6 Leading In Vitro Diagnostics (IVD) Companies in China: A Comprehensive Overview

Embark on a journey into the heart of China's medical innovation as we unveil the prowess of the nation's top In Vitro Diagnostics (IVD) companies. In this comprehensive exploration, we shed light on the impactful contributions and far-reaching influence of six industry leaders: Mindray Medical, Snibe Diagnostic, Dirui Medical, Autobio Diagnostics, YHLO Biotech, and BSBE. Venture with us to discover how these pioneering enterprises are shaping the realm of diagnostics, propelling healthcare to new horizons.

1. Mindray Medical

- Global Leader in Medical Devices, Major Winner in Domestic Group Purchasing

Mindray Medical, founded in 1991, is primarily engaged in the research, development, manufacturing, marketing, and servicing of medical devices. The company is committed to providing high-quality products and services to global healthcare institutions. Mindray has deep-rooted expertise in the field of medical devices, forming three major business segments and four seed businesses through organic growth, acquisitions, and diversification. The three major business segments include Life Information & Support, In Vitro Diagnostics (IVD), and Medical Imaging, while the four seed businesses cover Animal Health, AED, Minimally Invasive Surgery, and Orthopedic Consumables. Mindray currently has over 50 overseas subsidiaries worldwide, serving more than 190 countries and regions. It has research and development centers in Europe, Seattle, Silicon Valley, and New Jersey. Mindray's products and services are used in over 99% of top-tier hospitals in China, more than 660 European teaching hospitals, and the top 20 ranked hospitals in the United States are all Mindray customers.

Mindray's IVD products include various tests such as immune diagnostics, biochemical diagnostics, coagulation, microbiology, blood cell analysis, and urine testing, covering multiple IVD product lines. On the instrument side, Mindray offers multiple instrument options for each product line, achieving comprehensive coverage of instruments. On the reagent side, Mindray's biochemical reagents cover 10 categories, including liver function, kidney function, cardiac markers, diabetes, etc. Its chemiluminescent reagents cover 10 categories, including tumor markers, thyroid function, infectious diseases, sex hormones, etc. In terms of biochemical instrument types, Mindray has introduced fully automated biochemical analyzers, modular biochemical testing systems, and biochemical immunology analysis lines. Among them, the modular biochemical testing system BS-2800M has a one-touch start function, enabling testing initiation in just 1 minute under any state, with a single module testing speed reaching 2400T/H, making it one of the top 7 biochemical analyzers in China. In terms of reagent raw materials, Mindray acquired HyTest, a globally renowned IVD raw material company in 2021, achieving independent and controllable core technology in the IVD raw material field. In terms of revenue, Mindray achieved rapid and steady growth in its IVD business over the past five years, increasing from 4.626 billion yuan in 2018 to 10.256 billion yuan in 2022, doubling its revenue, with a CAGR of 17.26% from 2018 to 2022. In 2022, the revenue from chemiluminescence increased by nearly 30%.

2. Snibe Diagnostic

- Strong Domestic Installed Base, Growth Potential in Overseas Markets

Snibe Diagnostic, established in 1995, primarily engages in the research, development, production, sales, and customer service of in vitro diagnostics products. Since its inception, Snibe has focused on research in the field of chemiluminescent immunoassay and has developed, produced, and sold a series of fully automated chemiluminescent immunoassay instruments and supporting reagents, making it a leader in the domestic chemiluminescent field. The company has established four major technical platforms: nanomagnetic microsphere development, key reagent development, fully automated diagnostic instrument development, and diagnostic reagent development. Snibe has successively developed the first fully automated chemiluminescent instrument and its matching reagents in China, as well as the ultra-high-speed fully automated chemiluminescent immunoassay system MAGLUMI X8, breaking the long-term technical monopoly of multinational companies.

Snibe's revenue and net profit are impressive, with a continuous focus on the high-end market. Snibe's revenue increased from 1.384 billion yuan in 2018 to 3.047 billion yuan in 2022, achieving rapid growth with a compound annual growth rate of 22%. In 2022, the global cumulative sales/installations of the high-end machine X8 reached 1,842 units, a year-on-year growth of 69.61%, and the proportion of high-end machines continued to rise.

Snibe emphasizes the sale of chemiluminescent instruments and actively promotes installations in hospitals, with the proportion of instrument revenue increasing year by year. As of the end of 2022, Snibe had installed more than 11,300 units of chemiluminescent immunoassay instruments domestically, and had provided services to medical terminals in 151 countries and regions overseas, achieving cumulative sales of chemiluminescent immunoassay instruments exceeding 15,100 units. Benefiting from active sales policies, Snibe's terminal customer base continues to grow. As of the end of 2022, Snibe had provided services to nearly 8,700 medical institutions in China, including 1,380 tertiary hospitals, achieving a coverage rate of 55.66% in domestic tertiary hospitals.

Snibe values the development of overseas markets. In 2022, the company established a total of 5 overseas subsidiaries in Russia, Brazil, Mexico, Pakistan, and Peru, implementing localized operations to drive market expansion and terminal service capabilities in key overseas countries. In recent years, overseas revenue has continuously increased, and the proportion of overseas revenue has increased from 19.69% in 2017 to 31.84% in 2022. Despite the impact of the pandemic, overseas revenue has continued to grow against the trend. The overseas market has vast potential and is expected to open a second growth curve for the company, gaining the first-mover advantage and brand advantage in the overseas market, contributing to the company's revenue.

3. Dirui Medical

- Empowering Business Development under CR's Ownership, Driving Growth through Seven Production Lines

Dirui, engaged in the research, development, production, marketing, and service of medical testing instruments and supporting reagents, originated in urine analysis and gradually expanded its business to biochemical analysis, chemiluminescent immunoassay, gynecological secretion analysis, blood cell analysis, coagulation analysis, and integrated laboratories, with a total of seven product lines. After China Resources' acquisition, driven by CR's management and business empowerment, Dirui implemented a strategic shift focused on sales, adding over 200 new domestic distributors and more than 50 new international distributors in 2022, achieving a year-on-year growth of 70.11% in instrument revenue.

In 2022, Dirui launched over 10 new products, including instruments such as the CM-640/640i fully automated chemiluminescent immunoassay analyzer and BCA-4000 fully automated coagulation analyzer, and reagents mainly enhancing the detection of chemiluminescent immunoassay. Currently, the biochemical production line covers multiple project detections, including thyroid function, infectious diseases, sex hormones, bone metabolism, and inflammation, meeting the clinical needs of different scales of terminals. In terms of revenue, due to the pandemic and the transfer of subsidiary equity, the revenue declined in 2020 and 2021. After business integration, it quickly resumed rapid growth, reaching a growth rate of 34.69% in 2022 and soaring to 46.54% in Q1 202

4. Autobio Diagnostics

- Expanding Production Lines Based on Luminescence, Focusing on Product Line Layout

Autobio Diagnostics focuses on the research, development, integration, and service of in vitro diagnostic reagents and instruments, covering various testing fields such as immunity, microbiology, biochemistry, molecular biology, and coagulation. The company is committed to providing comprehensive product solutions and overall services to medical laboratories. Autobio places technological innovation at the forefront of its development strategy, with R&D investment accounting for over 11% for many years. It has established a research and development system centered in Zhengzhou, with branches in Beijing, Shanghai, Suzhou, Shenzhen, and North America. As of the end of 2022, Autobio had obtained 1,154 patents (including 51 international patents), including 124 invention patents, and obtained registration certificates (records) for 651 products and CE certification for 444 products. Autobio's marketing network covers 30 provincial-level administrative regions in China and has established sales and maintenance outlets in more than 80 countries and regions worldwide.

In 2022, Autobio launched the new generation high-throughput chemiluminescent immunoassay analyzer Autolumo A6000 series, further enriching the chemiluminescent product line to meet the testing needs of large and medium-sized medical laboratories, positioning itself in the ranks of high-speed chemiluminescent instruments. Autobio's independently developed and manufactured assembly line Autolas X-1 Series was officially launched in 2022. This assembly line improves several key performance indicators, better cost control, and meets the needs of domestic laboratories. Some performance indicators approach or even exceed those of international brands, assisting products to enter tertiary hospitals and achieve domestic substitution. In terms of reagents, Autobio's reagent varieties cover multiple testing directions, including infectious diseases, reproductive endocrinology, and thyroid function, placing them at the forefront of domestic enterprises.

5. YHLO Biotech

- Leading Immunodiagnostic Company, Highlighting Self-developed Projects

YHLO Biotech, established in 2008, focuses on the research, development, production, and sales of in vitro diagnostic instruments and supporting reagents, mainly using the chemiluminescent immunoassay as the core technology. The company also engages in the agency sales of certain non-self-produced medical device products. Currently, YHLO Biotech has four major in vitro diagnostic technology platforms: chemiluminescence, immune imprinting, immune fluorescence, and enzyme-linked immunoassay. Its products cover a wide range of business areas, including autoimmunity, infectious immunity, reproductive health, diabetes, cardiovascular, tumor monitoring, and endocrine metabolism. As of the end of 2022, YHLO Biotech's own products cover over 4,400 domestic terminal medical institutions, with 1,330 tertiary hospitals and 1,023 tertiary Grade A hospitals, achieving a national coverage rate of 61.96%, leading the industry.

Since 2013, YHLO Biotech has focused on the construction of the magnetic microparticle chemiluminescence platform and has successfully developed a complete magnetic microparticle chemiluminescence platform, making it one of the earliest domestic companies to industrialize magnetic microparticle chemiluminescent immunoassay instruments and supporting reagents. In terms of diagnostic reagents, YHLO Biotech's product portfolio covers stable quality routine testing items such as the pre-operative eight, thyroid function, tumor markers, etc. It also has outstanding characteristic testing projects in the field of self-immunity and reproductive health. Over a quarter of YHLO Biotech's reagents in its menu are in the self-immunity domain, allowing for rapid entry into higher-level hospitals. In terms of diagnostic instruments, the company's products cover ultra-high-speed, high-speed, medium-speed, and low-speed all-level chemiluminescent immunoassay analyzers. It also deploys single-person POCT chemiluminescent immunoassay analyzers as well as enzyme-linked immunoassay, immune imprinting, and immune fluorescence chromatography diagnostic instruments, forming a complete luminescence production line. Regarding fully automated production lines and supporting systems, the company has introduced an open-ended production line and an intelligent clinical laboratory software system, supporting five analysis platforms: biochemistry, immunity, coagulation, blood cells, and glycosylated hemoglobin, connecting up to 12 analytical systems simultaneously.

6. Beijing Strong Biotechnologies, Inc.(BSBE)

- Fortifying Main Operations through Industry Partnerships, Expanding Offerings via Acquisitions

Beijing Strong Biotechnologies, Inc., founded in 2001 and listed on the GEM in 2014, is a high-growth enterprise primarily engaged in the research, development, production, and sales of biochemical diagnostics, blood coagulation testing, blood typing, and tumor pathology testing. Leveraging its advantages in self-sufficient biochemistry, the company has a diversified series of in vitro diagnostic products and has also ventured into chemiluminescence and POCT product lines. BSBE has a vast sales network nationwide, forming a marketing and service network covering the entire globe.

BSBE is one of the domestic manufacturers with the most complete variety of biochemical diagnostic reagents, especially in the high-end diagnostic reagent field. Currently, the main types of biochemical diagnostic reagents include liver function, renal function, special proteins, and glycemic metabolism, among others. BSBE's self-owned brand "Gcell" has high industry recognition and covers most items of in vitro biochemical diagnostic reagents, including cystatin C, homocysteine, and bile acids (TBA), among others. In terms of biochemical testing instruments, BSBE cooperates with Mindray to sell the high-end biochemical analyzer G92000, with a maximum throughput of 2,000T/H and the ability to simultaneously test 67 biochemical items, demonstrating excellent performance. BSBE has a close business relationship with the multinational giant Abbott. As of April 2023, BSBE has a total of 42 cooperation projects on the Abbott ARCHITECT platform, and in 2021, 32 new cooperation projects were added to the Abbott Alinity c platform. Furthermore, more than 60 projects will be added to the cooperation menu of the Abbott Alinity c platform, helping to further enhance the brand awareness of BSBE.

Conclusion: Igniting a Diagnostic Revolution

The top six In Vitro Diagnostics (IVD) companies in China are propelling a transformative wave within the global medical landscape. These industry giants, namely Mindray Medical, Snibe Diagnostic, Dirui Medical, Autobio Diagnostics, YHLO Biotech, and BSBE, are at the forefront of innovation, pioneering cutting-edge medical technologies and amplifying their reach across borders.

Their relentless commitment to research, development, and superior product offerings has significantly impacted healthcare, facilitating accurate diagnostics, expediting treatment plans, and ultimately saving lives. Moreover, their strategic expansions and mergers signify a robust presence in both domestic and international markets, promising a lasting influence on the evolving field of medical diagnostics.

In an era where precise and rapid diagnostics are crucial, these companies stand as beacons of progress, accelerating the journey towards a healthier, more informed world. As they continue to advance, collaborate, and revolutionize the diagnostics landscape, the future holds exciting prospects, promising an era of even more accessible, efficient, and innovative medical diagnostics.

- Recommended Further Reading

[1]. 2023 IVD Market in China: A Comprehensive Analysis of 6 Key Segments

[2]. Introduction of the Top 9 Chinese Biochemistry Analyzer Manufacturers

[3]. How to Successfully Enter the Chinese POCT Medical Device Market as an Overseas Distributor

(References and data sources: Northerst Securities of China东北证券, Official websites of the six companies, China Commercial Industry Research Institute中商产业研究院, Chinese Website of Laboratory Medicine, MDCLOUD)