Bio-Techne
Bio-Techne stands as a pivotal global leader in the exosome diagnostics market, primarily due to its strategic acquisition of Exosome Diagnostics Inc. in 2018. This move solidified its dominance, making it one of the few companies currently offering commercial, exosome-based diagnostic tests. Its flagship product, the ExoDx Prostate (EPI) Test, is a groundbreaking, non-invasive liquid biopsy used for the risk assessment of prostate cancer. This test leverages exosome technology to analyze biomarkers found in urine, offering clinicians a precise tool for early-stage risk stratification without the need for invasive procedures. Beyond this commercial success, Bio-Techne provides an extensive portfolio of research reagents and tools essential for exosome isolation, characterization, and analysis, supporting researchers worldwide in both academic and pharmaceutical settings. The company’s continued focus on translating exosome research into reliable clinical products reinforces its position at the forefront of precision diagnostics, driving the integration of this technology into mainstream clinical practice.
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Evox Therapeutics
Evox Therapeutics, headquartered in Oxford, UK, is recognized as a leader in the exosome therapeutics space, focusing on engineering exosomes for the treatment of severe rare genetic diseases. The company’s core innovation is the proprietary DeliverEX® platform, which is designed to overcome the critical challenge of delivering complex biologics, such as RNA interference (RNAi) and gene-editing tools, across hard-to-reach biological barriers, particularly the blood-brain barrier (BBB) for central nervous system (CNS) disorders. DeliverEX enables the customization of exosome membranes to enhance drug loading, targeting efficiency, and systemic delivery capability. This innovative approach has positioned Evox to address limitations faced by traditional gene therapies and conventional delivery vehicles. Evox has secured significant partnerships, including a multi-program collaboration with Eli Lilly, to leverage its platform for developing targeted therapies. By focusing on creating safe, repeatable, and non-immunogenic drug delivery systems, Evox aims to transform the treatment landscape for life-limiting conditions.
Codiak BioSciences
Codiak BioSciences is a pioneering biotechnology company dedicated to establishing an entirely new class of medicines known as exosome therapeutics. Founded in 2015, the company focuses on engineering exosomes for targeted drug delivery, concentrating on critical areas such as oncology, neurological diseases, and vaccine development. Codiak’s proprietary engEx platform allows for the precise customization of exosomal surfaces, payloads, and targeting moieties, transforming naturally occurring extracellular vesicles into highly sophisticated therapeutic delivery systems. This technology enables the company to load therapeutic agents, including proteins and nucleic acids, and direct them specifically to diseased tissues while sparing healthy ones. Codiak has successfully advanced multiple candidates into early clinical trials, demonstrating the potential of engineered exosomes to deliver drugs efficiently to traditionally difficult-to-reach sites like solid tumors and brain regions affected by neurodegenerative disorders. Their work underscores a fundamental belief in the power of exosomes to revolutionize drug delivery and treatment efficacy.
Aegle Therapeutics
Aegle Therapeutics Corp. is a clinical-stage biopharmaceutical company based in Miami, Florida, specializing in developing novel extracellular vesicle (EV) therapies, including exosomes, derived from allogeneic bone marrow mesenchymal stem cells (BM-MSCs). Aegle’s mission is to harness the inherent regenerative, immunomodulatory, and anti-inflammatory properties of these vesicles to address severe dermatological disorders with high unmet medical needs, such as burns and epidermolysis bullosa (a rare pediatric connective tissue disorder). Their lead product candidate, AGLE-102, is a therapeutic composite of EVs that has progressed into Phase 1/2a clinical studies. This therapy is designed to promote tissue repair and reduce inflammation, translating the natural functions of MSC-derived exosomes into clinical benefits. Aegle’s focus on using cell-free biologics for tissue regeneration highlights its pioneering role in advancing exosome therapies from the lab to human clinical trials for challenging skin conditions.
Capricor Therapeutics
Capricor Therapeutics is a clinical-stage biotechnology company focused on the discovery, development, and commercialization of transformative cell and exosome-based therapeutics for rare disorders, notably Duchenne muscular dystrophy (DMD). While initially known for cardiac cell therapy, Capricor significantly expanded its focus to leverage the potent paracrine signaling of exosomes isolated from its proprietary cardiosphere-derived cells (CDCs). These CDC-derived exosomes (CAP-2003) are rich in microRNAs and bioactive factors that modulate inflammation and fibrosis. Furthermore, Capricor has developed the proprietary StealthX exosome platform, which enables designer protein surface expression, efficient cargo loading, and targeted delivery. This technology is being deployed in two modalities: precision therapeutics for genetic diseases and vaccinology. A key application is their exosome-based multivalent vaccine candidate for the prevention of SARS-CoV-2, demonstrating the platform’s versatility across regenerative medicine and infectious disease prophylaxis.
Aruna Bio
Aruna Bio, based in Atlanta, Georgia, is forging a unique path in exosome therapeutics by focusing exclusively on neural-derived exosomes. The company leverages the intrinsic ability of these exosomes, derived from neural stem cells, to naturally cross the blood-brain barrier (BBB). This innate CNS-homing capability positions Aruna to unlock transformative treatments for neurological conditions, where conventional drug delivery methods often fail due to insufficient brain penetration. Aruna’s lead clinical program, AB126, is under development for acute ischemic stroke, a condition with severely limited treatment options. Beyond stroke, the company is utilizing its platform as a precision delivery system for various therapeutic payloads—including RNA, small molecules, and gene-editing tools—aimed at neurodegenerative diseases such as ALS and multiple sclerosis (MS). By concentrating on neurotherapeutics and capitalizing on the natural delivery mechanism of neural exosomes, Aruna Bio provides a distinctive advantage in addressing intractable CNS disorders.
ILIAS Biologics
ILIAS Biologics is a clinical-stage biotech company specializing in the development of engineered exosome therapeutics, distinguished by its proprietary loading platform technology, EXPLOR (Exosome engineering for Protein Loading via Optically Reversible protein-protein interaction). The company’s core competency lies in overcoming a major challenge in exosome therapy: efficiently loading large therapeutic payloads, such as high molecular weight proteins, into exosomes without compromising their structural integrity or function. The EXPLOR platform enables the systematic and scalable manufacturing of engineered exosomes with therapeutic proteins encased inside. This technology is designed to maximize the therapeutic potential of exosomes for systemic drug delivery. ILIAS Biologics successfully completed a Phase 1 clinical trial in Australia for its candidate ILB-202, marking the world’s first systemic administration clinical trial for an engineered exosome therapeutic, positioning the company as a global pioneer in delivering complex biologics via engineered extracellular vesicles.
EXO Biologics
EXO Biologics is a clinical-stage pioneer in developing and manufacturing exosome-based therapies, utilizing a “Triple Axis Strategy” focused on rare inflammatory diseases and advancing drug delivery solutions. The company is maximizing the therapeutic potential of exosomes by enabling them to be loaded with specific therapeutic molecules. A critical component of EXO Biologics’ offering is its CDMO subsidiary, ExoXpert, which became the first European CDMO specializing in exosomes to receive Good Manufacturing Practice (GMP) certification for its state-of-the-art manufacturing facility. This certification validates the company’s capability for large-scale, standardized production of high-quality exosomes. Furthermore, EXO Biologics achieved a major milestone by successfully loading GMP-grade exosomes with mRNA and DNA payloads, significantly accelerating the development of exosome-based gene therapies. Their focus on both proprietary therapeutics and reliable CDMO services solidifies their role as a leading innovator in exosome commercialization and clinical development.
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