Emerging Trends, Challenges, and Opportunities in Protein Therapeutics

Protein-based therapies are proving effective in the clinic, and their potential is recognized. More than 100 genuine and equivalent modified therapeutic proteins have been approved for clinical use in the European Union and the United States, with revenues of US$ 108 billion in 2010, with monoclonal antibodies(mAbs) accounting for over half of the sales (48%). Based on their pharmacological activity, the therapeutic protein-based treatments can be divided into five categories: (1) replacing a missing/abnormal protein, (2) augmenting an existing pathway, (3) providing a novel function/activity, (4) interfering with a molecule/organism, and (5) delivering other compounds, proteins, cytotoxic drug, or effector proteins. Therapeutic proteins include antibodies, Fc fusion proteins, anticoagulants, enzymes, growth factors, hormones, interleukins, and thrombolytics. Recombinant proteins are used in most commercialized protein therapies, and several are now being investigated in clinical trials for cancer, immunological disorders, infections, and other health issues. Bispecific mAbs and multispecific fusion proteins, mAbs, and proteins with improved pharmacokinetics are currently being developed. To overcome substantial obstacles such as resistance to therapy, access to targets, biological system complexity, and individual heterogeneity, a paradigm change in techniques and knowledge of processes is necessary.