Noninvasive Cancer Diagnostics: Technologies and Global Markets

 Published On: Aug, 2017 |    No of Pages: 335 |  Published By: BCC Research-JT Gabrielsen Consulting LLC Research | Format: PDF
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The global market for noninvasive cancer diagnostics was valued at $107.4 billion in 2016. This market is estimated to grow from nearly $114.6 billion in 2017 to $159.8 billion by 2022 with a compound annual growth rate (CAGR) of 6.9% for the period of 2017-2022.

Report Includes

-An overview of the global noninvasive cancer diagnostics market.
-Analyses of global market trends, with data from 2016, estimates for 2017 and projections of compound annual growth rates (CAGRs) through 2022.
-Analysis of the market by principle technology and by geography.
-Detailed breakdown of advanced non-invasive approaches.
-Coverage of segmentation of the cell-free DNA diagnostic methods.
-A look at major factors driving the growth of the non-invasive cancer diagnostic and technologies market.
-Profiles of major players in the industry.

Report Scope

The aim of this report is to initially conduct a review of the noninvasive cancer diagnostics products currently available; assess the market potential by clinical application; examine statistics on the incidence and mortality of cancer; review the issues facing the use of noninvasive cancer diagnostics; and review some of the latest developments into new and innovative noninvasive cancer diagnostic products, their technologies, and their intended clinical applications.

Key objectives are to conduct and provide an analysis of the market value, growth rates, market shares, and market development, as well as examine the market dynamics and market factors influencing the growth and development of this market. This report also looks at the challenges and potential threats facing the industry, and the factors influencing the market shares of the major market suppliers as well as smaller indigenous manufactures in local markets. The emphasis of this report is to provide the reader with:

-A detailed analysis of the revenues and forecasts for the global noninvasive cancer diagnostics market with a further, more detailed analysis and forecast of the revenues for the global market subdivided by major market subsegments by geographic region and finally by selected country.
-A detailed analysis of the global market share, together with a further, more detailed analysis of the market share by geographic region and finally by selected country.

In addition, this analysis provides a:

-Detailed review of the current products, their indications and availability for all the market segments identified.
-Profile of the individual market subsegments within the major market segments analyzed and the distinguishing features of each of the market subsegments.
-Review of the major market opportunities through the recognition of specific high-growth and emerging market opportunities.
-Brief description of the historical development for each of the major market segments.
-Profile of the leading suppliers of noninvasive cancer diagnostics and related products, together with related information about specific products.

The study will allow the reader to:

-Evaluate the effect of strategic factors such as technology-driven change and industry consolidation for the noninvasive cancer diagnostics market.
-Investigate the current market dynamics that are driving change in the noninvasive cancer diagnostics market.
-Assess future growth opportunities in the noninvasive cancer diagnostics market.
-Review the main products in each sector and plan a product entry strategy in line with the strengths and weaknesses of the competition.
-Utilize the report to help realize a company’s position in the marketplace and to provide insight into the future of the market and the opportunities that exist.
Chapter 1: Introduction 1
Study Goals and Objectives 2
Scope of Report 2
Methodology and Information Sources 3
Primary Data and Information Gathering 3
Secondary Data and Information Gathering 4
Market Share Analysis and Market Forecast Prediction 4
Geographic Breakdown 5
Analyst's Credentials 9
Related BCC Research Reports 9

Chapter 2: Summary and Highlights 11
Summary of Key Findings 11
Diagnostic Imaging Segment 13
Advanced Diagnostics Segment 13
Conventional Segment 14

Chapter 3: Market and Technology Review: Diagnostic Imaging 16
Real-time In Vivo Cancer Diagnosis using Raman Spectroscopy 16
In-Vivo Fluorescence Imaging in Personalized Cancer Diagnostics 18
Direct Imaging 18
Indirect Fluorescence Imaging 19
Magnetic Resonance Imaging (MRI) Scans 19
Development to the RF Subsystem 22
Positron Emission Tomography (PET) Scan 26
Positron Emission Tomography (PET)/Magnetic Resonance Imaging (MRI) 29
Mammography 31
Digital Mammography Systems 32
Breast Tomosynthesis Systems 35
Ultrasound 36
Barium Swallow or Enema 41
Bone Scans (MRI, CT and PET) 42
Market Estimate 42

Chapter 4: Market and Technology Review: Advanced Noninvasive Cancer
Diagnostic Assays and Technologies 44
Introduction to Circulating Nucleic Acids (CNAs) 46
Circulating Nucleic Acids as a Diagnostic Tool 49
Circulating DNA as a Biomarker of Cancer 50
Use of Circulating DNA for Prenatal Diagnosis (Conventional) 50
Use of Circulating DNA for Prenatal Diagnosis (Noninvasive) 51
Circulating RNA as a Biomarker of Cancer 51
Methods Used for the Detection of Circulating Nucleic Acids 55
Liquid Biopsy 56
Janssen Diagnostics 58
Roche Molecular Systems Inc. 59
Genomic Health 59
Foundation Medicine 60
Veracyte 60
Trovagene Inc. 60
Myriad Genetics 61
OncoCyte Corp. 61
Illumina 61
NeoGenomics Laboratories 62
Biocept Inc. 62
Vermillion Inc. 63
Sysmex Inostics, a subsidiary of Sysmex Corp. 63
Guardant Health 63
Product Development and New Initiatives in Liquid Biopsy 63
Molecular Cytogenetic/Gene Expression Studies 65
Amplify and Detect Diminished Amounts of RNA Consistently 68
Analyze Hundreds of Genes 69
Proteomics and New Protein Markers 69
Inside the ProteinChip System 70
Proteome Pattern Recognition 71
Next-Generation Sequencing (NGS) Studies 72
Illumina Solexa System 73
Roche 454 Sequencing 73
Thermo Fisher Scientific Ion Personal Genome Machine (PGM) 74
Thermo Fisher Scientific SOLiD (Sequencing by Oligonucleotide Ligation and Detection) 74
Oxford Nanopore Technologies 75
The Third-Generation Sequencer 75
Clinical Acceptance of a New Diagnostic Assay 76
Saliva-Based Oral Cancer Diagnostics 78
Advanced Tissue Staining (Immunohistochemistry (IHC) and in situ Hybridization (ISH)) 79
Optical Biopsy 80
Market Estimate 81

Chapter 5: Market and Technology Review: Conventional Noninvasive Cancer
Diagnostic Assays and Tests 83
Pap Test and HPV Testing 84
Tumor Biomarker Testing 86
MammaPrint Specifications 92
Genomic Health’s Oncotype DX Breast Cancer Test 93
The Prosigna Breast Cancer Prognostic Gene Signature Assay (formerly called the PAM50 test) 94
Sales and Marketing Strategies for Cancer Tests 95
Fecal Occult Blood Tests (FOBT) 97
Digital Rectal Exam (DRE) 100
Multigated Acquisition (MUGA) Scans 100
Market Estimate 101

Chapter 6: Incidence, Prevalence and Mortality Statistics for Cancer: A Global
Summary 103
Cancer: The Disease 103
Cancer: A Statistical Analysis of the Disease Incidence and Prevalence 104
Incidence and Prevalence Rates for Major Cancer Types 104
Regional Patterns of Cancer 113
Europe 113
North America 113
Asia-Pacific 115
Latin and Central America 116
Middle East/Africa 116
The Global Cancer Burden and Worldwide Cancer Risk Factors 117
Tobacco Use and Statistics 117
Alcohol Abuse and Cancer Statistics 118
Obesity and Cancer Statistics 118
Infectious Diseases and Cancer 118
Inherited Genes/Diseases and Cancer 119
Sun, U.V. and Cancer 120
Hormones and Cancer 120

Chapter 7: Noninvasive Cancer Diagnostics Market by Cancer Type 122
Global Noninvasive Cancer Diagnostics Market, by Cancer Type 122
Global Market Drivers 127
Global Market Restraints 131
Regional Noninvasive Cancer Diagnostics Market Assessment: North America 133
Selected Market Drivers: North America 133
Selected Market Restraints: North America 136
Selected Country: Noninvasive Cancer Diagnostics Market, by Cancer Type 138
Regional Noninvasive Cancer Diagnostics Market Assessment: Europe 140
Selected Market Drivers: Europe 141
Selected Market Restraint: Europe 143
Selected Country: Noninvasive Cancer Diagnostics Market, by Cancer Type 144
Regional Noninvasive Cancer Diagnostics Market Assessment: Asia-Pacific 152
Selected Market Drivers: Asia-Pacific 153
Selected Market Restraints: Asia-Pacific 157
Regional Noninvasive Cancer Diagnostics Market Assessment: Central and Latin America 162
Selected Market Drivers: Central and Latin America 163
Selected Market Restraints: Central and Latin America 166
Regional Noninvasive Cancer Diagnostics Market Assessment: Middle East/Africa 171
Selected Market Drivers: Middle East/Africa 174
Selected Market Restraints: Middle East/Africa 175

Chapter 8: Market Analysis by Technology, End User and Market Share 179
Global Noninvasive Cancer Diagnostics Market, by Technology 179
Regional Noninvasive Cancer Diagnostics Market, by Technology: North America 183
Regional Noninvasive Cancer Diagnostics Market, by Technology: Europe 186
Regional Noninvasive Cancer Diagnostics Market, by Technology: Asia-Pacific 189
Regional Noninvasive Cancer Diagnostics Market, by Technology: Central and Latin America 191
Regional Noninvasive Cancer Diagnostics Market, by Technology: Middle East/Africa 194
Global Noninvasive Cancer Diagnostics Market, by End-User 196
General Clinical Reference Laboratories 199
Market Share Analysis by Technology: Noninvasive Cancer Diagnostics Market 200

Chapter 9: Technological Advances, Trends and Opportunities 211
Key Technological Developments and Advances, Market Trends and Opportunities 211
Developments and Advances, Trends and Opportunities in Diagnostic Imaging 211
Developments and Advances, Trends and Opportunities in Advanced Noninvasive Approaches 214
Developments and Advances, Trends and Opportunities in Screening Assays 217
Opportunities for IVDMIA Companies 220

Chapter 10: Regulatory and Legislative Requirements 223
United States 223
How are IVDs Classified? 223
FDA Regulations Relating to Companion Diagnostics 226
Laboratory Developed Tests (LDTs) 227
Centers for Medicare & Medicaid Services (CMS) 228
The 2010 Affordable Care Act 229
Private Insurance 229
Europe 231
(General) Medical Device Directive, MDD (93/42/EEC) 232
Active Implantable Medical Device Directive, AIMDD (90/383/EEC 233
In Vitro Diagnostic Medical Device Directive, IVDMDD (98/79/EC) 234
Proposal for Changes to the Medical Device Directive, MDD (93/42/EEC) 234
Japan 236
Marketing Authorization System 237
China 239
Overview of the Healthcare System 239
Healthcare Reforms 241
Healthcare Institutions 241
India 245
Overview of the Healthcare System 245
Hospital Resources 248
Population Statistics 249
South Korea 250
Brazil 251
Background 251
Regulatory and Legislative Requirements 253
Market Entry and Reimbursement of Medical Devices: Brazil 254
Argentina 255
Background 255
Government-funded Public Health Sector 256
Social Health Insurance Sector 256
Private Sector 257
Regulatory and Legislative Requirements 257
Mexico 258
Legislation and Regulations Governing Medical Devices in Mexico 259
Health Insurance Structure in Mexico 260

Chapter 11: Patent Review of Key Technologies 262
Microarray Patents 263
LOAC Patents 268
Clinical Next-Generation Sequencing (NGS) Patents 270
Clinical NGS Patents Summary 270
Clinical NGS Patents by Indication 272

Chapter 12: Company Profiles 275
Appendix A: Company Addresses and Contact Details 335
Appendix B: Government Regulatory Agencies and Professional Organizations 349

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