A Survey of Commercial Biomolecules, Delimited to Pharmaceuticals and Medical Devices

Sammanfattning: Biologics — biomolecule-based therapeutics — are predicted to become the next generation of therapeutical drugs. The pharmaceutical industry is investing a great amount of money into research in this medical field, which shows the importance and the need of analyses regarding biological drugs. This report is a survey of commercial biologics in which the market and trends regarding the past, present and future are analysed. The results are based on a literature study limited to commercial biologics — either as chemical entities, as conjugates to another class of biomolecules or as medical devices. The market for biomolecule-based therapeutics and medical devices is predicted to flourish as the new generations of peptides, proteins, oligonucleotides, carbohydrates and lipids increase in both approvals and sales. The fact that scientists have gained a broader comprehension on a molecular level due to advanced technologies has resulted in biologics reaching clinical maturity. The optimized pharmacokinetic properties, greater specificity, and the increased therapeutic window have led to reduced side effects compared to traditional therapeutical alternatives. Due to new development approaches — peptidomimetics — the stability of peptides has shown to increase. This results in a huge market and development potential. The protein therapeutics market is the largest among biologics, and their subgroup — the monoclonal antibody-based therapeutics market — is the fastest growing. With a high growth rate of novel therapeutics in development, the market will continue to expand. Conjugated monoclonal antibodies (ADC) and GalNAc conjugates to small interfering RNA are just a few examples of high potential drugs that are expected to increase on the market and in clinical development. Oncology is the dominating therapeutic area, where great success has been observed in both clinical and pre-clinical studies. Lipid conjugates have proven to be efficient in the treatment of tumour cells and the cytotoxic ADC grant great hope for the biomolecule-based therapeutics market. The market is also expected to grow for establishing biologics; for example the increasing need of anticoagulants is predicted to double the Heparin market to 2023 and the demand for novel treatment alternatives opens market opportunities for Heparin biosimilars. The biological vaccine market is also predicted to grow together with biologics, as mutated animal-spread diseases increase in number.