The global urinalysis market size was estimated at USD 1.37 billion in 2015.The magnitude of the target diseases, such as UTI, kidney diseases, and diabetes, is immense with the occurrence of millions of new cases every year. Urinalysis is used as the primary diagnostic tool for the diagnosis and management of these diseases.
The huge base of the target population and the observed high, unmet clinical needs in the under-developed regions provide the market with a large pool of opportunities for potential growth. To capitalize on these opportunities, the development of diagnostic tools that can respond to these unmet clinical needs at an affordable price is mandatory.
Furthermore, the growing prevalence of sedentary lifestyle in individuals fuels the epidemic in many regions. However, the lack of adequate healthcare infrastructure in low-income countries is a major restraint in the adoption of the latest diagnostic tools for urinalysis. The provision for carrying out rapid and accurate diagnosis with improved ease-of-use is the core strategy adopted by the key market players for catering to the unmet clinical needs in these regions.
U.S. urinalysis market, by application, 2012 - 2022 (USD Million)
The market is segmented on the basis of products into two segments, instruments, and consumables. Automated and semi-automated biochemical urine analyzers, urine sediment analyzers, and microscopic urine analyzers are the majorly used instruments in the urinalysis market.
Technological advancements in the instruments are estimated to accentuate the growth of this segment with a CAGR of over 7% over the forecast period. Fully automated urine strip readers and automated urine sediment analyzers, such as UriSed mini and UriSed 2 from 77 Elektronika Kft, represent the technologically advanced instruments available in the market.
Moreover, the development of wireless communication and miniaturized PoC urinalysis instruments is a boon to the market. These advancements provide single-level access to the results throughout the hospital at the same time.
Urinalysis testing is used as the frontline diagnostic tool in the diagnosis of various metabolic abnormalities and UTIs. Urinalysis is also used as a disease management tool for the treatment of chronic diseases, such as diabetes, Chronic Kidney Disease (CKD), and urinary bladder cancer.
The growing prevalence of target diseases, such as diabetes, kidney diseases, and Urinary Tract Infections (UTI) and the introduction of technologically advanced, rapid, non-invasive, and user-friendly tools for urinalysis are estimated to be the major growth drivers of this market.
Urinalysis is found to have the highest application in the diagnosis of UTI with a market share of over 25% in 2014, majorly owing to the high prevalence of hospital-acquired urinary tract infections, especially in females, and efficient diagnosis by urinalysis
Clinical laboratories segment was the largest end-use segment accounting for over 40% of the market share in 2014 and their dominion is expected to continue over the forecast period. High procedure volumes associated with these establishments are the primary reasons attributing to its high share.
The rising trend of automation being used in the urine analysis diagnostics is anticipated to provide an ancillary force for the growth of point-of-care and self-testing based urinalysis devices. The home care segment is estimated to witness a significant growth in the coming decade owing to the aforementioned factors.
North America dominated the overall urinalysis market in 2014. The major driver identified for the large market share includes presence of key market players in the region such as Alere, Inc., Siemens Healthcare, Bio-Rad, and Beckman Coulter. Moreover, introduction of the automated urine sediment analyzers such as digital flow morphology (digital imaging) & fluorescence flow cytometry coupled with high healthcare expenditure in this region which is around 14% of the GDP responsible for the high growth potential of this market.
Asia Pacific is expected to witness the fastest growth with a CAGR of around 8% during the forecast period. The increasing penetration rate of advanced urine analyzers, the presence of local urine analyzer manufacturers, such as Mindray and Urit medical, and a large base of the target population with unmet clinical needs are expected to reinforce the market growth over the forecast period.
Competitive Market Share Insights
The global urinalysis market players include Alere, Inc., ARKRAY, Inc., Bio-Rad, Mindray, Roche Diagnostics, Siemens Healthcare, and Sysmex. Mergers and acquisitions with an objective to cover a vast distribution area and to focus on novel product development are the key strategies implemented by these players.
Moreover, investments in the improved and automated diagnostic tools for urine analysis are expected to be a transforming decision for product developers and end-users, such as hospitals and clinical laboratories.
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