Basics, Technical Explanations, Industry Economics, Ethical Issues, and more.

Biotechnology Industry Facts:

The biotechnology industry originated in the 1970s, based largely on a new recombinant DNA technique whose details were published in 1973 by Stanley Cohen of Stanford University and Herbert Boyer of the University of California, San Francisco. Recombinant DNA is a method of making proteins—such as human insulin and other therapies—in cultured cells under controlled manufacturing conditions. Boyer went on to co-found Genentech, which today is biotechnology’s largest company by market capitalization.

Biotechnology has created more than 200 new therapies and vaccines, including products to treat cancer, diabetes, HIV/AIDS and autoimmune disorders.

Biotechnology is responsible for hundreds of medical diagnostic tests that keep the blood supply safe from the AIDS virus and detect other conditions early enough to be successfully treated. Home pregnancy tests are also biotechnology diagnostic products.

Consumers are enjoying biotechnology foods such as papaya, soybeans and corn. Biopesticides and other agricultural products also are being used to improve our food supply and to reduce our dependence on conventional chemical pesticides.

Environmental biotechnology products make it possible to clean up hazardous waste more efficiently by harnessing pollution-eating microbes without the use of caustic chemicals.

Industrial biotechnology applications have led to cleaner processes that produce less waste and use less energy and water in such industrial sectors as chemicals, pulp and paper, textiles, food, energy, and metals and minerals. For example, most laundry detergents produced in the United States contain biotechnology-based enzymes.

DNA fingerprinting, a biotech process, has dramatically improved criminal investigation and forensic medicine, as well as afforded significant advances in anthropology and wildlife management.

The biotech industry is regulated by the U.S. Food and Drug Administration (FDA), the Environmental Protection Agency (EPA) and the Department of Agriculture (USDA).

As of Dec. 31, 2005, there were 1,415 biotechnology companies in the United States, of which 329 were publicly held.

Market capitalization, the total value of publicly traded biotech companies (U.S.) at market prices, was $410 billion as of Dec. 31, 2005.

The biotechnology industry has mushroomed since 1992, with U.S. health-care biotech revenues increasing from $8 billion in 1992 to $50.7 billion in 2005.

Biotechnology is one of the most research-intensive industries in the world. The U.S. biotech industry spent $19.8 billion on research and development in 2005.

The top five biotech companies invested an average of $130,000 per employee in R&D in 2005.

In 1982, recombinant human insulin became the first biotech therapy to earn FDA approval. The product was developed by Genentech and Eli Lilly and Co.

Corporate partnering has been critical to biotech success. In 2005, biotech companies signed 564 new agreements with pharmaceutical firms and 354 with fellow biotechs, according to BioWorld.

Most biotechnology companies are young companies developing their first products and depend on investor capital for survival. Biotechnology attracted more than $20 billion in financing in 2005 and has raised more than $100 billion since 2000.

The biosciences—including not just biotechnology but all life sciences activities—employed 1.2 million people in the United States in 2004 and generated an additional 5.8 million related jobs.

The average annual wage of U.S. bioscience workers was $65,775 in 2004, more than $26,000 greater than the average private sector annual wage.

Bioethanol—made from crop wastes using biotech enzymes—could meet a quarter of U.S. energy needs by 2025.

The Biotechnology Industry Organization (BIO) was founded in 1993 to represent biotechnology companies at the local, state, federal and international levels. As of December 2006, BIO’s membership consisted of more than 1,100 biotechnology companies, academic centers, state and local associations and related enterprises.

Download Guide to Biotechnology 2007

PDF format, 1.68MB, 140Pages.

The Guide to Biotechnology is compiled by the Biotechnology Industry Organization (BIO)
Debbie Strickland, BIO, Director of Marketing, Editor

Contributors
Deb Carstoiu, BIO, Director of State Media Relations and Advocacy
Elinor Van Dyck, Blue House Publishing, Art Director
Barbara Glenn, BIO, Managing Director of Animal Bitoechnology
Crispin Littlehales, Writer/Editor
Adrienne Massey, Ph.D., Writer/Editor

Contents:

Biotechnology: A Collection of Technologies 1
What Is Biotechnology?.......................................................1
Cells and Biological Molecules............................................1

Biotechnology Industry Facts 2
Market Capitalization, 1994–2005......................................3
U.S. Industry Statistics: 1994–2005....................................3
New Biotech Drug and Vaccine Approvals/
New Indication Approvals by Year.................................4
North American Biotech Companies by State and Province...................................4
Total Financing, 1998–2005................................................5
Biotech Industry Financing, 2005......................................5

Time Line 6
Biotechnology Policy Milestones......................................16

The Technologies and Their Applications 18
Bioprocessing Technology.................................................18
Monoclonal Antibodies......................................................18
Cell Culture.......................................................................19
Recombinant DNA Technology.........................................21
Cloning..............................................................................21
Protein Engineering .........................................................22
Biosensors .........................................................................22
Nanobiotechnology............................................................23
Microarrays........................................................................23

Biotechnology Tools in Research and Development 25
Research Applications.......................................................25
Includes stem cell technology, cloning, microarray
technology, antisense and RNA interference, and gene
knockouts
Putting the Pieces Together: ‘Omics’................................29
Genomics, proteomics and bioinformatics
Product Development Applications..................................31

Health-Care Applications 34
Diagnostics........................................................................34
Therapeutics......................................................................34
Personalized Medicine.......................................................37
Regenerative Medicine......................................................39
Vaccines.............................................................................39
Plant-Made Pharmaceuticals.............................................41

Therapeutic Developement Overview 42
Biotech Drug Development Process.................................44

Approved Biotechnology Drugs 45

Agricultural Production Applications 65
Crop Biotechnology...........................................................65
Includes production improvement, impact on developing countries,
environmental and economic benefits, and regulations
Forest Biotechnology........................................................69
Animal Biotechnology.......................................................70
Includes companion animals, applications for human
medicine, and environmental and conservation efforts
Aquaculture.......................................................................76
Global Area of Transgenic Crops,
1995 to 2005: Industrial and Developing Countries...78
Global Area of Transgenic Crops in 2004 and 2005
by Country ...................................................................78
Global Area of Transgenic Crops in 2004 and
2005 by Crop ................................................................79
Global Area of Transgenic Crops, 1996 to 2005,
by Crop .........................................................................79
Global Area of Transgenic Crops in 2004 and
2005 by Trait ................................................................80

Global Area of Transgenic Crops, 1995 to 2005,
by Trait .........................................................................80
Transgenic Crop Area as Percentage of
Global Area of Principal Crops.....................................81
Global Status of Biotech Crops in 2005............................81

Agricultural Biotech Products on the Market 82
Food Biotechnology 87
Improving the Raw Materials............................................87
Food Processing................................................................88
Food Safety Testing...........................................................89

Industrial and Environmental Applications 90
Industrial Sustainability....................................................90
Biocatalysts........................................................................91
Biofuel ...............................................................................92
Green Plastics....................................................................93
Nanotechnology.................................................................93
Environmental Biotechnology..........................................94
Industries That Benefit......................................................95
Some Industrial Biotech Applications
by Sector.......................................................................95

Consumer Products Made with Industrial Biotechnology 96
Examples of Industrial Enzymes 98
Preparedness for Pandemics and Biodefense 100
Policy................................................................................100
A Strategic Asset..............................................................100
Vaccines, monoclonal antibodies, DNA- or RNA-based
therapeutics, and detection and diagnosis
Other Approaches............................................................101

Other Uses 102
DNA Fingerprinting........................................................102

Ethics 104
BIO Activities...................................................................104
Ethical Issues...................................................................105

BIO Statement of Ethical Principles 109
Intellectual Property 111
What Is a Patent?.............................................................111
The Purpose of a Patent..................................................111
Patentable Inventions......................................................112
Patent Requirements.......................................................112
The Patent Application....................................................113
Patenting Organisms.......................................................113
Patent Licensing..............................................................114

Biotechnology Resources 115
Periodicals, Headline Services and Web Sites................115
General Science Journals ...............................................116
Biotech Education & Careers..........................................116
Selected Recent Reports on Biotechnology....................116
Glossary 119

Visit Biotechnology Industry Organization (BIO) Website

BIO is the world's largest biotechnology organization, providing advocacy, business development and communications services for more than 1,150 members worldwide. Our mission is to be the champion of biotechnology and the advocate for our member organizations -both large and small.

BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology technologies. Corporate members range from entrepreneurial companies developing a first product to Fortune 100 multinationals. We also represent state and regional biotech associations, service providers to the industry and academic centers.

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