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2031 年北美生物製剂市场预测 - 区域分析 - 按产品、应用、来源和製造

North America Biologics Market Forecast to 2031 - Regional Analysis - by Product, Application, Source, and Manufacturing

出版日期: 2025年04月14日 | 出版商:

The Insight Partners | 英文 146 Pages | 订单完成后即时交付

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简介目录图表

2023 年北美生物製剂市场价值为 2,302.561 亿美元，预计到 2031 年将达到 8,888.8 亿美元；预计 2023 年至 2031 年复合年增长率为 18.4%。

慢性病盛行率上升推动北美生物製剂市场发展

根据Ellerston Capital Limited发表的一项名为《慢性病：生物学方法》的研究，全球每年有4,100万人死于慢性病，占全球死亡人数的74%。 2020年，癌症导致近1,000万人死亡，即每6例死亡病例中就有1例。根据GLOBOCAN的数据，2020年全球登记的癌症病例为1,930万例，预计2030年将上升至2,460万例。此外，自体免疫疾病的盛行率每年以3-9%的速度成长。预计到2030年，阿兹海默症的病例将达到7,800万例，到2050年将达到1.39亿例。根据世界卫生组织（WHO）的数据，全球每年约有1700万人在70岁前死于非传染性疾病。

抗体和疫苗等生物製剂能够提供更具针对性的治疗，因为它们旨在以特定方式与免疫系统相互作用，从而发挥治疗或预防作用。生物製剂透过阻断免疫系统中过度活跃的成分（在许多情况下是蛋白质）——这些成分会损害关节、皮肤和其他身体部位——在治疗某些慢性自体免疫疾病方面具有广阔的潜力。利用生物製剂治疗癌症是指利用人体免疫细胞杀死癌细胞；干扰素、白血球介素和单株抗体 (mAb) 等细胞激素是治疗癌症最常使用的生物疗法。抗淀粉样蛋白单株抗体在针对阿兹海默症患者的临床研究中也显示出良好的治疗效果。溃疡性结肠炎和克隆氏症等慢性疾病包括反覆发作的结肠粘膜层发炎。美国食品药物管理局已批准一些用于治疗克隆氏症的生物製剂，包括英夫利西单抗、阿达木单抗和那他珠单抗。此外，生物製剂是治疗类风湿性关节炎的主要方法之一。随着医生和患者对传统疗法的偏好转向积极疗法，生物製剂在类风湿性关节炎治疗中的需求也不断增长。治疗药物是针对不同免疫反应途径的部分或完全人源化蛋白质。因此，慢性病盛行率的上升推动了生物製剂市场的成长。

北美生物製剂市场概况

就收入而言，北美占据生物製剂市场的最大份额。该地区的市场成长归因于关键生物製剂製造企业的存在以及研发支出的增加。根据 JAMA Network 发表的一篇文章，生物製剂研发支出占美国总研发支出的 37%。该国生物製剂处方数量和针对性药物开发的投资正在增加。此外，反义、基因疗法和 RNAi 疗法等几种新型生物药物的批准预计将进一步推动市场成长。根据美国国家生物技术资讯中心 (NCBI) 发表的一篇文章，该国在 2022 年创下了生物製剂获批比例的历史最高纪录，即 40%，这表明生物製剂在药物应用中的稳定性。此外，这类药物占药品核准总量的 30%。 2024年5月，Biocon Biologics Ltd (BBL) 获得美国食品药物管理局 (FDA) 批准 YESAFILI（阿柏西普），作为 Eylea 的首个生物替代品。 YESAFILI 是一种血管内皮生长因子 (VEGF) 抑制剂，用于治疗多种不同类型的眼科疾病。

北美生物製剂市场收入及预测（2031年）（百万美元）

北美生物製剂市场细分

北美生物製剂市场分为产品、应用、来源、製造和国家。

根据产品类型，北美生物製剂市场细分为单株抗体、疫苗、重组激素/蛋白质、细胞和基因疗法以及其他。单株抗体在2023年占据了最大的市场。

从应用角度来看，北美生物製剂市场主要分为癌症、传染病、自体免疫疾病等。 2023年，癌症领域占据了最大的市场。

依来源划分，北美生物製剂市场分为哺乳动物和微生物两大类。 2023年，哺乳动物类生物製剂占了更大的市场。

根据製造方式，北美生物製剂市场分为外包和内部製造。 2023年，外包部分占据了更大的市场。

就国家而言，北美生物製剂市场分为美国、加拿大和墨西哥。 2023年，美国占据了北美生物製剂市场的主导地位。

AbbVie Inc、Pfizer Inc、三星生物製品有限公司、ADMA Biologics, Inc.、无锡生物製品有限公司、Catalent Inc、AGC Biologics AS、阿斯利康公司、安进公司、Nitto Avecia 和 Quality Assistance sa 是北美生物製品市场的一些领先公司。

According to a study titled "Chronic Disease: A Bio-Logical Approach," published in Ellerston Capital Limited, 41 million people worldwide die from chronic diseases every year, accounting for 74% of all deaths worldwide. Cancer was responsible for almost 10 million deaths in 2020, i.e., 1 in every 6 deaths. According to GLOBOCAN, 19.3 million cancer cases were registered worldwide in 2020, and the number is estimated to rise to 24.6 million by 2030. In addition, the prevalence of autoimmune diseases increases annually by 3-9%. The number of Alzheimer's disease cases is expected to reach 78 million by 2030 and 139 million by 2050. According to the World Health Organization (WHO), every year, ~17 million people across the world succumb to death due to noncommunicable diseases before the age of 70.

Biologics such as antibodies and vaccines offer more targeted treatment because they are designed to interact with the immune system in specific ways to deliver a therapeutic or prophylactic effect. Biological drugs have the promising potential to treat a few chronic autoimmune diseases by blocking the overactive components (proteins in many cases) of the immune system, which damage joints, skin, and other body parts. The treatment of cancer with biologics involves using the body's immune cells to kill cancerous cells; cytokines such as interferons, interleukins, and monoclonal antibodies (mAbs) are the most commonly used biologic therapies employed to treat cancer. Anti-amyloid mAbs have also shown promising therapeutic effects in clinical studies conducted on Alzheimer's disease patients. Chronic diseases such as ulcerative colitis and Crohn's disease include recurring episodes of inflammation of the mucosal layer of the colon. The US Food and Drug Administration has approved a few biological drugs for the treatment of Crohn's disease; these include infliximab, adalimumab, and natalizumab. Further, biological disease-modifying antirheumatic drugs are one of the major approaches to treating rheumatoid arthritis. With the shift in doctors' and patients' preference from conventional to aggressive approaches, the demand for biologics in the treatment of rheumatoid arthritis is also on the rise. Therapeutics use are partially or fully humanized proteins targeting different immune response pathways. Therefore, the increasing prevalence of chronic diseases drives the growth of the biologics market.

North America Biologics Market Overview

North America holds the largest share of the biologics market in terms of revenue. Market growth in this region is attributed to the presence of key biologics manufacturing players and the increasing spending on R and D. According to an article published in the JAMA Network, biologics R and D spending accounted for 37% of total R and D spending in the US. The number of prescriptions written for biologics and investments in the development of targeted drugs are on the rise in the country. Additionally, the approval of several novel biological drugs such as antisense, gene therapy, and RNAi therapeutics is expected to further drive the market growth. As per an article published by the National Center for Biotechnology Information (NCBI), the country recorded historically the highest percentage of biologics approvals in 2022, i.e., 40%, which indicates the stability of biologics in pharmaceutical applications. Moreover, this category of drugs accounts for 30% of the total drug approvals. In May 2024, Biocon Biologics Ltd (BBL) received FDA approval for YESAFILI (aflibercept) as the first biological alternative to Eylea. YESAFILI is a vascular endothelial growth factor (VEGF) inhibitor used to treat several different types of ophthalmology conditions.

North America Biologics Market Revenue and Forecast to 2031 (US$ Million)

North America Biologics Market Segmentation

The North America biologics market is categorized into product, application, source, manufacturing, and country.

Based on product, the North America biologics market is segmented into monoclonal antibodies, vaccine, recombinant hormones/proteins, cell and gene therapy, and others. The monoclonal antibodies segment held the largest market share in 2023.

In terms of application, the North America biologics market is categorized into cancer, infectious diseases, autoimmune diseases, and others. The cancer segment held the largest market share in 2023.

By source, the North America biologics market is bifurcated into mammalian and microbial. The mammalian segment held a larger market share in 2023.

Based on manufacturing, the North America biologics market is bifurcated into outsourced and in-house. The outsourced segment held a larger market share in 2023.

In terms of country, the North America biologics market is segmented into the US, Canada, and Mexico. The US dominated the North America biologics market share in 2023.

AbbVie Inc, Pfizer Inc, Samsung Biologics Co Ltd, ADMA Biologics, Inc., Wuxi Biologics Inc, Catalent Inc, AGC Biologics AS, AstraZeneca Plc, Amgen Inc, Nitto Avecia, and Quality Assistance s.a. are some of the leading companies operating in the North America biologics market.

1. Introduction

1.1 Report Guidance
1.2 Market Segmentation

2. Executive Summary

2.1 Key Insights
2.2 Market Attractiveness

3. Research Methodology

3.1 Secondary Research
3.2 Primary Research
- 3.2.1 Hypothesis formulation:
- 3.2.2 Macroeconomic factor analysis:
- 3.2.3 Developing base number:
- 3.2.4 Data Triangulation:
- 3.2.5 Country-level data:

4. North America Biologics Market - Key Market Dynamics

4.1 Market Drivers
- 4.1.1 Increasing Prevalence of Chronic Diseases
- 4.1.2 Preference for Outsourcing Manufacturing Operations
4.2 Market Restraints
- 4.2.1 High Cost of Biologics
4.3 Market Opportunities
- 4.3.1 Gene and Cell Therapy Advancements in Biologics
4.4 Future Trends
- 4.4.1 Strategic Initiatives by Companies
4.5 Impact of Drivers and Restraints:

5. Biologics Market - North America Analysis

5.1 North America Biologics Market Revenue (US$ Million), 2021-2031
5.2 North America Biologics Market Forecast Analysis

6. North America Biologics Market Analysis - by Product

6.1 Monoclonal Antibodies
- 6.1.1 Overview
- 6.1.2 Monoclonal Antibodies: North America Biologics Market - Revenue and Forecast, 2021-2031 (US$ Million)
6.2 Vaccine
- 6.2.1 Overview
- 6.2.2 Vaccine: North America Biologics Market - Revenue and Forecast, 2021-2031 (US$ Million)
6.3 Recombinant Hormones/Proteins
- 6.3.1 Overview
- 6.3.2 Recombinant Hormones/Proteins: North America Biologics Market - Revenue and Forecast, 2021-2031 (US$ Million)
6.4 Cell and Gene Therapy
- 6.4.1 Overview
- 6.4.2 Cell and Gene Therapy: North America Biologics Market - Revenue and Forecast, 2021-2031 (US$ Million)
6.5 Others
- 6.5.1 Overview
- 6.5.2 Others: North America Biologics Market - Revenue and Forecast, 2021-2031 (US$ Million)

7. North America Biologics Market Analysis - by Application

7.1 Cancer
- 7.1.1 Overview
- 7.1.2 Cancer: North America Biologics Market - Revenue and Forecast, 2021-2031 (US$ Million)
7.2 Infectious Diseases
- 7.2.1 Overview
- 7.2.2 Infectious Diseases: North America Biologics Market - Revenue and Forecast, 2021-2031 (US$ Million)
7.3 Autoimmune Diseases
- 7.3.1 Overview
- 7.3.2 Autoimmune Diseases: North America Biologics Market - Revenue and Forecast, 2021-2031 (US$ Million)
7.4 Others
- 7.4.1 Overview
- 7.4.2 Others: North America Biologics Market - Revenue and Forecast, 2021-2031 (US$ Million)

8. North America Biologics Market Analysis - by Source

8.1 Mammalian
- 8.1.1 Overview
- 8.1.2 Mammalian: North America Biologics Market - Revenue and Forecast, 2021-2031 (US$ Million)
8.2 Microbial
- 8.2.1 Overview
- 8.2.2 Microbial: North America Biologics Market - Revenue and Forecast, 2021-2031 (US$ Million)

9. North America Biologics Market Analysis - by Manufacturing

9.1 Outsourced
- 9.1.1 Overview
- 9.1.2 Outsourced: North America Biologics Market - Revenue and Forecast, 2021-2031 (US$ Million)
9.2 In-house
- 9.2.1 Overview
- 9.2.2 In-house: North America Biologics Market - Revenue and Forecast, 2021-2031 (US$ Million)

10. North America Biologics Market - Country Analysis

10.1 North America
- 10.1.1 North America Biologics Market - Revenue and Forecast Analysis - by Country
  - 10.1.1.1 North America Biologics Market - Revenue and Forecast Analysis - by Country
  - 10.1.1.2 United States: North America Biologics Market - Revenue and Forecast, 2021-2031 (US$ Million)
    - 10.1.1.2.1 United States: North America Biologics Market Share - by Product
    - 10.1.1.2.2 United States: North America Biologics Market Share - by Application
    - 10.1.1.2.3 United States: North America Biologics Market Share - by Source
    - 10.1.1.2.4 United States: North America Biologics Market Share - by Manufacturing
  - 10.1.1.3 Canada: North America Biologics Market - Revenue and Forecast, 2021-2031 (US$ Million)
    - 10.1.1.3.1 Canada: North America Biologics Market Share - by Product
    - 10.1.1.3.2 Canada: North America Biologics Market Share - by Application
    - 10.1.1.3.3 Canada: North America Biologics Market Share - by Source
    - 10.1.1.3.4 Canada: North America Biologics Market Share - by Manufacturing
  - 10.1.1.4 Mexico: North America Biologics Market - Revenue and Forecast, 2021-2031 (US$ Million)
    - 10.1.1.4.1 Mexico: North America Biologics Market Share - by Product
    - 10.1.1.4.2 Mexico: North America Biologics Market Share - by Application
    - 10.1.1.4.3 Mexico: North America Biologics Market Share - by Source
    - 10.1.1.4.4 Mexico: North America Biologics Market Share - by Manufacturing

11. Industry Landscape

11.1 Overview
11.2 Market Initiative
11.3 Partnerships and Collaborations
11.4 Other Developments

12. Company Profiles

12.1 AbbVie Inc
- 12.1.1 Key Facts
- 12.1.2 Business Description
- 12.1.3 Products and Services
- 12.1.4 Financial Overview
- 12.1.5 SWOT Analysis
- 12.1.6 Key Developments
12.2 Pfizer Inc
- 12.2.1 Key Facts
- 12.2.2 Business Description
- 12.2.3 Products and Services
- 12.2.4 Financial Overview
- 12.2.5 SWOT Analysis
- 12.2.6 Key Developments
12.3 Samsung Biologics Co Ltd
- 12.3.1 Key Facts
- 12.3.2 Business Description
- 12.3.3 Products and Services
- 12.3.4 Financial Overview
- 12.3.5 SWOT Analysis
- 12.3.6 Key Developments
12.4 ADMA Biologics, Inc.
- 12.4.1 Key Facts
- 12.4.2 Business Description
- 12.4.3 Products and Services
- 12.4.4 Financial Overview
- 12.4.5 SWOT Analysis
- 12.4.6 Key Developments
12.5 WuXi Biologics Inc
- 12.5.1 Key Facts
- 12.5.2 Business Description
- 12.5.3 Products and Services
- 12.5.4 Financial Overview
- 12.5.5 SWOT Analysis
- 12.5.6 Key Developments
12.6 Catalent Inc
- 12.6.1 Key Facts
- 12.6.2 Business Description
- 12.6.3 Products and Services
- 12.6.4 Financial Overview
- 12.6.5 SWOT Analysis
- 12.6.6 Key Developments
12.7 AGC Biologics AS
- 12.7.1 Key Facts
- 12.7.2 Business Description
- 12.7.3 Products and Services
- 12.7.4 Financial Overview
- 12.7.5 SWOT Analysis
- 12.7.6 Key Developments
12.8 AstraZeneca Plc
- 12.8.1 Key Facts
- 12.8.2 Business Description
- 12.8.3 Products and Services
- 12.8.4 Financial Overview
- 12.8.5 SWOT Analysis
- 12.8.6 Key Developments
12.9 Amgen Inc
- 12.9.1 Key Facts
- 12.9.2 Business Description
- 12.9.3 Products and Services
- 12.9.4 Financial Overview
- 12.9.5 SWOT Analysis
- 12.9.6 Key Developments
12.10 Nitto Avecia
- 12.10.1 Key Facts
- 12.10.2 Business Description
- 12.10.3 Products and Services
- 12.10.4 Financial Overview
- 12.10.5 SWOT Analysis
- 12.10.6 Key Developments
12.11 Quality Assistance s.a.
- 12.11.1 Key Facts
- 12.11.2 Business Description
- 12.11.3 Products and Services
- 12.11.4 Financial Overview
- 12.11.5 SWOT Analysis
- 12.11.6 Key Developments

13. Appendix

13.1 About Us

简介目录图表

List Of Tables

Table 1. North America Biologics Market Segmentation
Table 2. North America Biologics Market - Revenue and Forecast, 2021-2031 (US$ Million)
Table 3. North America Biologics Market - Revenue and Forecast, 2021-2031 (US$ Million) - by Product
Table 4. North America Biologics Market - Revenue and Forecast, 2021-2031 (US$ Million) - by Application
Table 5. North America Biologics Market - Revenue and Forecast, 2021-2031 (US$ Million) - by Source
Table 6. North America Biologics Market - Revenue and Forecast, 2021-2031 (US$ Million) - by Manufacturing
Table 7. North America Biologics Market - Revenue and Forecast, 2021-2031 (US$ Million) - by Country
Table 8. United States: North America Biologics Market - Revenue and Forecast, 2021 - 2031 (US$ Million) - by Product
Table 9. United States: North America Biologics Market - Revenue and Forecast, 2021 - 2031 (US$ Million) - by Application
Table 10. United States: North America Biologics Market - Revenue and Forecast, 2021 - 2031 (US$ Million) - by Source
Table 11. United States: North America Biologics Market - Revenue and Forecast, 2021 - 2031 (US$ Million) - by Manufacturing
Table 12. Canada: North America Biologics Market - Revenue and Forecast, 2021 - 2031 (US$ Million) - by Product
Table 13. Canada: North America Biologics Market - Revenue and Forecast, 2021 - 2031 (US$ Million) - by Application
Table 14. Canada: North America Biologics Market - Revenue and Forecast, 2021 - 2031 (US$ Million) - by Source
Table 15. Canada: North America Biologics Market - Revenue and Forecast, 2021 - 2031 (US$ Million) - by Manufacturing
Table 16. Mexico: North America Biologics Market - Revenue and Forecast, 2021 - 2031 (US$ Million) - by Product
Table 17. Mexico: North America Biologics Market - Revenue and Forecast, 2021 - 2031 (US$ Million) - by Application
Table 18. Mexico: North America Biologics Market - Revenue and Forecast, 2021 - 2031 (US$ Million) - by Source
Table 19. Mexico: North America Biologics Market - Revenue and Forecast, 2021 - 2031 (US$ Million) - by Manufacturing

List Of Figures

Figure 1. North America Biologics Market Segmentation - Country
Figure 2. North America Biologics Market - Key Market Dynamics
Figure 3. Impact Analysis of Drivers and Restraints
Figure 4. North America Biologics Market Revenue (US$ Million), 2021-2031
Figure 5. North America Biologics Market Share (%) - by Product (2023 and 2031)
Figure 6. Monoclonal Antibodies: North America Biologics Market - Revenue and Forecast, 2021-2031 (US$ Million)
Figure 7. Vaccine: North America Biologics Market - Revenue and Forecast, 2021-2031 (US$ Million)
Figure 8. Recombinant Hormones/Proteins: North America Biologics Market - Revenue and Forecast, 2021-2031 (US$ Million)
Figure 9. Cell and Gene Therapy: North America Biologics Market - Revenue and Forecast, 2021-2031 (US$ Million)
Figure 10. Others: North America Biologics Market - Revenue and Forecast, 2021-2031 (US$ Million)
Figure 11. North America Biologics Market Share (%) - by Application (2023 and 2031)
Figure 12. Cancer: North America Biologics Market - Revenue and Forecast, 2021-2031 (US$ Million)
Figure 13. Infectious Diseases: North America Biologics Market - Revenue and Forecast, 2021-2031 (US$ Million)
Figure 14. Autoimmune Diseases: North America Biologics Market - Revenue and Forecast, 2021-2031 (US$ Million)
Figure 15. Others: North America Biologics Market - Revenue and Forecast, 2021-2031 (US$ Million)
Figure 16. North America Biologics Market Share (%) - by Source (2023 and 2031)
Figure 17. Mammalian: North America Biologics Market - Revenue and Forecast, 2021-2031 (US$ Million)
Figure 18. Microbial: North America Biologics Market - Revenue and Forecast, 2021-2031 (US$ Million)
Figure 19. North America Biologics Market Share (%) - by Manufacturing (2023 and 2031)
Figure 20. Outsourced: North America Biologics Market - Revenue and Forecast, 2021-2031 (US$ Million)
Figure 21. In-house: North America Biologics Market - Revenue and Forecast, 2021-2031 (US$ Million)
Figure 22. North America Biologics Market Breakdown, by Key Countries, 2023 and 2031 (%)
Figure 23. United States: North America Biologics Market - Revenue and Forecast, 2021- 2031 (US$ Million)
Figure 24. Canada: North America Biologics Market - Revenue and Forecast, 2021- 2031 (US$ Million)
Figure 25. Mexico: North America Biologics Market - Revenue and Forecast, 2021- 2031 (US$ Million)