![]() |
市場調查報告書
商品編碼
1880593
重組白蛋白市場規模、佔有率、成長及全球產業分析:依類型、應用和地區劃分的洞察與預測(2024-2032)Recombinant Albumin Market Size, Share, Growth and Global Industry Analysis By Type & Application, Regional Insights and Forecast to 2024-2032 |
||||||
由於生物製藥、細胞療法和藥物遞送技術的進步推動了對高純度血清替代品的需求不斷增長,全球重組白蛋白市場持續穩步擴張。根據2024年的報告,預計該市場在2024年將達到1.428億美元,2025年將達到1.507億美元。預計到2032年將進一步成長至2.285億美元,在此期間的複合年增長率(CAGR)為6.05%。亞太地區持續保持領先地位,在2024年將佔全球市場的48.38%,這主要得益於不斷擴大的治療性生產能力和強勁的研發活動。
重組白蛋白因其無病毒、可擴展且符合GMP規範的生產方式,正迅速成為人類血白蛋白的替代品。其廣泛的應用,包括細胞培養基、診斷、生物製劑和藥物傳遞系統,使其成為現代生物醫學製造的關鍵組成部分。隨著細胞和基因療法在全球的擴展,由於其穩定性、保護性和生物相容性,對重組白蛋白的需求持續成長。
市場動態
市場推動因素
市場成長的關鍵推動因素是重組白蛋白在細胞和基因療法中日益廣泛的應用。這些療法需要高度穩定的添加劑,以在生產和儲存過程中保護脆弱的細胞和治療分子。重組白蛋白可以提高細胞活力、減少聚集並支持病毒載體的生產。這種日益增長的整合正在創造強勁的長期需求。例如,2021年2月,Albumedix與細胞和基因治療加速器(Cell and Gene Therapy Catapult)合作,開始研究用於病毒載體生產的白蛋白解決方案,凸顯了該公司日益增長的戰略重要性。
市場限制因子
儘管成長潛力巨大,但由於重組生產的複雜性,市場面臨供應限制。嚴格的GMP要求、昂貴的純化技術以及與傳統生物製劑相比較低的產量,都增加了生產的挑戰。這些阻礙因素可能導致供應短缺和成本上升。 2022年,三菱化學集團公司因無法維持穩定的供應而停止了重組白蛋白的生產,這反映了製造商面臨的挑戰。
市場機會
奈米顆粒白蛋白結合(nab)藥物遞送系統研發的進展帶來了巨大的機會。 nab技術可提高溶解度並降低毒性,使其可用於配製化療藥物和生物製劑。 2024年10月,山德士在美國推出了白蛋白結合型紫杉醇的仿製藥,這標誌著基於白蛋白的給藥系統正被越來越廣泛地採用。腫瘤學和再生醫學領域的持續進步預計將在2032年之前改善市場前景。
市場趨勢
主要公司擴大產能已成為新興的關鍵趨勢。在先進療法生產商需求不斷增長的推動下,各公司正在投資建造更大的生物加工設施和進行上游創新。 2025年3月,煙台普濟藥業科技宣布擴大其重組白蛋白生產基礎設施,這標誌著全球正在擴大高純度白蛋白的供應規模。
區隔市場概覽
依劑型劃分
2024年,溶液劑型憑藉其降低污染風險、高均勻性和即用型等優勢,佔了市場主導地位。新產品的推出,包括 InVitria 於 2025 年 2 月推出的 Optibumin 25(一種用於細胞和基因治療生產的 25% 重組白蛋白溶液),進一步鞏固了該區隔市場的地位。
依應用領域劃分
2024 年,治療藥物領域佔了最大的市場佔有率。這主要歸功於重組白蛋白作為生物製劑生產中的賦形劑和穩定劑的廣泛應用。持續的合作,例如 Albumedix 與 Heartseed 在 2023 年的合作,將推動重組白蛋白治療用途的拓展。
依最終使用者劃分
2024 年,製藥和生技公司在最終用戶領域佔領先地位,這得益於其強大的研發投入、生產擴張和策略商業化協議。2024年6月,Dyadic International與Proliant Health & Biologicals合作開發重組白蛋白產品,彰顯了該公司致力於擴大該領域供應的決心。
亞太地區仍是領先市場,2024年市場規模達6,910萬美元,主要得益於生物製藥活動的擴張、慢性病盛行率的上升以及區域內強有力的合作。北美市場預計到2025年將穩定成長至4,450萬美元,這得益於先進的研發基礎設施和強大的生物製劑生產基地。歐洲市場預計到2025年將成長至2,400萬美元,主要得益於治療藥物的廣泛應用。拉丁美洲以及中東和非洲地區預計將實現溫和增長,這主要得益於再生醫學的日益普及和醫療保健能力的提升。
The global recombinant albumin market continues to expand steadily as advancements in biopharmaceuticals, cell therapy, and drug delivery technologies increase the demand for high-purity serum alternatives. According to the 2024 report, the market was valued at USD 142.8 million in 2024, is expected to reach USD 150.7 million in 2025, and is forecasted to grow to USD 228.5 million by 2032, exhibiting a CAGR of 6.05% during the assessment period. Asia Pacific remained the leading region, accounting for 48.38% of the global market in 2024, supported by expanding therapeutic manufacturing capabilities and strong R&D activity.
Recombinant albumin is rapidly becoming a preferred substitute for human-derived albumin due to its virus-free, scalable, and GMP-compliant production. Its extensive applications in cell culture media, diagnostics, biologics formulation, and drug delivery systems make it a crucial component in modern biomedical manufacturing. As cell and gene therapies expand globally, demand for recombinant albumin continues to increase, driven by its stabilizing, protective, and biocompatible attributes.
Market Dynamics
Market Drivers
A major driver for market growth is the expanding adoption of recombinant albumin in cell and gene therapy. These therapies require highly stable excipients capable of protecting fragile cells and therapeutic molecules during manufacturing and storage. Recombinant albumin enhances viability, reduces aggregation, and supports viral vector manufacturing. This growing integration creates strong long-term demand. In February 2021, for example, Albumedix partnered with the Cell and Gene Therapy Catapult to investigate its albumin solutions for viral vector production, highlighting its increasing strategic importance.
Market Restraints
Despite strong growth potential, the market faces supply limitations due to the complexity of recombinant production. Strict GMP conditions, expensive purification technologies, and lower yields compared to traditional biologics increase production challenges. These constraints can lead to supply shortages and higher costs. In 2022, Mitsubishi Chemical Group Corporation discontinued its recombinant albumin production due to an inability to maintain stable supply, reflecting the difficulties faced by manufacturers.
Market Opportunities
Growing research and development in nanoparticle albumin-bound (nab) drug delivery systems presents significant opportunities. Nab technology enhances solubility and reduces toxicity, making it useful in chemotherapy and biologics formulation. In October 2024, Sandoz launched a generic paclitaxel albumin-bound formulation in the U.S., demonstrating increased adoption of albumin-based delivery systems. Continued advancements in oncology and regenerative medicine are expected to enhance market prospects through 2032.
Market Trends
A key emerging trend is the expansion of manufacturing capacity by leading players. With rising demand from advanced therapy manufacturers, companies are investing in larger bioprocessing facilities and upstream innovation. In March 2025, Yantai Projiji Pharmaceutical Technology announced the expansion of its recombinant albumin production infrastructure, indicating a global shift toward scaling high-purity albumin supply.
Segmentation Overview
By Dosage Form
The solution form dominated the market in 2024 due to reduced contamination risk, high consistency, and ready-to-use formulations. New product launches continue to strengthen this segment, including the February 2025 launch of Optibumin 25 by InVitria, a 25% recombinant albumin solution designed for cell and gene therapy manufacturing.
By Application
The therapeutics segment held the largest share in 2024, driven by recombinant albumin's wide use as an excipient and stabilizer in biologics production. Ongoing collaborations such as Albumedix's partnership with Heartseed in 2023 reinforce the expanding therapeutic applications of recombinant albumin.
By End User
Pharmaceutical and biotechnology companies dominated the end-user segment in 2024, supported by strong R&D investments, manufacturing expansion, and strategic commercialization agreements. In June 2024, Dyadic International partnered with Proliant Health & Biologicals to develop recombinant albumin products, emphasizing the sector's commitment to scaling supply.
Asia Pacific remained the leading market, valued at USD 69.1 million in 2024, supported by growing biopharmaceutical activity, rising prevalence of chronic diseases, and strong regional collaborations. North America is forecasted to grow steadily, reaching USD 44.5 million by 2025, driven by advanced R&D infrastructure and a strong biologics manufacturing base. Europe is expected to expand to USD 24.0 million in 2025, supported by increasing adoption in therapeutic applications. Latin America and the Middle East & Africa are projected to grow moderately, driven by rising adoption of regenerative medicine and expanding healthcare capabilities.
Conclusion
With the market rising from USD 142.8 million in 2024 to an estimated USD 228.5 million by 2032, recombinant albumin continues to solidify its position as an essential component in biologics, advanced therapies, and drug delivery innovations. Strategic partnerships, increased manufacturing capacity, and expanding therapeutic pipelines will remain key growth drivers over the forecast period.
Segmentation By Dosage Form
By Application
By End User
By Geography