The SARM1 Inhibitors Market is estimated to be valued at USD 5 Mn in 2024 and is expected to reach USD 727 Mn by 2031, growing at a compound annual growth rate (CAGR) of 103.7% from 2024 to 2031.

The market is expected to witness positive growth over the forecast period. Factors such as high prevalence of neurological disorders such as spinal cord injuries and growing research & development for new drug molecules are expected to drive the demand. Promising clinical trial results of SARM1 inhibitors in treating various neurological conditions will further provide impetus to the growth. Additionally, rising geriatric population prone to neurological diseases complemented with increasing healthcare expenditures is anticipated to support the revenue generation.

Market Driver - Increasing investment in neurological research, particularly in SARM1 inhibition, is propelling the market

Investment in neurological research has been increasing steadily over the past few years. There has been a growing acknowledgement of the impacts of neurodegenerative diseases on public health and economies. Several funding agencies and foundations have increased their budgets towards finding treatments for conditions such as Alzheimer's, Parkinson's, and ALS. Research into the mechanisms underlying axon degeneration has received significant support. One promising new area is SARM1 inhibition.

Studies have found that SARM1 plays a key role in axon self-destruction, especially after injury. Blocking SARM1 could prevent nerve damage from various neurological insults and diseases. This has sparked huge interest from both public and private funders. Over the past five years, NIH grants focused on SARM1 biology and its therapeutic potential have doubled. Several pharmaceutical and biotech companies have also entered this field through acquisitions and internal research initiatives. A few have progressed candidate inhibitors into preclinical and clinical testing.

Market Driver - The rising prevalence of neurodegenerative diseases globally

 Neurodegenerative conditions like Alzheimer's and Parkinson's are increasing at an alarming rate as the population ages globally. It is estimated that over 50 million people are living with dementia worldwide currently and the numbers are projected to triple in the coming decades. Even in countries with improved healthcare systems and life expectancy, the prevalence of these diseases keeps rising unabated. The personal and societal burden of neurodegeneration is enormous and will continue growing unless effective treatment options become available.

Patients and their caregivers are desperate for therapies that can slow or halt disease progression. The lack of approved disease-modifying treatments has left a large unmet need. Numerous clinical trials of potential therapies have failed due to various reasons in recent years. This has increased the urgency to explore newer pathways and targets. SARM1 inhibition is a promising avenue as it could provide neuroprotection in a broad array of neurological conditions. Blocking the SARM1 pathway may prove to be disease-modifying rather than just symptomatic. Significant resources are being put towards validating SARM1 as a drug target for neurodegeneration.

Market Challenge - The high cost and complexity of drug development for neurodegenerative disorders may limit market growth

Developing drugs to treat neurodegenerative disorders poses significant challenges due to the complex nature of the diseases and limited understanding of disease pathways and mechanisms. Drug discovery and development involves long clinical trial periods spanning several years to test efficacy and safety. However, neurodegenerative diseases typically affect elderly populations who may not be eligible for clinical trials due to comorbidities. Additionally, outcomes can be difficult to measure objectively and endpoints may need to show changes in functioning over many years to demonstrate benefit. These complexity factors contribute to high development costs, with estimates ranging from $800 million to $2 billion for each new drug. Manufacturers must consider cost recovery and balancing high R&D investments with pricing. The risk of drug failure remains high even after large investments. These market barriers may disincentivize investment in rare disease areas like neurodegeneration where the number of treatable patients is small. High drug prices could also limit access for patients. Overall, the costs and inherent uncertainty involved pose significant challenges for market growth.

 Market Opportunity: Advances in precision medicine offer growth potential

 Recent years have seen major advances in the understanding of genetic contributions and molecular pathways involved in neurodegenerative disorders. This has enabled the application of precision or personalized medicine approaches targeting specific patient subpopulations. For example, identifying biomarkers that stratify patients based on disease subtypes or progression stages allows clearer evaluation of drug efficacy. Advances are also being made in developing therapies tailored to genetic mutations associated with familial forms of diseases. These personalized strategies hold promise to more effectively treat subsets of patients. Additionally, emerging technologies like computer modeling of brain networks offer potential to better predict drug effects and optimize dosing regimens. Such precision approaches aim to maximize benefits and minimize side effects for patients. If successful, they could justify higher drug prices and promote further investment. Overall, ongoing progress in stratifying these complex diseases offers significant growth potential for molecularly targeted SARM1 inhibitor therapies.

The treatment of neurodegenerative diseases typically follows a stepwise approach based on disease progression and severity of symptoms. For mild cases of Alzheimer's disease, prescribers commonly start with cholinesterase inhibitor medications such as donepezil (Aricept). These drugs work to boost acetylcholine levels in the brain and provide cognitive benefits.

As Alzheimer's advances to a moderate stage, combination therapy may be prescribed to target multiple symptoms. A common regimen is donepezil plus memantine (Namenda), a N-methyl D-aspartate receptor antagonist. This drug combination aims to improve memory, thinking, behavior and daily function.

For late-stage Alzheimer's and severe dementia, non-pharmacologic approaches become important. At this point, medications provide little cognitive benefit but may help manage behaviors like aggression, anxiety and insomnia. Antipsychotics like quetiapine (Seroquel) are often used off-label for their sedating effects.

Beyond medications, prescribers also consider factors like insurance coverage, cost to patients, caregiver support and ability to adhere to dosage schedules. Their preferences can be influenced by clinical trials data as well as interactions with pharmaceutical representatives and opinion leaders.

Lung cancer is typically classified into four main stages—I, II, III, and IV—depending on the size and spread of the primary tumor and whether it has metastasized to lymph nodes or distant organs. Treatment options vary significantly depending on the stage.

For stage I non-small cell lung cancer (NSCLC), the preferred option is usually surgery to remove the tumor. For stage II, surgery is again the primary choice, and may be supplemented with adjuvant chemotherapy using a platinum-based doublet like cisplatin/carboplatin with drugs like pemetrexed, gemcitabine or taxanes to reduce the risk of recurrence. Stage III NSCLC involves lymph node involvement, making it less suitable for surgery alone. The standard of care is neoadjuvant chemotherapy with cisplatin/carboplatin plus a taxane, followed by concurrent chemoradiation using a platinum-based regimen with radiation therapy. This is sometimes followed by adjuvant immunotherapy with drugs like pembrolizumab or nivolumab to activate the immune system against lung cancer cells.

For stage IV metastatic NSCLC, platinum-doublet chemotherapy remains a first-line option. However, immunotherapy with PD-1 inhibitors like pembrolizumab, nivolumab or atezolizumab have become increasingly prominent first-line treatments due to superior efficacy and reduced side effects compared to chemotherapy. For patients with EGFR or ALK mutations, targeted therapies like gefitinib, erlotinib or alectinib are preferred.

Collaboration and partnerships have been a major winning strategy for companies in this space. In 2021, Cleave Therapeutics entered a collaboration with Eli Lilly to develop and commercialize SARM1 inhibitors for degenerative diseases. This gave Cleave access to Lilly's significant R&D and commercialization capabilities while reducing development costs.

Targeting indications with high unmet need and market potential has also proven successful. In 2020, Astellas chose to develop its SARM1 inhibitor ASP-7037 for Spinal Muscular Atrophy (SMA). SMA represents a huge market opportunity given there are only two approved therapies. By targeting this indication, Astellas positioned itself to capture a large portion of the SMA market if ASP-7037 is approved.

Focusing on neurodegenerative diseases has paid off as they represent large patient populations and reimbursement is often favorable. Disorders like ALS, MS and spinal cord injury have few approved treatment options, so SARM1 inhibitors could see rapid adoption. Cleave and Astrocyte are specifically developing therapies for ALS and spinal cord injury based on this strategy.

Advancing clinical programs rapidly has also helped companies establish a competitive position. Cleave initiated a Phase 1 trial of CLV-048 within 12 months of being founded and reported initial results in 18 months, demonstrating progression speed. Quick clinical advancement signals commitment and de-risks programs from competing therapies.

Licensing approved technologies accelerated development timelines. In 2019, Astellas licensed the rights to ASP-7037 from Astrocite, enabling it to leverage preclinical work already completed on the compound and advance it into clinical trials more rapidly versus internal discovery. This allowed Astellas to establish an early-mover advantage in the clinic versus internal pipeline programs.

Insights, By Indication: Unmet medical needs drive the amyotrophic lateral sclerosis drives market growth

 Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, sub-segment contributes the highest share of 45.7% in the SARM1 inhibitors market owing to significant unmet medical needs. ALS is a fatal neurodegenerative disease with limited treatment options and high mortality rates. Currently, there is no cure for ALS and the only FDA approved drug, Riluzole, provides modest benefits. This clearly indicates a high unmet need for more effective therapies.

SARM1 inhibition is emerging as a promising therapeutic approach for ALS. Preclinical studies have demonstrated that SARM1 plays a critical role in neuroinflammation and neuronal cell death associated with ALS. Inhibiting SARM1 can potentially halt disease progression by preventing axonal degeneration and neuronal loss. Several pharmaceutical companies are actively developing small molecule SARM1 inhibitors for ALS with some candidates already in clinical trials. If proven safe and effective, these inhibitors can provide substantial clinical benefits to ALS patients and even become the standard of care.

Insights, By Type of Molecule: Advantages over biologics drive small molecules demand

The small molecules sub-segment dominates the SARM1 inhibitors market with a market share of 60.4%, owing to various advantages over biologic molecules. Small molecule drugs are easier to develop and manufacture at large scale as compared to biologics. They have better stability, require less complex supply chain and quality control testing. More importantly, small molecules generally demonstrate superior tissue penetration and achieve higher concentrations in the central nervous system (CNS).

Targeting SARM1, a protein localized in axons and neuronal cell bodies, requires inhibitors with excellent CNS penetration ability. Most ALS patients also have significant neuromuscular denervation which necessitates inhibitors that can effectively reach degenerating motor neurons and neuromuscular junctions. Small molecules, due to their optimal physicochemical properties, are better equipped than biologics to overcome the blood-brain-barrier and reach subcellular sites of SARM1 action. These critical pharmacokinetic advantages make small molecule SARM1 inhibitors highly desirable for developing effective ALS therapies.

• The SARM1 inhibitors market is poised for exponential growth, driven by rising investment in research, particularly in North America. The increasing prevalence of neurodegenerative diseases such as ALS and MS, coupled with advancements in precision medicine, positions SARM1 inhibitors as a promising therapeutic frontier. The market’s rapid expansion is also fueled by ongoing preclinical studies and the growing involvement of both academic institutions and biotech companies.
• Washington University has been at the forefront, receiving 64% of grants for SARM1 research, highlighting its key role in market innovation.

The major players operating in the SARM1 inhibitors market include Disarm Therapeutics, Nura Bio, Washington University, Asha Therapeutics and UCB Pharma.

• In April 2024, Asha Therapeutics announced preclinical studies for ASHA-624, a promising therapy aimed at inhibiting the SARM1 protein for treating ALS, indicating potential market expansion.
• In June 2023, Washington University secured the highest grants for SARM1 research, reinforcing its leading position in the market.

• By Indication
  • Amyotrophic Lateral Sclerosis (ALS)
  • Multiple Sclerosis (MS)
  • Peripheral Neuropathies
  • Glaucoma
• By Type of Molecule
  • Small Molecules
  • Biologics