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
CATLCATL(SZ:300750)2025-09-29 03:06

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.