Development of therapeutic antibodies for the treatment of diseases.

The U.S. FDA has just approved its 100th monoclonal antibody product. 

The first monoclonal antibody (mAbs) was produced in 1975. Thirty-five years on from the FDA’s approval of the first monoclonal antibody, these biologics account for nearly a fifth of the agency’s new drug approvals each year. The technology has come to be used by scientists all over the world, and led to a Nobel Prize in 1984.

The first therapeutic antibody to be approved for clinical practice was anti-CD3 muronamab (Orthoclone OKT3) in 1986, which was used to combat acute transplant rejection. The first antibody approved for oncology patients was rituximab in 1997. As of March 2021, 100 therapeutic mAbs have been approved by the U.S. FDA.

The importance of this class of drugs cannot be overstated. More than 50 percent of biologic drugs on the market today are mAbs.

Since the licensing of the first mAbs for clinical use over 30 years ago, the market-segment has expanded exponentially and is now valued at hundreds of billions of dollars. The global therapeutic monoclonal antibody market was valued at approximately US$115.2 billion in 2018, and is expected to generate revenue of $300 billion by 2025.

The emergence of monoclonal antibodies has proven to be a pivotal turning point in scientific research. This 2020 publication via @BioMedCentral provides a comprehensive look into the historical development of therapeutic antibodies.