Market Forecasts for Immuno-Oncology Diagnostics with COVID-19 Impact and Updates

Explosion in immuno-oncology therapies creates an exploding diagnostic market. Diagnostics plays new key role in Therapeutic Development and Clinical Trials

Diagnostics, companion diagnostics, is driving the success of Immuno-oncology Therapeutics. An entire new segment of the diagnostics industry is being created and its not a small segment either. It promises to grow dramatically. Histology, genomics and liquid biopsy are converging. A complicated network of pharmaceutical companies, diagnostic companies and instrumentation suppliers are jockeying for position in a new approach to conquering cancer. The approach seems to be working and showing great promise.

A revolution in cancer therapy is underway. New therapy based on using the body’s natural immune defenses is having unprecedented success but diagnostics, especially biomarkers, are desperately needed to help select the right therapy.

The technology is moving faster than the market. The impact on the health care industry is enormous. Tumor Mutational Burden? Checkpoint Inhibitors? Cytokines? Find out about the technology in readily understood terms that explain the jargon. Find the opportunities and the pitfalls. Understand growth expectations and the ultimate potential market size in this new expanded and comprehensive report.

The report includes five year market forecasts.

1 Market Guides

1.1 Situation Analysis & Impact of COVID-19 Pandemic
1.2 Guide for Executives and Marketing Staff
1.3 Guide for Investment Analysts and Management Consultants

2 Introduction and Market Definition

2.1 What are Immuno-Oncology Diagnostics?
2.2 Immuno-oncology - the looming cure
2.2.1 Immuno-oncology Diagnostics Takes a Leading Role
2.3 Market Definition
2.3.1 Market Size
2.3.2 Currency
2.3.3 Years
2.4 Methodology
2.4.1 Authors
2.4.2 Sources
2.5 Perspective: Healthcare, the IVD Industry, and the COVID-19 Pandemic
2.5.1 Global Healthcare Spending
2.5.2 Spending on Diagnostics
2.5.3 Important Role of Insurance for Diagnostics

3 Immunotherapy - Guide to Immune Technologies

3.1 The Immune System
3.1.1 Innate immune system
3.1.1.1 Surface barriers
3.1.1.2 Inflammation
3.1.1.3 Complement system
3.1.1.4 Cellular barriers
3.1.1.5 Natural killer cells
3.1.2 Adaptive immune system
3.1.2.1 Lymphocytes
3.1.2.2 Killer T cells
3.1.2.3 Helper T cells
3.1.2.4 Gamma delta T cells
3.1.2.5 B lymphocytes and antibodies
3.1.3 Tumor immunology - the immune surveillance system
3.2 Immuno Oncology Diagnostics
3.2.1 Checkpoint Assays
3.2.1.1 Outlook for Checkpoint Assays
3.2.2 Cytokine Assays
3.2.2.1 Outlook for Cytokine Assays
3.2.3 Genomic Germline
3.2.3.1 Outlook for Genomic Germline
3.2.4 Genomic Tumour
3.2.4.1 Outlook for Genomic Tumour
3.2.5 Tumor Microenviroment
3.2.5.1 Outlook for Tumor Microenvironment
3.2.6 Others
3.2.6.1 Outlook for Other Diagnostics

4 Industry Overview

4.1 Players in a Dynamic Market
4.1.1 Academic Research Lab
4.1.2 Diagnostic Test Developer
4.1.3 Genomic Instrumentation Supplier
4.1.4 Cell Separation and Viewing Instrumentation Supplier
4.1.5 Pharmaceutical/Reagent Supplier
4.1.6 Independent Testing Lab
4.1.7 Public National/regional lab
4.1.8 Hospital lab
4.1.9 Physician Lab
4.1.10 Audit Body
4.1.11 Certification Body

5 Market Trends

5.1 Factors Driving Growth
5.1.1 Outcome potential
5.1.2 Companion Diagnostics
5.1.3 Funding
5.1.4 Technology Environment
5.1.5 Target Solutions
5.2 Factors Limiting Growth
5.2.1 Complex Role of Diagnostics
5.2.2 Clinical Trials Role
5.2.3 Protocols
5.3 Diagnostic Technology Development
5.3.1 Combinations - Issues and Complexity
5.3.2 Shifting Role of Diagnostics
5.3.3 Multiplexing and Foundation One
5.3.4 The Disruption Dynamic
5.3.5 The Race for Biomarkers
5.3.6 The Next Five Years

6 Cancer Immuno-Oncology Diagnostics Recent Developments

6.1 Recent Developments - Importance and How to Use This Section
6.1.1 Importance of These Developments
6.1.2 How to Use This Section
6.2 Lucence Liquid Biopsy Test Tracks Immune Treatment ctDNA Changes
6.3 Qiagen, OncXerna Close Companion Dx Development Deal
6.4 Natera Test to Guide Therapy for Bladder Cancer
6.5 Veracyte Halio Acquisition to Boost Immuno-oncology Activity
6.6 Freenome Eyes New Dx Possibilities
6.7 Oncocyte Data has Potential as Immunotherapy Response Predictor
6.8 OncoDNA use HalioDx to Expand into North America
6.9 Adaptive Biotechnologies, Q2 Solutions Agreement for ImmunoSeq Assay .
6.10 Qiagen Expands Immuno-Oncology Portfolio
6.11 Immune Profiling System Redirected to Fight COVID-19
6.12 IncellDx Awarded PD-L1 Detection Patent
6.13 FDA Approves CDx for Trastuzumab
6.14 Promega Nabs CE Mark for Microsatellite Instability IVD
6.15 ArcherDx partners with AstraZeneca for Immuno-Oncology
6.16 Germline Results Guides Precision Therapy
6.17 Agilent PD-L1 Assay Gets FDA Approval
6.18 Bayer, OrigiMed Form Companion Diagnostic Development Alliance
6.19 Bio-Me to Develop Microbiome Biomarker Test for Cancer Immunotherapy
6.20 SkylineDx, BioInvent Collaborate to Characterize Predictive Immunological
Signatures
6.21 Biocare Medical Launches 7 Novel IVD Antibodies
6.22 Oncocyte to Acquire Insight Genetics for $12M
6.23 Novigenix and BioLizard to develop NGS Based Diagnostic Algorithm
6.24 Biodesix and Immodulon Collaborate for Pancreatic Cancer Treatment
6.25 Generex to Merge with NuGenerex Immuno-Oncology
6.26 Cellgen Diagnostics and Genomic Testing Cooperative Partner to Develop
Companion Diagnostics for Cancer Therapies
6.27 Hematogenix Launches FDA Approved Immuno-oncology Test for Triple Negative Breast Cancer
6.28 Icon Acquires MolecularMD

7 Profiles of Key Immuno-oncology Companies

7.1 10x Genomics, Inc.
7.2 Abbott Diagnostics
7.3 AccuraGen Inc.
7.4 Adaptive Biotechnologies
7.5 Aethlon Medical
7.6 Agena Bioscience, Inc
7.7 Agilent/Dako
7.8 Anchor Dx
7.9 ANGLE plc
7.10 ApoCell, Inc.
7.11 ARUP Laboratories
7.12 Asuragen
7.13 AVIVA Biosciences
7.14 Baylor Miraca Genetics Laboratories
7.15 Beckman Coulter Diagnostics
7.16 Becton, Dickinson and Company
7.17 BGI Genomics Co. Ltd
7.18 Bioarray Genetics
7.19 Biocartis
7.20 Biocept, Inc.
7.21 Biodesix Inc.
7.22 BioFluidica
7.23 BioGenex
7.24 BioIVT
7.25 Biolidics Ltd
7.26 bioMérieux Diagnostics
7.27 Bioneer Corporation
7.28 Bio-Rad Laboratories, Inc.
7.29 Bio-Reference Laboratories
7.30 Bio-Techne
7.31 Bioview
7.32 Bolidics
7.33 Boreal Genomics
7.34 Bristol-Myers Squibb
7.35 Burning Rock
7.36 Cancer Genetics
7.37 Caris Molecular Diagnostics
7.38 Castle Biosciences, Inc.
7.39 CellMax Life
7.40 Cepheid (Danaher)
7.41 Charles River Laboratories
7.42 Chronix Biomedical
7.43 Circulogene
7.44 Clinical Genomics
7.45 Cynvenio
7.46 Cytolumina Technologies Corp.
7.47 CytoTrack
7.48 Datar Cancer Genetics Limited
7.49 Diagnologix LLC
7.50 Diasorin S.p.A.
7.51 Enzo Biochem
7.52 Epic Sciences
7.53 Epigenomics AG
7.54 Eurofins Scientific
7.55 Exosome Diagnostics
7.56 Exosome Sciences
7.57 Fabric Genomics
7.58 Fluidigm Corp
7.59 Fluxion Biosciences
7.60 Foundation Medicine
7.61 Freenome
7.62 FUJIFILM Wako Diagnostics
7.63 GeneFirst Ltd.
7.64 Genetron Holdings
7.65 GenomOncology
7.66 GILUPI Nanomedizin
7.67 Grail, Inc.
7.68 Guardant Health
7.69 HalioDx
7.70 HansaBiomed
7.71 HeiScreen
7.72 Helomics
7.73 Horizon Discovery
7.74 HTG Molecular Diagnostics
7.75 iCellate
7.76 Illumina
7.77 Incell Dx
7.78 Inivata
7.79 Integrated Diagnostics
7.80 Invitae Corporation
7.81 Invivogen
7.82 Invivoscribe
7.83 Janssen Diagnostics
7.84 MDNA Life SCIENCES, Inc.
7.85 MDx Health
7.86 Menarini Silicon Biosystems
7.87 Millipore Sigma
7.88 Miltenyi Biotec
7.89 MIODx
7.90 miR Scientific
7.91 Molecular MD
7.92 MyCartis
7.93 Myriad Genetics/Myriad RBM
7.94 NantHealth, Inc.
7.95 Natera
7.96 NeoGenomics
7.97 New Oncology
7.98 NGeneBio
7.99 Novogene Bioinformatics Technology Co., Ltd.
7.100 Oncocyte
7.101 OncoDNA
7.102 Ortho Clinical Diagnostics
7.103 Oxford Nanopore Technologies
7.104 Panagene
7.105 Perkin Elmer
7.106 Personal Genome Diagnostics
7.107 Personalis
7.108 Precipio
7.109 PrecisionMed
7.110 Promega
7.111 Qiagen Gmbh
7.112 Rarecells SAS
7.113 RareCyte
7.114 Roche Molecular Diagnostics
7.115 Screencell
7.116 Sense Biodetection
7.117 Serametrix
7.118 Siemens Healthineers
7.119 Silicon Biosystems
7.120 simfo GmbH
7.121 Singlera Genomics Inc.
7.122 Singulomics
7.123 SkylineDx
7.124 Stratos Genomics
7.125 Sysmex Inostics
7.126 Tempus Labs, Inc.
7.127 Thermo Fisher Scientific Inc.
7.128 Thrive Earlier Detection
7.129 Todos Medical
7.130 Trovagene
7.131 Volition
7.132 Vortex Biosciences

8 The Global Market for Immuno-Oncology Diagnostics

8.1 Global Market Overview by Country
8.1.1 Table - Global Market by Country
8.1.2 Chart - Global Market by Country
8.2 Global Market by Assay Type - Overview
8.2.1 Table - Global Market by Assay Type
8.2.2 Chart - Global Market by Assay Type - Base/Final Year Comparison
8.2.3 Chart - Global Market by Assay Type - Base Year
8.2.4 Chart - Global Market by Assay Type - End Year
8.2.5 Chart - Global Market by Assay Type - Share by Year
8.2.6 Chart - Global Market by Assay Type - Segments Growth

9 Global Immuno-Oncology Diagnostic Markets - By Assay Type

9.1 Checkpoint
9.1.1 Table Checkpoint - by Country
9.1.2 Chart - Checkpoint Growth
9.2 Cytokine
9.2.1 Table Cytokine - by Country
9.2.2 Chart - Cytokine Growth
9.3 Germline Genetic
9.3.1 Table Germline Genetic - by Country
9.3.2 Chart - Germline Genetic Growth
9.4 Genetic Tumor
9.4.1 Table Genetic Tumor - by Country
9.4.2 Chart - Genetic Tumor Growth
9.5 Tumor Microenvironment
9.5.1 Table Tumor Microenvironment - by Country
9.5.2 Chart - Tumor Microenvironment Growth
9.6 Other
9.6.1 Table Other - by Country
9.6.2 Chart - Other Growth

10 Appendices

10.1 FDA Cancer Drug Approvals by Year
10.2 Clinical Trials Started 2010 to 2016
10.3 Prevalence of Cancer Treatments
10.4 United States Medicare System: 2021 Clinical Laboratory Fees Schedule

List of Tables

Table 1 List of Cancers by Mortality
Table 2 Overview of Innate and Adaptive Immunity
Table 3 FDA Approved Monoclonal Antibodies in Cancer treatment
Table 4 FDA Approved Companion diagnostics in Cancer treatment
Table 5 Market Players by Type
Table 6 Five Factors Driving Growth
Table 7 Three Factors Limiting Growth
Table 8 - Global Market by Region
Table 9 Global Market by Assay Type
Table 10 Checkpoint by Country
Table 11 Cytokine by Country
Table 12 Germline Genetic by Country
Table 13 Genetic Tumor by Country
Table 14 Tumor Microenvironment by Country
Table 15 Other by Country
Table 16 2021 Clinical Lab Fee Schedule

List of Figures

Figure 1 Cancer Death Rates - USA, CDC
Figure 2 The Lab Test Pie
Figure 3 Helper T Cell Roles
Figure 4 Antibody Diagram
Figure 5 Macrophages attack a Cancer Cell
Figure 6 The Tumour Micro Environment
Figure 7 Comparing IO Diagnostic and Traditional Testing
Figure 8 Growth rates of IO DiagnosticTechnologies
Figure 9 Global Market Density Chart
Figure 10 Global Market by Assay Type - Base vs. Final
Figure 11 Global Market by Assay Type Base Year
Figure 12 Global Market by Assay Type End Year
Figure 13 Assay Type Share by Year
Figure 14 Assay Type Segments Growth
Figure 15 Checkpoint Growth
Figure 16 Cytokine Growth
Figure 17 Germline Genetic Growth
Figure 18 Genetic Tumor Growth
Figure 19 Tumor Microenvironment Growth
Figure 20 Other Growth
Figure 21 FDA Cancer Drug Approvals by Year
Figure 22 Clinical Trials for Immunotherapy by Year
Figure 23 Pie Chart of Prevalence of Cancer Treatments