Summary

Overview
Global Diabetic Neuropathic Pain Market reached US$ 1.8 billion in 2022 and is expected to reach US$ 2.8 billion by 2030, growing with a CAGR of 6.1% during the forecast period 2023-2030.
The development of novel treatments for diabetic neuropathy is a trend for the global diabetic neuropathic pain market. For instance, on July 27, 2023, Gujarat‐based pharma company Asprius Lifesciences announced that it has developed treatment for diabetic neuropathy, a condition that results in nerve damage in peripheral areas of the body. The company said it has already filed a patent for the Fixed-Dose Combination (FDC) that holds promise in treating peripheral neuropathy, a prevalent condition affecting over 2 percent of the global population.
Nerve damage caused by diabetes leads to diabetic neuropathy, a condition that results from uncontrolled high blood sugar levels. Diabetic neuropathic pain is a chronic pain type that arises from this condition. This pain exhibits symptoms such as burning sensations, discomfort, numbness, tingling, and shooting or stabbing pain. Peripheral neuropathy, autonomic neuropathy, proximal neuropathy, and focal neuropathy are the different forms of diabetic neuropathic pain. The treatment options available for diabetic neuropathic pain include analgesics, antidepressants, anticonvulsants, and others.
Furthermore, the increasing clinical trials of drugs, increasing prevalence of peripheral neuropathy, and novel treatment for diabetic neuropathic pain are the factors expected to drive the market over the forecast period.
Dynamics
Potential Treatment for Diabetic Neuropathic Pain is Expected to Drive Market Growth
The article from the National Center for Biotechnology Information, published in 2022, has shed light on the effectiveness of lipoic acid as a potent antioxidant that could potentially improve nerve blood flow, reduce oxidative stress, and enhance distal nerve conduction in patients with diabetic neuropathy. This powerful antioxidant has been proposed as a promising treatment for diabetic neuropathic pain, owing to its ability to alleviate symptoms and improve the quality of life in patients suffering from painful diabetic neuropathy.
Furthermore, lipoic acid has been shown to increase the levels of reduced glutathione, which is an important endogenous antioxidant, and to help regulate blood sugar levels. In clinical trials, it was found that 600 mg of alpha-lipoic acid was effective in managing pain associated with diabetic neuropathy. However, further research is required to establish its efficacy and safety.
Therefore, the impact of lipoic acid on the market will ultimately depend on the successful translation of recent advancements into practical treatments for those suffering from diabetic neuropathic pain. Hence, owing to the above factors, the market is expected to drive the market over the forecast period.
Increasing Clinical Trials of Drugs for Diabetic Neuropathic Pain is Expected to Drive Market Growth
The EPPIC-Net: Novaremed Painful Diabetic Peripheral Neuropathy ISA (EN21-01) is an ongoing clinical trial that aims to explore the potential of NRD135S in alleviating the symptoms of painful diabetic peripheral neuropathy (PDPN). As a double-blind Phase II study, it is designed to evaluate the pharmacokinetics/pharmacodynamics, safety, tolerability, and efficacy of NRD135S over 13 weeks.
Currently in development, NRD135S is a novel drug expected to provide a treatment option for PDPN. Researchers aim to compare its effects to a placebo pill without active ingredients to evaluate its safety and efficacy in treating diabetic neuropathy pain.
The clinical trial conducted by Novaremed Ltd. involves multiple locations in the United States and Europe. Participants will be randomly assigned to receive either NRD135S or a placebo pill, ensuring unbiased results. If found safe and effective, NRD135S could significantly impact those suffering from PDPN. Results are expected in 2023, revealing the drug's potential in treating diabetic neuropathy pain. Hence, owing to the above factors, the market is expected to drive over the forecast period.
Rising Funds for Research in Non-Opioid Treatments for Painful Diabetic Peripheral Neuropathy is Expected to Drive Market Growth
The NIH HEAL Initiative Report published in 2022, states that the organization is actively supporting researchers who are working towards developing non-opioid treatments for diabetic neuropathic pain. This is being done to reduce the risk of dependence or addiction that is often associated with opioid-based treatments. To this end, one of the projects that have been funded through the EPPIC-NET program is a phase 2 clinical trial that will be testing a potential new treatment for painful diabetic peripheral neuropathy.
The molecule being tested in this trial has already shown great promise in preclinical studies and is believed to have the potential to provide effective pain relief without the risk of addiction or dependence. It is hoped that this new treatment will prove to be a game-changer for patients suffering from diabetic neuropathic pain, who often have to rely on opioid-based treatments that come with a host of negative side effects.
In addition to this, the NIH HEAL Initiative is also funding research that recognizes the crucial role that an individual's environment plays in drug use and the development of chronic pain. By taking a more holistic approach to pain management, the organization is hoping to develop treatments that not only alleviate pain but also address the underlying issues that contribute to it.
Therefore, the NIH HEAL Initiative's efforts are a significant step towards revolutionizing pain management and improving the lives of millions of people who suffer from chronic pain. Hence, owing to the above factors, the market is expected to drive over the forecast period.
Side Effect of Diabetic Neuropathy Treatment is Expected to Hamper the Market Growth
Diabetic neuropathy affects up to 70% of diabetic people, usually in the feet, legs, arms, and hands, with symptoms like discomfort, tingling, burning, and numbness. Managing severe diabetic neuropathy can be challenging, with limited care options available. The American Academy of Neurology recommends pregabalin, gabapentin, duloxetine, venlafaxine, and other drugs as the most powerful medications to alleviate the symptoms.
Prescription medication is often the only option, such as NSAIDs, which can cause stomach trouble, heart disease, and other side effects. Tricyclic antidepressants are the most powerful pain-related antidepressants that affect the norepinephrine and serotonin levels of the brain, but they can cause drowsiness, weight gain, dry mouth, dry eyes, and other side effects. Similar drugs may also lead to blood pressure, heart rate issues, and dizziness. Hence, owing to the above factors, the market is expected to hamper over the forecast period.
Segment Analysis
The global diabetic neuropathic pain market is segmented based on neuropathy type, drug class, distribution channel and region.
The Peripheral Neuropathy from the Neuropathy Type Segment Accounted for Approximately 41.5% of the Diabetic Neuropathic Pain Market Share
Diabetic Peripheral Neuropathy (DPN) is a nerve damage that can occur as a complication of diabetes mellitus. Diabetes mellitus is a chronic metabolic disorder characterized by high blood sugar levels. The peripheral nerves, which are responsible for transmitting information between the central nervous system (brain and spinal cord) and the rest of the body, including the limbs and organs, are specifically affected by DPN.
To treat peripheral neuropathy, antidepressants such as nortriptyline, desipramine, imipramine, and amitriptyline are used. Other types of antidepressants, such as duloxetine, venlafaxine, paroxetine, and citalopram, are also used. Additionally, anticonvulsants such as gabapentin and pregabalin are prescribed for the treatment of peripheral neuropathy. Sometimes skin creams, patches, or sprays such as lidocaine are also used.
The market segment growth of diabetic peripheral neuropathy is expected to be driven by factors such as the increasing prevalence of the condition, pharmacological advances in the management of diabetes-associated peripheral neuropathy, and increasing clinical trials of drugs over the forecast period.
For instance, according to ClinicalTrials.Gov., an early phase 1 randomized controlled trial sponsored by the China Academy of Chinese Medical Sciences and led by Zhong Wang is evaluating the effectiveness of Liuweiluobi Granule, a Chinese herbal medicine, in improving neurotransmission function in patients with diabetic peripheral neuropathy (DPN).
The study aims to assess whether Liuweiluobi Granule can effectively enhance neurotransmission function in patients with diabetic peripheral neuropathy. Preliminary animal experiments suggested that the granule's effects on protecting peripheral motor nerves and reducing inflammation. Additionally, the granule did not show toxicity at a certain concentration.
Therefore, the results will provide valuable insights into the potential benefits of using Liuweiluobi Granule as a treatment for diabetic peripheral neuropathy.
Further, researchers at Loma Linda University Health have discovered a new treatment for diabetic peripheral neuropathy (DPN) called Intraneural Facilitation (INF). INF treatment is effective in reducing pain caused by DPN by restoring blood flow to damaged nerves. The previous treatment for DPN included glycemic control, foot care, pain management, and medication utilization as recommended by the American Diabetes Association.
However, the benefits of pharmacology have only shown modest results in slowing the progression of the disease and reducing pain associated with DPN. INF treatment involves three holds or positions that widen tiny openings in arteries surrounding nerves, improving blood flow to targeted nerves. Improved blood flow stimulates healing and reduces or stops nerve pain. One of the lead researchers, Mark Bussell, DPT, who developed INF treatment, hypothesized that INF would decrease perceived pain, and improve balance, ambulation, quality of life, and protective sensory function in patients with moderate-to-severe DPN.
This study enrolled patients with Type 2 diabetes mellitus and moderate-to-severe DPN symptoms below the ankle for a single-blind, randomized clinical trial. Patients were randomly assigned to receive either INF or sham treatment. INF physical therapists provided therapy for 50 to 60 minutes, three times a week for three weeks, while the sham treatment group was led to believe they received therapy for three weeks. Quality of life, balance, gait, protective sensory function, and pain outcome measures were compared between the two groups using pre- and post-treatment data. The INF group showed post-treatment improvements in protective sensory function and composite static balance score, and INF treatment improved pain perception.
Therefore, INF treatment is effective in reducing pain caused by diabetic peripheral neuropathy (DPN) by restoring blood flow to damaged nerves. The treatment also improves pain perception, protective sensory function, and composite static balance score in patients with moderate-to-severe DPN. Hence, owing to the above factors, the market segment is expected to hold the largest market share over the forecast period.
Geographical Penetration
North America Accounted for Approximately 39.7% of the Market Share in 2022, Owing to the Rising Investments in the Treatment of Diabetic Neuropathy, Increasing Prevalence of Peripheral Neuropathy, and Increasing Clinical Trials for Drugs
North America region is expected to hold the largest market share over the forecast period owing to the rising investments for the treatment of diabetic neuropathy, increasing prevalence of peripheral neuropathy, and increasing clinical trials for drugs.
For instance, in 2022, EPPIC-Net is a consortium funded by the National Institutes of Health’s Helping to End Addiction Long-term (HEAL) initiative to accelerate the development of non-addictive pain therapies by supporting early-phase clinical trials of promising agents. Drs. Robinson-Papp and George led a team to create the platform protocol for this trial, a novel approach that includes multiple subgroups and substudies and enables the evaluation of more than one investigational agent. The platform protocol creates a standardized, rigorous process for assessing pharmaceutical agents that could accelerate time to market.
Additionally, on November 16, 2020, a $3 million NIH grant was awarded to a team of U.S./Canadian investigators, including researchers from the EVMS Strelitz Diabetes Center, to study a potentially groundbreaking treatment for diabetic neuropathy. In collaboration with the University of California San Diego and Canadian drug development company WinSanTor, the EVMS scientists secured the NIH-NIDDK Small Business Innovation Research (SBIR) grant. The EVMS team has been granted approximately $1 million to conduct a phase 2 clinical study of the medication Pirenzepine for neuropathy. EVMS is the only site in the U.S. researching this medication for neuropathy. Hence, owing to the above factors, the North American region is expected to hold the largest market share over the forecast period.
Competitive Landscape
The major global players in the diabetic neuropathic pain market include Eli Lilly and Company, Grünenthal, Collegium Pharmaceutical, Inc., Lupin, Daiichi Sankyo, Azurity Pharmaceuticals, Inc., Novartis AG, Pfizer, Inc., Endo International plc. (Par Pharmaceutical) and Johnson & Johnson (Janssen Pharmaceuticals) among others.
COVID-19 Impact Analysis
The COVID-19 pandemic has had a significant impact on the market for Diabetic Neuropathic Pain (DNP) treatments and various aspects of healthcare. Healthcare services, including elective procedures and non-urgent medical appointments, were disrupted, leading to delays in diagnosis, treatment adjustments, and follow-up care for DNP patients. Clinical trials and research activities related to DNP treatments were also put on hold due to lockdowns, restrictions, and reprioritization of resources toward COVID-19 research, which could affect the introduction of new therapies or the advancement of existing ones.
The COVID-19 pandemic overwhelmed hospitals and healthcare facilities with cases, leading to a diversion of resources, personnel, and attention away from other medical conditions such as DNP. This strain on the healthcare system could have affected timely access to care for DNP patients. Telehealth services were rapidly adopted as in-person visits became less feasible. While this allowed some DNP patients to receive consultations and follow-up care remotely, it might not have been as effective for certain diagnostic and treatment procedures.
Diabetic patients, including those with DNP, were considered at higher risk for severe COVID-19 complications, leading to increased precautions and avoidance of healthcare settings, potentially impacting disease management. Medical conferences and educational events were moved to virtual platforms, impacting the dissemination of new research, treatment guidelines, and information about DNP management.
Russia-Ukraine Conflict Analysis
The conflict between Russia and Ukraine has the potential effect on the healthcare sector and the market for Diabetic Neuropathic Pain (DNP) treatments. In areas affected by conflict, healthcare resources, and infrastructure could be redirected to emergency services and treating war-related injuries, potentially reducing the focus on chronic conditions like DNP and limiting the availability of specialized care. Additionally, research and development activities related to DNP treatments could be hampered in regions directly affected by the conflict, as institutions and researchers shift their focus to more immediate concerns, delaying advancements in DNP therapies.
By Neuropathy Type
• Peripheral Neuropathy
• Autonomic Neuropathy
• Proximal Neuropathy
• Focal Neuropathy
By Drug Class
• Antidepressants
o Tricyclic Antidepressants (TCAs)
 Amitriptyline
 Nortriptyline
 Desipramine
 Imipramine
o Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs)
 Duloxetine
 Venlafaxine
o Serotonin Reuptake Inhibitors (SSRIs)
 Citalopram
 Paroxetine
• Anticonvulsants
o Calcium alpha-2-delta anticonvulsants
 Gabapentin
 Pregabalin
o Sodium channel anticonvulsants
 Carbamazepine
 Topiramate
• Analgesics
o Opioid Analgesics
 Morphine
 Oxycodone
 Tapentadol
o Topical Analgesics
 Capsaicin
 Lidocaine
By Distribution Channel
• Hospital Pharmacy
• Retail Pharmacy
• Online Pharmacy
By Region
• North America
o U.S.
o Canada
o Mexico
• Europe
o Germany
o U.K.
o France
o Spain
o Italy
o Rest of Europe
• South America
o Brazil
o Argentina
o Rest of South America
• Asia-Pacific
o China
o India
o Japan
o Australia
o Rest of Asia-Pacific
• Middle East and Africa
Key Developments
• On July 22, 2022, Vertex Pharmaceuticals Incorporated announced that following the positive Phase 2 results earlier this year and having reached an agreement on the design of the pivotal development program with the U.S. Food and Drug Administration (FDA), Vertex plans to advance the selective NaV1.8 inhibitor VX-548 into Phase 3 clinical trials in the fourth quarter of 2022. Vertex also intends to initiate a Phase 2 dose-ranging study of VX-548 in neuropathic pain by the end of this year. In addition, the FDA has granted VX-548 Breakthrough Therapy Designation for the treatment of moderate-to-severe acute pain.
Why Purchase the Report?
• To visualize the global diabetic neuropathic pain market segmentation based on neuropathy type, drug class, distribution channel, and region, as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development.
• Excel data sheet with numerous data points of diabetic neuropathic pain market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.
DataM Intelligence Opinion:
According to the DataM Intelligence, the management of Diabetic Neuropathic Pain (DNP) is a complex issue that requires addressing various factors. While promising treatment options, clinical trials, and research funding provide hope for better outcomes, the healthcare sector has faced challenges due to geopolitical events and disruptions like COVID-19. All stakeholders need to stay informed and engaged to make the most of new opportunities and overcome obstacles.
The market for treating Diabetic Neuropathic Pain (DNP) has the potential for growth through innovative approaches. Studies have shown lipoic acid's antioxidative effects, while ongoing clinical trials explore non-opioid options, such as NRD135S. The Intraneural Facilitation (INF) treatment has shown promise in enhancing blood flow and reducing pain. However, current treatment side effects and geopolitical events, such as conflicts and the COVID-19 pandemic, pose challenges. Meeting the evolving needs of DNP patients requires adaptable healthcare systems that balance advancements and challenges.
The global diabetic neuropathic pain market report would provide approximately 61 tables, 59 figures, and 186 Pages.
Target Audience 2023
• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies

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