Molecular Diagnostics Market Analysis By Product (Instruments, Reagents), By Test Location (Point of Care, Self Test, Central Laboratories), By Application (Oncology, Breast Cancer, Prostate Cancer , Colorectal Cancer Pharmacogenomics, Infectious Disease, MRSA, Clostridium Difficile, Vancomycin-resistant Enterococci, Carbapenem-resistant Bacteria Testing, Flu, Respiratory Syncytial Virus (RSV), Candida, Tuberculosis and drug-resistant TB), By Technology And Segment Forecasts To 2022

Published: November 2015 | Report Code: 978-1-68038-086-6 | Report Format: PDF

Industry Insights

Global molecular diagnostics market size was valued at over USD 4.8 billion in 2014 and is expected to witness lucrative growth over the forecast period. Molecular diagnostics helps in the early detection of cancer, genetic disorders, and other infectious diseases.New technology has enabled instruments to offer fast and accurate test results. This ability of the diagnostic tool has resulted in a rapid rise in penetration levels especially, in the point of care facilities. Molecular diagnostics has also given rise to the concept of personalized medicine.

Growing prevalence of infectious diseases and hospital acquired infections are expected to drive market growth during the forecast period.Increasing demand for point of care facilities boosts the molecular diagnostics industry growth majorly due to rising demand for quick and remote healthcare delivery.

The introduction of favorable regulatory initiatives aimed at promoting a point of care diagnosis over other forms is expected to serve the market as a high impact rendering driver. For instance, the introduction of Clinical Laboratory Improvement Amendments (CLIA) in the U.S. is expected to boost usage rates during the forecast period.

Moreover,growing geriatric population base leads to increase in demand for molecular diagnostic tools. According to the estimates published by the WHO, the global population base within the age group of 65 years and above is estimated to rise up to 16% by 2050.Growing geriatric population base in Asian countries such as China has large untapped opportunities in terms of healthcare, which is expected to drive market growth during the forecast period.

Other factors such as the rising healthcare expenditure and increasing healthcare awareness boost the concept of self-care management. Early diagnosis for lifestyle diseases such as diabetes and cardiovascular diseases helps the patients with better treatment and cure for the diseases.

The growing demand for home healthcare as a result of government initiatives such as Center for Medicare and Medicaid Services (CMS) and rising patient awareness targeted at minimizing hospital stays and associated expenditure further boost the molecular diagnostics market growth. 

U.S. molecular diagnostics market, by product, 2012-2022, (USD Million)

U.S. molecular diagnostics market

Product Insights

Reagents, instruments, and other diagnostics including services and software programs used for running the instrumentation process, are the major product segments analyzed in this study. The market was dominated by reagents accounting for a market share of over 50.0% in 2014.

Some key growth factors of this segment include diagnosis and validation of different diseases and high usage of reagents such as formamide, salts, dextran sulfate heparin, and SDS for prevention of DNA breaking, removal of proteins and InSitu Hybridization (ISH).

Reagents are also likely to grow at a lucrative CAGR of around 10.0% during the forecast period. The increasing use of molecular diagnostic technologies in research and development coupled with rising demand for point of care and OTC and self-test products are expected to drive segment growth.

Test Location Insights

Test location plays an imperative role justifying market trends in the molecular diagnostics market. The market trends are based on the need for cost effective, rapid and patient-friendly diagnostic tools. This has resulted in the categorization of the market on the basis of test locations into the point of care (PoC), self-test and OTC and central laboratories.

Central laboratories was the largest market in 2014, with revenues valued at over USD 3,000 million. Key factors responsible for its large footprint in the industry include high procedure volumes and extensive presence of ancillary support in terms of man power and infrastructure.

The point of care (PoC) diagnosis segment is estimated to witness the fastest growth of over 10.5% owing to, the increasing demand for faster healthcare delivery, bed side testing, and increasing patient awareness levels. The introduction of new products for PoC diagnosis such as nucleic acid point of care device for amplification, detection, and extraction is expected to boost usage rates over the forecast period.

Application Insights

Key application areas of molecular diagnostics include oncology, pharmacogenomics, infectious diseases, genetic testing, neurological disease, cardiovascular disease, food safety, and microbiology. Application areas are prioritized on the basis of disease burden, growth in prevalence and the need for early diagnosis etc.

Infectious diseases dominated the applications market with a revenue share of over 50.0% in 2014. The presence of large test volumes and an extensive portfolio of commercialized products such as multiplex PCR in the detection of myriad of infectious viruses, bacteria, and pathogens are expected to drive growth over the forecast period. Moreover, growing number of initiatives aimed at curbing healthcare expenditure related to hospital acquired infections or HAIs are likely to boost usage rates.

Oncology is identified as the fastest growing application. The market for molecular diagnostics for oncology is estimated to grow at a CAGR of around 12% over the forecast period due to the rising prevalence of cancer, increasing demand for early diagnosis, and the introduction of specific biomarkers for treatment.

Technology Insights

The introduction of technologically advanced products on the grounds of accuracy, portability, and cost-effectiveness is expected to serve this market as a high impact rendering driver. For instance, DNA sequencing is one the fastest growing application segments of the molecular diagnostics market. It finds extensive applications in the field of R&D pertaining to this field.

Technology segment of the market includes PCR, in-situ hybridization, TMA, sequencing, chips & microarrays, mass spectrometry, and other technologies including southern blotting, northern blotting, and electrophoresis.

The market for Polymerase Chain Reaction (PCR) accounted for over 45.0% of the total revenue in 2014. This technology is preferred by healthcare professionals and researchers owing to its ability to detect molecular changes. The increasing use of multiplex PCR technologies and real-time PCR equipment is likely to further boost market growth. PCR tests offered by companies such as Roche for CT/NG (Chlamydia trachomatis/Neisseria gonorrhoeae) and HIV qualitative and quantitative tests will also contribute towards strengthened segment growth.

Sequencing is anticipated to witness significant growth during the forecast period. The market for sequencing based molecular diagnosis is likely to grow at a CAGR of around 15.0% from 2015 to 2022.DNA sequencing technologies are integrally linked with drug discovery, novel drug development, and personalized medicine.

The rapid adoption of various diagnostic kits for genetic diseases and blood screening for infectious diseases along with the use of molecular diagnostics for food safety; offering rapid detection of the food borne pathogens are further fostering industry growth.

Regional Insights

In 2014, North America was identified as the largest regional molecular diagnostics market accounting for over 44.0% of the overall revenue. Increasing R&D investments by large pharmaceutical and biotechnology companies, demand for early diagnosis, presence of sophisticated healthcare infrastructure and high penetration of technological advancements in the field are some factors attributing to the region's market position.

Developing countries of Asia-Pacific region is expected to show high potential for the growth of this industry with CAGR of around 12.0% owing to factors such as increasing healthcare awareness, favorable regulatory landscape, and increasing the prevalence of target diseases such as diabetes, cardiovascular diseases, and infectious diseases.

The Asia Pacific molecular region is expected to serve as the support system for the market players. High growth as a consequence of improving usage rates supported by improving healthcare infrastructure and the presence of high unmet needs in the emerging markets of India, China, and South East Asia are expected to ensure future sustainability.

Rising instances of external funding to conduct clinical studies pertaining to the field of molecular diagnosis are also expected to drive the market. The manufacturers for molecular diagnostic devices have increased their focus on developing countries like China and India to tap the unmet needs of the patients. For instance, companies such as KindstarGlobalgene Technology, Inc. and Insight Genetics are focusing on cancer care enhancement in the People’s Republic of China.

CompetitiveMarket Share Insights

Key players in this market include Abbott laboratories, Alere Inc., Bayer Healthcare, Becton Dickinson, Bio-Rad Laboratories, bioMerieux, Cephid, Dako, Hologic (Gen-probe), Danaher Corporation, Novartis, Johnson and Johnson, Qiagen N.V, Siemens Healthcare,Roche Diagnostics, and Sysmex Corporation.

New product development, mergers, and acquisitions along with venture capital investments owing to challenging economic conditions of the developed and developing nations are some major strategies adopted by these players. 

Key question answered by the report
  • What was the market size from 2013 to 2015?
  • What will be the market growth till 2024 and what will be the resultant market forecast in the year?
  • How will the market drivers, retraints and future opportunieties affect the market dynamics and a subsequent analysis of the associated trends?
  • What segment and region will drive or lead market growth and why?
  • A comprehensive mapping of the competitive landscape and the market participants behavior.
  • What are the key sustainability strategies adopted by market players? An in-depth analysis of these strategies and their impact on competition and growth.
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