到 2031 年病毒载体制造市场规模、份额和趋势

Publication Month : Feb 2024

  • Report Code : TIPRE00038970
  • Category : Biotechnology
  • Status : Data Released
  • No. of Pages : 150
Inquire Before Buy

PRICING

$5190

$4671

【研究报告】病毒载体制造市场预计将从2022年的12.9亿美元增长到2030年的50亿美元;预计 2022-2030 年市场复合年增长率为 18.4%。

市场洞察和分析师观点:

病毒载体有助于将遗传物质传递到细胞中。各种类型的病毒载体可用于将核酸携带到细胞的遗传组成中,包括慢病毒、腺病毒、逆转录病毒和腺相关病毒,每种病毒载体对于某些应用都有其自身的优点和缺点。病毒载体用于基因和细胞治疗,作为预防性和治疗性疫苗的基础。推动市场增长的关键因素是病毒载体疗法的临床研究和开发的增加以及对基因治疗的需求的增加。然而,复杂的病毒载体开发过程阻碍了病毒载体制造市场的增长。此外,病毒载体制造商的技术进步和战略活动预计将在未来几年带来新的病毒载体制造市场趋势。

增长驱动因素和限制:

细胞和基因疗法的最新发展使得治疗各种疾病成为可能,包括先天性疾病和癌症,这增加了病毒载体制造市场规模。根据爱思唯尔杂志 2022 年 9 月发表的《基因治疗临床试验,我们该何去何从》的研究显示,首个基因治疗产品 Gendicine 经过约 686 项临床试验,经中国国家食品药品监督管理总局批准用于头颈癌治疗管理局(SFDA)。 2012年,随着欧洲药品管理局(EMA)批准Glybera,临床试验增加了一倍,表明脂蛋白脂肪酶缺乏。同样,2017年FDA批准了两款嵌合抗原受体(CAR)产品——Kymriah和Yescarta。此外,2019 年,FDA 批准了 Zolgensma(迄今为止最昂贵的药物),这是一种腺相关病毒载体 (AAV),在进行基因疗法治疗小儿脊髓性肌萎缩症时应用。

同样,近年来,美国食品和药物管理局(FDA)批准了许多基于病毒载体的基因疗法。据FDA组织和先进疗法办公室(OTAT)称,截至2023年8月,已有超过30种病毒载体治疗产品获得FDA批准。同样,根据 Evaluate Pharma 的数据,截至 2023 年 2 月,约有 120 种病毒载体疗法正在进行 II 期试验。因此,每年批准的基因治疗产品和基于病毒载体的基因疗法的显着增加推动了病毒载体制造市场规模。

然而,开发病毒载体是一个复杂的过程,涉及病毒载体生产和质量方面的挑战控制措施。病毒载体的生产需要专门的设备和设施,并遵守良好生产规范(GMP)和其他监管标准,以确保最终产品的纯度、安全性和有效性。由于满足这些要求的资源和专业知识有限,这可能会给制造商,特别是小公司或新进入者带来重大挑战。此外,大规模病毒载体生产面临着各种其他挑战,例如生产系统的不兼容,这可能会影响病毒载体开发的不同阶段。

据Patheon(Thermo Fisher Scientific的服务品牌)称,病毒载体的商业化需要监管方面的考虑,以减轻不必要的风险,例如压缩的时间线、检测挑战和变异性、使用致瘤细胞系的原材料以及商业规模的有限批次。因此,复杂的病毒载体开发过程阻碍了病毒载体制造市场的扩张。

战略见解

报告细分和范围:

“病毒载体制造市场分析”已通过考虑以下部分进行:类型、疾病适应症、应用和最终用户。根据类型,市场分为腺病毒载体、腺相关病毒载体、慢病毒载体、逆转录病毒载体等。按疾病适应症,市场分为癌症、遗传性疾病、传染病等。在应用方面,市场分为治疗开发、疫苗开发和研究。根据最终用户,病毒载体制造市场分为制药和生物技术公司、研究机构以及 CDMO 和 CRO。从地域上看,市场主要分为北美(美国、加拿大和墨西哥)、欧洲(西班牙、英国、德国、法国、意大利和欧洲其他地区)、亚太地区(韩国、中国、印度、日本、澳大利亚和亚太地区其他地区)、中东和非洲(南非、沙特阿拉伯、阿联酋以及中东和非洲其他地区)以及南美洲和中美洲(巴西、阿根廷和其他地区)南美洲和中美洲)。

细分分析:

根据类型,市场分为腺病毒载体、腺相关病毒载体、慢病毒载体、逆转录病毒载体等。腺相关病毒载体细分市场在 2022 年占据最大的病毒载体制造市场份额。慢病毒载体细分市场预计在 2022 年至 2030 年期间复合年增长率最高。

病毒载体制造市场,按类型 - 2022 年和2030

根据疾病适应症,病毒载体制造市场分为癌症、遗传性疾病、传染病等。癌症细分市场在 2022 年占据最大的市场份额,遗传性疾病细分市场预计 2022 年至 2030 年复合年增长率最高。

按应用划分,市场分为治疗方法开发、疫苗开发和研究。 2022 年,疫苗开发领域占据最大的市场份额,预计治疗药物开发领域在 2022-2030 年期间复合年增长率最高。

就最终用户而言,市场分为制药和生物技术公司、研究机构以及 CDMO 和 CRO。预计制药和生物技术公司细分市场将在 2022 年至 2030 年期间占据重要的病毒载体制造市场份额。

区域分析:

全球病毒载体制造市场报告的范围集中在北方美洲、欧洲、亚太地区、南美洲和中美洲以及中东和非洲。

就收入而言,北美主导了病毒载体制造市场份额。美国医疗基础设施的发展、癌症和遗传性疾病的患病率以及医疗保健服务支出的增加是推动该国市场增长的关键因素。例如,据美国癌症协会估计,2022 年,美国将诊断出约 190 万新癌症病例,并报告超过 609,000 例癌症死亡病例。因此,在临床试验、疫苗开发以及癌症治疗和其他疾病的生物医学研究中使用病毒载体将极大地影响病毒载体制造市场的增长。

行业发展和未来机遇:

病毒载体制造市场预测可以帮助该市场的利益相关者规划他们的增长战略。下面列出了市场上主要参与者采取的一些举措:

2023 年 7 月,Biovian Oy 宣布扩建其位于芬兰图尔库的制造工厂。该公司宣布对占地 69,000 平方英尺的设施进行超过 5000 万美元(约合 55 美元)的重大投资。该设施拥有先进技术和尖端设备,以支持先进治疗药物产品的开发和制造,例如腺病毒和腺相关病毒载体(AAV)疗法。该生产设施还设有专门的 A 至 D 级洁净室区域,用于原料药材料和最终药品的生产。 2023 年 5 月,全球领先的生物制药合同开发和制造组织 (CDMO) AGC Biologics 推出了两个病毒载体平台: BravoAAV 和 ProntoLVV。 AGC Biologics 的创新平台利用其在慢病毒载体 (LVV) 和 AAV 开发、制造和分析方面 30 年的综合经验,提供快速、有效和可重复的临床和商业 GMP 生产和发布。由于其专利方法和衣壳特异性平台方法,CDMO 可以在九个月内提供 GMP 产品,从而缩短开发时间。 2023 年 3 月,康泰伦特宣布扩展其 UpTempo 平台流程,用于 AAV 的开发和 CGMP 制造。 Catalent 是促进发现和提供更好的患者药物的全球先驱。该平台现在包括内部克隆 HEK293 细胞系和商业质粒,以促进基因疗法研究和生产的强大供应链,并加快首次人体临床评估的持续时间。2023 年 3 月,Vector Biolabs 宣布完成设施扩建。新建的工厂设有办公空间、仓库、质量控制实验室和洁净室制造套件。凭借额外的产能,即使现场需求增长,Vector 将能够继续提供快速响应时间,并扩展其产品范围,以包括新产品表征和质量控制服务。2022 年 8 月,默克成为首批 CDMO 和技术开发商之一随着 VirusExpress 293 AAV 生产平台的推出,提供完整的病毒载体制造产品,包括 AAV、慢病毒、CDMO、CTO 和工艺开发。借助这个新平台,生物制药企业现在可以加速临床制造,同时最大限度地减少与工艺开发相关的成本和时间。 2020 年 9 月,OXGENE 正式推出了其可扩展的无质粒 AAV 制造方法。 OXGENE 最近开发的 TESSA 技术解决了与大规模可靠和一致的 AAV 生产相关的全行业问题。竞争格局和主要公司:

Charles River Laboratories、Merck KGaA、Biovian Oy、Global Life Sciences Solutions USA LLC 、Lonza Group Ltd、Creative Biogene、VIVEbiotech SL、Genezen Laboratories Inc、GenScript Biotech Corporation 和 AGC Biologics 是病毒载体制造市场的知名参与者。这些公司专注于新技术、现有产品的进步和地域扩张,以满足全球不断增长的消费者需求并增加其专业产品组合的产品范围。
Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

This text is related
to segments covered.

Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country Scope
Country Scope

This text is related
to country scope.

Frequently Asked Questions


What are the growth estimates for the viral vector manufacturing market till 2030?

The viral vector manufacturing market is expected to be valued at US$ 5.00 billion in 2030.

Which disease indication segment dominates the viral vector manufacturing market?

Based on disease indication, the viral vector manufacturing market is segmented into cancer, genetic disorders, infectious disease, and others. The cancer segment held the largest market share in 2022, and the genetic disorders segment is anticipated to register the highest CAGR from 2022 to 2030.

Which end user segment dominates the viral vector manufacturing market?

In terms of end user, the viral vector manufacturing market is segmented into pharmaceutical & biotechnology companies, research institutes, and CDMOs & CROs. In 2022, the pharmaceutical & biotechnology companies segment held the largest market share and is anticipated to register the highest CAGR during 2022–2030.

Which application segment dominates the viral vector manufacturing market?

By application, the viral vector manufacturing market is differentiated into therapeutics development, vaccine development, and research. In 2022, the vaccine development segment held the largest market share, and the therapeutics development segment is anticipated to register the highest CAGR during 2022–2030.

What is viral vector manufacturing?

Viral vectors help deliver genetic material into cells. Various types of viral vectors can be used to carry nucleic acids into the genetic composition of cells, including lentivirus, adenovirus, retrovirus, and adeno-associated virus, each with its own set of benefits and drawbacks for certain applications. Viral vectors are used in gene and cell therapy as a basis for prophylactic and therapeutic vaccines.

What factors drive the viral vector manufacturing market?

Key factors driving the viral vector manufacturing market growth are increasing clinical studies and development of viral-vector therapeutics and increasing demand for gene therapy.

What was the estimated viral vector manufacturing market size in 2022?

The viral vector manufacturing market was valued at US$ 1.29 billion in 2022.

Which type segment dominates the viral vector manufacturing market?

Based on type, the viral vector manufacturing market is differentiated into adenoviral vectors, adeno-associated viral vectors, lentiviral vectors, retroviral vectors, and others. The adeno-associated viral vectors segment held the largest market share in 2022. The lentiviral vectors segment is anticipated to register the highest CAGR during 2022–2030.

Who are the major players in the viral vector manufacturing market?

The viral vector manufacturing market majorly consists of the players, including Charles River Laboratories, Merck KGaA, Biovian Oy, Global Life Sciences Solutions USA LLC, Lonza Group Ltd, Creative Biogene, VIVEbiotech SL, Genezen Laboratories Inc, GenScript Biotech Corporation, and AGC Biologics

The List of Companies - Viral Vector Manufacturing Market 

  1. Charles River Laboratories
  2. Merck KGaA
  3. Biovian Oy
  4. Global Life Sciences Solutions USA LLC
  5. Lonza Group Ltd
  6. Creative Biogene
  7. VIVEbiotech SL
  8. Genezen Laboratories Inc
  9. GenScript Biotech Corporation
  10. AGC Biologics

The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.

  1. Data Collection and Secondary Research:

As a market research and consulting firm operating from a decade, we have published and advised several client across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.

Several associations trade associates, technical forums, institutes, societies and organization are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in last 3 years are scrutinized and analyzed to understand the current market trends.

  1. Primary Research:

The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.

For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.

A typical research interview fulfils the following functions:

  • Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
  • Validates and strengthens in-house secondary research findings
  • Develops the analysis team’s expertise and market understanding

Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:

  • Industry participants: VPs, business development managers, market intelligence managers and national sales managers
  • Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.

Below is the breakup of our primary respondents by company, designation, and region:

Research Methodology

Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.

  1. Data Analysis:

Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.

  • Macro-Economic Factor Analysis:

We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.

  • Country Level Data:

Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.

  • Company Profile:

The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.

  • Developing Base Number:

Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.

  1. Data Triangulation and Final Review:

The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.

We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.

We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.

Your data will never be shared with third parties, however, we may send you information from time to time about our products that may be of interest to you. By submitting your details, you agree to be contacted by us. You may contact us at any time to opt-out.

Related Reports