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Published by: Fuji-Keizai USA, Inc.
Published: Apr. 1, 2003 - 162 Pages
Table of Contents
1. Current Overview Of Biopharmaceutical Research And Development
The Pharmaceutical R&D Process
Figure 1. The Drug Development Process
Overview Of Major Therapeutic Market Segments
Figure 2. Distribution Of Companies And Their Products Among The Therapeutic Classes Of Emerging
Biopharmaceutical Companies.
Autoimmune/Inflammation Market Segment
Figure 3. Distribution Of Lead Drug Candidates By Stage Of Development (All Market Segments)
Cancer Therapy Market Segment
Cns/Neurology Market Segment
Cell Or Gene Therapy Market Segment
Infectious Disease Therapy Market Segment
Tissue Engineering Market Segment
Enabling Technology Market Segment
Htp Screening Market Segment
2. Focus Of Biopharmaceutical R&D And Business
Overview Of Emerging Biopharmaceutical Companies
Figure 4. The Number Of Emerging Biopharmaceutical Companies In Each Major Market Segment
Figure 5. Approximate Number Of Employees Within Emerging Biopharmaceutical Companies By
Market Segment
Figure 6. Relative Numbers Of Employees By Market Segment In The Emerging Biopharmaceutical
Industry
Figure 7. Distribution Of Emerging Biopharmaceutical Companies By Year Of Incorporation
Table 1. The Largest Emerging Biopharmaceutical Companies Profiled
Autoimmune/Inflammation Market Segment
Table 2. Participants In The Autoimmune/Inflammation Market Segment.
Figure 8. Size Of Participants In The Autoimmune/Inflammation Market Segment In 2002
Cancer Therapy Market Segment
Table 3. Participants In The Cancer Therapy Market Segment
Cns/Neurology Market Segment
Table 4. Participants In The Cns/Neurology Market Segment
Figure 9. Size Of Participants In The Cns Market Segment In 2002
Cell Or Gene Therapy Market Segment
Table 5. Participants In The Cell/Gene Therapy Market Segment
Figure 10. Size Of Participants In The Cell/Gene Therapy Market Segment In 2002
Infectious Disease Therapy Market Segment
Table 6. Participants In The Infectious Disease Market Segment
Tissue Engineering Market Segment
Table 7. Participants In The Tissue Engineering Market Segment
Figure 11. Size Of Participants In The Tissue Engineering Market Segment In 2002
Enabling Technology Market Segment
Table 8. Participants In The Enabling Technology Market Segment
Htp Screening Market Segment
Table 9. Participants In The Htp Screening Market Segment
Figure 12. Sizes Of Large And Small Emerging Technology Participants In 2002
Figure 13. Size Of Participants In The Htp Screening Market Segment In 2002
3. Product Pipeline By Therapeutic Category
Overall Product Pipeline By Stage
Figure 14. Breakdown Of Lead Drug Candidates By Stage Of Development
Overall Product Pipeline By Therapeutic Category
Figure 15. The Number Of Lead Drug Candidates By Disease Focus
Autoimmune And Inflammation Therapies
Figure 16. Distribution Of Drug Candidates By Stage Of Development At Companies In The
Autoimmune/Inflammation Market Segment
Table 10. Lead Drug Candidates Under Development In The Autoimmune/Inflammation Market
Segment
Cancer Therapies
Figure 17. Distribution Of Drug Candidates By Stage Of Development In The Cancer Market Segment
Table 11. List Of Lead Drug Candidates Under Development At Companies In The Cancer Market
Segment
Cns/Neurology Drugs
Figure 18. Distribution Of Drug Candidates By Stage Of Development At Companies In The
Cns/Neurology Market Segment
Table 12. List Of Lead Drug Candidates Under Development At Companies In The Cns/Neurology
Market Segment
Cell Or Gene Therapy Products
Table 13. List Of Lead Drug Candidates Under Development At Cell/Gene-Based Therapy Companies
Figure 19. Distribution Of Drug Candidates By Stage Of Development At Cell/Gene Therapy
Companies
Infectious Disease Therapies
Figure 20. Distribution Of Drug Candidates By Stage Of Development At Companies In The Infectious
Disease Market Segment
Table 14. List Of Lead Drug Candidates Under Development At Companies In The Infectious Disease
Market Segment
4. Partnership Opportunities With Emerging Companies
Autoimmune/Inflammation Segment Analysis And Evaluation
Table 15. Analysis And Evaluation Of The Autoimmune/Inflammation Market Segment Participants
Cancer Therapy Segment Analysis And Evaluation
Table 16. Analysis And Evaluation Of The Cancer Market Segment Participants
Table 17. Late-Stage Lead Drug Candidates In The Cancer Market Segment
Cns/Neurology Segment Analysis And Evaluation
Table 18. Analysis And Evaluation Of The Cns/Neurology Market Segment Participants
Table 19. Late-Stage Lead Drug Candidates In The Cns/Neurology Market Segment
Cell/Gene Therapy Segment Analysis And Evaluation
Table 20. Analysis And Evaluation Of The Cell/Gene Therapy Market Segment Participants
Infectious Disease Segment Analysis And Evaluation
Table 21. Analysis And Evaluation Of The Infectious Disease Market Segment Participants
Table 22. Late-Stage Lead Drug Candidates In The Infectious Disease Market Segment
Tissue Engineering Segment Analysis And Evaluation
Table 23. Analysis And Evaluation Of The Tissue Engineering Market Segment Participants
Enabling Technology Segment Analysis And Evaluation
Table 24. Analysis And Evaluation Of The Enabling Technology Market Segment Participants
Htp Screening Segment Analysis And Evaluation
Table 25. Analysis And Evaluation Of The Htp Screening Market Segment Participants
5. Company Profiles: Activities Of Leading Emerging Firms
Autoimmune And Inflammation Market Segments
Chemocentryx, Inc.
Elusys Therapeutics, Inc.
Epicyte
Exhale Therapeutics, Inc.
Geneex, Inc.
Hawaii Biotech, Inc.
Santarus, Inc.
Cancer Therapy Market Segment
Advanced Life Sciences, Inc.
Cancervax Corp.
Ceptyr, Inc.
Conforma Therapeutics Corp.
Cyternex, Inc.
Echelon Biosciences, Inc.
Emergen, Inc.
Eximias Pharmaceutical Corporation
Favrille, Inc.
Helix Twelve Pharmaceuticals
Immunicon Corp.
Libraria, Inc.
Metabasis Therapeutics, Inc.
Raven Biotechnologies, Inc.
Receptron, Inc.
Signature Bioscience, Inc.
Structural Genomix Inc.
Syrrx, Inc.
Transave, Inc.
Triad Therapeutics, Inc.
Vaccinex, Inc.
Cns/Neurology Market Segment
Ceregene, Inc.
Epicept
Miicro Inc.
Nanomed Pharmaceuticals, Inc.
Neurogenetics, Inc.
Neuromed Technologies, Inc.
Nyxis Neurotherapies, Inc.
Psynomics, Inc.
Rejuvenon Corp.
Sention, Inc.
Targeted Molecules Corp.
Transmolecular, Inc.
Cell Or Gene Therapy Market Segment
Copernicus Therapeutics, Inc.
Directgene, Inc.
Genteric
Intronn, Inc.
Maxcyte Inc.
Nephros Therapeutics, Inc.
Neuronyx, Inc.
Ppl Therapeutics Inc.
Replicor, Inc.
Infectious Disease Therapy Market Segment
Anadys Pharmaceuticals, Inc.
Biosyn, Inc.
Biota, Inc.
Divergence, Inc.
First Circle Medical
Functional Genetics, Inc.
Iomai Corporation
Ligocyte Pharmaceuticals Inc.
Message Pharmaceuticals, Inc.
Mithragen Inc.
Newbiotics, Inc.
Nucleonics, Inc.
Phagetech Inc.
Quorex Pharmaceuticals, Inc.
Tao Biosciences, Inc.
Tissue Engineering Market Segment
Automated Cell Technologies, Inc.
Applied Tissue Technologies, Llc
Cellect Bio, Inc.
Regen Biologics, Inc.
Tissue Engineering Inc.
Tissueinformatics, Inc.
Enabling Technology Market Segment
B310
Bionaut Pharmaceuticals, Inc.
Bioseek, Inc.
Chemcodes, Inc.
Genoptix
Gryphon Therapeutics, Inc.
Iris Ao Inc.
Iatroquest
Lipocine, Inc.
Nanostream, Inc.
Novasite Pharmaceuticals, Inc.
Phenomix, Inc.
Picoliter Inc.
Plexxikon Inc.
Target Discovery, Inc.
U.S. Genomics
Xenogen Corporation
Htp Screening Market Segment
Aptus Pharmaceuticals, Inc.
Auilix Biopharma, Inc.
Combimatrix Corp.
Consensus Pharmaceutics, Inc.
Genphar, Inc.
Guava Technologies, Inc.
Nimblegen Systems, Inc.
Novasite Pharmaceuticals, Inc.
Virtual Arrays, Inc.
6. Summary
Appendices
Appendix 1 -Autoimmune And Inflammation Company Contacts
Appendix 2 - Cancer Therapy Company Contacts
Appendix 3 - Cns/Neurology Company Contacts
Appendix 4 - Cell Or Gene Therapy Company Contacts
Appendix 5 - Infectious Disease Company Contacts
Appendix 6 - Tissue Engineering Company Contacts
Appendix 7 - Enabling Technology Company Contacts
Appendix 8 - Htp Screening Company Contacts
AbstractThe pharmaceutical industry is one of the most profitable sectors of the Fortune 500 with profits of approximately 18% of revenue compared to a median of 5% for other industry segments. However, this market is facing increasing competitive pressure due to escalating R&D costs, shortened patent life due to the long product approval process, increased sales and marketing costs, pricing pressures, and entrance of more competitors into the industry. It is estimated that large pharmaceutical companies (or Pharma as they are generally referred to in the industry) require 3-5 new lead drug candidates (defined as New Chemical Entities or NCEs) each year to sustain double-digit growth rates. Despite the fact that R&D costs have been increasing (typically $300-500 million per NCE), the average number of NCEs have been dropping over the last decade to under one per year across the industry. Thus, there is increasing pressure on Pharma to find newer discovery and development paradigms. Two of the strategies that have most successfully been employed to do this involve forming partnerships with non-competitive biopharmaceutical companies.
The first strategy used by Pharma to broaden their product pipeline is to identify and license promising lead compounds that are in mid- to late-stage clinical trials. Joint late-stage development and co-marketing of those drugs that benefit both the Pharma and biopharmaceutical companies because early-stage studies have established clinical utility and potential efficacy/safety. In addition, the cost of late-stage development (i.e. the 60% of R&D expenditure in clinicals) and marketing can be shared.
An alternative strategy to increase the numbers of lead compounds in late-stage development is to invest in newer technologies to address bottlenecks in the pharmaceutical discovery pipeline. Recent advances in genomic technologies have shifted the major bottleneck from discovery to high-throughput (HTP) screening of large libraries of small molecules (chemicals). The chemicals in these libraries are frequently in limited supply and may be unstable to repetitive freeze-thaw cycles required for sequentially testing and screening in different studies. Thus, for emerging technologies to improve HTP screening methods or to improve the handling of these large libraries of chemicals are highly desirable to Pharma.
This report profiles 92 emerging biopharmaceutical companies that are located in the United States and Canada. These companies are in 8 different market segments and represent a total market size of approximately $880 million in annual R&D expenditures. The primary therapeutic areas under active development include ones directed toward autoimmune/inflammation, cancer, CNS/neurology, cell/gene therapy, and infectious diseases. In addition, several of the emerging biopharmaceutical companies are focused on platform or technology areas to support the pharmaceutical discovery process. Those market segments include tissue engineering, enabling technology platform providers, and companies with novel approaches to HTP screening.
The emerging biopharmaceutical industry, while very young, has several aggressive players with broad product pipelines. The majority of these companies are less than five years old yet have an average of 3-4 products in their pipelines. Approximately half of the products in these pipelines are therapeutic agents (170 new chemical entities or drug leads) including several in late Phase I, Phase II or even Phase III clinical studies and represent key licensing opportunities for Pharma or for more established biotechnology companies.
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