With the increasing number of recombinant protein therapeutics gaining approval by the U.S. Food and Drug Administration (FDA) annually, there is an increase in the demand of cell lines for production of these biotherapeutics. From 2006 to 2011 an average of 15 novel recombinant protein therapeutics and in 2014, 11 novel recombinant protein therapeutics have been approved by US FDA. About forty-seven monoclonal antibody products have been approved in the U.S., Europe and other global markets, of which over 60% were produced in mammalian cell culture. Moreover, the rise in the geriatric population coupled with prevalence of diseases is one of the major factors driving the demand for cell line development for biotherapeutics. The increasing demand for monoclonal antibodies across the globe boosts the market growth. In addition, the increasing number of initiatives taken by the government of various countries by funding the life science research and development is expected to propel this market in coming years.

Diseases such as cancer, rheumatoid arthritis, multiple sclerosis, and diabetes have gripped at an ever-increasing number of people across the world. A large number of these recorded patients are present in developed economies, where there is a high growth rate in the demand for biotherapeutics. The eventual release of several biopharmaceutical drugs will accelerate the demand for cell line development.

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The global biotherapeutics cell line development market is expected to reach close to US$100 mn by the end of 2022. It was recorded at US$56 mn in 2014 and is expanding at a positive CAGR of 7.50% within a forecast period from 2015 to 2022.

What Role Does the FDA Play in the Proliferation of Biotherapeutics Cell Line Development Processes?

The key factor that is boosting the demand for biotherapeutics cell line development processes is the increasing prevalence of diseases that require them for treatment, coupled with the growing geriatric demographic which is the most susceptible to these diseases. While this has provided a great impetus for cell line development processes, yet another driver has been provided by the U.S. FDA recently. Between 2006 and 2011, about 15 novel recombinant protein therapeutics were approved the regulatory body per year on average. In 2014, 11 of these were additionally approved. On a global front, nearly 47 different monoclonal antibodies have been approved and more than 60% of these antibodies are created through mammal-based cell cultures. These high approval rates have created a massive demand for biotherapeutics cell line development over the recent past.

Where Should Cell Line Development Players Look to in the Future?

Regionally speaking, most of the demand for biotherapeutics cell line development has been coming from North America till recently. The region is highly advanced in a lot of medical and healthcare fields and has always been in a consistently leading position in terms of medical research. This is largely because of the very high demand for advanced treatment methods by the large patient pool in the region. For similar reasons on a slightly lower scale, Europe has been second in terms of demand for biotherapeutics cell line development.

The future of this market, however, is expected to lie in the emerging economies. Asia Pacific was fourth in terms of demand for biotherapeutics cell line development in 2014, but is showing an astounding growth rate in this demand at the moment. This growth in demand is expected to continue accelerating for the coming years, owing to a storming rise by this region’s healthcare sector. It thus forms the largest untapped market for biotherapeutics cell line development players till 2022.

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What Role will Single Cell Cloning Hold in the Future of Biotherapeutics Cell Line Development?

In 2014, 96% of the global biotherapeutics cell line development market was taken up by single cell cloning, in terms of process. Till recently it has been the singular most important process in biotherapeutics cell line development, with all its key sub-segments. The introduction of ClonePix and FACS in the recent past have added a lot of weight to single cell cloning, further increasing its demand as a biotherapeutics cell line development process. Single cell cloning will thus remain the leading process in this field for quite a while longer.

However, transfection and selection as a collective process is turning many heads. This process is expected to show a phenomenal growth rate over the coming years and eat into the single cell cloning process’s share in value. A key reason for this surge in demand for transfection and selection is the increasing demand for the use of monoclonal antibodies.

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