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市場調查報告書
商品編碼
1967671
細胞冷凍保存市場-全球產業規模、佔有率、趨勢、機會、預測:按產品、應用、地區和競爭對手分類,2021-2031年Cell Cryopreservation Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product, By Application, By Region & Competition, 2021-2031F |
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全球細胞冷凍保存市場預計將從 2025 年的 118.4 億美元成長到 2031 年的 165.4 億美元,複合年成長率為 5.73%。
這種將生物樣本冷卻至冰點以下以終止其代謝並確保其未來使用活性的過程,隨著再生醫學的興起和生物銀行在臨床研究中的關鍵作用而不斷發展。此外,生物製藥研發的持續投入也推動了市場的長期擴張,因為人們對可靠保存複雜細胞產品的需求日益成長。
| 市場概覽 | |
|---|---|
| 預測期 | 2027-2031 |
| 市場規模:2025年 | 118.4億美元 |
| 市場規模:2031年 | 165.4億美元 |
| 複合年成長率:2026-2031年 | 5.73% |
| 成長最快的細分市場 | 細胞凍存液 |
| 最大的市場 | 北美洲 |
儘管取得了這些進展,低溫運輸基礎設施所需的巨額資本和營運成本仍然是重大障礙,限制了其快速擴充性。此外,研發過程中需要可靠儲存的候選治療藥物數量不斷增加,進一步加劇了這些成本。根據再生醫學聯盟的數據,2024年全球共有2,406項細胞和基因療法臨床試驗正在進行中。雖然如此龐大的數量表明市場需求強勁,但儲存如此大量的生物材料所帶來的複雜財務挑戰仍然阻礙著高效的供應鏈管理。
再生醫學和細胞治療領域的快速發展正在推動市場成長,因為這需要強大的低溫運輸基礎設施。隨著基因編輯療法從臨床試驗走向商業市場,對分散式儲存設施的需求日益成長,而旨在加速產品研發的大規模產業投資也推動了這一趨勢。 2024年10月,再生醫學聯盟報告稱,該領域在上半年已籌集了109億美元的資金籌措。隨後,各公司正在建立廣泛的治療網路。例如,2025年2月,Vertex Pharmaceuticals宣布,到2024年底,該公司已在全球建立了50多個認證的治療中心,凸顯了冷凍保存技術在維持其自主研發產品活性的重要性。
此外,不孕症的增加和輔助生殖技術(ART)需求的成長正顯著推動市場成長,因為現代生殖醫學高度依賴生物樣本的玻璃化和冷凍保存。該行業正經歷著向「全冷凍保存」策略和選擇性生育治療保存的重大轉變,從而催生了對長期儲存能力的需求。 2025年4月,輔助生殖技術協會(SART)報告稱,其成員診所在2023年進行了432,641個體外受精(IVF)週期。手術量的激增直接推動了對用於長期保存精子、卵子和胚胎的先進冷凍保存培養基和自動化儲存解決方案的需求。
建造和維護低溫運輸基礎設施所需的巨額資本和營運成本是細胞冷凍保存市場成長的主要障礙。建立可靠的儲存設施需要前期投資大量資金,用於購買專用冷凍庫、自動化監控系統和備用電源系統,以確保樣品安全。除了這些初始成本外,持續的液態氮採購、設備維護以及遵守嚴格的法規也給儲存服務提供者和生物製藥研發公司帶來了持續的財務負擔。
整個研發過程中需要安全長期儲存的大量生物材料進一步加劇了這項財務負擔。隨著治療產品線的擴展,保存這些珍貴材料的總成本不斷上升,往往會對規模小規模的研發公司造成沉重的預算壓力。 2024年,美國基因與細胞治療學會(ASGCT)報告稱,全球共有4021種基因、細胞和RNA療法處於不同的開發平臺階段。管理如此龐大的研發資產的儲存物流需要大量資金,這實際上限制了市場高效擴張的能力。
在生物銀行工作流程中,機器人自動化正被日益廣泛地應用於樣本管理,以減少人為接觸並確保處理過程中的溫度穩定性。為了提高效率並減少錯誤,各機構正在部署自動化檢索系統,將樣本儲存在超低溫環境中,避免人工操作和溫度波動。這一趨勢體現在對先進管理基礎設施投資的增加。 Azenta Life Sciences 在 2025 年 5 月發布的報告顯示,其樣本管理解決方案在 2025 會計年度第二季度的收入達到 8000 萬美元,同比成長 8%,這主要得益於市場對自動化存儲和臨床樣本服務的強勁需求。
同時,為了滿足細胞和基因療法嚴格的監管要求,符合GMP規範的即用型冷凍保存培養基正成為市場趨勢。研發人員正逐步拋棄傳統的血清基培養基和自製培養基,轉而選擇化學成分明確的培養基,以提高批間一致性並降低毒性風險。隨著商業治療方法生產的擴大,這些最佳化工具的應用正在加速。 2025年5月,BioLife Solutions宣布其細胞處理收入已達2,160萬美元,年增33%。這主要歸功於其GMP級培養基被整合到17種已通過核准的商業化治療方法的生產中。
The Global Cell Cryopreservation Market is projected to expand from USD 11.84 Billion in 2025 to USD 16.54 Billion by 2031, reflecting a compound annual growth rate of 5.73%. This process, which entails cooling biological specimens to sub-zero temperatures to halt metabolism and ensure viability for later use, is growing due to the rise of regenerative medicine and the critical role of biobanking in clinical studies. Furthermore, continued funding for biopharmaceutical research and development underpins long-term market expansion by creating a need for dependable storage for increasingly sophisticated cellular products.
| Market Overview | |
|---|---|
| Forecast Period | 2027-2031 |
| Market Size 2025 | USD 11.84 Billion |
| Market Size 2031 | USD 16.54 Billion |
| CAGR 2026-2031 | 5.73% |
| Fastest Growing Segment | Cell Freezing Media |
| Largest Market | North America |
Despite these advancements, significant barriers exist regarding the substantial capital and operating costs needed for cold chain infrastructure, limiting rapid scalability. The burden of these expenses is magnified by the increasing quantity of therapeutic candidates requiring reliable preservation during development. Data from the Alliance for Regenerative Medicine indicates that 2,406 clinical trials for cell and gene therapies were active globally in 2024. Although this high volume suggests robust demand, the financial intricacies involved in storing such a large amount of biological material continue to impede efficient supply chain management.
Market Driver
The rapid growth of the regenerative medicine and cell therapy sectors propels the market by demanding strong cold chain infrastructure. As gene-edited treatments move from clinical trials to the commercial market, there is a growing need for decentralized preservation facilities, a trend bolstered by significant industry investment aimed at speeding up pipeline development. The Alliance for Regenerative Medicine reported in October 2024 that the sector secured $10.9 billion in the first half of the year. Consequently, companies are building vast treatment networks; for instance, Vertex Pharmaceuticals noted in February 2025 that it had established over 50 authorized treatment centers worldwide by the end of 2024, highlighting the reliance on cryopreservation for maintaining autologous product viability.
Additionally, the rising prevalence of infertility and the demand for Assisted Reproductive Technologies (ART) significantly boost market growth, as modern fertility procedures rely heavily on the vitrification of biological samples. There is a notable industry shift toward "freeze-all" strategies and elective fertility preservation, necessitating long-term storage capabilities. In April 2025, the Society for Assisted Reproductive Technology reported that member clinics performed 432,641 IVF cycles in 2023. This increase in procedure volume directly drives the need for sophisticated cryopreservation media and automated storage solutions to preserve gametes and embryos over long periods.
Market Challenge
The substantial capital and operational costs required to build and sustain cold chain infrastructure represent a major obstacle to the growth of the cell cryopreservation market. Setting up reliable storage facilities demands heavy upfront investment in specialized freezers, automated monitoring, and backup power systems to guarantee sample safety. Beyond these initial expenditures, ongoing costs for liquid nitrogen, equipment upkeep, and adherence to strict regulations impose a continuous financial burden on preservation providers and biopharmaceutical developers.
This economic strain is worsened by the massive volume of biological materials needing secure, long-term storage throughout the development process. As the therapeutic pipeline grows, the total cost of preserving these delicate materials rises, often straining the budgets of smaller development companies. The American Society of Gene & Cell Therapy noted in 2024 that the global pipeline contained 4,021 gene, cell, and RNA therapies across various stages. Managing the storage logistics for such a vast array of developmental assets necessitates significant capital, effectively limiting the market's ability to scale operations efficiently.
Market Trends
Biobanking workflows are increasingly incorporating robotic automation to transform sample management, reducing human contact and ensuring stable temperatures during handling. To enhance efficiency and decrease errors, facilities are adopting automated retrieval systems that keep samples at ultra-low temperatures without the fluctuations caused by manual access. This trend is reflected in rising investments in advanced management infrastructure; Azenta Life Sciences reported in May 2025 that its Sample Management Solutions revenue hit $80 million in the second quarter of fiscal 2025, an 8% rise driven by strong demand for automated storage and clinical sample services.
Concurrently, there is a significant shift toward using ready-to-use, GMP-compliant cryopreservation media to satisfy rigorous regulatory requirements for cell and gene therapies. Developers are abandoning traditional serum-based or homemade formulations in favor of chemically defined options that provide better consistency between lots and lower toxicity risks. The uptake of these optimized tools is speeding up as commercial therapies expand manufacturing; BioLife Solutions announced in May 2025 that its cell processing revenue grew 33% year-over-year to $21.6 million, largely due to the integration of its GMP-grade media into the production of 17 approved commercial therapies.
Report Scope
In this report, the Global Cell Cryopreservation Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:
Company Profiles: Detailed analysis of the major companies present in the Global Cell Cryopreservation Market.
Global Cell Cryopreservation Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report: