Taking existing antibodies and converting them into ones with higher therapeutic activity.
Creates new intellectual property claims. Simple recombinant humanized antibody template; install CDRs from existing antibodies.
Changing Dynamic of the Therapeutic Monoclonal Antibody Market
Revenues from therapeutic monoclonal antibodies (mAbs) are predicted to rise to $62bn next year. These revenues are derived from less than 30 approved products some achieving more than $6bn per year. By 2020 we expect to have 70 approved products generating $125bn/year.
The success of the industry has been driven by the introduction of not only novel products but also validation of targets into and including parameters of the marketplace. With the maturation of the industry, success has begat copies; i.e. biosimiliars. Biotechnology and pharmaceutical companies are racing to introduce humanized antibodies with identical CDR sequences (antigen binding portion) to compete against mAbs coming off patent. In a related approach, companies are also developing mAbs directed to single, distinct epitopes from FDA approved antibodies to validated targets.
The appeal of biosimiliar mAb development is the combination of low risk development, foreshortened and reduced regulatory requirements but with a high revenue potential. The downside is that these markets will be highly divided with little competitive advantage that will guarantee a company market share.
This conundrum represents the opportunity for PxRadia.