Insulin, which helps millions of diabetics worldwide to regulate their blood sugar levels, holds the distinction of being the first modern medicine to be produced using biotechnological methods. Since the last three decades, the demand for biotherapeutics has shown a steep upward growth trajectory because there is now a greater demand for treating serious diseases such as cancer, rheumatoid arthritis, and multiple sclerosis.
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This rising demand for biotherapeutics, coupled with several biopharmaceutical drugs nearing late-stage clinical trials, has consequently created appreciable demand for cell line development. That’s because an appreciable number of biotherapeutics are recombinant monoclonal antibodies produced in mammalian cell lines. While producing cell lines wasn’t a commercially feasible process until a few years ago, that scenario has long changed. Advances in biotechnology now enable biotech and life sciences companies to produce cell line on a large scale for protein-based therapeutics.
The global biotherapeutics cell line development market had a valuation of US$56.03 mn as of 2014. As per the projections of Transparency Market Research, the market is expected to rise to US$99.84 mn by 2022. This translates to a compounded annual growth (CAGR) rate of 7.5% between 2015 and 2022.
What do the numbers speak of the demand for biotherapeutics cell line development market?
The number of recombinant protein therapeutics approved by the United States’ Food and Drug Administration (FDA) has only risen with every passing year. Taking this rise into consideration, there is a parallel increase in the demand for cell lines to produce biotherapeutics. In 2014, for instance, 11 novel recombinant protein therapeutics received FDA’s stamp of approval. From 2006 to 2011, TMR analysts say that on an average, 15 novel recombinant drugs were approved by the US FDA.
In the U.S., Europe, and other important global markets, the number of monoclonal antibody products approved approximates 47. Of these, more than 60% were reportedly produced in mammalian cell culture.
North America, Europe, and Asia Pacific: The Largest Biotherapeutics Cell Line Development Markets, in that Order
North America’s leading position in the global biotherapeutics cell line development market in 2014 can be ascribed to the presence of a number of large biopharmaceutical manufacturers here. The expanding geriatric population base here also presents a massive opportunity for the biotherapeutics industry. Europe, the second-largest market for biotherapeutics cell line development has remained firmly on the growth track thanks to a rising demand for biotherapeutics.
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However, the future of the biotherapeutics cell line development market lies in Asia Pacific, which was ranked as the third-largest market globally. The potential that APAC presents can be gauged from the prediction that the region will exhibit the highest CAGR globally. This, coupled with considerable investments made by large multinationals in countries such as China and India will make the market worth tracking. Latin America is yet another high-potential market for biotherapeutics cell line development. Countries such as Brazil, especially are emerging as attractive markets for biotherapeutics cell line development.