Intranasal Therapeutics and Drug Delivery Systems Market - Distribution by Target Indications (Acute Repetitive Clusters, Anaphylaxis, COVID-19, Dry Eye Disease, Hypoglycemia, Influenza, Major Depressive Disorder, Migraine, Nasal Polyps and Prader-Willi Syndrome), Type of Molecule (Biologics and Small Molecules), Key Players, and [D] Key Geographical Regions (North America, Europe and Asia-Pacific)
Intranasal drug administration is a non-invasive approach, which involves the delivery of target drug from nose to the brain, through the olfactory and trigeminal nerve pathways, bypassing the blood-brain barrier. It is worth mentioning that the drug is transported to the central nervous system using intracellular and extracellular pathways
Intracellular Pathway
- Endocytosis into the neuron – Internalization of the target drug by the neuron marks the beginning of the intracellular mechanism adopted via the intranasal route of drug administration.
- Translocation within neuron to CNS – Post the internalization of target drug by olfactory neuron, cargo-containing endosome is transported via soma, along the length of the axon. It is also worth highlighting that some of the chemical is transported to the Golgi, where it is further transported to the olfactory bulb by anterograde or retrograde axonal intracellular transport.
- Exocytosis and brain distribution - Axonal transport transfers drug-containing vesicles towards the olfactory neuron axonal terminal and the olfactory bulb. The contents of the vesicles are then exocytosed and discharged onto the post-synaptic cells of the olfactory bulb, once it reaches the nerve terminal.
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Extracellular Pathway
Transport across the nasal epithelia and tight junctions – Intranasal drug administration via the extracellular pathway begins as the target drug passes through the nasal epithelia, paracellular cleft and navigating tight-junctions (TJ).
Perineural transportation from lamina propria to brain - The target medication can be administered to different routes from the lamina propria. For instance, drugs can pass through the perineural gap between the olfactory neuron-ensheathing cells and the olfactory neural fibroblasts to reach the CNS. A constant layer of interconnected olfactory ensheathing surrounds the axons, covering the distance from the olfactory epithelium to the olfactory bulb.
Additional layers of olfactory neural fibroblasts cover this ensheathing layer, eventually producing a perineural sheath. The olfactory neural fibroblasts layer is also continuous with the meninges that coat the brain, implying that the perineural space created by the ensheathing layer and olfactory neural fibroblasts layer communicates directly with the subarachnoid space. The extracellular fluid of the nasal lamina propria is thus continuous with the cerebrospinal fluid of the subarachnoid space in the region around the axons of the olfactory sensory neurons. Thus, making it possible for target drug to travel through different sections.
Intranasal Therapeutics and Drug Delivery Systems
With the increase in the number of infections and diseases around the globe, it has become necessary for the medical practitioners to undertake analysis in a more dynamic and effective manner. And here’s where the flow cytometers come in handy. This has led to the evolution of several contract research organizations, which are currently undertaking analysis on the behalf of researchers and medical teams through flow cytometers. Though flow cytometers can be used in various domains, but specifically as of now, it is being majorly used in the healthcare and immunology domain. Like, flow cytometers are currently being used for diagnosis and detection of leukemia, lymphoma and prognosis of HIV.
Analytical - Intranasal Therapeutics and Drug Delivery Systems
The demand for analytical services using flow cytometry has accelerated during COVID-19 pandemic. Based on that, on average we have observed a rise in the number of contract research organizations providing analysis of PBMC, whole blood cells, and bone marrow aspirates. Similarly, in recent years the researchers have found that stem cells have the potential for future research avenues in several fields. Thus, there has been a spike in the market of iPSC (induced pluripotent stem cells), where researchers have relied on flow cytometry for research and academic purposes.
Additionally, flow cytometers are also being used for undertaking cell profiling and subsetting. Cell profiling and subsetting are majorly used to profile and quantify the cells for analysis and other purposes. Along the same line, intracellular staining is also being undertaken routinely through flow cytometry to quantify intracellular components of the cells for research and other purposes. Almost all the companies which we have profiled were undertaking intracellular staining.
Similarly, in recent flow cytometry is also being applied for quantifying and analyzing rare cells. Scientifically rare cells are those cells that don't show any normal characteristics. Like for example, circulating tumor cells (CTC) or rare circulating endothelial cells (CEC),. The main objective of quantifying and analyzing the rare cells is to prognose the disease. Therefore, if we can quantify the rare cells, we would be successfully able to understand the status of the disease (if any).
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Intranasal Therapeutics and Drug Delivery Systems Market - Current Market Landscape (Drug Delivery Systems)
During our research, we were able to identify 20 players that are engaged in the development of intranasal drug delivery systems. most of the players (45%) engaged in this domain were established before 2001. Further, over the last decade, the clinical trial planning and design has witnessed a surge in the establishment of new players.
It is worth highlighting that most of the intranasal drug delivery system developers are presently based in North America (75%), followed by those headquartered in Asia-Pacific & RoW (15%). Examples of players based in Europe include (in alphabetical order) Bespak and Nemera.
Intranasal Therapeutics and Drug Delivery Systems Market - Current Market Landscape (Drug Pipeline)
During our research, we were able we were able to identify over 75 intranasal therapeutics. The intranasal therapeutics domain is presently dominated by neurological disorders (36%), followed by those being evaluated for infectious diseases (26%).
It is worth highlighting most of the small molecule based intranasal therapeutics (17%) have been approved. Further, (11%) biologic based intranasal therapies are being evaluated in phase II studies. Notable examples include (in alphabetical order) B244 (AOBiome Therapeutics), COVIDROPS (Sorrento Therapeutics) and Foralumab (Tiziana Life Sciences).
More than 34,000 patients have been recruited / enrolled in clinical trials focused on intranasal therapies across different regions
A significant increase in the number of clinical trials registered for the evaluation of intranasal therapeutics, during the period 2015-2021. This growth can be attributed to the established therapeutic potential of some of the approved intranasal therapeutics. It is also worth highlighting that, over the years, most of the trials (14) were registered in 2020.
It is worth highlighting most of the trials (111) are centered in North America. Within this region, majority of the trials were / are being conducted in sites in the US (93), followed by those located in Mexico (12) and Canada (6). Furthermore, in Europe, maximum trial sites are in Germany (7), followed by the UK (7) and Belgium (6).
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At present, 19 start-ups are driving innovation in this domain; various R&D initiatives have been undertaken by these players over the last few years
It is worth mentioning, most of the start-ups (16) engaged in this domain are based in North America, followed by those located in Europe (2). Examples of start-ups based in Asia-Pacific include (in reverse chronological order of year of establishment) Nasus Pharma (2019).
Further, start-ups engaged in the development of intranasal therapeutics have progressed 15 drug candidates to clinical stages. It is worth highlighting that only one drug candidate, (TYRVAYA), which is developed by Oyster Point Pharma for the treatment of dry eye disease, has received approval till date. Notable examples of start-ups evaluating therapeutics in phase III trials include (in chronological order of their developmental stage) Levo Therapeutics (LV-101, Phase III) and Nasus pharma (NS-001, Phase III).
The market is expected to witness a healthy growth of over 23% in the coming decade; the opportunity is likely to be well distributed across various target indications, types of molecules and different regions
In terms of target indication dry eye disease (64.8%) is likely to capture the maximum share, and this trend is unlikely to change in the foreseen future as well. This can be attributed to a significant increase in the number of patients suffering from such disease conditions and limited availability of effective treatment modalities.
In terms of phase of trial, in 2022, the intranasal therapeutics market for small molecules is likely to capture the maximum share, and this trend is unlikely to change considerably in the foreseen future, as a large number of such therapies are currently being evaluated in late clinical stages. On the other hand, the market for biologics is estimated to grow at a faster pace (22%). Further, Oyster Point Pharma (67%) captures the highest share of the overall market, and this trend is unlikely to change significantly in the foreseen future, as well. Furthermore, as per our proprietary model, in 2022, the intranasal therapeutics market in North America is anticipated to capture the maximum share (83.4%), and this trend is unlikely to change considerably in the foreseen future as well. This is followed by the share captured by the markets in Europe (7.2%) and Asia-Pacific (0.2%).
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