The biopharmaceutical industry is in the midst of an exciting transformation as biologics experience massive growth â€” even outpacing the small-molecule segment (1). Biologics are predicted to comprise over a quarter of the pharmaceutical market in 2020 (2). At the same time, a plethora of new biologically derived therapy concepts â€” e.g., cell and gene therapies â€” are in development. Some biologics classes have become mainstream â€” e.g., monoclonal antibodies â€” with biosimilars entering the market and contract manufacturing organizations (CMOs) expanding their volume output. It is hard to say which of the novel and more personalized therapeutic concepts will disrupt the market in the coming years.
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1 Kent D, Rickwood S, Di Biase S. Disruption and Maturity: The Next Phase of Biologics. QuintilesIMS White Paper 2017; www.iqvia.com/-/media/iqvia/pdfs/nemea/uk/ disruption_and_maturity_the_next_phase_of_biologics.pdf.
2 Winning with Biosimilars: Opportunities in Global Markets. Deloitte: New York, NY, 2017; https://www2.deloitte.com/content/dam/Deloitte/global/Documents/Life-Sciences-Health-Care/gx-lshc-biosimilars-globalwhitepaper.pdf.
3 Smith S. 36 Pharma Companies Using Artificial Intelligence in Drug Discovery. BenchSci Blog 11 December 2019; https://blog.benchsci.com/pharma-companies-using-artificial-intelligence-in-drug-discovery.
4 Walker S. Motorsports Has Been Doing IoT, Big Data, Real-Time Analytics for Decades. Gartner Blog Network 5 January 2017; https://blogs.gartner.com/simonwalker/2017/01/05/motorsports-has-been-doing-iot-bigdata-real-time-analytics-for-decades.
5 Idoine C. Citizen Data Scientists and Why They Matter. Gartner Blog Network 13 May 2018; https://blogs.gartner.com/carlie-idoine/2018/05/13/citizen-data-scientists-and-why-they-matter.
6 CBER/CDER/CVM. Process Validation: General Principles and Practices â€” Guidance for Industry. US Food and Drug Administration: Rockville, MD, January 2011; www.fda.gov/media/71021/download.
7 ICH Q8: Pharmaceutical Development. US Fed. Reg. 71(98) 2009; https://database.ich.org/sites/default/files/Q8_R2_Guideline.pdf.
8 ICH Q9: Quality Risk Management. US Fed. Reg. 71(106) 2006: 32105â€“32106; https://database.ich.org/sites/default/files/Q9_Guideline.pdf.
9 ICH Q10: Pharmaceutical Quality System. US Fed. Reg. 74(66) 2009: 15990â€“15991; https://database.ich.org/sites/default/files/Q10_Guideline.pdf.