市場調查報告書
商品編碼
1546287
幹細胞治療的全球市場的評估:各類型,細胞源,各治療領域,各終端用戶,各地區,機會,預測(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 |
全球幹細胞治療市場規模預計將從 2023 年的 3.0282 億美元增至 2031 年的 9.7578 億美元,預計 2024-2031 年的複合年增長率為 15.75%。該市場正在迅速活躍,近年來在收入和基礎設施方面都顯示出巨大的成長。由於生物技術研究的成長,預計該市場將繼續以更強勁的速度成長。
幹細胞療法是一種再生醫學方法,利用幹細胞刺激對特定疾病或受損或功能障礙組織的反應。市場主要受到再生醫學需求不斷增長、生物技術研究領域成長以及支持新療法開發的投資者動力等因素的影響。監管批准在幹細胞治療市場的成長中發揮著至關重要的作用。這是因為新的批准為其他市場進入者提供了更多機會,並激勵他們朝某個方向進行研究。目前,美國食品藥物管理局(USFDA)只認可基於造血幹細胞移植的幹細胞療法。同樣,歐洲藥品管理局 (EMA) 對基於幹細胞的治療的批准實施了嚴格的規定,並根據《2007 年歐盟先進藥物法案》對其進行審查。
由於幹細胞修飾是幹細胞治療的支柱,因此存在許多倫理問題,對幹細胞治療的發展和廣泛使用構成重大威脅。這些治療方法的高價格也是這個市場的一個挑戰,因為它們涉及大量的資金和時間投入。儘管有這些挑戰,幹細胞治療市場仍顯著成長,預計在預測期內將繼續成長。最近的監管批准刺激了市場擴張。例如,2023年12月,歐洲藥品管理局(EMA)建議批准第一個使用尖端基因編輯技術CRISPR/Cas9的藥物。該藥物名為 Casgevy(exagamglogene autotemcel),旨在治療 12 歲及以上人群的輸血依賴性β地中海貧血和嚴重鐮狀細胞疾病。此治療適用於適合造血幹細胞移植但無合適供者的患者。
技術進步與創新研究推動市場成長
幹細胞療法於 1956 年首次以其原始形式引入,此後已顯示出多項技術進步。近年來,透過幹細胞基因重編程實現快速定向分化、細胞外基質、培養基、生長因子、解離試劑、冷凍保存、自動化、機器人技術、腫瘤學、神經學等方面的進步、幹細胞治療的利用等科技進步心血管疾病、造血系統疾病等廣泛的治療應用正在促進幹細胞治療市場的需求。近年來的新研究成果為市場帶來了廣闊的機會。
例如,2023年11月,來自新加坡-麻省理工學院研究與技術聯盟(SMART)跨學科研究小組(IRG)製造個人化醫療批判性分析(CAMP)的研究人員合作開發了突破性技術與生物加工技術研究所(BTI) 和國立大學衛生系統(NUHS) 合作。此技術可直接從純骨髓(也稱為骨髓抽吸物(BMA))中萃取間質幹細胞(MSC),無需稀釋。骨髓抽吸物是間質幹細胞的重要來源。
投資者興趣和政府支持增加,以加速市場成長
特定市場的資本投資是主要驅動力。生物技術研究市場,例如幹細胞治療市場,需要大量資金來開發產品並將其推向市場。最近的趨勢是幹細胞療法開發方面出現了一些值得注意的公共和私人投資趨勢。政府以補貼、補貼和直接投資等形式提供支持,有利於市場擴張。近年來,包括美國、加拿大、肯亞和印度在內的多個國家的政府在幹細胞研究方面投入了大量資金。
本報告提供全球幹細胞治療市場相關調查分析,提供市場規模與預測,市場動態,主要企業的形勢及預測等資訊。
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.