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市场调查报告书
商品编码
1818079
2032 年生技药品和生物相似药市场预测:按产品类型、治疗领域、製造商、分销管道、最终用户和地区进行的全球分析Biologics & Biosimilars Market Forecasts to 2032 - Global Analysis By Product Type, Therapeutic Area, Manufacturing Source, Distribution Channel, End User, and By Geography |
根据 Stratistics MRC 的数据,全球生技药品和生物相似药市场预计在 2025 年达到 5,382 亿美元,到 2032 年将达到 1,2198.6 亿美元,预测期内复合年增长率为 12.4%。
生技药品是指利用活细胞或生物体製造的创新疗法,例如单株抗体、蛋白质和疫苗,用于治疗慢性和严重。生物相似药是在生技药品专利保护到期后研发的,其安全性、有效性和品质与生物製剂相似,从而确保相同的治疗效果。这些经济高效的选择扩大了患者获得重要疗法的管道。生技药品和生物相似药协同作用,透过推进医疗解决方案、降低治疗成本和改善整体临床疗效,提升医疗保健水准。
慢性病增多
在全球范围内,癌症、糖尿病和自体免疫疾病等慢性疾病的发生率不断上升,推动了对生技药品和生物相似药的需求。医疗保健系统优先考虑能够提高疗效、减少副作用的长期治疗方案。具有标靶作用机制的生技药品正成为疾病管理策略的核心。随着患者群体老化和诊断能力的提高,对生技药品的需求持续增长。生物相似药作为一种经济高效的替代方案,正日益受到青睐,尤其是在医疗保健预算紧张的市场。这种日益增长的需求正在加速整个生物製药产业的创新和投资。
开发和製造成本高
生技药品和生物相似药的开发涉及从细胞株工程到纯化和验证的复杂流程。严格的监管要求和漫长的临床试验时间进一步加剧了高成本。生产设施必须满足严格的品质标准,并且通常需要专业的基础设施和熟练的人员。低温运输物流和污染控制的需求进一步增加了营运成本。规模较小的公司面临进入壁垒,限制了竞争,并减缓了市场扩张。因此,定价仍然是一个挑战,尤其是在新兴国家。
研发和製造领域的技术进步
先进的分析技术和人工智慧驱动的建模技术正在加速药物研发并缩短开发週期。细胞培养基和表达系统的创新正在提高产量和产品一致性。自动化数位双胞胎正被用于优化设施运营并减少人为错误。这些进步正在降低成本,并实现复杂生技药品的可扩展生产。随着技术的成熟,提供具有竞争力的生物相似药产品的公司得以进入市场。
激烈的竞争和价格压力
专利到期导致多家製药公司进入该领域,加剧了价格竞争。法规虽然不断发展,但仍是阻碍市场进入和增加合规成本的障碍。付款人和医疗保健提供者要求降低价格,从而挤压了整个价值链的利润率。品牌忠诚度和医生对生物相似药的犹豫也影响了采用率。如果没有差异化和策略定位,企业将在日益商品化的环境中面临失去市场份额的风险。
COVID-19的影响
疫情扰乱了生技药品和生物相似药的临床试验、供应链和生产流程。封锁措施以及疫苗和紧急治疗资源的重新分配,推迟了与新冠疫情无关的产品上市。然而,这场危机凸显了生技药品在管理感染疾病和免疫反应的重要性。生物製药公司加速数位转型,并采用远端监控和分散式检测模式。各国政府和监管机构引入了灵活的框架,以维持药物研发的连续性。疫情后的策略越来越强调生技药品生产的韧性、敏捷性和全球协作。
生技药品领域预计将成为预测期内最大的细分市场
由于疗效卓越且适应症不断扩展,生技药品领域预计将在预测期内占据最大市场份额。单株抗体、重组蛋白和基因疗法正在获得广泛的临床认可。复杂疾病的日益普及推动了对生物目标疗法的需求。在可靠的临床数据和患者接受度的支持下,监管核准正在加速。生技药品的研发投入持续超过其他领域,巩固了其市场领先地位。随着生技药品的普及,其在全球生技药品支出中的份额预计将稳步上升。
生物製药公司部门预计在预测期内以最高复合年增长率成长
在积极创新和产品线不断拓展的推动下,生物製药公司预计将在预测期内实现最高成长率。这些公司利用先进的平台进行生技药品的合成、配製和递送。战略联盟和许可协议使其能够更快地进入市场并扩大地域覆盖范围。生物製药公司也正在投资生物相似药组合,以抓住专利到期后的机会。他们的敏捷性和对利基疗法的专注使其在持续成长方面占据有利地位。在个人化医疗需求日益增长的背景下,生物製药公司在生技药品开发方面处于主导。
受医疗保健支出成长和患者人数不断增加的推动,预计亚太地区将在预测期内占据最大的市场份额。中国、印度和韩国等国家正在大力投资,以更新生技药品基础设施和法规。国内製造商正在扩大生产规模,以满足国内和出口需求。政府倡议正在推动生物相似药的推广应用,以降低治疗成本。临床试验活动蓬勃发展,亚太地区正逐渐成为生技药品研究的中心。该地区的人口和经济动态是该行业的关键成长引擎。
在技术领先地位和强劲的生物製药投资的推动下,北美预计将在预测期内实现最高的复合年增长率。美国和加拿大正在透过产学研合作和联邦资金推动生技药品创新。监管机构正在简化生物相似药的核准途径,鼓励市场竞争。精准医疗和生技药品的应用正在各个治疗领域加速发展。数位健康整合和人工智慧主导的药物开发正在提高效率和疗效。
According to Stratistics MRC, the Global Biologics & Biosimilars Market is accounted for $538.20 billion in 2025 and is expected to reach $1219.86 billion by 2032 growing at a CAGR of 12.4% during the forecast period. Biologics are innovative therapies produced using living cells or organisms, such as monoclonal antibodies, proteins, and vaccines, that target chronic and severe diseases. Biosimilars, created after biologics lose patent protection, are close replicas in terms of safety, efficacy, and quality, ensuring similar therapeutic effects. These cost-effective options expand patient access to critical treatments. Together, biologics and biosimilars enhance healthcare by advancing medical solutions, reducing treatment costs, and improving overall clinical outcomes.
Rising prevalence of chronic diseases
The increasing global burden of chronic illnesses such as cancer, diabetes, and autoimmune disorders is fuelling demand for biologics and biosimilars. Healthcare systems are prioritizing long-term treatment solutions that offer improved efficacy and reduced side effects. Biologics, with their targeted mechanisms, are becoming central to disease management strategies. As patient population's age and diagnostic capabilities improve, the need for biologic therapies continues to rise. Biosimilars are gaining traction as cost-effective alternatives, especially in markets with strained healthcare budgets. This growing demand is accelerating innovation and investment across the biopharmaceutical landscape.
High development and manufacturing costs
Developing biologics and biosimilars involves complex processes, from cell line engineering to purification and validation. These high costs are compounded by stringent regulatory requirements and extended clinical trial timelines. Manufacturing facilities must meet rigorous quality standards, often requiring specialized infrastructure and skilled personnel. The need for cold chain logistics and contamination control further increases operational expenses. Smaller firms face barriers to entry, limiting competition and slowing market expansion. As a result, pricing remains a challenge, especially in emerging economies.
Technological advancements in R&D and manufacturing
Advanced analytics and AI-driven modelling are enhancing drug discovery and reducing development timelines. Innovations in cell culture media and expression systems are improving yield and product consistency. Automation and digital twins are being adopted to optimize facility operations and reduce human error. These advancements are lowering costs and enabling scalable production of complex biologics. As technology matures, more players can enter the market with competitive biosimilar offerings.
Intense competition and pricing pressure
Patent expirations are opening the door to multiple entrants, intensifying pricing battles. Regulatory pathways, while evolving, still pose hurdles that delay market access and increase compliance costs. Payers and healthcare providers are demanding lower prices, squeezing margins across the value chain. Brand loyalty and physician hesitancy toward biosimilars also impact adoption rates. Without differentiation and strategic positioning, companies risk losing market share in an increasingly commoditized landscape.
Covid-19 Impact
The pandemic disrupted clinical trials, supply chains, and manufacturing schedules for biologics and biosimilars. Lockdowns and resource reallocation toward vaccines and emergency treatments delayed non-COVID product launches. However, the crisis also highlighted the importance of biologics in managing infectious diseases and immune responses. Biopharma companies accelerated digital transformation, adopting remote monitoring and decentralized trial models. Governments and regulators introduced flexible frameworks to maintain continuity in drug development. Post-pandemic strategies now emphasize resilience, agility, and global collaboration in biologics manufacturing.
The biologics segment is expected to be the largest during the forecast period
The biologics segment is expected to account for the largest market share during the forecast period, its superior therapeutic outcomes and expanding indications. Monoclonal antibodies, recombinant proteins, and gene therapies are gaining widespread clinical acceptance. Increasing prevalence of complex diseases is driving demand for targeted biologic treatments. Regulatory approvals are accelerating, supported by robust clinical data and patient advocacy. Investment in biologics R&D continues to outpace other segments, reinforcing its market leadership. As biologics become more accessible, their share in global pharmaceutical spending is expected to rise steadily.
The biopharma companies segment is expected to have the highest CAGR during the forecast period
Over the forecast period, the biopharma companies segment is predicted to witness the highest growth rate, driven by aggressive innovation and pipeline expansion. These firms are leveraging advanced platforms for biologic synthesis, formulation, and delivery. Strategic collaborations and licensing agreements are enabling faster market entry and broader geographic reach. Biopharma players are also investing in biosimilar portfolios to capture post-patent opportunities. Their agility and focus on niche therapies position them well for sustained growth. As demand for personalized medicine increases, biopharma companies are leading the charge in biologics development.
During the forecast period, the Asia Pacific region is expected to hold the largest market share supported by rising healthcare expenditure and expanding patient populations. Countries like China, India, and South Korea are investing heavily in biologics infrastructure and regulatory modernization. Local manufacturers are scaling up production to meet domestic and export demand. Government initiatives are promoting biosimilar adoption to reduce treatment costs. Clinical trial activity is surging, with Asia Pacific emerging as a hub for biologics research. The region's demographic and economic dynamics make it a key growth engine for the industry.
Over the forecast period, the North America region is anticipated to exhibit the highest CAGR, furled by technological leadership and robust biopharma investment. The U.S. and Canada are advancing biologics innovation through academic-industry partnerships and federal funding. Regulatory agencies are streamlining approval pathways for biosimilars, encouraging market competition. Adoption of precision medicine and biologic therapies is accelerating across therapeutic areas. Digital health integration and AI-driven drug development are enhancing efficiency and outcomes.
Key players in the market
Some of the key players profiled in the Biologics & Biosimilars Market include Amgen, Sanofi, Pfizer, Eli Lilly, Novartis, Viatris, Biocon Biologics, AbbVie, Samsung Bioepis, Teva Pharmaceuticals, Celltrion, Fresenius Kabi, Roche, Boehringer Ingelheim, and Merck KGaA.
In September 2025, Novartis AG has reached an agreement to purchase the New York-based firm, Tourmaline Bio Inc., in a deal valued at a staggering $1.4 billion. This move is aimed at reducing systemic inflammation, which is termed a major driver of cardiovascular disease. Novartis has been on the lookout for deals that would amplify its sales beyond 2025.
In August 2025, Sanofi announces the completion of its acquisition of Vigil Neuroscience, Inc. This acquisition strengthens Sanofi's early-stage pipeline in neurology with VG-3927, a novel, oral, small-molecule TREM2 agonist, which will be evaluated in a phase 2 clinical study in patients with Alzheimer's disease. In addition, the acquisition of Vigil's preclinical pipeline will further strengthen Sanofi's research in various neurodegenerative diseases.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.