Monoclonal antibodies (mAbs) currently represent the largest class of biopharmaceutical products. With the approval of chimeric monoclonal antibody products, followed by the approval of humanized and then fully human monoclonal antibodies, the rate of product approvals and sales of monoclonal antibody products has increased dramatically. The number of monoclonal antibody products approved for commercial sale in the US and Europe has grown steadily, with average three to five new products are approved per year for the last several years. Out of the total monoclonal antibody products approved and marketed in the United States and Europe, only about 5% are produced in E. coli, while all of the other products are produced in mammalian cells. Genetically-engineered mice now act as robust engines for the generation of diverse repertoires of affinity-matured, fully-human variable regions with intrinsic drug-like properties necessary for successful development including high potency, specificity, manufacturability, solubility and low risk of immunogenicity.
According to TABS Therapeutic Antibody Database, and data collected from various public sources, such as papers, patents, meeting abstracts, etc., nearly 400 patents were filed for new therapeutic antibodies against human antigens in 2015. Out of the 3515 antibodies currently in the database in each development phase, about 77% of all the mAbs were in preclinical stage, while 10%, 9%, 3%, and 2% mAbs were in Phase I, Phase II, Phase III, and FDA approved stages, respectively.
Today, human and humanized mAbs comprise 63% of approved mAb products. Nearly 60 mAbs were approved for human use or in regulatory review by mid-2016. Of those, 29% were derived from transgenic mice engineered to express human antibody repertoires.
- In 2013, global sales revenue for all monoclonal antibody products was nearly US$ 75 billion with an average compound annual growth rate of 20%, representing approximately half of the total sales of all biopharmaceutical products. Based on a review of historical sales data, company annual reports, and sales projection data, the monoclonal antibody market will continue to grow at a CAGR of 8.5% or more for the next several years to reach nearly US$ 130 billion by 2020.
- Global Monoclonal Antibody Therapeutics Market by Source Type (Chimeric and Humanized, Human, Murine, Others), Therapy Type (Antibody-Directed Enzyme Prodrug Therapy, Antibody-Drug Conjugates, Radioimmunotherapy), Application (Autoimmune Diseases, Cancer, Hematological Diseases, Infection, Ophthalmological Diseases, Others), and End User (Hospitals, Private Clinics, Research Institutes) 2016-2020
- Major players operating in the global therapeutic monoclonal antibody market include AbbVie, Inc., Alexion Pharmaceuticals, Amgen, Inc., Bayer Healthcare Pharmaceuticals, Biogen. Inc., Bristol-Myers Squibb Company, Eli Lilly and Co., F. Hoffmann-La Roche Ltd., GlaxoSmithKline plc., Johnson & Johnson, Merck & Co., Inc., Novartis Pharmaceuticals, Pfizer, Inc., Regeneron Pharmaceuticals, Sanofi, Spectrum Pharmaceuticals, Takeda Pharmaceutical Co., and UCB.
- Rapid advancement of scientific understanding of disease at a molecular level (genomics, proteomics and systems biology) continue to provide important new targets for modulating disease.
- The production of most monoclonal antibody products is easily amenable to efficient platform-based approaches and antibodies are generally well-tolerated and highly specific, the risk of unexpected safety issues in human clinical trials of monoclonal antibody products is lower than with many other types of therapeutic products. With the right platform, antibodies are easy to isolate and the immune system generates a library of billions of different antibodies, each antibody with a unique specificity.
- Worldwide aging population and the increasing standard of living in emerging markets is fueling the growth in monoclonal antibody product sales in the global market.
- As the biopharmaceutical industry matures with substantially improved process yields and reduced actual manufacturing costs, supply of large quantities of therapeutic monoclonal antibody products is becoming a major cost-effective measure against a wide range of indications including autoimmune diseases, cancer, hematological diseases, infection, ophthalmological diseases, others.
- There is also a surging interest in biosimilar monoclonal antibodies in the global markets of Latin America, China, Southeast Asia, India, and Russia, with several monoclonal antibody products already approved in these regions.
- Similarly, the introduction of biosimilars in these markets is likely to have a very large impact on the global sales of monoclonal antibody products as biosimilar monoclonal antibodies are approved in geographies that are currently unable to access expensive innovator products.
The continued growth in sales of the currently approved monoclonal antibody products, along with the over 300 monoclonal antibody product candidates currently in development, many for multiple indications, will result in continued growth in sales of monoclonal antibody products in the coming years and will continue to drive the overall sales of all biopharmaceutical products. Recent research has focused on improving the efficacy of existing mAbs by optimizing affinity and adding other beneficial modifications with emerging antibody agents that provide valuable new treatment options.