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.
中国医疗器械 -专家电话会议要点:中国体外诊断(IVD)市场动态观察China Medtech _Expert call takeaways_ Pulse check on China's IVD market_ Deng_ Expert call takeaways_ Pulse check on China‘s IVD market