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1764936

2031 年北美生物製劑市場預測 - 區域分析 - 按產品、應用、來源和製造

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 | 訂單完成後即時交付

價格

簡介目錄圖表

2023 年北美生物製劑市場價值為 2,302.561 億美元，預計到 2031 年將達到 8,888.8 億美元；預計 2023 年至 2031 年複合年成長率為 18.4%。

慢性病盛行率上升推動北美生物製劑市場發展

根據Ellerston Capital Limited發表的一項名為《慢性病：生物學方法》的研究，全球每年有4,100萬人死於慢性病，佔全球死亡人數的74%。 2020年，癌症導致近1,000萬人死亡，即每6例死亡病例中就有1例。根據GLOBOCAN的數據，2020年全球登記的癌症病例為1,930萬例，預計2030年將上升至2,460萬例。此外，自體免疫疾病的盛行率每年以3-9%的速度成長。預計到2030年，阿茲海默症的病例將達到7,800萬例，到2050年將達到1.39億例。根據世界衛生組織（WHO）的數據，全球每年約有1700萬人在70歲前死於非傳染性疾病。

抗體和疫苗等生物製劑能夠提供更具針對性的治療，因為它們旨在以特定方式與免疫系統相互作用，從而發揮治療或預防作用。生物製劑透過阻斷免疫系統中過度活躍的成分（在許多情況下是蛋白質）——這些成分會損害關節、皮膚和其他身體部位——在治療某些慢性自體免疫疾病方面具有廣闊的潛力。利用生物製劑治療癌症是指利用人體免疫細胞殺死癌細胞；干擾素、白血球介素和單株抗體 (mAb) 等細胞激素是治療癌症最常使用的生物療法。抗澱粉樣蛋白單株抗體在針對阿茲海默症患者的臨床研究中也顯示出良好的治療效果。潰瘍性結腸炎和克隆氏症等慢性疾病包括反覆發作的結腸粘膜層發炎。美國食品藥物管理局已批准一些用於治療克隆氏症的生物製劑，包括英夫利西單抗、阿達木單抗和那他珠單抗。此外，生物製劑是治療類風濕性關節炎的主要方法之一。隨著醫生和患者對傳統療法的偏好轉向積極療法，生物製劑在類風濕性關節炎治療中的需求也不斷成長。治療藥物是針對不同免疫反應途徑的部分或完全人源化蛋白質。因此，慢性病盛行率的上升推動了生物製劑市場的成長。

北美生物製劑市場概況

就收入而言，北美佔據生物製劑市場的最大佔有率。該地區的市場成長歸因於關鍵生物製劑製造企業的存在以及研發支出的增加。根據 JAMA Network 發表的一篇文章，生物製劑研發支出占美國總研發支出的 37%。該國生物製劑處方數量和針對性藥物開發的投資正在增加。此外，反義、基因療法和 RNAi 療法等幾種新型生物藥物的批准預計將進一步推動市場成長。根據美國國家生物技術資訊中心 (NCBI) 發表的一篇文章，該國在 2022 年創下了生物製劑獲批比例的歷史最高紀錄，即 40%，這表明生物製劑在藥物應用中的穩定性。此外，這類藥物佔藥品核准總量的 30%。 2024年5月，Biocon Biologics Ltd (BBL) 獲得美國食品藥物管理局 (FDA) 批准 YESAFILI（阿柏西普），作為 Eylea 的首個生物替代品。 YESAFILI 是一種血管內皮生長因子 (VEGF) 抑制劑，用於治療多種不同類型的眼科疾病。

北美生物製劑市場收入及預測（2031年）（百萬美元）

北美生物製劑市場細分

北美生物製劑市場分為產品、應用、來源、製造和國家。

根據產品類型，北美生物製劑市場細分為單株抗體、疫苗、重組激素/蛋白質、細胞和基因療法以及其他。單株抗體在2023年佔據了最大的市場。

從應用角度來看，北美生物製劑市場主要分為癌症、傳染病、自體免疫疾病等。 2023年，癌症領域佔據了最大的市場。

依來源分類，北美生物製劑市場分為哺乳動物和微生物兩大類。 2023年，哺乳動物類生物製劑佔了更大的市場。

根據製造方式，北美生物製劑市場分為外包和內部製造。 2023年，外包部分佔據了更大的市場。

就國家而言，北美生物製劑市場分為美國、加拿大和墨西哥。 2023年，美國佔據了北美生物製劑市場的主導地位。

AbbVie Inc、Pfizer Inc、三星生物製品有限公司、ADMA Biologics, Inc.、無錫生物製品有限公司、Catalent Inc、AGC Biologics AS、阿斯利康公司、安進公司、Nitto Avecia 和 Quality Assistance sa 是北美生物製品市場的一些領先公司。

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

簡介目錄圖表

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)