Biotechnology – A Continual Revolution in Product Development and Healthcare – 1st 20 Years versus 2nd 20 Years and Beyond.

Abstract

Biotechnology (the science and the business) has revolutionized product development and healthcare worldwide over the past 40 years with novel molecules, new companies, and major advances in disease mitigation. The revolution has continued and even accelerated as can be observed in comparing the last 20 years (2000-2019) versus first 20 years (1980-1999), and the recent years of 2020 and 2021 as well. This biotech review addresses the many product categories, indications, research, companies, business changes, and product sales, especially comparing these two time periods and demonstrating the substantial growth and impact of biotechnology and continuing the revolution through the last two years (2020-2021). Over 500 biotech products are available worldwide in 10 different categories of molecules for over 460 indications with over 160 biotech and pharma companies marketing the products. Biosimilar products (close duplicates of marketed products) have become commonplace in last 15 years. The top companies in biotech research and sales over these 40 years include Roche, Amgen, and Novo Nordisk, along with all the pharma companies becoming engaged. Twenty plus of the leading biotech companies have been acquired over these times. All of pharma is now dedicated to biotech molecule development independently and mostly in extensive collaboration with biotech companies. Clinical research has expanded with the top 90 biotech companies that spend at least $100 million in one year totaling over $50 billion in 2020, along with tens of billions from pharma companies for biotech research & development. Over 600 molecules are being studied in phase three clinical trials. Worldwide biotech sales grew to $327 million in 2020 from $35 billion in 2001 with biotech over 25% of all drug sales. The biotech revolution is alive and well and continuing with novel molecules from exiting and more new biotech and pharma companies for further advances in healthcare. This treatise addresses the biotechnology revolution and its dramatic growth and expansion, covering the past 42 years from 1980 to 2021, where-in the author has been collecting data for the last 25 years and maintains 35 biotech databases, which are being reviewed in this publication, and are encompassed in his new database publication, Evens RP. Global Biotech Database e-Sourcebook 2021, Editor – Kenneth KI, Publisher - Tufts Center for the Study of Drug Development, Tufts University, Boston, MA 12/2021. The data sets, tables, and graphs all come from the database publication with data updates for 2021 as available. The definition of products in biotechnology in this publication encompasses nine product categories; recombinant proteins, monoclonal antibodies (also fragments and antibody-drug conjugates), peptides (recombinant and molecular engineered), vaccines (recombinant and molecular engineered), oligonucleotides (RNA inhibitory molecules and gene therapies), cell therapies, tissue therapies, liposomes, and polymers. Naturally occurring substances and extracts from nature or blood can be biologicals, but they are not biotech and are excluded, as well as diagnostic agents being excluded.