MANUFACTURING
BIOLOGICS RESHAPING PHARMACEUTICAL MARKET The Biotherapeutics market has gained substantial attention and evolved as a profit-making segment of the pharma industry for a decade. This article sheds light on how next-generation proteins are reshaping the market and talk about innovative strategies that pharma companies are thinking of to cut down the developmental cost incurred for producing a safe and efficacious biotherapeutic product and improvising patient experience. Prasanthi Polamreddy, Scientific Manager Excelra Knowledge Solutions Pvt Ltd.
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he biotherapeutics market is booming. Currently, annual growth rate of biologics is double that of conventional pharma and is forecasted to grow rapidly. Increase in incidence of chronic diseases like cancer, diabetes, autoimmune diseases, genetic conditions‌etc and acceptance of biotherapeutics because of their high efficacy and safety are some of the major factors driving the biopharmaceutical market. Also, biologics gained edge in diseases that could not be successfully targeted by small molecule drugs especially oncology indications and autoimmune ailments. And today biotherapeutics industry moved one more step ahead and invested in the development of next generation biologics which forms the current era. However, despite the considerable demand, high cost associ-
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P H A RM A F O C U S A S I A
ISSUE 39 - 2020
ated with biotherapeutics restricts market growth. Evolution of biotherapeutics
Since the launch of breakthrough therapeutic drug – Insulin (enzyme replacement therapy) in 1982, the growth potential of biologics has been promising. In its early days, this industry faced some serious concerns. Despite vast challenges in its path, this industry evolved as multibilliondollar market and today 7 of the top 10 bestselling drugs are biologics. Many innovative therapies were launched till date and comprise vaccines, enzymes-based therapies, cell therapies, gene therapies, immunotherapies, peptides and protein products. Monoclonal antibodies (mAbs) revolutionised the biotherapeutics market and rose to leading position among the other biologic products.
Antibody drug conjugates
The increased scale of demand for effective biologics, especially monoclonal antibodies and continuous efforts to improvise the therapeutic potential led to advancement of protein engineering technologies which further fuelled the development of next generation biologics. These next generation biologics are characterised by longer half-life and low immunogenicity and comprise antibody drug conjugates (ADCs), bi-specific and multi-specific antibodies, fusion proteins, engineered cells and antibody-like proteins (ALPs). ADCs are one of the lucrative classes of engineered proteins and were proven to be effective in combating cancer, especially haematological malignancies and breast cancer. Though the side effect profile of ADCs is comparable to that of chemotherapeutics, it has not dampened their development and rather intensified ADC R&D. Currently there are almost 600 clinical trials focused on ADCs of which 40 trials are evaluating ADC and check point inhibitor combinations in oncology indications.
