生物製药市场机会、成长动力、产业趋势分析及 2025 - 2034 年预测

2024 年全球生物製药市场价值为 4,225 亿美元，预计到 2034 年将以 8.2% 的复合年增长率增长至 9,215 亿美元，这得益于慢性病和罕见患者病率的上升，以及对生物製剂和精准治疗的需求不断增加。随着全球医疗保健系统转向个人化治疗，生物製药因其在分子层面上针对疾病机制的能力而获得发展动力。生物技术的快速进步——尤其是基因编辑、细胞疗法和下一代蛋白质工程等领域——为治疗曾经被认为无法治癒的疾病开闢了新的可能性。

生活方式相关疾病的负担日益加重、人口老化以及肿瘤学、神经病学和免疫学领域未满足的临床需求继续推动全球需求。政府和私人投资者正在向研发投入大量资金，推动创新管道并加快药物开发时间表。监管机构也采取了加快审批途径，以便更快地将救命的治疗方法推向市场，进一步促进成长。随着生物相似药和数位疗法进入主流医疗保健，各地区复杂治疗的可负担性和可近性正在提高，重塑了全球生物製药领域的竞争格局。

细胞和基因疗法等生物技术的突破正在改变肿瘤学、免疫学和神经病学的治疗模式。生物相似药正变得越来越普及，提高了可负担性并扩大了获得救命生物製剂的机会。高成本生物製剂的生物相似药日益增多，有助于解决药物可近性问题，尤其是在发展中市场。 mRNA技术的创新也正在重新定义疾病预防和治疗方案，为该领域的快速扩张做出重大贡献。在药物研发和临床试验中采用人工智慧和数位平台正在简化操作并提高药物研发的成功率。

按产品类型划分，单株抗体领域在 2023 年创造了 2,250 亿美元的收入，这得益于其在治疗癌症、自体免疫疾病和传染病等复杂健康状况方面的高效性和特异性。该领域强劲的市场表现归功于持续的研究和开发、生物药物审批的增加以及治疗应用的扩大。抗体工程的不断进步和多种适应症的临床突破正在推动全球对单株抗体疗法的需求。

在应用方面，肿瘤学领域在 2024 年占据了 30.9% 的显着市场。随着治疗变得更加有针对性和有效性，生物製药在癌症治疗中的应用正在迅速扩大。全球癌症负担日益加重，推动了对提供分子精度和免疫系统调节的生物疗法的需求。阻止肿瘤进展和干扰癌细胞讯号传导的创新方法正在重塑癌症治疗模式，进一步推动该领域的成长。

2023 年，美国生物製药市场产值达 1,552 亿美元。其领先地位得益于强有力的监管政策、先进的研究基础设施以及生物技术公司、製药巨头和学术机构之间的合作。该国对基因编辑、生物製剂和个人化医疗的关注巩固了其全球地位。强劲的研发投入和先进治疗平台的快速采用继续推动该地区的市场扩张。

全球生物製药市场的主要活跃参与者包括默克、强生、辉瑞、葛兰素史克、山德士、武田製药、拜耳、安进、赛诺菲、罗氏、诺华、阿斯特捷利康、诺和诺德、艾伯维、百健、礼来和百时美施贵宝。这些公司透过扩大产品线、收购生物技术新创公司和建立策略全球合作伙伴关係来增强其市场影响力。对研发、治疗多样化以及临床试验和药物输送优化的数位化整合进行大量投资仍然是重中之重。与研究机构和医疗保健提供者的合作正在加速监管部门的审批，并确保创新疗法更快上市。

目录

第一章：方法论与范围

第二章：执行摘要

第三章：行业洞察

• 产业生态系统分析
• 产业衝击力
  • 成长动力
    • 慢性病盛行率上升
    • 生物技术和基因治疗的进展
    • 生物相似药的采用日益增多
  • 产业陷阱与挑战
    • 生产和开发成本高
    • 监管和审批的复杂性
• 成长潜力分析
• 监管格局
• 波特的分析
• PESTEL分析

第四章：竞争格局

• 介绍
• 公司矩阵分析
• 公司市占率分析
• 主要市场参与者的竞争分析
• 竞争定位矩阵
• 策略仪表板

第五章：市场估计与预测：依产品类型，2021-2034

• 主要趋势
• 单株抗体
• 疫苗
• 荷尔蒙
• 促红血球生成素
• 胰岛素
• 生长和凝血因子
• 干扰素
• 其他产品类型

第六章：市场估计与预测：按应用，2021-2034

• 主要趋势
• 肿瘤学
• 血液疾病
• 传染病
• 代谢性疾病
• 心血管疾病
• 神经系统疾病
• 免疫学
• 其他应用

第七章：市场估计与预测：依药物类型，2021-2034

• 主要趋势
• 专有（品牌）
• 生物相似药

第八章：市场估计与预测：按製造类型，2021-2034 年

• 主要趋势
• 外包
• 内部

第九章：市场估计与预测：按管理路线，2021-2034

• 主要趋势
• 注射剂
• 口服
• 其他给药途径

第 10 章：市场估计与预测：按处方类型，2021-2034 年

• 主要趋势
• 处方药
• 非处方药

第 11 章：市场估计与预测：按配销通路，2021-2034 年

• 主要趋势
• 医院药房
• 药局和零售药局
• 网路药局

第 12 章：市场估计与预测：按地区，2021 年至 2034 年

• 主要趋势
• 北美洲
  • 我们
  • 加拿大
• 欧洲
  • 德国
  • 英国
  • 法国
  • 西班牙
  • 义大利
  • 荷兰
• 亚太地区
  • 中国
  • 日本
  • 印度
  • 澳洲
  • 韩国
• 拉丁美洲
  • 巴西
  • 墨西哥
  • 阿根廷
• 中东和非洲
  • 南非
  • 沙乌地阿拉伯
  • 阿联酋

第十三章：公司简介

• AbbVie
• Amgen
• AstraZeneca
• Bayer
• Biogen
• Bristol-Myers Squibb
• Eli Lilly
• F. Hoffmann-La Roche
• GlaxoSmithKline
• Johnson & Johnson
• Merck
• Novartis
• Novo Nordisk
• Pfizer
• Sanofi
• Sandoz
• Takeda Pharmaceutical

The Global Biopharmaceutical Market was valued at USD 422.5 billion in 2024 and is estimated to grow at a CAGR of 8.2% to reach USD 921.5 billion by 2034, driven by the rising prevalence of chronic illnesses and rare diseases, along with increasing demand for biologics and precision therapies. As healthcare systems worldwide shift toward personalized treatment, biopharmaceuticals are gaining momentum for their ability to target disease mechanisms at the molecular level. The rapid advancements in biotechnology-especially in areas like gene editing, cell therapies, and next-gen protein engineering-are unlocking new possibilities for treating conditions once considered incurable.

The growing burden of lifestyle-related diseases, aging populations, and unmet clinical needs in oncology, neurology, and immunology continue to propel global demand. Governments and private investors are pouring significant capital into R&D, boosting innovation pipelines and accelerating drug development timelines. Regulatory agencies are also adopting expedited approval pathways to bring life-saving treatments to market faster, further encouraging growth. As biosimilars and digital therapeutics enter mainstream healthcare, affordability and access to complex treatments are improving across various regions, reshaping the competitive landscape of the global biopharmaceutical space.

Breakthroughs in biotechnology, such as cell and gene therapies, are transforming the treatment landscape for conditions in oncology, immunology, and neurology. Biosimilars are becoming more widely available, improving affordability and expanding access to life-saving biologics. The growing availability of biosimilar versions of high-cost biologics is helping address drug accessibility issues, especially in developing markets. Innovations in mRNA technology are also redefining disease prevention and treatment protocols, contributing significantly to the sector's rapid expansion. The adoption of AI and digital platforms in drug discovery and clinical trials is streamlining operations and enhancing success rates across drug pipelines.

By product type, the monoclonal antibodies segment generated USD 225 billion in 2023, owing to their high efficacy and specificity in managing complex health conditions like cancer, autoimmune diseases, and infectious ailments. The strong market performance of this segment is attributed to continuous research and development, increasing approvals for biologic drugs, and broadening therapeutic applications. Ongoing advancements in antibody engineering and clinical breakthroughs across multiple indications are fueling the demand for monoclonal antibody therapies worldwide.

On the application front, the oncology segment held a significant market share of 30.9% in 2024. The use of biopharmaceuticals in cancer care is expanding rapidly as treatments become more targeted and effective. The growing global cancer burden is pushing the demand for biologic-based therapies that offer molecular precision and immune system modulation. Innovative approaches that block tumor progression and interfere with cancer cell signaling are reshaping the cancer treatment paradigm, further driving growth in this segment.

The U.S. Biopharmaceutical Market generated USD 155.2 billion in 2023. Its leadership is supported by robust regulatory policies, cutting-edge research infrastructure, and collaborations among biotech firms, pharmaceutical giants, and academic institutions. The country's focus on gene editing, biologics, and personalized medicine has strengthened its global position. Strong R&D investments and rapid adoption of advanced therapy platforms continue to fuel market expansion across the region.

Key players active in the Global Biopharmaceutical Market include Merck, Johnson & Johnson, Pfizer, GlaxoSmithKline, Sandoz, Takeda Pharmaceutical, Bayer, Amgen, Sanofi, F. Hoffmann-La Roche, Novartis, AstraZeneca, Novo Nordisk, AbbVie, Biogen, Eli Lilly, and Bristol-Myers Squibb. These companies are enhancing their market presence by expanding product pipelines, acquiring biotech startups, and forming strategic global partnerships. Heavy investments in R&D, therapeutic diversification, and digital integration for clinical trials and drug delivery optimization remain top priorities. Collaborations with research institutions and healthcare providers are accelerating regulatory approvals and ensuring faster time-to-market for innovative therapies.

Table of Contents

Chapter 1 Methodology and Scope

• 1.1 Market scope and definitions
• 1.2 Research design
  • 1.2.1 Research approach
  • 1.2.2 Data collection methods
• 1.3 Base estimates and calculations
  • 1.3.1 Base year calculation
  • 1.3.2 Key trends for market estimation
• 1.4 Forecast model
• 1.5 Primary research and validation
  • 1.5.1 Primary sources
  • 1.5.2 Data mining sources

Chapter 2 Executive Summary

• 2.1 Industry 360⁰ synopsis

Chapter 3 Industry Insights

• 3.1 Industry ecosystem analysis
• 3.2 Industry impact forces
  • 3.2.1 Growth drivers
    • 3.2.1.1 Rising prevalence of chronic diseases
    • 3.2.1.2 Advancements in biotechnology and gene therapy
    • 3.2.1.3 Growing adoption of biosimilars
  • 3.2.2 Industry pitfalls and challenges
    • 3.2.2.1 High production and development costs
    • 3.2.2.2 Regulatory and approval complexities
• 3.3 Growth potential analysis
• 3.4 Regulatory landscape
• 3.5 Porter's analysis
• 3.6 PESTEL analysis

Chapter 4 Competitive Landscape, 2024

• 4.1 Introduction
• 4.2 Company matrix analysis
• 4.3 Company market share analysis
• 4.4 Competitive analysis of major market players
• 4.5 Competitive positioning matrix
• 4.6 Strategy dashboard

Chapter 5 Market Estimates and Forecast, By Product Type, 2021-2034 ($ Mn)

• 5.1 Key trends
• 5.2 Monoclonal antibody
• 5.3 Vaccine
• 5.4 Hormone
• 5.5 Erythropoietin
• 5.6 Insulin
• 5.7 Growth and coagulation factor
• 5.8 Interferon
• 5.9 Other product types

Chapter 6 Market Estimates and Forecast, By Application, 2021-2034 ($ Mn)

• 6.1 Key trends
• 6.2 Oncology
• 6.3 Blood disorders
• 6.4 Infectious diseases
• 6.5 Metabolic diseases
• 6.6 Cardiovascular diseases
• 6.7 Neurological diseases
• 6.8 Immunology
• 6.9 Other applications

Chapter 7 Market Estimates and Forecast, By Drug Type, 2021-2034 ($ Mn)

• 7.1 Key trends
• 7.2 Proprietary (Branded)
• 7.3 Biosimilars

Chapter 8 Market Estimates and Forecast, By Manufacturing Type, 2021-2034 ($ Mn)

• 8.1 Key trends
• 8.2 Outsource
• 8.3 In-house

Chapter 9 Market Estimates and Forecast, By Route of Administration, 2021-2034 ($ Mn)

• 9.1 Key trends
• 9.2 Injectables
• 9.3 Oral
• 9.4 Other routes of administration

Chapter 10 Market Estimates and Forecast, By Prescription Type, 2021-2034 ($ Mn)

• 10.1 Key trends
• 10.2 Prescription medicines
• 10.3 Over the counter (OTC) medicines

Chapter 11 Market Estimates and Forecast, By Distribution channel, 2021-2034 ($ Mn)

• 11.1 Key trends
• 11.2 Hospital pharmacies
• 11.3 Drug stores and retail pharmacies
• 11.4 Online pharmacies

Chapter 12 Market Estimates and Forecast, By Region, 2021-2034 ($ Mn)

• 12.1 Key trends
• 12.2 North America
  • 12.2.1 U.S.
  • 12.2.2 Canada
• 12.3 Europe
  • 12.3.1 Germany
  • 12.3.2 UK
  • 12.3.3 France
  • 12.3.4 Spain
  • 12.3.5 Italy
  • 12.3.6 Netherlands
• 12.4 Asia Pacific
  • 12.4.1 China
  • 12.4.2 Japan
  • 12.4.3 India
  • 12.4.4 Australia
  • 12.4.5 South Korea
• 12.5 Latin America
  • 12.5.1 Brazil
  • 12.5.2 Mexico
  • 12.5.3 Argentina
• 12.6 Middle East and Africa
  • 12.6.1 South Africa
  • 12.6.2 Saudi Arabia
  • 12.6.3 UAE

Chapter 13 Company Profiles

• 13.1 AbbVie
• 13.2 Amgen
• 13.3 AstraZeneca
• 13.4 Bayer
• 13.5 Biogen
• 13.6 Bristol-Myers Squibb
• 13.7 Eli Lilly
• 13.8 F. Hoffmann-La Roche
• 13.9 GlaxoSmithKline
• 13.10 Johnson & Johnson
• 13.11 Merck
• 13.12 Novartis
• 13.13 Novo Nordisk
• 13.14 Pfizer
• 13.15 Sanofi
• 13.16 Sandoz
• 13.17 Takeda Pharmaceutical