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市場調查報告書
商品編碼
1701878
2025 年至 2033 年幹細胞製造市場報告(按產品、應用、最終用戶和地區)Stem Cell Manufacturing Market Report by Product, Application, End User, and Region 2025-2033 |
2024年全球幹細胞製造市場規模達142億美元。展望未來, IMARC Group預計到2033年市場規模將達到258億美元,2025-2033年期間的成長率(CAGR)為6.8%。幹細胞研究投資的增加、慢性病盛行率的上升、生物技術的進步、學術界和工業界之間的合作、嚴格的法規以及對幹細胞療法的認知的不斷提高正在刺激市場的成長。
增加對幹細胞研究和再生醫學的投資
由於大量資金湧入幹細胞研究和再生醫學,全球幹細胞製造市場正在經歷顯著的成長。政府和私人組織正在向這些領域投入資源,並認知到它們徹底改變醫療保健的潛力。這項驅動力源自於幹細胞療法在治療神經退化性疾病和脊髓損傷等以前無法治癒的疾病方面的良好前景。例如,2023 年 8 月發表在《新英格蘭醫學雜誌》上的一篇文章揭示了幹細胞基因療法在治療鐮狀細胞疾病 (SCD) 方面的預期潛力。這些投資支持尖端研究、先進製造技術的開發和臨床試驗的擴展。例如,2021 年 9 月,LifeCell International Pvt. Ltd 從 OrbiMed Asia Partners IV 獲得了 225 億印度盧比(2720 萬美元)的投資,以進一步利用其技術專長和廣泛的網路進軍生育健康和細胞治療等相鄰的新領域。此外,2023 年 11 月,專門從事重組蛋白和必需試劑的美國公司 ACROBiosystems Inc. 推出了 GM 級 DLL4 蛋白,這是 Delta 樣配體 4 (DLL4) 的可溶形式,對幹細胞的發育和分化至關重要。
慢性病盛行率上升及對創新治療的需求
推動全球幹細胞製造市場發展的另一個重要驅動力是慢性病的日益普及。糖尿病、心臟病和自體免疫疾病等疾病的發生率正在上升,需要新穎有效的治療方法。幹細胞療法透過再生受損的組織和器官,在治療這些疾病方面具有巨大的前景。例如,2021 年 3 月,Vertex Pharmaceuticals 獲得 FDA 對 VX-880 的快速通道認證,VX-880 是一種針對 1 型糖尿病患者的人類幹細胞衍生療法。此外,根據美國食品藥物管理局(FDA)2022年12月提供的資料,美國有超過7,000種罕見疾病,影響超過3,000萬人。慢性病的盛行率隨著年齡的成長而上升,而幹細胞製造在對抗這些疾病方面顯示出良好的前景。例如,世界衛生組織 2021 年 10 月的一份情況說明書預測,到 2030 年,全球 65 歲以上人口將達到 14 億,預計到 2050 年這一數字將加倍,達到 22 億。
生物技術和細胞培養技術的進展
生物技術和細胞培養技術的進步正在徹底改變幹細胞製造領域。這項促進因素對於提高幹細胞生產的效率和可擴展性至關重要。 3D細胞培養系統和生物反應器等細胞培養技術的突破使得大量培養高品質幹細胞成為可能。此外,CRISPR-Cas9 等基因編輯技術的創新可以精確控制幹細胞特性,進一步擴大其治療潛力。這些進步不僅簡化了製造流程,而且還確保了幹細胞療法的安全性和質量,從而增強了醫療專業人員和患者的信心。例如,2021 年 9 月,專門從事幹細胞製造的美國生物技術公司 Cellino 展示了其系統如何整合人工智慧、機器學習和雷射以及其他硬體和軟體,以提高產量並降低生產成本。
耗材佔據市場主導地位
由於基於幹細胞的研究和治療的日益普及,幹細胞製造市場中的消耗品部分正在經歷強勁成長,需要持續供應消耗品,包括細胞培養基、試劑和生長因子。隨著該領域研究的不斷擴展,對這些必需材料的需求也不斷增加。此外,幹細胞臨床試驗和再生醫學應用的不斷成長也刺激了消耗品的消耗。臨床研究和治療開發需要一致且可靠的高品質耗材來源,以確保基於幹細胞治療的安全性和有效性。與此相符的是,消費品生產技術的進步正在推動成長。
研究應用主導市場
幹細胞製造市場中研究應用部分的成長得益於對科學知識的不懈追求和幹細胞生物學的突破性發現。幹細胞是研究各種生物過程、疾病機制和潛在治療途徑的重要工具。再生醫學、發育生物學和藥物開發等不同領域的研究人員都依賴幹細胞來推進他們的研究。此外,分配給幹細胞研究的資金和補助不斷增加,促進了這一領域的成長。政府、私人機構和非營利組織認知到幹細胞研究的變革潛力,並提供資金支持以推動創新。此外,幹細胞培養技術、基因編輯和細胞表徵工具的技術進步提高了研究應用的效率和準確性。這些進步使研究人員能夠研究更廣泛的幹細胞類型並對其進行精確操作,從而進一步擴大研究的可能性範圍。例如,2023 年 5 月,Sernova 宣布與阿斯特捷利康進行研究合作,以評估新型潛在治療細胞應用。
製藥和生物技術公司主導市場
全球人口的不斷成長和人口老化趨勢推動了製藥和生物技術公司的成長。隨著人口老化,對醫療保健服務、藥物和創新療法的需求不斷增加,為製藥和生物技術公司提供了龐大的市場。此外,心血管疾病、癌症和糖尿病等慢性疾病的盛行率不斷上升,使得持續研究和開發新的藥物解決方案成為必要。這些公司在開發先進藥物和療法以應對這些健康挑戰方面發揮關鍵作用。此外,基因治療、精準醫療和生物製藥等生物技術的進步正在塑造這個產業。
北美佔據明顯優勢,佔據最大的幹細胞製造市場佔有率
市場研究報告也對所有主要區域市場進行了全面分析,包括北美(美國和加拿大);歐洲(德國、法國、英國、義大利、西班牙、俄羅斯等);亞太地區(中國、日本、印度、韓國、澳洲、印尼等);拉丁美洲(巴西、墨西哥等);以及中東和非洲。報告顯示,北美佔據最大的市場佔有率。
受政府和私人對幹細胞研究和再生醫學的大量投資推動,北美地區的幹細胞製造市場正在強勁成長。這些資金承諾支持尖端研究、臨床試驗和先進製造技術的開發。此外,糖尿病、心臟病和神經退化性疾病等慢性病的盛行率在北美呈上升趨勢。幹細胞療法為解決這些問題提供了創新的解決方案,從而推動了其生產的需求。與此相符的是,該地區擁有高度發展的生物技術部門,在細胞培養技術和生物加工技術方面取得了重大進展。這確保了高效、可擴展的幹細胞生產,鞏固了該產業在北美的立足點。此外,北美的監管框架為幹細胞研究和臨床試驗提供了有利的環境,促進了成長和創新。學術機構和產業參與者之間的合作努力以及公眾對幹細胞治療潛力的認知不斷提高是額外的驅動力。
(請注意,這只是關鍵參與者的部分列表,完整列表在報告中提供。)
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.)