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The Worldwide Market for Cancer Diagnostics


Attention: There is an updated edition available for this report.

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?


  • Executive Summary
    • INTRODUCTION
    • SCOPE AND METHODOLOGY
    • SIZE AND GROWTH OF THE MARKET
      • Table Market Summary Worldwide Market for In Vitro Cancer Diagnostics 2004–2009
    • MARKET TRENDS
      • Positive Trends
      • Negative Trends
  • Introduction
    • BACKGROUND
    • CANCER:DIAGNOSIS AND MANAGEMENT OF A CHRONIC DISEASE
    • POINT OF VIEW
  • Trends and Issues
    • BACKGROUND
    • DEMOGRAPHICS OF CANCER,WORLDWIDE
      • Table Old-Age Dependency Ratios Comparative Projections by Leading Country 2000, 2025
    • WORLD CANCER TESTING: SCREENING AND GOVERNMENT-SUPPORTED PROGRAMS
      • In the United States
      • In Europe
    • TRENDS IN PATIENT CARE AND REIMBURSEMENT
      • Table Selected Home-Based Cancer Tests
    • REGULATORY REQUIREMENTS OF NEW PRODUCTS
    • STRATEGIC ALLIANCES: RX–DX AND DX–DX PARTNERSHIPS
      • Table Selected Company Alignments for Cancer Diagnostics
      • Table Selected Collaborations with Treatment Centers
      • Table Selected Agreements Between Companies and Reference Laboratories
      • Table Selected Tests Offered by Reference Laboratories
      • Table Selected Pharmacodiagnostic Tests, 2005
      • Table Selected Pharmaceutical–IVD Company Alliances, 2005
    • THE PROMISE OF PERSONALIZED MEDICINE
      • Table Selection of Tumor Targets as Applied to Specific Drugs
      • Table Potential Cancer Biomarkers
    • THE SEARCH FOR NON-INVASIVE TOOLS
      • Table Selected Non-Invasive Cancer Tests
      • 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
        • Table Selected Tumor-Associated Antigens
      • Future Prospects
        • Table Selected Gene Methylation Tests
    • THE ROLE OF IN VIVO CANCER DIAGNOSTICS: CELLULAR AND MOLECULAR IMAGING
  • Market Analysis IVD Tests in Cancer Segments
    • BACKGROUND
    • WORLD SEGMENTS OF THE MARKET FOR CANCER DIAGNOSTICS
      • Table Cancer Demographics Populations, Cancer Incidence, Share of Incidence, and Share of IVD Cancer Market by Geographic Region 2005
      • Table World Cancer Test Sales by Geographic Region (North America, Europe, Japan, Rest of World) 2004-2009
    • LEADING SUPPLIERS
      • Table Cancer Diagnostics and the Top 10 IVD Companies Segments of Participation 2005
      • Table Revenues of Selected Cancer Diagnostic Companies 2001-2005
    • SCREENING TESTS
      • HAAH
      • ECPKA
      • The Cancer Profile
      • Cancer-Specific Tests
        • Table Selected Breast Cancer Test Innovations
        • Table Selected FOB Test Innovations
        • Table Selected Prostate Cancer Test Innovations
  • Market Analysis— Cancer Tests in IVD Segments
    • CANCER DIAGNOSTICS AND IVD MARKETS
      • Table Worldwide Market for Selected Cancer In Vitro Diagnostics Revenues and Growth Rate by Testing Segment 2004-2009
    • CANCER TESTS IN CLINICAL CHEMISTRY
    • CANCER TESTS IN IMMNUNOCHEMISTRY
      • Table Lab-Based Cancer Immunoassay Sales 2004-2009
      • Table Selected Cancer Immunoassay Innovations
      • Table Worldwide Rapid Cancer Test Sales by Test Category 2004-2009
    • CANCER TESTS IN HISTOLOGY AND CYTOLOGY
      • Table Worldwide Histology/Cytology Sales by Test Type (ISH, IHC, HER-2, HPV, Pap, Tissue Microarray, Flow Cytometry) 2004-2009
      • Table Revenue of Selected Cytometry Imaging Companies
      • Table Selected Automated Imaging Innovation
      • Table Selected Major Protein and Molecular Markers
    • TISSUE MICROARRAYS
      • Table Selected Laser Microdissection Instrument Products
    • CANCER TESTS IN FLOW CYTOMETRY
      • Table Selected Flow Cytometry Innovation
    • CIRCULATING TUMOR CELLS IN CANCER DIAGNOSTICS
      • Table Selected Circulating Tumor Cell Products
    • MOLECULAR ASSAYS IN CANCER DIAGNOSTICS
      • Table Selected Molecular Tests for Cancer
    • CANCER TESTS IN PHARMACODIAGNOSTICS
      • Table Selected PGx Products, 2003-2005
    • BIOCHIPS AND ARRAYS IN CANCER DIAGNOSTICS
      • Table Selected Arrays and Biochips
    • CANCER SAMPLE PREPARATION TECHNIQUES
    • CANCER MARKERS IN RESEARCH AND DEVELOPMENT
      • Table Selected Histology Innovations
    • THE COMMERCIAL OUTLOOK FOR CANCER DIAGNOSTICS
      • Table Technology Penetration Forecast for Cancer IVDs 2004-2020
  • 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
  • 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
  • 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.
    • 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
    • POWER3MEDICAL 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. (MONOGRAM BIOSCIENCES,INC.)
    • WAVESENSE LLC
    • XENOMICS,INC.

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