Core Insights - The in vitro diagnostics (IVD) industry is a crucial component of modern healthcare, providing essential data for disease prevention, diagnosis, and treatment through various testing methods [1][5][10] - China's IVD market has surpassed 120 billion yuan in 2024, with a projected growth to 165 billion yuan by 2029, reflecting a compound annual growth rate of 5-8% [1][10][19] - The industry is experiencing significant domestic substitution, with over 80% of Class III diagnostic products being domestically produced, while the share of imported products has decreased from 29.3% to 19.5% from 2021 to 2024 [1][14] Industry Overview - IVD encompasses several testing methods, including biochemical, immunological, molecular, microbiological, blood diagnostics, and point-of-care testing (POCT) [2][5] - The industry is transitioning from scale expansion to high-quality development, driven by government policies and technological innovations [5][21] Policy and Regulatory Environment - Recent government policies, such as the "14th Five-Year Plan for Bioeconomic Development" and the "Comprehensive Action Plan for Improving Medical Quality (2023-2025)," provide a strong impetus for the IVD industry [5][7] - The introduction of the "List of In Vitro Diagnostic Reagents Exempt from Clinical Trials (2025)" has expanded the range of products available in the market [7] Market Dynamics - The IVD industry is characterized by a multi-tiered market structure, with foreign giants dominating the high-end market and domestic leaders gradually increasing their market share [15][19] - The competitive landscape is evolving, with leading companies like Mindray Medical and New Industry Bio showing strong performance, while former leaders in COVID-19 testing, such as Da An Gene and BGI, are seeking business transformation [19][20] Growth Trends - The IVD industry is witnessing a shift towards precision and intelligent diagnostics, with advancements in molecular diagnostics, chemiluminescence, and POCT technologies [21][22] - The integration of AI and big data is enhancing diagnostic efficiency, while the demand for home health management and early cancer screening is rising due to an aging population [21][24] Competitive Landscape - The first tier of the market is dominated by international giants like Roche and Abbott, while domestic leaders such as Mindray and New Industry Bio are gaining traction in immunological and molecular diagnostics [15][19] - The market is seeing increased consolidation, with leading companies acquiring smaller firms to enhance their technological capabilities [23] Registration and Product Development - The registration of IVD products has been robust, with a compound annual growth rate of 25.3% from 2021 to 2024, indicating a vibrant development in the sector [14] - In 2024, the registration of domestic Class III diagnostic products reached 533, accounting for 80.5% of total IVD product registrations [14]