Demand for Biologics and Biosimilar Drugs, a Big Push for Cell-based Assays Market
The biotech revolution has ushered a new class of therapeutic agent known as biologics, they treat common to life-threatening diseases such as arthritis, cancer, diabetes, and inflammatory diseases. Because biologics are highly target specific, and efficient in treating disease conditions there has been an increasing interest from large pharma companies to niche players, to have a slice of this high-value pharma market. In 2018, biologics dominated the list of blockbuster drugs with 6 drugs featuring in the top 10 selling drugs list. In 2018, the FDA approved 59 drugs, of that 17 were biologics which accounts to about 28.8% of total approvals. The global market for biotech based drugs was estimated to be ~$230-$240 billion in 2018.
Small molecule drugs are synthesized chemically to derive highly homogenous structure with predictive function, in contrast, biologics are extracted from biological sources involving live systems (mammalian cells, microbes, fungi, etc) and have a complex manufacturing process and purification steps requiring skilled manpower. The FDA and other similar regulatory agencies around the world prescribe stringent quality control requirements to ensure that the end product is manufactured to ensure purity and quality of final products do not cause any undesired side effects. The guidance document for biologics manufacturers suggests the development of the potency tests in parallel to the drug development process. The potency testing should include product characterization where relevant pre-clinical investigations, proof of concept studies, early clinical studies, available historical experience, and available reference materials and controls related to product class should be included which provides a basic understanding regarding product attributes and biological activities that contribute to functioning and the mechanism of action studies where cell-based assays play an important role.
Cell-based assays can be used for measurements of primary potency and evaluation of antibody internalization which enable full characterization of the various biological activities of the molecule. The cell-based assays are required in various phases of drug development and manufacturing such as in-vitro comparability testing, characterization studies, potency assay development, quality control testing of manufactured biologic drugs, drug stability testing and Nab assay for immunogenicity screening.
Another area of biotech drugs that is set for rapid growth is biosimilars segment, the copycats of biologics, many blockbuster biologic drugs are losing their patent protection by 2020 and have to compete with a huge pipeline of biosimilars in the pharmaceutical market space. The biosimilars are expected to decrease the financial burden and create a huge market for manufacturers of these drugs. But the manufacturing of biosimilars is as complicated as that of biologics and similar process controls are required. A small change in condition can alter the final product and the whole batch of product may need to be discarded. Here again, the cell-based potency tests play an important role in the biosimilar development and manufacturing phases. As the market for biologics and biosimilar product are expected to rise, the demand for cell-based assay products and services is set to grow at very high growth rate. According to IQ4I analysis, the market for Cell-based assays was estimated to reach $20.1 billion by 2025 growing at a CAGR of 8.0%.