市场调查报告书
商品编码
1546287
干细胞治疗的全球市场的评估:各类型,细胞源,各治疗领域,各终端用户,各地区,机会,预测(2017年~2031年)Stem Cell Therapy Market Assessment, By Type, By Cell Source, By Therapeutic Area, By End-user, By Region, Opportunities and Forecast, 2017-2031F |
全球干细胞治疗市场规模预计将从 2023 年的 3.0282 亿美元增至 2031 年的 9.7578 亿美元,预计 2024-2031 年的复合年增长率为 15.75%。该市场正在迅速活跃,近年来在收入和基础设施方面都显示出巨大的成长。由于生物技术研究的成长,预计该市场将继续以更强劲的速度成长。
干细胞疗法是一种再生医学方法,利用干细胞刺激对特定疾病或受损或功能障碍组织的反应。市场主要受到再生医学需求不断增长、生物技术研究领域成长以及支持新疗法开发的投资者动力等因素的影响。监管批准在干细胞治疗市场的成长中发挥着至关重要的作用。这是因为新的批准为其他市场进入者提供了更多机会,并激励他们朝某个方向进行研究。目前,美国食品药物管理局(USFDA)只认可基于造血干细胞移植的干细胞疗法。同样,欧洲药品管理局 (EMA) 对基于干细胞的治疗的批准实施了严格的规定,并根据《2007 年欧盟先进药物法案》对其进行审查。
由于干细胞修饰是干细胞治疗的支柱,因此存在许多伦理问题,对干细胞治疗的发展和广泛使用构成重大威胁。这些治疗方法的高价格也是这个市场的一个挑战,因为它们涉及大量的资金和时间投入。儘管有这些挑战,干细胞治疗市场仍显着成长,预计在预测期内将继续成长。最近的监管批准刺激了市场扩张。例如,2023年12月,欧洲药品管理局(EMA)建议批准第一个使用尖端基因编辑技术CRISPR/Cas9的药物。该药物名为 Casgevy(exagamglogene autotemcel),旨在治疗 12 岁及以上人群的输血依赖性β地中海贫血和严重镰状细胞疾病。此治疗适用于适合造血干细胞移植但无合适供者的患者。
技术进步与创新研究推动市场成长
干细胞疗法于 1956 年首次以其原始形式引入,此后已显示出多项技术进步。近年来,透过干细胞基因重编程实现快速定向分化、细胞外基质、培养基、生长因子、解离试剂、冷冻保存、自动化、机器人技术、肿瘤学、神经学等方面的进步、干细胞治疗的利用等科技进步心血管疾病、造血系统疾病等广泛的治疗应用正在促进干细胞治疗市场的需求。近年来的新研究成果为市场带来了广阔的机会。
例如,2023年11月,来自新加坡-麻省理工学院研究与技术联盟(SMART)跨学科研究小组(IRG)製造个人化医疗批判性分析(CAMP)的研究人员合作开发了突破性技术与生物加工技术研究所(BTI) 和国立大学卫生系统(NUHS) 合作。此技术可直接从纯骨髓(也称为骨髓抽吸物(BMA))中萃取间质干细胞(MSC),无需稀释。骨髓抽吸物是间质干细胞的重要来源。
投资者兴趣和政府支持增加,以加速市场成长
特定市场的资本投资是主要驱动力。生物技术研究市场,例如干细胞治疗市场,需要大量资金来开发产品并将其推向市场。最近的趋势是干细胞疗法开发方面出现了一些值得注意的公共和私人投资趋势。政府以补贴、补贴和直接投资等形式提供支持,有利于市场扩张。近年来,包括美国、加拿大、肯亚和印度在内的多个国家的政府在干细胞研究方面投入了大量资金。
本报告提供全球干细胞治疗市场相关调查分析,提供市场规模与预测,市场动态,主要企业的形势及预测等资讯。
Global stem cell therapy market is projected to witness a CAGR of 15.75% during the forecast period 2024-2031, growing from USD 302.82 million in 2023 to USD 975.78 million in 2031. The stem cell therapy market is rapidly flourishing and has shown tremendous growth in terms of revenue and infrastructural growth in recent years. The market is expected to keep growing at a stronger pace owing to growing biotechnology research.
Stem cell therapy is a type of regenerative medicine approach involving the use of stem cells to promote the response against specific diseases and injured or dysfunctional tissues. The market is mainly influenced by factors like growing demand for regenerative medicine, the blooming biotechnology research sector, and investor's traction to support the development of novel therapies. Regulatory approvals play a very crucial role in stem cell therapy market growth, as new approvals open more opportunities for other market players and motivate research to be directed in a certain direction. At present, the United States Food and Drug Administration (USFDA) only allows stem cell therapies based on hematopoietic (or blood) stem cell transplantation. Similarly, the European Medicines Agency (EMA) also imposes strict regulations on the approval of stem cell-based therapies and considers them under EU advanced therapy legislation, 2007.
As stem cell modification is the root of stem cell therapies, there are a significant number of ethical concerns, that pose a major threat to the growth and adoption of stem cell therapies. High prices of these therapies due to lots of capital and time investment also act as a challenge in this market. Despite all the challenges, the market for stem cell therapies has grown significantly and is expected to keep growing during the forecast period. Recent regulatory approvals gave a thrust to the market expansion. For instance, in December 2023, the European Medicines Agency (EMA) recommended the approval of the first medicine that uses CRISPR/Cas9, a cutting-edge gene-editing technology. The medicine, called Casgevy (exagamglogene autotemcel), is intended for treating transfusion-dependent beta-thalassemia and severe sickle cell disease in patients 12 years and older. This treatment is suitable for individuals for whom hematopoietic stem cell transplantation is appropriate and a suitable donor is not available.
Technological Advances and Innovative Research Drive Market Growth
Stem cell therapy was first introduced in its primitive form in 1956, and since then, it has witnessed several technological advancements. In recent times, technical advancements like rapid directed differentiation through genetic reprogramming in stem cells advances in the extracellular matrix, culture media, growth factors, dissociation reagents, and cryopreservation, automation, and robotic technologies, utilization of stem cell therapies for a wide variety of therapeutic applications like oncology, neurology, cardiovascular diseases, hemopoietic system disorders, etc. have contributed for the stem cell therapy market demands. Novel research outcomes in recent times show promising opportunities for the market.
For instance, in November 2023, the researchers from the Critical Analytics for Manufacturing Personalized Medicine (CAMP) Interdisciplinary Research Group (IRG) of Singapore-MIT Alliance for Research and Technology (SMART), MIT's research enterprise in Singapore, developed a groundbreaking technology in collaboration with the Agency for Science, Technology and Research (ASTAR) Bioprocessing Technology Institute (BTI) and National University Health System (NUHS). This technology can extract mesenchymal stem cells (MSCs) directly from pure bone marrow, also known as bone marrow aspirate (BMA), without dilution. Bone marrow aspirate is a crucial source of MSCs.
Rising Investors' Interest and Government Support to Accelerate the Market Growth
Capital investment in a particular market, acts as a major driver. The biotechnological research market, like the stem cell therapy market, requires huge amounts of funding for product development and market launches. In recent years, several notable investment trends from the public and private sectors in the development of stem cell therapies have been noticed. Government support in the form of grants, subsidies, or direct investments promotes market expansion. Governments of several nations, like the United States, Canada, Kenya, India, etc., have invested significantly in stem cell research initiatives in recent years.
For instance, the Australian government invested around USD 101 million (AUD 150 million) for the Stem Cell Therapies Mission with a roadmap of 10 years. Similarly, investment initiatives from market leaders have also been reported. In December 2023, FUJIFILM Holding Corporation invested USD 200 million in two subsidiaries to significantly expand its global cell therapy contract development and manufacturing (CDMO) capabilities. This investment will enable FUJIFILM to support the expanding cell therapy market.
Oncology Segment Dominates the Global Stem Cell Therapy Market
The oncology therapeutic area is the most explored application of stem cell therapy due to its high success rate. The unique properties of different stem cell types make them well-suited for a variety of applications in cancer diagnosis, treatment, and supportive care. As these technologies advance, stem cell-based therapies are poised to play an increasingly important role in the fight against cancer. Recent regulatory approvals further strengthened the dominance of the oncology segment. For instance, in April 2023, the USFDA approved Omisirge (omidubicel-only), a significantly modified allogeneic (donor) cord blood-based cell therapy developed by Gamida Cell Inc. This therapy is designed to speed up the recovery of neutrophils (a subset of white blood cells) in the body and reduce the risk of infection. The product is meant to be used in adults and pediatric patients aged 12 years and older with blood cancers who are undergoing umbilical cord blood transplantation following a myeloablative conditioning regimen, which involves treatments such as radiation or chemotherapy.
Asia-Pacific Shows Rapid Growth in the Stem Cell Therapy Market
Asia-Pacific is home to the world's fastest-growing economies like India, China, Japan, etc., which is also reflected in the stem cell therapy market growth trends within the region. Several reasons behind the faster growth rate of the market in Asia-Pacific include growing disease prevalence and subsequent rise in demand for regenerative medicines, favorable government policies, and support for biotechnology research. Rising medical tourism and economic efficiency further support the growth of the market. Enhanced investments in the region also act as a major driver.
For instance, in May 2023, United States-based StemCures announced that it would establish India's largest stem cell manufacturing laboratory in Hyderabad, Telangana, with a projected investment of USD 54 million. The plant aims to produce high-quality and cost-effective stem cell treatments for various serious medical conditions using cutting-edge technology and knowledge from the United States. The project is expected to create up to 150 jobs in two phases. StemCures is currently finalizing its stem cell line research and development at Aspire Bionest, University of Hyderabad, and preparing to initiate its Phase-1 manufacturing laboratory.
Future Market Scenario (2024-2031F)
The stem cell therapy market holds tremendous growth opportunities for the future; as the demand for regenerative medicine rises, automation in the production of stem cells, along with the inclusion of artificial intelligence and other technologies, will rise significantly. Currently, the process of stem cell therapy is manual, but several attempts are being made to automate the process through artificial intelligence and several other tools from physics. The prospective automation will be able to overcome two major challenges of stem cell therapy: safety and scalability. Notable market activities have been reported in recent times for this innovation. For instance, Cellino Biotech, Inc., an American company, has developed a system that combines stem cell biology, machine learning, and laser physics to automate the manufacturing of stem cells. The laser editing system removes unwanted cells and delivers cargo to individual cells. This automated, AI-enabled manufacturing process is crucial for producing large numbers of patient-specific cells with low batch-to-batch variability, which is needed for clinical trials and the commercialization of stem cell therapy.
Key Players Landscape and Outlook
Several market players like AstraZeneca PLC, JCR Pharmaceuticals Co., Ltd., Celgene Corporation, Janssen Global Services, LLC, Takeda Pharmaceutical Company Limited, Novo Nordisk A/S, BlueRock Therapeutics LP, Gilead Sciences, Inc., Vertex Pharmaceuticals Incorporated, Bristol-Myers Squibb Company, etc. are contributing to the stem cell therapy market through novel products, innovative researches, regulatory approvals, etc. The industry accumulates a number of players ranging from small start-ups to global giants like AstraZeneca. Various market tactics like mergers and acquisitions, collaborations, and other deals among market players indicate active market growth.
In April 2024, Century Therapeutics, Inc. expanded its clinical development of CNTY-101, a CD19-targeting Invariant Natural Killer (iNK) cell therapy, into additional autoimmune disease indications. The company secured a USD 60 million private placement to support this expansion and acquired Clade Therapeutics, a biotech company focused on Induced pluripotent stem cells (iPSC)-derived cell therapies. This deal strengthens Century's position in allogeneic, iPSC-derived cell therapy and brings in additional pipeline programs and technology, positioning Century as a leader in the cell therapy space.
In February 2024, STEMCELL Technologies Canada Inc., Canada's largest biotechnology company, acquired all assets of SQZ Biotechnologies Co, a Massachusetts-based biotech known for its cell therapy delivery technology called mechanoporation. This acquisition includes SQZ's portfolio of over 400 patents and trademarks, other intellectual property, proprietary equipment, and its head license with the Massachusetts Institute of Technology. This move will enable STEMCELL to exclusively commercialize the CellPore Transfection System and associated CellPore Transfection Kits for use in all markets, including clinical applications. STEMCELL aims to transform patient outcomes by making life-changing cell therapies widely and rapidly accessible.
All segments will be provided for all regions and countries covered
Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.