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市场调查报告书
商品编码
1701878
2025 年至 2033 年干细胞製造市场报告(按产品、应用、最终用户和地区)Stem Cell Manufacturing Market Report by Product, Application, End User, and Region 2025-2033 |
2024年全球干细胞製造市场规模达142亿美元。展望未来, IMARC Group预计到2033年市场规模将达到258亿美元,2025-2033年期间的成长率(CAGR)为6.8%。干细胞研究投资的增加、慢性病盛行率的上升、生物技术的进步、学术界和工业界之间的合作、严格的法规以及对干细胞疗法的认识的不断提高正在刺激市场的成长。
增加对干细胞研究和再生医学的投资
由于大量资金涌入干细胞研究和再生医学,全球干细胞製造市场正在经历显着的成长。政府和私人组织正在向这些领域投入资源,并认识到它们彻底改变医疗保健的潜力。这项驱动力源自于干细胞疗法在治疗神经退化性疾病和脊髓损伤等以前无法治癒的疾病方面的良好前景。例如,2023 年 8 月发表在《新英格兰医学杂誌》上的一篇文章揭示了干细胞基因疗法在治疗镰状细胞疾病 (SCD) 方面的预期潜力。这些投资支持尖端研究、先进製造技术的开发和临床试验的扩展。例如,2021 年 9 月,LifeCell International Pvt. Ltd 从 OrbiMed Asia Partners IV 获得了 225 亿印度卢比(2720 万美元)的投资,以进一步利用其技术专长和广泛的网络进军生育健康和细胞治疗等相邻的新领域。此外,2023 年 11 月,专门从事重组蛋白和必需试剂的美国公司 ACROBiosystems Inc. 推出了 GM 级 DLL4 蛋白,这是 Delta 样配体 4 (DLL4) 的可溶形式,对干细胞的发育和分化至关重要。
慢性病盛行率上升及对创新治疗的需求
推动全球干细胞製造市场发展的另一个重要驱动力是慢性病的日益普及。糖尿病、心臟病和自体免疫疾病等疾病的发生率正在上升,需要新颖有效的治疗方法。干细胞疗法透过再生受损的组织和器官,在治疗这些疾病方面具有巨大的前景。例如,2021 年 3 月,Vertex Pharmaceuticals 获得 FDA 对 VX-880 的快速通道认证,VX-880 是一种针对 1 型糖尿病患者的人类干细胞衍生疗法。此外,根据美国食品药物管理局(FDA)2022年12月提供的资料,美国有超过7,000种罕见疾病,影响超过3,000万人。慢性病的盛行率随着年龄的增长而上升,而干细胞製造在对抗这些疾病方面显示出良好的前景。例如,世界卫生组织 2021 年 10 月的一份情况说明书预测,到 2030 年,全球 65 岁以上人口将达到 14 亿,预计到 2050 年这一数字将翻一番,达到 22 亿。
生物技术和细胞培养技术的进展
生物技术和细胞培养技术的进步正在彻底改变干细胞製造领域。这项驱动因素对于提高干细胞生产的效率和可扩展性至关重要。 3D细胞培养系统和生物反应器等细胞培养技术的突破使得大量培养高品质干细胞成为可能。此外,CRISPR-Cas9 等基因编辑技术的创新可以精确控制干细胞特性,进一步扩大其治疗潜力。这些进步不仅简化了製造流程,而且还确保了干细胞疗法的安全性和质量,从而增强了医疗专业人员和患者的信心。例如,2021 年 9 月,专门从事干细胞製造的美国生物技术公司 Cellino 展示了其係统如何整合人工智慧、机器学习和雷射以及其他硬体和软体,以提高产量并降低生产成本。
耗材占据市场主导地位
由于基于干细胞的研究和治疗的日益普及,干细胞製造市场中的消耗品部分正在经历强劲增长,需要持续供应消耗品,包括细胞培养基、试剂和生长因子。随着该领域研究的不断扩展,对这些必需材料的需求也不断增加。此外,干细胞临床试验和再生医学应用的不断增长也刺激了消耗品的消耗。临床研究和治疗开发需要一致且可靠的高品质耗材来源,以确保基于干细胞治疗的安全性和有效性。与此相符的是,消费品生产技术的进步正在推动成长。
研究应用主导市场
干细胞製造市场中研究应用部分的成长得益于对科学知识的不懈追求和干细胞生物学的突破性发现。干细胞是研究各种生物过程、疾病机制和潜在治疗途径的重要工具。再生医学、发育生物学和药物开发等不同领域的研究人员都依赖干细胞来推进他们的研究。此外,分配给干细胞研究的资金和补助不断增加,促进了这一领域的成长。政府、私人机构和非营利组织认识到干细胞研究的变革潜力,并提供资金支持以推动创新。此外,干细胞培养技术、基因编辑和细胞表征工具的技术进步提高了研究应用的效率和准确性。这些进步使研究人员能够研究更广泛的干细胞类型并对其进行精确操作,从而进一步扩大研究的可能性范围。例如,2023 年 5 月,Sernova 宣布与阿斯特捷利康进行研究合作,以评估新型潜在治疗细胞应用。
製药和生物技术公司主导市场
全球人口的不断增长和人口老化趋势推动了製药和生物技术公司的成长。随着人口老化,对医疗保健服务、药物和创新疗法的需求不断增加,为製药和生物技术公司提供了庞大的市场。此外,心血管疾病、癌症和糖尿病等慢性疾病的盛行率不断上升,使得持续研究和开发新的药物解决方案成为必要。这些公司在开发先进药物和疗法以应对这些健康挑战方面发挥关键作用。此外,基因治疗、精准医疗和生物製药等生物技术的进步正在塑造这个产业。
北美占据明显优势,占据最大的干细胞製造市场份额
市场研究报告也对所有主要区域市场进行了全面分析,包括北美(美国和加拿大);欧洲(德国、法国、英国、义大利、西班牙、俄罗斯等);亚太地区(中国、日本、印度、韩国、澳洲、印尼等);拉丁美洲(巴西、墨西哥等);以及中东和非洲。报告显示,北美占据最大的市场份额。
受政府和私人对干细胞研究和再生医学的大量投资推动,北美地区的干细胞製造市场正在强劲成长。这些资金承诺支持尖端研究、临床试验和先进製造技术的开发。此外,糖尿病、心臟病和神经退化性疾病等慢性病的盛行率在北美呈上升趋势。干细胞疗法为解决这些问题提供了创新的解决方案,从而推动了其生产的需求。与此相符的是,该地区拥有高度发展的生物技术部门,在细胞培养技术和生物加工技术方面取得了重大进展。这确保了高效、可扩展的干细胞生产,巩固了该产业在北美的立足点。此外,北美的监管框架为干细胞研究和临床试验提供了有利的环境,促进了成长和创新。学术机构和产业参与者之间的合作努力以及公众对干细胞治疗潜力的认识不断提高是额外的驱动力。
(请注意,这只是关键参与者的部分列表,完整列表在报告中提供。)
The global stem cell manufacturing market size reached USD 14.2 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 25.8 Billion by 2033, exhibiting a growth rate (CAGR) of 6.8% during 2025-2033. Increasing investments in stem cell research, rising chronic disease prevalence, advancements in biotechnology, collaborations between academia and industry, stringent regulations, and expanding awareness of stem cell therapies are stimulating the market growth.
Increasing Investments in Stem Cell Research and Regenerative Medicine
The global stem cell manufacturing market is experiencing a significant upsurge due to the substantial investments pouring into stem cell research and regenerative medicine. Governments and private organizations are channeling resources toward these fields, recognizing their potential to revolutionize healthcare. This driver is fueled by the promising prospects of stem cell therapies in addressing previously untreatable conditions, such as neurodegenerative diseases and spinal cord injuries. For instance, an article published in the New England Journal of Medicine in August 2023 revealed the anticipated potential of stem cell gene therapy in treating Sickle Cell Disease (SCD). These investments support cutting-edge research, the development of advanced manufacturing techniques, and the expansion of clinical trials. For example, in September 2021, LifeCell International Pvt. Ltd received an investment of INR 225 crore (USD 27.2 million) from OrbiMed Asia Partners IV to further leverage its technological expertise and wide network to foray into adjacent new categories like fertility health and cell-based therapeutics. Moreover, in November 2023, ACROBiosystems Inc., a US-based company specializing in recombinant proteins and essential reagents, launched GM-grade DLL4 protein, a soluble form of Delta-like Ligand 4 (DLL4), crucial in stem cell development and differentiation.
Rising Prevalence of Chronic Diseases and the Demand for Innovative Treatments
Another vital driver propelling the global stem cell manufacturing market is the escalating prevalence of chronic diseases. Conditions like diabetes, heart disease, and autoimmune disorders are on the rise, necessitating novel and effective treatments. Stem cell therapies hold immense promise in addressing these ailments by regenerating damaged tissues and organs. For instance, in March 2021, Vertex Pharmaceuticals received FDA grant as a fast track designation to VX-880, a human stem-cell derived therapy for patients with Type-1 diabetes. Moreover, as per the December 2022 data provided by the US Food and Drug Administration (FDA), there are over 7,000 rare diseases that affect more than 30 million people in the United States. The prevalence of chronic diseases rises with age, and stem cell manufacturing exhibits promise in combating these conditions. For example, a World Health Organization factsheet from October 2021 projects that globally there will be 1.4 billion people over the age of 65 by 2030 and this number is expected to double at 2.2 billion by 2050.
Advancements in Biotechnology and Cell Culture Techniques
Advancements in biotechnology and cell culture techniques are revolutionizing the field of stem cell manufacturing. This driver is pivotal in enhancing the efficiency and scalability of stem cell production. Breakthroughs in cell culture technology, such as 3D cell culture systems and bioreactors, enable the cultivation of high-quality stem cells in larger quantities. Additionally, innovations in genetic editing techniques, like CRISPR-Cas9, offer precise control over stem cell characteristics, further expanding their therapeutic potential. These advancements not only streamline the manufacturing process but also ensure the safety and quality of stem cell-based therapies, instilling confidence among healthcare professionals and patients alike. For instance, in September 2021, Cellino, a US-based biotech company with specialization in stem cell manufacturing, presented how its system integrates AI, machine learning, and lasers, along with other hardware and software, to enhance yields and reduce production costs.
Consumables dominate the market
The consumables segment within the stem cell manufacturing market is experiencing robust growth due to the increasing adoption of stem cell-based research and therapies, necessitating a constant supply of consumables, including cell culture media, reagents, and growth factors. As research in this field expands, so does the demand for these essential materials. Moreover, the growing number of stem cell clinical trials and applications in regenerative medicine fuels the consumption of consumables. Clinical research and therapy development require a consistent and reliable source of high-quality consumables to ensure the safety and efficacy of stem cell-based treatments. In line with this, technological advancements in the production of consumables are driving growth.
Research applications dominate the market
The growth of the research applications segment within the stem cell manufacturing market is underpinned by the relentless pursuit of scientific knowledge and breakthrough discoveries in stem cell biology. Stem cells serve as essential tools for investigating various biological processes, disease mechanisms, and potential therapeutic avenues. Researchers across diverse fields, including regenerative medicine, developmental biology, and drug development, rely on stem cells to advance their studies. Moreover, the increasing funding and grants allocated to stem cell research bolster this segment's growth. Governments, private institutions, and non-profit organizations recognize the transformative potential of stem cell research and provide financial support to drive innovation. Additionally, technological advancements in stem cell culture techniques, genetic editing, and cell characterization tools enhance the efficiency and accuracy of research applications. These advancements enable researchers to work with a broader range of stem cell types and manipulate them with precision, further expanding the scope of research possibilities. For instance, in May 2023, Sernova announced research collaboration with AstraZeneca to evaluate novel potential therapeutic cell applications.
Pharmaceutical & biotechnology companies dominate the market
The growth of pharmaceutical and biotechnology companies is propelled by the continuous expansion of the global population and the aging demographic trends. With an aging population, the demand for healthcare services, medications, and innovative therapies rises, providing a substantial market for pharmaceutical and biotechnology companies to cater to. Moreover, the increasing prevalence of chronic diseases, including cardiovascular disorders, cancer, and diabetes, necessitates ongoing research and the development of new pharmaceutical solutions. These companies play a pivotal role in creating advanced drugs and therapies to combat these health challenges. Furthermore, advancements in biotechnology, including gene therapy, precision medicine, and biopharmaceuticals, are shaping the industry.
North America exhibits a clear dominance, accounting for the largest stem cell manufacturing market share
The market research report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America accounted for the largest market share.
The North American region is experiencing robust growth in the stem cell manufacturing market, propelled by the substantial government funding and private investments in stem cell research and regenerative medicine. These financial commitments support cutting-edge research, clinical trials, and the development of advanced manufacturing techniques. Moreover, the prevalence of chronic diseases, such as diabetes, heart disease, and neurodegenerative disorders, is on the rise in North America. Stem cell therapies offer innovative solutions to address these conditions, fueling demand for their production. In line with this, the region boasts a highly developed biotechnology sector, leading to significant advancements in cell culture techniques and bioprocessing technologies. This ensures efficient and scalable stem cell production, strengthening the industry's foothold in North America. Furthermore, regulatory frameworks in North America provide a conducive environment for stem cell research and clinical trials, fostering growth and innovation. Collaborative efforts between academic institutions and industry players, along with growing public awareness of the potential of stem cell-based treatments, are additional drivers.
(Please note that this is only a partial list of the key players, and the complete list is provided in the report.)