市場調査レポート
商品コード
1546287
幹細胞治療の世界市場の評価:タイプ別、細胞源別、治療領域別、エンドユーザー別、地域別、機会、予測(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 |
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幹細胞治療の世界市場の評価:タイプ別、細胞源別、治療領域別、エンドユーザー別、地域別、機会、予測(2017年~2031年) |
出版日: 2024年09月03日
発行: Market Xcel - Markets and Data
ページ情報: 英文 244 Pages
納期: 3~5営業日
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世界の幹細胞治療の市場規模は、2023年の3億282万米ドルから2031年に9億7,578万米ドルに達すると予測され、予測期間の2024年~2031年にCAGRで15.75%の成長が見込まれます。市場は急速に活性化しており、近年は収益面でもインフラ面でも驚異的な成長を見せています。市場は、バイオテクノロジー研究の成長により、今後もさらに力強いペースで成長すると予測されます。
幹細胞治療は、特定の疾患や損傷した、または機能不全に陥った組織に対する反応を促進するために幹細胞を使用する再生医療アプローチの一種です。市場は主に、再生医療に対する需要の高まり、バイオテクノロジー研究部門の成長、新治療法の開発を支援する投資家の勢いといった要因の影響を受けています。規制当局の承認は幹細胞治療市場の成長において極めて重要な役割を果たします。なぜなら、新たな承認は他の市場参入企業により多くの機会を与え、研究を特定の方向に向かわせる動機付けとなるからです。現在、米国食品医薬品局(USFDA)は造血幹細胞移植に基づく幹細胞治療のみを認めています。同様に、欧州医薬品庁(EMA)も、幹細胞を用いた治療法の承認に厳格な規制を課し、2007年のEUの先進医療法に基づいて検討しています。
幹細胞の改変は幹細胞治療の根幹をなすものであるため、幹細胞治療の成長と普及にとっての大きな脅威となる倫理的な懸念が数多く存在します。また、多くの資本と時間を投資するため、これらの治療法の価格が高いことも、この市場における課題となっています。このような課題にもかかわらず、幹細胞治療市場は大きく成長しており、予測期間にも成長し続ける見込みです。近年の規制当局の承認が市場拡大に弾みをつけました。例えば2023年12月、欧州医薬品庁(EMA)は、最先端の遺伝子編集技術であるCRISPR/Cas9を用いた初の医薬品の承認を推奨しました。Casgevy(exagamglogene autotemcel)と呼ばれるこの医薬品は、12歳以上の輸血依存性β-サラセミアと重症鎌状赤血球症の治療を目的としています。この治療は、造血幹細胞移植が適切で、適切なドナーが得られない患者に適しています。
技術的進歩と革新的研究が市場成長を促進
幹細胞治療は1956年に原始的な形式で初めて導入されて以来、複数の技術的進歩を示してきました。近年では、幹細胞の遺伝子再プログラミングによる迅速な指向性分化のような技術的進歩や、細胞外マトリクス、培養液、成長因子、解離試薬、凍結保存、自動化、ロボット技術の進歩、腫瘍学、神経学、心血管疾患、造血器疾患などの幅広い治療用途への幹細胞治療の利用などが、幹細胞治療市場の需要に寄与しています。近年の新しい研究成果は、市場に有望な機会をもたらしています。
例えば2023年11月、Singapore-MIT Alliance for Research and Technology(SMART)のInterdisciplinary Research Group(IRG)のCritical Analytics for Manufacturing Personalized Medicine(CAMP)の研究者が、科学技術研究庁(ASTAR)のBioprocessing Technology Institute(BTI)とNational University Health System(NUHS)と共同で画期的な技術を開発しました。この技術は、骨髄穿刺液(BMA)としても知られる純粋な骨髄から、希釈することなく間葉系幹細胞(MSC)を直接抽出することができます。骨髄穿刺液は間葉系幹細胞の重要な供給源です。
市場成長を加速させる投資家の関心の高まりと政府の支援
特定の市場への資本投資は、大きな促進要因として作用します。幹細胞治療市場のようなバイオテクノロジー研究市場は、製品の開発や市場投入に莫大な資金を必要とします。近年の動向として、幹細胞治療の開発に対する官民からの注目すべき投資動向がいくつか見られます。助成金、補助金、直接投資といった形での政府支援は、市場の拡大を促進します。米国、カナダ、ケニア、インドなど、複数の国の政府は近年、幹細胞研究活動に多額の投資を行っています。
当レポートでは、世界の幹細胞治療市場について調査分析し、市場規模と予測、市場力学、主要企業の情勢と見通しなどを提供しています。
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.