Table of Contents

Executive Summary………………………………………………………………………………………………… ES-1
i. Molecular diagnostics market for oncology …………………………………………………………………..ES-1
a. Selected market drivers and limiters…………………………………………………………ES-5
b. Market leaders……………………………………………………………………………………….ES-6
ii. Methodology …………………………………………………………………………………………………………..ES-6

Exhibit ES-1: Global market for molecular in vitro diagnostic tests for infectious disease, oncology, genetic testing, and blood screening, by segment ($m), 2017 and 2022 ….. ES-1
Exhibit ES-2: Molecular in vitro diagnostic tests for oncology, global market forecast ($m), by type of cancer, 2017-22………………………………………………………………………………….ES-3
Exhibit ES-3: Molecular in vitro diagnostic tests for oncology, global market forecast ($m), by region, 2017-22…………………………………………………………………………………………….ES-4

1. Market Environment……………………………………………………………………………………………. 1-1
1.1 Overview of molecular in vitro diagnostics…………………………………………………………………. 1-2
1.2 Market trends…………………………………………………………………………………………………………. 1-4
1.2.1 Advantages of molecular cancer testing versus immunochemical and biochemical methods…………………………………………………………………. 1-4
1.2.2 Companion diagnostics and pharmacogenomics…………………………………….. 1-6
1.2.3 Reimbursement ………………………………………………………………………………… 1-10
1.2.4 Regulatory issues………………………………………………………………………………. 1-10
1.2.5 Liability issues …………………………………………………………………………………… 1-11
1.3 Target market segments for molecular cancer diagnostics…………………………………………. 1-12
1.4 Bibliography…………………………………………………………………………………………………………. 1-13

Exhibit 1-1: Global market for molecular in vitro diagnostic tests for infectious disease, oncology, genetic testing, and blood screening, by segment ($m), 2017 and 2022 …….1-1
Exhibit 1-2: Selected molecular in vitro diagnostic tests for oncology, 2018 ……………………………….. 1-3
Exhibit 1-3: Range of applicability of biochemical assay, immunochemical, and molecular testing in oncology applications…………………………………………………………………………………………. 1-5
Exhibit 1-4: Selected molecular companion diagnostic tests and associated targeted therapies……. 1-8

2. Cancer Incidence and Prevalence by Type………………………………………………………………. 2-1
2.1 Breast cancer…………………………………………………………………………………………………………. 2-8
2.2 Prostate cancer………………………………………………………………………………………………………. 2-8
2.3 Lung cancer……………………………………………………………………………………………………………. 2-9
2.4 Colorectal cancer…………………………………………………………………………………………………… 2-9
2.5 Melanoma…………………………………………………………………………………………………………… 2-10
2.6 Pancreatic cancer…………………………………………………………………………………………………. 2-10
2.7 Hepatocellular cancer…………………………………………………………………………………………… 2-11
2.8 Cervical cancer…………………………………………………………………………………………………….. 2-12
2.9 Oral cancer………………………………………………………………………………………………………….. 2-12
2.10 Leukemia and lymphoma …………………………………………………………………………………….. 2-13
2.11 Stomach cancer ………………………………………………………………………………………………….. 2-13
2.12 Bibliography……………………………………………………………………………………………………….. 2-14

Exhibit 2-1: Cancer incidence by country/region, 2015…………………………………………………………2-2
Exhibit 2-2: Cancer incidence by country/region, 2020…………………………………………………………….. 2-3
Exhibit 2-3: Cancer incidence by country/region, 2025…………………………………………………………….. 2-4
Exhibit 2-4: Cancer incidence forecast, by country/region, 2015-25…………………………………………… 2-5
Exhibit 2-5: Cancer prevalence, by country/region, 2012………………………………………………………….. 2-7

3. Analytical Platforms for Molecular In Vitro Diagnostics for Oncology ………………………… 3-1
3.1 Polymerase chain reaction and other nucleic acid amplification technologies……………….. 3-4
3.2 In situ hybridization………………………………………………………………………………………………… 3-6
3.3 Immunohistochemistry …………………………………………………………………………………………… 3-6
3.4 Next-generation sequencing ……………………………………………………………………………………. 3-7
3.5 Microarrays……………………………………………………………………………………………………………. 3-9
3.6 Flow cytometry…………………………………………………………………………………………………….. 3-10
3.7 Other molecular diagnostic technologies…………………………………………………………………. 3-11
3.8 Bibliography…………………………………………………………………………………………………………. 3-13

Exhibit 3-1: Types of analytical platforms employed in molecular cancer diagnostics, 2018 ………… 3-2
Exhibit 3-2: Selected next-generation sequencing technologies, 2018 ……………………………………….. 3-8

4. Molecular In Vitro Diagnostic and Screening Tests for Oncology………………………………… 4-1
4.1 Market drivers and limiters……………………………………………………………………………………… 4-1
4.2 End-user characteristics ………………………………………………………………………………………….. 4-5
4.3 Market for molecular diagnostics, by cancer type and geographic region……………………… 4-6
4.3.1 Breast cancer molecular IVD market, by geographic region …………………….. 4-9
4.3.2 Prostate cancer molecular diagnostics market, by region………………………. 4-10
4.3.3 Lung cancer molecular diagnostics market, by region……………………………. 4-13
4.3.4 Colorectal cancer molecular diagnostics market, by region……………………. 4-15
4.3.5 Melanoma molecular diagnostics market, by region …………………………….. 4-17
4.3.6 Hepatocellular cancer molecular diagnostics market, by region……………… 4-19
4.3.7 Pancreatic cancer molecular diagnostics market, by region …………………… 4-19
4.3.8 Cervical cancer molecular diagnostics market, by region……………………….. 4-20
4.3.9 Leukemia and lymphoma molecular diagnostics market, by region ………… 4-22
4.3.10 Stomach cancer molecular diagnostics market, by region ……………………. 4-24
4.3.11 Market for molecular diagnostic products for other cancer types, by region ………………………………………………………………………………………. 4-24
4.4 Competitive analysis……………………………………………………………………………………………… 4-27
4.4.1 Company sales by cancer type……………………………………………………………. 4-29
4.4.2 Molecular testing laboratory revenues ……………………………………………….. 4-32
4.5 Bibliography………………………………………………………………………………………………………….. 4-34

Exhibit 4-1: Molecular in vitro diagnostic tests for oncology, global market forecast ($m), 2017-22 …………………………………………………………………………………………………….4-3
Exhibit 4-2: Molecular in vitro diagnostic tests for oncology, global market forecast ($m), by region, 2017-22 …………………………………………………………………………………………….. 4-4
Exhibit 4-3: Molecular in vitro diagnostic tests for oncology, global market forecast ($m), by type of cancer, 2017-22………………………………………………………………………………….. 4-8
Exhibit 4-4: Molecular in vitro diagnostic tests for breast cancer, global market forecast ($m), by region, 2017-22………………………………………………….. 4-10
Exhibit 4-5: Molecular in vitro diagnostic tests for prostate cancer, global market forecast ($m), by region, 2017-22………………………………………………….. 4-12
Exhibit 4-6: Molecular in vitro diagnostic tests for lung cancer, global market forecast ($m), by region, 2017-22………………………………………………….. 4-14
Exhibit 4-7: Global sales of targeted drugs used in lung cancer therapy ($m), 2015-17………………. 4-15
Exhibit 4-8: Molecular in vitro diagnostic tests for colorectal cancer, global market forecast ($m), by region, 2017-22………………………………………………….. 4-16
Exhibit 4-9: Global sales of targeted drugs used in colorectal cancer therapy ($m), 2015-17 ………………………………………………………………………………………………………….. 4-16
Exhibit 4-10: Molecular in vitro diagnostic tests for melanoma, global market forecast ($m), by region, 2017-22…………………………………………………. 4-18
Exhibit 4-11: Global sales of targeted drugs used in melanoma therapy ($m), 2015-17 ……………… 4-18
Exhibit 4-12: Molecular in vitro diagnostic tests for cervical cancer, global market forecast ($m), by region, 2017-22…………………………………………………. 4-21
Exhibit 4-13: Prevalence of human papilloma virus infection, by geographic region…………………… 4-21
Exhibit 4-14: Molecular in vitro diagnostic tests for leukemia/lymphoma, global market forecast ($m), by region, 2017-22…………………………………………………. 4-23
Exhibit 4-15: Molecular in vitro diagnostic tests for other cancer types, global market forecast ($m), by region, 2017-22…………………………………………………. 4-26
Exhibit 4-16: Molecular in vitro diagnostic tests for oncology, share by supplier ($m), 2017………………………………………………………………………………………………………………. 4-29
Exhibit 4-17: Molecular in vitro diagnostic tests for oncology, company sales by cancer type ($m), 2017 ………………………………………………………….. 4-31
Exhibit 4-18: Molecular oncology in vitro diagnostic testing services market ($m), 2017………………………………………………………………………………………………………………. 4-33

APPENDIX: COMPANY LISTING……………………………………………………………………………………………………..A-1