Unlike chemically synthesized drugs, whose structure is known and reproducible, biological drugs are derived from living cells and are sensitive, complex mixtures requiring cutting-edge biological technologies for their production. The growing importance of biosimilars in recent years is reflected in a corresponding rise in market value. The value of the global biologic therapeutic drug market reached approximately US$230 billion in 2014 and, according to BCC Research, will increase to nearly $390 billion by the end of 2019. This corresponds to a compound annual growth rate (CAGR) of just over 10%. BCC Research also estimates that biosimilars accounted for nearly $2.0 billion of the biologic therapeutic drug market in 2014 and that this segment is growing at a CAGR of 15%. Key drivers for the growth of biologic therapeutic drugs include the aging of the global population and the worldwide increase in chronic diseases; biologic drugs are very effective for treating arthritis, diabetes and heart diseases. Rising wealth and improving healthcare systems in emerging regions are also having a positive impact on the demand for biopharmaceuticals. The higher growth rate for biosimilars is due to the fact that numerous blockbuster monoclonal antibody (mAb)-based drugs will be off patent by 2020.
Despite this strong growth, competition in the biopharmaceutical market is fierce. Governments, insurance carriers, and patients are all looking for new drugs with demonstrated value in terms of both cost and efficacy. To gain real market share, being first to market is imperative — whether for branded products or biosimilars. There is, consequently, tremendous pressure to reduce development times and costs while still providing safe drugs. Targeted therapies such as antibody– drug conjugates that include large- and small-molecule components, although highly potent, can create safety and handling challenges. For a biosimilar, it is necessary to demonstrate similarity to its branded biologic. This requires extensive characterization of the drug candidate during development and requisite controls during the manufacturing process.
Biopharmaceutical manufacturers are therefore seeking new processes as well as analytical technologies and relevant combinations that can help reduce complexity and increase productivity and efficiency. In particular, there is a need for processing equipment and analytical tools/ techniques that facilitate continuous processing and enable the seamless integration of different upstream and downstream bioprocess steps.