Global Nucleic Acid Testing Market--New Product Development Opportunities and Business Expansion Strategies For Instrument and Reagent Suppliers

Published by: Venture Planning Group

Published: Jun. 1, 2011 - 1050 Pages


Table of Contents

Introduction



Worldwide Market And Technology Overview

A. DNA Sequencing

1. Introduction

2. Sequencing Methods

3. Autoradiography

4. The Human Genome Project

5. Sequencing Automation

6. Image Scanners

7. Fluorescent Detection

8. Gene Profiling

9. Gene Expression

10. Polymorphism Screening

11. Protein Interaction Networks

B. DNA And RNA Probe Technology

1. Basic Principles

2. Probe Preparation

3. The DNA Probe Test

a. Sample Preparation

b. Hybridization

c. Separation

d. Detection/Measurement

4. Test Formats

a. Filter Hybridization

b. Southern Blot

c. Northern Blot

d. In Situ Hybridization

e. Others

5. Labeling Techniques

6. Amplification Methods

Polymerase Chain Reaction

Temperature Cyclers

PCR Variations

Immuno-PCR

QC-PCR

DAP-PCR

Strand Displacement Activation

TMA

Ligase Chain Reaction

Branched DNA

Hybridization Protection Assay

Nucleic-Acid Sequence-Based Amplification

Self-Sustained Sequence Replicase

Others

Ampliprobe

CAR

CAS

CPT

Dendritic Polymer Technology

ISO-CR

LAT

Probe Networks

RAMP

Repair Chain Reaction

Rolling Circles

Sequence Independent Gene Amplification

Sequence Initiation Reaction

SISPA

C. Detection Technologies

1. Radioactive Methods

a. Overview

b. Major Isotopes

P-32

S-35

H-3

I-125

2. Non-Isotopic Methods

a. Enzymatic Labels

b. Chemical Labeling

Indirect Chemical Labeling

Direct Chemical Labeling

c. Fluorescence

d. Chemiluminescence

e. Electrical Conductivity

D. Instrumentation Review

1. Abbott LCx

2. Autogenomics Infinity

3. Beckman Coulter/Biomek FK

4. Becton Dickinson SDA

5. Bio-Rad GeneScope

6. Gen-Probe Tigris

7. Nanosphere Verigen Series

8. Roche Cobas Amplicor

9. Tecan LS Series

E. Biochips: Genosensors, Microarrays, and Labs-on-the-Chip

Liquid Transportation and Mixing

Separation

Reaction

Detection

F. Pharmacogenomics

G. Major Applications

1. Microbiology/Infectious Diseases

a. Overview

b. Major Infectious Diseases

AIDS

Structure and Composition

Classification

AIDS Origins

Animal Lentivirus Systems

Virus Receptors

HIV Infections in Humans

Pathogenesis and Pathology

CD4T Lymphocytes and Memory Cells

Monocytes and Macrophages

Lymphoid Organs

Neural Cells

Viral Coinfections

Clinical Findings

Plasma Viral Load

Pediatric AIDS

Neurologic Disease

Opportunistic Infections

Cancer

Immunity

Laboratory Diagnosis

Virus Isolation

Serology

Viral Nucleic Acid/Antigen Detection

Epidemiology

Worldwide Spread of AIDS

United States

Routes of Transmission

Prevention, Treatment, And Control

Antiviral Drugs

Vaccines

Transmission HIV in Blood Products

HIV Transmission in Transplant and Artificial Insemination Recipients

Diagnostic Tests

Enzyme Immunoassay Interpretation

Specificity, Sensitivity and Predictive Value

Competition Assays

Western Blot Technique

Immuno-Fluorescence Assays (IFA)

Radioimmunoprecipitation

HIV-1/HIV-2 Combination Testing

Methods of HIV-Antigen Detection

Antigen Assays and Blood Screening

Urine Tests

DNA Probes

Overview

Quantitative PCR

In Situ PCR

Needed Improvements

Viral Load/Drug Resistance Testing

Genotype and Phenotype Testing

Blood Banking Considerations

Adenovirus

Background

Diagnostic Tests

Vaccines and Drugs

Adeno-Associated Viruses (AAV)

Anthrax/Bacillus Anthracis

Background

Diagnostic Tests

Vaccines and Drugs

Babesiosis

Background

BEA and Other Bartonella Diseases

Background

Diagnostic Tests

Vaccines and Drugs

Chagas Disease

Background

Campylobacter

Background

Diagnostic Tests

Culture Identification

Vaccines and Drugs

Chlamydia

Background

Chlamydia psittaci

Chlmaydia pneumoniae

Chlamydia trachomatis

Diagnostic Tests

Vaccines and Drugs

Creutzfeldt-Jakob’s Disease

Background

Blood Transmission

Diagnostic Tests

Major Commercial and Academic Players

Bayer

Disease Sciences/Bio Tec Global

Imperial College School of Medicine

Ortho-Clinical Diagnostics

Pall

ProMetic Life Sciences

Proteome Sciences/Idexx

Q-One Biotech

Serono

U.S. Agricultural Research Service

Drugs

Vaccines

Cytomegalovirus

Background

Chorioretinitis

Gastrointestinal

Central Nervous System Disease

Diagnostic Tests

Vaccines and Drugs

Ebola Virus

Background

Epidemiology

Clinical Syndromes

Diagnostic Tests

Vaccines and Drugs

EchoVirus

Background

Acute Aseptic Meningitisis

Encephalitis

Exanthems

Respiratory Disease

Myopericarditis

Neonatal Infections

Diagnostic Tests

Vaccines and Drugs

Encephalitis

Background

Diagnostic Tests

Vaccines and Drugs

Enteroviruses

Background

Diagnostic Tests

Viral Isolation and Identification

Antibody Tests

Vaccines and Drugs

Epstein-Barr Virus

Background

Diagnostic Tests

Vaccines and Drugs

Gonorrhea

Background

Diagnostic Tests

Vaccines and Drugs

Hepatitis

Hepatitis A

Hepatitis B

Structure and Composition

Replication

Hepatitis C

Hepatitis D (Delta)

Hepatitis E

Hepatitis G

Hepatitis Infections Pathology

Clinical Findings

Laboratory Tests

Hepatitis A

Hepatitis B

Hepatitis C

Hepatitis D

Hepatitis E

Virus-Host Immune Reactions

Epidemiology

Hepatitis A

Hepatitis B

Hepatitis C

Hepatitis D (Delta)

Vaccines and Drugs

Herpes Simplex Virus

Background

Diagnostic Tests

Vaccines and Drugs

Legionella

Background

Diagnostic Tests

Vaccines and Drugs

Lyme Disease

Background

Clinical Description

Clinical Case Definition

Laboratory Criteria for Diagnosis

Case Classification

Diagnostic Tests

Vaccines and Drugs

Malaria

Mycoplasma

Background

Ureaplasma Urealyticum & Mycoplasma Hominis

Diagnostic Tests

Vaccines and Drugs

Papillomaviruses/HPV

Background

HPV in Cancer

Cervical Neoplasm

Diagnostic Tests

Vaccines and Drugs

Prevention

Parvovirus B19

Background

Microbiology

Epidemiology

Clinical Syndromes

Erythema Infectiosum (Slapped Cheek)

Adult Polyarthropathy

Transient Aplastic Crisis

Transient Pancytopenia

Red Cell Aplasia in Immunocompromised

Perinatal Infections

Diagnostic Test

Vaccines and Drugs

Pneumonia

Background

Diagnostic Tests

Vaccines and Drugs

Polyomaviruses

Background

Diagnostic Tests

Vaccines and Drugs

Salmonellosis

Background

Diagnostic Tests

Vaccines and Drugs

Shigellosis

Background

Diagnostic Tests

Vaccines and Drugs

Streptococci

Background

Diagnostic Tests

Vaccines and Drugs

Group A Streptococci

Group B Streptococci

Toxoplasmosis

Background

Diagnostic Tests

Vaccines and Drugs

Tuberculosis

Background

Diagnostic Tests

Microscopic Characteristics

Cultural Characteristics

Skin Tests

MDRTB

Vaccines and Drugs

West Nile Virus

Background

Clinical Syndromes

Diagnostic Tests

Vaccines and Drugs

Yersinia

Background

Diagnostic Tests

Vaccines and Drugs

c. Antibiotic Susceptibility

2. Cancer Testing

a. Overview

b. Major Cancer Types

Prostate

Lung

Colon and Rectum

Breast

Skin

Uterine

Leukemia

Oral

c. Oncogenes

Abl/abl-bcr

AIB1

BRCA1

CD44

C-fos

C-myb

C-myc

CYP17

Erb-B

HPC1

N-myc

P40

P51

P53

PIK3CA

PTI-1

Ras

Reg

Sis

Src

3. Genetic Diseases

a. Overview

b. Nucleic Acid Amplification

c. Chromosome Imaging

d. Genomics Technologies

e. Proteomics Technologies

f. Current Pharmacogenomic Tests

g. Future Pharmacogenomic Testing

h. Major Diseases

Achondroplasia

Autosomal Dominant Polycystic Kidney Disease

Cancer

Cosmetogenomics

Cystic Fibrosis

Down's Syndrome

Duchenne and Becker Muscular Dystrophy

Factor V (Leiden)

Factor IX Deficiency

Fragile X Syndrome

Heart Disease

Hemochomatosis

Hemophilia

Huntington's Disease

Maternal-Fetal Incompatibility

Multiple Endocrine Neoplasia

Phenylketonuria (PKU)

Polycystic Kidney Disease (PKD)

Prenatal Screening

Retinitis Pigmentosa

Retinoblastoma

Sickle Cell Anemia

Spinal Muscular Atrophy

Vitamin B12 Metabolism

i. Social Issues and Concerns

4. Forensic Testing

a. Overview

b. Multilocus and Single Locus Probes

Multilocus Probes

Single Locus Probes

PCR and RFLP

c. The FBI

d. DNA Profile Data Banks

U.S.A.

U.K.

e. Judicial Implementation

f. Major Crime Categories

g. Factors Contributing to the DNA Probe Market Expansion

Technology Availability

Use of Hair as Evidence

h. Wildlife Forensics

5. Paternity Testing/HLA Typing

6. Other Applications

a. Disease Susceptibility Testing

b. Cardiovascular Diseases

c. Diabetes

d. Alzheimer's Disease

e. Plasma Purification

f. Organ Transplantation

g. Water Contamination

h. Others

G. Cost Analysis

1. Equipment

2. Consumables

H. Competing/complementing Technologies

1. Monoclonal Antibodies/Immunoassays

2. RNA Probes

3. Two-Dimensional Electrophoresis

4. Flow Cytometry

I. Reimbursement Issues

J. Worldwide Market Overview

1. Business Environment

2. Market Structure

3. Market Size and Growth



France

A. Executive Summary

B. Business Environment

C. Market Structure

D. Market Size, Growth And Major Suppliers’ Sales And Market Shares



Germany

A. Executive Summary

B. Business Environment

C. Market Structure

D. Market Size, Growth And Major Suppliers’ Sales And Market Shares



Italy

A. Executive Summary

B. Business Environment

C. Market Structure

D. Market Size, Growth And Major Suppliers’ Sales And Market Shares



Japan

A. Executive Summary

B. Business Environment

C. Market Structure

D. Market Size, Growth And Major Suppliers’ Sales And Market Shares



Spain

A. Executive Summary

B. Business Environment

C. Market Structure

D. Market Size, Growth And Major Suppliers’ Sales And Market Shares



U.K.

A. Executive Summary

B. Business Environment

C. Market Structure

D. Market Size, Growth And Major Suppliers’ Sales And Market Shares



U.S.A.

A. Executive Summary

B. Business Environment

1. Health Care Expenditures

2. Cost Consciousness

3. Reimbursement

4. Industry Consolidation

5. Managed Care

a. HMO

b. PPO

6. Hospitals

7. Admissions

8. Length of Stay

9. Industry Diversification

10. Physician Demographics

11. Population Aging

a. Chronic Illness

b. Disease Incidence

c. Susceptibility to Iatrogenesis

d. Multiple Illness Cases

12. Laboratory Regulations

13. FDA Reform

C. Market Structure

1. Hospitals

2. Commercial/Private Laboratories

3. Blood Banks

D. Market Size, Growth and Major Suppliers’ Sales and Market Shares



Major Product Development Opportunities

A. Instrumentation

B. Reagent Kits and Test Systems/panels

C. Computers, Software and Automation

D. Auxiliary Products



Design Criteria For Decentralized Testing Products



Alternative Market Penetration Strategies

A. Internal Development

B. Collaborative Arrangements

C. University Contracts

D. Distribution Strategies For Decentralized Testing Markets

1. Marketing Approaches

2. Product Complexity

3. Customer Preference

4. Established Suppliers

5. Emerging Suppliers

6. Major Types Of Distributors

7. Market Segmentation



Potential Market Entry Barriers And Risks

A. Market Maturity

B. Cost Containment

C. Competition

D. Technological Edge And Limitations

E. Patent Protection

F. Regulatory Constraints

G. Decentralized Testing Market Challenges



Competitive Profiles

Abbott

Aclara

Affymetrix

Agilent

Ambion

Applera

Applied Gene Technologies

Beckman Coulter

Becton Dickinson

Biokit

BioMerieux

Biotest

Boston Biomedica

Caliper

Cepheid

Chiron

Decode

Diadexus

Digene

Eiken

Enzo

Exact Sciences

Fujirebio

Gen-Probe

Gene Tec

Illumina

Innogenetics

Kreatech

Li-Cor

Molecular Diagnostics

Myriad Genetics

Nanogen

Nuvelo

Orchid Biosciences

Qiagen

Roche

Sangtec

Sequenom

Scienion

Sierra Diagnostics

Shimadzu

Takara Bio

Tepnel Life Sciences

Tecan Group

Third Wave



Appendixes

Appendix I: Major Companies Developing or Marketing NAT Reagents and Test Kits

Appendix II: Major Universities and Research Centers Developing NAT Technologies

Appendix III: Glossary of Terms

Appendix IV: Currency Exchange Rates



List of Tables

Major Companies Developing or Marketing Thermocyclers

Major Companies Developing or Marketing AIDS NAT And Other Direct Identification Tests

Major Companies Developing or Marketing Adenovirus NAT And Other Direct Identification Tests

Major Companies Developing or Marketing Campylobacter NAT And Other Direct Identification Tests

Major Companies Developing or Marketing Chlamydia NAT And Other Direct Identification Tests

Major Companies Developing or Marketing CMV NAT And Other Direct Identification Tests

Major Companies Developing or Marketing EBV NAT And Other Direct Identification Tests

Major Companies Developing or Marketing Gonorrhe NAT And Other Direct Identification Tests

Major Companies Developing or Marketing Hepatitis NAT And Other Direct Identification Tests

Major Companies Developing or Marketing Herpes NAT And Other Direct Identification Tests

Major Companies Developing or Marketing Legionella NAT And Other Direct Identification Tests

Major Companies Developing or Marketing Lyme Disease NAT And Other Direct Identification Tests

Major Companies Developing or Marketing Mycoplasma NAT And Other Direct Identification Tests

Major Companies Developing or Marketing Papilloma Virus NAT And Other Direct Identification Tests

Major Companies Developing or Marketing Pneumonia NAT And Other Direct Identification Tests

Major Companies Developing or Marketing Salmonella NAT And Other Direct Identification Tests

Major Companies Developing or Marketing Shigella NAT And Other Direct Identification Tests

Major Companies Developing or Marketing Streptococci NAT And Other Direct Identification Tests

Major Companies Developing or Marketing Toxoplasmosis NAT And Other Direct Identification Tests

Major Companies Developing or Marketing Tuberculosis NAT And Other Direct Identification Tests

Major Companies Developing or Marketing Cancer NAT Tests

Major Companies Developing or Marketing NAT Assays For Genetic Diseases

Worldwide, Laboratories Performing DNA Sequencing By Country

Worldwide, NAT Market, Potential Laboratory Universe by Country

Worldwide, NAT Volume Forecast by Country

Worldwide, NAT Market Forecast by Country

Summary Table France, NAT Volume And Sales Forecast by Major Application

France, Laboratories Performing DNA Sequencing By Market Segment

France, NAT Market Potential Laboratory Universe by Market Segment

France, NAT Volume Forecast By Major Application

France, Major Infectious Disease NAT Volume Forecast

France, Infectious Disease Screening NAT Volume Forecast

France, NAT Market Forecast By Major Application

France, Infectious Disease Screening NAT Reagent Market Forecast by Test

France, NAT Market By Major Supplier

France, HIV/Hepatitis NAT Market By Major Supplier

Summary Table Germany, NAT Volume And Sales Forecast by Major Application

Germany, Laboratories Performing DNA Sequencing by Market Segment

Germany, NAT Market Potential Laboratory Universe By Market Segment

Germany, NAT Volume Forecast By Major Application

Germany, Major Infectious Disease NAT Volume Forecast

Germany, Infectious Disease Screening NAT Volume Forecast

Germany, NAT Market Forecast By Major Application

Germany, Infectious Disease Screening NAT Reagent Market Forecast by Test

Germany, NAT Market by Major Supplier

Germany, HIV/Hepatitis NAT Market by Major Supplier

Summary Table Italy, NAT Volume And Sales Forecast by Major Application

Italy, Laboratories Performing DNA Sequencing by Market Segment

Italy, NAT Market Potential Laboratory Universe by Market Segment

Italy, NAT Volume Forecast By Major Application

Italy, Major Infectious Disease NAT Volume Forecast

Italy, Infectious Disease Screening NAT Volume Forecast

Italy, NAT Market Forecast By Major Application

Italy, Infectious Disease Screening NAT Reagent Market Forecast by Test

Italy, NAT Market By Major Supplier

Italy, HIV/Hepatitis NAT Market By Major Supplier

Summary Table Japan, NAT Volume And Sales Forecast by Major Application

Japan, Laboratories Performing DNA Sequencing by Market Segment

Japan, NAT Market Potential Laboratory Universe by Market Segment

Japan, NAT Volume Forecast By Major Application

Japan, Major Infectious Disease NAT Volume Forecast

Japan, Infectious Disease Screening NAT Volume Forecast

Japan, NAT Market Forecast By Major Application

Japan, Infectious Disease Screening NAT Market Forecast by Test

Japan, NAT Market By Major Supplier

Japan, HIV/Hepatitis NAT Market by Major Supplier

Summary Table Spain, NAT Volume And Sales Forecast by Major Application

Spain, Laboratories Performing DNA Sequencing by Market Segment

Spain, NAT Market, Potential Laboratory Universe by Market Segment

Spain, NAT Volume Forecast by Major Application

Spain, Major Infectious Disease NAT Volume Forecast

Spain, Infectious Disease Screening NAT Volume Forecast

Spain, NAT Market Forecast By Major Application

Spain, Infectious Disease Screening NAT Reagent Market Forecast by Test

Spain, NAT Market By Major Supplier

Spain, HIV/Hepatitis NAT Market by Major Supplier

Summary Table U.K., NAT Volume And Sales Forecast by Major Application

U.K., Laboratories Performing DNA Sequencing by Market Segment

U.K., NAT Market Potential Laboratory Universe by Market Segment

U.K., NAT Volume Forecast By Major Application

U.K., Major Infectious Disease NAT Volume Forecast

U.K., Infectious Disease Screening NAT Volume Forecast

U.K., NAT Market Forecast By Major Application

U.K., Infectious Disease Screening NAT Reagent Market Forecast by Test

U.K., NAT Market by Major Supplier

Summary Table U.S.A., NAT Volume And Sales Forecast by Major Application

U.S.A., Laboratories Performing DNA Sequencing by Market Segment

U.S.A., NAT Market, Potential Laboratory Universe by Market Segment

U.S.A., NAT Volume Forecast By Major Application

U.S.A., Major Infectious Disease NAT Volume Forecast

U.S.A., Infectious Disease Screening NAT Volume by Test Forecast

U.S.A., NAT Market Forecast By Major Application

U.S.A., Infectious Disease Screening NAT Reagent Market Forecast by Test

U.S.A., NAT Market by Major Supplier

U.S.A., HIV/Hepatitis C NAT Market By Major Supplier

U.S.A., West Nile Virus NAT Market By Major Supplier

Abstract

This comprehensive seven-country report is designed to help current suppliers and potential market entrants identify and evaluate major business opportunities emerging in the NAT market during this decade.

Highlights

  • Business and technological trends in seven major markets
  • Five- and ten-year test volume and sales forecasts
  • Market shares of leading competitors
  • Feature comparison of major analyzers
  • Profiles of market players and start-up firms developing innovative technologies and products
  • Specific product and business opportunities for instrument and consumable suppliers.
Rationale

The NAT market is unquestionably the most rapidly growing segment of the in vitro diagnostics industry. The next ten years will witness significant developments in reagent systems and automation, as well as introduction of a wide range of new products that will require innovative marketing approaches. The rate of market penetration into routine clinical laboratories, however, will depend on the introduction of cost-effective and automated systems with amplification methods.

In order to successfully capitalize on the opportunities presented by the NAT market, many companies are already exploiting new molecular technologies as corporate strategic assets, managed in support of business and marketing strategies. Integrating new technology planning with business and corporate strategies will be one of the most challenging tasks for diagnostic companies during the next ten years.

Geographic Coverage

  • France
  • Germany
  • Italy
  • Japan
  • Spain
  • UK
  • USA
Worldwide Market Overview
  • Laboratories performing DNA sequencing and NAT by country and market segment.
  • Ten-year test volume and sales projections by country.
Market Segmentation Analysis
  • Sales and market shares of major suppliers of NAT reagent kits and components.
  • Ten-year test volume and sales forecasts for major applications, including:
    • Infectious Diseases
    • Forensic Testing
    • Cancer
    • Paternity Testing/HLA Typing
    • Genetic Diseases
    • Others
  • Ten-year test volume and sales projections for over 30 NAT assays.
  • A comprehensive analysis of the sequencing market, by country and laboratory segment, including:
    • Industrial
    • Academic
    • Government
    • Commercial
  • Detailed market segmentation analysis, including review of the market dynamics, trends, structure, size, growth and major suppliers, by country.
Product/Technology Review
  • Comparison of leading NAT analyzers from Abbott, Beckman Coulter, BD, Bio-Rad, Gen-Probe, Roche, Tecan and other suppliers.
  • Extensive review of NAT technologies, test formats, detection methodologies, trends in testing automation and over 30 target/signal amplification methods, including:
    • PCR
    • bDNA
    • SDA
    • NASBA
    • TMA
    • SSSR, and others
    • LCR
  • Worldwide listings of companies, universities and research centers developing new NAT technologies and products.
Competitive Assessments
  • Extensive strategic assessments of major suppliers and emerging market entrants, including their sales, product portfolios, marketing tactics, collaborative arrangements and new technologies/products in R&D.
  • Comprehensive listings of companies developing and marketing NAT products, by test and application.
Opportunities and Strategic Recommendations
  • Specific new product development opportunities with potentially significant market appeal during the next ten years.
  • Design criteria for new products.
  • Alternative market penetration strategies.
  • Potential market entry barriers and risks.
  • Business planning issues and concerns.
Methodology

This report is based on a combination of primary and secondary information sources, including interviews with laboratory directors and executives of leading diagnostic companies and start-up firms developing innovative technologies and products in the U.S., five major European countries and Japan.

In addition to primary sources of information, a comprehensive review of the most recent technical and business publications, manufacturer product and financial literature, as well as Venture Planning Group’s proprietary data base was conducted.

Please note: The delivery time for the electronic version of this report is between 1-3 business days to allow the preparation of an updated version prior to dispatch.

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