细胞治疗市场规模报告| 2027 年分享与趋势

  • Report Code : TIPRE00009666
  • Category : Biotechnology
  • Status : Published
  • No. of Pages : 201
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[研究报告] 细胞治疗市场预计将从2019年的72.605亿美元增长到2027年的125.6323亿美元;进一步估计 2020 年至 2027 年复合年增长率为 7.2%。  

市场洞察和分析师观点:

细胞疗法是将活的完整细胞注射、植入或移植到患者体内的过程。这项技术依赖于用健康的功能细胞替代功能失调的细胞。主要用于此类先进疗法的细胞是干细胞,因为它们能够分化成修复受损或有缺陷的组织或细胞所需的特定细胞。此外,细胞疗法在再生医学的开发中也有应用。

增长动力和挑战:

再生疗法旨在诱导细胞、组织和器官再生并恢复其功能。每年向美国食品和药物管理局 (FDA) 提交的人体临床试验再生医学申请数量不断增加。这正在推动细胞治疗市场的发展。根据再生医学联盟的数据,2019年第三季度,全球正在进行1,052项利用再生医学的临床试验; 2019 年正在进行 218 项细胞疗法试验(41 项 I 期试验、147 项 II 期试验、30 项 III 期试验)。再生药物开发的快速进展为慢性病提供更有效的解决方案正在推动市场发展。细胞疗法是再生医学领域增长最快的领域之一。诺华的 Kymriah 是第一个用于治疗 B 细胞急性白血病的细胞治疗解决方案,这为这种新兴治疗方法带来了机会。此外,再生医学提供商RepliCel拥有多种再生医学产品正在研发中,其中三种产品——RCH-01、RCS-01和RCT-01——正处于开发阶段。此外,Sernova 致力于再生医学技术的开发,拥有庞大的针对糖尿病、A 型血友病和甲状腺机能亢进等病症的产品线。

此外,慢性病心血管疾病、神经系统疾病、自身免疫性疾病和癌症等疾病是全世界死亡和残疾的主要原因。根据疾病控制与预防中心的数据,2019 年,美国每 10 人中就有近 6 人患有至少一种慢性病。由于忙碌的生活方式,心血管疾病(CVD)是导致死亡的一个重要原因。根据世界卫生组织 (WHO) 的数据,CVD 是全球第一大死亡原因,估计每年夺去 1,790 万人的生命。癌症是全世界死亡的主要原因之一,这种疾病影响着大量人口;因此,它给社会带来了巨大的经济负担。据世界卫生组织称,2018 年,全球约有 960 万人因癌症死亡。然而,越来越多的关于开发有效治疗该疾病的研究正在积极影响市场的增长。基因疗法和细胞疗法正在改变癌症治疗格局;例如,诺华 Kymriah 用于治疗弥漫性大 B 细胞淋巴瘤。更多此类产品的推出将推动对细胞治疗的需求,从而推动未来几年细胞治疗市场的增长。

然而,细胞治疗的高昂成本产品制造正在阻碍市场增长。细胞疗法的价格很高,因为它具有复杂的制造过程并且使用生物成分。此外,耗材和设备的成本要高得多,这导致细胞疗法的成本高昂。例如,Miltenyi Biotec 提供的试剂盒价格为 500 美元至 5,000 美元不等。同样,安装设备的资本成本也接近200万美元。因此,与细胞治疗价格相关的挑战限制了细胞治疗市场的增长。

战略见解

报告细分和范围:

根据治疗类型,全球细胞治疗市场分为同种异体和自体细胞。细胞治疗市场按产品细分为消耗品、设备、系统和软件。全球细胞治疗市场以技术为基础细分为病毒载体技术、基因组编辑技术、体细胞技术、细胞永生化技术、细胞可塑性技术、三维技术等。根据应用,全球细胞治疗市场已细分为肿瘤学、心血管、骨科、伤口管理和其他应用。根据最终用户,全球细胞治疗市场分为医院、研究机构等。

全球细胞治疗市场根据地理位置分为北美(美国) 、加拿大和墨西哥)、欧洲(德国、法国、意大利、英国、西班牙和欧洲其他地区)、亚太地区(澳大利亚、中国、日本、印度、韩国和亚太地区其他地区)、中东和美国非洲(南非、沙特阿拉伯、阿联酋以及中东和非洲其他地区)以及南美和非洲中美洲(巴西、阿根廷以及南美洲和中美洲其他地区)

全球细胞治疗市场的细分分析:< /strong>

根据治疗类型,全球细胞治疗市场分为同种异体和自体细胞。 2019年,同种异体细分市场在治疗类型细分市场中占有最大的市场份额。同种异体疗法是由非相关供体组织大批量生产的。同种异体疗法是预先大量进行的,并用于治疗许多患者。由于这些产品是大量生产的,因此需要遵循良好生产规范(GMP),因此生产的产品受到质量控制。制造商越来越重视创新,致力于再生疗法的开发。由于同种异体干细胞疗法的有效性,许多再生治疗应用已在美国、欧洲和亚太地区获得临床试验的批准。此次临床试验的批准正在帮助市场参与者推出新的产品线,以加速使用同种异体干细胞疗法的干细胞治疗的整体产品需求,并增加同种异体细胞治疗市场的需求。然而,自体部分预计在预测期内将以最快的复合年增长率增长。

细胞治疗市场(按治疗类型) 2019年和2027年

细胞治疗市场按产品细分为消耗品、设备、系统和软件。 2019年,耗材在该产品领域占据最大的市场份额。此外,预计同一细分市场增长最快,在预测期内复合年增长率最高。

全球细胞治疗市场根据技术细分为病毒载体技术、基因组编辑技术、体细胞技术、细胞永生化技术、细胞可塑性技术、三维技术。病毒载体技术领域在 2019 年占据最大的市场份额。同样,病毒载体技术领域预计在预测期内复合年增长率最高。

根据应用,全球细胞治疗市场已细分为肿瘤学、心血管、骨科、伤口管理和其他应用。 2019年,肿瘤学领域在应用领域占据最大的市场份额。此外,预计同一细分市场的需求将以最快的速度增长,在预测期内复合年增长率最高。

根据最终用户,全球细胞疗法市场分为医院、研究机构和其他。 2019年,研究机构细分市场在最终用户细分市场中占有最大的市场份额。此外,预计同一细分市场的需求将会增长,在预测期内复合年增长率最高。

区域分析:

根据地理位置,全球细胞治疗市场分为五个关键区域:北美、欧洲、亚太地区、南美洲和南美洲。中美洲、中东和非洲非洲。 2019年,北美在全球细胞治疗市场规模中占有最大份额,预计亚太地区在预测期内的复合年增长率最高。

在北美,美国是细胞疗法的最大市场。市场增长归因于研究和开发的增加以及干细胞、基因和免疫疗法等细胞疗法的日益采用。遗传和细胞疾病发病率的不断上升导致对细胞疗法的需求不断增加。 2020 年 PhRMA 关于细胞和基因治疗产品线的报告发现,美国有 400 种细胞和基因疗法正在开发中,针对多种疾病。这些重点关注从癌症到遗传性疾病再到神经系统疾病的各种疾病和病症。截至 2020 年 2 月,美国批准了 9 种细胞或基因治疗产品 –治疗癌症、眼部疾病和罕见的遗传性疾病。此外,该国正在经历越来越多的创新细胞疗法的初创企业。此外,政府日益增长的支持正在促进细胞疗法的增长,从而影响市场的增长。例如,根据美国基因与医学协会的说法,细胞治疗 (ASGCT) 是一个公共组织,为从事基因和细胞治疗的科学家、医生、专业人士和患者倡导者提供会员资格。 ASGCT 旨在增强有关临床应用细胞和基因疗法的知识、教育和意识。

此外,该国拥有最多数量的参与研究的市场参与者以及细胞和基因疗法的产品开发。市场领导者正在投入巨资建设基因和细胞治疗制造工厂。例如,2019 年 11 月,诺华公司 (Novartis AG) 和辉瑞公司 (Pfizer Inc) 已投资约 20 亿美元用于基因治疗制造。诺华公司计划投资5亿美元,辉瑞公司投资6亿美元建设各自的生产工厂。此外,公司已经在市场上推出了他们的细胞疗法。例如,2019 年 5 月,FDA 批准了 AveXis(诺华)的 Zolgensma 治疗一种罕见的肌肉疾病。这是一种基因疗法,售价200万美元。该公司的目标是到 2022 年底在市场上推出 40 种新的基因疗法。因此,由于上述因素,预计该市场将在预测期内占据主导地位。

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行业发展和未来机遇:

全球细胞治疗市场主要参与者采取的各种举措如下:

  1. 2020 年 11 月,诺华获得了使用 Mesoblast 的细胞疗法 Remestemcel-L 治疗 COVID-19 的全球许可。该交易为 Mesoblast 带来了 5000 万美元的预付款和合作伙伴的支持,这可能有助于解决 FDA 提出的关键质量属性问题。
  2. 2020 年 7 月,MEDIPOST 完成了 NEUROSTEM 治疗阿尔茨海默病的 2a 期临床试验。
  3. 2019 年 12 月,百时美施贵宝宣布斥资 740 亿美元收购新基 (Celgene),组建新的合并公司,拥有 8 种产品,年销售额和近期收入潜力超过 10 亿美元新推出的产品价值超过 150 亿美元。
  4. 2019 年 5 月,MediWound Ltd. 与 Vericel Corporation 签订独家许可和供应协议,以在北美实现 NexoBrid 的商业化。 NexoBrid 已在欧盟和其他国际市场获得批准。根据许可协议的条款,Vericel 向 MediWound 支付了 1750 万美元的预付款,并在美国 BLA 批准后追加支付 750 万美元。
  5. 2016 年 2 月,JCR Pharmaceuticals Co. Ltd ., 在日本推出了间充质干细胞产品 TEMCELL HS Inj.,用于治疗儿童和成人的急性移植物抗宿主病 (aGVHD)。

Covid-19 影响:

细胞治疗市场在 COVID-19 危机之初出现了一些短缺。其中一些因素包括因封锁而导致的供应链和需求中断。然而,由于政府的支持举措,对细胞疗法的需求急剧增加。例如,英国政府已向细胞和基因治疗弹射器制造创新中心拨款 1 亿欧元资金,以加快英国 COVID-19 疫苗的生产。此外,在 COVID-19 危机的初始阶段,由于封锁和供应链中断,细胞治疗的需求因客户行为的变化而受到干扰。随着危机的发展,医疗保健专业人员意识到,利用创新技术开发新疗法对于缓解这场前所未有的危机至关重要。例如,FDA 为可能的 COVID-19 疗法制定了一个独特的紧急计划,即冠状病毒治疗加速计划 (CTAP)。该计划重点关注尽快为患者提供新疗法的方法。同时查明它们是有益还是有害。

此外,FDA 还批准了 AlloVir, Inc. 的 ALVR109 新药研究申请,用于治疗高危人群2020 年 9 月,成人感染 COVID-19 的风险增加。旨在增强患者免疫系统并消除病毒的各种干细胞疗法为市场提供了显着的增长前景。例如,Lattice Biologics 与 Alumina Partners 合作,加速了其基于干细胞的 AminioBoost 疗法的 COVID-19 的 1 期临床试验。此外,FDA还批准了一项临床试验,研究使用脐带间充质干细胞治疗COVID-19患者,以预防肺部炎症。所有这些发展都刺激了细胞治疗市场的需求。

竞争格局和主要公司:

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全球细胞治疗市场上有许多知名的参与者。排名前十的细胞治疗公司是 Vericel Corporation、MEDIPOST、NuVasive Inc.、Mesoblast Limited、JCR Pharmaceuticals Co.。有限公司,史密斯&amp; Nephew、百时美施贵宝公司、Cells for Cells、Stemedica Cell Technologies Inc. 和 Castle Creek Biosciences Inc. 等。这些公司专注于各种新产品开发和地域扩张。这有助于他们满足全球不断增长的消费者需求,并扩大其专业产品组合的产品范围。他们在全球范围内拥有广泛的业务,这使他们能够为大量客户提供服务。此外,这还提供了增加市场份额的机会。

Report Coverage
Report Coverage

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

Segment Covered
Segment Covered

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Regional Scope
Regional Scope

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

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Frequently Asked Questions


What is cell therapy?

Cell therapy is a procedure where living and intact cells are injected, implanted, or grafted into the patient's body. This technology relies on replacing dysfunctional cells with healthy functioning ones. Cells mainly used for such advanced therapies are stem cells, because of their ability to differentiate into the specific cells required for repairing damaged or defective tissues or cells. Moreover, cell therapy also has applications in the development of regenerative medicines.

What are the driving factors for the cell therapy market across the globe?

The growth of the market is attributed to increasing prevalence of chronic diseases, rising adoption of regenerative medicines, and increasing number of approvals for cell-based therapies. However, the high cost of cell therapy manufacturing hinders the growth of the market.

What is the regional market scenario of cell therapy?

Global cell therapy market is segmented by region into North America, Europe, Asia Pacific, Middle East & Africa and South & Central America. The North American region is the largest shareholder and the Asia Pacific is the fastest growing market for cell therapy. The market growth in the North American region is expected due to increasing investment in research activities, and product launches.

The List of Companies - Cell Therapy Market

  1. Vericel Corporation
  2. MEDIPOST
  3. NuVasive, Inc.
  4. Mesoblast Limited
  5. JCR Pharmaceuticals Co. Ltd.
  6. Smith & Nephew
  7. Bristol-Myers Squibb Company
  8. Cells for Cells
  9. Stemedica Cell Technologies, Inc,
  10. Castle Creek Biosciences, Inc.

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.

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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:

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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.

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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.

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