The exosome therapies market is expected to experience significant growth due to increased interest in regenerative medicine, cancer treatments, and drug delivery systems. Leading Indications with therapies in the late stage of development are DMD, ALS, ADRS, and DFUs, are expected to drive the exosomes market. As exosomes offer targeted, less invasive treatment options, demand is projected to rise, with market value expected to expand substantially over the next decade.
LAS VEGAS, Jan. 13, 2025 -- DelveInsight's Exosome Therapies Market Insights report includes a comprehensive understanding of emerging exosome therapies, market share of individual therapies, and forecasted exosome therapies market size uptil 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].
Key Takeaways from the Exosome Therapies Market Report
- As per DelveInsight's analysis, the exosome therapies market size in the 7MM is expected to grow at a considerable CAGR by 2034.
- In terms of the overall pipeline, there are more than 100 exosome therapies in different phases of development including Phase III, Phase II, Phase I, Preclinical, and Discovery phase, with roughly 15+ human trials.
- Leading late and mid-stage companies such as Direct Biologics, Capricor Therapeutics, BrainStorm Cell Therapeutics, Rion, and OBCTCD24 are expected to enter the exosome therapy market in the coming years.
- Multiple early-stage players such as Aegle Therapeutics, ZEO ScientifiX, StemXO Therapeutics, Codiak BioSciences, Vitti Labs, Aruna Bio, EXO Biologics, EV Therapeutics, ReNeuron, Coya Therapeutics, Evox Therapeutics, and others are also developing novel exosome therapies Some of the key exosome therapies in the pipeline include CAP-1002, ExoFlo, Debamestrocel, PEP (Purified Exosome Product) –TISSEEL, AGLE-102, VL-PX10, AB126, EV101, COYA 201, and others.
- Recently in January 2025, NurExone Biologic announced that it has acquired a master cell bank from a U.S. manufacturer, this Acquisition marks a major step in ensuring a stable and scalable supply chain for the production of exosome-based therapies for clinical needs and eventual patient treatment.
- In July 2024, Aruna Bio announced the issuance of a US Patent for the composition of matter for neural exosomes used to deliver therapeutics to the brain.
- In July 2024, ILIAS Biologics announced that they have received the final clinical study report (CSR) for ILB-202, from a Phase I clinical trial completed in Australia in November last year.
- In April 2024, Biological Dynamics joined the growing list of customers adopting the ExoVerita Pro instrument, a cost-efficient, automated exosomal enrichment platform.
- In April 2024, EXO Biologics secured up to EUR 16 million in Series A funding for exosome therapeutic development and clinical supply.
- In April 2024, ExoXpert entered a strategic partnership with Neucore Bio to leverage ExoXpert's platform for the evaluation of advanced exosome loading.
- In April 2024, INOVIQ and Promega signed a global supply and distribution agreement for EXO-NET. Last year's company entered into a Co-Marketing agreement.
- In March 2024, VivaZome Therapeutics and La Trobe University collaborated to explore the therapeutic potential of extracellular vesicles in models of stroke in the laboratory of Professor Chris Sobey.
Discover which therapies are expected to grab the exosome therapies market share @ Exosome Therapies Market Report
Exosome Therapies Market Dynamics
The exosome therapy market is emerging as a dynamic sector within the biopharmaceutical industry, driven by significant advancements in understanding the role of exosomes in intercellular communication and their therapeutic potential. One of the key drivers of market growth is the rising prevalence of chronic diseases and the demand for more effective treatment modalities. Traditional therapies often face challenges such as limited efficacy and adverse side effects, prompting a shift toward innovative approaches like exosome-based therapies.
The ability of exosomes to facilitate targeted delivery and modulate immune responses enhances their appeal in treating complex diseases. Additionally, advancements in isolation and characterization techniques are improving the scalability and reproducibility of exosome production, which is crucial for commercial viability.
Despite its potential, the exosome therapy market also faces several challenges. Regulatory hurdles remain a significant concern, as the regulatory frameworks for cell-based therapies and advanced medicinal products are still evolving. Ensuring the safety and efficacy of exosome therapies through rigorous clinical trials is paramount, but the complexity of exosome biology poses difficulties in standardization and quality control. Furthermore, the market is becoming increasingly competitive, with numerous biotech companies and academic institutions entering the field, leading to a surge in research and development activities.
Partnerships and collaborations between academic institutions and pharmaceutical companies are becoming increasingly common to accelerate the development of exosome therapies. These collaborations aim to leverage the strengths of both parties—academic research capabilities and pharmaceutical development expertise—to bring innovative products to market more efficiently. Moreover, as the understanding of exosome biology expands, new therapeutic applications are likely to emerge, broadening the scope of exosome therapies beyond current indications and further stimulating market growth.
In conclusion, the exosome therapy market is poised for significant expansion, driven by technological advancements, increasing disease prevalence, and growing investment in research. While challenges remain, the ongoing innovation and collaborative efforts within the field suggest a promising future for exosome-based therapies as they move from bench to bedside, offering new hope for patients suffering from a variety of conditions.
Exosome Therapies Treatment Market
Exosome-based therapies represent a rapidly evolving field of research with the potential to transform various medical domains, such as drug delivery, regenerative medicine, and diagnostic methods. The effectiveness of exosomes is entirely reliant on the origin of the donor cells, which can have either beneficial or harmful effects. In regenerative medicine, particularly with incubated cell preparations, exosome research shows potential as a therapy that could modify diseases, particularly for autoimmune disorders. However, it is crucial to note that exosome therapies are not yet approved by the FDA, and their application should be restricted to research protocols or FDA Biologics License Applications.
Several therapies are presently in the pre-clinical development phase for various respiratory and autoimmune conditions. Due to their ability to target similar cells and recognize themselves, exosomes and their hybrid systems are gaining attention as viable alternatives to traditional drug carriers. These materials hold promise for a range of applications, such as chemotherapy, gene therapy, and photothermal therapy. Furthermore, multifunctional exosomes can be developed by loading multiple therapeutic agents at the same time.
Learn more about the anticipated leading exosome therapies @ Exosome Therapies
Key Emerging Exosome Therapies and Companies
Some of the drugs in the pipeline include CAP-1002 (Capricor), ExoFlo (Direct Biologics), and AGLE-102 (Aegle Therapeutics) among others.
CAP-1002 (deramiocel) is composed of cardiosphere-derived cells, which are precursor cells that generate heart cells and produce small vesicles known as exosomes. These exosomes play a role in regulating immune system activity and promoting cellular regeneration. The drug is currently undergoing Phase III clinical trials for treating Duchenne muscular dystrophy.
In August 2024, Capricor Therapeutics announced a successful pre-BLA meeting with the FDA that took place in the third quarter of 2024. Furthermore, Capricor shared encouraging results from the 36-month follow-up of the HOPE-2 OLE study at the Parent Project Muscular Dystrophy (PPMD) Annual Conference. The Phase III HOPE-3 trial for deramiocel in DMD is fully enrolled and is expected to provide top-line results from Cohort A in the fourth quarter of 2024.
ExoFlo is an extracellular signal product derived from human bone marrow mesenchymal stem cells (MSCs) and is rich in growth factors and extracellular vesicles, including exosomes. Direct Biologics is currently running the global Phase III EXTINGUISH ARDS clinical trial to evaluate ExoFlo for treating hospitalized adults with moderate to severe ARDS. Furthermore, the company has begun Phase I clinical trials of ExoFlo for ulcerative colitis and Crohn's disease, as well as expanded access trials for solid abdominal organ transplantation and severe ARDS patients.
AGLE-102 comprises COL7 protein and COL7A1 mRNA, which has been shown in preclinical models to stimulate Recessive Dystrophic Epidermolysis Bullosa (RDEB) cells, which cannot produce COL7, to generate it. This therapy has the potential to promote functional regeneration and the organization of complex tissue structures in patients with dystrophic epidermolysis bullosa and epidermolysis bullosa, potentially speeding up healing, minimizing scarring, and enhancing overall appearance.
Furthermore, AGLE-102 is non-immunogenic and possesses the immunomodulatory and anti-inflammatory properties associated with mesenchymal stem cells (MSCs). Aegle's Phase I/II clinical trial of AGLE-102 for individuals with RDEB is currently open for enrollment.
The anticipated launch of these emerging therapies are poised to transform the exosome therapies market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the exosome therapies market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
To know more about exosome therapies clinical trials, visit @ Exosome-based Therapies
Exosome Overview
Extracellular vesicles (EVs) act as carriers for transferring various molecules, including proteins, lipids, DNA, RNA, and miRNAs, between cells. They play a role in many physiological and pathological processes, such as the elimination of unwanted proteins, antigen presentation, genetic exchange, immune response, angiogenesis, inflammation, tumor metastasis, and the spread of pathogens or oncogenes.
The two most researched types of EVs are exosomes and microvesicles (MVs). Exosomes are nano-sized extracellular particles produced naturally by all cells and can be engineered to deliver therapies specifically to targeted cells. Recent research has emphasized the role of exosomes in modulating immune responses and their significant potential as biomarkers for autoimmune disease detection.
While exosome technology is still in its early stages clinically, it is emerging as a novel drug delivery system that is beginning to enter clinical applications. Currently, EVs are being studied for various therapeutic and diagnostic purposes.
Exosome Therapies Epidemiology Segmentation
In 2023, in the US, DMD cases were predominantly caused by large mutations, followed by small mutations, with the least cases attributed to point mutations. It has been observed that within a year, 5–10% of the patients with mild atopic dermatitis progress to moderate/severe. The exosome therapies market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:
- Total Prevalent Cases of Selected Indications for Exosome Therapy
- Total Eligible Patient Pool for Exosome Therapy in Selected Indications
- Total Treated Cases in Selected Indications for Exosome Therapy
Exosome Therapies Report Metrics | Details |
Study Period | 2025–2034 |
Exosome Therapies Report Coverage | 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] |
Key Exosome Therapies Companies | Direct Biologics, Capricor Therapeutics, BrainStorm Cell Therapeutics, Aegle Therapeutics, Vitti Labs, Rion, Aruna Bio, EXO Biologics, EV Therapeutics, ReNeuron, Coya Therapeutics, Evox Therapeutics, and others |
Key Exosome Therapies | CAP-1002, ExoFlo, Debamestrocel PEP (Purified Exosome Product) –TISSEEL, AGLE-102, VL-PX10, AB126, EV101, COYA 201, and others |
Scope of the Exosome Therapies Market Report
- Exosome Therapies Therapeutic Assessment: Exosome emerging therapies
- Insights on Patient burden: Understanding the treatable patient pool
- Exosome Therapies Market Dynamics: Conjoint Analysis of Emerging Exosome Therapies
- Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
- Unmet Needs, KOL's views, Analyst's views, Exosome Therapies Market Access and Reimbursement
Discover more about exosome therapies in development @ Exosome Therapies Clinical Trials
Table of Contents
1 | Key Insights |
2 | Report Introduction |
3 | Key Highlights |
4 | Executive Summary of Exosome Therapy |
5 | Key Events |
6 | Eligible Patient Pool and Market Forecast Methodology |
7 | Exosome Therapy Market Overview at a Glance in the 7MM |
7.1 | Market Share (%) Distribution by Therapies in 2028 |
7.2 | Market Share (%) Distribution by Therapies in 2034 |
8 | Background and Overview |
8.1 | Introduction |
8.2 | Existing Treatment in Potential Indications |
9 | Target Patient Pool |
9.1 | Key Findings |
9.2 | Assumptions and Rationale: 7MM |
9.3 | Epidemiology Scenario in the 7MM |
9.3.1 | Total Cases of Selected Indications for Exosome Therapy in the 7MM |
9.3.2 | Total Eligible Patient Pool for Exosome Therapy in Selected Indications in the 7MM |
9.3.3 | Total Treated Cases in Selected Indications for Exosome Therapy in the 7MM |
10 | Emerging Drugs |
10.1 | Key Competitors |
10.2 | CAP-1002: Capricor Therapeutics |
10.2.1 | Product Description |
10.2.2 | Other developmental activity |
10.2.3 | Clinical developmental activities |
10.2.3.1 | Clinical trial information |
10.2.4 | Safety and efficacy |
10.3 | ExoFlo: Direct Biologics |
10.3.1 | Product Description |
10.3.2 | Other developmental activity |
10.3.3 | Clinical developmental activities |
10.3.3.1 | Clinical trial information |
10.3.4 | Safety and efficacy |
10.4 | AGLE-102: Aegle Therapeutics |
10.4.1 | Product Description |
10.4.2 | Other developmental activity |
10.4.3 | Clinical developmental activities |
10.4.3.1 | Clinical trial information |
10.4.4 | Safety and efficacy |
*List to be continued in the full report | |
11 | Exosome Therapy: 7MM analysis |
11.1 | Key Findings |
11.2 | Market Outlook |
11.3 | Conjoint Analysis |
11.4 | Key Market Forecast Assumptions |
11.4.1 | Cost Assumptions and Rebates |
11.4.2 | Pricing Trends |
11.4.3 | Analogue Assessment |
11.4.4 | Launch Year and Therapy Uptakes |
11.5 | United States Market Size |
11.5.1 | Market Size by Indications in the US |
11.5.2 | Market Size by Therapies in the US |
11.6 | EU4 and the UK Market Size |
11.6.1 | Market Size by Indications in EU4 and the UK |
11.6.2 | Market Size by Therapies in EU4 and the UK |
11.7 | Japan Market Size |
11.7.1 | Market Size by Indications in Japan |
11.7.2 | Market Size by Therapies in Japan |
12 | Unmet Needs |
13 | SWOT Analysis |
14 | KOL Views |
15 | Market Access and Reimbursement |
16 | Appendix |
16.1 | Bibliography |
16.2 | Report Methodology |
17 | DelveInsight Capabilities |
18 | Disclaimer |
19 | About DelveInsight |
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