This analysis explores the reasons behind China’s large share—representing 70% of global CRP test volumes in 2023—and the implications for the IVD industry worldwide.
Rapid Expansion of the CRP Testing Market in China
With a population of 1.47 billion, CRP testing in China has become widespread and deeply integrated into healthcare diagnostics. Several factors contribute to China’s prominence in the global CRP market:
Local Healthcare Demand and Diagnostic Practices: CRP testing has become a routine diagnostic marker for inflammation and infection in China. By contrast, in countries such as Malaysia, CRP tests are more selectively applied, typically reserved for severe cases. This difference in clinical practices drives significantly higher CRP test volumes in China than the global average.
Efficient Testing Platforms: Chinese companies such as Mindray have made notable advances in hematology instrumentation, introducing combined CBC (complete blood count) and CRP testing solutions. This integration allows hospitals to obtain two results from a single blood draw, addressing the high demand for efficient and multifunctional diagnostic solutions. The ability to perform these tests together not only increases efficiency but has also positioned CRP as a preferred testing method in many healthcare facilities.
Supportive Policy Environment: Since 2010, China’s IVD industry has benefited from a supportive policy framework, enabling local companies to rise rapidly. Although recent policies have shifted focus, centralized procurement policies and lower market entry barriers have further accelerated CRP market localization. Compared to cost-intensive tests like chemiluminescence immunoassays (CLIA), CRP testing remains relatively affordable and thus has not been included in centralized procurement. This omission has contributed to the market’s rapid expansion.
The Absence of Global Competitors and Reasons Behind It
Despite technological advantages, international companies have not fully capitalized on the CRP testing market’s growth in China. For instance, Horiba pioneered CRP testing on hematology platforms over a decade ago. However, due to a delayed response to China’s rapidly growing market demand, they missed a significant opportunity. This gap allowed domestic companies to expand swiftly, leading to Chinese firms’ dominance in the local CRP testing market. Additionally, international companies were less able to meet the demand for high-speed, high-frequency testing, an essential requirement in the Chinese healthcare system.
Progress in Domestic Alternatives for CRP Antibodies and Reagents
Antibodies and reagents are the core of CRP testing. In the past, China heavily relied on imported raw materials in this area. Recently, however, local companies have made technological breakthroughs and improved production processes, gradually achieving independence in antibody manufacturing. This shift has reduced costs while enhancing supply chain stability and production capacity. In particular, polyclonal antibodies, known for their high sensitivity and rapid response, align well with the high testing demand in China.
Ensuring the quality of antibodies and reagents requires sophisticated production processes and strict batch-to-batch consistency, coupled with robust supply chain management. With the cost pressures resulting from centralized procurement policies, domestic reagent manufacturers must focus on controlling costs while maintaining quality. Companies like Big Diagnostics, for instance, have leveraged stable supplies of polyclonal antibodies to progressively capture more market share.
Impact on the Global IVD Industry
The rapid development of the CRP testing market in China has reshaped the global IVD landscape. By building expertise and technical strength in CRP testing, Chinese companies have laid a strong foundation for expanding into international markets. As the world’s largest CRP testing market, China serves not only as a testing ground for competitive capabilities but also as a reflection of the IVD industry’s global development trends. In emerging markets, Chinese companies, equipped with competitively priced and adaptable products, are well-positioned to capture additional market share.
Moreover, the maturation of the CRP testing market in China presents the global diagnostics industry with a new perspective on sustainable growth—highlighting how to achieve it by optimizing costs without compromising product quality.
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