![]() |
市場調査レポート
商品コード
1701878
幹細胞製造市場レポート:製品別、用途別、エンドユーザー別、地域別、2025年~2033年Stem Cell Manufacturing Market Report by Product, Application, End User, and Region 2025-2033 |
||||||
カスタマイズ可能
|
幹細胞製造市場レポート:製品別、用途別、エンドユーザー別、地域別、2025年~2033年 |
出版日: 2025年04月01日
発行: IMARC
ページ情報: 英文 144 Pages
納期: 2~3営業日
|
幹細胞製造の世界市場規模は2024年に142億米ドルに達しました。IMARC Groupは、2025年から2033年にかけての成長率(CAGR)は6.8%で、2033年には258億米ドルに達すると予測しています。幹細胞研究への投資の増加、慢性疾患罹患率の上昇、バイオテクノロジーの進歩、産学連携、厳しい規制、幹細胞治療に対する認知度の拡大などが市場成長を刺激しています。
幹細胞研究と再生医療への投資の増加
世界の幹細胞製造市場は、幹細胞研究および再生医療への多額の投資により、著しい盛り上がりを見せています。政府や民間組織は、ヘルスケアに革命をもたらす可能性を認識し、これらの分野に資源を投入しています。この原動力は、神経変性疾患や脊髄損傷など、これまで治療不可能とされてきた疾患に対する幹細胞治療の有望な見込みにあります。例えば、2023年8月にNew England Journal of Medicineに掲載された論文では、鎌状赤血球症(SCD)の治療における幹細胞遺伝子治療の可能性が期待されていることが明らかにされました。これらの投資は、最先端の研究、高度な製造技術の開発、臨床試験の拡大を支援しています。例えば、2021年9月、LifeCell International Pvt. Ltdは、OrbiMed Asia Partners IVから225カロールインドルピー(2,720万米ドル)の投資を受け、同社の技術的専門知識と幅広いネットワークをさらに活用し、不妊治療や細胞ベースの治療薬など、隣接する新たなカテゴリーに進出しました。さらに、2023年11月には、組換えタンパク質と必須試薬を専門とする米国のACROBiosystems Inc.が、幹細胞の発生と分化に重要なデルタ様リガンド4(DLL4)の可溶型であるGMグレードのDLL4タンパク質を上市しました。
慢性疾患の増加と革新的治療への需要
世界の幹細胞製造市場を推進するもう一つの重要な原動力は、慢性疾患の有病率の上昇です。糖尿病、心臓病、自己免疫疾患などの治療が増加傾向にあり、斬新で効果的な治療法が必要とされています。幹細胞治療は、損傷した組織や臓器を再生させることにより、これらの病気に対処する上で非常に有望です。例えば、2021年3月、Vertex Pharmaceuticalsは、1型糖尿病患者に対するヒト幹細胞由来治療薬VX-880のファスト・トラック指定をFDAから受けました。さらに、米国食品医薬品局(FDA)が2022年12月に発表したデータによると、米国には3,000万人以上が罹患する7,000以上の希少疾患が存在します。慢性疾患の罹患率は加齢とともに上昇しますが、幹細胞製造はこうした疾患との闘いに有望です。例えば、2021年10月に発表された世界保健機関(WHO)のファクトシートによると、2030年までに世界全体で65歳以上の高齢者が14億人になり、2050年までにその数は22億人と倍増すると予測されています。
バイオテクノロジーと細胞培養技術の進歩
バイオテクノロジーと細胞培養技術の進歩は、幹細胞製造の分野に革命をもたらしています。この原動力は幹細胞製造の効率と拡張性を高める上で極めて重要です。3D細胞培養システムやバイオリアクターのような細胞培養技術における画期的な進歩は、高品質の幹細胞をより大量に培養することを可能にします。加えて、CRISPR-Cas9のような遺伝子編集技術の革新は、幹細胞の特性を正確にコントロールし、治療の可能性をさらに広げます。これらの進歩は、製造工程を合理化するだけでなく、幹細胞を用いた治療法の安全性と品質を保証し、ヘルスケア関係者や患者に信頼感を与えています。例えば、2021年9月、幹細胞製造に特化した米国のバイオテクノロジー企業であるCellinoは、AI、機械学習、レーザー、その他のハードウェアやソフトウェアを統合したシステムにより、歩留まりを向上させ、製造コストを削減する方法を発表しました。
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.)