The 2012 US Molecular Diagnostics Market

NEW YORK, April 18, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

The 2012 US Molecular Diagnostics Market

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This report presents a comprehensive analysis of the US molecular diagnostics market, including:

• Major issues pertaining to the US molecular diagnostics laboratory practice, as well as key economic, regulatory, demographic, social and technological trends with significant market impact during the next ten years.
• An extensive review of DNA probe and biochip technologies, test formats, detection methodologies, trends in testing automation and amplification methods.
• Ten-year test volume and reagent sales forecasts for the following categories:

   -  Infectious Diseases

   -  Genetic Diseases

   - Cancer

   -  Paternity Testing/HLA Typing

   -  Forensic Testing

• Review of testing methodologies an instrumentation technologies.
• Feature comparison of automated and semiautomated analyzers.
• Sales and market shares of leading suppliers.
• Over 60 specific opportunities for molecular diagnostic instruments, test systems, IT and auxiliary products.
• Profiles of major suppliers, and emerging market entrants, including their sales, product portfolios, marketing tactics, technological know-how, new products in R&D, collaborative arrangements and business strategies.
• Alternative market penetration strategies.
• Potential market entry barriers and risks.
• Business planning issues and concerns.

Contains 880 pages and 37 tables

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

- Solid Phase Amplification

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. Beckman Coulter/Biomek FK

3. Becton Dickinson SDA

4. Bio-Rad GeneScope

5. Gen-Probe Tigris

6. Roche Cobas Amplicor

7. 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

- Virus Isolation

- Serology

- Viral Nucleic Acid/Antigen Detection Epidemiology

- Worldwide Spread of AIDS

- United States

- Routes of Transmission 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 BCL-2 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. Periodontal Disease

f. Plasma Purification

g. Organ Transplantation

h. Water Contamination

i. Other

H. Competing/complementing Technologies

1. Monoclonal Antibodies/Immunoassays

2. RNA Probes

3. Two-Dimensional Electrophoresis

4. Flow Cytometry

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. PPO

b. HMO

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

- Affymetrix

- Agilent

- Applied Gene Technologies

- Arca

- Beckman Coulter/Danaher

- Becton Dickinson

- Biokit

- BioMerieux

- Bio-Rad

- Biotest

- Caliper

- Cepheid

- Decode

- Diadexus

- Eiken

- Enzo

- Exact Sciences

- Fujirebio

- Gen-Probe

- Hologic

- Illumina

- Innogenetics/Solvay

- Kreatech

- Li-Cor Biosciences

- Life Technologies

- Monogram Biosciences

- Myriad Genetics

- Nanogen/Elitech

- Novartis

- Orchid CellMark

- Ortho-Clinical Diagnostics

- Proteome Sciences

- Qiagen

- Roche

- Scienion

- Sequenom

- Shimadzu

- Siemens

- Sierra Molecular

- Takara Bio

- Tecan Group

Appendixes

Appendix I: Major Universities and Research Centers

Developing Molecular Diagnostic

Technology

Appendix II: Glossary of Terms

Appendix III: Currency Exchange Rates

List of Tables

Major Companies Developing or Marketing AIDS Molecular

Diagnostic And Other Direct Identification Tests

Major Companies Developing or Marketing Adenovirus

Molecular Diagnostic And Other Direct

Identification Tests

Major Companies Developing or Marketing Campylobacter

Molecular Diagnostic And Other Direct

Identification Tests

Major Companies Developing or Marketing Chlamydia

Molecular Diagnostic And Other Direct

Identification Tests

Major Companies Developing or Marketing CMV Molecular

Diagnostic And Other Direct Identification Tests

Major Companies Developing or Marketing EBV Molecular

Diagnostic And Other Direct Identification Tests

Major Companies Developing or Marketing Gonorrhea

Molecular Diagnostic And Other Direct

Identification Tests

Major Companies Developing or Marketing Hepatitis

Molecular Diagnostic And Other Direct

Identification Tests

Major Companies Developing or Marketing Herpes

Molecular Diagnostic And Other Direct

Identification Tests

Major Companies Developing or Marketing Legionella

Molecular Diagnostic And Other Direct

Identification Tests

Major Companies Developing or Marketing Lyme

Disease Molecular Diagnostic And Other Direct

Identification Tests

Major Companies Developing or Marketing Mycoplasma

Molecular Diagnostic And Other Direct

Identification Tests

Major Companies Developing or Marketing Papilloma

Virus Molecular Diagnostic And Other Direct

Identification Tests

Major Companies Developing or Marketing Pneumonia

Molecular Diagnostic And Other Direct

Identification Tests

Major Companies Developing or Marketing Salmonella

Molecular Diagnostic And Other Direct

Identification Tests

Major Companies Developing or Marketing Shigella

Molecular Diagnostic And Other Direct

Identification Tests

Major Companies Developing or Marketing Streptococci

Molecular Diagnostic And Other Direct

Identification Tests

Major Companies Developing or Marketing Toxoplasmosis

Molecular Diagnostic And Other Direct

Identification Tests

Major Companies Developing or Marketing Tuberculosis

Molecular Diagnostic And Other Direct

Identification Testsncogenes Potential Application in Cancer Diagnosis

Major Companies Developing or Marketing Cancer

Molecular Diagnostic Tests

Major Companies Developing or Marketing Molecular

Diagnostic Test For Genetic Diseases

Summary Table U.S.A., Molecular Diagnostics Test Volume

And Sales Forecast by Major Application

U.S.A., Laboratories Performing

DNA Sequencing by Market Segment

U.S.A., Molecular Diagnostics Market, Potential

Laboratory Universe by Market Segment

U.S.A., Molecular Diagnostics Test Volume Forecast

By Major Application

U.S.A., Major Infectious Disease Molecular

Diagnostics Test Volume Forecast

U.S.A., Infectious Disease Screening

NAT Volume by Test Forecast

U.S.A., Molecular Diagnostics Market Forecast

By Major Application

U.S.A., Infectious Disease Screening Nat Reagent

Market Forecast by Test

U.S.A., Molecular Diagnostics Market by Major Supplier

U.S.A., HIV/Hepatitis C NAT Market Reagent Sales

By Major Supplier

U.S.A., West Nile Virus NAT Market Reagent Sales

By Major Supplier

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