapeutic area (autoimmune disorders, cardiovascular disorders, infectious diseases, metabolic disorders, oncological disorders and other disorders), end-users (pharmaceutical / biopharmaceutical companies and contract manufacturing organizations / others), type of player (industry and non-Industry), company size (small, mid-sized and large) and key geographical regions (North America (US, Canada and Mexico), Europe (Austria, France, Germany, Italy, Spain, Switzerland, UK and Rest of Europe), Asia-Pacific (China, India, Japan, South Korea and Rest of Asia-Pacific) and Rest of the World (Argentina, Brazil, Iran, Israel and Other Countries). 

In order to account for future uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base, and optimistic scenarios, representing different tracks of the industry’s growth.

The opinions and insights presented in this study were influenced by the discussions conducted with multiple stakeholders in the biologics fill finish manufacturing market. In addition, the research report features detailed transcripts of interviews held with the following industry stakeholders:

  • Chief Commercial Officer, Large Company, Germany
  • Vice President Business Development, Large Company, US
  • Vice President Business Development & Marketing, Mid-sized Company, US
  • Research Director and Head of Formulation Development, Very Large Company, India
  • Business Development Manager, Mid-sized Company, Czech Republic
  • Business Development Manager, Mid-sized Company, Netherlands
  • Technology Watch Manager, Mid-sized Company, France
  • Former Global Business Development Manager, Mid-sized Company, Netherlands
  • Business Development Specialist, Mid-sized Company, Poland 

Further, all actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this market report are in USD, unless otherwise specified.

Biologics Fill Finish Manufacturing Market Segmentation Overview

Market Share by Type of Primary Packaging Container

Based on type of primary packaging container, the global biologics fill finish manufacturing market is segmented into ampoules, cartridges, syringes and vials. It is worth mentioning that currently, vials occupy the highest share in the overall biologics fill finish manufacturing market, and this trend is unlikely to change in the foreseen future. This can be primarily attributed to various advantages offered by vials, such as ease of filling, ability to pre-sterilize the containers using various terminal sterilization techniques and minimal risk of breakage during handling and transportation as compared to other primary packaging containers. Further, it is worth highlighting that, in the coming years, syringes segment is anticipated to grow at a relatively faster CAGR of 8.7%.

Market Share by Type of Biologic Manufactured

Based on type of biologic manufactured, the global biologics fill finish manufacturing market is segmented into antibodies, cell therapies, gene therapies, oligonucleotides, recombinant proteins, vaccines and other biologics. It is worth mentioning that, currently, antibodies occupy the highest share in biologics fill finish manufacturing market, and this trend is unlikely to change during the forecast period. This can be attributed to the increasing application of antibodies, specifically monoclonal antibodies, owing to their high specificity and low toxicity. This has led to high success rates of these molecules in the treatment of various hard-to-treat conditions, such as cancer and infectious diseases, eventually resulting in a surge in the demand for antibody fill finish services. Therefore, in the coming years, this segment is estimated to grow at a higher CAGR as compared to other types of biologics.

Market Share by Scale of Operation

Based on scale of operation, the global biologics fill finish manufacturing market is segmented into preclinical / clinical and commercial scale. Presently, the market is dominated by the revenues generated from biologics fill finish services at commercial scale and this trend (in terms of market share) is likely to remain the same during the forecast period.

Market Share by Therapeutic Area

Based on therapeutic area, the global biologics fill finish manufacturing market is segmented into autoimmune disorders, cardiovascular disorders, infectious diseases, metabolic disorders, oncological disorders and other disorders. The oncological disorders segment is anticipated to capture the largest share in the overall market. This can be attributed to the substantial increase in the regulatory approval of biologics intended for the treatment of oncological disorders.

Market Share by Key Geographical Regions

This segment highlights the distribution of biologics fill finish manufacturing market across various geographies, such as North America (US, Canada and Mexico), Europe (Austria, France, Germany, Italy, Spain, Switzerland, UK and Rest of Europe), Asia-Pacific (China, India, Japan, South Korea and Rest of Asia-Pacific) and rest of the World (Argentina, Brazil, Iran, Israel and Other Countries). According to our projections, currently, Europe is likely to capture the majority share (40%) of the overall market. However, in the coming years, the market in Asia-Pacific is likely to grow at a relatively higher CAGR (8.6%), during the period 2024-2035.

Biologics Fill Finish Manufacturing Market: Key Insights

The Biologics Fill Finish Manufacturing Market (4th Edition): Industry Trends and Global Forecasts, till 2035 – Distribution by Type of Primary Packaging Container (Ampoules, Cartridges, Syringes and Vials), Type of Biologic Manufactured (Antibodies, Cell Therapies, Gene Therapies, Oligonucleotides, Recombinant Proteins, Vaccines and Other Biologics), Scale of Operation (Preclinical / Clinical and Commercial), Therapeutic Area (Autoimmune Disorders, Cardiovascular Disorders, Infectious Diseases, Metabolic Disorders, Oncological Disorders and Other Disorders), End Users (Pharmaceutical / Biopharmaceutical Companies and Contract Manufacturing Organizations / Others), Type of Player (Industry and Non-Industry), Company Size (Small, Mid-sized and Large) and Key Geographical Regions (North America (US, Canada and Mexico), Europe (Austria, France, Germany, Italy, Spain, Switzerland, UK and Rest of Europe), Asia-Pacific (China, India, Japan, South Korea and Rest of Asia-Pacific) and Rest of the World (Argentina, Brazil, Iran, Israel and Other Countries) market report features an extensive study of the current market landscape, market size and future opportunities within the domain of biologics fill finish, during the given forecast period. Further, the market report highlights the efforts of several stakeholders in this rapidly emerging segment of the pharmaceutical industry. Key takeaways of the market report is briefly discussed below. 

Competitive Landscape of Biologics Fill Finish Manufacturing Market: Over 40% of the Fill Finish Manufacturing Companies are Large Players

The biologics fill finish market landscape features the presence of 240 very large, large, mid-sized and small contract manufacturing organizations involved in offering aseptic fill finish services for biologics across different scales of operations, such as preclinical, clinical, and commercial scale. Close to 60% of these fill finish manufacturing companies were established between 2001 and 2020, indicating a growing demand for the manufacturing of finished dosage forms for both novel and conventional biologic molecules. 

Additionally, close to 35% of the fill finish companies are based in North America and Europe, each. Further, within Europe, Germany emerged as the hub of biologics fill/finish CMOs. Further, 70% of the companies are engaged in manufacturing proteins / peptides; notable examples (arranged in alphabetical order) include 3P Biopharmaceuticals, Akron Bio, Creative Biolabs, HALIX and WuXi Biologics.

Market Share Analysis: Vials are the Most Widely Adopted Primary Packaging Containers for Sterile Filling of Biologics

Pharmaceutical vials have become the most preferred primary packaging container for the sterile filling of biologics. This can be attributed to the fact that vials are made of strong and durable materials, such as borosilicate glass, that are capable of withstanding the extreme conditions during the handling, thereby reducing the risk of product loss. Notably, close to 95% of the fill finish contract manufacturing companies provide vial filling services for the biologics. Examples of large companies involved in offering only vial filling services (based in Europe, arranged in alphabetical order) include Bachem, BioNTech, BSP Pharmaceuticals, Miltenyi Biotec and Oxford BioMedica.

Capacity Analysis: Majority of the Global Biologics Fill Finish Manufacturing Capacity is Installed in Facilities Owned by Large and Very Large Companies 

Majority (60%) of the biologics fill finish capacity for ampoules is installed at facilities located in Europe. Within Europe, close to 30% of the ampoule filling capacity is available with the facilities based in France. Moreover, for cartridges, over 35% of the capacity is installed in Europe. Of these, more than 25% of the capacity is installed in the facilities located in Germany. Further, it is worth mentioning that, over the past few years, the vial filling capacity in Asia-Pacific has increased at a substantial pace. This growth can be attributed to the technical advances, low labor costs and socio-economic reforms favoring the growth of specialty industries, such as the sterile fill finish industry.

Demand Analysis: Estimates of the Annual Demand for Biologics Fill Finish

The demand for biologics fill finish is projected to reach 28.5 million liters in 2035, growing at a CAGR of 12.8%. In addition, the commercial and clinical demand for biologics fill finish is projected to reach over 24.6 million liters and 3.9 million liters, respectively, in 2035. Further, in terms of the type of primary packaging container used, the current demand is driven by vials, and this trend is unlikely to change in the foreseen future.

Market Size Analysis: Global Biologics Fill Finish Manufacturing Market to Witness Substantial Market Growth

The global market for biologics fill finish is estimated to be worth $5.3 billion in 2024. Driven by the growing potential of various biologic molecules and anticipated regulatory approvals, the biologics fill finish manufacturing market is anticipated to grow at a CAGR of 7.4% during the forecast period. It is worth highlighting that the contract manufacturers in this domain have built capabilities for novel drug modalities such as cell and gene therapy and increased their capacities by setting up new fill finish lines. Increasing number of biologic drug developers are now relying on the biologic CMOs for their fill finish needs. As such, the rising preference for outsourcing fill finish services will drive the biologics fill finish manufacturing market growth over the forecast period.

Regional Analysis: Europe Emerges as the Hub of Biologics Fill Finish Manufacturing Market; Asia-Pacific to be the Fastest Growing Market

In 2024, Europe is anticipated to capture 40% of the overall biologics fill finish manufacturing market share. This can be attributed to the growing demand for biologic drugs in Europe which has increased remarkably owing to the piqued interest of healthcare industry towards personalized medicine which has facilitated a surge in the R&D investments and number of clinical studies pertaining to the development of various biologic drugs, such as cell therapies, gene therapies, monoclonal antibodies and oligonucleotides / oligonucleotide-based products. Further, it is noteworthy that, in the coming years, the market in Asia-Pacific is likely to grow at a higher CAGR of 8.6%, owing to the lower manufacturing costs, cheap and skilled labor and supportive regulatory landscapes in this region.

Leading Companies in Biologics Fill Finish Manufacturing Market

Examples of key fill finish manufacturing companies (which have also been profiled in this market report; the complete list of companies is available in the full report) include AbbVie Contract Manufacturing, Asymchem, Boehringer Ingelheim BioXcellence, Catalent Biologics, Charles River, Elements Material Technology, Evonik, Fareva, Fresenius Kabi, GSK, Hetero, Lonza, Patheon pharma services, Pierre Fabre, Recipharm, Sandoz, Syngene, WACKER and WuXi Biologics. This market report includes an easily searchable excel database of all the fill finish companies offering aseptic fill finish services for biologic drugs.

Biologics Fill Finish Manufacturing Market Report Coverage

The market report presents an in-depth analysis, highlighting the capabilities of various fill finish manufacturing companies, across different geographies. Amongst other elements, the market report includes:

  • A preface providing an introduction to the full report, Biologics Fill Finish Manufacturing Market (4th Edition), till 2035.
Biologics Fill Finish Manufacturing Market List Biologics Fill Finish Manufacturing Market Competitiveness Analysis Biologics Fill Finish Manufacturing Market Partnerships
  • An outline of the systematic research methodology adopted to conduct the study on biologics fill finish services, providing insights on the various assumptions, methodologies, and quality control measures employed to ensure accuracy and reliability of our findings.
  • An overview of economic factors that impact the overall biologics fill finish manufacturing market, including historical trends, currency fluctuation, foreign exchange impact, recession, and inflation measurement.
  • An executive summary of the insights captured during our research. It offers a high-level view on the current state of biologics fill finish manufacturing market and its likely evolution in the mid-long term.
  • A general overview on the types of biopharmaceuticals, commonly outsourced operations in the biopharmaceutical development industry and biologics fill finish operations. Additionally, the chapter features a detailed discussion on the key parameters to be considered while selecting companies for fill finish services for biopharmaceuticals. Further, it highlights the various advantages along with the potential risks and challenges associated with outsourcing fill finish operations to the contract manufacturers. 
  • A comprehensive assessment of the biologics fill finish manufacturing companies, based on several relevant parameters, such as year of establishment, company size (in terms of number of employees), location of headquarters, location of fill finish facilities, scale of operation (preclinical, clinical and commercial), type of biologic manufactured (antibodies, antibody drug conjugates, biosimilars, cell therapies, gene therapies, oligonucleotides / nucleic acids, proteins / peptides, vaccines, viral vectors / plasmid DNA and others), type of dosage form (liquid and lyophilized), type of primary packaging container used (ampoules, cartridges, syringes and vials) and additional services offered (lyophilization / freeze drying, sterilization, labeling / serialization, testing (after filling), storage, secondary packaging and distribution / shipping / logistics).
  • Elaborate profiles of prominent players (shortlisted based on our proprietary criteria) involved in offering biologics fill finish services. Each profile features a brief overview of the company (including information on year of establishment, location of headquarters and number of employees), financial information (if available), fill / finish service portfolio, recent developments and an informed future outlook. 
  • A detailed competitiveness analysis of the biologics fill/finish contract manufacturing organizations offering services across various packaging containers, based on supplier strength (in terms of years of experience and company size), portfolio strength (in terms of biologic manufactured, scale of operation and type of packaging containers used) and service strength (in terms of number of additional drug product-related services offered and number of facilities).
  • A detailed analysis of various partnerships and collaborations established by stakeholders in this industry.  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 biologics fill finish manufacturing market. Further, the instances were analyzed based on year of partnership, scale of operation, type of service offered, type of process involved, type of biologic involved, and location of headquarters or location of facility. It also highlights the most active players in terms of number of partnerships established.  
  • A detailed analysis of the expansion initiatives undertaken by various contract manufacturing organizations to enhance biologics fill finish capabilities, based on various parameters, such as year of expansion, type of expansion, type of primary packaging container used, type of service offered, type of biologic involved, scale of operation, and expansion details. It also highlights the most active players in terms of number of expansion initiatives.
Biologics Fill Finish Manufacturing Market Installed Capacity Biologics Fill Finish Manufacturing Market Demand Analysis Biologics Fill Finish Manufacturing Market Scale of Operation
  • An estimate of the global, installed biologics fill finish capacity, based on information reported by various industry stakeholders in the public domain. The analysis highlights the distribution of the available capacity for various primary packaging containers used (ampoules, cartridges, syringes and vials) based on company size (small, mid-sized, and large and very large firms) and key geographical regions (North America, Europe, Asia-Pacific and Rest of the World).
  • An informed estimate of the annual demand for biologics fill-finish manufacturing, taking into account the top 35 biologics, based on various relevant parameters, such as target patient population, dosing frequency, and dose strength of the aforementioned products
  • An analysis on the key performance indicators for service providers in the biologics fill finish domain, 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, scale of operation, installed biologic fill/finish capacity and annual demand in that particular geographical 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.
  • An in-depth analysis of the factors that can impact the growth of the biologics fill finish manufacturing market. It also features identification and analysis of key drivers, potential restraints, emerging opportunities, and existing challenges.
  • A detailed biologics fill finish manufacturing market forecast in order to estimate the current market size and future opportunity over the next 11 years. Based on multiple parameters, likely adoption trends and through primary validations, we have provided an informed estimate on the market size during the forecast period, 2024-2035. 
  • Detailed projections of the current and future opportunity within the biologic fill finish manufacturing market across different types of primary packaging containers, such as ampoules, cartridges, syringes and vials.
  • Detailed projections of the current and future opportunity within the biologics fill finish manufacturing industry across different types of biologics manufactured, such as antibodies, cell therapies, gene therapies, oligonucleotides, recombinant proteins, vaccines and others.
  • Detailed projections of the current and future opportunity within the biologics fill finish manufacturing market across different scales of operation, such as preclinical / clinical and commercial.
  • Detailed projections of the current and future opportunity within the biologics fill finish manufacturing market across different therapeutic areas, such as autoimmune disorders, cardiovascular disorders, infectious diseases, metabolic disorders, oncological disorders and other disorders.
  • Detailed projections of the current and future opportunity within the biologics fill finish manufacturing industry across different end users, such as pharmaceutical / biopharmaceutical companies and contract manufacturing organizations / others.
  • Detailed projections of the current and future opportunity within the biologics fill finish manufacturing market across different types of players, such as industry and non-industry.
  • Detailed projections of the current and future opportunity within the biologics fill finish manufacturing industry based on company size, including small, mid-sized and large.
  • Detailed projections of the current and future opportunity within the biologics fill finish manufacturing market across key geographical regions, such as North America (US, Canada and Mexico), Europe (Austria, France, Germany, Italy, Spain, Switzerland, UK and Rest of Europe), Asia-Pacific (China, India, Japan, South Korea and Rest of Asia-Pacific) and rest of the world (Argentina, Brazil, Iran, Israel and Other Countries).
Biologics Fill Finish Manufacturing Market Company Size Biologics Fill Finish Manufacturing Market Movement Analysis Biologics Fill Finish Manufacturing Market Penetration Growth

Recent Developments in Biologics Fill Finish Manufacturing Market

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

  • In January 2024, AbbVie Contract Manufacturing announced the expansion of its biologics manufacturing capabilities through an investment of $223 million at its facility based in Singapore.
  • In October 2023, Lonza expanded its biologics fill finish capabilities by adding a dedicated filling lines for clinical and commercial supply of antibody drug conjugates at its facility based in Stein, Switzerland.
  • In September 2023, Recipharm entered into a strategic partnership with Ahead Therapeutics to offer process development, manufacturing and analytical services for lipid nanoparticles intended to encapsulate the latter company’s antigen peptide drug.
  • In June 2023, Catalent Biologics expanded its OneBio® Suite, an integrated solution for development, manufacturing, and supply of variety of biologic modalities, including antibodies, recombinant proteins, mRNA and cell and gene therapies.
  • In May 2023, Patheon expanded its sterile manufacturing capabilities in Asia-Pacific region by installing an automated aseptic vaccine filling line at its facility based in Singapore.
     

Author(s): Simriti Gupta, Pemba Lahmo, Asmita Deka Dey

Frequently Asked Questions

Question 1: What is aseptic fill finish in pharmaceutical industry?

Answer: Aseptic fill finish is defined as the process of filling the purified bulk formulation into pre-sterilized primary packaging containers for distribution across clinical and commercial scale of operation.

Question 2: How big is the biologics fill finish manufacturing market?

Answer: The biologics fill finish market size is anticipated to be worth $ 5.3 billion in 2024.

Question 3: What is the anticipated CAGR of biologics fill finish manufacturing market?

Answer: The biologics fill finish manufacturing industry is anticipated to grow at a CAGR of 7.4% during the forecast period, 2024-2035.

Question 4: Which type of biologics occupy the largest market share of the biologics fill finish manufacturing market?

Answer: Currently, antibodies have the largest market share (39%).

Question 5: Which region is expected to witness the highest growth rate in biologics fill finish manufacturing market?

Answer: Asia-Pacific is likely to grow at the highest CAGR, during the forecast period 2024-2035.

Question 6: What is the most preferable primary packaging container used for fill/finish of biologics?

Answer: Currently, vials are the most widely adopted (94%) primary packaging containers used for filling of various biologics drugs such as cell therapies, antibodies and vaccines.

Question 7: What is the additional drug product-related services offered by fill/finish CMOs?

Answer: The additional drug-product-related services offered by fill finish companies include lyophilization, sterilization, labeling / serialization, testing (after filling), storage, secondary packaging and distribution / shipping / logistics.

Question 8: Who are the leading companies in the biologics fill finish manufacturing market?

Answer: AbbVie Contract Manufacturing, Asymchem, Boehringer Ingelheim BioXcellence, Catalent Biologics, Charles River, Elements Material Technology, Evonik, Fareva, Fresenius Kabi, GSK, Hetero, Lonza, Patheon pharma services, Pierre Fabre, Recipharm, Sandoz, Syngene, WACKER and WuXi Biologics.

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