Biologics and Biosimilars Sales Market Future Technological Advancement Pfizer,Roche, Amgen,AbbVie,Sanofi,Johnson & Johnson,Novo Nordisk,Novartis

As biosimilars are widely used in prevention and treatment of a range of chronic diseases, such as diabetes, cancers, CVDs, autoimmune diseases, rheumatoid arthritis, kidney failure, growth hormone deficiency, hematological diseases, and infectious diseases, the demand for biosimilars is likely to gather momentum within the next few years. Growing geriatric population is another major factor identified to primarily drive the market for biosimilars.

Moreover, they are increasingly gaining preference over conventional biologics, attributed to relatively lesser costs compared to that of their parent biological drugs. Various government and private bodies are increasingly promoting the usage of biosimilars over conventional biologics and synthetic drug products. This will remain a major factor propelling the market for biosimilars. High costs of existing biological drugs and rapidly growing pharmaceutical realm will collectively foster the market for biosimilars. However, high manufacturing costs and complexity may remain longstanding roadblocks to mainstream production of biosimilars. Moreover, availability of affordable generic drugs in market may also hamper the sales of biosimilars. The most prominent restraint for manufacturers is to establish the biosimilarity through extensive analytical characterization.

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The first generation of biologic drugs, such as insulin or growth hormone, were natural proteins produced through large-scale production techniques, and mostly used as replacement therapies for patients suffering from deficiency. In newer drugs, natural proteins are altered, by a process known as protein engineering, to perform specific tasks. The key advantage of biologics over small molecules is that they mimic the normal complex function(s) of proteins within the body, which often cannot be replicated by a small molecule, inherently foreign to the body.

While the advantages of biologics are known, there are some challenges too. The molecules are complex and delicate, and require careful handling. Sometimes a modification in one corner of such a large molecule may be difficult to detect by analytical techniques but may have significant impact on its function. Protein drugs are difficult to take as well. They must be injected, infused or inhaled, as they are destroyed in the stomach when swallowed. The key step in the production of a biologic drug is to create a ‘genetically engineered’ animal cell or microorganism (or in some cases plant or animal), i.e. one whose genetic code has been modified to produce the desired protein. The overall drug development pathway for biologics remains the same as small molecules, starting with identifying the target, validating the information, screening and testing, followed by pre-clinical and clinical trials before its commercial approval.

The market is driven by factors such rising prevalence of chronic diseases such as cancer and diabetes supplement the growing demands of pharmaceutical drugs, especially for the high priced patented drugs. However, the market growth is limited by the high cost of reference products increases the financial burden on patients as well as reimbursement service providers. The lack in economies of scale due to lower demand is a factor that results in these high costs. Furthermore, the growth of the biosimilars market is hampered due to the lack of regulatory guidelines, consumers brand preferences, reluctance of physicians to prescribed biosimilars and the high capital required for research and development.

However, biosimilars applications in autoimmune and chronic diseases exhibit the highest potential due to the changing off patent scenario. Biopharmaceutical industry is vastly dependent on the advanced technologies used in various procedures of development and manufacturing. These technologies are acting as a mandate for every single operation in biopharmaceutical and healthcare research industry. Some of the significant technologies are discussed in the report includes, Monoclonal Antibodies (MAb) Technology, Recombinant DNA Technology (rDNA technology), Nuclear magnetic resonance (NMR) technology, Chromatography, Electrophoresis, Mass Spectrometry, Western Blotting and Bioassay. Monoclonal antibody technology and bioassay technologies are the most significant technologies used in biosimilar development and validation.

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