全球外泌體市場－市場規模、預測、臨床試驗與趨勢（2026 年）

外泌體是來自核內體的細胞外囊泡（EVs），大小範圍為30至150奈米。由於幾乎所有活細胞都會利用外泌體介導的通訊，因此外泌體會由多種細胞分泌。外泌體攜帶細胞特異性內容物，例如蛋白質、脂質和核酸，這些內容物會被受體細胞選擇性地吸收。

近年來，外泌體技術發展迅速，隨著其在液態生物檢體、精準醫療和再生醫學等領域的應用，預計市場將實現顯著成長。特別是，癌細胞來源的外吐小體是用於癌症檢測、診斷和治療選擇的重要生物標記資訊來源，因為它們能夠透過調節血管生成、轉移和免疫反應來影響細胞侵襲性。

外吐小體的內容物可為多種疾病提供預後訊息，不僅包括癌症，還包括心血管疾病、腎臟疾病、神經退化性疾病和代謝性疾病。研究人員已發現、鑑定並報告了外泌體腔內存在數百種不同的生物分子，這些生物分子與外泌體生物標記密切相關。這項發現極大地推動了外泌體相關癌症生物標記研究的快速發展，包括利用外泌體進行各種腫瘤疾病的檢測、監測和治療。

值得注意的是，外泌體存在於多種體液中，包括血清、血漿、尿液、精液、腦脊髓液、唾液、淚液和母乳。因此，基於外泌體的診斷方法具有微創、易用且快速檢測的優點。此外，外泌體還可以作為預後指標，預測患者對特定治療方案的反應。

此外，外泌體也被探索用作無細胞治療劑。例如，對於因蛋白質或微型RNA缺陷而患病的患者，可以分離出患者自身的外吐小體，並用合適的siRNA或蛋白質對其進行修飾，然後將其重新注射回患者體內進行治療。目前正在研究多種建構藥物包覆外吐小體的方法，而外外吐小體本身有時也能發揮顯著作用。例如，間質幹細胞（MSC）來源的外吐小體能夠抑制發炎、預防疤痕組織形成並誘導健康的免疫反應。

此外，近年來，與外吐小體相關的科學論文、專利（智慧財產權）和臨床試驗的數量急劇增加。

最後，外吐小體目前被廣泛應用於以下領域：

• 1. 診斷：疾病檢測的生物標記
• 2. 再生醫學：用於組織修復、創傷治療和疾病逆轉的無細胞療法。
• 3. 藥物傳遞：標靶治療藥物傳遞載體
• 4. 研究產品：用於研究細胞間通訊和疾病機制的工具。
• 5. 皮膚科和美容醫學：傷口修復、活膚、抗衰老治療和毛髮再生療法。
• 6. 新的應用領域：外泌體疫苗、免疫療法（利用活化的 T 細胞和 NK 細胞衍生的外泌體）、獸醫學、農業（植物來源的外泌體）等。

世界外泌體

市場——這一科學領域正在迅速發展。研究人員目前已在ExoCarta等專用資料庫中註冊了超過11.9萬條與外泌體相關的蛋白質條目，單一外泌體攜帶數十至1000-2000種不同的蛋白質，這些蛋白質反映了其母細胞的生理狀態。截至2026年6月，PubMed.gov收錄了4,4211篇關於外泌體研究的論文。與2010年的282篇相比，這是一個顯著的成長，預計僅2025年一年的論文數量就將達到6304篇。目前，亞太地區佔全球外泌體相關論文總數的52%，其次是歐洲（28%）和美國（20%），儘管美國仍保持最高的引用影響力，並在臨床應用方面處於領先地位。

哈佛大學在論文發表數量和引用影響力方面均領先所有機構，而卡羅林斯卡學院則是治療應用領域的領先研究中心。專利申請數量也大幅成長，從2000年的8件增加到2025年的1921件，其中美國（總計22120件）、世界智慧財產權組織（WIPO）和中國是主要管轄區。臨床開發也緊追在後，目前全球已註冊579項與外泌體相關的臨床試驗。美國（149項）和中國（138項）處於主導地位，腫瘤治療領域約佔治療研發管線的30%。

雖然目前尚無任何基於外泌體的治療或診斷產品獲得美國食品藥物管理局 (FDA) 的全面批准，但這種情況正在改變。該領域最引人注目的項目之一是 Capricor Therapeutics 公司的 DelamioCel (CAP-1002)，一種用於治療Duchenne氏肌肉失養症(DMD) 相關心肌病的藥物。 DelamioCel 採用同種異體心肌細胞 (CDC) 進行細胞治療，但其作用機制提案是外泌體介導的。具體而言，CDC 會分泌外泌體，從而將巨噬細胞從促發炎模式轉化為修復模式。 FDA 授予 DelamioCel 優先審查資格，但在 2026 年 7 月，其諮詢委員會以 9 比 3 的投票結果否決了最初關於批准其用於治療心肌病的建議。作為回應，Capricor 提交了其 III 期 HOPE-3 試驗的補充數據，並將申請範圍縮小至「維持上肢功能」。作為回應，FDA 將目標審查日期（PDUFA）延長至 2026 年 11 月 22 日。

在診斷領域，目前已有兩種經CLIA認證的實驗室自建檢測（LDT）投入使用。一種是「ExoDx Prostate IntelliScore (EPI)」，由Bio-Techne於2025年出售，現由MDxHealth運營；另一種是「ExoTRU」，是由Bio-Techne/Thermo Fisher Scientific開發的腎移植排斥反應檢測。

此外，該產業的投資和併購活動十分活躍。自2010年以來，專注於外泌體領域的公司獲得的創業投資資金籌措已接近6億美元，僅在2023年至2026年中期，就透過一些引人注目的資金籌措輪籌集了約1.55億美元，例如EXO Biologics的1870萬美元A輪融資、Annie Aesthetic Holdings的6500萬美元的融資隨著各大公司紛紛尋求取得診斷和技術平台，策略性收購正在推動該產業的重組。特別值得注意的是MDxHealth以1500萬美元從Bio-Techne手中收購了Exosome Diagnostics（及其ExoDx前列腺檢測產品）；ExoCoBio收購了BENEV的多數股權，以擴大其在全球美容行業的經銷網路；以及Evox Therapeutics收購了Codiak Biosciences的工程化外泌體技術平台。

同時，生物製藥公司與外泌體創新者之間的許可和合作活動（包括 Capriccio Therapeutics、RION、Lonza 和 Evox Therapeutics 等公司的交易）越來越以里程碑式的契約結構為特徵，契約金額高達 10 億美元，這反映了大型製藥企業在進行昂貴的後期臨床試驗之前，努力確保自己的遞送平台和生產能力。

全球外泌體市場

報告－為了分析這個快速成熟的產業，BioInformant發布了這份長​​達384頁的全球策略報告。該報告考察了以下細分市場的需求：

• 研究產品
• 開發和製造
• 診斷和治療
• 醫學美容
• 即用型外泌體

這些細分市場目前已在全球創造了可觀的收入，預計未來幾年將實現顯著成長。本報告說明了各細分市場截至2034年的詳細、精確數據和預測。目前，科學研究產品仍是最大的細分市場，醫療和美容產品緊隨其後，並且是近期收入成長最快的細分市場。診斷產品是成長最快的細分市場，其成長速度尤其迅猛，尤其是在其目前小規模的基數基礎上。另一方面，隨著首批獲批產品上市，治療產品有望迎來快速成長。從區域來看，北美在全球銷售佔有率中佔主導地位，其次是歐洲，然後是亞太地區。亞太地區的成長主要得益於中國在全部區域總銷售額中佔的壓倒性佔有率。

本報告詳細介紹了涵蓋外泌體市場的135家全球競爭對手。這些公司包括研究工具供應商，如賽默飛世爾科技、凱傑和Bio-Techne；臨床階段創新企業，如Capriccio Therapeutics、Evox Therapeutics和Aruna Bio；以及美容市場領導企業，如ExocoBio、Lyon Aesthetics和嵌合體 Labs。

目前，外泌體產業呈現以下發展趨勢：

• 研究外泌體及其應用的科學論文數量正在迅速增加。
• 越來越多的臨床試驗正在檢驗利用外泌體進行治療和診斷的方法。
• 投資者對外泌體技術的興趣日益濃厚
• 日益激烈的智慧財產權（IP）環境
• 多元化的合作發展夥伴關係
• 在全球主要生命科學市場中，與外泌體相關的競爭者數量正在迅速增加。

本報告闡明了以下幾點：

• 利用外泌體開發治療和診斷藥物的臨床開發平臺
• 按階段、地區、適應症和申辦方分類的臨床試驗趨勢
• 按司法管轄區、權利人及創新領域分類的專利趨勢
• 產業併購趨勢、資金籌措案例和策略聯盟
• 全球外泌體市場競爭對手的詳細概況
• 六大細分市場到 2034 年的市場規模估算與預測。
• 關鍵產業趨勢、競爭機會與未來展望

全球市場競爭異常激烈，您可能沒有時間自行進行市場調查。取得這份報告，即可立即掌握最新資訊，無需耗費大量時間進行研究，也不會錯過任何關鍵機會。

關於BioInformant：BioInformant是一家擁有超過19年經驗的美國市場研究公司，每年讀者近百萬家。作為第一個也是唯一一家專注於幹細胞產業的市場研究公司，BioInformant的研究成果被「華爾街日誌」、AABB和「Vogue」等知名刊物引用。 BioInformant總部位於華盛頓特區，其戰略位置毗鄰美國國立衛生研究院（NIH）、美國食品藥物管理局（FDA）、馬裡蘭州生物技術走廊以及國會位置的政策制定者，這為其發展提供了得天獨厚的優勢。

如「調查方法」部分所述，本報告的內容是利用各種資訊來源彙編而成的。

Exosomes are extracellular vesicles (EVs) of endosomal origin that range in size between 30 and 150 nanometers. Exosomes are secreted by a wide range of cells, since virtually all living cells utilize exosome-mediated communication. Exosomes carry cell-specific cargos of proteins, lipids, and nucleic acids that are selectively taken up by recipient cells.

Exosome technologies have been developing rapidly in recent years and substantial growth is expected for the market as they get integrated into the fields of liquid biopsy, precision medicine and regenerative medicine. In particular, cancer derived exosomes influence the invasive potential of cells by regulating angiogenesis, metastasis, and immunity, making them an extremely useful source of biomarkers for use in cancer detection, diagnosis, and therapeutic selection.

The cargo contained within exosomes can offer prognostic information for range of diseases-including cardiovascular, renal, neurodegenerative, and metabolic diseases-as well as cancer. Researchers investigating exosome biomarkers have discovered, identified, and reported the presence of hundreds of biomolecules within the lumen of exosomes. This discovery has compelled a rapid rise in exosome-related cancer biomarker research, including the use of exosomes for the detection, monitoring, and treatment of a diverse range of oncologic conditions.

Importantly, exosomes are present within a diverse range of biofluids, including serum, plasma, urine, seminal fluid, CSF, saliva, tears and breast milk. For this reason, exosome-based diagnostics are minimally invasive, offering ease of use and speed of detection. Exosomes can also act as prognostic indicators and predictors of a patient’s response to a specific course of treatment.

Exosomes are also being explored for their use as cell-free therapeutics. For example, if a patient has a disease caused by a missing or defective protein or microRNA, the patient’s exosomes can be isolated, modified with the appropriate siRNA or protein, and injected back into the patient for treatment. Numerous approaches are being researched for creating drug-loaded exosomes and exosomes themselves can exert powerful effects. For example, mesenchymal stem cell (MSC) derived exosomes have the capacity to suppress inflammation, prevent scar tissue formation, and mediate a healthy immune response.

Additionally, there has also been tremendous growth in the number of exosome scientific publications, patents (intellectual property), and clinical trials in recent years.

Finally, exosomes are now being used in a diverse range of applications, including:

• 1. Diagnostics: Biomarkers for disease detection
• 2. Regenerative Medicine: Cell-free therapeutics being leveraged for tissue repair, wound healing, and reversal of disease
• 3. Drug Delivery: Vehicles for targeted therapeutic delivery
• 4. Research Products: Tools for studying cell communication and disease mechanisms
• 5. Dermatology and Aesthetics: Wound repair, skin rejuvenation, anti-aging treatments, and hair restoration.
• 6. Emerging Applications: Exosome vaccines, immunotherapies (leveraging exosomes from activated T cells or NK cells), veterinary medicine, agricultural applications (plant-derived exosomes), and beyond.

Global Exosome Market

The science is scaling fast. Today, researchers have catalogued more than 119,000 exosome-associated protein entries in dedicated databases like ExoCarta, and a single exosome can carry anywhere from a few dozen to 1,000–2,000 distinct proteins reflecting the physiological state of its parent cell. As of June 2026, PubMed.gov indexes 44,211 published papers on exosome research - up from just 282 in 2010, with annual output alone reaching 6,304 papers in 2025. Asia/Pacific now produces 52% of global exosome publications, followed by Europe (28%) and the United States (20%), though the U.S. retains the highest citation impact and remains the top country for clinical translation.

Harvard University leads all institutions by publication volume and citation impact, with Karolinska Institutet a leading center for therapeutic applications. Patent activity has grown just as sharply, from 8 filings in 2000 to 1,921 in 2025, with the United States (22,120 total filings), WIPO, and China as the leading jurisdictions. Clinical development has kept pace: 579 exosome-related trials are now registered globally, led by the United States (149 trials) and China (138), with oncology representing roughly 30% of the therapeutic pipeline.

No exosome-based therapeutic or diagnostic has yet received full FDA approval, but that is poised to change. One of the most closely watched programs in this space is Capricor Therapeutics’ Deramiocel (CAP-1002) for Duchenne Muscular Dystrophy (DMD) cardiomyopathy. Deramiocel is administered as a cell therapy, allogeneic cardiosphere-derived cells (CDCs), but its proposed mechanism of action is exosome-mediated: the CDCs work by secreting exosomes that shift macrophages from a pro-inflammatory to a healing phenotype. The FDA granted Deramiocel Priority Review, but a July 2026 advisory committee voted 9–3 against recommending approval for the original cardiomyopathy indication. In response, Capricor submitted additional Phase 3 HOPE-3 data and narrowed its proposed indication to preservation of upper-limb function; the FDA has since extended its target action (PDUFA) date to November 22, 2026.

On the diagnostics side, two tests already operate as CLIA-certified Laboratory Developed Tests: the ExoDx Prostate IntelliScore (EPI), now under MDxHealth following its 2025 divestiture from Bio-Techne, and ExoTRU, a kidney transplant-rejection assay from Bio-Techne/Thermo Fisher Scientific.

The industry is also seeing intensifying investment and dealmaking activity. Venture capital funding into exosome-focused companies has mobilized close to $600 million since 2010, with roughly $155 million raised between 2023 and mid-2026 alone across notable rounds such as EXO Biologics’ $18.7 million Series A, Annie Aesthetic Holdings’ $65 million Series B, and PranaX Corporation’s $17 million Series A. Strategic acquisitions are consolidating the space as larger players move to secure diagnostic and technology platforms - most notably MDxHealth’s purchase of Exosome Diagnostics (and its ExoDx Prostate test) from Bio-Techne for $15 million, ExoCoBio’s acquisition of majority ownership in BENEV to expand global aesthetic distribution, and Evox Therapeutics’ acquisition of Codiak Biosciences’ engineered exosome technology platform.

Meanwhile, licensing and partnership activity between biopharma and exosome innovators - including deals involving Capricor Therapeutics, RION, Lonza, and Evox Therapeutics - increasingly features milestone-based structures reaching up to $1 billion, reflecting how major pharmaceutical players are moving to lock in proprietary delivery platforms and manufacturing capacity ahead of costly late-stage clinical trials.

Global Exosome Market Report

To characterize this rapidly maturing industry, BioInformant has released this global strategic report - now spanning 384 pages - exploring demand across these distinct market segments:

• Research Products
• Development & Manufacturing
• Diagnostics, Therapeutics
• Medical Aesthetics
• Ready-to-Use Exosomes

Collectively, these segments are already generating substantial global revenue and are on track for dramatic multi-year expansion, with the report detailing precise figures and forecasts for each segment through 2034. Research Products remains the largest segment currently, while Medical Aesthetics ranks a close second and is the fastest-growing segment in immediate revenue terms. Diagnostics is the fastest-growing segment by percentage, expanding at an especially steep rate off a small current base, while Therapeutics is poised for a sharp inflection point as the first approved products reach the market. Geographically, North America commands the largest share of global revenue by a wide margin, followed by Europe, with Asia-Pacific close behind - led overwhelmingly by China’s outsized share of the regional total.

The report features in-depth profiles of 135 global competitors spanning the exosome marketplace, from research-tool suppliers like Thermo Fisher Scientific, QIAGEN, and Bio-Techne to clinical-stage innovators like Capricor Therapeutics, Evox Therapeutics, and Aruna Bio, and aesthetic-market leaders like ExoCoBio, Rion Aesthetics, and Kimera Labs.

Today the exosome industry is witnessing:

• A surging number of scientific papers investigating exosomes and their applications
• Rising numbers of clinicals trials investigating exosome therapeutics and diagnostics
• Swelling appetite among investors for exosome technology
• An increasingly competitive IP environment
• A diverse range of co-development partnerships
• Proliferating numbers of exosome competitors in all major life science markets worldwide

This report reveals:

• The clinical pipeline for exosome therapeutics and diagnostics
• Clinical trial activity by phase, geography, application, and sponsor
• Patent landscape trends by jurisdiction, assignee, and domain of innovation
• Industry M&A activity, financing events, and strategic partnerships
• Detailed profiles of competitors from across the global exosome marketplace
• Market size determinations across six segments, with forecasts through 2034
• Key industry trends, competitive opportunities, and future outlook

With the competitive nature of this global market, you don’t have the time to do the research yourself. Claim this report to become immediately informed, without sacrificing hours of research or missing critical opportunities.

About BioInformant

With an online readership of nearly one million viewers per year, BioInformant is a U.S. market research firm with 19+ years of experience. As the first and only market research firm to specialize in the stem cell industry, BioInformant research has been cited by the Wall Street Journal, AABB, and Vogue Magazine. Headquartered in Washington, DC, BioInformant is strategically positioned to be near the National Institutes of Health (NIH), the U.S. FDA, the Maryland Biotech Corridor, and policy makers on Capitol Hill.

The content within this report was compiled using a diverse range of sources, as described in this Research Methodology.

View Table of Contents: The Global Exosome Market – Market Size, Forecasts, Trials and Trends, 2026