ADMA Biologics (NASDAQ:ADMA) is a biopharmaceutical company developing superior products for immunodeficient patients at risk for infection. Its lead product candidate, RI-022 demonstrated positive results in the pivotal phase 3 study in patients with Primary Immunodeficiency Disease (PIDD). PIDD is a class of 250 presentations of inherited genetic disorders that cause an individual to have a deficient or absent immune system response due to either a lack of necessary antibodies or a failure of these antibodies to function properly. It has a prevalence of about 1 in 1200 people. PIDD patients are more vulnerable to infection and suffer deeper complications of infection, which have been estimated to cost the medical industry 6 billion dollars per year. Patients afflicted with PIDD generally receive a monthly outpatient infusion of exogenous immunoglobin therapy known as IVIG to prevent infection. PIDD global annual market was valued at 4.36 billion dollars in 2014 and is estimated to reach 7.56 billion by 2023 at a CAGR of 6.1% from 2015 to 2023.
The company technology for generating plasma screens for high polyclonal antibody titers in donor serum, and mixes it with normal plasma. The process yields an IG rich product with meets the FDA release specifications for treatment of patients with PIDD as well as specified levels of RSV antibodies in the final preparation. The process is protected by an issued patent to eliminate lot-to-lot variability of certain specific polyclonal antibodies.
