全球及中国制药中的生物制造行业研究及十五五规划分析报告

Core Viewpoint - The article discusses the evolution and current state of biomanufacturing in the pharmaceutical industry, highlighting the shift from traditional chemical synthesis to biologically driven innovations, emphasizing the importance of advanced technologies and collaborative networks in enhancing production efficiency and meeting market demands [1][4][5]. Group 1: Industry Characteristics - Biomanufacturing utilizes living biological systems to produce complex biological molecules for therapeutic use, adhering to strict regulatory standards to ensure product safety and efficacy [1]. - The industry is experiencing a dual-track evolution in R&D, focusing on both molecular innovation and process optimization, leading to a blurred line between drug design and manufacturing processes [4]. - Key technological advancements include the transition to continuous production, digitalization, and platform-based processes, which enhance production efficiency and reduce costs [5]. Group 2: Market Size and Growth - The global biomanufacturing market is projected to grow from approximately $518.56 billion in 2024 to $952.18 billion by 2031, with a CAGR of 9.39% from 2025 to 2031 [9]. - In China, the biomanufacturing market is expected to expand from about $42.08 billion in 2024 to $86.16 billion by 2031, with a CAGR of 11.14% during the same period [9]. Group 3: Competitive Landscape - The biomanufacturing sector is dominated by major players such as Roche, Merck, and Johnson & Johnson, with the top five companies holding approximately 37% of the global market share [10]. - There is a trend towards outsourcing manufacturing to Contract Development and Manufacturing Organizations (CDMOs) to enhance flexibility and focus on core R&D activities [6]. Group 4: Opportunities and Drivers - The emergence of new therapeutic modalities, such as gene therapy and mRNA platforms, is driving significant market demand and creating high-value manufacturing requirements [11]. - Government policies and public health priorities are fostering domestic manufacturing capabilities, providing opportunities for companies involved in vaccine and critical drug production [11]. Group 5: Supply Chain Dynamics - The upstream segment of biomanufacturing includes essential supplies like equipment and raw materials, with multinational corporations dominating this space [16]. - The midstream segment focuses on the R&D and production of biological drugs, with a notable shift towards digital factories and modular production capabilities [17]. - The downstream segment primarily serves healthcare providers and patients, with government procurement and cold chain logistics playing crucial roles in distribution [18].