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1、World Market for Cancer Diagnostics 5th 2013 Kalorama Information Reproduction without prior written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited. THEWORLDMARKETFORCANCER DIAGNOSTICS,5THEDITION AKALORAMA INFORMATION MARKETINTELLIGE
2、NCE REPORT The World Market for Cancer Diagnostics has been prepared by Kalorama Information. We serve business and industrial clients in the United States and abroad with a complete line of information services and research publications. Kalorama Information Market Intelligence Reports are specific
3、ally designed to aid the action- oriented executive by providing a thorough presentation of essential data and concise analysis. Author: Shara Rosen Publication Date: May 2013 2013 Kalorama Information Reproduction without prior written permission, in any media now in existence or hereafter develope
4、d, in whole or in any part, is strictly prohibited. T A B L E O F C O N T E N T S CHAPTER ONE: EXECUTIVE SUMMARY? Introduction . 1? Scope and Methodology 4? Size and Growth of the Market 8? Test Segments . 9? Geographic Distribution 14? Market Trends . 16? CHAPTER TWO: INTRODUCTION? Background 19? C
5、ancer - Diagnosis And Therapy Management 22? Point of View 28? CHAPTER THREE: MARKET ISSUES IN THE COMMERCIALIZATION OF CANCER DIAGNOSTICS? Background 31? Demographics of cancer, A Global Phenomenon 34? Cancer World Market Estimate . 37? Cancer in the World - Screening and Government Supported Progr
6、ams 39? United States . 42? Canada . 46? Europe . 47? China . 50? India . 51? Africa . 52? Commercializing Next Generation Cancer Tests . 53? Clinical Molecular Test Reimbursement Coding In The U.S. . 57? Test Services Route For Cancer Innovation . 60? Regulatory Requirements of Cancer Tests . 65? G
7、ene Patents and Test Commercialization . 70? Impact of Companion Test Development 82? The Physicians Role in Test Acceptance 85? 2013 Kalorama Information Reproduction without prior written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibi
8、ted. CHAPTER FOUR: TECHNOLOGICAL TRENDS THAT ENABLE THE FUTURE OF CANCER DIAGNOSTICS? Background 89? Biomarkers: Issues in Research to Clinic 91? Miniaturization and Multiplexed Assays 95? The Emergence Of Non-Invasive Tools . 99? Bioinformatics Data To Information 104? New Technologies Applied To C
9、ancer Diagnostics 109? Overview . 109? Digital PCR . 110? Mass Spectrometry 112? Chromosome Analysis 115? Next- Generation Sequencing 119? Sample Preparation and System Automation 126? The Role of In Vivo Cellular and Molecular Imaging 129? CHAPTER FIVE: MARKET ANALYSIS CANCER TESTING? The Market fo
10、r Cancer Diagnostics . 131? Major Vendors and Companies to Watch . 133? Acquisitions, Alliances and Collaborations . 137? Screening The Debate Continues 145? Prospects for Decentralized Cancer Testing . 152? Cancer Specific Tests 154? Breast Cancer 155? Colon Cancer . 156? Lung Cancer 159? Ovarian C
11、ancer 161? Pancreatic Cancer 163? CHAPTER SIX: CANCER TESTS IN CLINICAL CHEMISTRY? Selected Tissue Function Clinical Chemistry Tests 165? Major Players In Chemistry Analyzers and Reagents . 166? CHAPTER SEVEN: IMMUNOASSAY CANCER TESTS Role Of Immunoassays In Cancer Management 169? Selected Widely Us
12、ed Tumor Markers . 170? Lab-Based Assays 174? POC rapid tests . 179? Colon Cancer . 180? 2013 Kalorama Information Reproduction without prior written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited. 2013 Kalorama Information Reproduct
13、ion without prior written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited. Prostate Cancer 182? Bladder Cancer 183? CHAPTER EIGHT: TISSUE- AND CELL-BASED CANCER TESTS Background 185? Market Overview . 189? Pap Smear in fact in 2009 th
14、e American Association for Cancer Research (AACR) held its 100th annual meeting. It is a testament to the awesome complexity of this group of diseases that after 100 years, there are few (if any) cancer researchers or physicians that would claim to fully understand what they are dealing with. Howeve
15、r cancer testing is maturing and advancing from the somewhat elementary diagnostics of the 1980s and 1990s to an era of cancer medicine in the 2000s where treatment is personalized to the patient. More recently cancer researchers and oncologists refer to precision cancer technologies that work to de
16、termine the genetic and protein components of individual tumors with more precision than ever before. This more precise data are then used to develop a tumor related treatment program. Thus we now enter the era of precision cancer medicine. Precision medicine, a new paradigm in cancer management, pa
17、rtners accurate diagnosis of primary tumor site and predictive biomarkers to drive targeted therapy. Cancer does not develop overnight, minute tumors develop sometimes years before a cancer is detectable by physical exam, microscopic tissue analysis, current blood tests and diagnostic imaging techni
18、ques. The goal of new cancer diagnostics is to screen for these cancer cells before a tumor forms and has a chance to cause significant tissue damage. Research has shown that cancer survival rates improve with early therapeutic intervention. Like the layers of an onion, the deeper research delves in
19、to the core of the cancer conundrum, the more areas for research are uncovered. But many would agree that there has been considerable headway in the past few years. Yet in 2012, we find ourselves still in the 2013 Kalorama Information Reproduction without prior written permission, in any media now i
20、n existence or hereafter developed, in whole or in any part, is strictly prohibited. C H A P T E R O N E Executive Summary INTRODUCTION Cancer research has been ongoing for at least 100 years; in fact in 2009 the American Association for Cancer Research (AACR) held its 100th annual meeting. It is a
21、testament to the awesome complexity of this group of diseases that after 100 years, there are few (if any) cancer researchers or physicians that would claim to fully understand what they are dealing with. However cancer testing is maturing and advancing from the somewhat elementary diagnostics of th
22、e 1980s and 1990s to an era of cancer medicine in the 2000s where treatment is personalized to the patient. More recently cancer researchers and oncologists refer to precision cancer technologies that work to determine the genetic and protein components of individual tumors with more precision than
23、ever before. This more precise data are then used to develop a tumor related treatment program. Thus we now enter the era of precision cancer medicine. Precision medicine, a new paradigm in cancer management, partners accurate diagnosis of primary tumor site and predictive biomarkers to drive target
24、ed therapy. Cancer does not develop overnight, minute tumors develop sometimes years before a cancer is detectable by physical exam, microscopic tissue analysis, current blood tests and diagnostic imaging techniques. The goal of new cancer diagnostics is to screen for these cancer cells before a tum
25、or forms and has a chance to cause significant tissue damage. Research has shown that cancer survival rates improve with early therapeutic intervention. Like the layers of an onion, the deeper research delves into the core of the cancer conundrum, the more areas for research are uncovered. But many
26、would agree that there has been considerable headway in the past few years. Yet in 2012, we find ourselves still in the 2013 Kalorama Information Reproduction without prior written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited. C H
27、A P T E R O N E Executive Summary INTRODUCTION Cancer research has been ongoing for at least 100 years; in fact in 2009 the American Association for Cancer Research (AACR) held its 100th annual meeting. It is a testament to the awesome complexity of this group of diseases that after 100 years, there
28、 are few (if any) cancer researchers or physicians that would claim to fully understand what they are dealing with. However cancer testing is maturing and advancing from the somewhat elementary diagnostics of the 1980s and 1990s to an era of cancer medicine in the 2000s where treatment is personaliz
29、ed to the patient. More recently cancer researchers and oncologists refer to precision cancer technologies that work to determine the genetic and protein components of individual tumors with more precision than ever before. This more precise data are then used to develop a tumor related treatment pr
30、ogram. Thus we now enter the era of precision cancer medicine. Precision medicine, a new paradigm in cancer management, partners accurate diagnosis of primary tumor site and predictive biomarkers to drive targeted therapy. Cancer does not develop overnight, minute tumors develop sometimes years befo
31、re a cancer is detectable by physical exam, microscopic tissue analysis, current blood tests and diagnostic imaging techniques. The goal of new cancer diagnostics is to screen for these cancer cells before a tumor forms and has a chance to cause significant tissue damage. Research has shown that can
32、cer survival rates improve with early therapeutic intervention. Like the layers of an onion, the deeper research delves into the core of the cancer conundrum, the more areas for research are uncovered. But many would agree that there has been considerable headway in the past few years. Yet in 2012,
33、we find ourselves still in the One: Executive Summary 2 2013 Kalorama Information Reproduction without prior written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited. One: Executive Summary 2 2013 Kalorama Information Reproduction with
34、out prior written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited. muddy waters of cancer diagnosis and treatment. Cancer continues to rank among the worlds deadliest and most costly diseases. Cancer is the number two killer disease a
35、fter cardiovascular disease, worldwide. All countries and races bear the burden of cancer. There is not one nation in the world that is not affected. The highest incidences of cancer are in western nations, but so are the highest survival rates resulting from an investment in diagnostics and treatme
36、nt programs. The lowest recorded incidences of cancer are in the developing countries but they also suffered higher rates of death by cancer. Developing countries do not have adequate healthcare. According to a report from the American Cancer Society “Global Cancer Facts lymphoma and cancer of the c
37、olon, cervix, breast and prostate are not considered a death sentence. In spite of concerted efforts for early diagnosis and to refine therapy decision making, death rates for other cancers remains high. Thus it is obvious that for cancers such as lung, ovarian, bladder, liver, pancreas and others,
38、the state- of- the- art in cancer diagnostics and therapeutics are missing the boat. As researchers continue to unravel the complexities of disease processes, it has become increasingly apparent that future diagnostics will go beyond correlating a single protein or gene to a disease, and instead wil
39、l look at characteristic gene and protein patterns or signatures to diagnose and predict disease progression. Several forces are working to bring these genetic and proteomic tests into routine practice. Companies and government research agencies are focusing on novel and unique technologies. Referen
40、ce labs such as LabCorp, Quest Diagnostics, Specialty Labs and ARUP and numerous private pathology labs now offer sophisticated genetic and proteomic tests that they have developed alone and in collaboration with IVD companies. Finally industry innovators such as Affymetrix, Illumina, Life Technolog
41、ies, Agilent, Roche Diagnostics, Greiner Bio- One and Ipsogen have made a concerted effort to adapt research tools such as biochips and gene sequencing for clinical labs. Blood- based tests are useful in the clinical setting due to their cost- effectiveness and ease- of- use. Cancer researchers cont
42、inue to work on improving the sensitivity and specificity of blood- based markers, with the goal of achieving the highest level of diagnostic accuracy possible. The tests target circulating tumor cells, RNA and DNA in plasma and autoantibodies. Recent studies suggest that combining several select tu
43、mor markers, possibly in a multiplex mode, could lead to more sensitive and specific assays for the early detection of cancer. With the anticipated growth in cancer cases as the world population ages, the discovery of more effective and personalized cancer management tools has become critical. It is
44、 becoming too expensive to continue prescribing drugs that are largely ineffective. Numerous test services are now available to help physicians tailor drugs more precisely to individual tumors. It is anticipated that in the future, cancer drugs labels will indicate the genetic signature for which th
45、ey are authorized instead of the tissue of origin such as breast, lung, etc. One: Executive Summary 4 2013 Kalorama Information Reproduction without prior written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited. One: Executive Summary
46、 4 2013 Kalorama Information Reproduction without prior written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited. From a commercial standpoint, tests for cancer management will remain a high priority for the next 25 years. Immunoassays
47、 and histological analysis of biopsied tissue are the mainstay of in vitro cancer diagnostics in 2012. The maturation and standardization of molecular tests with next generation technologies will enhance the diagnostic and prognostic ability of cancer diagnostics. SCOPE AND METHODOLOGY This report i
48、s written from the point of view of diagnostic modalities for the detection and management of cancer and in particular solid tumors. The technology to detect cancers of the blood - lymphomas, myelomas and leukemias - is mature and well established. The routine complete blood count screens for blood
49、cell abnormalities and is followed by bone marrow analysis and flow cytometric studies of the blood cell surface markers. These to arrive at a more specific diagnosis. As such this report does not discuss area of hematological cancer diagnosis in great detail. Market analysis in this report covers world markets for in vitro cancer diagnostics, however the reader will find a bias toward the developed areas of the globe - - N. America, Japan and Western Europe. However cancer is a growing global problem and where po