Commercial Biotechnology Industry Review

Report Highlights

INTRODUCTION

This archive is drawn from two BCC newsletters, Applied Genetics News, and its replacement, Cell Therapy News.

Companies are moving from drug discovery and development based in medicinal chemistry to designing and developing drugs based on information provided by genomics and related technologies. A number of monoclonal antibody-based products, notably Herceptin and Rituxan, have entered the market. At the same time, new technologies have allowed the development of antibody-substitutes called aptamers, to be developed. With the completion of the human genome, many new potential drug targets are available. At the same time, it has become clear that a sincere effort must be made to understand protein interactions before disease processes can be fully understood.

Even as we enter the post-genomic phase of drug discovery, a whole new method of treating disease, stem cell therapy has begun to permeate medicine. This is not exactly a new technology, since such therapy in the form of bone marrow transplants, has been performed for decades. But new sources of stem cells have become available: umbilical cord blood; and more controversially, human fetuses produced as a byproduct of assisted reproduction. Stem cell therapy offers the possibility of treating chronic diseases, like diabetes, Parkinson's, and arthritis, without medicine.

The total market for biotechnology-enabling technologies is expected to rise at an AAGR (average annual growth rate) of between 18.5% and 23.0% to as much as $34 billion in 2005. Nearly a billion of this will be related to stem cell therapies, mostly for cytokines and products to facilitate hematopoietic stem cell transplants. Enabling drug discovery technologies — genomics, proteomics, pharmacogenomics, and bioinformatics — represent the bulk of the market for biotechnology products. This combined market segment is expected to grow at an AAGR of 17.7% to cross $17 billion by 2005. The sectors contributing most to the growth of enabling technologies are pharmacogenomics, which currently have AAGR exceeding 100%, and microarray assays, both DNA and protein chips, which will have an AAGR approaching 40% during the same period.

Sales in the selected product categories — therapeutic antibodies: polyclonal and monoclonal; gene therapy: cancer and other diseases; antisense — will rise at an AAGR of between 19.5% and 30%. The potential market for gene therapy has suffered from a number of setbacks, in particular, unexpected deaths, some of healthy patients, in clinical trials. Gene therapy products face a difficult road to commercialization.

The biotechnology revolution affects nearly every sector of the economy, including medicine, agriculture, bioremediation, and even fuel production. It also influences bioprocess technology, along with supportive reagents and equipment. Today, the importance of biotechnology to the economy is without doubt. The emerging alliance of biotechnology with nanotechnology promises further remarkable advances.

Stem cell therapy, right now, in a bit of a limbo state, with political conservatives objecting (somewhat incoherently, in our view) to any therapies resulting from the use of embryonic stem cells. At the same time, some pioneering tissue engineering companies, Advanced Tissue Sciences, Biotransplant and Organogenesis have gone bankrupt as private sources of funds have dried up, and the future remains clouded.

Keeping up with all the changing technical and commercial activities is precisely what this anthology provides. This anthology details the sweep of biotechnology activities: in the laboratory, in commercial production and in the marketplace, as well as changes in the cell therapy industry

Included in the following pages are stories on:

• Bioprocess technology
• Infectious diseases
• Clinical trials
• Therapeutic cloning
• Diagnostics
• Stem cell therapies
• Agricultural genetics
• Tissue engineering
• RNA silencing
• Cancer
• Genome projects
• Regulatory activity
• Instrumentation
• Cell-based assays
• Vaccines
• Patents.