Over the past 100 years, remarkable advances have been made in our understanding of the mechanisms of blood coagulation. Starting with early clinical observations of rare patients with hereditary clotting disorders, our knowledge has increased keeping pace with the introduction of new technologies: from simple laboratory tests to protein chemistry, to DNA technology, and to gene targeting technology. Vast research and development efforts from manufacturers have led to the development of highly reliable analyzers in the recent past and the market continues to witness the introduction of high precision and advanced product varieties at a steady pace.
Significant advances have also been made in the capability and flexibility of coagulation instrumentation since analyzers in laboratories and hospitals have to run around the clock to deliver quick and reliable results. Current technologies now allow a complete walkaway environment in which, after specimens and reagents are loaded and the testing sequence is initiated, the operator can move on to perform other tasks. The latest POC coagulation analyzers generate timely results without sacrificing the diagnostic quality controls provided by the central lab. Failure pattern sensors, which detect insufficient sample levels and clots and cap piercing, which enhances safety and sample integrity have also been introduced.
Coagulation analyzers were mostly designed for running clotting tests. In recent decades, however, these instruments have become increasingly equipped with additional technical tools to perform a broader test menu for the investigation of bleeding and thrombotic disorders. The current generation of coagulation analyzers is fully automated, and combines several technologies in the same instrument. The most relevant advancement includes combination of different assay procedures in a single equipment and various commercially available analyzers, which are capable of performing tests such as prothrombin time, activated partial thromboplastin time, D-Dimer, and fibrinogen. These analyzers can perform chromogenic and immunologic assays as well. Moreover, these instruments now have the capacity of holding more samples, providing faster results, and increasing the efficiency of laboratory workflow. Integration of the system with track line systems and work cells, may also improve the reliability of analysis in terms of single detection system and pre-analytical check for interfering substances.
Indian Market Dynamics
The Indian coagulation instruments and reagents market in 2016 is estimated at 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 semi-automated 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 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.
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 Markets and Markets. Increasing high incidences of cardiovascular diseases (CVDs) and blood related disorders, rising geriatric population, growing prevalence of autoimmune diseases, and increasing healthcare expenditure worldwide are some of the major factors contributing to the growth of this market.
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.
Moreover, high growth potential in the Asian region provides growth opportunities to players in the market. On the other hand, slow adoption of advanced instruments in emerging economies, stringent regulatory policies, and high cost of fully automated analyzers are the major factors restraining the growth of this market.
Geographically, the coagulation analyzers market is dominated by North America, followed by Europe, and Asia. Growth in the North American market is primarily driven by increasing aging population, increasing prevalence of CVDs, and favorable healthcare norms.
The developing countries are currently investing a huge amount of government funds to procure and install such medical instruments into their public healthcare facilities. The Middle East and Africa regional segment in expected to display significant growth due to the presence of an adequate number of hospitals, clinics, and health centers backed by skilled healthcare personnel equipped to deliver safe and effective services. In this region, governments of several countries are focused on the expansion of healthcare services.
The market is highly fragmented due to the presence of numerous small and large vendors. Most international pharmaceutical companies are facing challenges such as price pressure, regulatory constraints, and competition from local and other international pharmaceutical companies in the market. The competitive environment in the market is expected to intensify with an increase in product extensions, technological innovations, and increase in mergers and acquisitions. For instance, Werfen Life acquired Accriva Diagnostics, a provider of diagnostic solutions in coagulation, to strengthen its global position. Moreover, many local and regional vendors are offering specific application products for varied end-users.
Players are mostly present in the international space, and due to easy global accessibility, they are competing directly to gain bigger share. The new vendor entrants in the market are finding it hard to compete with the international vendors based on quality, reliability, and innovations in technology. Key players in the coagulation analyzers market include Siemens AG, Thermo Fisher Scientific Inc., Roche Diagnostics, Alere Inc., Sysmex Corporation, Diagnostica Stago, Helena Laboratories, Instrumentation Laboratory, International Technidyne Corporation, Beckman Coulter Inc., and Nihon Kohden Corporation.
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. New promising analyzers for fast and reliable diagnosis are also being developed. 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 these developments. It is anticipated that blood coagulation research will continue to play a leading role in promoting better care for patients with such disorders.
- lScientists 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 Wyss 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.
The Wyss Institute's hemostasis monitoring device has been developed with translation and versatility in mind, and it uses inexpensive in-line pressure sensors to measure clot formation. As a result, the device does not require additional instrumentation and it can be integrated directly into the blood lines of extracorporeal devices. The ability of the device to be configured for lab use or real-time patient monitoring opens the door for countless potential uses to be developed to leverage its coagulation assaying power toward improving patient care.
- lIn 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.
If the device proves effective in that initial evaluation, the company would seek to launch a full clinical trial within the following two years; and would seek FDA approval. To monitor clotting, the device uses an electrical technique called miniaturized dielectric spectroscopy. In essence, the technique applies an external electric field to the drop of blood, and then quantitatively measures how the blood affects that field. The measurements reflect the ability of the blood to clot. Because the device works so quickly, emergency responders could use it on site to determine whether a patient in trauma is on one of the blood-thinner medications.
The Road Ahead
Current analyzers are witnessing huge transformation in terms of design and function. New coagulometers use various methods of commencement and observation for expansion in plasma or clots in blood. They are specifically designed to handle a large number of patients, permitting the storage up to 600 patient tests per well. With the sensitive nature of patient health information, new coagulation analyzers come with built-in quality control and security lockout protocols to ensure safe and secure use.
The market boasts of a wide variety of semiautomatic as well as automatic varieties of coagulation analyzers, with the semiautomatic varieties requiring the involvement of clinical technicians to prepare and introduce samples. Machines with multiple channels and capability of analyzing a number of different samples at the same time are also available in the marketplace. The technological advancements will increase significantly in the coming years owing to the high rate of adoption of these instruments in laboratories, hospitals, and diagnostic centers. Over the years, factors like portability, accuracy, connectivity, timely results, and ease of use will be the
primary focus for vendors to come up with effective and efficient solutions in terms of design.
Currently, India is undergoing a paradigm shift in terms of modernization of its healthcare facilities. This includes government funding for the installation of such diagnostic instruments into public healthcare facilities. For instance, the Hemophilia Federation of India has proposed to build several Hemophilia Care Centers, which would create effective mechanism for diagnosis and treatment of the coagulation disorder. Furthermore, with increasing investment in the improvement of healthcare infrastructures and government's aim to provide quality, affordable healthcare to all, the coagulation analyzers market will witness a huge surge in growth opportunities in the coming few years.