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Exosomes have incredible properties that enable researchers to engineer exosomes as carriers for the delivery of drugs, as well as perfectly target tissues of interest, while evading or modulating immune responses. Today, drug delivery and development of exosome-mediated therapies is a growing market segment, with over 60 companies forging ahead in this field. Many of the recent advances in exosome research are technology-based and this helps researchers to quantify exosome cargoes and subtypes, allowing for the tracking of exosomes with remarkable precision. This is helping companies to regulate exosome drug dosage and delivery, as well as delivering effective treatments for hard-to-treat diseases, such as cancer and neurodegenerative diseases.
In recent years, there have been increased interactions between pharmaceutical companies and academic scientists working within the fields of neuroscience, cell and gene therapy, molecular biology, and imaging. These interactions are expediting the effective translation of bench discoveries to clinical trials in humans.
Because of their natural properties as intracellular messengers, many companies are commercializing naïve exosomes, which are the exosomes naturally released by cells. Additionally, both small and large companies are now developing engineered exosomes, an approach that has the potential to facilitate drug delivery to hard-to-reach tissues, such as the central nervous system (CNS).
Exosome-Based Therapies
In recent years, several universities and research hospitals have performed small-scale Phase I clinical trials using exosomes. So far, only a few companies, such as Aegle Therapeutics, Exopharm Ltd, United Therapeutics, Avalon Globocare, and Direct Biologics, have reached the pivotal point of transitioning exosome therapeutics into human trials. Despite all of this exciting progress, as of today, no exosome therapeutic has yet to gain U.S. FDA approval.
Exosome-based therapeutics are most likely to reach commercialization in the U.K., Italy, and South Korea earlier than in the U.S., because companies in these countries have a larger number of products in their pipelines.
Nonetheless, globally, several exosome-based skincare cosmeceuticals are distributed and sold through dermatologist’s offices and aesthetic clinics. Exosomes are now being utilized within the global cosmetics industry to manufacture and market skincare products that use the power of these small extracellular vesicles to enhance a broad range of traits. Exosomes can provide bioactive substances such as proteins, lipids, and nucleic acids to the target cells to alter gene expression and cellular function. Importantly, exosomes can also induce collagen formation, enhance tissue regeneration, and exert anti-inflammatory properties.
These products are often used when patients receive various types of treatments, such laser and micro-needling treatments, to promote skin longevity. Laboratory-based exosome studies have shown enhanced outcomes in skin rejuvenation, scar revision, hair restoration and fat graft survival. Products are also being developed for wound healing and ocular treatments, as well as anti-aging applications.
The Market for Exosome Diagnostics
So far, only two exosome-based diagnostics have gained FDA’s Fast Track Approval. One is Exosome Diagnostics/Bio-Techne’s ExoDx Prostate IntelliScore (EPI) test. The Breakthrough Device Designation was awarded on June 17, 2019. By granting the designation, FDA has acknowledged the need to avoid a painful and invasive prostate biopsy. The second diagnostic was Guardant Health’s Guardant360CDx, approved by the U.S. FDA on August 13, 2020. It is an exosome-based diagnostic that can detect metastatic non-small cell lung cancer (NSCLC).
According to Cancer.Net, in 2023, an estimated 288,300 men in the U.S. were expected to be diagnosed with prostate cancer. Worldwide, an estimated 1,414,259 people were diagnosed with prostate cancer in 2020. The average age at the time of diagnosis is 66 years. It is estimated that 34,700 deaths from this disease occurred in the U.S. in 2023. In 2020, an estimated 375,304 people worldwide died from prostate cancer.
According to Science News, globally each year, more than 1.3 million new cases are diagnosed. When Europe and North America are combined, nearly 2.0 million biopsies are tested every year. The ExoDx prostate test is a urine-based test indicated for men 50 years of age and older with a prostate-specific antigen (PSA) 2-10ng/ml. The test provides a risk score. The test can help reassure a patient to avoid a prostate biopsy or improve patient compliance with physician recommendation. The ExoDx Prostate Test was evaluated in two clinical trials with 1,022 patients and used in more than 30,000 patients since it was first launched. The cost of a test is $760.
Guardant Health’s Guardant360 CDx has been approved for tumor mutation profiling, in patients with any solid cancerous tumor. The test has also been approved as a companion diagnostic to identify non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) alterations who may benefit from treatment with Tagrisso (osimertinib). The test offers patients and clinicians a simple, faster blood test to help inform personalized treatment options. The test has been used by more than 7,000 oncologists, and more than 150,000 Guardant360 tests have been performed in the U.S. to date. The cost of a single test is about $4,216.
The two approved exosome-based diagnostics are now generating commercial revenue and a few more diagnostics and therapeutics are expected to reach the market in the next few years. Overall, the global market for exosome diagnostics and therapeutics is anticipated to grow to over $1 billion by 2030, with a significant six-year CAGR of 10.5% over this period. Key factors that are expected to fuel the growth of the market include an increased demand for diagnostics for cancer.
Ready to learn more about this expanding market? View the global strategic report, the “Global Exosome Market – Market Size, Forecast, Trials, and Trends, 2024“.
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