Top 10 Biologics CDMO With Capacity / Capability Expansions in 2023

The growing demand for biologics has compelled the biologics CDMO engaged in biologics contract manufacturing industry to expand their existing capabilities / capacities in order to accommodate the future needs of their clients We analyzed more than 305 industry players that offer contract manufacturing services for biologics. In this article, discover insights on top 10 Biologics CDMO.

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Over the last few decades, the development landscape of small molecule drugs has been significantly impacted by various biotechnology breakthroughs. Further, with the advent of novel technologies, biologics represent one of the fastest growing segments of the pharmaceutical industry and have made a significant impact by delivering ground-breaking treatment for a myriad of disease indications, including immunological, oncological, and rare disorders. 

Although biopharmaceuticals offer significant profit margins, they are generally associated with high costs of development and complex manufacturing protocols. This has compelled many biopharmaceutical developers to outsource various aspect of their operations to contract service providers to manufacture the biologics. Further, driven by the rising chronic diseases and growing demand for targeted biologics / personalized medicine, the global biologics contract manufacturing market is anticipated to witness substantial growth during the forecast period. There are several novel biologics that are proving their efficacy for the treatment of disorders such as cancer. Gene therapy is a leading market segment of the biologics market, which has seen several approvals and success stories. Additionally, there has been a surge in the demand for the starting material for cell and gene therapies, plasmid DNA (pDNA) and viral vectors. A number of biologics CDMO are doing capability / capacity expansions for plasmid DNA manufacturing and viral vector manufacturing.

Roots Analysis has conducted an exhaustive study on Biologics Contract Manufacturing Market featuring the current market landscape of biologics CDMO and future opportunity, over the forecast period 2023-2035.

Table of Contents

Below, we have listed (in alphabetical order), the top 10 biologics cdmo, based on their service portfolio / capabilities.

Company	Year of Establishment	Headquarters	Employee Count
AGC Biologics	2018		1,001-5,000
Catalent Biologics	2007		10,001+
Cell Therapies	2003		51-200
Charles River Laboratories	1947		10,001+
FUJIFILM Diosynth Biotechnologies	2011		2-10
Lonza	2011		11-50
Samsung BioLogics	2011		1,001 to 5,000
Sandoz	1886		10,001+
Vetter Pharma	1950		5,001 to 10,000
WuXi Biologics	2010		10,001+

Interested in exploring all 305+ biologics contract manufacturing organizations?

AGC Biologics, a Relatively New Entrant in Cell and Gene Therapy Manufacturing  is Not Shying Away from Investments in Capacity Expansion

AGC Biologics is a subsidiary of AGC (formerly known as Asahi Glass) engaged in multiple businesses, including flat glass, automotive glass, display, electronic materials, chemicals, ceramics, and applied glass materials. It is worth mentioning that the firm’s pharmaceutical contract manufacturing business was launched in 2000. Further, in 2018, AGC unified its bioscience segment with its acquired companies, Biomeva (acquired in 2016) and CMC Biologics (acquired in 2017), to form a combined business entity named AGC Biologics. The company’s foray into cell and gene therapy manufacturing began with the acquisition of MolMed in 2020.1 

Till now, AGC Biologics has supported commercial and well as clinical batch batch manufacturing for sevra biologics, including four commercial viral vector products, three commercial cell therapies and more than 30 cell and gene therapy clinical trials across Europe and the U.S.

The following table presents the details on the biologics CDMO services offered by AGC Biologics:

Company	Year of Establishment
Number of Facility	7
Location of Manufacturing Facility	Chiba, Japan Colorado, US (2) Copenhagen, Denmark Heidelberg, Germany Milan, Italy Washington, US
Scale of Operation	Preclinical Manufacturing Clinical Manufacturing Commercial Manufacturing
Type of Biologic Manufactured	The company offers manufacturing services for the following biologics: Monoclonal Antibodies Antibody Fragments Biosimilars Cell Therapies Gene Therapies Plasmid DNA / Viral Vectors Proteins / Peptides Vaccines
Type of Expression System Used	Mammalian Microbial

Recent Capability / Capacity Expansion Initiatives Undertaken by AGC Biologics:

• In October 2023, pDNA manufacturing expansion was completed at Heidelberg, Germany facility.
• In August 2023, the firm expanded its manufacturing capabilities with the addition of 50L, 400L and 2,000L suspension single use bioreactors in order to increase the gene therapy capacity at its facility based in Milan, Italy.
• In the same month, the biologics CDMO also added three production suites at its cell and gene therapy manufacturing site at Colorado, US. 
• In May 2023, the firm launched BravoAAV and ProntoLVV platforms for the development and manufacturing of viral vectors.

Catalent, Expanding the Biologics Manufacturing Capability While Handling the Regulatory Woes

Catalent Biologics is a US-based global service provider that offers development solutions and advanced delivery technologies for drugs, biologics, and other consumer health products. It claims to provide its services to pharmaceutical and biotechnology companies based in the US, Europe, and other locations. With a focus on operational and quality excellence, the firm intends to continue making investments in growth-enabling capacity and capabilities. In year 2022, the company faced multiple regulatory issues at its Bloomington and Brussels manufacturing facility, leading to slower production which is continuing in 2023.²

The following table presents the details on the biologics CDMO services offered by Catalent:

Company	Year of Establishment
Number of Facility	14
Location of Manufacturing Facility	Anagni, Italy Brussels, Belgium California, US Gosselies, Belgium Indiana, US Limoges, France  Maryland, US (2) Missouri, US North Carolina, US North Rhine-Westphalia, Germany New Jersey, US Oxford, UK Wisconsin, US
Scale of Operation	Preclinical Manufacturing Clinical Manufacturing Commercial Manufacturing
Type of Biologic Manufactured	The company offers manufacturing services for the following biologics: Antibody Drug Conjugates Antibody Fragments Biosimilars Cell Therapies Gene Therapies Plasmid DNA / Viral Vectors Proteins / Peptides Vaccines
Type of Expression System Used	Mammalian Microbial

Recent Capability / Capacity Expansion Initiatives Undertaken by Catalent:

• In June 2023, the company expanded OneBio Suite, an integrated development, manufacturing, and supply solution, for a variety of biologic modalities, including antibody and recombinant proteins, cell and gene therapies, and mRNA.
• In March 2023, the company expanded UpTempo, an adeno-associated viral platform, which was launched in 2022, to accelerate the development and cGMP manufacturing of adeno-associated viral vectors.
• In January 2023, the firm announced the expansion of its manufacturing capabilities with the addition of a new commercial-scale plasmid DNA (pDNA) manufacturing facility in Gosselies, Belgium.

Cell Therapies Offers a Comprehensive Suite of Services, From the Initial Processing of Cells to the Final Delivery of Therapeutic Treatments for Cell and Gene Therapies

Cell Therapies, an Australian contract development and manufacturing organization is engaged in providing manufacturing services for cellular immunotherapies, cell therapies, gene therapies, and regenerative medicines, from the initial research stages to clinical and commercialization scale. It is worth highlighting that the company has 13 cleanrooms, operating in accordance with the good manufacturing practices (GMP).

The following table presents the details on the biologics CDMO services offered by Cell Therapies:

Company	Year of Establishment
Number of Facility	1
Location of Manufacturing Facility	Melbourne, Australia
Scale of Operation	Clinical Manufacturing Commercial Manufacturing
Type of Biologic Manufactured	The company offers manufacturing services for the following biologics: Cell Therapies Gene Therapies

Recent Capability / Capacity Expansion Initiatives Undertaken by Cell Therapies:

• In July 2023, the company expanded its manufacturing capabilities with the addition of three large-scale highthroughput GMP manufacturing suites for increasing cell and gene therapy capacities, at its facility in Melbourne, Australia.

Charles River Laboratories, Expanded its Capabilities in Biologics Manufacturing With the Acquisition of Multiple Biologics CDMO

Charles River Laboratories is a US-based contract development and manufacturing organization that specializes in providing innovative solutions and services for biopharmaceuticals. Owing to its expertise spanning more than 70 years, the firm is focused on delivering high-quality and reliable outcomes to its clients worldwide. Notably, the company claims to have the first commercial genetic monitoring program.  Further, the company states to support the development of around 10 FDA approved cell and gene therapies from discovery to commercialization. Additionally, in 2021, the firm had performed more than 1,000 cell and gene therapy studies. The company expanded its portfolio of cell and gene therapy manufacturing services with the acquisition of Cognate BioServices, Cobra Biologics and Vigene Biosciences in 2021.³

The following table presents the details on the biologics CDMO services offered by Charles River Laboratories:

Company	Year of Establishment
Number of Facility	6
Location of Manufacturing Facility	Keele, UK Maryland, US (2) Sodertalje, Sweden Sundsvall, Sweden Tennessee, US
Scale of Operation	Preclinical Manufacturing Clinical Manufacturing Commercial Manufacturing
Type of Biologic Manufactured	The company offers manufacturing services for the following biologics: Antibody Drug Conjugates Biosimilars Cell Therapies Gene Therapies Nucleic acid / Oligonucleotides Plasmid DNA / Viral Vectors Proteins / Peptides Vaccines
Type of Expression System Used	Insect Cell Lines Mammalian Microbial

Recent Capability / Capacity Expansion Initiatives Undertaken by Charles River Laboratories:

• In September 2023, the company announced the launch of its lentiviral vector (LVV) manufacturing platform, Lentivation, with the aim to reduce LVV manufacturing timelines (by 60%) for gene and gene-modified cell therapies.
• In January 2023, the company announced the launch of its eXpDNA plasmid platform in order to optimize the development and manufacturing timelines for plasmid DNA.

FUJIFILM Diosynth Biotechnologies is Meeting the Demand for Early Stage Clinical Trials Through Recent Expansions

FUJIFILM Diosynth Biotechnologies (a subsidiary of FUJIFILM) is a contract development and manufacturing organization engaged in the development of biologics. In order to accelerate the development of life-changing therapies, the company claims to be focused on combining technical expertise in mammalian cell culture, microbial fermentation, and cell and gene therapy with top-notch cGMP manufacturing facilities. As per the firm’s website, it has over 30 years of experience in this domain, and its service portfolio spans across monoclonal antibodies, cell therapies, gene therapies, proteins, vaccines, and viral vectors.  

The following table presents the details on the biologics CDMO services offered by FUJIFILM Diosynth Biotechnologies:

Company	Year of Establishment
Number of Facility	6
Location of Manufacturing Facility	California, US Hillerod, Denmark Massachusetts, US North Carolina, US (2) Texas, US Teesside, UK
Scale of Operation	Preclinical Manufacturing Clinical Manufacturing Commercial Manufacturing
Type of Biologic Manufactured	The company offers manufacturing services for the following biologics: Monoclonal Antibodies Cell Therapies Gene Therapies Plasmid DNA / Viral Vectors Proteins / Peptides Vaccines
Type of Expression System Used	Insect Cell Lines Mammalian Microbial

Recent Capability / Capacity Expansion Initiatives Undertaken by FUJIFILM Diosynth Biotechnologies:

• In September 2023, the company announced the completion of its new facility based in Darlington, UK in order to manufacture viral gene therapies, oncolytic viruses and viral vaccines for clinical trials. This expansion is particularly focused on early stage clinical trial viral vector products.4
• In June 2023, the company announced the expansion of its contract development and manufacturing services through the addition of a new sales office in Tokyo, Japan.

Lonza, a Well Recognized Biologics CDMO, has a Five Year Plan Ready with the Key Areas of Focus Identified

Lonza is a Swiss pharmaceutical manufacturing company that claims to be one of the leading players in the biopharmaceutical contract manufacturing market. The firm offers a wide range of products and services, such as R&D and manufacturing services, to the pharmaceutical, healthcare and life science industries, as well as academic and government research institutes. Additionally, the company extends its services to manufacturers of consumer health products, distributors, formulators and service-based companies. It is worth noting that the company maintains a global presence with operations spanning across 30 sites, worldwide. At the Capital Markets Day held in October 2023, the company recognized ADC, biologics drug product, cell and gene therapies and small molecules as the areas of investment for the period 2024 – 2028.⁵

The following table presents the details on the biologics CDMO services offered by Lonza:

Company	Year of Establishment
Number of Facility	14
Location of Manufacturing Facility	Basel, Switzerland Bavaria, Germany Berkshire, UK California, US Cambridge, UK Galicia, Spain Guangdong, China Liege, Belgium Limburg, Netherlands Massachusetts, US New Hampshire, US Texas, US Tuas, Singapore Valais, Switzerland
Scale of Operation	Preclinical Manufacturing Clinical Manufacturing Commercial Manufacturing
Type of Biologic Manufactured	The company offers manufacturing services for the following biologics: Antibody Drug Conjugates Monoclonal Antibodies Cell Therapies Gene Therapies Nucleic Acids / Oligonucleotides Plasmid DNA and Viral Vectors Proteins / Peptides Vaccines
Type of Expression System Used	Mammalian Microbial

Recent Capability / Capacity Expansion Initiatives Undertaken by Lonza:

• In October 2023, the company announced the construction of a new filling line for the commercial supply of antibody drug conjugates at its facility based in Stein, Switzerland.
• In June 2023, the swiss biologics CDMO acquired Synaffix to strengthen its ADC capabilities.
• In March 2023, the company expanded its drug product cGMP clinical and commercial manufacturing capabilities at its facility based in Visp, Switzerland by the addition of liquid and lyophilized vial filling isolator lines for multiple modalities.

Samsung Biologics, Drawing Close to Completion of its Fifth Biologics Manufacturing Facility Which Aims to Make it a Leading Biologics CDMO in Terms of Capacity 

Samsung Biologics is a contract manufacturing company, established in 2011 as a joint venture between Samsung affiliated companies and Quintiles Transnational. The company claims to provide various services, such as process development, cGMP manufacturing, aseptic fill / finish, quality, and project management services to its clients.  It is worth highlighting that, in February 2022, Samsung Biologics was recognized for its capability, compatibility, expertise, quality, reliability and service at an event hosted by Life Science Leader and Outsourced Pharma.  

The following table presents the details on the biologics CDMO services offered by Samsung Biologics:

Company	Year of Establishment
Number of Facility	1
Location of Manufacturing Facility	Incheon, South Korea
Scale of Operation	Preclinical Manufacturing Clinical Manufacturing Commercial Manufacturing
Type of Biologic Manufactured	The company offers manufacturing services for the following biologics: Monoclonal Antibodies Vaccines Plasmid DNA / Viral Vectors
Type of Expression System Used	Mammalian

Recent Capability / Capacity Expansion Initiatives Undertaken by Samsung Biologics:

• In March 2023, the company announced the construction of a fifth plant, at its facility in Incheon, South Korea, as part of its strategic expansion in response to increased market demand. Upon its completion, expected in April 2025, the plant is expected to hold a manufacturing capacity of 180,000 L and will expand the company’s total site capacity to 784,000 L.⁶

Sandoz Aims to drive Innovation in the Healthcare Industry by Freeing up Resources Sustainably and Responsibly While Continuing to Address Global Health Challenges

Sandoz, a division of Novartis, is dedicated to enhancing the global healthcare of millions of patients by providing them access to high-quality medicines. Presently, the company claims to offer around 1,000 molecules, including biosimilars and generic antibiotics, intended for the treatment of various disease indications including generic cardiovascular, central nervous system, ophthalmology, oncology, and respiratory diseases. Additionally, the company offers a variety of drug delivery devices, such as inhalables, injectables, oral solids, and films and transdermal patches.  

The following table presents the details on the biologics CDMO services offered by Sandoz:

Company	Year of Establishment
Number of Facility	3
Location of Manufacturing Facility	Kundl, Austria Menges, Slovenia Schaftenau, Austria
Scale of Operation	Preclinical Manufacturing Clinical Manufacturing Commercial Manufacturing
Type of Biologic Manufactured	The company offers manufacturing services for the following biologics: Monoclonal Antibodies Biosimilars Proteins / Peptides
Type of Expression System Used	Mammalian Microbial

Recent Capability / Capacity Expansion Initiatives Undertaken by Sandoz:

• In July 2023, the company announced the expansion of its end-to-end biosimilars drug substance and drug product development capabilities with the addition of a new center at its facility in Ljubljana, Slovenia, through an investment of USD 90 million.
• In May 2023, the company announced the expansion of its biopharma technical development (BioTD) capabilities with the addition of a new facility in Holzkirchen, Germany, in order to provide high-quality biosimilars through an investment of EUR 25 million.
• In March 2023, the company signed the memorandum of understanding (MOU) at its facility in Lendava, Slovenia in order to support the increasing global demand for biosimilar medicines.

Vetter Pharma is Specialized in Aseptic Filling and Packaging of Injectable Drugs in Vials, Syringes, Cartridges and Dual-Chamber Systems

Vetter Pharma is a leading contract development and manufacturing organization (CDMO) that claims to have more than 40 years of experience in contract manufacturing services, including drug development, clinical and commercial manufacturing, device assembly and packaging, analytical services, and logistics. Further, the firm operates through its state-of-the-art manufacturing facilities that are equipped with advanced technologies and systems with around 20 aseptic filling lines.

The following table presents the details on the biologics CDMO services offered by Vetter Pharma:

Company	Year of Establishment
Number of Facility	3
Location of Manufacturing Facility	Illinois, US Rankweil, Austria Ravensburg, Germany
Scale of Operation	Preclinical Manufacturing Clinical Manufacturing Commercial Manufacturing
Type of Biologic Manufactured	The company offers manufacturing services for the following biologics: Monoclonal Antibodies Proteins / Peptides Vaccines

Recent Capability / Capacity Expansion Initiatives Undertaken by Vetter Pharma:

• In May 2023, the company expanded its clinical development and manufacturing offerings at its facility in Rankweil, Austria.

WuXi Biologics, an Asia Pacific Based Biologics CDMO, Names ADC, Bispecific Antibodies, Fusion Proteins and Vaccines as Growth Drivers 

WuXi Biologics claims to be one of the leading global contract research, development and manufacturing organization, offering end-to-end solutions related to biologics. The services offered by the company include integrated drug discovery, drug development and manufacturing biologics-related services from concept to commercial manufacturing.  It is worth highlighting that the company claims its cGMP biologics manufacturing facility as one of the few facilities in China, operating in compliance with global regulatory standards.  Further, the company is currently supporting over 610 integrated client projects, including 22 projects in commercial manufacturing stage.  The company has gained multiple projects for bispecific, ADC, fusion proteins and vaccines.⁷

The following table presents the details on the biologics CDMO services offered by WuXi Biologics:

Company	Year of Establishment
Number of Facility	15
Location of Manufacturing Facility	Dundalk, Ireland (2) Hebei, China Jiangsu, China (3) New Jersey, US North Rhine–Westphalia, Germany (2) Pennsylvania, US Shanghai, China (2) Sichuan, China Zhejiang, China (2)
Scale of Operation	Preclinical Manufacturing Clinical Manufacturing Commercial Manufacturing
Type of Biologic Manufactured	The company offers manufacturing services for the following biologics: Monoclonal Antibodies Antibody Drug Conjugates Antibody Fragments Biosimilars Bispecific Antibodies Cell Therapies Gene Therapies Plasmid DNA / Viral Vectors Proteins / Peptides Vaccines
Type of Expression System Used	Insect Cell Lines Mammalian Microbial Yeast

Recent Capability / Capacity Expansion Initiatives Undertaken by WuXi Biologics:

• In June 2023, the company announced the expansion of its drug substance and drug product manufacturing capabilities by increasing the capacity to 24,000 L, at its facility based in North Rhine–Westphalia, Germany.¹⁹

What About the Other Biologics Contract Manufacturers?

The above presentation features 10 biologics cdmo selected from a pool of over 305 companies that we have compiled. If you're interested, you can download the Sample Report on this topic by Roots Analysis. For personalized assistance in identifying the most relevant solutions based on your specific criteria, please don't hesitate to reach out to us at sales@rootsanalysis.com.

About Author

Jasmeet Bhalla

With an experience of over 4 years with Roots Analysis, Jasmeet is adept at generating useful insights from unstructured / structured datasets. As a senior analyst at Roots Analysis, she has assisted several clients across multiple industry verticals within the healthcare industry. These verticals include contract services, devices / technologies, and drugs / disease indications. Since the findings of the research are aimed at supporting the clients to make thoughtful decisions for their business, she has hands-on experience on competitive landscape assessment, benchmarking, market sizing and forecasting, as well as several quantitative / qualitative / strategic frameworks.
 

Sources:1 https://www.agcbio.com/news/agc-to-complete-the-acquisition-of-molmed-on-july-31-2020
Sources:2 https://www.reuters.com/business/healthcare-pharmaceuticals/contract-drug-manufacturer-catalent-warns-hit-fourth-quarter-results-2023-04-14/
Sources:3 https://ir.criver.com/news-releases/news-release-details/charles-river-laboratories-completes-acquisition-vigene
Sources:4 https://www.pharmtech.com/view/fujifilm-diosynth-biotechnologies-completes-new-viral-vector-gene-therapy-manufacturing-facility-in-uk
Sources:5 https://www.lonza.com/-/media/Lonza/Lonzacom/investor-relations/files/17_October_2023_CMD_presentation.pdf
Sources:6 https://samsungbiologics.com/media/company-news/samsung-biologics-accelerates-timeline-of-new-fifth-plant-to-be-operational-by-april-2025
Sources:7 https://www.nasdaq.com/press-release/wuxi-biologics-reports-solid-2023-interim-results-2023-08-23