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Coagulation Instruments and Reagents

Continuous Advancement for Coagulation Testing

Rapid expansion in hospitals and primary healthcare centers, and favorable government initiatives to improve the healthcare delivery are expected to be high-impact rendering drivers.

Rising technological advancements in coagulation analyzers are expected to be the most impact rendering drivers for lucrative growth of over the years. Automation is the key development that has occurred in recent years. The most relevant advancement includes combination of different assay procedures in a single instrument and various commercially available analyzers, which are capable of performing tests such as prothrombin time (PT), activated partial thromboplastin time (APTT), D-dimer, and fibrinogen. These instruments can perform chromogenic and immunologic assays as well. Moreover, these systems may have the capacity of holding more samples, providing faster results, and increasing the efficiency of laboratory workflow. New advanced instrumentation has made coagulation testing more standardized, consistent, and cost-effective.

Indian Market Dynamics
  The Indian coagulation instruments and reagents market in 2016 is estimated at Rs. 123 crore, with reagents dominating with an 88 percent share. The fully automated instruments have a 66 percent market share in the instruments segment. A rough estimate indicates the installed base in 2016 as 3650 instruments, with semiautomated instruments at 3200 units, and fully automated ones at 450 units. This segment sees an annual growth of about 10–12 percent, with the fully automated segment growing at 7–8 percent, and private laboratories accounting for 80 percent of the fully automated instruments sales.

The market continues to be dominated by Stago (including Trinity) and Werfen Medical India (IL), followed by the aggressive presence of Sysmex. Tulip has presence in the reagents segment.

The consumer demand for blood coagulation analyzers has led to a shift in  diagnostic testing from hospitals and commercial laboratories to the patient’s home. A high percentage of people are living in rural areas, which have less diagnostic centers due to lack of infrastructure and low disposable income. This has led to less spending on basic healthcare facilities in rural areas. As a result, several diagnostic testing solutions providers are planning to venture into the country.

In the coming years, numerous diagnostic centers will be established in rural areas propelled by improved diagnostic tools, enhanced treatment monitoring, increased availability of over-the-counter tests, easy availability of coagulation solutions at affordable prices, and high investments from the private sector. It may lead to the growth of this market and provide huge opportunities for coagulation analyzer manufacturers in the country. The crux will be the affordability of the tests and the paying capacity of patients.

Global Market
The global coagulation analyzers market is projected to reach USD 4.84 billion by 2021 from USD 2.98 billion in 2016, at a CAGR of
10.2 percent, predicts MarketsandMarkets. Special emphasis on providing quality and timely care to patients is expected to propel the growth of the diagnostic market, which in turn is anticipated to cause a hike in the demand for analyzers. Rapid expansion in hospitals and primary healthcare centers, and favorable government initiatives to improve the healthcare delivery are expected to be high-impact rendering drivers. Also, availability of advanced instruments, which have higher accuracy and features to perform multiple tests, is another vital driver for growth of the market.

Research Update
Advances in basic research have been successfully translated into improved methods for the diagnosis of coagulation disorders as well as development of modern technologically advanced analyzers. Based on the unique nature of blood coagulation research the close interactions and collaborations between basic scientists and clinicians will play a major role in the development. It is anticipated that the research will continue to play a leading role in promoting better care for patients.

Scientists at the Wyss Institute for Biologically Inspired Engineering at Harvard University have devised a better assay for testing blood’s clotting tendency, which could one day prove lifesaving in a variety of clinical situations in which a patient’s health is jeopardized by abnormal blood coagulation and platelet function. The team led by their Founding Director Donald Ingber developed a novel microfluidic device in which blood flows through a life-like network of small vessels, where it is subjected to true-to-life shear stresses and force gradients of the human vascular network. Using automated pressure sensors and a proprietary algorithm developed by the team, data acquired from the device is analyzed in real-time, precisely predicting the time at which a certain blood sample will obstruct the blood vessel network. It can be used with blood samples or potentially be integrated into patients’ blood flow lines; so that one day clinicians could have the foresight they need to prevent life-threatening events such as blood clotting or internal hemorrhaging

In a recent study conducted at the Case Western Reserve University, researchers have developed a portable sensor that can assess the clotting ability of a person’s blood, 95 times faster than current methods, using only a single drop of blood. Even better, the device provides more information about the blood than existing approaches. The technology has been licensed by a company that expects to bring it to market by 2019. The device is designed to minimize the time and effort for blood-sample preparation and can be used at the doctor’s office or other points of care for patients on anticoagulation therapy, antiplatelet therapy, or who have suffered a traumatic injury causing bleeding. In preliminary tests, however, the technology provided results in 15 minutes, as compared to conventional measures that can take a day or longer to yield results

Road Ahead
The development of coagulation assay technology has progressed significantly to a point where it now allows individuals to assess their own clotting status in the comfort of their own homes. While the technologies being used may be ingenious, the adoption of new instruments is not without many significant challenges which include the quality, robustness, and cost of the underlying technology, regulatory approval, clinical acceptance, and the ultimate market size. It is not surprising then, that much technological development has been predominantly incremental in nature. It is assumed that further technological development will continue to make these instruments cheaper, quicker, and simpler to use.

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