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生物製剂

市场调查报告书

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1733154

2026 年至 2032 年生技药品市场（依产品、来源、适应症、通路及地区划分）

Biologics Market By Product, Source, Indication, Distribution Channel & Region for 2026-2032

出版日期: 2025年04月29日 | 出版商:

Verified Market Research | 英文 202 Pages | 商品交期: 2-3个工作天内

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简介目录

2026-2032年生技药品市场估值

糖尿病和癌症等慢性疾病的盛行率不断上升，以及个人化医疗和生物技术的市场发展改善了治疗的可及性和有效性，是推动生技药品市场发展的主要因素。据 Verified Market Research 分析师称，生技药品市场规模预计将从 2024 年的 3,529.5 亿美元下降，预测期内达到 5,294.6 亿美元的估值。

受託研究机构的成长提高了生物製药製造能力，大型製药公司的大量投资以及新治疗方法的接受度不断提高是推动生物製药市场扩张的关键因素。由于需求的增加，市场将从 2026 年到 2032 年以 5.2% 的复合年增长率成长。

生技药品市场定义/概述

生技药品是由生物体或其成分（例如细胞、蛋白质或核酸）製成的治疗产品。与化学製成的传统药物不同，生技药品通常是使用先进的生物技术製成的大型复杂分子。它们独特的结构使它们能够直接参与生物过程，从而有效治疗多种疾病。生物製药具有广泛的治疗应用，特别是在肿瘤学领域，单株抗体可以针对癌细胞，同时最大限度地减少对健康器官的损害。它也用于治疗自体免疫疾病，透过调节免疫反应来减轻症状，而不会完全抑制免疫功能。

慢性病的增加将如何推动生物製药的采用？

癌症、糖尿病和自体免疫疾病等慢性疾病的盛行率不断上升是生技药品市场的主要驱动力。根据世界卫生组织 (WHO) 的数据，癌症是世界第一大死亡原因，2020 年导致约 1,000 万人死亡。 WHO 预测，到 2040 年，癌症新发病例数将达到 3,020 万，比 2020 年增加 47%。患者群体的扩大预计将推动对更有效治疗复杂疾病的生物製药的需求。

生物技术的不断进步和向个人化治疗的转变正在推动生物製药市场向前发展。美国食品药物管理局（FDA）积极支持此一趋势。 2022年，FDA生技药品评估与研究中心（CBER）批准了17种新型生技药品，包括基因和细胞疗法。这比 2021 年的 10 个核准有显着增长，表明生技药品在满足未满足的医疗需求方面的重要性日益增加。

此外，製药公司正在投入大量资源进行生物製药的研发，这正在刺激市场的发展。根据美国药品研究与工业协会（PhRMA）的数据，光是美国生物製药公司在2020年就将在研发上投入910亿美元。这占了该行业整体研发支出的很大一部分，显示生技药品是製药业创新和未来成长的重要领域。

生技药品市场面临的主要挑战是什么？

生技药品开发是一个耗时且资金密集的过程，需要在研究、临床试验和生产方面投入大量资金。这些高价格对新进者来说是一个障碍，因为从初始投资到市场核准的时间可能长达数年。这些经济障碍限制了竞争和创新，减少了患者获得创新生物製药的机会。

此外，生物製药采用涉及活细胞的复杂製造程序製成，因此比典型的药物复杂得多。由于翻译后变化而导致的关键品质参数的变化导致了产品品质的变化。这种复杂性不仅增加了製造成本，而且难以确保遵守严格的监管标准，进一步阻碍了市场扩张。

The increasing prevalence of chronic illnesses like diabetes and cancer, along with developments in personalized medicine and biotechnology that improve treatment accessibility and efficacy, is the main factor propelling the biologics market. According to the analyst from Verified Market Research, the biologics market is estimated to reach a valuation of USD 529.46 Billion over the forecast subjugating around USD 352.95 Billion valued in 2024.

The growth of contract research organizations that improve biomanufacturing capabilities, significant investments from large pharmaceutical companies, and the increasing acceptance of novel therapies are important factors driving the biologics market expansion. This increase in demand enables the market to grow at a CAGR of 5.2% from 2026 to 2032.

Biologics Market: Definition/ Overview

Biologics are therapeutic products made from living creatures or their components, such as cells, proteins, and nucleic acids. Unlike conventional medications, which are chemically made, biologics are usually huge, complex molecules created using advanced biotechnological technologies. Their unique structure enables them to engage directly with biological processes, making them effective in treating a variety of disorders. Biologics have a wide range of therapeutic applications, most notably in oncology, where monoclonal antibodies target cancer cells while limiting injury to healthy organs. They are also used to treat autoimmune illnesses by regulating the immune response and reducing symptoms without completely suppressing immune function.

How Does Increasing Prevalence of Chronic Diseases Drive the Adoption of Biologics?

The increased prevalence of chronic diseases like cancer, diabetes, and autoimmune disorders is a significant driver of the biologics market. According to the World Health Organization (WHO), cancer is the biggest cause of death worldwide, accounting for approximately 10 million deaths in 2020. The WHO predicts that the number of new cancer cases will reach 30.2 million by 2040, a 47% increase over 2020. This expanding patient group is likely to drive up demand for biologic medicines, which are more successful in treating complicated disorders.

Continuous biotechnology advancements and a shift toward customized therapy are moving the biologics market ahead. The United States Food and Drug Administration (FDA) has aggressively supported this trend. In 2022, the FDA's Center for Biologics Evaluation and Research (CBER) authorized 17 new biologics, including gene and cell therapies. This is a huge rise from the ten approvals granted in 2021, illustrating the growing importance of biologics in meeting unmet medical needs.

Furthermore, pharmaceutical companies are spending significant resources on biologics research and development, which is fueling market growth. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), biopharmaceutical businesses in the United States alone spent USD 91 Billion on research and development in 2020. This accounts for a considerable amount of the industry's total R&D spending and demonstrates the increased emphasis on biologics as an essential field for innovation and future growth in the pharmaceutical sector.

What are the Primary Challenges Faced by the Biologics Market?

Biologics development is a time-consuming and capital-intensive process that requires significant investment in research, clinical trials, and production. These high prices hinder new competitors from entering the market, as the lengthy timelines-from initial investment to market approval-last several years. This financial barrier limits competition and innovation, reducing the availability of innovative biologic drugs for patients.

Furthermore, biologics are made using elaborate manufacturing procedures that include living cells, making them far more complex than typical medications. Variability in important quality parameters due to post-translational changes causes discrepancies in product quality. This complexity not only raises production costs but also makes it difficult to ensure compliance with tight regulatory standards, further impeding market expansion.

Category-Wise Acumens

What are the Potential Factors Driving the Monoclonal Antibodies in the Market?

According to VMR analysis, the monoclonal antibodies segment is estimated to hold the largest market share during the forecast period. The growing prevalence of chronic diseases, such as cancer and autoimmune disorders, drives up demand for monoclonal antibodies. In comparison to standard medicines, these therapies provide tailored therapy alternatives that improve patient results while minimizing adverse effects. As healthcare professionals seek efficient treatments for managing complex illnesses, the dependence on monoclonal antibodies grows, cementing their market dominance.

Continuous advances in biotechnology have improved the development and production methods for monoclonal antibodies. Innovations such as enhanced cell line engineering and more efficient production procedures have resulted in larger yields at cheaper costs. These developments not only facilitate the introduction of new monoclonal antibody medicines but also make them more accessible to patients, contributing to their market leadership in biologics.

Furthermore, the strong pipeline of monoclonal antibody candidates in clinical trials is a key reason for this segment's dominance. Numerous new medicines are being developed to address a variety of ailments, including previously difficult-to-treat conditions. The approval and subsequent commercialization of these novel treatments are projected to drive growth in the monoclonal antibody segment, garnering considerable investment and interest from pharmaceutical firms.

How Does the Rising Cancer Incidence Drive Biologics for Oncology?

The oncology segment is estimated to dominate the biologics market during the forecast period. The rising global incidence of cancer is a primary driver for the oncology segment. As the number of cancer cases increases, there is a growing desire for better treatment options. Biologics, specifically monoclonal antibodies, and immunotherapies, have demonstrated extraordinary success in targeting cancer cells, resulting in better patient outcomes and driving market expansion in this segment.

Biotechnology innovations have resulted in the creation of targeted therapies that attack cancer cells while causing minimal damage to healthy tissues. These developments improve therapy efficacy while reducing side effects, making biologics the favored option for oncologists. The ongoing research and development in this area strengthens the oncology segment's position in the biologics market.

Furthermore, significant investments in cancer research by both the governmental and private sectors are moving the oncology segment forward. Clinical studies and the development of innovative biologic therapeutics are receiving increased funding, making it easier to bring new treatments to market. This infusion of cash promotes discovery and accelerates the availability of sophisticated biologics for cancer treatment, thereby reinforcing the segment's leadership.

Country/Region-wise Acumens

What Drivers Contribute to the Dominance of North America in the Market?

According to VMR analyst, North America is estimated to dominate the biologics market during the forecast period. North America has a high incidence of chronic diseases that are frequently treated using biologics. According to the Centers for Disease Control and Prevention (CDC), by 2020, 6 in 10 adults in the United States had a chronic condition, with 4 in 10 having two or more. According to the CDC, 34.2 million Americans (10.5% of the population) have diabetes, for which numerous biologic therapies are available. The region's high prevalence of chronic diseases fuels the need for innovative biologics.

Furthermore, North America, particularly the United States, has a strong R&D ecosystem for biologics. The FDA said that in fiscal year 2021, it authorized ten new biologics licensing applications (BLAs). Also, the National Institutes of Health (NIH) budget for fiscal year 2021 was $42.9 billion, with a sizable amount going toward research that supports biologic development. This solid R&D foundation adds to the region's dominant position in the biologics market.

What are the Significant Factors Driving the Asia Pacific's Biologics Market?

The Asia Pacific region is estimated to exhibit the highest growth within the market during the forecast period. The Asia Pacific region is undergoing tremendous population expansion and aging, which raises the demand for innovative medical therapies such as biologics. According to the United Nations Economic and Social Commission for Asia and the Pacific (ESCAP), the region's population is predicted to increase from 4.3 billion in 2020 to 4.7 billion in 2050. Also, the proportion of individuals aged 65 and up is expected to quadruple from 13% in 2020 to 26% by 2050. This demographic transition is expected to increase the prevalence of age-related disorders, driving up demand for biologics.

Furthermore, the Asia-Pacific region is experiencing an increase in chronic diseases, many of which are efficiently treated using biologics. According to the World Health Organization (WHO), non-communicable diseases (NCDs) account for 71% of all deaths worldwide, with a disproportionate impact on low- and middle-income nations, many of which are in Asia Pacific. According to the International Diabetes Federation (IDF), 463 million persons globally have diabetes in 2019, with the Asia Pacific area accounting for 60% of the total. This substantial illness burden is a strong motivator for the use of biologics.

Competitive Landscape

The competitive landscape of the biologics market is distinguished by a dynamic interaction between innovation, collaboration, and regulatory challenges. As the need for biologic medicines grows due to increased chronic disease occurrences and advances in customized medicine, companies are increasing their investment in R&D to improve their product offerings.

Some of the prominent players operating in the biologics market include:

Abbvie, Inc.
Amgen, Inc.
Eli Lilly & Company
Pfizer, Inc.
Samsung Biologics
Sanofi
Merck & Co., Inc.
F Hoffman La Roche
Celltrion
Addgene

Latest Developments

In March 2023, Sandoz announced plans to invest USD 400 million in developing a biologics manufacturing facility in Slovenia.

1 INTRODUCTION OF GLOBAL BIOLOGICS MARKET

1.1 Overview of the Market
1.2 Scope of Report
1.3 Assumptions

2 EXECUTIVE SUMMARY

3 RESEARCH METHODOLOGY OF VERIFIED MARKET RESEARCH

3.1 Data Mining
3.2 Validation
3.3 Primary Interviews
3.4 List of Data Sources

4 GLOBAL BIOLOGICS MARKET OUTLOOK

4.1 Overview
4.2 Market Dynamics
- 4.2.1 Drivers
- 4.2.2 Restraints
- 4.2.3 Opportunities
4.3 Porters Five Force Model
4.4 Value Chain Analysis

5 GLOBAL BIOLOGICS MARKET, BY PRODUCT

5.1 Overview
5.2 Monoclonal Antibodies
5.3 Vaccines
5.4 Recombinant Hormones/Proteins
5.5 Gene Based Biologics
5.6 Cellular Based Biologics

6 GLOBAL BIOLOGICS MARKET, BY SOURCE

6.1 Overview
6.2Microbial
6.3 Mammalian

7 GLOBAL BIOLOGICS MARKET, BY SOURCE

7.1 Oncology
7.2 Immunological Disorders
7.3 Cardiovascular Disorders
7.4 Hematological Disorders

8 GLOBAL BIOLOGICS MARKET, BY DISTRIBUTION CHANNEL

8.1 Hospital Pharmacies
8.2 Retail Pharmacies
8.3 Online Pharmacies

9 GLOBAL BIOLOGICS MARKET, BY GEOGRAPHY

9.1 Overview
9.2 North America
- 9.2.1 U.S.
- 9.2.2 Canada
- 9.2.3 Mexico
9.3 Europe
- 9.3.1 Germany
- 9.3.2 U.K.
- 9.3.3 France
- 9.3.4 Rest of Europe
9.4 Asia Pacific
- 9.4.1 China
- 9.4.2 Japan
- 9.4.3 India
- 9.4.4 Rest of Asia Pacific
9.5 Rest of the World
- 9.5.1 Latin America
- 9.5.2 Middle East

10 GLOBAL BIOLOGICS MARKET COMPETITIVE LANDSCAPE

10.1 Overview
10.2 Company Market Ranking
10.3 Key Development Strategies

11 COMPANY PROFILES

11.1 Abbvie Inc.
- 11.1.1 Overview
- 11.1.2 Financial Performance
- 11.1.3 Product Outlook
- 11.1.4 Key Developments
11.2 Amgen Inc.
- 11.2.1 Overview
- 11.2.2 Financial Performance
- 11.2.3 Product Outlook
- 11.2.4 Key Developments
11.3 Eli Lilly & Company
- 11.3.1 Overview
- 11.3.2 Financial Performance
- 11.3.3 Product Outlook
- 11.3.4 Key Developments
11.4 Pfizer Inc.
- 11.4.1 Overview
- 11.4.2 Financial Performance
- 11.4.3 Product Outlook
- 11.4.4 Key Developments
11.5 Samsung Biologics
- 11.5.1 Overview
- 11.5.2 Financial Performance
- 11.5.3 Product Outlook
- 11.5.4 Key Developments
11.6 Sanofi
11.1 Overview
- 11.6.2 Financial Performance
- 11.6.3 Product Outlook
- 11.6.4 Key Developments
11.7 Merck & Co. Inc.
- 11.7.1 Overview
- 11.7.2 Financial Performance
- 11.7.3 Product Outlook
- 11.7.4 Key Developments
11.8 F Hoffman La Roche
- 11.8.1 Overview
- 11.8.2 Financial Performance
- 11.8.3 Product Outlook
- 11.8.4 Key Developments
11.9 Celltrion
- 11.9.1 Overview
- 11.9.2 Financial Performance
- 11.9.3 Product Outlook
- 11.9.4 Key Developments
11.10 Addgene
- 11.10.1 Overview
- 11.10.2 Financial Performance
- 11.10.3 Product Outlook
- 11.10.4 Key Developments