Exosome Diagnostic and Therapeutics Market Outlook:
Exosome Diagnostic and Therapeutics Market size was valued at USD 1.6 billion in 2024 and is projected to reach USD 9.3 billion by the end of 2037, rising at a CAGR of 18.8% during the forecast period, 2025 to 2037. In 2025, the industry size of exosome diagnostic and therapeutics is estimated at USD 1.7 billion.
The increasing adoption of liquid biopsy technologies, escalating demand for cancer diagnostics and therapeutic applications in regenerative medicine, are readily bolstering market growth internationally. In this context, an article in the National Institute of Health estimates 2.2 million new cancer cases in 2025 in the U.S., whereas the World Health Organization notes 55.6 million global dementia cases, creating a huge demand for exosome-based diagnostics and therapeutics. Besides, the National Cancer Institute states that the market is further propelled by the adoption of non-invasive diagnostics, with liquid biopsies serving 14% to 25% of oncology patients by 2030.
Furthermore, the global trade aspect in the worldwide market is effectively dominated by the U.S., Germany, and China, with the U.S. yearly importing over USD 120 million worth of bioreactor components revealed by the ITA data. On the other hand, Asia Pacific, especially India and South Korea, are emerging as cost-optimized manufacturing hubs for reagents, diminishing the high production costs. Moreover, assembly line automation is also reducing production costs, with 60% of large-scale manufacturers adopting closed-system bioreactors, thereby creating a positive impact on the market.
Exosome Diagnostic and Therapeutics Market - Growth Drivers and Challenges
Growth Drivers
- Improvement and cost-effectiveness in healthcare quality: There has been a constant shift in evidence-based treatment protocols that is significantly uplifting the market. In this context, a study was published by AHRQ in 2022 that found exosome-based liquid biopsies for early cancer detection reduced hospitalizations by 23.5%, thus saving USD 1.9 billion in health and medical costs in the U.S. within two years. Besides the Breakthrough Device Program by the FDA, accelerated approvals for over 5 exosome diagnostic tests since 2023, improving diagnostic accuracy by 35.4% when compared to traditional procedures.
- Industry partnerships and innovations: This kind of activities in the market denotes an optimistic opportunity for the players across all nations. For instance, in 2024, Thermo Fisher Scientific announced a partnership with Mayo Clinic to commercialize exosome-based Alzheimer’s diagnostics, grabbing a 16.4% market share in the neurology sector. On the other hand, Bio-Techne in 2023 launched an automated exosome isolation system that reduces processing costs by 32% thus suitable for market upliftment.
Historical Patient Growth Analysis: Exosome Diagnostic and Therapeutics Users (In Millions)
|
Country |
2010 |
2015 |
2020 |
CAGR (2010-2020) |
|
U.S. |
0.27 |
0.74 |
1.87 |
22.2% |
|
Germany |
0.12 |
0.32 |
0.97 |
28.1% |
|
France |
0.07 |
0.24 |
0.71 |
29.9% |
|
Spain |
0.05 |
0.13 |
0.43 |
30.3% |
|
Australia |
0.05 |
0.21 |
0.32 |
27.6% |
|
Japan |
0.14 |
0.47 |
1.22 |
26.2% |
|
India |
0.06 |
0.31 |
1.07 |
38.8% |
|
China |
0.17 |
0.82 |
2.52 |
32.5% |
Feasible Expansion Models Shaping the Exosome Diagnostic and Therapeutics Market
|
Strategy |
Region |
Impact (2022-2024) |
|
Local OEM Partnerships |
India |
13.6% Revenue Increase |
|
HTA-Led Reimbursement |
Germany |
€225 Million New Coverage |
|
Tiered Pricing Models |
China |
32% Cost Reduction |
|
FDA Fast-Track |
U.S. |
17% Faster Approvals |
Challenges
- Prohibitive production costs: Despite the presence of a reliable consumer base, the market still faces obstacles in terms of GMP-compliant manufacturing, which presents financial hurdles. Exemplifying the same, U.S. FDA 2023 data reveals that clean room facilities cost USD 14 million to USD 22 million to establish, further adding expenses on manufacturers. Besides, the small batch production imposes USD 210,000, making scalability challenging for almost all companies. Furthermore, Lonza’s automated Swiss facility necessitated USD 62 million in upfront investment, restricting profitability.
- Patient affordability barriers: The aspect of affordability is yet another factor negatively influencing the market progress in almost all nations. In this regard ICMR report in 2023 stated that in India, AIMS observed that 86.5% of eligible patients cannot afford USD 1,600 exosome tests. Similarly, in Germany, 26.4% of prescribed tests remain unfilled owing to the copay requirements. However, the tiered pricing model implemented by Qiagen improved access by 18.6%.
Exosome Diagnostic and Therapeutics Market Size and Forecast:
| Report Attribute | Details |
|---|---|
|
Base Year |
2024 |
|
Forecast Year |
2025-2037 |
|
CAGR |
18.8% |
|
Base Year Market Size (2024) |
USD 1.6 billion |
|
Forecast Year Market Size (2037) |
USD 9.3 billion |
|
Regional Scope |
|
Exosome Diagnostic and Therapeutics Market Segmentation:
Type Segment Analysis
Based on type, the therapeutics segment is anticipated to garner the highest share of 62.4% in the exosome diagnostic and therapeutics market during the forecast timeline. Advancements in drug delivery and growing clinical trials are the key factors propelling the dominance of the segment. Testifying to this NIH study in 2023 stated that exosome-based therapeutics offer targeted drug delivery with reduced side effects, especially in cancer and neurodegenerative applications. On the other hand, over 200 exosome-based clinical trials are in the pipeline, with firms such as Codiak BioSciences and Evox Therapeutics leading in exosome-engineered therapies, thus denoting a wider segment scope.
Application Segment Analysis
In terms of application oncology segment is expected to attain a lucrative share of 38.3% in the market by the end of 2037. The segment’s growth originates from its therapeutic potential in immunotherapy and the rising instances of cancer among the worldwide population. The tumor-derived exosomes can be engineered to deliver anticancer drugs or stimulate immune responses, thereby enhancing treatments such as CAR-T therapy. Further, the WHO projection of 30 million new cancer cases by the end of 2030 will create a heightened demand for advanced procedures.
Our in-depth analysis of the global exosome diagnostic and therapeutics market includes the following segments:
|
Segment |
Subsegment |
|
Type |
|
|
Application |
|
|
End User |
|
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Exosome Diagnostic and Therapeutics Market - Regional Analysis
North America Market Insights
North America is projected to remain dominant in the exosome diagnostic and therapeutics market with a share of 42.4% during the forecast timeline. The region’s dominance is effectively attributed to strong R&D investments, advanced healthcare infrastructure, and supportive policies. For instance, in 2023 National Institute of Health granted USD 5.2 billion for exosome research, reflecting the region’s commitment towards this sector. Furthermore, liquid biopsy adoption and private sector collaborations have paved the way for a comprehensive market development.
The U.S. is the leading player in the regional exosome diagnostic and therapeutics market, which is highly supported by precision medicine demand and support from federal healthcare systems. In this regard, Medicare in 2024 reported that its spending surpassed USD 810 million, offering coverage to a high volume of exosome-based diagnostics processes. Besides, the private healthcare investments reached USD 2.2 billion in 2024, with Exosome DX tests currently offering coverage to over 10 cancer types. The presence of key players and their aim to scale up manufacturing further complements the country’s growth, where Thermo Fisher inaugurated a USD 210 million exosome facility in 2024.
There is a huge exposure for Canada’s exosome diagnostic and therapeutics market on account of robust provincial healthcare investments. In this regard, CIHI, in 2024, stated that federal funding reached USD 3.3 billion in 2023, with Ontario leading with 18.2% spending growth between 2021 to 2024. During the same time, Health Canada reported an approval of 3 exosome therapies, including exoPro for osteoarthritis, attracting more players to establish their footprint in this sector. In addition, there are over 50 clinical trials in the pipeline, of which 42% target autoimmune disorders, thereby inducing growth in the country’s market.
Europe Market Insights
Europe is likely to remain the second-largest shareholder in the global exosome diagnostic and therapeutics market with a share of 28.5% during the discussed timeframe. The strong regulatory frameworks, robust healthcare infrastructure, and growing demand for cancer applications are the key factors stimulating growth in the region. Testifying to the same, EMA appreciably fast-tracked over 15 exosome-based therapies since 2022, including EV-based diagnostics. Besides the EU Health Data Space, in 2024 allocated €2.6 billion in funding for exosome research, thus indicating a prolific market opportunity.
The U.K. is significantly growing in the regional exosome diagnostic and therapeutics market, with the presence of NHS integration and R&D tax incentives. In this regard National Health Service in 2023 successfully implemented a Long-Term Plan that prioritizes exosome-based early cancer detection, where £502.6 million was allocated towards liquid biopsy adoption. Besides, Oxford Nanopore in 2024 announced that it received EMA approval, thus boosting the diagnostics segment. Therefore, all of these factors provide a great opportunity for firms to capitalize on this landscape.
Germany also follows in Europe’s exosome diagnostic and therapeutics market with robust growth opportunities, such as expanded healthcare spending and strategic collaborations. For instance, in 2024, the country’s healthcare spending reached €4.3 billion, reflecting a significant increase owing to the rising demand for diagnostic and therapeutic services. Besides the BMG’s Exosome Initiative offers funding to over 15 startups, whereas the EU’s Health Data Space supports GMP manufacturing hubs in Berlin, thus creating an optimistic market opportunity.
APAC Market Insights
Asia Pacific is anticipated to reflect the fastest growth in the exosome diagnostic and therapeutics market, fueled by the chronic disease prevalence, government-backed biotechnology initiatives, and increasing adoption of precision medicine. Besides the robust government grants and regulatory support, elevate the region’s captivity in this sector. In this regard, manufacturing expansion with Malaysia’s Bioeconomy Corp investing USD 205 million in exosome production reflects the huge potential for both domestic and international pioneers in this landscape.
The exosome diagnostic and therapeutics market in China is gaining increased traction with massive government investments and rapid adoption of advanced diagnostics. For instance, in 2024, the country allocated USD 5.3 billion towards exosome research and commercialization, which marks a 16.7% rise over the last five years. In addition, 1.6 million patients were reported to utilize exosome diagnostics in 2023, which has escalated the interest of domestic leaders to invest in this sector. Further, WuXi AppTec and SinocellTech are expanding production capabilities, with WuXi’s USD 1.2 billion Shanghai facility expected to double exosome manufacturing capacity by 2025.
India’s exosome diagnostic and therapeutics market is proactively developing with expanded healthcare spending and rising burden of chronic diseases. Exemplifying this, the government spending for exosome technologies has reached USD 1.9 billion in 2023, resulting in an increase of 18.4% in comparison to the previous years. The domestic firms are advancing exosome therapies, where Stempeutics in 2024 received DCGI approval for an exosome-based osteoarthritis treatment. The National BioPharma Mission also supports innovation with USD 205 million assigned toward extracellular vesicle research.
Country-wise Government Policies and Initiatives
|
Country |
Key Policy/Initiative |
Budget (USD) |
Launch Year |
|
Japan |
AMED Exosome R&D Program + Sakigake Scheme |
$3.2 billion (2024) |
2021-2022 |
|
South Korea |
Bio-Health 2030 Strategy + MFDS Approvals |
$1.6 billion (2022-2024) |
2022 |
|
Australia |
Medical Research Future Fund (MRFF) |
$153 million |
2021 |
|
Malaysia |
Bioeconomy Corporation Initiative |
$205 million |
2023 |
Key Exosome Diagnostic and Therapeutics Market Players:
- Company Overview
- Business Strategy
- Key Product Offerings
- Financial Performance
- Key Performance Indicators
- Risk Analysis
- Recent Development
- Regional Presence
- SWOT Analysis
The global exosome diagnostic and therapeutics market is considered to be highly consolidated, with Thermo Fisher, Bio-Techne, and Lonza dominating with the largest revenue shares. These players leverage advanced diagnostic tools and GMP manufacturing to secure their market positions. Simultaneously, the emerging nations compete with the presence of affordable solutions, where South Korea and India are gaining traction, thus suitable for upliftment all over the world.
Here is the list of some key players operating in the global market:
|
Company |
Country |
Market Share (2024) |
Industry Focus |
|
Thermo Fisher Scientific |
U.S. |
13.6% |
Exosome isolation, sequencing, and diagnostic tools |
|
Bio-Techne |
U.S. |
10.5% |
Exosome biomarkers, ELISA kits, and research tools |
|
Lonza Group |
Switzerland |
8.7% |
GMP-compliant exosome manufacturing for therapies |
|
Qiagen |
Germany |
7.1% |
Exosome RNA/DNA extraction and liquid biopsy solutions |
|
Illumina |
U.S. |
6.4% |
Exosome-based genomic profiling & diagnostics |
|
Danaher (Beckman Coulter) |
U.S. |
xx% |
Exosome isolation and characterization systems |
|
Roche Diagnostics |
Switzerland |
xx% |
Exosome-based cancer diagnostics & liquid biopsy |
|
Sartorius AG |
Germany |
xx% |
Exosome analytics and bioprocessing tools |
|
Malvern Panalytical |
UK |
xx% |
Nanoparticle tracking analysis (NTA) for exosomes |
|
Exosome Diagnostics (Bio-Techne) |
U.S. |
xx% |
Clinical exosome tests (e.g., ExoDx Prostate) |
|
Evox Therapeutics |
UK |
xx% |
Engineered exosome therapies for rare diseases |
|
Codiak BioSciences |
U.S. |
xx% |
Exosome-based immunotherapies (engEx Platform) |
|
System Biosciences |
U.S. |
xx% |
Exosome isolation kits & engineered exosomes |
|
Aethlon Medical |
U.S. |
xx% |
Exosome filtration for infectious disease diagnostics |
|
Capricor Therapeutics |
U.S. |
xx% |
Exosome-based regenerative medicine |
Below are the areas covered for each company under the top global manufacturers:
Recent Developments
- In May 2024, Roche Diagnostics introduced the ExoHER2 BC Assay, a blood-based exosome test for monitoring HER2-positive breast cancer progression, which provides real-time treatment response data, cutting diagnostic turnaround time by 42.6%.
- In March 2024, Bio-Techne announced the launch of ExoDx Lung Test, a non-invasive liquid biopsy for early-stage lung cancer detection that analyzes exosomal RNA to identify high-risk patients with 92.2% accuracy, reducing unnecessary biopsies.
Author Credits: Radhika Pawar
- Report ID: 7857
- Published Date: Jul 01, 2025
- Report Format: PDF, PPT
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Exosome Diagnostic and Therapeutics Market Report Scope
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