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肿瘤基因检测二次拐点
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中信证券:二次拐点已至,肿瘤基因检测处于爆发前夜
Xin Lang Cai Jing· 2026-01-19 00:54
Core Viewpoint - The Chinese tumor gene testing industry is expected to enter a second turning point due to new regulatory policies from the National Medical Products Administration, National Healthcare Security Administration, and National Health Commission, which will promote healthy industry development from 2026 to 2030, marking a golden development period for the sector [1][2]. Industry Overview - In 2022, China reported 4.82 million new cancer cases and 2.57 million cancer deaths, the highest globally. Tumor gene testing is primarily used for early screening, companion diagnosis, and prognosis monitoring [2][11]. - The upcoming policies will standardize the industry across multiple dimensions, including registration, pricing, insurance, and clinical application, leading to a new round of industry consolidation where smaller companies lacking qualifications, technology, and funding will be eliminated [2][11]. Comparison with Other Markets - The current stage of China's tumor gene testing industry is comparable to the mid-development phase of the U.S. market, particularly between 2010 and 2018. The expectation is for accelerated registration approvals and increased insurance coverage for next-generation sequencing (NGS) products in China [3][12]. - The U.S. market for tumor companion diagnostics is projected to reach $4 billion by 2030, with early screening and recurrence monitoring markets expected to reach $5.8 billion and $4.8 billion, respectively, totaling $14.6 billion. In contrast, China's market for companion diagnostics is expected to reach 5.7 billion yuan, early screening 3.3 billion yuan, and recurrence monitoring 3.6 billion yuan, totaling 12.6 billion yuan by 2030 [4][13]. Domestic and International Landscape - The industry is seeing the emergence of leading companies in specific segments, leading to a more stable market structure [5][14]. - Domestic companies are actively competing and improving their capabilities, with a complete industrial chain in place [6][15]. Investment Strategy - The complete industrial chain of China's tumor gene testing sector presents significant investment opportunities. The current recommendations include focusing on "gene sequencing providers" and "leading companies in tumor companion diagnostics" [8][17].