Molecular diagnosis enables early detection of cancer, infectious diseases and genetic disorders by using genetic technologies and has applications in detection of abnormalities in the pre-natal stage. Molecular diagnosis is undergoing a transformation to understand and detect various diseases that could possibly turn into severe social and economic burden later. Key molecular diagnostic techniques include DNA sequencing, amplification techniques such as Polymerase Chain Reaction (PCR) and Ligase Chain Reaction (LCR) and hybridization techniques, spectral karyotype imaging and DNA microarrays. PCRs can be used to detect malignant diseases such as leukemia and lymphoma, and viral infections, whereas spectral karyotype imaging technology helps in detection of chromosomal abnormalities in the pre-natal stage. The introduction of CLIA waived tests pertaining to point of care molecular diagnostics and advanced cancer diagnostic technologies such as companion diagnostics are two of the primary growth drivers of this market. Moreover, growing prevalence of cancer and lifestyle habits such as smoking, tobacco consumption and excessive alcohol consumption coupled with growing geriatric population base and the growing demand for genetic testing are expected to positively impact the growth of this market. The global molecular diagnostics market was valued at USD 4,476.6 million in 2013 and is expected to grow at a CAGR of 8.7% from 2014 to 2020.
Key product segments analyzed and reported in this study include instruments, reagents and others. The global reagents for molecular diagnostics product segment dominated the overall market in terms of revenue share in 2013 at 54.6% and its market was valued at USD 2,445.6 million in 2013. High usage rates of reagents used in molecular diagnostic tests and the growing use of these tests in non medical facilities such as home and the increasing demand for over the counter tests are some of the drivers of this market. In addition, this product segment is expected to grow at the fastest rate of 9.9% over the next six years majorly on account of the rising demand for genetic testing and advanced cancer diagnostic tests in countries with high unmet medical needs such as India, China and Brazil. The global instruments for molecular diagnostics market followed the reagents segment in terms of revenue share in 2013 at 38.4% owing to the relatively high price of these products and the growing market penetration of instrument manufacturers in the Asia Pacific and Latin American regions with constantly developing healthcare infrastructure.
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Key technology segments analyzed and reported in this study include PCR, in situ hybridization, chips and microarrays, mass spectrometry, sequencing and others. The PCR based molecular diagnostics market dominated the market in terms of revenue share and its market was valued at USD 2,144.3 million in 2013. This technology involves the amplification of target DNA sequences and therefore, finds extensive application in the field of genetic testing. Researchers and medical practitioners utilize PCR technology to amplify the DNA sequence responsible for triggering cancer in a patient and develop subsequent treatment procedures for it. Growing prevalence of cancer and consequent rise witnessed in cancer research public and private funding is one of the most significant growth drivers of this technology segment.
Key application segments analyzed and reported in this study include oncology, pharmacogenomics, infectious disease testing, genetic testing, neurological diseases, cardiovascular diseases and others. The oncology application segment dominated the overall market in terms of revenue share in 2013 at approximately 34%. The presence of high prevalence of cancer and the development of advanced cancer diagnostic tests such as companion diagnostics are some of the factors attributing to its high market share. Companion diagnostics is based on the concepts of personalized medicine and involves the identification of biomarker response in a particular population of patients. Moreover, the introduction of such advanced diagnostic technologies will prove as a cost effective option and will further propel the growth of the oncology application market. The pharmacogenomics application segment followed the oncology segment in terms of revenue share in 2013 at 26.3%. Pharmacogenomics refer to the study of genetic mapping based patient’s response to a particular therapy or drug. The growing demand for personalized medicine as a cost effective and efficient diagnostic and therapeutic tool is one of the major growth drivers of this market.
Key test location segments analyzed and reported in this study include point of care, self testing or OTC and hospitals and clinics. The hospitals and clinics market dominated the overall market in terms of revenue share and its market was valued at USD 3,222.7 million in 2013. The presence of high volume of molecular diagnostic tests in this segment is one of the primary growth drivers of this market. However, the point of care market is expected to grow at the fastest rate of 13.3% from 2014 to 2020 on account of the growing initiatives aimed at reducing hospital stays to curb healthcare spending and demand for rapid diagnosis near patient site.
North America dominated the market in 2013 and was valued at USD 1,997.9 million. The presence of sophisticated healthcare infrastructure, government support pertaining to research and development exercises and the presence of high patient and practitioner awareness levels are some of the drivers of this market. Europe followed North America in terms of revenue share in 2013 at 32.8% owing to the presence of high prevalence rates of target diseases coupled with high healthcare expenditures in Western European countries. The Asia Pacific molecular diagnostics market is expected to exhibit the highest growth rate of 12.7% from 2014 to 2020 due to the presence of high unmet medical needs coupled with rapidly rising patient awareness levels and healthcare expenditures in countries such as India and China.
The global molecular diagnostics market is highly competitive and fragmented in nature, led by Roche Diagnostics with a market share of 32% in 2012. In order to consolidate their position and gain market share, the market is set to witness a flurry of mergers acquisitions, participants such as Hologic have entered into strategic acquisitions and mergers in an attempt to gain share via market expansion. E.g. Hologic acquired Gen-Probe in August, 2012. Some of the other players of this market include Novartis, bioMerieux, Siemens Healthcare, Abbott Laboratories, Becton Dickinson and Company, Qiagen, Hologic, Cepheid and others.