Numerous diagnostic centers will be established in rural areas in the coming years propelled by improved diagnostic tools, enhanced treatment monitoring, easy availability of coagulation solutions at affordable prices, and high investments from the private sector.
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.
- 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 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.
- 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.
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.
Coagulation Market in India
The haemostasis market is growing globally with the increase in the aging population, prevalence of clotting disorders, and an increase in DVT and CHD populations. The increasing prevalence of cardiovascular risk factors like dyslipidaemia, diabetes, obesity, physical inactivity, hypertension, and tobacco use is the major factor for the increase in CVD cases in India.
The Indian coagulation segment is estimated at 125 crore in 2016. PT, APTT, and fibrinogen are the three major parameters in the coagulation testing where PT testing contributes 75 percent followed by APTT at 20 percent. Compared to other segments, coagulation testing is highly sensitive especially in the pre-analytical phase where sample collection, separation, and transportation play an important role in determining the result along with the sensitivity of reagents used. Majority of the coagulation testing is performed in hospitals or attached laboratories as compared to stand alone labs.
When compared to the clinical chemistry segment, automation is not popular in the coagulation market in rural areas due to the high cost of the hardware and consumables. The automation segment is controlled mainly by the multinational companies with their fully automated systems which are placed on reagent rental in high workload laboratories. In semiautomated systems, the market is controlled by European and Japanese brands. Low-cost Chinese instruments are finding it difficult to gain the market share.
With advancements in IT and electronics, the new-generation coagulation systems are coming up with advanced technologies to make testing easy. Specially in PT estimation, proper ISI values need to be entered into the system before testing. In majority of the cases improperly entered ISI value is one of the culprits for error in the PT estimation.
To address this, instrument manufacturers have come up with a new semiautomated coagulation system with smart card technology, where all the details like ISI values or calibration curves of the specific reagents are encoded in the smart chip to eliminate analytical errors. These systems are highly compact using densitometric principle, dual wavelength measurement giving accurate results, and are affordable for the rural population in India. We are expecting that more such innovative systems are going to be introduced in the coming future with added parameters to make the coagulation testing easy and affordable for the common man.
General Manager, Business Development,
Growing at a Steady Pace
The global coagulation analyzer market is projected to reach USD 4.84 billion by 2021 at a CAGR of 10.2 percent. The Indian market was estimated at approximately 100 crore in 2016, growing at a CAGR of 11 percent. The market is dominated by reagents at 75 crore while instruments have a share of 30 crore. Most of the fully automated coagulation analyzers are placed on reagent rental. Sysmex, Stago, and IL lead the market in the fully automated segment while Transasia Bio-Medicals Ltd. predominates the semiautomated segment. ECL 105, a single-channel analyzer from Transasia has already become a market leader in just one year of launch.
On technology trends
The semiautomated single-channel segment has seen significant advances in the recent past. In addition to the basic clot detection method, a wide range of tests such as PT, APTT, FBG, TT, factors, Lupus, and D Dimer have been introduced, thereby expanding the test menu. Availability of advanced software with LJ graphs and calibration curves has further improved the accuracy and precision of reporting. Instrument interfacing to LIS and specimen bar coding capabilities reduce the dependence on manual record maintenance. Fully automated systems are now offering higher throughput to meet the needs of laboratories with high demand.
On key growth drivers
Key growth drivers include high-throughput results, increasing adoption of automation, and development of high sensitivity and specificity of coagulation analyzers. Small laboratories are now moving for automation and witnessing a growth of over 50 percent.
On buyer’s perspective
Small semiautomated systems are in demand by laboratories with low workload. Customers prefer systems that meet their basic requirements and are capable of testing other parameters such as fibrinogen, factors, lupus, or D dimer, in the near future. Medium workload users prefer fully automated four-channel systems. Few companies cater to this segment. Transasia’s recent launch, ECL 760 meets the needs of these customers. A huge range of analyzers with different detection principles are available for high end workload users such as corporate hospitals, reference centers, and central labs.
On challenges and opportunities
Coagulation plays a critical role in diagnostics and hence customers expect automated systems with precise and consistent reporting. After sales-service plays a very important role since addressing the needs of the customers in remote locations is a challenge for most companies.
On future outlook
The Indian coagulation market is growing steadily. The lower and mid segments are growing at twice the pace with the introduction of new products every year. Specialized tests are being added to the higher segment to cater to the needs of the high end customers.
Product Manager – Coagulation,
Transasia Bio-Medicals Ltd.
“Status of hemostasis can be measured in vivo with the help of thrombin generation (TG) which includes plasmic coagulation, cellular coagulation, and formation of cross-linked fibrin.
The test is useful for cancer patients as they are more at increased risk for venous thromboembolism (VTE). Laboratory diagnosis measured overall thrombophillic tendency useful to assess VTE risk. Investigation of TG assay is one of the key processes in hemostasis, for prediction of cancer-associated VTE. CATS (Vienna Cancer and Thrombosis Study) conducted an observational cohort study of patients in newly diagnosed patients or on progressive disease without chemotherapy or radiotherapy or surgery performed on them.
The study concludes with occurrence of objective confirmation of symptomatic fatal VTE within a follow-up of two years from the date of enrolment of the patient.
To all the concerned clinicians to put the test to its best use.”
Compact Diagnostics (I) Pvt. Ltd.
IVD – Glimpse of Blood Investigation Technology
In vitro diagnostics (IVD) are very different from other medical devices – they do not come in direct contact with patient, value of the knowledge and information they deliver and no therapeutic effect claimed. IVD products include not only the instruments, systems, and reagents used to perform the tests, but also the products intended for use in the collection, preparation, and examination of specimens taken from the human body. And these IVD medical devices are categorized into three alignes by FDA, align I – low-risk medical devices, align II – intermediate-risk medical devices, and align III – high-risk medical devices.
IVDs fulfill their role based on information that they provide and not on their direct action on the patient. This is of fundamental importance also related to matters dealing with product validation and testing. The validity of a medical device, or of a drug, is ultimately tested only by seeing how it performs on a patient while this approach will never be possible for an IVD. The quality of the information delivered by an IVD is assessed by measuring the analytical precision of the test or assay and by the clinical evidence of the information provided.
We all understand how important it is to be very precise specifically when testing blood for blood-typing (identifying blood type) or blood screening for HIV, hepatitis C etc. We all understand the clinical relevance of these assays. So while on one hand it is definitely correct to seek a high level of safety for both medical devices and IVDs it is important to maintain the differences between these two categories of medical devices – one that comes in direct contact
and the other that does not. Only in this way we will continue to have a well-balanced and effective regulatory system.
National Sales Manager – IVD,
Nihon Kohden India Pvt. Ltd.
“Indian coagulation market is a significantly growing market in the IVD segment. We are the market leader in the coagulation segment worldwide. The coagulation laboratory is an ever-changing environment, populated by latest automated analyzers by the Stago Group that offer advances in both volume and variety of tests. In continuation, now Stago is entering a very specialized and niche segment like Aggregometery and fully automatic thrombin generation to provide a better solution for the benefit of patient care. These will be the future of coagulation testing.”
Stago India Pvt. Limited