February 12, 2024
Monoclonal antibody production is one of the most thriving branches of the pharmaceutical industry.1 The enhanced interest in antibody production is due to the success of antibody treatments which are used to trigger an immune response against infectious diseases and cancers.2
Even though the industry is rapidly growing, companies that specialize in antibody production have to face different difficult challenges. This means that access to the industry can still be limited to smaller businesses because of a lack of technological equipment, for example.
In the following we take a closer look at the top five companies in terms of annual revenue in the U.S., that dominate the field of antibody research, development and production. Further, we dive in the field of promising pioneers with a focus on mAb production for the use of cancer treatments.
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There are several key players in the antibody industry. Although listing all of them would exceed the scope of this article, we listed five of the leading monoclonal antibody companies, ranked by revenue:
Some of these companies have become branch leaders in several pharmaceutical areas. What unites them is that they are all also involved in monoclonal antibody technology, which will be further illustrated below. The figures were taken from the source GlobalData.3
Location: Headquartered in New Jersey, USA
Total company revenue 2023: USD 85,159.00 (US$m)
Involvement in Monoclonal Antibodies: Johnson & Johnson is a trailblazer in monoclonal antibody research, particularly in cancer therapies. Based in New Jersey, USA, the company's notable contribution includes Darzalex, the world's first FDA-approved monoclonal antibody for multiple myeloma. Stelara’s (antibody product to treat active psoriatic arthritis in pediatric patients) global sales, on the other hand, valued USD 5.2 billion as of H1 2023. In addition, their ongoing clinical trials feature a promising pipeline, with a focus on expanding antibody-based treatments for various cancers and other medical conditions.4 5 6
Location: Based in Shanghai, China
Total company revenue 2023: USD 82,062.24 (US$m)
Involvement in Monoclonal Antibodies: Pioneering monoclonal antibodies in China, Sinopharm Group Co. Ltd. has a significant impact on treatments of infectious diseases. Notable achievements include the collaboration on a combined ambasvirumab/romisevirumab therapy as a treatment option for coronavirus infections.7
Location: Headquarters in Basel, Switzerland
Total company revenue 2023: USD 65,356.19 (US$m)
Involvement in Monoclonal Antibodies: F. Hoffmann-La Roche Ltd. stands as a global innovator in monoclonal antibody research, also focussing on oncology. Headquartered in Basel, Switzerland, their portfolio boasts specialized antibodies for cancer treatment, such as Rituxan and Herceptin. 8 9
Location: Based in Kenilworth, United States
Total company revenue 2023: USD 60,115.00 (US$m)
Involvement in Monoclonal Antibodies: Merck & Co., Inc., headquartered in the United States, is at the forefront of advancing oncology through monoclonal antibody development. Their portfolio includes Keytruda, a revolutionary therapy for various malignancies, with sales of USD 6.3 billion in the third quarter of 2023. Merck & Co., Inc. continues to spearhead advancements in the field, contributing to improved patient outcomes in oncology. 10 11
Location: Headquartered in New York, USA
Total company revenue 2023: USD 58,496.00 (US$m)
Involvement in Monoclonal Antibodies: Driving immunotherapy innovations globally, Pfizer Inc., based in New York, USA, is a major player in monoclonal antibody research. Offering antibodies for medical conditions like infectious diseases and cancers, Pfizer's portfolio features products like Besponsa® against acute lymphatic leukemia.12
In the last three years, the patents filed for antibody discovery have skyrocketed to 633,000 patents in the biopharmaceutical industry. With the interest in antibody research, development and manufacturing ever rising, there are several companies on the rise in this sector that did not make it (yet) on the list above.
The following five pharmaceutical companies all share a strong focus on the development and production of high quality antibodies used in the treatment of different cancers and have the potential to become one of the key players in the field of monoclonal antibody therapy.
Please note that the list is not exhaustive, as names like Genentech Unit, GlaxoSmithKline and AstraZeneca should be mentioned in this context as well, together with many more that would exceed the scope of this article.
With a focus on multi-functional protein therapeutics, Molecular Partners is a pioneer in the field of genetically engineered antibodies. The company based in Switzerland offers customized antibody production with the help of e.coli fermentation. They have several projects for antibodies in the pipeline, including a partnership with Novartis for the development of antibodies used for solid tumor therapy. Furthermore, their DARPin therapeutics can be designed to combine multiple functions in a single molecule.13
MacroGenics is an American based company with headquarters in Maryland. The antibodies that are still in development broadly focus on the area of oncology, especially in the treatment of solid tumors and early stage malignancies. Additionally, they have developed margetuximab, an mAb used in the treatment of metastatic breast cancer with remarkable progression-free survival rates in a phase 3 clinical trial.14
Complix specializes in cell penetrating Alphabody therapy, an innovative approach to antibody development and research. Their main research focus is on antibodies and delivery agents used in orally administered cancer drugs. The company is based in Belgium and has several biotherapeutics against viral diseases, oncology and autoimmunity.
Regeneron, a pharmaceutical company based in the U.S, Maryland, has widely been recognized for their antibodies against infectious diseases like Casirivimab and Imdevimab, which are used for the treatment of mild to moderate COVID-19. Both showed good results with high-risk adult patients in terms of reduced hospitalization rates after a coronavirus infection. Moreover, they have several antibody drugs for the treatment of different cancers in the pipeline. Among them are cemiplimab, an antibody used for cell carcinoma and ubamatamab used to treat ovarian cancer.
The company based in Indianapolis was founded in 1876. Next to Eli Lilly’s Bamlanivimab, the first mAb granted Emergency Use Authorization by the FDA to treat mild COVID-19 infections, they are specializing in the development of antibodies in the treatment for different cancers. Among them is enoblituzumab, an antibody used in the treatment of prostate cancer. Further, Eli Lilly collaborated with AstraZeneca to create an effective drug used against leukemia.
Worldwide, the market for mAbs makes up approximately half of the generated income by the biopharmaceutical market. Although this qualifies mAb production as a lucrative business, there are a number of challenges producers have to face.
Keeping up with healthcare requirements, like the production of vaccines during a pandemic for example, can be hard due to a lack of calculation potential. This means that upscaling and downscaling solutions and the right biotechnological equipment has to be at hand to meet demands.
Further, manufacturing is highly regulated in order to adhere with public health laws. Clinical trials can take up a lot of time, although in some cases like the pandemic, processes could be sped up due to EUA (emergency use authorization). 15 16
The demands pharmaceutical companies have to face in regards to mAb production call for qualified and sensible solutions. This is why technology by Single Use Support addresses the main needs to make the process from research to development and production more flexible, efficient and cost-effective.
Protection systems for single-use bioprocess containers, like the RoSS ® shell, help to guarantee that monoclonal antibodies and other biologics are safe from contamination exposure and damage during the freezing, as well as subsequent transport or shipping. With RoSS.FILL, an automated filling and dispensing solution, bags can be filled in the desired containers, with the option to scale up with multiple racks. The different products have been designed to implement automated closed and sterile solutions that can be used for upstream and downstream processes to cater to changing requirements and make life easier for immunology pioneers.
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