Diabetic Peripheral Neuropathy Market

Key Highlights:

• The diabetic peripheral neuropathy market size in 2022 was highest in the US among the 7MM, accounting for approximately USD 900 million, which is expected to increase by 2032.
• The increasing number of obese, diabetic, and geriatric populations and improved diagnosis of diabetic peripheral neuropathy will fuel market growth.
• There are four different types of diabetic neuropathy such as peripheral neuropathy, autonomic neuropathy, focal neuropathies, and proximal neuropathy. Their occurrence percentage is the following:

• There are several forms of diabetic peripheral neuropathy. The most common type is distal symmetric polyneuropathy, accounting for approximately 75% of diabetic peripheral neuropathies.
• Therapies that control higher blood sugars, reduce insulin resistance, and decrease fat accumulation, ultimately benefit patients with diabetic peripheral neuropathy. There is a huge opportunity in terms of patient volume to directly treat diabetic peripheral neuropathy since most of the patients require to opt for treatment for diabetic peripheral neuropathy in the early stages because the loss of nerve functions cannot be reversed.
• Gabapentin’s such as Neurontin are mostly recommended in the class to treat diabetic peripheral neuropathy, but side effects associated with their uses are major limitations, which creates lacunae in the current treatment landscape of diabetic peripheral neuropathy.
• Other diabetic peripheral neuropathy pipeline drugs being developed by companies such as Helixmith’s VM202, Lexicon Pharmaceuticals’ LX9211, Glenmark Pharmaceuticals’ GRC 17536, Regency Pharmaceuticals’ Ricolinostat, and Pure Green’s CBD, among others that will fuel market.

DelveInsight's “Diabetic Peripheral Neuropathy – Market Insights, Epidemiology, and Market Forecast – 2032” report delivers an in-depth understanding of diabetic peripheral neuropathy, with pathophysiology, various kinds of effects of diabetic peripheral neuropathy, factors affecting the disease, etc. The report also provides historical and forecasted diabetic peripheral neuropathy epidemiology, market trends in the 7MM geography, and unmet medical needs to curate the best opportunities and assess the market’s underlying potential.

The diabetic peripheral neuropathy epidemiology-based market analysis report provides current treatment practices, which include antiseizure drugs involving Lyrica (Pfizer), Nucynta (Assertio Therapeutics, formerly known as Depomed), Cymbalta (Eli Lilly), Effexor (Pfizer), etc., and emerging drugs such as Regency Pharmaceuticals’ ricolinostat. The report also covers the market share of individual therapies and the current and forecasted 7MM Diabetic Peripheral Neuropathy market size from 2019 to 2032.

Diabetic Peripheral Neuropathy Market

Key players such as Helixmith’s VM202, Lexicon Pharmaceuticals’ LX9211, Glenmark Pharmaceuticals’ GRC 17536, Regency Pharmaceuticals’ Ricolinostat, Pure Green’s CBD and others are evaluating their lead candidates in different stages of clinical development, respectively. They aim to investigate their products for the treatment of Diabetic peripheral neuropathy. The diabetic peripheral neuropathy Market has been categorized by Drug Class (antiseizure drugs, antidepressants, opioids, and non-opioid pain relief medication), Route of Administration (Injectable, Oral, Topical, and Other Routes), etc.

• The total Diabetic Peripheral Neuropathy market size in the 7MM was approximately USD 2,740 million in 2022 and is projected to increase during the forecast period (2023–2032).
• In 2022, the highest Diabetic Peripheral Neuropathy market share was captured by the US (~60%), followed by Japan (15%), out of all the 7MM countries.
• The market size in the 7MM will grow at a CAGR of ~6.0% due to improved awareness about the disease, market operations like mergers and acquisitions, and the launch of emerging therapies.
• Among EU4 countries, Germany accounted for the maximum Diabetic Peripheral Neuropathy market size in 2022.
• In Japan, the Diabetic Peripheral Neuropathy market size is expected to increase at a CAGR of ~7.5% during the forecast period (2023–2032).

Diabetic Peripheral Neuropathy Drug Chapters

The Diabetic Peripheral Neuropathy drug chapters possess a detailed analysis of marketed and late-stage (Phase III and Phase II) Diabetic Peripheral Neuropathy pipeline drugs. The marketed drugs segment is mostly catered by therapeutic classes such as Tricyclics Antidepressants, Antiseizure drugs SNRIs, and others. Furthermore, the key players for emerging drugs and their respective drug candidates include Helixmith’s VM202, Lexicon Pharmaceuticals’ LX9211, Glenmark Pharmaceuticals’ GRC 17536, and others. The drug chapter also helps understand the Diabetic Peripheral Neuropathy clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.

Marketed Drugs

Tricyclic antidepressants

Tricyclic antidepressants, including amitriptyline, desipramine, and imipramine, may relieve mild-to-moderate symptoms. In the case of the use of opioids, it depends upon the extent of the condition, and normally physicians avoid its usage. Serotonin and norepinephrine reuptake inhibitors (SNRIs) can also help relieve symptoms, mainly pain associated with Diabetic Peripheral Neuropathy.

Antiseizure Drugs

The market holds certain approved drugs to relieve the pain of Diabetic Peripheral Neuropathy such as antiseizure drugs, antidepressants, opioids, non-opioid pain relief medication, etc. The antiseizure drugs involve Lyrica (Pfizer), Nucynta (Assertio Therapeutics, formerly known as Depomed), Cymbalta (Eli Lilly), Effexor (Pfizer), etc. Antiseizure drugs are generally used as a symptomatic option to relieve pain but may possess side effects.

Note: Detailed current therapies assessment will be provided in the full report of Diabetic Peripheral Neuropathy

Emerging Drugs

VM202: Helixmith

Helixmith’s VM202 is a DNA-based drug designed to produce two isoforms of HGF (hepatocyte growth factor), HGF728 and HGF723. When VM202 is delivered to the affected area by a single intramuscular injection, this drug enters a small portion of the surrounding muscle cells. In 2018, US FDA granted RMAT designation to VM202-Diabetic Peripheral Neuropathy. Based on the cumulative evidence of efficacy and safety from the Phase III-1b study and earlier clinical studies, the drug showed significant and clinically meaningful pain reduction. The company is conducting a Phase III clinical trial to assess VM202 (Engensis) in participants with painful Diabetic Peripheral Neuropathy.

LX9211: Lexicon Pharmaceutical

Lexicon Pharmaceutical’s LX9211 is an orally-delivered, selective small molecule inhibitor of AAK1. In December 2020, the drug received Fast Track designation from the US FDA for the development in Diabetic Peripheral Neuropathy pain. In June 2022, the company announced the topline results of Phase II [RELIEF-DPN-1] in painful Diabetic Peripheral Neuropathy. The drug achieved the primary endpoint of the study, demonstrating a statistically significant reduction in the average daily pain score.

Note: Detailed emerging therapies assessment will be provided in the final report.

Diabetic Peripheral Neuropathy Market Outlook

Diabetic Peripheral Neuropathy is a type of nerve damage that can occur if one has diabetes. High blood sugar (glucose) can injure nerves throughout the body. Diabetic Peripheral Neuropathy most often damages nerves in the legs and feet. The market of Diabetic Peripheral Neuropathy does not hold a definitive cure, but treatments are available to manage the symptoms only. The main goals of treatment involve a slow progression of the disease, relieving pain, managing complications, and restoring function. The first line of therapy involves lowering blood glucose levels by reducing the intake of carbohydrate-rich food products. This will help in improving the current symptoms due to nerve pain.

The dynamics of the Diabetic peripheral neuropathy market are anticipated to change as companies across the globe are thoroughly working toward developing new drug therapy options to treat this disease.

Diabetic Peripheral Neuropathy Drug Class Insights

The current Diabetic Peripheral Neuropathy treatment consists of different approaches classified into pharmacologic and physical therapy. The pharmacological therapies include antidepressants, opioids, non-opioid pain relief medication, etc. The antiseizure drugs involve Lyrica (Pfizer), Nucynta (Assertio Therapeutics, formerly known as Depomed), Cymbalta (Eli Lilly), Effexor (Pfizer), etc. Antiseizure drugs are generally used as a symptomatic option to relieve pain but may possess side effects. In the case of antidepressants, Tricyclics, including amitriptyline, desipramine, and imipramine, may provide relief for mild-to-moderate symptoms. In the case of the use of opioids, it depends upon the extent of the condition, and normally physicians avoid its usage.

Further, another treatment regimen for treating Diabetic Peripheral Neuropathy involves physical therapy. Physical therapy is generally used with medications as this might help relieve pain and reduce the risk of dependency on opioids. Physical therapy includes painless electrical nerve stimulation, which might help reduce stiffness and enhance the healing of foot ulcers. Gait training is also involved in physical therapy in which the patients are helped with their movement issues while walking. Therapeutic ultrasound is another type of physical therapy that uses high-frequency sound waves to stimulate the tissue beneath the skin. This can help some patients to regain sensitivity in their feet. Regular massages or manual therapy can also be followed to stretch the muscles. Due to inadequate blood supply, massage can inhibit muscle contractions, spasms, and atrophy.

This section focuses on the Diabetic Peripheral Neuropathy market uptake rate of potential drugs expected to be launched in the market during 2019–2032. For example, for VM202, which is expected to be launched in the US in 2026, the drug uptake is expected to be slow-medium, with a probability-adjusted peak patient share of 1.5% in the US, expected to peak at 9 years from the year of launch.

Further detailed analysis of emerging therapies drug uptake in the report…

Diabetic Peripheral Neuropathy Epidemiology

As the market is derived using a patient-based model, the Diabetic Peripheral Neuropathy epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Prevalent Cases of Diabetic Peripheral Neuropathy, Type-specific Cases of Diabetic Peripheral Neuropathy, and Age-specific Cases of Diabetic Peripheral Neuropathy, in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), and the United Kingdom, and Japan from 2019 to 2032. The total number of incident cases of Diabetic Peripheral Neuropathy in the 7MM was approximately 29,218,300 cases in 2022 and is projected to increase during the forecast period (2023–2032).

• The total number of Prevalent Cases of Diabetic Peripheral Neuropathy in the US was around 17,531,000 in 2022.
• The United States contributed to the largest number of prevalent cases of Diabetic Peripheral Neuropathy (~60%) in the 7MM in 2022. Whereas EU4 and the UK, and Japan accounted for around 25% and 15% of the total prevalent cases in the 7MM, respectively, in 2022.
• Among the EU4 countries, Germany accounted for the largest number of total prevalent cases, followed by the UK, whereas Spain accounted for the lowest number of cases in 2022.
• DelveInsight projects an increasing trend for type-specific cases of Diabetic Peripheral Neuropathy due to improved diagnosis strategies and increasing awareness about long-term complications.

Diabetic Peripheral Neuropathy Pipeline Development Activities

The report provides insights into different therapeutic candidates such as VM202, LX9211, GRC 17536, and others in different phases of clinical trials. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Diabetic Peripheral Neuropathy emerging therapies.

Diabetic Peripheral Neuropathy Disease Understanding and Treatment Algorithm

Diabetic Peripheral Neuropathy Overview

Diabetic peripheral neuropathy (DPN) is the presence of signs and symptoms of peripheral nerve dysfunction in people with diabetes. It affects nearly 50% of adults with diabetes during their lifetime and is associated with substantial morbidity, including pain, foot ulcers, and lower limb amputation. There are several forms of diabetic peripheral neuropathy. The most common type is distal symmetric polyneuropathy which can be classified as primarily small-fiber, primarily large-fiber, or mixed small and large fiber and accounts for approximately 75% of all diabetic peripheral neuropathies.

The root cause of diabetic peripheral neuropathy includes, over time, blood glucose levels that keep increasing along with high levels of fats, such as triglycerides, in the blood due to diabetes, which damages nerves. High blood glucose levels can also damage the small vessels nourishing nerves with oxygen and nutrients; without enough oxygen and nutrients, nerves cannot function well.

Diabetic Peripheral Neuropathy Diagnosis

Diagnosis of Diabetic Peripheral Neuropathy is mainly based on characteristic symptoms and signs. Nerve conduction studies (NCS) are one of the gold-standard techniques for diagnosing Diabetic Peripheral Neuropathy. It evaluates the occurrence and development of Diabetic Peripheral Neuropathy by detecting the ability of the peripheral nerve to transmit electrical signals in patients with Diabetic Neuropathy.

The patient journey begins with an examination of symptoms by a physician. The most prominent barriers experienced by people accessing care and the influencers acting on providers ultimately affect the person with chronic Diabetic Peripheral Neuropathy, their quality of care, financial burden, mental health, and quality of life.

Further details related to country-based variations are provided in the report.

Diabetic Peripheral Neuropathy Treatment

Based on real-world-prescription pattern analysis, the current standard of care is limited to intensive blood glucose control and symptomatic treatment. Studies have found that in the early stage of type 1 diabetes, blood glucose management and control can effectively prevent or delay the occurrence of peripheral neuropathy. However, the progress of peripheral neuropathy can help patients with Diabetic Peripheral Neuropathy, but the loss of nerve cells only be slowed down by management treatment for type 2 diabetes is irreversible. According to multiple pieces of evidence, it has been found that opioids are used far less frequently in Japan than in the US.

The American Academy of Neurology (AAN) has released new guidance detailing optimal pharmacologic and no pharmacologic management of painful diabetic neuropathy, the organization’s first update since its 2011 guideline recommendations. Another treatment regimen for treating Diabetic Peripheral Neuropathy involves physical therapy. Physical therapy is generally used in combination with medications as this might help relieve pain and reduce the risk of dependency on opioids.

KOL Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on Diabetic Peripheral Neuropathy's evolving treatment landscape, patient reliance on conventional therapies, patient’s therapy switching acceptability, and drug uptake along with challenges related to accessibility, including Medical/scientific writers and Professors from renowned universities in the US, Europe, UK, and Japan.

DelveInsight’s analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers such as Massachusetts General Hospital, the University of Utah, Shinshu University School of Medicine, Stony Brook University, etc., were contacted. Their opinion helped understand and validate current and emerging therapy treatment patterns of Diabetic Peripheral Neuropathy market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and Market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Market Access and Reimbursement

The cost of newly Diabetic Peripheral Neuropathy approved medications is usually high, and because of it, patients escape from proper treatment or opt for off-label and cheap medications. It affects market access to newly launched medications, and reimbursement is crucial. The decision to reimburse often comes down to the drug's price relative to the benefit it produces in treated patients. Market access and reimbursement options can differ depending on regulatory status, target population size, the setting of care, unmet needs, the magnitude of incremental benefit claims, and costs.

The report further provides detailed insights on the Diabetic Peripheral Neuropathy drug’s country-wise accessibility and Diabetic Peripheral Neuropathy reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report

• The Diabetic Peripheral Neuropathy report covers a segment of key events, an executive summary, descriptive overview of Diabetic Peripheral Neuropathy, explaining the transition from acute to chronic pain, the pathophysiology of pain, and the various factors affecting the intensity and duration of Diabetic Peripheral Neuropathy.
• Comprehensive insights have been provided into the Diabetic Peripheral Neuropathy epidemiology segments and forecasts, the future growth potential of Diabetic Peripheral Neuropathy diagnosis rate, disease progression, and treatment guidelines.
• Additionally, an all-inclusive account of both the current and emerging Diabetic Peripheral Neuropathy therapies, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
• A detailed review of the Diabetic Peripheral Neuropathy market, historical and forecasted market size, Diabetic Peripheral Neuropathy market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM Diabetic Peripheral Neuropathy market.

Diabetic Peripheral Neuropathy Report Insights

• Diabetic Peripheral Neuropathy Patient Population
• Therapeutic Approaches
• Diabetic Peripheral Neuropathy Pipeline Analysis
• Diabetic Peripheral Neuropathy Market Size and Trends
• Existing and future Market Opportunity

Diabetic Peripheral Neuropathy Report Key Strengths

• Ten Year Forecast
• The 7MM Coverage
• Diabetic Peripheral Neuropathy Epidemiology Segmentation
• Key Cross Competition
• Attribute Analysis
• Diabetic Peripheral Neuropathy Drugs Uptake
• Key Diabetic Peripheral Neuropathy Market Forecast Assumptions

Key Questions

Market Insights

• What was the Diabetic Peripheral Neuropathy total market size, the market size by therapies, and market share (%) distribution in 2019, and what would it look like in 2032? What are the contributing factors for this growth?
• Which Diabetic Peripheral Neuropathy drug class will be the largest contributor in 2032?
• What are the pricing variations among geographies for Diabetic Peripheral Neuropathy approved and off-label therapies?

Epidemiology Insights:

• What is the diagnostic pattern of Diabetic Peripheral Neuropathy?
• Which type of severity is the largest contributor in patients affected with Diabetic Peripheral Neuropathy?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:

• What key designations have been granted for the emerging therapies for Diabetic Peripheral Neuropathy?
• What is the cost burden of Diabetic Peripheral Neuropathy approved therapies on the patient?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?

Reasons to buy

• Highlights of Access and Reimbursement policies of approved Diabetic Peripheral Neuropathy therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet need of the existing market so that the upcoming players can strengthen their development and launch strategy.