The coagulation laboratory is an ever-changing environment, populated by automated analyzers that offer advances in both volume and variety of tests. Hardware and software innovations provide for random-access testing with multitest profiles. In the past, the routine coagulation test menu consisted of prothrombin time (PT) with the international normalized ratio (INR), partial thromboplastin time (PTT), activated partial thromboplastin time (aPTT), fibrinogen, thrombin time, and D-dimer assays. More specialized testing was performed in tertiary care institutions or reference laboratories employing medical laboratory scientists with specialized training.
With the introduction of new instrumentation and test methodologies, coagulation testing capabilities have expanded significantly, so that many formerly specialized tests can now be performed easily by general medical laboratory staff. New instrumentation has made coagulation testing more standardized, consistent, and cost effective.
Operators must develop expertise in correlating critical test results with the patient's diagnosis or condition when monitoring antithrombotic therapy. Good method validation of procedures, cognitive ability, and theoretical understanding of the hemostatic mechanism are still required to ensure the accuracy and validity of test results so that the physician can make an informed decision about patient care.
Indian Market Dynamics
The Indian market for coagulation instruments and reagents in 2014 saw 11 percent growth over 2013. The market is estimated at Rs.102 crore, with reagents dominating at Rs.71.5 crore.
The instruments at Rs.30.5 crore continue to have a contribution of Rs.18.1 crore from fully automated instruments. The market for semi-automated instruments, constituting single-channel, 2-channel and 4-channel, was estimated at Rs.12.4 crore in 2014.
Stago, including Trinity Biotech (which sold its worldwide coagulation business to the Stago Group in 2010, and its products in India are marketed by Rapid Diagnostics), leads the segment. Instrumentation Laboratory, as part of Werfen Group, now marketing its products in India under the brand name of Werfen Medical India and Sysmex are aggressive in this segment. 2014 saw the entry of Abbot in this segment in India.
In 2015, there has been some churn at the vendor front. Stago, which had set up its own office in India in 2013, has parted ways with Suyog Diagnostics in July 2015. Werfen Medical India has partnered with Suyog Diagnostics as one of its leading distributors marketing its coagulation line of products in India. Sysmex, earlier represented by Transasia, is entering the market on its own (only for coagulation) for all new contracts. Roche, having launched its coagulation products in Europe, is expected to launch in India in 2016.
Coagulation testing, which encompasses both laboratory and point-of-care (POC) testing, continues to be one of the most important segments of in vitro diagnostics market. New models of laboratory coagulation testing devices and reagents, which are dominated by PT and aPTT, and include upgrades such as greater automation and integration of more esoteric coagulation tests, such as D-dimer and antiphospholipid assays, are being introduced.
Global coagulation analyzers market is expected to witness lucrative growth owing to factors such as increasing geriatric population and rising prevalence of blood-related disorders. Furthermore, key factors driving the market growth include high throughput results from hemostasis analyzers, increasing adoption of automated hemostasis instruments, and development of high sensitivity and specificity of coagulation analyzers. Additionally, the effects of blood component therapy contribute to growth of coagulation analyzers market. In 2014, consumables segment was estimated to account for the highest share in the coagulation analyzers market in terms of revenue. Clinical laboratory analyzers market was one of the fastest growing segments over the last seven years due to technological advancements such as dual- and four-channel systems simultaneously useful for testing of PT, aPTT, FIB, and TT (thrombin time). Technological advancements in point-of-care procedures such as outpatient anticoagulation, cardiac surgery units, and dialysis units along with quality assurance to overcome adverse reaction caused due to anticoagulation therapy and home testing services is anticipated to gear up the market growth.
The key regional segments include North America, Europe, Asia-Pacific, Latin America, and MEA. In 2014, North America held the largest share of coagulation analyzers market, followed by Europe. Key factors attributing to its large share include increasing prevalence of blood-related disorders, constant technological advancements, high disposable income, and improved healthcare infrastructure. Furthermore, increasing number of mergers and acquisitions, high R&D expenditure, and favorable government initiatives for new product development are expected to propel market growth in this region. Asia-Pacific is expected to be the fastest growing regional market over the forecast period as a consequence of significant factors such as increasing need for coagulation diagnostic procedures, and increasing patient awareness about technological developments integrated with improving healthcare infrastructure. Furthermore, new market entrants owing to less competition are expected to play a vital role in providing growth platform to the coagulation analyzers market in this region over the next seven years.
Key players operating in coagulation analyzers market are Sysmex Corporation, Nihon Kohden Corporation, Thermo Fisher Scientific, Inc., Opero Biotech and Healthcare, Helena Laboratories, Roche Diagnostics, Diagnostica Stago, and Siemens Healthcare. New product launches such as, Xprecia stride coagulation analyzer, and automated blood coagulation analyzers (120 tests/hour) are the key factors adopted by major players to build up their position in the global coagulation analyzers market. Strategic initiatives such as partnerships, collaborations, and acquisitions are adopted by a significant number of players to improve their product quality and expand their presence in the market. Novel approaches conducted by these players in order to overcome hemostatic disorders are expected to boost the market growth.
Indian Market Dynamics is Based on market research conducted by Medical Buyer in November 2015