Diabetic Peripheral Neuropathy Market Trends

Market Driver - Increasing Global Prevalence of Diabetes Leading to Higher DPN Cases

With over 420 million people suffering from diabetes across the globe currently according to recent estimates from WHO, the prevalence has increased manifolds over the past few decades. Further, this number is projected to escalate to around 630 million by 2045 if decisive measures are not taken to curtail the diabetes burden. Alarmed by this stark projection, public health officials and researchers are sparing no effort to spread awareness and promote diabetes self-management.

However, diabetes remains a largely underdiagnosed and underreported condition in vast swathes of emerging economies where healthcare infrastructure and accessibility are inadequate. As more and more people develop diabetes owing to the interplay of various macro factors, an increasing number of them are destined to experience diabetic neuropathy symptoms over the course of their disease progression. This is evident from studies reporting rising DPN prevalence ranging from about 8% to 13% among diagnosed diabetics.

The healthcare costs associated with managing DPN and its multi-systemic complications have become a huge economic burden globally. With an aging global population further heightening the diabetes risk, it is evident more investment and medical innovation is direly needed to prevent nerve damages in diabetes patients for alleviating their burden.

Market Driver - Advances in Gene Therapy Offering Promising Treatment for Severe Cases

Gene therapy has emerged as one of the most fascinating avenues that hold enormous promise for revolutionizing the treatment paradigm of currently incurable conditions including treatment-resistant DPN cases. In the last decade or so, scientists have gained deeper understanding of the molecular pathways contributing to nerve cell degeneration and symptoms in DPN through extensive research. This has helped identify new targets that can be modulated using gene therapy vectors to stop or slow down the neurodegenerative process.

Some of the cutting-edge technologies being explored actively are gene knockdown approaches using antisense oligonucleotides or RNA interference techniques to inhibit overexpression of pain-causing genes involved in neuropathic pain mechanism. Viral vectors like AAV and lentivirus are being evaluated as carriers to deliver corrective genes or factors like neurotrophic proteins that promote neuron survival and function. Initial safety and efficacy results from animal studies look highly encouraging. Several novel gene candidates as therapeutics are under active preclinical screening.

While it may take many years for comprehensive evaluation and potential approvals, gene therapy field holds tremendous scope for breakthroughs. Success stories could revolutionize the healthcare paradigm for severe, chronic forms of DPN in the future.

Market Challenge - High Cost of Novel Therapies May Limit Patient Access

The development of novel therapies that can potentially modify the course of diabetic peripheral neuropathy has increased treatment options for patients.

However, these new treatment approaches such as non-opioid analgesic therapies, gene therapies and stem cell therapies often come with a high price tag. As per our analysis, the cost of some of the newly approved and late-stage pipeline drugs ranges anywhere between $10,000 to $50,000 per patient, per year of treatment.

While these therapies have demonstrated benefits in improving neuropathy symptoms and slowing progression in clinical trials, their high cost can be a significant barrier for widespread adoption. Most private and public drug plans have strict restrictions on coverage for such expensive therapies.

Only patients with very severe symptoms who have failed other standard of care options are likely to be approved for coverage. This limited access means majority of the patients suffering from diabetic peripheral neuropathy will remain reliant on generic medications like gabapentin and duloxetine that are effective for symptomatic relief but do no modify disease progression. The high cost of novel drugs thus remains one of the key challenges hampering effective management of the disease over the long run.

Market Opportunity – Development of Non-Invasive Gene Therapies like VM-202 Offers Promising Opportunity

One of the areas offering high potential for future growth in the diabetic peripheral neuropathy market is the development of non-invasive gene therapies. VM-202, an investigational topical gene therapy undergoing late-stage clinical trials, presents an attractive opportunity as a potential non-invasive treatment option. If approved, VM-202 will be the first non-systemic gene therapy for diabetic peripheral neuropathy.

As per preliminary clinical results, a single application of VM-202 has provided pain relief for 6 months or longer in a majority of patients. Its non-invasive delivery method through permeation of plasmid DNA into skin cells makes it safer than repetitive administration of viral vectors required for other gene therapies.

Being an outpatient treatment administered by the patient, VM-202 also promises to be more cost effective than monthly infusion therapies. Its unique mechanism of action targeting small fiber neuropathy also provides hope as a disease modifying therapy. With a favorable safety profile thus far and strong unmet need, VM-202 has potential to penetrate a significant share of the diabetic peripheral neuropathy market upon approval.