Global molecular diagnostics market size was valued at USD 4.47 billion in 2013. Key growth drivers of the molecular diagnostics industry include rising geriatric population base, unmet needs pertaining to chronic conditions, and demand for faster and accurate tool pertinent to infectious diseases.
Increasing prevalence of Hospital-Acquired Infections (HAI), rising demand for point-of-care facilities, and introduction of technologically advanced products are impact-rendering drivers for this market over the forecast period. According to the estimates of the WHO, the average prevalence rate of hospital-acquired infections in Europe and the U.S. was valued at 7.1% and 4.5%, respectively, in 2010. Moreover, experts suggest that on account of rising prevalence of infectious diseases, the aforementioned prevalence rate is expected to rise over the next decade (2010 to 2020).
The introduction of GeneXpert Omni by Cepheid, a portable and fully automated system catering to users in point-of-care healthcare facilities and small peripheral laboratories, is a fine example of increasing focus on R&D for technology and innovation in the industry. Growing use of multiplex PCR technologies and real-time PCR equipment is also likely to boost market growth over the forecast period.
North America molecular diagnostics market, by product, 2012-2020 (USD Million)
In 2013, the molecular diagnostics polymerase chain reaction (PCR) technology occupied over 45.0% of the global revenue share. PCR is the simplest and foremost procedure conducted prior to the commencement of any investigation involving nucleotides and genetic material. Increasing application of the same in the fields of pharmacogenomics, drug discovery & development, AIDS, and cancer research directly impacts the market demand for PCR technologies.
The in situ hybridization technology segment is expected to grow at a healthy rate of over 11.0% during the forecast period owing to, the increase in the size of cancer affected population and need for early cancer diagnosis.
Genetic sequencing is also expected to witness rapid gain in demand owing to, the potential decrease in cost and increase in the portability of DNA sequencers combined with the development of next-generation sequencing techniques providing high throughput analysis and sequencing of genomic data.
The market for molecular reagents is expected to reach over USD 4,500.0 million by 2020 majorly owing to high usage rates, growing R&D initiatives involving diagnostic technologies coupled with rising demand for point-of-care, OTC, and self test products. The introduction of portable instruments such as MinION Analyzer developed by Oxford Nanopore is expected to boost usage rates of instrument segment in the next six years.
Test Location Insights
Central laboratories dominated the overall market in terms of revenue in 2013 at 65.8% due to high procedure volumes and the extensive presence of ancillary support in terms of man power and infrastructure.
Growing demand for bedside patient care owing to a flourishing home healthcare industry coupled with rising market penetration rates of decentralized healthcare establishments is one of the major factors that can be attributed to rapid growth of the point-of-care market.
Molecular diagnostic tools found the largest application in infectious disease testing in 2013. Infectious disease testing generated over 49.0% of the total revenue in 2013 owing to, the presence of large test volumes and an extensive portfolio of commercialized products.
On the other hand, segments entailing lucrative opportunities such as oncology and pharmacogenomics are expected to outgrow the former in terms of growth rate. The oncology testing and pharmacogenomics markets are marked by the presence of broad avenues for development of diagnostic applications at molecular levels in the fields of personalized medicine for cancer medication and new drug discovery.
North America was the largest regional market with revenues valued at over USD 1,950.0 million in 2013. The presence of favorable government initiatives pertaining to product development, sophisticated healthcare infrastructure, and high incidence rates of target diseases coupled with relatively higher patient awareness levels in this region are some of the prominent drivers.
The Asia Pacific molecular diagnostic market is expected to witness lucrative growth of over 12.0% during the forecast period. The rising prevalence of infectious diseases in emerging economies of India and China, and the increasing profit margins in MDx tests will also be responsible in shaping the further growth of this regional industry.
The global molecular diagnostics market share was led by Roche in 2013. The marketplace is highly competitive and consolidated in nature. In a probe to consolidate their position, the industry is witnessing a marathon of mergers acquisitions, for example, Hologic acquired Gen-Probe in August, 2012.
New product introduction is another distinctive feature of this market increasing competitive rivalry, for example, Abbot introduced real-time molecular test for Human Papillomavirus (HPV) in China to improve cervical screening options in 2013. Prominent players include Hologic, Novartis, Siemens Healthcare, bioMerieux, Becton Dickinson and Company, Abbott Laboratories, Cepheid, and Qiagen.