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生物製劑分子標靶治療學

市場調查報告書

商品編碼

1290357

全球單克隆抗體治療劑市場 - 2023-2030年

Global Monoclonal Antibody Therapeutics Market - 2023-2030

出版日期: 2023年06月12日 | 出版商:

DataM Intelligence | 英文 195 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄

市場概況

全球單克隆抗體療法市場在2022年達到1,906.983億美元，預計到2030年將見證有利可圖的成長，達到5,313.146億美元。在預測期內（2023-2030年），全球單克隆抗體療法市場預計將呈現14.1%的複合成長率。

單克隆抗體治療劑（mAbs）是由相同的抗體（或簡單的抗體片段）以同質的方式產生。產品中每個抗體分子的抗原識別位點、生物相互作用、親和力和下游的生物後果都是相同的。這使mAbs有別於多克隆抗體，後者的蛋白質序列和表位識別範圍多種多樣

全球單克隆抗體治療劑市場正在擴大，其因素包括自身免疫性疾病的發病率不斷提高，治療管道的規模不斷擴大，生物製藥公司的投資及其在各國即將獲得的醫療批准也為單克隆抗體治療劑市場成長創造了積極的前景。

市場動態

越來越多的監管部門批准和推出的療法推動了單克隆抗體治療劑市場的成長

各監管機構對用於癌症或自身免疫性疾病的不同單克隆抗體療法的監管批准數量不斷增加，主要生物製藥公司的臨床試驗不斷增加，癌症患者人口增加，以及新的、創新的、技術先進的療法，都有助於全球單克隆抗體療法市場的成長。

此外，2023年1月5日，Nirsevimab的生物製劑許可申請（BLA）被美國FDA、藥物評價和研究中心批准，用於治療24個月以下、在整個第二輪RSV季節仍易發生嚴重呼吸道合胞病毒（RSV）疾病的兒童，以及進入或已經經歷第一個RSV季節的嬰兒和新生兒。因此，生物製藥公司推出的新型療法越來越多，推動了單克隆抗體治療劑市場的發展。

生物技術公司在研究和開發方面的投資不斷增加，為製造商創造了有利可圖的機會

由於主要參與者或生物技術企業在研發能力方面的支出或投資不斷增加，以實現獨特的技術突破，單克隆抗體治療劑的市場機會不斷增加。推動單克隆抗體療法市場的另一個趨勢是呼吸系統疾病的發生率越來越高。

此外，2023年4月，楊森生物技術公司和紐約大學格羅斯曼醫學院的研究人員進行的早期實驗表明，一種生物工程的候選藥物可以預防金黃色葡萄球菌的感染。

報告詳細介紹了對mAbtyrins的初步評估，這是一種源自工程人類單克隆抗體（mAb）的組合分子，是一種能夠粘附並識別金黃色葡萄球菌以便被免疫細胞吸收和根除的蛋白質。 Centyrins是附著在mAb上的微小蛋白質，可以阻止這些病菌在人類免疫細胞中鑽洞藏身。

較高的成本和嚴格的監管措施將阻礙市場的成長。

然而，包括單克隆抗體和重組蛋白在內的生物治療劑已經發展成為當代醫學的基礎，但對於中低收入國家的人口來說，仍然在很大程度上遙不可及，部分原因在於其高昂的成本，儘管經常提供比標準護理更多的臨床益處是對單克隆抗體治療劑市場的一個制約因素。

一種mAb的平均年成本為96,731美元，對於34種mAb-適應症組合，它超過了100,000美元。儘管在獲批的mAb-適應症組合中佔40%，但血液學和腫瘤學mAb佔價格在10萬美元以上的組合中的85%以上。因此，上述這些因素限制了單克隆抗體治療劑市場的成長。

COVID-19影響分析

各個行業的公司的財務健康都受到COVID-19大流行病和全世界眾多國家封鎖的影響。因此，在COVID-19公共衛生緊急情況期間，美國食品和藥物管理局（FDA）發布了指導方針，其中包括幫助贊助商和研究人員的一般考慮因素，確保試驗參與者的安全，堅持良好的臨床實踐（GCP），並儘量減少試驗完整性的風險。

這些治療性單克隆抗體也被用於控制COVID-19。例如，2022年2月11日，禮來公司宣布Bebtelovimab，一種對Omicron變體表現出中和作用的抗體，獲得了美國食品和藥物管理局（FDA）的緊急使用授權（EUA）。

俄烏戰爭影響分析

俄羅斯-烏克蘭衝突估計對全球單克隆抗體療法市場的影響不大，因為該地區的主要市場參與者數量較少。然而，在預測期內，原料進出口的影響預計對全球單克隆抗體治療劑市場的成長影響不大。

Market Overview

The Global Monoclonal Antibody Therapeutics Market reached US$ 190,698.3 million in 2022 and is projected to witness lucrative growth by reaching up to US$ 531,314.6 million by 2030. The global monoclonal antibody therapeutics market is expected to exhibit a CAGR of 14.1% during the forecast period (2023-2030).

Monoclonal antibody therapeutics (mAbs) are generated from identical antibodies (or simply antibody fragments) in a homogeneous manner. The antigen recognition site, biological interactions, affinity and downstream biologic consequences of every antibody molecule in the product are identical. This sets mAbs apart from polyclonal antibodies, which have a diverse range of protein sequences and epitope recognition

The global market for monoclonal antibody therapeutics is expanding as a result of factors including the increasing prevalence of autoimmune disorders, the growing size of the therapeutic pipeline, investment by biopharmaceutical companies and their upcoming medical approvals across countries are also creating a positive outlook for the monoclonal antibody therapeutics market growth.

Market Dynamics

Increasing Regulatory Approvals and Launch of Therapies Drive the Growth of the Monoclonal Antibody Therapeutics Market

The growing number of regulatory approvals by various regulatory bodies for different monoclonal antibodies therapeutics utilized for cancer or autoimmune diseases, the growing clinical trials by major biopharmaceutical companies, an increase in the population with cancer, and new, innovative, technologically sophisticated therapies are all contributing to the growth of the global market for monoclonal antibody therapeutics.

Furthermore, on January 5, 2023, Nirsevimab's Biologics License Application (BLA) was approved by the U.S. FDA, Center for Drug Evaluation and Research for the treatment of children up to 24 months old who are still susceptible to developing severe respiratory syncytial virus (RSV) disease throughout the second RSV season as well as for infants and newborns entering or already experiencing their first RSV season. Hence, the growing number of novel therapies launched by biopharmaceutical companies is driving the monoclonal antibody therapeutics market.

The Growing Investments in Research and Development by Biotechnology Companies Create Lucrative Opportunities for Manufacturers

Due to increasing spending or investments in research and development capabilities by key players or biotechnology businesses for unique technological breakthroughs, there is a growing market opportunity for monoclonal antibody therapeutics. Another trend driving the monoclonal antibody therapies market is the increasing occurrence of respiratory diseases.

Furthermore, in April 2023, early experiments conducted by researchers at Janssen Biotech, Inc. and NYU Grossman School of Medicine demonstrated that a bioengineered medication candidate can prevent infection with the bacterium species Staphylococcus aureus.

It details the preliminary evaluation of mAbtyrins, a combination molecule derived from an engineered human monoclonal antibody (mAb), a kind of protein that adheres to and identifies S. aureus for uptake and eradication by immune cells. Centyrins, tiny proteins that are attached to the mAb, stop these germs from drilling holes in the human immune cells where they hide.

Higher Costs and Strict Regulatory Measures will Hamper the Growth of the Market.

However, biotherapeutics, including monoclonal antibodies and recombinant proteins, which have grown into the foundation of contemporary medicine, are still largely beyond reach for populations in middle- and low-income countries, in part due to their high costs, despite often providing clinical benefits over the standard of care is a restraint for monoclonal antibody therapeutics market.

The average yearly cost of a mAb was $96,731, and for 34 mAb-indication combos, it exceeded $100,000. Despite making up 40% of the approved mAb-indication combinations, hematology and oncology mAbs accounted for over 85 percent of those with a price tag of $100,000 or higher. Hence these above mentioned factors are limiting the monoclonal antibody therapeutics market's growth.

COVID-19 Impact Analysis

The financial health of companies across all industries has been impacted by the COVID-19 pandemic and lockdown in numerous nations throughout the world. Therefore, for the period of the COVID-19 public health emergency, the U.S. Food and Drug Administration (FDA) issued guidelines that include general considerations to aid sponsors and researchers, ensuring the safety of trial participants, adhering to good clinical practice (GCP), and minimizing risks to trial integrity.

These therapeutic monoclonal antibodies were also used to control COVID-19. For instance, on February 11, 2022, Eli Lilly and Company announced that Bebtelovimab, an antibody that exhibits neutralization against the Omicron variant, received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).

Russia-Ukraine War Impact Analysis

The Russia-Ukraine conflict is estimated to have a low impact on the global monoclonal antibody therapeutics market, owing to the low number of key market players in this region. However, the impact of the import and export of raw materials is expected to have little influence over the global monoclonal antibody therapeutics market growth over the forecast period.

Segment Analysis

The global monoclonal antibody therapeutics market is segmented based on product type, application, production source, distribution channel and region.

Humanoid from the Production Source Segment Accounts for 45.79% of the Market Share Owing to Rising Novel Product Launches.

A humanized antibody possesses three advantages over a native mouse mAb: it is less immunogenic (since the immune response is primarily directed against the mouse Ig constant region); it can perform human effector functions; and its serum half-life in humans is significantly longer. Researchers have extracted the mouse CDRs targeted against a relevant human antigen and assembled them in a human antibody framework to further humanize these antibodies.

A humanized IgG4 anti-PD-1 monoclonal antibody called tislelizumab is being researched as a monotherapy and in conjunction with other treatments. Treatment of inoperable recurrent metastatic or locally progressed esophageal squamous cell carcinoma (ESCC) is possible in patients who had previously received systemic therapy with the anti-PD-1 immune checkpoint inhibitor tislelizumab.

Geographical Analysis

North America Accounted for Approximately 40.2% of the Market Share in 2022, Owing to the Strong Presence of Major Players and Increasing Healthcare Infrastructure Investment

Manufacturers have chances to expand their operations in this region because of the rising demand for monoclonal antibody therapeutics for advancements in North America. The area has many producers and suppliers, and its rapid economic development has raised industrial production of monoclonal antibody therapeutics, which has increased the demand.

North America has a large number of producers and suppliers, and as a result of the swift economic development of the area, industrial production has increased, fueling the demand for monoclonal antibody therapeutics.

Rising new product types or applications will drive market growth. Growth is also fueled by rising technological advancements, regulatory approvals, and novel product launches. Researchers are becoming more aware of various kinds of treatment approaches for cancer or various other disorders, leading to the expansion of the market in this region.

Competitive Landscape

The major global players in the monoclonal antibody therapeutics market include: F. Hoffmann-La Roche, Sanofi, Merck & Co. Inc., Pfizer Inc., GSK Plc, Eli Lily and Co., Regeneron Pharmaceuticals Inc., AstraZeneca, and Bayers AG among others.

Why Purchase the Report?

To visualize the global monoclonal antibody therapeutics market segmentation based on product type, application, production source, end user and region, as well as understand key commercial assets and players.
Identify commercial opportunities by analyzing trends and co-development.
Excel data sheet with numerous data points of monoclonal antibody therapeutics market-level with all segments.
PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
Product mapping available as Excel consisting of key products of all the major players.

The global monoclonal antibody therapeutics market report would provide approximately 53 tables, 54 figures and 195 Pages.

Target Audience 2023

Manufacturers/ Buyers
Industry Investors/Investment Bankers
Research Professionals
Emerging Companies

1. Methodology and Scope

1.1. Research Methodology
1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

3.1. Snippet by Product Type
3.2. Snippet by Application
3.3. Snippet by End User
3.4. Snippet by Region

4. Dynamics

4.1. Impacting Factors
- 4.1.1. Drivers
  - 4.1.1.1. Increasing Regulatory Approvals and Launch of Therapies
  - 4.1.1.2. Rising Incidence of Cancer and Other Chronic Diseases
- 4.1.2. Restraints
  - 4.1.2.1. Higher Costs and Strict Regulatory Measures
- 4.1.3. Opportunity
  - 4.1.3.1. The Growing Investments in Research and Development by Biotechnology Companies
- 4.1.4. Impact Analysis

5. Industry Analysis

5.1. Porter's 5 Forces Analysis
5.2. Supply Chain Analysis
5.3. Pricing Analysis
5.4. Regulatory Analysis

6. COVID-19 Analysis

6.1. Analysis of COVID-19
- 6.1.1. Scenario Before COVID-19
- 6.1.2. Scenario During COVID-19
- 6.1.3. Scenario Post COVID-19
6.2. Pricing Dynamics Amid COVID-19
6.3. Demand-Supply Spectrum
6.4. Government Initiatives Related to the Market During Pandemic
6.5. Manufacturers Strategic Initiatives
6.6. Conclusion

7. By Product Type

7.1. Introduction
- 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 7.1.2. Market Attractiveness Index, By Product Type
7.2. Naked *
- 7.2.1. Introduction
- 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
7.3. Fusion Protein
7.4. Antibody Fragment
7.5. Conjugate
7.6. Multi-specific

8. By Application

8.1. Introduction
- 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 8.1.2. Market Attractiveness Index, By Application
8.2. Cancer *
- 8.2.1. Introduction
- 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
8.3. Autoimmune Diseases
8.4. Infectious Diseases
8.5. Others

9. By Production Source

9.1. Introduction
- 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Production Source
- 9.1.2. Market Attractiveness Index, By Production Source
9.2. Human *
- 9.2.1. Introduction
- 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
9.3. Humanized
9.4. Chimeric
9.5. Others

10. By End User

10.1. Introduction
- 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
- 10.1.2. Market Attractiveness Index, By End User
10.2. Hospital *
- 10.2.1. Introduction
- 10.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
10.3. Specialty Centers
10.4. Research Institutes

11. By Region

11.1. Introduction
- 11.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
- 11.1.2. Market Attractiveness Index, By Region
11.2. North America
- 11.2.1. Introduction
- 11.2.2. Key Region-Specific Dynamics
- 11.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 11.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 11.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Production Source
- 11.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
- 11.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 11.2.7.1. The U.S.
  - 11.2.7.2. Canada
  - 11.2.7.3. Mexico
11.3. Europe
- 11.3.1. Introduction
- 11.3.2. Key Region-Specific Dynamics
- 11.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 11.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 11.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Production Source
- 11.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
- 11.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 11.3.7.1. Germany
  - 11.3.7.2. The U.K.
  - 11.3.7.3. France
  - 11.3.7.4. Italy
  - 11.3.7.5. Spain
  - 11.3.7.6. Rest of Europe
11.4. South America
- 11.4.1. Introduction
- 11.4.2. Key Region-Specific Dynamics
- 11.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 11.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 11.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Production Source
- 11.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
- 11.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 11.4.7.1. Brazil
  - 11.4.7.2. Argentina
  - 11.4.7.3. Rest of South America
11.5. Asia-Pacific
- 11.5.1. Introduction
- 11.5.2. Key Region-Specific Dynamics
- 11.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 11.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 11.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Production Source
- 11.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
- 11.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 11.5.7.1. China
  - 11.5.7.2. India
  - 11.5.7.3. Japan

Australia

11.5.7.4. Rest of Asia-Pacific

11.6. Middle East and Africa
- 11.6.1. Introduction
- 11.6.2. Key Region-Specific Dynamics
- 11.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 11.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 11.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Production Source
- 11.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User

12. Competitive Landscape

12.1. Competitive Scenario
12.2. Market Positioning/Share Analysis
12.3. Mergers and Acquisitions Analysis

13. Company Profiles

13.1. F. Hoffmann-La Roche *
- 13.1.1. Company Overview
- 13.1.2. Product Portfolio and Description
- 13.1.3. Financial Overview
- 13.1.4. Key Developments
13.2. Novartis AG
13.3. Merck & Co. Inc.
13.4. Pfizer Inc.
13.5. Eli Lilly and Co. (Lilly)
13.6. Sanofi
13.7. AstraZeneca
13.8. Bayer AG
13.9. Regeneron Pharmaceuticals Inc.
13.10. GSK Plc

LIST NOT EXHAUSTIVE