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生物製劑基因治療學和RNAi

市場調查報告書

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1557331

病毒載體製造市場－2024年至2029年預測

Viral Vector Manufacturing Market - Forecasts from 2024 to 2029

出版日期: 2024年08月27日 | 出版商:

Knowledge Sourcing Intelligence | 英文 140 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄

病毒載體製造市場預計將從2024年的1,192,033,000美元成長到2029年的2,612,384,000美元，複合年成長率為16.99%。

病毒載體製造涉及重要載體的開發，例如用於運輸治療基因的腺病毒載體、慢病毒載體和逆轉錄病毒載體。由於其高性能，病毒載體已應用於基因治療和疫苗治療。這些應用的成長也推動了對病毒載體的需求，從而提高了整體製造水準。

此外，病毒載體也用於治療多種疾病，包括心血管疾病、各種癌症、感染疾病和代謝疾病。因此，臨床試驗數量的增加和對有效疾病治療方法的認知不斷增強，預計將在預測期內進一步推動病毒載體製造市場的成長。

由於技術和平台的複雜性，載體設計、生產、包裝和發布測試都受到限制且具有挑戰性。因此，該領域的許多參與者經常尋求涵蓋多個方面的策略聯盟和收購，例如提供臨床級產品，以成功共同開發基於病毒製劑的產品。

此外，有效表達治療基因的能力和非致病性也是推動該市場成長的因素。預計推動市場成長的其他主要因素包括生物製藥生產投資的增加以及人口老化的加劇、醫療保健支出和技術進步（特別是在基因工程領域）。

此外，由於全球疾病負擔增加，醫療保健設施的便利性增加以及疾病治療需求的增加也是預測期內推動該市場成長的一些因素。然而，這個利基產業向大規模生產的轉變是在一定程度上抑制市場成長的因素之一。

病毒載體製造市場促進因素：

治療學方面的有利投資預計將增加對病毒載體的需求。

攜帶遺傳訊息的病毒載體可以直接針對疾病，進而改變細胞功能。由於這些優點，載體在基因治療中得到了廣泛的應用，它們將健康的基因拷貝傳遞到細胞中。癌症、心血管疾病和神經退化性疾病的盛行率日益增加，導致了基因治療開發的各種研究合作和投資。

例如，2023年8月，Astella Pharma Inc.和Poseida Therapeutics宣布進行5,000萬美元策略性投資，以支持後者在癌細胞治療方面的進展。這項投資將使 Astera 能夠進一步專注於開發下一代免疫腫瘤藥物。

同樣，2023年11月，Astra Zeneca與 Cellectis 簽訂了合作和投資協議，以加強免疫學、腫瘤學和罕見疾病領域下一代療法的開發。根據此次合作，Astra Zeneca將利用 Intelis 的基因編輯技術開發新型細胞和基因療法。

疫苗開發設施的持續建設進一步推動了整體市場的擴張。

全球感染疾病的規模不斷擴大，對各種有效疫苗來對抗它們的需求也不斷增加。例如，BioNtech SE於2022年6月宣布將在盧安達建立mRNA疫苗生產設施。

同樣，2024 年 7 月，美國衛生與公共服務部宣布向 Moderna 提供約 1.76 億美元，用於開發基於 mRNA 的流感疫苗。這項投資是透過 BARDA（生物醫學高級研究與開發局）新成立的快速反應合作夥伴汽車聯盟宣布的。

病毒載體製造市場地理前景

據估計，北美將佔據很大的市場佔有率。

按地區分類，北美地區有望顯著成長。在美國和加拿大主要新興市場開發並核准新疫苗和基因療法開發後，由於持續的治療學合作研究，預計該地區將佔據重要的市場佔有率。

例如，2023年12月，美國食品藥物管理局核准了兩種基於細胞的基因療法Casgevy和Lyfgenia，用於治療12歲及以上的鐮狀細胞患者。這種治療方法代表了基因療法的革命性進步，並將改善影響近 10 萬美國人的鐮狀細胞疾病的治療。

同樣，2023 年 10 月，紐約州州長宣布投資 9,800 萬美元，擴大羅斯威爾公園綜合癌症中心的基因治療研發業務。此次擴建將使羅斯威爾公園成為紐約第一個基因治療中心，並符合政府在生命科學領域實現新里程碑的承諾。

此外，美國政府也投資擴大醫療設施和研究機構，以加強對各種慢性疾病的治療，這對病毒載體的需求有正面影響。此外，輝瑞、佳樂士、Astra Zeneca等大型製藥公司的進駐也為未來的市場拓展鋪平了道路。

2024年2月，Astra Zeneca宣布斥資3億美元在羅克維爾建立最先進的設施，用於開發以T細胞治療為中心的商業細胞治療平台。該設施還將促進未來重要的癌症臨床試驗，以促進癌症治療的進步。

病毒載體製造的主要市場開拓

2024 年 2 月，新南威爾斯州政府成立了一家商業公司，在 Westmead 經營病毒載體生產設施。近1.345億美元已投入生產用於臨床和研究試驗的病毒載體產品，該機構將確保政府的長期病毒載體生產運作。
2022 年 6 月，Avid Bioservices, Inc. 在其 Current Good Manufacturing Plant (CG Plant) 製造工廠運作了新的病毒載體開發、分析和製程開發套件。
2022 年 5 月，AGC Biologics 宣布增加病毒載體懸浮技術和製造能力，以支持其位於科羅拉多州朗蒙特的商業級園區的基因療法開發和製造。

病毒載體製造市場區隔與分析如下：

按類型

逆轉錄病毒載體
慢病毒載體
腺病毒載體
其他

按用途

疫苗學
基因治療

按最終用戶

製藥和生物技術公司
研究所
受託研究機構

按地區

北美洲
美國
加拿大
墨西哥
南美洲
巴西
阿根廷
其他
歐洲
英國
德國
法國
西班牙
其他中東/非洲
UAE
沙烏地阿拉伯
其他
亞太地區
中國
印度
日本
韓國
泰國
印尼
台灣
其他

Viral vector manufacturing involves developing crucial carriers such as adenoviral vectors, lentiviral vectors, and retroviral vectors used to transport therapeutic genes. Owing to their high-performance benefits, viral vectors find applicability in gene therapy and vaccinology. It also bolstered growth in such applications, which is majorly driving the demand for viral vectors, thereby propelling their overall manufacturing level.

Moreover, viral vectors have been utilized to treat a variety of diseases that are inclusive of but not limited to cardiovascular diseases, different types of cancer, hematologic, infectious, and metabolic diseases. Hence, the growing number of clinical trials and the expanding cognizance of effective modes of disease treatment are further expected to drive the viral vector manufacturing market growth during the forecast period.

Vector designing, production, packaging, and release testing are subject to limited availability and challenges due to the complex nature of technologies and platforms. Hence, many players in this space frequently seek strategic collaborations and acquisitions that cover many aspects, such as the delivery of clinal grade products, to facilitate the successful collaboration development of viral agent-based products.

Moreover, the efficient ability to express the therapeutic genes and their non-pathogenic nature is another factor responsible for driving this market's growth. The other key factors expected to drive the market's growth are the increasing investment in biopharmaceutical production coupled with the growing aging population, healthcare expenditure, and technological advancement, especially in the genetic engineering segment.

Furthermore, the increasing accessibility of healthcare facilities and the growing demand for disease treatment due to the increasing global burden of diseases are a few of the other factors poised to drive the growth of this market during the forecast period. Nevertheless, the transition of this niche industry to high manufacturing is one such factor that may restrain the market's growth to a certain extent.

Viral Vector Manufacturing Market Drivers:

Favorable investments in therapeutics are expected to bolster the demand for viral vectors.

Viral vectors with genetic information can directly target the disease, thereby altering cell functioning. Due to such benefits, vectors find high applicability in gene therapy to assist in delivering a healthy copy of a gene in the cell. The growing prevalence of cancer, cardiovascular, and neurodegenerative disease has led to various research collaborations and investments in gene and therapeutic therapies development.

For instance, in August 2023, Astella Pharma Inc. and Poseida Therapeutics announced a strategic investment of US$50 million to support the latter's advancements in cancer cell therapy. This investment would also further Astella's focus on developing next-generation immune-oncology drugs.

Likewise, in November 2023, AstraZeneca formed a collaboration and an investment agreement with Cellectis to bolster next-generation therapeutics development in immunology, oncology, and rare disease fields. Under the collaboration, AstraZeneca would leverage Cellectis gene editing technologies for developing novel cell & gene therapy products.

The ongoing establishment of vaccine development facilities has furthered the overall market expansion.

The scale of infectious disease globally is on the rise, and to combat it, the demand for various effective vaccines is also growing, which has led to the establishment of new vaccine manufacturing facilities in major economies. For instance, in June 2022, BioNtech SE announced the establishment of an mRNA vaccine production facility in Rwanda, which would provide all manufactured vaccines in member states of the African Union.

Likewise, in July 2024, the U.S. Department of Health and Human Services announced the provision of nearly US$176 million to Moderna for developing an mRNA-based influenza vaccine. The investment was announced through BARDA's (Biomedical Advanced Research and Development Authority) new Rapid Response Partnership Vehicle Consortium.

Viral Vector Manufacturing Market Geographical Outlook

North America is estimated to account for a remarkable share of the market.

Region-wise, the North American region is poised for significant growth. It will account for a considerable market share fuelled by the ongoing research collaboration for therapeutics followed by the development and approval of new vaccine & gene therapy development in major regional nations, namely the United States and Canada.

For instance, in December 2023, the Food and Drug Administration approved two-cell-based gene therapies, "Casgevy" and "Lyfgenia", for treating sickle cell disease in 12-year-old and older patients. The therapies signal an innovative advancement in gene therapy and will improve the treatment of sickle cell disease, which affects nearly 100,000 Americans.

Likewise, in October 2023, the Governor of New York announced an investment of US$98 million to expand the gene therapy-related research & development operations at the Roswell Park Comprehensive Cancer Center. This expansion would make Roswell New York's first gene therapy hub and also comply with the government's commitment to achieve new milestones in the life science sector.

Additionally, the US government is also investing in healthcare facilities and research institutes expansion to bolster the treatment of various chronic diseases, which has positively impacted the demand for viral vectors. Moreover, the well-established presence of major pharmaceutical companies, namely Pfizer, Galax Smith Kline, and AstraZeneca, has paved the way for future market expansion.

In February 2024, AstraZeneca announced an investment of US$300 million in establishing its state-of-the-art facility in Rockville to develop commercial cell therapy platforms, mainly on T-cell therapies. The facility will also facilitate critical cancer trials in the future to bolster the advancement in cancer treatment.

Viral Vector Manufacturing Key Market Developments

In February 2024, the New South Wales government established a commercial company to operate its viral vector manufacturing facility in Westmead. This establishment would ensure the government's long-term run in viral vector manufacturing since it has already committed nearly $134.5 million to manufacture viral vector products for clinical and research trials.
In June 2022, Avid Bioservices, Inc. inaugurated the analytical and process development suites in the company's new viral vector development and Current Good Manufacturing Plant manufacturing facility. The viral vector facility's CGMP manufacturing suites were set up online by mid-2023.
In May 2022, AGC Biologics announced the addition of the viral vector suspension technology and capacity to aid the development and manufacturing of gene therapies at its commercial-grade campus in Longmont, Colorado.

The Viral Vector Manufacturing market is segmented and analyzed as given below:

By Type

Retroviral Vectors
Lentiviral Vectors
Adenoviral Vectors
Others

By Application

Vaccinology
Gene Therapy

By End-User

Pharmaceutical & Biotechnology Companies
Research Institutes
Contract Research Organization

By Geography

North America
United States
Canada
Mexico
South America
Brazil
Argentina
Others
Europe
United Kingdom
Germany
France
Spain
Others
Middle East and Africa
UAE
Saudi Arabia
Others
Asia Pacific
China
India
Japan
South Korea
Thailand
Indonesia
Taiwan
Others

1. INTRODUCTION

1.1. Market Overview
1.2. Market Definition
1.3. Scope of the Study
1.4. Market Segmentation
1.5. Currency
1.6. Assumptions
1.7. Base and Forecast Years Timeline
1.8. Key Benefits for the Stakeholder

2. RESEARCH METHODOLOGY

2.1. Research Design
2.2. Research Processes

3. EXECUTIVE SUMMARY

3.1. Key Findings

4. MARKET DYNAMICS

4.1. Market Drivers
4.2. Market Restraints
4.3. Porter's Five Forces Analysis
- 4.3.1. Bargaining Power of Suppliers
- 4.3.2. Bargaining Power of Buyers
- 4.3.3. Threat of New Entrants
- 4.3.4. Threat of Substitutes
- 4.3.5. Competitive Rivalry in the Industry
4.4. Industry Value Chain Analysis
4.5. Analyst View

5. VIRAL VECTOR MANUFACTURING MARKET BY TYPE

5.1. Introduction
5.2. Retroviral Vectors
5.3. Lentiviral Vectors
5.4. Adenoviral Vectors
5.5. Others

6. VIRAL VECTOR MANUFACTURING MARKET BY APPLICATION

6.1. Introduction
6.2. Vaccinology
6.3. Gene Therapy

7. VIRAL VECTOR MANUFACTURING MARKET BY END-USER

7.1. Introduction
7.2. Pharmaceutical & Biotechnology Companies
7.3. Research Institutes
7.4. Contract Research Organizations

8. VIRAL VECTOR MANUFACTURING MARKET BY GEOGRAPHY

8.1. Introduction
8.2. North America
- 8.2.1. United States
- 8.2.2. Canada
- 8.2.3. Mexico
8.3. South America
- 8.3.1. Brazil
- 8.3.2. Argentina
- 8.3.3. Others
8.4. Europe
- 8.4.1. United Kingdom
- 8.4.2. Germany
- 8.4.3. France
- 8.4.4. Spain
- 8.4.5. Others
8.5. Middle East and Africa
- 8.5.1. UAE
- 8.5.2. Saudi Arabia
- 8.5.3. Others
8.6. Asia Pacific
- 8.6.1. China
- 8.6.2. India
- 8.6.3. Japan
- 8.6.4. South Korea
- 8.6.5. Thailand
- 8.6.6. Indonesia
- 8.6.7. Taiwan
- 8.6.8. Others