中国仿制药行业市场竞争加剧

Core Insights - The article discusses the impact of the "volume-based procurement" policy on the Chinese generic drug industry, highlighting increased competition and challenges such as product homogeneity and cost-cutting in production [2][3][11] Market Overview - The Chinese generic drug market has maintained a scale of approximately 900 billion yuan, with an increase in the number of companies and products intensifying market competition [2] - As of 2024, the number of generic drugs that have passed consistency evaluations or are considered equivalent has increased by over two-thirds compared to three years prior, primarily driven by a few companies and previously approved products [2][7] Regulatory Environment - The Chinese government has emphasized improving the quality of generic drugs as a key reform goal since 2015, with consistency evaluations becoming a prerequisite for participation in centralized procurement [4][5] - Despite the increase in evaluated products, a significant proportion of generic drugs have yet to meet the evaluation standards, indicating a low market concentration [5][7] Product Trends - In 2024, the number of evaluated or equivalent generic drug varieties reached 914, a significant increase from 543 in 2021, with 70% of these concentrated in 33% of companies [7] - The report indicates that the market for biosimilars is also experiencing similar trends, with over 50% of the 87 approved biosimilars being antibody biosimilars [11] Production Dynamics - The report notes a significant increase in the participation of contract manufacturing in centralized procurement, with 31% of selected products in the tenth round being produced by contract manufacturers, up from 3% in the second round [13][15] - The need for effective quality management and regulatory oversight in contract manufacturing has become increasingly critical as the industry faces pressures from policy changes and market competition [15][16]