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市场调查报告书
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1820369

2025 年至 2033 年生物製剂市场规模、份额、趋势及预测（依来源、产品、疾病、製造及地区）

Biologics Market Size, Share, Trends and Forecast by Source, Product, Disease, Manufacturing, and Region, 2025-2033
出版日期: | 出版商: IMARC | 英文 135 Pages | 商品交期: 2-3个工作天内

价格

2024年，全球生物製剂市场规模达3,776亿美元。展望未来， IMARC Group预测，到2033年，市场规模将达到7,697亿美元，2025年至2033年期间的复合年增长率为7.38%。目前，北美占据市场主导地位，2024年的市占率将超过44.8%。慢性病盛行率的上升需要更有效的治疗方案，持续的技术进步促进了标靶治疗的发展，以及先进药物传递系统的出现，这些都是推动生物製剂市场份额增长的一些因素。

由于对创新疗法的需求不断增长以及生物技术的进步，全球生物製剂市场正在快速扩张。生物製剂是源自生物体的产品，此类产品包括单株抗体、疫苗、细胞和基因疗法以及重组蛋白。所有这些疗法都在改变医疗保健，因为它们为糖尿病、癌症和自体免疫疾病等慢性疾病提供了有针对性且有效的治疗方案。慢性病发病率的上升以及老龄化人口的增加，大大推动了生物製剂的应用。此外，研发投入正在加速下一代生物製剂（包括生物相似药）的上市，这些生物製剂提供了具有成本效益的替代方案。法规和审批的支持也为生物製剂市场的成长铺平了道路。

美国已成为生物製剂的重要区域市场。创新疗法需求的不断增长、生物技术的进步以及人们对个人化医疗日益增长的兴趣，共同推动着生物製剂市场的发展。癌症、自体免疫疾病和糖尿病等慢性病的高发生率，推动了生物治疗的需求。生物相似药的进一步扩张以及生物製剂替代传统药物的趋势，正在进一步推动市场成长。根据生物製剂市场分析报告，在政府利好政策的支持下，製药公司在研发方面的投资稳定成长，促进了市场的成长。此外，医疗基础设施和报销政策的改善进一步提高了生物製剂的可近性。此外，对精准医疗和生物製剂未来发展的关注将有助于美国市场稳步成长。

生物製剂市场趋势：

标靶治疗的持续创新

复杂分子生物製剂市场的一个重要趋势是标靶治疗的不断创新。这些疗法旨在专门作用于导致疾病的某些细胞或分子，从而提高治疗效果并最大限度地减少副作用。鑑于癌症和自体免疫疾病等疾病的严重性，标靶治疗提供了一种新颖而有效的治疗途径。根据欧洲肿瘤内科学会的数据，2006 年至 2020 年间，共有 51 种药物获得 72 次批准，针对 18 种癌症的 36 种基因组适应症，这使基因组标靶治疗的适用性从 5.13% 提高到 13.60%，反应率从 2.73% 提高到 2.73% 提高到 2.73%。同时，基因组资讯疗法将适用性从 10.70% 提高到 27.30%，反应率从 3.33% 提高到 11.10%。例如，2024年3月，加州理工学院的研究人员发明了一种超音波活化的药物传递系统，专注于将副作用降至最低的癌症治疗。该技术结合了气体囊泡和机械响应性分子来活化药物，从而精准地减少对健康组织的伤害。同样，《自然医学》杂誌于2024年3月发布了一项报告，研究了復发性胶质母细胞瘤（rGBM）患者接受鞘内注射二价嵌合抗原受体T细胞（T细胞）的结果。这些T细胞是自体的，具有双重靶向两种蛋白质的功能：表皮生长因子受体（EGFR）和白细胞介素-13受体α2（IL13Ra2）。这些标靶T细胞能够抑制侵袭性脑肿瘤的生长。大规模科学研究已经能够在分子层面上揭示疾病的机制，从而提供了一种比传统方法更有效、更毒性更低的专门治疗方法。这一趋势可能带来研发投入的增加，以及对个人化医疗的更多关注。它们的推出及其后续成功可以显着增加对复杂分子的需求，从而成为市场的关键催化剂。人们对疗效更高、毒性更低的精准治疗的偏好日益增长，这加速了市场对标靶生物製剂的需求。

先进药物输送系统的出现

药物输送系统在医疗保健领域的重要性日益凸显，它通常决定复杂分子治疗的疗效和患者依从性。该领域的创新形式多样，从控释机製到基于奈米技术的输送系统。据报道，到2024年，奈米技术的全球市场规模预计将超过1,250亿美元。奈米技术将透过促进标靶药物传递、增强癌症治疗以及提高生物分子的稳定性和有效性，彻底改变生物製剂。例如，北卡罗来纳大学的科学家于2024年1月推出了「时空按需贴片」（SOP），这是一种类似创可贴的无线药物输送系统。此无线贴片可以接收来自电脑或智慧型手机的指令，并透过微针进行调度和控制给药。这将使患者更容易遵循治疗计划，从而在临床实践中获得更好的疗效。新的输送系统最终可能会以每週甚至每月的剂量取代每日註射，显着提高患者的便利性和继续接受治疗的意愿。大量资金正投入到生物製剂的研发中，旨在最大限度地提高复杂分子的治疗效率。此类药物递送系统研究的进展显着提升了生物製剂市场的价值，并带来了成长机会，满足了人们对更高效、更患者友好的治疗方案的巨大需求。这种创新驱动的环境反映出，人们对符合以病人为中心的照护模式的递送方法的需求日益增长。

监理变化与协调

医疗保健产业的公司不得不应对错综复杂、异常艰难的监管环境。然而，监管协调正在使情况变得更加明朗。美国食品药物管理局（FDA）与国际协调理事会（ICH）合作，于2023年7月发布了名为「良好临床实践（GCP）E6(R3)」的指南草案，该草案指出，该草案的实施旨在「提供统一的标准，促进ICH成员国和地区之间临床资料的相互认可，从而增强临床试验的创新性和效率」。透过不同国家之间统一或相互认可的审批流程，市场准入门槛大幅降低，这意味着新产品和现有产品现在可以比以往更快地覆盖更广泛的患者群体。创新疗法的快速推广及其显着的地域扩展具有重要意义。这种监管实践的良好协调加快了审批速度并扩大了市场准入，正在推动全球复杂生物製剂分子市场的持续成长，从而创造积极的生物製剂市场前景。这些监管简化措施也鼓励全球製造商更积极投资跨境生物製剂开发。

目录

第一章：前言

第二章：范围与方法

  • 研究目标
  • 利害关係人
  • 资料来源
    • 主要来源
    • 二手资料
  • 市场评估
    • 自下而上的方法
    • 自上而下的方法
  • 预测方法

第三章：执行摘要

第四章：简介

第五章：全球生物製剂市场

  • 市场概况
  • 市场表现
  • COVID-19的影响
  • 市场预测

第六章：市场区隔：依来源

  • 微生物
  • 哺乳动物
  • 其他的

第七章：市场区隔：依产品

  • 单株抗体
  • 疫苗
  • 重组蛋白
  • 反义、RNAi和分子治疗
  • 其他的

第八章：市场区隔：依疾病

  • 肿瘤学
  • 免疫疾病
  • 心血管疾病
  • 血液系统疾病
  • 其他的

第九章：市场区隔：依製造业

  • 外包
  • 内部

第十章：市场细分：按地区

  • 北美洲
    • 美国
    • 加拿大
  • 亚太
    • 中国
    • 日本
    • 印度
    • 韩国
    • 澳洲
    • 印尼
    • 其他的
  • 欧洲
    • 德国
    • 法国
    • 英国
    • 义大利
    • 西班牙
    • 俄罗斯
    • 其他的
  • 拉丁美洲
    • 巴西
    • 墨西哥
    • 其他的
  • 中东和非洲

第 11 章：SWOT 分析

第 12 章：价值链分析

第 13 章：波特五力分析

第 14 章：价格分析

第 15 章：竞争格局

  • 市场结构
  • 关键参与者
  • 关键参与者简介
    • AbbVie Inc.
    • Amgen Inc.
    • AstraZeneca plc
    • F. Hoffmann-La Roche Ltd
    • GlaxoSmithKline plc
    • Johnson & Johnson
    • Merck KGaA
    • Novartis AG
    • Pfizer Inc.
    • Sanofi
Product Code: SR112025A3883

The global biologics market size was valued at USD 377.6 Billion in 2024. Looking forward, IMARC Group estimates the market to reach USD 769.7 Billion by 2033, exhibiting a CAGR of 7.38% from 2025-2033. North America currently dominates the market, holding a market share of over 44.8% in 2024. The rising prevalence of chronic diseases, which necessitate more effective treatment options, continuous technological advancements facilitating the development of increasingly targeted therapies, and the emergence of advanced drug delivery systems are some of the factors catalyzing the biologics market share.

The global biologics market is expanding at a very fast pace due to the increasing demand for innovative therapies and biotechnology advancement. Biologics are products that derive from living organisms, and such products include monoclonal antibodies, vaccines, cell and gene therapies, and recombinant proteins. All of these therapies are altering health care since they bring focused, effective treatments for chronic diseases such as diabetes, cancer and autoimmune diseases. The increasing incidence of chronic diseases, along with the geriatric population, is highly driving the uptake of biologics. Furthermore, investments in research and development are fast-tracking the launch of next-generation biologics, including biosimilars, which provide cost-effective alternatives. Support from regulations and approvals has also paved the way for the biologics market growth.

The United States has emerged as a key regional market for biologics. The market is fueled by growing demand for innovative therapies, advancements in biotechnology, and increasingly interested in personalized medicine. The high incidence of chronic conditions, such as cancer, autoimmunity disorders, and diabetes, is driving the demand for biological treatments. The further expansion of biosimilars and the trend toward more use of biologic medicines over traditional pharmaceuticals is fueling further market growth. As per the biologics market analysis report, steadily growing investment research and development by pharmaceutical companies in support of favorable government policies promote growth in the market. Moreover, improvement in infrastructure for healthcare and reimbursement policy further enhances the availability of biological drugs. Further, a focus on precision medicine and the future of biologics is going to help the U.S. market grow steadily.

Biologics Market Trends:

Continuous innovations in targeted therapies

One of the significant biologics market trends for complex molecules is the continuous innovation in targeted therapies. These are therapies designed to specifically act on certain cells or molecules responsible for disease, thus increasing treatment effectiveness while minimizing side effects. Given the critical nature of diseases like cancer and autoimmune disorders, targeted therapies offer a novel and effective avenue for treatment. According to the European Society for Medical Oncology, between 2006 and 2020, there were 72 approvals for 51 drugs targeting 36 genomic indications across 18 types of cancer, which increased eligibility for genome-targeted therapies from 5. 13% to 13. 60% and increased response rates from 2. 73% to 7. 04%. Meanwhile, genome-informed therapies increased eligibility from 10. 70% to 27. 30% and response rates improved from 3. 33% to 11. 10%. For example, in March 2024, Caltech researchers created an ultrasound-activated drug-delivery system that focused on cancer treatment with minimum side effects. This technique combines gas vesicles and mechanophores to activate drugs, thereby reducing harm to healthy tissues precisely. Similarly, Nature Medicine released its report in March 2024 on the results of patients with recurrent glioblastoma (rGBM) treated intrathecally with bivalent chimeric antigen receptor T-cells, being autologous, with dual targeting of two proteins: epidermal growth factor receptor (EGFR), interleukin-13 receptor alpha 2 (IL13Ra2). These targeted T-cells against aggressive brain tumor growth end. Science research in large scales has been able to reveal mechanisms of diseases at the molecular level, and thus a treatment approach has been provided with specialized therapies that are much more effective and less toxic than traditional approaches. This trend is likely to see increased investments in research and development, along with a heightened focus on personalized medicine. Their introduction and subsequent success can significantly increase the demand for complex molecules, thereby acting as a critical catalyst for the market. The rising preference for precision treatments that offer higher efficacy and lower toxicity is accelerating market demand for targeted biologics.

Emergence of advanced drug delivery systems

Drug delivery systems have become increasingly important in healthcare, often determining the efficacy and patient compliance for complex molecular treatments. Innovation in this field takes many forms, from controlled-release mechanisms to nanotechnology-based delivery systems. According to reports, nanotechnology is expected to cross USD 125 Billion worldwide by 2024, which transforms biologics by facilitating targeted drug delivery, boosting cancer therapies, and increasing the stability and effectiveness of biomolecules. An example includes scientists from the University of North Carolina, who, in January 2024, launched the Spatiotemporal On-Demand Patch SOP, a wireless drug delivery system that resembles a band-aid. The wireless patch can receive commands from the computer or smartphone, where its delivery can be scheduled and controlled on the microneedle. This will allow a patient to follow the plan for their treatment much easier, leading to better outcomes in clinical practice. New delivery systems might eventually replace daily injections with a weekly or even a monthly dose, significantly increasing patient convenience and willingness to stay on treatment. Major investments are pouring into their research and development with the intention of maximizing the therapeutic efficiency of complex molecules. Such research in drug delivery systems advances significantly contribute to the biologics market value and opportunities for growth in satisfying a huge demand for more efficient, patient-friendly therapeutic alternatives. This innovation-driven environment reflects growing demand for delivery methods that align with patient-centric care models.

Regulatory changes and harmonization

Companies in the healthcare industry have had to grapple with a very difficult, labyrinthine regulatory environment. However, regulatory harmonization is making the scenario increasingly straightforward. The draft guidance of July 2023 from the US Food and Drug Administration, titled "Good Clinical Practice (GCP) E6(R3)", in cooperation with the International Council for Harmonisation (ICH), says it has been put in place "to provide a unified standard to facilitate mutual acceptance of clinical data between ICH member countries and regions in order to enhance more innovative and efficient design of clinical trials.". Reduced substantially, market entry barriers through unified or mutually recognized approval processes across different countries mean new and existing products can now easily reach a much wider patient base much sooner than they previously could. The rapid rollout of innovative therapies to patients and their significant geographic expansion has significant implications. This favorable alignment of regulatory practices, which expedites approval and expands market access, is driving ongoing growth in the global market for complex biologics molecules, thereby creating a positive biologics market outlook. These regulatory streamlining efforts are also encouraging global manufacturers to invest more aggressively in cross-border biologics development.

Biologics Industry Segmentation:

Analysis by Source:

  • Microbial
  • Mammalian
  • Others

The microbial sources account for a majority share of 58.5% driven mainly by their cost-effectiveness, scalability, and high productivity in biologics manufacture. Microorganisms such as E. coli and yeast are very widespread to produce recombinant proteins, enzymes, and vaccines because they produce at very fast growth rates and because of simpler genetic manipulation. The manufacture of biologics involving minimal post-translational modification is very good with the system, and therefore, they dominate insulin, growth hormones, and certain therapeutic enzymes. Advances in the technological aspects of fermentation systems and bioprocessing techniques have further increased yield and efficiency, thus making microbial platforms even more attractive. Increasing demand for biosimilars and the trend of precision medicine continue to fuel investment in microbial technologies. Pharmaceutical companies also prefer microbial systems as they help them meet regulatory compliance while lowering production costs. These factors will ensure the continued dominance of microbial platforms in biologics manufacturing.

Analysis by Product:

  • Monoclonal Antibodies
  • Vaccines
  • Recombinant Proteins
  • Antisense, RNAi, and Molecular Therapy
  • Others

Monoclonal antibodies represent the largest segment with a share of 66.7% due to their crucial role in cancer, autoimmune diseases, and infectious disorders. The accuracy in the specificity of targeting antigens has placed them in a position as indispensable in personalized medicine. New areas of improvement in antibody engineering include bispecific antibodies and antibody-drug conjugates, which improve the efficacy of the therapeutic products. More investments in R&D have accelerated the regulatory approvals of these products, and they are increasingly being applied in clinical practice. The growing adoption of biosimilar monoclonal antibodies offers cost-effective solutions, widening their accessibility and further fueling market expansion. With ongoing innovation and the rising prevalence of chronic diseases, monoclonal antibodies remain a cornerstone of biologics development and commercialization, ensuring sustained growth.

Analysis by Disease:

  • Oncology
  • Immunological Disorders
  • Cardiovascular Disorders
  • Hematological Disorders
  • Others

The oncology segment holds the largest share of 28.7%, supported by a global rise in cancer prevalence and the increasing adoption of targeted therapies. Advances in biologic products such as monoclonal antibodies, checkpoint inhibitors, and cell-based therapies offer improved survival advantages and quality of life as a part of cancer care. Investment in precision medicines and innovative developments in immuno-therapies also augment growth in this space. Further regulatory approval of new biologic products for varied types of cancers drives demand and supports growth in this market. As biologics demonstrate efficacy in managing and perhaps even curing cancers, their application within oncology remains on track, making it the most profitable segment in the market for biologics.

Analysis by Manufacturing:

  • Outsourced
  • In-House

In-house manufacturing leads the market with an 84.8% share, driven by the need to have greater control over production processes, intellectual property protection, and regulatory standards that are quite stringent. Companies using the in-house capacity can directly control quality assurance, respond quicker to production problems, and maintain integration with internal R&D teams. This also contributes to cost optimization in the long run by eliminating dependency on other partners. Such capability to streamline operations with proprietary knowledge, especially about high-value biologics, gives the advantage to in-house manufacturing. More importantly, modular and continuous manufacturing technologies have advanced with which companies have developed means to enhance scalability as well as efficiency, where different production demands can be met accordingly, but they do not have any external dependence on partners.

Regional Analysis:

  • North America
    • United States
    • Canada
  • Asia Pacific
    • China
    • Japan
    • India
    • South Korea
    • Australia
    • Indonesia
    • Others
  • Europe
    • Germany
    • France
    • United Kingdom
    • Italy
    • Spain
    • Russia
    • Others
  • Latin America
    • Brazil
    • Mexico
    • Others
  • Middle East and Africa

North America held the highest share in 2024, with over 44.8%. North America dominates the market due to its developed healthcare infrastructure and increased investments in biopharmaceutical research. It contains numerous top biopharmaceutical companies and research organizations. Such innovation by various entities in the region creates an optimistic outlook for the market. Favorable regulatory support in the form of fast-track approvals for biologics and various financial incentives for extensive research and development activities are also contributing to the market growth. Furthermore, increasing patient awareness and willingness to adopt new therapies are further fueling the demand for biologics in North America. The U.S. also constitutes the biggest market in the region, primarily due to high healthcare spending, broad insurance coverage, and increasing chronic and lifestyle-related diseases.

Advanced demand for biologic therapies, accelerating healthcare, and improving infrastructure for healthcare drive the Asia Pacific biologics market. The increasing prevalence of chronic diseases coupled with an increased awareness about, and affordability of, biologics is promoting growth in the market. Government incentives to develop biosimilars are also driving market growth and have surged healthcare expenditure in the nations of China and India. A huge patient population and increasing research and development are two of the primary drivers of this market growth in the region.

In Europe, a well-developed healthcare system with higher accessibility toward advanced biologic treatment enhances the market growth for biologics. A high rate of incidence of autoimmune diseases, cancer, and other chronic conditions stimulates the need for biologics. Governments' support with positive regulation sets an impetus to accept biosimilars. The region's focus on research and innovation with a strong healthcare infrastructure provides the right environment to grow in biologics. In addition, increased expenditure on healthcare, as well as collaborative efforts between the public and private sectors, contribute to the momentum of this market.

In Latin America, better access to healthcare is fueling the growth of biologics. The region is also witnessing increased investments in the healthcare sector and a greater prevalence of chronic diseases. Affordability and access to biologics are improving through the efforts of governments, thereby increasing demand. Biosimilar adoption is also increasing along with regional initiatives that help cut drug costs. Brazil, Mexico, and Argentina are some of the major contributors to this growth due to increasing awareness about biologics and the expansion of healthcare markets, which attracts investments from multinational pharmaceutical companies.

The biologics market of the Middle East and Africa is expanding due to increasing health investments in the region, development in healthcare facilities, and greater demand for advanced therapies. More chronic diseases are being noticed in the region, including diabetic conditions, cardiovascular disease, and cancer, which is making the demand for these biologic drugs rise. The government is also investing in healthcare reforms to make access to biologics better, especially in countries like the UAE, Saudi Arabia, and South Africa. The use of biosimilars and health awareness among patients is also increasing market growth.

Key Regional Takeaways:

United States Biologics Market Analysis

In 2024, the United Sates accounts for 88.70% of the biologics market in North America. The adoption of advanced treatments is transforming medicine by offering more personalized treatment options in the US. Advanced therapies are now tailored to specific disease mechanisms and have resulted in outcomes that traditional methods often cannot achieve. According to HIPAA Journal, the average private healthcare spending in the U. S. is USD 11,197 per person annually (CMS, 2024), which reflects this growing trend toward personalized medicine. This movement opens high-technology avenues for biologics to satisfy a diversity of medical needs. Shifting focus toward personalized medicine has significantly improved the condition of people with chronic diseases. Innovation in R&D is bringing safer and more efficient next-generation therapies. The tie-up between service providers, who are the healthcare operators, and the biotech organizations is accelerating non-stop new technology interventions into treatment modules while ensuring an effective governance architecture that will ensure and continue to drive safety coupled with innovation. Furthermore, better support for patients is bridging the access gaps to advanced therapies and leads to better management of disease. These collaborations are sowing a rich healthcare future that continually pushes the limits of medical advancement.

Asia Pacific Biologics Market Analysis

Fast innovations in advanced medical technologies are altering the treatment paradigms and providing tailored strategies that are meeting unmet clinical needs. Initiatives in the expansion of capacity for production are making access more widespread, thus facilitating the reduction of barriers to healthcare services. Collaboration between local research institutes and international companies promotes knowledge sharing and, thus, the pace of innovation. Sensitization and training programs are significantly increasing the patient's understanding and embracing of new therapeutic interventions. Investment in the healthcare structure is opening opportunities for many, especially those in the urban areas, to have access to complex treatment modalities. According to the Ministry of Health and Family Welfare, the healthcare structure of India is aided by an increase in government health spending, reaching about USD 51 Billion in 2021-22, and an aim for public investment to increase to 2.5% of GDP by 2025, builds support for the biologics ecosystem by enhancing the ease of access to superior health facilities through initiatives like National Health Mission and Ayushman Bharat Health Infrastructure Mission. The introduction of low-cost biosimilars plays a vital role in ensuring the extension of innovative medicines, thereby ensuring diverse population groups benefit from medical innovation.

Europe Biologics Market Analysis

European countries are emerging as leaders in healthcare innovation, focusing on cutting-edge research and novel medical breakthroughs. With more financial investment in biotechnology and clinical trials, the way is now becoming smooth for effective treatment options for complex health problems. Accelerations in the pace of disease management research and development resulting from collaborations between academic institutes and pharmaceutical companies have paved the way for better services to patients. Huge coverage of insurance systems and reimbursement structures make specialist care accessible as well as affordable for most of the population. This is seen in Germany; according to Germany Visa, Germany has allocated approximately $521.5 Billion toward healthcare in 2021, with over 90% of its population falling under statutory health insurance. This extensive coverage leads to a higher life expectancy and allows for significant investments in biologics focused on conditions like cancer and cardiovascular diseases. Moreover, sustainability is also becoming a priority, with green manufacturing approaches on the rise. The cross-border sharing of clinical data also supports the adoption of more advanced medical practices, leading to better healthcare delivery throughout the region.

Latin America Biologics Market Analysis

Advances in therapy in the field have been based on meeting local needs with specific tailored solutions, ensuring wider suitability. A greater emphasis on research and development in specific therapeutic areas helps to bring about cost-effective breakthroughs without compromising efficacy. According to the International Trade Administration, U. S. Department of Commerce, Brazil is the largest healthcare market in Latin America, with 9.47% of its GDP allocated to healthcare (USD161 Billion), which strengthens strong research and development programs that improve biologics innovation. With 427,097 hospital beds and public-private partnerships, its focus on innovation, including vaccine manufacturing and therapeutic developments, provides extensive opportunities for biologics to address chronic illnesses and prepare for pandemics. Using the latest emerging technologies, the region is able to show excellent local production capabilities, which is necessary to increase availability. Moreover, cross-industry efforts directed toward increasing knowledge-sharing and skill development create an environment that fosters transformational improvements.

Middle East and Africa Biologics Market Analysis

Biologics are transforming the treatment landscapes as they have precision in targeting the disease mechanisms. These therapies allow for more effective and tailored interventions, particularly with complex conditions, as they focus on root causes rather than merely addressing symptoms. Their capacity to provide individualized treatments promotes better results and lower probabilities of adverse side effects, thus instilling trust among patients and health professionals. At the same time, the growing prevalence of cancer has created a demand for innovative therapies. According to the WHO, the surging cancer rates in the Arab World, with an anticipated 1.8-fold increase in incidence by 2030, underscore the escalating burden of disease. This surge presents a significant opportunity for biologics, offering advanced therapeutic solutions to confront the rising public health challenge. This shift is driven by increased awareness about early diagnosis and improved access to advanced medical treatments. With the emphasis on improving outcomes, the uptake of innovative therapies is gaining pace steadily, making it a very lively environment for enhancements in treatment protocols and patient care.

Competitive Landscape:

Increasing focus is on strategic collaborations, acquisitions, and research for improving their market positioning by players in the biologics market. They are also focusing on advancement in monoclonal antibodies, gene therapies, and cell-based therapies that have potential applications in dealing with the complexity of disease states, including cancer, autoimmune diseases, and many genetic conditions. Next-generation biologics, including bispecific antibodies and CAR-T therapies, are investments by companies to fill in unmet medical needs. Biosimilars, too, are aggressively being developed by various market players, which take advantage of patent expiries for blockbuster biologic drugs, making them cost-efficient alternatives for originators. Biologic manufacturing processes have also become optimized through advanced technologies like automation, AI, and machine learning to enhance efficiency and scalability. These strategies are expected to fuel market growth and innovation over the coming years.

The report provides a comprehensive analysis of the competitive landscape in the biologics market with detailed profiles of all major companies, including:

  • AbbVie Inc.
  • Amgen Inc.
  • AstraZeneca plc
  • F. Hoffmann-La Roche Ltd
  • GlaxoSmithKline plc
  • Johnson & Johnson
  • Merck KGaA
  • Novartis AG
  • Pfizer Inc.
  • Sanofi

Key Questions Answered in This Report

  • 1.How big is the biologics market?
  • 2.What is the future outlook of biologics market?
  • 3.What are the key factors driving the biologics market?
  • 4.Which region accounts for the largest biologics market share?
  • 5.Which are the leading companies in the global biologics market?

Table of Contents

1 Preface

2 Scope and Methodology

  • 2.1 Objectives of the Study
  • 2.2 Stakeholders
  • 2.3 Data Sources
    • 2.3.1 Primary Sources
    • 2.3.2 Secondary Sources
  • 2.4 Market Estimation
    • 2.4.1 Bottom-Up Approach
    • 2.4.2 Top-Down Approach
  • 2.5 Forecasting Methodology

3 Executive Summary

4 Introduction

  • 4.1 Overview
  • 4.2 Key Industry Trends

5 Global Biologics Market

  • 5.1 Market Overview
  • 5.2 Market Performance
  • 5.3 Impact of COVID-19
  • 5.4 Market Forecast

6 Market Breakup by Source

  • 6.1 Microbial
    • 6.1.1 Market Trends
    • 6.1.2 Market Forecast
  • 6.2 Mammalian
    • 6.2.1 Market Trends
    • 6.2.2 Market Forecast
  • 6.3 Others
    • 6.3.1 Market Trends
    • 6.3.2 Market Forecast

7 Market Breakup by Product

  • 7.1 Monoclonal Antibodies
    • 7.1.1 Market Trends
    • 7.1.2 Market Forecast
  • 7.2 Vaccines
    • 7.2.1 Market Trends
    • 7.2.2 Market Forecast
  • 7.3 Recombinant Proteins
    • 7.3.1 Market Trends
    • 7.3.2 Market Forecast
  • 7.4 Antisense, RNAi and Molecular Therapy
    • 7.4.1 Market Trends
    • 7.4.2 Market Forecast
  • 7.5 Others
    • 7.5.1 Market Trends
    • 7.5.2 Market Forecast

8 Market Breakup by Disease

  • 8.1 Oncology
    • 8.1.1 Market Trends
    • 8.1.2 Market Forecast
  • 8.2 Immunological Disorders
    • 8.2.1 Market Trends
    • 8.2.2 Market Forecast
  • 8.3 Cardiovascular Disorders
    • 8.3.1 Market Trends
    • 8.3.2 Market Forecast
  • 8.4 Hematological Disorders
    • 8.4.1 Market Trends
    • 8.4.2 Market Forecast
  • 8.5 Others
    • 8.5.1 Market Trends
    • 8.5.2 Market Forecast

9 Market Breakup by Manufacturing

  • 9.1 Outsourced
    • 9.1.1 Market Trends
    • 9.1.2 Market Forecast
  • 9.2 In-House
    • 9.2.1 Market Trends
    • 9.2.2 Market Forecast

10 Market Breakup by Region

  • 10.1 North America
    • 10.1.1 United States
      • 10.1.1.1 Market Trends
      • 10.1.1.2 Market Forecast
    • 10.1.2 Canada
      • 10.1.2.1 Market Trends
      • 10.1.2.2 Market Forecast
  • 10.2 Asia-Pacific
    • 10.2.1 China
      • 10.2.1.1 Market Trends
      • 10.2.1.2 Market Forecast
    • 10.2.2 Japan
      • 10.2.2.1 Market Trends
      • 10.2.2.2 Market Forecast
    • 10.2.3 India
      • 10.2.3.1 Market Trends
      • 10.2.3.2 Market Forecast
    • 10.2.4 South Korea
      • 10.2.4.1 Market Trends
      • 10.2.4.2 Market Forecast
    • 10.2.5 Australia
      • 10.2.5.1 Market Trends
      • 10.2.5.2 Market Forecast
    • 10.2.6 Indonesia
      • 10.2.6.1 Market Trends
      • 10.2.6.2 Market Forecast
    • 10.2.7 Others
      • 10.2.7.1 Market Trends
      • 10.2.7.2 Market Forecast
  • 10.3 Europe
    • 10.3.1 Germany
      • 10.3.1.1 Market Trends
      • 10.3.1.2 Market Forecast
    • 10.3.2 France
      • 10.3.2.1 Market Trends
      • 10.3.2.2 Market Forecast
    • 10.3.3 United Kingdom
      • 10.3.3.1 Market Trends
      • 10.3.3.2 Market Forecast
    • 10.3.4 Italy
      • 10.3.4.1 Market Trends
      • 10.3.4.2 Market Forecast
    • 10.3.5 Spain
      • 10.3.5.1 Market Trends
      • 10.3.5.2 Market Forecast
    • 10.3.6 Russia
      • 10.3.6.1 Market Trends
      • 10.3.6.2 Market Forecast
    • 10.3.7 Others
      • 10.3.7.1 Market Trends
      • 10.3.7.2 Market Forecast
  • 10.4 Latin America
    • 10.4.1 Brazil
      • 10.4.1.1 Market Trends
      • 10.4.1.2 Market Forecast
    • 10.4.2 Mexico
      • 10.4.2.1 Market Trends
      • 10.4.2.2 Market Forecast
    • 10.4.3 Others
      • 10.4.3.1 Market Trends
      • 10.4.3.2 Market Forecast
  • 10.5 Middle East and Africa
    • 10.5.1 Market Trends
    • 10.5.2 Market Breakup by Country
    • 10.5.3 Market Forecast

11 SWOT Analysis

  • 11.1 Overview
  • 11.2 Strengths
  • 11.3 Weaknesses
  • 11.4 Opportunities
  • 11.5 Threats

12 Value Chain Analysis

13 Porters Five Forces Analysis

  • 13.1 Overview
  • 13.2 Bargaining Power of Buyers
  • 13.3 Bargaining Power of Suppliers
  • 13.4 Degree of Competition
  • 13.5 Threat of New Entrants
  • 13.6 Threat of Substitutes

14 Price Analysis

15 Competitive Landscape

  • 15.1 Market Structure
  • 15.2 Key Players
  • 15.3 Profiles of Key Players
    • 15.3.1 AbbVie Inc.
      • 15.3.1.1 Company Overview
      • 15.3.1.2 Product Portfolio
      • 15.3.1.3 Financials
      • 15.3.1.4 SWOT Analysis
    • 15.3.2 Amgen Inc.
      • 15.3.2.1 Company Overview
      • 15.3.2.2 Product Portfolio
      • 15.3.2.3 Financials
      • 15.3.2.4 SWOT Analysis
    • 15.3.3 AstraZeneca plc
      • 15.3.3.1 Company Overview
      • 15.3.3.2 Product Portfolio
      • 15.3.3.3 Financials
      • 15.3.3.4 SWOT Analysis
    • 15.3.4 F. Hoffmann-La Roche Ltd
      • 15.3.4.1 Company Overview
      • 15.3.4.2 Product Portfolio
      • 15.3.4.3 SWOT Analysis
    • 15.3.5 GlaxoSmithKline plc
      • 15.3.5.1 Company Overview
      • 15.3.5.2 Product Portfolio
      • 15.3.5.3 Financials
      • 15.3.5.4 SWOT Analysis
    • 15.3.6 Johnson & Johnson
      • 15.3.6.1 Company Overview
      • 15.3.6.2 Product Portfolio
      • 15.3.6.3 Financials
      • 15.3.6.4 SWOT Analysis
    • 15.3.7 Merck KGaA
      • 15.3.7.1 Company Overview
      • 15.3.7.2 Product Portfolio
      • 15.3.7.3 Financials
      • 15.3.7.4 SWOT Analysis
    • 15.3.8 Novartis AG
      • 15.3.8.1 Company Overview
      • 15.3.8.2 Product Portfolio
      • 15.3.8.3 Financials
      • 15.3.8.4 SWOT Analysis
    • 15.3.9 Pfizer Inc.
      • 15.3.9.1 Company Overview
      • 15.3.9.2 Product Portfolio
      • 15.3.9.3 Financials
      • 15.3.9.4 SWOT Analysis
    • 15.3.10 Sanofi
      • 15.3.10.1 Company Overview
      • 15.3.10.2 Product Portfolio
      • 15.3.10.3 Financials
      • 15.3.10.4 SWOT Analysis

List of Figures

  • Figure 1: Global: Biologics Market: Major Drivers and Challenges
  • Figure 2: Global: Biologics Market: Sales Value (in Billion USD), 2019-2024
  • Figure 3: Global: Biologics Market Forecast: Sales Value (in Billion USD), 2025-2033
  • Figure 4: Global: Biologics Market: Breakup by Source (in %), 2024
  • Figure 5: Global: Biologics Market: Breakup by Product (in %), 2024
  • Figure 6: Global: Biologics Market: Breakup by Disease (in %), 2024
  • Figure 7: Global: Biologics Market: Breakup by Manufacturing (in %), 2024
  • Figure 8: Global: Biologics Market: Breakup by Region (in %), 2024
  • Figure 9: Global: Biologics (Microbial) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 10: Global: Biologics (Microbial) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 11: Global: Biologics (Mammalian) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 12: Global: Biologics (Mammalian) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 13: Global: Biologics (Other Sources) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 14: Global: Biologics (Other Sources) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 15: Global: Biologics (Monoclonal Antibodies) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 16: Global: Biologics (Monoclonal Antibodies) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 17: Global: Biologics (Vaccines) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 18: Global: Biologics (Vaccines) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 19: Global: Biologics (Recombinant Proteins) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 20: Global: Biologics (Recombinant Proteins) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 21: Global: Biologics (Antisense, RNAi and Molecular Therapy) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 22: Global: Biologics (Antisense, RNAi and Molecular Therapy) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 23: Global: Biologics (Other Products) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 24: Global: Biologics (Other Products) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 25: Global: Biologics (Oncology) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 26: Global: Biologics (Oncology) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 27: Global: Biologics (Immunological Disorders) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 28: Global: Biologics (Immunological Disorders) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 29: Global: Biologics (Cardiovascular Disorders) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 30: Global: Biologics (Cardiovascular Disorders) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 31: Global: Biologics (Hematological Disorders) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 32: Global: Biologics (Hematological Disorders) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 33: Global: Biologics (Other Diseases) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 34: Global: Biologics (Other Diseases) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 35: Global: Biologics (Outsourced) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 36: Global: Biologics (Outsourced) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 37: Global: Biologics (In-House) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 38: Global: Biologics (In-House) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 39: North America: Biologics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 40: North America: Biologics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 41: United States: Biologics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 42: United States: Biologics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 43: Canada: Biologics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 44: Canada: Biologics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 45: Asia-Pacific: Biologics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 46: Asia-Pacific: Biologics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 47: China: Biologics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 48: China: Biologics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 49: Japan: Biologics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 50: Japan: Biologics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 51: India: Biologics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 52: India: Biologics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 53: South Korea: Biologics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 54: South Korea: Biologics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 55: Australia: Biologics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 56: Australia: Biologics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 57: Indonesia: Biologics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 58: Indonesia: Biologics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 59: Others: Biologics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 60: Others: Biologics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 61: Europe: Biologics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 62: Europe: Biologics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 63: Germany: Biologics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 64: Germany: Biologics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 65: France: Biologics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 66: France: Biologics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 67: United Kingdom: Biologics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 68: United Kingdom: Biologics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 69: Italy: Biologics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 70: Italy: Biologics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 71: Spain: Biologics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 72: Spain: Biologics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 73: Russia: Biologics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 74: Russia: Biologics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 75: Others: Biologics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 76: Others: Biologics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 77: Latin America: Biologics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 78: Latin America: Biologics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 79: Brazil: Biologics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 80: Brazil: Biologics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 81: Mexico: Biologics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 82: Mexico: Biologics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 83: Others: Biologics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 84: Others: Biologics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 85: Middle East and Africa: Biologics Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 86: Middle East and Africa: Biologics Market: Breakup by Country (in %), 2024
  • Figure 87: Middle East and Africa: Biologics Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 88: Global: Biologics Industry: SWOT Analysis
  • Figure 89: Global: Biologics Industry: Value Chain Analysis
  • Figure 90: Global: Biologics Industry: Porter's Five Forces Analysis

List of Tables

  • Table 1: Global: Biologics Market: Key Industry Highlights, 2024 & 2033
  • Table 2: Global: Biologics Market Forecast: Breakup by Source (in Million USD), 2025-2033
  • Table 3: Global: Biologics Market Forecast: Breakup by Product (in Million USD), 2025-2033
  • Table 4: Global: Biologics Market Forecast: Breakup by Disease (in Million USD), 2025-2033
  • Table 5: Global: Biologics Market Forecast: Breakup by Manufacturing (in Million USD), 2025-2033
  • Table 6: Global: Biologics Market Forecast: Breakup by Region (in Million USD), 2025-2033
  • Table 7: Global: Biologics Market: Competitive Structure
  • Table 8: Global: Biologics Market: Key Players