Multiplex testing threatens existing infectious disease practice. The microbiology lab may disappear.
The Molecular Diagnostics - Infectious Disease sector of the clinical diagnostics industry is poised for record growth.
A market that just keeps on growing. In spite of the steady decline of disease prevalence, the diagnostic sector keeps growing. Find out about the exciting developments in multiplex assays which threaten to change diagnosis and treatment while limiting the threat of anti microbial drug resistance.
Infectious disease testing directly benefits from the explosion in biotechnology, especially genomics.
A range of dynamic trends are pushing market growth and company valuations. Trends like:
emerging economies and global prosperity
biotechnology advances in genetics
the rise of rapid testing
Exciting technical developments especially in the seesaw between sequencing and immunoassay, hold the promise of a dynamic, growing and evolving world market that holds the promise of diagnostics taking the lead in infectious disease eradication.
The report has hundreds of pages of information including a complete list of Current 2016 United States Medicare Fee Payment Schedules to help sharpen your pricing.
Key Topics Covered
1. Introduction and Market Definition 1.1 What is Molecular Diagnostics 1.2 The Diagnostics Revolution 1.3 Market Definition 1.3.1 Volumes 1.3.2 Prices 1.3.3 Revenue Market Size 1.4 Methodology 1.4.1 Authors 1.4.2 Sources 1.5 U.S. Medical Market and Clinical Laboratory Testing - Perspective 1.5.1 U.S. Medicare Expenditures for Clinical Testing
2. The Infectious Diseases - Market Analysis by Disease 2.1 HIV - Human Immunodeficiency Virus (AIDS) 2.1.1 Virology 184.108.40.206 Classification 220.127.116.11 Structure and genome 18.104.22.168 Tropism 22.214.171.124 Replication cycle 126.96.36.199 Genetic variability 2.1.2 Diagnosis 2.1.3 Testing 188.8.131.52 Antibody tests 184.108.40.206 Point of Care Tests (POCT) 220.127.116.11 Antigen Tests 18.104.22.168 Nucleic acid-based tests (NAT) 22.214.171.124 Other tests used in HIV treatment 2.1.4 Market Opportunity Analysis 2.2 HBV - Hepatitis B 2.2.1 Virology 126.96.36.199 Genome 188.8.131.52 Pathogenesis 184.108.40.206 Hepatitis B virus replication 220.127.116.11 Serotypes and genotypes 2.2.2 Mechanisms 2.2.3 Diagnosis 2.2.4 Market Opportunity Analysis 2.3 HCV - Hepatitis C 2.3.1 Taxonomy 2.3.2 Structure 18.104.22.168 Genome 2.3.3 Molecular biology 2.3.4 Replication 2.3.5 Genotypes 22.214.171.124 Clinical importance 2.3.6 Market Opportunity Analysis 2.4 HPV - Human papillomavirus 2.4.1 Virology 126.96.36.199 E6/E7 proteins 188.8.131.52 Role in cancer 184.108.40.206 E2 research 220.127.116.11 Latency period 18.104.22.168 Clearance 2.4.2 Diagnosis 22.214.171.124 Cervical testing 126.96.36.199 Oral testing 188.8.131.52 Testing men 184.108.40.206 Other testing 2.4.3 Market Opportunity Analysis 2.5 Influenza 2.5.1 Virology 220.127.116.11 Types of virus 18.104.22.168 Influenzavirus A 22.214.171.124 Influenzavirus B 126.96.36.199 Influenzavirus C 188.8.131.52 Structure, properties, and subtype no 184.108.40.206 Replication 2.5.2 Testing 220.127.116.11 Advantages/Disadvantages of Molecular Assays 2.5.3 Market Opportunity Analysis 2.6 CTGC - Chlamydia/Gonorhea 2.6.1 Gonorrhea 18.104.22.168 Diagnosis 22.214.171.124 Screening 2.6.2 Chlamydia 126.96.36.199 Diagnosis 188.8.131.52 Screening 2.6.3 Testing 184.108.40.206 Nucleic acid amplification tests (NAATs) 220.127.116.11 Performance of NAAT Tests 2.6.4 Market Opportunity Analysis 2.7 Tuberculosis 2.7.1 Mycobacteria 2.7.2 Diagnosis 18.104.22.168 Active tuberculosis 22.214.171.124 Latent tuberculosis 2.7.3 Epidemiology 2.7.4 Molecular Diagnostic Tests 2.7.5 Market Opportunity Analysis 2.8 MRSA - Methicillin-resistant Staphylococcus aureus 2.8.1 Diagnosis 2.8.2 FDA Approved Molecular Tests 2.8.3 Market Opportunity Analysis 2.9 VRE - Vancomycin-resistant Enterococcus 2.9.1 FDA Approved MDx Tests for VRE 2.9.2 Market Opportunity Analysis 2.10 Blood Screening 2.10.1 Collection and Testing 2.10.2 FDA Approved Multiplex Assays 2.10.3 Market Opportunity Analysis
3. Industry Overview 3.1 Industry Participants 3.1.1 IVD Supplier 3.1.2 Independent lab specialized/esoteric 3.1.3 Independent lab national/regional 3.1.4 Independent lab analytical 3.1.5 Public National/regional lab 3.1.6 Hospital lab 3.1.7 Physician lab 3.1.8 Audit body 3.2 The Clinical Laboratory Market Segments 3.2.1 Traditional Market Segmentation 3.2.2 Laboratory Focus and Segmentation 3.3 Industry Structure 3.3.1 Hospital Testing Share 3.3.2 Economies of Scale 126.96.36.199 Hospital vs. Central Lab 3.3.3 Physician Office Lab's 3.3.4 Physician's and POCT 3.4 Profiles of Key MDx Companies
Roche Molecular Diagnostics
4. Market Trends 4.1 Factors Driving Growth 4.1.1 New Genotypes Creating New Markets 4.1.2 Aging Population a Boon for All Diagnostics 4.1.3 Developing World Driving ID Dx Growth 4.1.4 Point of Care - Why Centralization is Losing Steam 4.1.5 Self Testing 4.1.6 The Need for Speed 4.2 Factors Limiting Growth 4.2.1 Lower Costs 4.2.2 Infectious Disease is Declining. 4.2.3 Wellness Hurts 4.2.4 Economic Growth improves Living Standards 4.3 Instrumentation and Automation 4.3.1 Instruments Key to Market Share 4.3.2 The Shrinking Machine 4.3.2 Multiplex, Point of Care and The Speed Factor 4.4 Diagnostic Technology Development 4.4.1 The Sepsis Testing Market - A New Direction? 4.4.2 POCT/Self Testing as a Disruptive Force 4.4.3 The Genetics Play - One Test for All Known Infections 4.4.4 Antibiotic Resistance Genes - Simplifying Diagnostics
5. Molecular Dx - Infectious Disease Recent Developments 5.1 Recent Developments - Importance and How to Use This Section 5.1.1 Importance of These Developments 5.1.2 How to Use This Section 5.2 Karius Test To Be Available in Brazil 5.3 Panagene's STD kit gains Approval 5.4 Startup Prominex Raises $4M in Series A1 5.5 Quidel Receives FDA Clearance for Its Point-of-Care Sofia Lyme Fluorescent Immunoassa 5.6 'Origami' diagnostics breakthrough set to benefit developing-world farmers 5.7 NYU researchers adapt HIV test to Zika virus 5.8 GA-EMS receives diagnostic device contract 5.9 Biocartis & Immunexpress Sign Partnership for Sepsis 5.10 PerkinElmer to Acquire Euroimmun for $1.3B 5.11 Alveo Closes Financing to Create Accessible Diagnostics Devices 5.12 Siemens Healthineers completes takeover of Fast Track Diagnostics 5.13 Sekisui Diagnostics Enters Strategic Alliance with Mesa Biotech Inc 5.14 Chembio and FIND to Develop Point-of-Care Multiplex Test 5.15 Locus Biosciences and IDbyDNA Partner to Develop Companion Diagnostic Test 5.16 Alere bags FDA nod for rapid flu diagnostic 5.17 FDA approves tests of tick-borne disease to protect blood supply 5.18 Qiagen Trichomonas Assay Gets CE Mark 5.19 Vela Diagnostics HSV Test Gets FDA Clearance 5.20 QIAGEN enters into agreement to acquire STAT-Dx 5.21 Bruker to Acquire Majority Stake in Infectious Disease MDx Firm Hain 5.22 Applied BioCode's Syndromic Gastrointestinal Pathogen Panel Approved by the FDA 5.23 Ares Genetics to develop AI diagnostic test for infectious diseases 5.24 FDA Considers Guidelines for NGS-Based Infectious Disease Diagnostics
6. Country Market Sizes - North America 6.1 United States of America 6.2 Canada
7. Country Markets - Europe 7.1 France 7.2 Germany 7.3 United Kingdom 7.4 Spain 7.5 Italy 7.6 Switzerland 7.7 Czech Republic 7.8 Belgium 7.9 Russia 7.10 Remainder of Europe and Former Soviet Union
8. Country Markets - Asia Pacific 8.1 China 8.2 Japan 8.3 South Korea 8.4 India 8.5 Australia 8.6 Rest of Asia Pacific
9. Country Markets - Latin America, Africa & The Middle East 9.1 Brazil 9.2 Mexico 9.3 Remainder of Latin America 9.4 Africa & The Middle East
10. Global Market Summary 10.1 Global Market
Appendices I. United States Medicare System: 2017 Clinical Laboratory Fees Schedule - National Limit and Midpoint II. FDA Approved Human Genetic Tests III. FDA Approved Microbial Tests III. FDA Approved Pharmacogenomics Tests