Author Archives: Dawn M. Ecker

The Therapeutic Monoclonal Antibody Product Market

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Commercial development of therapeutic monoclonal antibodies (MAbs) began in the early 1980s, and by 1986 the first MAb product had been approved in the United States: muromonab-CD3 (trade name Orthoclone OKT3, marketed by Janssen-Cilag) for prevention of kidney-transplant rejection. Since its approval, therapeutic MAbs and antibody-related products such as Fc-fusion proteins, antibody fragments, and antibody–drug conjugates (collectively referred to herein as “MAb productsâ€) have grown to become the dominant product class within the biopharmaceutical market. They have been approved for…

October 30, 2020

Supply and Demand Trends: Mammalian Biomanufacturing Industry Overview

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Since the 1986 approval of the first recombinant therapeutic antibody, OKT3, biopharmaceuticals have become a large percentage of overall pharmaceutical company revenue. In 2018, sales of the top five selling recombinant proteins — Humira (adalimumab, AbbVie), Keytruda (pembrolizumab, Merck), Herceptin (trastuzumab, Genentech), Enbrel (etanercept, Amgen), and Avastin (bevacizumab, Genentech), all antibodies — totaled over US$48 billion. The compound annual growth rate (CAGR) for antibodies revenue was about 20% from 2004 to 2014. Those products include naked monoclonal antibodies (MAbs), Fc-fusion…

February 7, 2020

Biopharmaceutical Indications and Targets: Past, Present, and Future

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Dawn M. Ecker, consultant and bioTRAK database manager, BioProcess Technology Group Over the past 15 years, the BioProcess Technology Group (BPTG, formerly BioProcess Technology Consultants) has built and maintained the proprietary internal bioTRAK database to track recombinant biopharmaceutical products from preclinical development through US and EU commercialization. In addition, the firm is watching other biopharmaceutical markets, including for gene therapies and modified cell therapies. BPTG also is considering regional products for regional markets and tracking manufacturing capacity required to manufacture…

July 11, 2019

The Value of Single-Use and Other Flexible Technologies

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The biopharmaceutical industry is adding mammalian cell culture capacity at rates that we haven’t seen in over a decade. Over the past five years (2012–2016), we estimate that industry-wide capacity has increased from 3.4 ML to 4.0 ML, an increase of 18% (1). We estimate that industry-wide capacity will increase over the coming five years (2016–2020) to 5.7 ML, an increase of >40%. Clearly, this growth is a response to the continued increase in demand for biopharmaceutical products and to…

May 19, 2017