Summary of Expert Call on China's IVD Market Industry Overview - **Industry**: In-vitro diagnostics (IVD) market in China - **Key Expert**: Mr. Fang, an IVD distributor with over 15 years of experience Key Points and Arguments Market Size and Performance in Q325 - **Chemiluminescent Immunoassay (CLIA)**: - Test volume decreased by **17% YoY** and revenue by **25% YoY** - Monthly stabilization observed in September 2025 after declines in July and August [2][7] - **Clinical Chemistry**: - Volume and revenue both down by **8% YoY** - Similar decline pattern as CLIA [2][7] - **Haematology**: - Volume increased by **8% YoY** and revenue by **6% YoY** - QoQ volume decline was less than **2%**, attributed to off-season for physical examinations [2][7] - **Haemostasis**: - Volume and revenue both up by **3% YoY**, with flat QoQ test volume [2][7] - **Point of Care Tests (POCT)**: - Volume and revenue decreased by **12% YoY**, with flat QoQ test volume [2][7] Channel Inventory and Import Substitution - **Channel Inventory**: - CLIA: Global brands have **10-12 weeks** of sales in inventory; local brands have **8-10 weeks** [3][10] - Haematology: Leading players had about **6 months** of sales in inventory last year, with ongoing destocking [3][10] - **Import Substitution**: - CLIA: Accelerated by volume-based procurement (VBP) in Q325, with domestic brands gaining acceptance in grade A tertiary hospitals [3][14] - Clinical Chemistry: Stable competitive landscape with significant domestic brand share [3][14] - Haematology: Import substitution noted in lower-tier markets and some top-tier hospitals [3][14] Future Market Growth Estimates - **2026 Outlook**: - CLIA: Expected market size shrinkage of **10%+ YoY** due to new reagent prices [4][12] - Clinical Chemistry: Anticipated growth below **5%** in 2026 [4][13] - Haematology: Expected growth around **10%** in 2026, with low likelihood of VBP [4][13] - Haemostasis: Potential for **10%** growth in 2026 without VBP [4][13] Impact of Policies and Pricing - **Test Unbundling Policy**: - Expected to lead to **~15%** volume decline for CLIA and **~5%** for clinical chemistry in Q325 [16] - Anticipated policy impact to fade by Q425 [16][17] - **VBP for Tumour Biomarkers and Thyroid Function Reagents**: - Implementation expected to start in October 2025, with price cuts of **20%+** for tumour markers and **10%+** for thyroid function reagents [18][19] Risks and Challenges - **Risks**: - Larger-than-expected price reductions and smaller-than-expected market share gains from VBP programs [23] - Weaker demand from equipment renewal programs and geopolitical risks affecting supply chains [23] Additional Insights - **Market Share Potential**: - Mindray could gain **2%** market share annually in the CLIA market over the next three years [15] - **Focus on High-Fee Tests**: - Tests with high fees, particularly CLIA tests, are likely to be prioritized for upcoming fee corrections [21][22] This summary encapsulates the key insights from the expert call regarding the current state and future outlook of China's IVD market, highlighting significant trends, challenges, and opportunities within the industry.