Peripheral neuropathy itself includes a constellation of several types with unique signs and symptoms. It results due to malfunctioning of the nerves ending up into severe damage, which further leads to improper signaling to various parts of the body. Neuropathies are bifurcated based on number of nerves, which are actually affected. For instance, if a single nerve is affected then it is called mono-neuropathy or if multiple nerves are damaged then denoted as polyneuropathies.
Peripheral Neuropathy: Epidemiology Insights
The report of peripheral neuropathy encompasses analysis based on segmentation fetched through the nine major markets based on following parameters:
- Prevalence of Peripheral Neuropathy in 9MM
- Diagnosed Prevalence of Peripheral Neuropathy in 9MM
- Age-specific Prevalence of Peripheral Neuropathy in 9MM
- Gender-specific Prevalence of Peripheral Neuropathy in 9MM
- Type-specific Prevalence of Peripheral Neuropathy in 9MM
The most commonly prevailing type of neuropathy is Diabetic neuropathy, whose prevalence is estimated to affect between 6% and 51% among adults with diabetes depending on age, duration of diabetes, glucose control, etc. As per the University of Chicago’s Center for Peripheral Neuropathy (UCCPN), approximately 60% of people with diabetes have some sort of nerve damage, whose advent is due to high blood sugar levels. On an average, the estimated prevalence of peripheral neuropathy among adults with diabetes in the United States is 28%. While, in context of European countries the prevalence ranges from 6% to 34% in diabetes mellitus patients. According to a Japan-based cross-sectional, population-based epidemiological survey with more than 5,000 respondents led to a neuropathic pain prevalence of 3.2%.
As per the Diabetic Foot Australia, which referred to an Australian study based on the best available evidence a conservative estimate that 21% of people with diabetes in Australia have diagnosed peripheral neuropathy. On the other hand, the reported prevalence of painful diabetic peripheral neuropathy (PDN) ranges widely, from 3.3% to 65.3%, because of differences in study design, diagnostic criteria and sampling size. A South-East Asia PDN epidemiological survey in 2016 found low screening rates, reflecting doctors’ poor attention to pain relief. Therefore, PDN may be under-reported in China, resulting in many patients experiencing chronic pain that impairs mental health, work and general quality of life.
Market Size for Peripheral Neuropathy
The market of peripheral neuropathy is differentiated based on following parameters such as:
- Drug-type (Marketed and Emerging drugs)
- Disease Type
In terms of treatment paradigm, the market holds several options including pharmacological, non-pharmacological, and alternative options. The symptomatic-based treatment alternatives for nerve pain mainly comprise of off-label therapies. Several classes of medications are employed such as anti-seizure drugs or anticonvulsants (pregabalin, duloxetine, or gabapentin), antidepressants (amitriptyline, desipramine (Norpramin) and imipramine). Another class of drug includes Serotonin and norepinephrine reuptake inhibitors (venlafaxine). There is no definitive cure available till date for the pain associated due to nerves, however, treatment slows down progression, relieves pain and manages complications so as to restore function.
Emerging Pipeline of Peripheral Neuropathy
Though the current market of peripheral neuropathy do not witness approved therapies, its pipeline or emerging landscape is quite diverse providing room for better treatment options to boon it market in near future. Several profound and efficient key players are robustly involved in developing interventions in variable stages of clinical stages to treat this debilitating disorder such as PledPharma; Solasia Pharma (PledOx; Calmangafodipir), Helixmith (Engensis), Aptinyx (NYX-2925), Asahi Kasei Pharma America Corporation (Thrombomodulin alfa), Lexicon Pharmaceuticals ; Bristol Myers Squibb (LX9211) and others.
PledPharma and Solasia Pharma via a conjoint license agreement are developing PledOx with its active pharmaceutical ingredient Calmangafodipir in phase III stage of clinical development for nerve damage associated with chemotherapy. The phase III trial has been recently stopped due to a data cut off targeted for the third quarter 2020. However, the likelihood of succeeding with the forthcoming POLAR trials where patient-reported symptoms after an entire course of treatment will be the primary endpoint. On the other hand, Helixmith is developing Engensis also known as VM202-DPN, which is a gene therapy in treating diabetic peripheral neuropathy in phase III stage of clinical development. In September 2019, Helixmith failed to make conclusions due to data contamination for its gene therapy Engensis, however, the company claimed that its drug is still safe and effective. Recently, in June 2020, the company stated that it re-initiated the phase III trial by submitting the protocol for the trial to the US Food and Drug Administration, wherein company plans to confirm the safety and effectiveness of its drug in 152 US patients at 15 medical institutions, including the Brigham and Women’s Hospital.
The phase II stage drug interventions are in development by Aptinyx, Asahi Kasei Pharma America Corporation, Lexicon Pharmaceuticals and others. NYX-2925 by Aptinyx is a novel, oral small molecule NMDA receptor modulator in development for the treatment of chronic nerve pain occurred due to diabetes. It helps in balancing the dysregulation of glutamatergic circuits in the brain, which is involved in the development of centralized chronic pain. Asahi Kasei Pharma America Corporation is developing Thrombomodulin alfa, which inhibits the coagulation process by accelerating the activation of protein C by thrombin. The activated protein C (APC) degrades Factor Va and Factor VIIIa, using protein S as a coenzyme, and inhibits coagulation by reducing thrombin generation in patients with Chemotherapy-induced Peripheral Neuropathy. LX9211 by Lexicon Pharmaceuticals is a potent, orally delivered, selective small molecule inhibitor of AAK1, a target discovered and extensively characterized in an alliance with Bristol Myers Squibb.
Despite of the recent advances in the era of neurology, some factors still remain unaddressed such as till date there is no approved therapy available to the patients posing an unmet need. At the same time potential pipeline, rise in prevalence, increasing demands of patients will drive the market of peripheral neuropathy in the future.
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