医药生物行业出海专题报告：医药出海：竞争升级，顺势而为

Industry Investment Rating - The report maintains a "Recommend" rating for the pharmaceutical and biotechnology industry, driven by the growing momentum of domestic companies expanding overseas [2] Core Views - The dual factors of overseas market attractiveness and domestic market competition pressure are accelerating the overseas expansion of domestic pharmaceutical companies [2] - The pharmaceutical industry's overseas expansion is transitioning from APIs and generics to innovative drugs, with license-out becoming the dominant model for innovative drug exports [2][25] - Domestic medical device companies are entering a high-quality development phase in overseas markets, with product competitiveness gradually reaching global standards [2][43] - The global pharmaceutical market is expected to grow at a CAGR of 5.8% from 2021 to 2027, reaching $2 trillion, providing significant opportunities for domestic companies [19] Domestic Pharmaceutical Overseas Expansion - The overseas revenue of A-share pharmaceutical companies grew from 31.175 billion yuan in 2010 to 246 billion yuan in 2023, with a CAGR of 17.22% [4] - In 2023, the overseas revenue of A-share pharmaceutical companies accounted for 9.86% of total revenue, down 2.11 percentage points year-on-year [4] - The overseas gross profit margin of A-share pharmaceutical companies reached 42.59% in 2023, lower than the domestic gross profit margin of 50.30% [5] - Chemical pharmaceuticals, medical services, and medical devices are the top three sectors in terms of overseas revenue, contributing 974.86 billion yuan, 681.63 billion yuan, and 680.83 billion yuan respectively in 2023 [7] Pharmaceutical Export Trends - In 2023, China's pharmaceutical exports totaled $102.06 billion, a year-on-year decrease of 20.7%, with Western drugs accounting for 50% of total exports [10][11] - APIs accounted for $40.91 billion of exports in 2023, down 20.7% year-on-year, with a 24.7% drop in average export prices [12] - Medical device exports reached $45.52 billion in 2023, down 22.8% year-on-year, with traditional medical device exports (excluding pandemic-related products) declining by only 3.1% [13] - Traditional Chinese medicine (TCM) exports totaled $5.46 billion in 2023, down 3.3% year-on-year, with plant extracts accounting for 59.7% of TCM exports [14] Overseas Market Opportunities - The global pharmaceutical market is projected to grow from $1.4 trillion in 2021 to $2 trillion by 2027, driven by population growth, aging, and improved healthcare systems [19] - The US pharmaceutical market is the largest globally, with innovative drugs accounting for 79% of sales in 2021, compared to only 11% in China [19] - Overseas pricing advantages are significant, with US drug prices being 10 times higher than those in China, providing strong incentives for domestic companies to expand overseas [20][21] Innovative Drug Overseas Expansion - In 2023, domestic companies completed 70 license-out deals, with a total disclosed transaction value exceeding $46.5 billion, a 69% increase from 2022 [25][26] - Baili Heng's HER3/EGFR bispecific ADC deal with BMS reached a potential total value of $8.4 billion, setting a new record for domestic innovative drug license-out transactions [26] - Collaborative development and independent overseas expansion models are also gaining traction, with companies like BeiGene and Legend Biotech achieving significant milestones in the US and European markets [29][31] Medical Device Overseas Expansion - Domestic medical device companies are making breakthroughs in high-end markets, with products in imaging, ultrasound, and in-vitro diagnostics reaching global standards [2][43] - In 2023, China's medical device exports totaled 249.1 billion yuan, with Asia, North America, and Europe being the top three markets, accounting for 34.45%, 27.92%, and 26.06% respectively [49] - Mindray Medical and United Imaging Healthcare are leading the way in ultrasound and MRI technologies, with products comparable to those of global leaders like GE and Philips [45][47] API and Generic Drug Overseas Expansion - China is the largest API producer globally, with a market share of 30% in 2022, up from 9.3% in 2008 [38] - In 2023, China's API exports reached $40.91 billion, down 20.7% year-on-year, with export volume increasing by 5.4% despite a 24.7% drop in average prices [39] - India and the US are the top two export markets for Chinese APIs, accounting for 12.77% and 10.39% of total exports respectively [41]