Description
Cancer, with its high prevalence and mortality rate, continues to rank among the world’s deadliest and most costly diseases. According to the WHO, in 2003, about 25 million people live with cancer and nearly 11 million new cases are diagnosed each year.
With advances in protein and cell chemistry, genetics and molecular biology researchers are making continued progress in understanding the disease. Further, cancer drug research is moving from traditional cytotoxic chemotherapies toward higher specificity immunological and biological approaches that target unique biochemical receptors and signaling pathways. These new drugs will be more cancer- and patient-specific and will have the potential for slowing cancer growth and inhibiting disease progression, with fewer adverse effects on the patient. As these drugs come to market, in vitro diagnostics will become critical to matching drug to cancer and to patient and then the monitoring of the drug’s action on the disease.
It is anticipated that many of the newer test modalities such as microarrays (chips), mass spectroscopy protein patterns, amplification of tumor cell DNA and RNA, and others will piggyback onto these trends in cancer diagnosis and treatment. There is the expectation that they will make a huge difference in the diagnosis, prognosis, and monitoring of cancer patients. On account of these developments, cancer testing has brought new life to the diagnostics industry in the form of new tests, technologies, new companies and renewed investor interest.
However, there are obstacles to the successful commercialization of these tests. First, they carry a hefty price tag—anywhere from $350.00 to $3500.00. There is considerable skepticism over the ability of health care systems, worldwide, to pay for these new tests, which so far have shown little effect on patient outcomes. Second, the 1990s tremendous strides were made in cancer management using more traditional tests including tissue biopsies and serum assays, which means that penetrating the existing clinical market will be challenging.
Our research indicates that in the next few years some 50 immunoassays for new tumor markers, 20 or so biochip systems, 25 tests for genes and proteins in peripheral blood are near market. Not to be left behind, at least 25 new immunohistochemical and in situ hybridization assays will be introduced in the near future. There are even several point-of-care DNA analysis systems in development, and just about every major cancer treatment center and research group is working on gene and protein patterns for the early detection of cancer.
This report, written from the point of view of in vitro diagnostic modalities for the early detection of cancer and in particular solid tumors, thoroughly reports the demographics and epidemiology of cancer, reviews emerging technologies and products, quantifies existing markets (in terms of both cancer tests in traditional IVD segments AND IVD tests in different cancer segments), and forecasts likely clinical and business scenarios in this rapidly changing industry.
The crucial question the report endeavors to answer are: How will the market for this mix of new and older technologies evolve over the next 5 to 10 years? What forces will ultimately shape the cancer management practice of the future? And who will succeed in the marketplace?
Table of Contents
CHAPTER ONE: Executive Summary
- Introduction
- Scope and Methodology
- Size and Growth of the Market
- Market Trends
- Positive Trends
- Negative Trends
CHAPTER TWO: Introduction
- Background
- Cancer: Diagnosis and Management of a Chronic Disease Point of View
CHAPTER THREE: Trends and Issues
- Background
- Demographics of Cancer, Worldwide
- World Cancer Testing: Screening and Government-Supported Programs
- In the United States
- In Europe
- Trends In Patient Care and Reimbursement
- Regulatory Requirements of New Products
- Strategic Alliances: Rx-Dx and Dx-Dx Partnerships
- The Promise of Personalized Medicine
- The Search for Non-Invasive Screening Tools
- Serum
- Saliva
- Transdermal/Optical
- Breath
- Hair
- Sputum
- Role of Diagnostic Tests in Cancer Management OR
- Where Have All The Immunoassays Gone?
- New Technologies Applied to Cancer Diagnostics
- Human Genomics for Early Cancer Assessment
- Proteomics, Mass Spectroscopy, and the Role of the Immune System
- Future Prospects
- Methylated Gene (meDNA) Patterns
- Circulating Cell-Free Nucleic Acids
- Raman Spectroscopy
- RNA—Ribonucleic Acid
- Stem Cell Markers
- The Role of In Vivo Cancer Diagnostics: Cellular and Molecular Imaging
CHAPTER FOUR: Market Analysis—IVD Tests in Cancer Segments
- Background
- World Segments of the Market for Cancer Diagnostics
- Leading Suppliers
- Screening Tests
- HAAH
- ECPKA
- The Cancer Profile
- Cancer-Specific Tests
- Bladder Cancer
- Breast Cancer
- Cervical Cancer
- Colon Cancer
- Lung Cancer
- Ovarian Cancer
- Prostate Cancer
CHAPTER FIVE: Market Analysis—Cancer Tests in IVD Segments
- Cancer Diagnostics and IVD Markets
- Cancer Tests in Clinical Chemistry
- Cancer Tests in Immnunochemistry
- Cancer Tests in Histology and Cytology
- Tissue Microarrays
- Cancer Tests in Flow Cytometry
- Circulating Tumor Cells in Cancer Diagnostics
- Molecular Assays in Cancer Diagnostics
- Cancer Tests in Pharmacodiagnostics
- Biochips and Arrays in Cancer Diagnostics
- Cancer Sample Preparation Techniques
- Cancer Markers in Research and Development
- The Commercial Outlook for Cancer Diagnostics
CHAPTER SIX: Conclusions and Strategic Implications
- First Conclusion
- Implication
- Second Conclusion
- Implication
- Third Conclusion
- Implication
- Fourth Conclusion
- Implication
- Fifth Conclusion
- Implication
- Sixth Conclusion
- Implication
- Unmet Market Needs
- First Unmet Need
- Second Unmet Need
- Third Unmet Need
CHAPTER SEVEN: The Top 10 IVD Companies and Their Investment in Cancer
- Roche Diagnostics
- Abbott Diagnostics
- Ortho Clinical Diagnostics
- Bayer Corporation, Healthcare Division
- Beckman Coulter, Inc.
- Dade Behring Inc.
- BD Biosciences Immunocytometry Systems
- bioMerieux Inc.
- Bio-Rad Laboratories Inc.
- Sysmex Corporation
CHAPTER EIGHT: Innovator Summaries
- ACLARA BioSciences, Inc. (merged with Virologic, Inc.)
- AdnaGen AG
- Affymetrix Inc.
- Agendia BV
- Althea Technologies, Inc.
- AMDL, Inc.
- Amnis Corporation
- Aphton Corp.
- Applied Imaging Corp.
- Aptamera, Inc. (Acquired by Antisoma PLC)
- Arcturus Bioscience Inc.
- Assay Designs, Inc.
- AutoGenomics, Inc.
- BioCurex, Inc.
- BioGenex Laboratories
- Biomarker Technologies LLC
- Biomedical Diagnostics, LLC
- Biomoda Inc.
- CCC Diagnostics LLC
- Cancer Genetics Inc.
- Cancer Research Technology Ltd.
- Cangen Biotechnologies, Inc.
- CeMines, Inc.
- Cepheid
- Chemicon International Inc.
- ChondroGene Ltd.
- Chronix Biomedical, Inc.
- Ciphergen Biosystems, Inc.
- Clarient (formerly Chromavision Medical Systems)
- Clinical Data, Inc.
- Correlogic Systems, Inc.
- Cytyc Corporation
- DakoCytomation A/S
- DermAlert, Inc.
- diaDexus Inc.
- DiaGenic ASA
- DiagnoCure
- Dianon Systems Inc.
- Digene Corporation
- DNA Direct, Inc.
- DNAPrint Genomics, Inc.
- Epigenomics AG
- EXACT Sciences Corporation
- Exagen Diagnostics, Inc.
- FujiFilm Medical Systems USA
- Fujirebio Diagnostics. Inc. (FDI)
- GenoMed, Inc.
- Genomic Health, Inc.
- Genoptix Inc.
- Genzyme Corporation
- Geron Corporation
- GMP Companies, Inc.
- Health Discovery Corp.
- Healthy Estrogen.com, Inc.
- IBEX Technologies Inc.
- Ikonisys, Inc.
- Illumina
- IMI International Medical Innovations Inc. (PreMD Inc.)
- Immunicon Corporation
- InterGenetics Incorporated
- IPSOGEN
- Matritech
- Molecular Diagnostics, Inc. (MDI) (formerly Ampersand Medical)
- Menssana Research, Inc.
- Microprevention Tests Ltd. (The Sage Group)
- OncoMethylome Sciences S.A.
- One Cell Systems, Inc.
- Orion Genomics
- Power3 Medical Products, Inc.
- Predicant Biosciences Inc. (formerly Biospect Inc.)
- Predictive Diagnostics, Inc. (PDI) (formerly known as Eclipse Diagnostics)
- Primagen Holding B.V.
- Proteus Diagnostics, Inc.
- Rubicon Genomics, Inc.
- Sakura Finetek USA Inc.
- ScheBo-Biotech AG
- Schleicher & Schuell BioScience, Inc.
- SomaLogic, Inc.
- Targeted Diagnostics & Therapeutics, Inc. (TDT)
- Targeted Molecular Diagnostics, LLC (TDM)
- Tessera Diagnostics
- Third Wave Technologies Inc.
- TriPath Imaging, Inc.
- U.S. LABS
- Ventana Medical Systems
- Veridex LLC
- Virologic, Inc.
- WaveSense LLC
- Xenomics, Inc.
List of Exhibits
CHAPTER ONE: Executive Summary
- Table 1-1: Market Summary Worldwide Market for In Vitro Cancer Diagnostics 2004-2009
CHAPTER THREE: Trends and Issues
- Table 3-1: Old-Age Dependency Ratios Comparative Projections by Leading Country 2000, 2025
- Table 3-2: Selected Home-Based Cancer Tests
- Table 3-3: Selected Company Alignments for Cancer Diagnostics
- Table 3-4: Selected Collaborations with Treatment Centers
- Table 3-5: Selected Agreements Between Companies and Reference Laboratories
- Table 3-6: Selected Tests Offered by Reference Laboratories
- Table 3-7: Selected Pharmacodiagnostic Tests, 2005
- Table 3-8: Selected Pharmaceutical-IVD Company Alliances, 2005
- Table 3-9: Selection of Tumor Targets as Applied to Specific Drugs
- Table 3-10: Potential Cancer Biomarkers
- Table 3-11: Selected Non-Invasive Cancer Tests
- Table 3-12: Selected Tumor-Associated Antigens
- Table 3-13: Selected Gene Methylation Tests
CHAPTER FOUR: Market Analysis IVD Tests in Cancer Segments
- Table 4-1: Cancer Demographics Populations, Cancer Incidence, Share of Incidence, and Share of IVD Cancer Market by Geographic Region 2005
- Table 4-2: World Cancer Test Sales by Geographic Region (North America, Europe, Japan, Rest of World) 2004-2009
- Table 4-3: Cancer Diagnostics and the Top 10 IVD Companies Segments of Participation 2005
- Table 4-4: Revenues of Selected Cancer Diagnostic Companies 2001-2005
- Table 4-5: Selected Breast Cancer test Innovations
- Table 4-6: Selected FOB Test Innovations
- Table 4-7: Selected Prostate Cancer Test Innovations
CHAPTER FIVE: Market Analysis Cancer Tests in IVD Segments
- Table 5-1: Worldwide Market for Selected Cancer In Vitro Diagnostics Revenues and Growth Rate by Testing Segment 2004-2009
- Table 5-2: Lab-Based Cancer Immunoassay Sales 2004-2009
- Table 5-3: Selected Cancer Immunoassay Innovations
- Table 5-4: Worldwide Rapid Cancer Test Sales by Test Category 2004-2009
- Table 5-5: Worldwide Histology/Cytology Sales by Test Type (ISH, IHC, HER-2, HPV, Pap, Tissue Microarray, Flow Cytometry) 2004-2009
- Table 5-6: Revenue of Selected Cytometry Imaging Companies 2002-2004
- Table 5-7: Selected Automated Imaging Innovation
- Table 5-8: Selected Major Protein and Molecular Markers
- Table 5-9: Selected Laser Microdissection Instrument Products
- Table 5-10: Selected Flow Cytometry Innovation
- Table 5-11: Selected Circulating Tumor Cell Products
- Table 5-12: Selected Molecular Tests for Cancer
- Table 5-13: Selected PGx Products, 2003-2005
- Table 5-14: Selected Arrays and Biochips
- Table 5-15: Selected Histology Innovations
- Table 5-16: Technology Penetration Forecast for Cancer IVDs 2004-2020
