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December 2024
The U.S. exosomes market was valued at US$ 75.30 million in 2023 and is projected to reach US$ 1,428.79 million by 2033, registering a CAGR of 34.22% from 2024 to 2033. The increasing number of cases of chronic conditions is driving the growth of the U.S. exosomes market.
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The U.S. exosomes market is expanding because of the increasing use of exosomes in diagnosing and treating various diseases and health conditions. Exosomes belong to a group of extracellular vesicles that come from the endosomal system and usually measure between 30 to 150 nanometers in size, making them the smallest kind of extracellular vesicle. These vesicles are surrounded by a lipid bilayer and are released into the surrounding space, carrying a mix of complex materials from the cell they originated from, such as proteins, lipids, mRNA, miRNA, and DNA. They serve the function of transporting and exchanging different substances between cells and are utilized as non-invasive indicators for various diseases.
| Company Name | Celularity Inc. |
| Headquarters | New Jersey, U.S. |
| Pipeline | The firm is working on creating placental exosomes (pExo) as possible therapies that can transport growth-promoting factors, aiding in the formation of neural cells, blood vessels, and muscle tissue. pExo shows specific markers for exosomes, such as CD9, CD63, and CD81, and holds more than a thousand unique proteins and microRNAs that play roles in various biological processes. pExo includes various types of cytokines and chemokines and helps grow primary human cells from various organs and tissues. The pExo pipeline is currently being assessed for potential uses in treating regenerative and age-related conditions at the pre-clinical level. |
| Company Name | Aethlon Medical |
| Headquarters | California, U.S. |
| Pipeline | In May 2024, the company announced the positive results of the phase I trial of Hemopurifier®. It will now move to the next stage. Designed to quickly reduce circulating viruses and exosomes that promote cancer, the Aethlon Hemopurifier® is a pioneering technology. The Hemopurifier® is a "Breakthrough Device" according to the FDA, meaning that it can be used to treat patients with life-threatening viruses that are not treated by approved therapies, as well as patients with advanced or metastatic cancer who are either intolerant of or unresponsive to standard-of-care therapy. |
Exosomes are vesicles released from cells that are crucial for communication between cells and are found in many bodily fluids such as blood, saliva, urine, and cerebrospinal fluid, among others. Exosomes are evidently occurring compounds that may withstand digestive enzymes because of the innate residences of exosomes, including their capability tissue of mobile selectivity. The capability to go blood-mind barriers causes fewer systemic consequences and occasional toxicity. These vesicles are particularly well-suited for cancer detection due to their distinct features. They are also valuable in predicting and identifying a range of illnesses, including cancer, heart and age-related diseases, arthritis, brain disorders, and diabetes.
Additionally, exosomes are utilized in medical research and early-stage clinical studies. In recent years, cures using extracellular vesicles have garnered substantial attention among industry stakeholders to remedy numerous target warning signs, generally owing to their numerous applications, including goal specificity, more advantageous tissue regeneration, and reduced irritation and chronic pain.
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There are currently no guidelines for exosome research, which is still in its early stages. Because of this, professionals adopt new methods and procedures that are readily available on the market without any hesitation. Mistakes committed during the synthesis of exosomes are not the only challenges scientists face throughout exosome research, development, and manufacturing. MSC-derived exosomes have garnered significant interest in recent times due to their ability to function as intercellular messengers. Their unique property makes them attractive for scientific applications such as medication delivery, gene therapy, vaccine research, and cancer diagnostics. Therefore, inventors of MSC-exosome treatments must modify their stem cell-free therapy method to accommodate the new exosome manufacturing process in order to produce effective exosome harvesting procedures and set industry-leading standards for exosome characterization and purification.
The primary goals of medical aesthetics include wound healing, anti-aging, preventing hyperpigmentation, and hair loss prevention. Exosomes have the power to influence apoptosis, angiogenesis, inflammation, and the growth and differentiation of cells. As a result, their applications in dermatology may be extensive. Exosomes may be used in dermatology for a variety of purposes, including hair growth, skin rejuvenation, pigmentation management, and scar prevention and therapy. Exosome applications in aesthetics are still in their early stage, and more studies might reveal new advantages and improve current therapies. Scientists are investigating ways to modify exosomes to deliver particular therapeutic payloads customized to meet the requirements of individual patients as technology develops. This customized strategy might precisely address particular issues.
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By product insights, the kits & reagents segment dominated the U.S. exosomes market in 2023. The isolation of exosomes is necessary for different applications, and this is achieved with the help of kits and reagents. Tying up water molecules by polymer precipitation decreases the solubility of exosomes and causes their precipitation, which in turn allows exosomes to be isolated from cells and heavy debris. After a low-speed centrifugation process, exosomes are extracted. By using this technique, Total Exosome Isolation reagents and kits facilitate the expeditious extraction of exosomes, starting with the collection of samples. Processing small sample quantities and managing numerous samples are just two of the many applications that may benefit greatly from the Total Exosome Isolation kits, chemicals, and procedures that go along with them.
By workflow insights, the downstream analysis segment held the largest U.S. exosomes market share in 2023. Cell surface marker analysis using flow cytometry, proteomic analysis using mass spectroscopy, protein Analysis using blotting & ELISA, and RNA analysis with NGS & PCR come under downstream analysis. Isolating, purifying, and concentrating the previously produced medicinal molecule or other product from the intricate bulk matrix is the aim of downstream processing. Optimizing the recovery of hMSC extracellular vesicles from the upstream program while eliminating impurities is the goal of scalable downstream processing. For exosomes to be a useful class of therapeutics, improvements in both upstream and downstream processes are required. Differential DNA and RNA expression between the illness and control is the most popular downstream use of exosomes. Producing biopharmaceuticals that are both safe and effective requires downstream processing. For patient safety and regulatory clearance, the finished product's purity and quality are essential.
According to workflow insights, the isolation methods segment is anticipated to grow at a significant rate during the forecast period. A diverse array of donor cells, such as tumor cells, macrophages, dendritic cells (DCs), and mesenchymal stem cells (MSCs), have been found to produce exosomes. A deeper comprehension of exosome properties and functions is critically needed, as they are involved in cellular interactions on a universal scale. As such, the present focus is on isolating exosomes and analyzing them biologically and genetically. Approximately 80% of exosome researchers worldwide still employ ultracentrifugation (which includes differential centrifugation) as their principal method of exosome separation.
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By application insights, the cancer segment dominated the market with the largest U.S. exosomes market share in 2023. Exosomes released by cancer cells have been shown in several studies to possess distinctive molecules that serve as molecular markers for cancer detection as well as a means of differentiating one exosome from another. Common molecular detection indicators found in exosomes that can be used to diagnose cancer include nucleic acids and proteins. It has been discovered that a variety of exosome protein indicators are helpful in the early detection of cancer and prognostic risk assessment. Other nucleic acid molecules contained in exosomes have also been shown to be helpful indicators for cancer detection, in addition to miRNA-like ones. Exosomes can be utilized in cancer treatment and can offer molecular detection markers for cancer diagnosis. Exosomes may transport a variety of medications, including lipids, proteins, nucleic acids, or other small molecule compounds, and are also useful as carriers of cancer therapies.
The major reason for the growth of the U.S. exosomes market is the increasing number of cancer cases in the U.S. According to the National Cancer Institute, around 2.0 million people are estimated to have cancer in the U.S.. Among all the cancers, breast cancer is the most common, with 310,720 women and 2,790 men being diagnosed with it. It is estimated that 611,720 people will die due to cancer in 2024 in the U.S.
By application insights, the infectious diseases segment is estimated to grow at the fastest CAGR during the forecast period of 2024-2033. Exosomes have a significant influence on how infections turn out. The phase and source of the cells that exosomes' biological role type and efficiency are determined by their genesis. Exosomes should be considered suitable candidates for creating a vaccine that can be used for both prevention and therapy since they contribute to the spreading and limiting of an illness. Using exosomes formed from APCs challenged by infections or developing vaccines based on containing microbial antigens as a strong adjuvant in conjunction with immune cells may be effective and less harmful long-term therapies. There is an additional potential that identifying substances with the ability to trigger the release of particular exosomes specifically might be beneficial in inhibiting infection and managing detrimental outcomes.
By end-user, the pharmaceutical & biotechnology companies segment dominated the U.S. exosomes market in 2023. As a result, much thought has been given to the creation of exosome-based nano-theranostic techniques for improving illness prognosis and therapeutic approaches. Exosomes are a special kind of nanoparticulate carrier for pharmaceutical medication delivery because of their advantageous biopharmaceutical characteristics. The pharmaceutical and biotech industries are getting closer to utilizing exosomes' therapeutic qualities to combat or deliver medications that will combat illnesses and viruses as our understanding of exosome biology and function grows. Exosomes now exhibit promise for use in a range of scientific, medical, and therapeutic contexts. Preclinical research is showing strong impacts, and preliminary clinical data is showing promising safety and effectiveness outcomes. Exosomes may be used as a delivery vehicle for proteins or nucleic acid payloads in medical treatments that target illnesses, alter immune responses, and restore tissue.
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