Billion-Dollar Acquisitions Ignite the Market: A Global Leader’s Localization Journey in Coagulation Analysis Systems
Since Japan established the world’s first fully automated laboratory assembly line in the 1980s, medical device giants such as Thermo Fisher Scientific, Roche, Abbott, and Siemens have successively launched smart laboratory transformations, introducing various IVD (In Vitro Diagnostics) automated assembly lines.
IVD automation lines originated in Japan and flourished in Europe and the United States. By introducing industrial automation concepts into laboratory testing, they connect testing systems and processing modules via tracks to enhance automation and standardization, thereby reducing overall turnaround time.
According to data from Inpeco, a leading global provider of upstream laboratory automation solutions, healthcare institutions utilizing automated laboratory workflows have achieved a 15% reduction in laboratory staffing, a 34% decrease in testing time, and a 46% reduction in sample collection time, even with a 10% increase in test volume. As these automated systems handle high-volume sample processing, they drive the sales of reagents and consumables. Consequently, an increase in market share for laboratory automation translates into higher reagent revenue and will also influence the landscape of the in vitro diagnostics (IVD) industry.
BCC data shows that the global market for laboratory automation lines was $11.9 billion in 2021 and is projected to reach $18.7 billion by 2027, with a CAGR of 7.9% from 2022 to 2027, outpacing the overall 5.5% growth rate of the global in vitro diagnostics industry.
Among these, coagulation testing, a rapidly developing niche within the in vitro diagnostics (IVD) sector in recent years, has seen sustained growth in interest. Relevant data show that over the past five years, the coagulation market’s share of the overall IVD market has gradually risen from approximately 5% to around 10%. A wave of innovative companies has begun to emerge, while IVD giants are accelerating their entry and strategic positioning in this space.
On March 15, 2023, global IVD giant Werfen (hereinafter referred to as “Werfen”) announced the completion of its acquisition of Immucor, a global leader in transfusion and transplantation diagnostics. Previously, Werfen had announced that it would acquire Immucor for $2 billion (approximately RMB 14.5 billion) to expand its leadership position in the specialized diagnostics sector.
On March 26, Zhongyuan Huiji and Chuanshi Biology held a signing ceremony, whereby Zhongyuan Huiji acquired 100% equity interest in Chuanshi Biology, officially entering the coagulation market.
Two major acquisitions occurred within half a month, reigniting the fervor in this sector. In this hotly contested arena, Sysmex holds a leading position in the global market.
In the Chinese market, Sysmex is the leader in hematology analyzers and an innovator in laboratory automation and intelligence. As early as 1960, Sysmex developed its first hematology analyzer, the CC-1001. In 1999, it launched the first hematology analysis assembly line, and in 2012, it introduced the first modular hematology analyzer, the XN series, solidifying its leading position.
Thrombosis and HemorrhageThrombosis and hemorrhage are clinical manifestations resulting from a disruption of the body’s hemostatic balance. Their etiologies are associated with numerous conditions, such as cardiovascular and cerebrovascular diseases, malignant tumors, obstetric complications, and postoperative complications. Thrombotic and hemorrhagic disorders involve nearly all clinical specialties. The diagnosis, treatment, monitoring, and prognosis of these conditions rely heavily on coagulation laboratory parameters.
As the aging of the population intensifies, the number of individuals suffering from cardiovascular and cerebrovascular diseases as well as chronic conditions is increasing year by year. This has led to a growing demand for thrombosis and hemostasis diagnostics, fostering a rapidly expanding coagulation diagnostics market.
With continuous advances in basic research on thrombosis and hemostasis, more mechanisms have been elucidated, leading to a deeper clinical understanding of various coagulation parameters. A single testing technology cannot address coagulation disorders caused by different primary diseases in clinical practice. Consequently, there is a growing demand for multi-item combined testing across multiple sample types, giving rise to fully automated coagulation analysis workflows.
Sysmex Corporation (hereinafter referred to as “Sysmex”) is a multinational enterprise established in 1968, formerly known as Toa Medical Electronics Co., Ltd. Primarily dedicated to the field of in vitro diagnostics, it is a globally renowned provider of comprehensive clinical laboratory solutions.
In 1961, Toa Tokushu Denki Kabushiki Kaisha (now TOA Corporation) established a policy to enter the field of medical electronic devices. The company built a new research laboratory, and three engineers began conducting research in this area.
Two years later, the laboratory successfully commercialized Japan’s first blood cell counter, the CC-1001 fully automated hematology analyzer. In 1966, it launched the CC-1002 fully automated hematology analyzer.
In 1968, TOA Medical Electronics Co., Ltd. (now Sysmex Corporation) was established to sell automated blood cell counters manufactured by TOA Electric Co., Ltd. (now TOA Corporation).
Over the past five decades, Sysmex has gradually evolved into a globally renowned in vitro diagnostics (IVD) company, with more than 70 branches across China, Europe, the Americas, and the Asia-Pacific region, and its products are available in over 190 countries worldwide. It holds a leading global position in hematology analysis, coagulation analysis, and urine sediment analysis, while also continuously expanding its capabilities in clinical chemistry, immunodiagnostics, and point-of-care testing. The HISCL series of high-sensitivity chemiluminescence immunoassay systems has been installed in more than 1,500 hospitals, offering nearly 60 routine and specialized immunoassay tests.
Sysmex’s ultimate goal is to promote the health of all humanity. Building on its accumulated technological and patented expertise, Sysmex is actively seeking to expand into new fields. In the future, it will focus its investments on the development and research of disease prevention, health protection, and optimization of testing processes, while expanding its business scope to include biochemistry, immunology, and point-of-care diagnostics, thereby consolidating and advancing its position as one of the top ten global diagnostic product companies.
Sysmex’s product portfolio is categorized into four major segments: hematology, urinalysis, immunology, and coagulation. The coagulation analysis systems include the CN6000, CN3000, CS-5100, CA-7000, CA-1500, CA-500, CS2400/2500, CS-2100i/2000i, and CS-1600/1300 series. On April 26, Sysmex launched its Hemostasis and Thrombosis Workstation, the CN6500, in Chongqing. This system integrates a coagulometer, platelet aggregometer, and chemiluminescence immunoassay analyzer, with testing menus covering the four major hemostasis and thrombosis pathways.
The current CS and CN series cover the full spectrum from basic to advanced fully automated coagulation analyzers. The CS-1300, a basic fully automated coagulation analyzer, integrates the latest advanced features of contemporary thrombosis/hemostasis analyzers. It offers an exceptional price-to-performance ratio rarely seen in the market, making it the preferred choice for large teaching hospitals and comprehensive hospital laboratories. With rapid processing capabilities of up to 180 tests per hour, it combines multiple detection methods: clotting, chromogenic substrate, and immunological assays. It features comprehensive random-access capability, provides two methods for fibrinogen determination, and is suitable for both high-volume routine testing and emergency use.
The mid-to-high-end fully automated coagulation analyzer CS-5100 offers ultra-fast processing capabilities, with throughput rates of 400 PT tests/hour and 202 D-Dimer tests/hour. Compared to similar products, its multi-parameter comprehensive processing capacity is improved by 30–50%. It can be integrated with Laboratory Automation Systems (LAS) to enhance overall testing efficiency.
The high-end fully automated coagulation analyzers CN6500 and CN6000 deliver comprehensive and highly accurate hemostasis test results at the world’s fastest analysis speed. Capable of multi-parameter testing, they offer a high-throughput capacity of 450 tests per hour. These instruments integrate clotting, chromogenic substrate, immunological, aggregation, and chemiluminescence methods into a single platform. With their highly ergonomic and intelligent design, as well as user-friendly operation, they are the preferred choice for large-scale laboratories.
Notably, the Sysmex CS-5100 and CN series island-type coagulation automation lines enable automated coagulation testing with minimal space and investment. This coagulation line is the only one featuring online cap-piercing capability, eliminating the need for an additional decapping module to save space, while reducing film-sealing operations to further optimize workflow. Operators can promptly identify abnormal specimens prior to testing and handle them appropriately to ensure accurate results. The system supports continuous sample loading, aligning better with routine laboratory operations and accelerating turnaround time (TAT).
In addition, the Sysmex CS-5100 and CN series coagulation analyzers can intelligently connect with Siemens track systems. This goes beyond simple equipment serial connection, truly achieving intelligent, centralized, and automated management of the coagulation testing line. It effectively reduces errors caused by human factors, improving the efficiency and throughput of the laboratory. By shortening turnaround time (TAT), it frees operators from repetitive manual tasks, allowing them to focus more on higher-value activities such as report review, result interpretation, clinical communication, and scientific research.
In China, Sysmex was one of the earliest imported IVD brands to establish a domestic manufacturing facility. In 1995, Jinan Sysmex Medical Electronics Co., Ltd. was founded to manufacture clinical laboratory analyzers and in vitro diagnostic reagents. In 2000, Sysmex Shanghai Ltd. was established. In 2003, Sysmex Biotechnology (Wuxi) Co., Ltd. was founded, and its Development Center was established in 2009, primarily focusing on the production of in vitro diagnostic reagents.
Currently, Sysmex has established a Beijing branch in China and set up liaison offices in multiple provinces and municipalities. With sales support and customer service networks covering the entire country, this marks the establishment and continuous improvement of Sysmex’s marketing and service system in China.
Leveraging the marketing and service system established through years of cultivation in the Chinese market, Sysmex has intensified its collaborations with local IVD enterprises in recent years, striving to further advance the market promotion of its products.
In February 2023, Sysmex entered into a strategic partnership with Pinfeng Medical. Through Sysmex’s established distribution network, this collaboration will bring Pinfeng Medical’s Kunlun series of high-speed clinical chemistry analyzers and automation lines to market alongside Sysmex’s product portfolio. By leveraging their respective strengths and integrating resources, the two companies aim to optimize their product offerings and foster comprehensive cooperation in total solutions for clinical chemistry and immunoassay diagnostics, thereby meeting the strong clinical demand for high-speed clinical chemistry analyzers and automated, intelligent testing systems.
This collaboration with PinFeng Medical’s high-speed biochemistry and smart automation lines signifies that Sysmex has perfected its total solution for domestically produced biochemical and immunological automation lines, enabling better service to customers in the Chinese market.
In recent years, driven by the impact of the COVID-19 pandemic and an accelerating aging society, the coagulation diagnostics sector has seen a surge in interest, with unprecedentedly fierce market competition. By examining the development trajectories of overseas giants, we can gain insights into the competitive dynamics of this sector, thereby laying the groundwork for the rise of domestic brands.