- Language: English
- 1123 Pages
- Published: September 2014
- Region: Global
Molecular Diagnostics Market by Application, Technology, End User, Product - Global Forecasts to 2018
- Published: October 2012
- Region: Global
- 392 Pages
- Markets and Markets
Molecular diagnostics (MDx) is a new class of diagnostic tests that identify nucleic acids or proteins to test the status of a disease. These nucleic acids or proteins, which belong to individual patients or foreign organisms, help determine a specific therapy, or risk of developing a specific disease, or other health conditions. MDx is the fastest growing segment within the in-vitro diagnostic (IVD) space, driven by accuracy, high sensitivity, fast turnaround time, easy workflow, and cost-effective testing. Owing to these factors, the molecular diagnostics market crossed $4.8 billion in 2011, and is poised to grow at a CAGR of 9.1% in the next five years.
MDx involves instruments and reagents that leverage multiple technologies to identify genetic variations. The technologies utilized in molecular diagnostics include polymerase chain reaction (PCR), transcription mediated amplification (TMA), hybridization (In-situ Hybridization & fluorescence in situ hybridization (FISH)), DNA Sequencing, next generation sequencing (NGS), microarrays, and others.
Molecular diagnostics (MDx) has emerged as one of the largest and fastest growing segments in the In vitro Diagnostic (IVD) industry. In the span of few years, molecular diagnostics has prospered from a non-existent market to a significant market. PCR tests such as the one from Roche for CT/NG and other tests such as HIV qualitative and HIV quantitative (viral load) are the key factors driving the expansion of the molecular diagnostics market. The private reference laboratories developed tests for infectious diseases and cancer mutations due to the rising incidences and the non-availability of FDA approved assays.
The market began to expand due to the existence of different diagnostic kits for genetic diseases and the blood screening for various infectious diseases. The demand for molecular testing increased and the FDA approved molecular diagnostic tests for determining genetic variation responses against cancer drugs. As a result, molecular diagnostic testing is growing at a rapid rate due to the rising adoption of rapid and quick diagnosis.
The reagents product segment accounted for the largest share of the total molecular diagnostics market in 2013 and will continue to grow in the next five years to retain its leading position. The high growth in this segment is attributed to the growing demand for molecular assays. Moreover, the rising incidences of infectious diseases such as HBV, HIV, CT/NG, and MRSA have also contributed to the largest share of the reagents market. The hospitals end user segment accounted for the second largest share in 2013. This segment can monitor various physiological parameters of a patient in order to have an overview of the patients' health and status. Due to the tremendous increase in the number of infectious diseases, hospitals are increasing their investments in molecular diagnostic testing.
The PCR technology segment, on the other hand, will be the fastest growing segment in the coming years due to the evolution in technology that helps in diagnosis of various diseases. With the growing incidences and increasing awareness of various diseases this market is set to grow at a faster pace. Under this segment, the INAAT segment is also expected to grow at a higher pace in the forecast period. The microarray technology is also expected to be among the fastest growing in all other segments of the molecular diagnostics market.
In 2013, North America accounted for the largest share and will retain its leading position by 2018. This growth is attributed to the increasing prevalence of lifestyle diseases and spread of various contagious diseases. Asia is the most lucrative region for molecular diagnostics in the next five years, and is poised to grow at a CAGR of 12.2% in the forecast period. The high population base and the improved purchasing power of patients will drive this market. Moreover, the economic crisis in western countries has propelled the companies to focus on the Asian region, thus leading to the economic growth and rise in the investments in this region, which is further driving the market in a positive direction.
The competitive landscape covers the growth strategies adopted by the industry players in the last three years. The company profiles comprises of the basic views on the key players in the molecular diagnostics market and their product portfolios, developments, and strategies adopted to maintain and increase their market share in the near future.
The above mentioned market research data, current market size, and forecast of the future trends will help the key players and new entrants to make necessary decisions regarding product offerings, geographic focus, change in strategic approach, R&D investments for innovations in products and technologies, and levels of output in order to remain successful.
Factors like increased awareness and acceptance of personalized medicine, advancements in molecular techniques, and increasing investments in genomics & proteomics research will spur the molecular diagnostics market in the future. Yet, reimbursement issues for non-coded tests and complex regulatory framework will restrict the growth of this market.
Molecular diagnostic tools have a vast base of end-users, which includes hospital-based laboratories, reference laboratories, and others (physicians' labs, research laboratories, other healthcare clinics, and government agencies). Hospitals offer the major chunk of business for MDx companies; however, reference laboratories are growing at a high CAGR and are driving the market, as they perform complex tests and offer expertise to small hospitals setups, clinical researchers, and insurance companies.
Although the market for molecular diagnostics is fragmented with more than 500 companies, the most prominent players are Roche Diagnostics (Switzerland), Novartis (Switzerland), Gen-Probe (U.S.), Qiagen (The Netherlands), Abbott Diagnostics (U.S.), Becton Dickinson (U.S.) and Cepheid (U.S.), to name a few.
Scope of the Report
This research report categorizes the global molecular diagnostics market into application, technology, and product type. All these markets are broken down into segments and sub-segments, providing exhaustive value analysis for 2010, 2011 and 2012, as well as forecast up to 2017. Each of the devices market is comprehensively analyzed at a granular level by geography (North America, Europe, Asia-Pacific, and Rest of the World) to provide in-depth information on the global scenario.
Global Molecular Diagnostics Market, By Application
- Infectious Diseases
- Blood Screening
Global Molecular Diagnostics Market, By Technology
- Polymerase chain reaction (PCR)
- Transcription-mediated amplification (TMA)
- Hybridization (In-situ hybridization & Fluorescent in situ hybridization (FISH))
- DNA Sequencing & Next-generation Sequencing
Global Molecular Diagnostics Market, By Product Type
- Services & Software
Global Molecular Diagnostics Market, By End-users
- Reference Laboratory
- Hospital Laboratory
Molecular Diagnostics Market, By Geography
- North America
- RoE (Rest of Europe)
- RoA (Rest of Asia)
- RoW (Rest of the World)
- Latin America
- Middle East & Africa
Each section of the report also provides market trends with respect to drivers, restraints, and opportunities. The report includes 21 company profiles and its competitive landscape section sketches the strategic developments in the market. SHOW LESS READ MORE >
1.1 Objectives of the Study
1.2 Report Description
1.3 Markets Covered
1.5 Market Scope
1.6 Research Methodology
1.6.1 Market Size Estimation & Data Triangulation
1.6.2 Key Data From Secondary Sources
1.6.3 Key Data Points From Primary Sources
2 Executive Summary
3 Premium Insight
4 Market Overview
4.2 Market Segmentation
4.3 Market Dynamics
220.127.116.11 Increasing Awareness and Acceptance of Personalized Medicine and Companion Diagnostics
18.104.22.168 Development of Biomarker Identification and Advancements in Molecular Techniques
22.214.171.124 Proteomics and Genomics Technology Research to Goad the Molecular Testing Market
126.96.36.199 Increase in AGing Population to Spur Growth of the Molecular Diagnostics Market
188.8.131.52 Reformations in the Reimbursement System
184.108.40.206 Increased Costs of Molecular Diagnostics tools With New and Complex Platforms Demand Skilled Labor and Mandatory Training
220.127.116.11 Reimbursement Issues
18.104.22.168 Complex Regulatory Framework to Delay Approvals of New Molecular Diagnostic Tests
22.214.171.124 Extending the Reach of Molecular Diagnostics
126.96.36.199 Emerging Technologies Can Soon Gain Importance in Molecular Diagnostic Tests
188.8.131.52 Lack of Budget and Labor
184.108.40.206 Stringent Regulatory Framework to Stifle the Growth of Mdx Market
4.4 Market Share Analysis
4.5 Molecular Diagnostic Laboratories and Tests
4.6 End-User Analysis
4.7 Effects of Obamacare on the Molecular Diagnostics Market
5 Global Molecular Diagnostics Market, By Application
5.2 Infectious Diseases
5.2.1 Hepatitis B Virus (HBV)
5.2.2 Hepatitis C Virus (HCV)
5.2.3 Human Immunodeficiency Virus (HIV)
5.2.4 Tuberculosis (TB)
5.2.5 Chlamydia Trachomatis and Neisseria Gonorrhea (CT/NG)
5.2.6 Human Papillomavirus (HPV)
5.2.7 Methicillin-Resistant Staphylococcus Aureus (MRSA)
5.3.1 Prostate Cancer
5.3.2 Breast Cancer
5.3.3 Colorectal Cancer
5.5 Blood Screening
6 Global Molecular Diagnostics Market, By Technology
6.2 Polymerase Chain Reaction (PCR)
6.3 Isothermal Nucleic Acid Amplification Technology (INAAT)
6.5 Hybridization (in Situ Hybridization and Fluorescence in Situ Hybridization)
6.6 Dna Sequencing & Next-Generation Sequencing
7 Global Molecular Diagnostics Market, By Product Type
7.4 Services & Software
8 Geographic Analysis
8.2 North America
8.3.6 Rest of Europe
8.4.4 Rest of Asia (ROA)
8.5 Rest of the World (ROW)
8.5.1 Latin America
8.5.3 Middle East & Africa
9 Competitive Landscape
9.2 New Product Launch
9.3 Mergers & Acquisitions
9.6 Other Developments
10 Company Profiles (Overview, Financials, Products & Services, Strategy, & Developments)*
10.1 Abbott Diagnostics, Inc.
10.2 Beckman Coulter, Inc.
10.3 Becton, Dickinson & Co.
10.4 Biomérieux Business Overview
10.5 Cepheid, Inc.
10.6 Gen-Probe, Inc. (Hologic, Inc.)
10.7 Novartis AG
10.9 Roche Diagnostics
10.1 Siemens Healthcare
*Details on Financials, Product & Services, Strategy, & Developments Might Not Be Captured in Case of Unlisted Companies.
- Abbott Diagnostics
- Beckman Coulter, Inc.
- Becton, Dickinson & Company
- Eurogentec Sa
- Genmark Diagnostics
- Genomic Health, Inc.
- Gen-Probe, Inc. (Hologic, Inc.)
- Innogenetics Nv
- Life Technologies Corporation
- Luminex Corporation
- Myriad Genetics, Inc.
- Novartis Ag
- Roche Diagnostics
- Siemens Healthcare