IVD出海

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华创医药周观点:IVD出海行业专题2025/10/18
华创医药组公众平台· 2025-10-18 14:09
Core Viewpoint - The IVD industry is experiencing rapid growth in domestic product registration and is increasingly focusing on international markets as a second growth curve, driven by domestic replacement and overseas expansion opportunities [13][17][27]. Market Review - The CITIC medical index fell by 2.60%, underperforming the CSI 300 index by 0.37 percentage points, ranking 14th among 30 primary industries [7]. - The top-performing stocks included Asia-Pacific Pharmaceutical, Duorui Pharmaceutical, and Guangsheng Tang, while the worst performers were Beida Pharmaceutical and Hualan Biological [7][11]. Industry and Stock Events - The IVD market is projected to grow significantly, with the global market expected to reach $128.2 billion by 2028, while China's IVD market is anticipated to grow to $8 billion [15][16]. - The registration of IVD products in China has shown robust growth, with a CAGR of 18.6% from 2021 to 2024, particularly in domestic products, which are expected to account for 80.5% of registrations by 2024 [14][17]. Overall Industry Perspective - The current valuation of the pharmaceutical sector is low, with public funds underweighting the sector. The industry is expected to benefit from macroeconomic factors and a recovery in demand for large-scale products [11]. - The domestic innovative drug sector is transitioning from quantity to quality, emphasizing differentiated products and internationalization [11]. - The medical device sector is witnessing a recovery in bidding volumes for imaging equipment and is expected to benefit from ongoing updates and overseas expansion [11]. IVD Industry Focus - The domestic IVD market is seeing accelerated replacement of imported products, with significant growth in the chemical luminescence segment, which is projected to grow at a CAGR of 15-20% from 2021 to 2025 [35]. - Companies like Mindray and New Industries are making significant strides in overseas markets, focusing on localization and expanding their product lines [32][35]. Company-Specific Developments - Mindray has strengthened its IVD capabilities through strategic acquisitions, enhancing its competitive edge in the international market [32]. - New Industries has successfully established a local operational model in India, which is now being replicated in other key markets, contributing to its overseas revenue growth [32][27]. - Ji'an Medical has rapidly expanded its brand presence in the U.S. market, leveraging its COVID-19 testing products to drive growth [33].
IVD出海行业专题:第146期:华创医药投资观点&研究专题周周谈-20251018
Huachuang Securities· 2025-10-18 12:12
Investment Rating - The report maintains a positive outlook on the IVD industry, highlighting the acceleration of domestic substitution and the potential for overseas expansion as key growth drivers [13][16]. Core Insights - The IVD market in China is experiencing rapid growth, with a significant increase in the registration of domestic products, indicating a strong trend towards domestic substitution [15][28]. - The global IVD market is projected to grow from $106.3 billion in 2023 to $128.2 billion by 2028, while China's IVD market is expected to grow from $5.9 billion to $8.0 billion in the same period, reflecting a higher growth rate compared to the global market [16][17]. - Chinese IVD companies are increasingly focusing on overseas markets, with strategies evolving from low-cost products to high-end offerings and local operational models [25][20]. Market Overview - The report notes that the IVD product registration in China has surged from 335 in 2021 to 662 in 2024, with a compound annual growth rate (CAGR) of 18.6%, and domestic products accounting for a growing share of the market [15][14]. - The domestic IVD market's substitution rate is accelerating, with significant representation from companies like Mindray and Wondfo in various diagnostic segments [15][13]. Regional Market Dynamics - The North American market represents the largest share of the global IVD market at 44.6%, followed by Europe at 31.4%, indicating substantial opportunities for Chinese companies to expand their presence [19][20]. - Emerging markets in Asia-Pacific are seen as critical entry points for Chinese IVD companies, with lower registration barriers and growing healthcare needs [20][22]. Company Strategies - Companies like Mindray and New Industries are actively pursuing overseas expansion through acquisitions and establishing local subsidiaries to enhance their market presence and operational capabilities [30][32]. - The report highlights the importance of localizing operations and adapting to regional market conditions as key strategies for successful international expansion [25][20]. Performance Metrics - In the first half of 2025, Chinese IVD companies reported higher growth rates in overseas revenues compared to domestic revenues, indicating a shift in focus towards international markets [28][27]. - Specific companies such as Mingde Biological and Nuo Wei Zhan have shown remarkable overseas revenue growth, with increases of 185.82% and 74.21% respectively [27][28].