Published Date : 2023-12-15
Published Date : 2023-12-15
Updated On : 2024-10-04
Pages : 157
Thelansis’s “Diabetic Peripheral Neuropathic Pain (DPNP) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033" covers disease overview, epidemiology, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential Diabetic Peripheral Neuropathic Pain treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).
Peripheral neuropathic pain (PNP) is a distressing and enduring chronic pain syndrome that can manifest following damage or disease affecting the peripheral somatosensory nervous system or due to drug triggers. PNP causes vary and can be categorized based on whether nerve damage arises from systemic factors like diseases, toxins, or medications or localized secondary effects like trauma, surgery, or cancer. The signs and symptoms of PNP can fluctuate as the disease progresses and can be influenced by the patient's emotional state and anxiety levels. Neuralgias typically exhibit characteristic episodic paroxysms, whereas other neuropathic pains may occur as isolated episodes or as increasing intensity attacks on top of a continuous pain background. Peripheral neuropathy encompasses various types, with risk factors contingent upon the underlying condition or the affected nerves. PNP can either be congenital or develop due to injury or illness. The most prevalent form of peripheral neuropathy is associated with diabetes, affecting approximately 60–70% of diabetic patients. The numerous causes of peripheral neuropathy can be categorized as hereditary, infectious, immunologic, metabolic, mechanical, cancer-related, toxic, or idiopathic. Neuropathic pain syndromes represent chronic pain disorders resulting from nervous system lesions or diseases that typically transmit pain signals. These conditions encompass various situations, including health conditions, specific medications, or trauma. However, in some instances, the cause remains unidentified, termed idiopathic neuropathy. The Neuropathic Pain Special Interest Group (NeuPSIG) of the International Association for the Study of Pain (IASP) recommends tricyclic antidepressants, gabapentin or pregabalin, and the SNRIs venlafaxine or duloxetine as first-line treatments for neuropathic pain. Second-line options encompass tramadol, topical lidocaine, or high-concentration capsaicin. Strong opioids (Morphine and Oxycodone) and botulinum toxin-A (BTX-A) are included as third-line treatments for peripheral neuropathic pain. Cannabinoids and valproate receive weak recommendations against their use in neuropathic pain. Chronic neuropathic pain is more prevalent in women and individuals over 50, typically affecting areas like the lower back and limbs and the neck and upper limbs.
North America- the United States and Canada
Europe- EU5 (Germany, France, Italy, Spain, and the United Kingdom)
Other countries- Japan & China
This section of the study covers country-specific current clinical practice, the standard of care, and significant limitations around addressing the unmet needs. Retrospective analysis and bench-marking of clinical study outcomes are presented in terms of Pre-treatment & post-treatment clinical and demographic patient characteristics. Essentially, this section will cover the evolution of the current competitive landscape and its impact on the future treatment paradigm.
KOLs across 8 MM markets from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs
- Data Inputs with sourcing
- Market Event and Product Event
- Country-specific Forecast Model
- Market uptake and patient share uptake
- Attribute Analysis
- Analog Analysis
- Disease burden and pricing scenario
- Summary and Insights
Optimization of cash flow/ revenue flow concerning all fixed and variable investments throughout the product development process. The rate of return on an investment is a critical indicator to ensure the profitability and break-even of the project.
The competitive landscape includes country-specific approved as well as pipeline therapies. Any asset/product-specific designation or review such as Orphan drug designation, Fast track, Priority Review, Breakthrough Therapy Designation, Rare Pediatric Disease Designation, and Accelerated Approval are tracked and supplemented with analyst commentary.
Detailed clinical trial data analysis and critical product positioning include trial design, primary outcomes, secondary outcomes, dosing and schedules, inclusion and exclusion criteria, recruitment status and essentially covers the reported adverse events. Majorly the trial analysis helps determine the potential of the critical assets and their probable filing and launch date.
This report presents the most important clinical unmet needs in the treatment, according to Thelansis research and analysis. Other essential unmet needs identified through our study include decreased cost burden on patients, improved administration convenience, and improved patient compliance.
S. no | Asset | Company | Stage |
1 | LX9211 | Lexicon Pharmaceuticals | Phase 2 |
2 | JMKX000623 | Jemincare | Phase 2 |
3 | Pregabalin | CSPC Ouyi Pharmaceutical Co., Ltd. | Phase 3 |
4 | HSK16149 | Haisco Pharmaceutical Group Co., Ltd. | Phase 2 |
5 | Mirogabalin | Daiichi Sankyo Co., Ltd. | Phase 3 |
6 | CBD/PEA | Pure Green Pharmaceuticals Inc. | Phase 1/2 |
7 | Suzetrigine | Vertex Pharmaceuticals Incorporated | Phase 3 |
8 | NYX-2925 | Aptinyx | Phase 2 |
9 | ETX-018810 | Eliem Therapeutics (UK) Ltd. | Phase 2 |
10 | Ricolinostat | Regenacy Pharmaceuticals LLC | Phase 2 |
Continued...
KOLs across 8 MM market from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs.
COUNTRY | No. Of KOLs |
USA | 17 |
GERMANY | 4 |
UK | 4 |
SPAIN | 3 |
FRANCE | 2 |
ITALY | 3 |
JAPAN | 3 |
CHINA | 4 |
Data Inputs with sourcing, Market Event, Product Event, Country specific Forecast Model, Market uptake and patient share uptake, Attribute Analysis, Analog Analysis, Disease burden, and pricing scenario, Summary, and Insights.
1. Diabetic Peripheral Neuropathic Pain (DPNP) – Key Findings Summary |
1.1. Clinical findings |
1.1.1. Disease overview |
1.1.2. Therapeutic practices |
1.1.3. Future outlook |
1.2. Commercial findings |
1.2.1. Diabetic Peripheral Neuropathic Pain (DPNP) market scenario 2023 |
1.2.2. Diabetic Peripheral Neuropathic Pain (DPNP) market scenario 2028 |
1.2.3. Diabetic Peripheral Neuropathic Pain (DPNP) market scenario 2033 |
2. Diabetic Peripheral Neuropathic Pain (DPNP) Overview |
2.1. Disease Introduction |
2.2. Pathophysiology |
2.3. Signs and Symptoms |
2.4. Risk Factors |
2.5. Etiology |
2.6. Classification |
2.7. Pathogenesis |
2.8. Diagnosis |
2.9. Complications |
2.10. Treatment Algorithm |
2.10.1. Treatment in US (guidelines) |
2.10.2. Treatment in EU-5 (guidelines) |
2.10.3. Treatment in Japan (guidelines) |
2.10.4. Treatment in China (guidelines) |
2.11. Treatment Goals for Diabetic Peripheral Neuropathic Pain (DPNP) |
2.12. Referral Patterns |
2.12.1. Referral Scenario in US |
2.12.2. Referral Scenario in EU-5 |
2.12.3. Referral Scenario in Japan |
2.12.4. Referral Scenario in China |
2.13. Diabetic Peripheral Neuropathic Pain (DPNP) Prognosis |
2.14. Healthcare burden |
2.14.1. Healthcare burden in US |
2.14.2. Healthcare burden in EU-5 |
2.14.3. Healthcare burden in Japan |
2.14.4. Healthcare burden in China |
2.15. Unmet Needs in Diabetic Peripheral Neuropathic Pain (DPNP) management |
2.16. Market Opportunity for Diabetic Peripheral Neuropathic Pain (DPNP) |
2.17. KOL Comments on current and upcoming/expected treatment practices in Diabetic Peripheral Neuropathic Pain (DPNP) |
3. Epidemiology |
3.1. Epidemiology Overview |
3.2. Epidemiology by Geography |
3.2.1. Diabetic Peripheral Neuropathic Pain (DPNP) Epidemiology in US (2023-2033) |
3.2.1.1. Incidence of Diabetic Peripheral Neuropathic Pain (DPNP) |
3.2.1.2. Diagnosed cases |
3.2.1.3. Treatable Patient Pool |
3.2.1.4. Epidemiology Trends |
3.2.2. Diabetic Peripheral Neuropathic Pain (DPNP) Epidemiology in EU-5 (2023-2033) |
3.2.2.1. Incidence of Diabetic Peripheral Neuropathic Pain (DPNP) |
3.2.2.2. Diagnosed cases |
3.2.2.3. Treatable Patient Pool |
3.2.2.4. Epidemiology Trends |
3.2.3. Diabetic Peripheral Neuropathic Pain (DPNP) Epidemiology in Japan (2023-2033) |
3.2.3.1. Incidence of Diabetic Peripheral Neuropathic Pain (DPNP) |
3.2.3.2. Diagnosed cases |
3.2.3.3. Treatable Patient Pool |
3.2.3.4. Epidemiology Trends |
3.2.4. Diabetic Peripheral Neuropathic Pain (DPNP) Epidemiology in China (2023-2033) |
3.2.4.1. Incidence of Diabetic Peripheral Neuropathic Pain (DPNP) |
3.2.4.2. Diagnosed cases |
3.2.4.3. Treatable Patient Pool |
3.2.4.4. Epidemiology Trends |
3.3. Epidemiology Trends (World-wide) |
4. Market Outlook |
4.1. US Diabetic Peripheral Neuropathic Pain (DPNP) Market Forecast 2023-2033 |
4.1.1. Market Progression (Futuristic) |
4.1.2. Market Trends and Expectations |
4.1.2.1. Worst case scenario |
4.1.2.2. Base Case Scenario |
4.1.2.3. Best Case Scenario |
4.1.3. Drivers and Barriers |
4.2. UK Diabetic Peripheral Neuropathic Pain (DPNP) Market Forecast 2023-2033 |
4.2.1. Market Progression (Futuristic) |
4.2.2. Market Trends and Expectations |
4.2.2.1. Worst case scenario |
4.2.2.2. Base Case Scenario |
4.2.2.3. Best Case Scenario |
4.2.3. Drivers and Barriers |
4.3. France Diabetic Peripheral Neuropathic Pain (DPNP) Market Forecast 2023-2033 |
4.3.1. Market Progression (Futuristic) |
4.3.2. Market Trends and Expectations |
4.3.2.1. Worst case scenario |
4.3.2.2. Base Case Scenario |
4.3.2.3. Best Case Scenario |
4.3.3. Drivers and Barriers |
4.4. Germany Diabetic Peripheral Neuropathic Pain (DPNP) Market Forecast 2023-2033 |
4.4.1. Market Progression (Futuristic) |
4.4.2. Market Trends and Expectations |
4.4.2.1. Worst case scenario |
4.4.2.2. Base Case Scenario |
4.4.2.3. Best Case Scenario |
4.4.3. Drivers and Barriers |
4.5. Italy Diabetic Peripheral Neuropathic Pain (DPNP) Market Forecast 2023-2033 |
4.5.1. Market Progression (Futuristic) |
4.5.2. Market Trends and Expectations |
4.5.2.1. Worst case scenario |
4.5.2.2. Base Case Scenario |
4.5.2.3. Best Case Scenario |
4.5.3. Drivers and Barriers |
4.6. Spain Diabetic Peripheral Neuropathic Pain (DPNP) Market Forecast 2023-2033 |
4.6.1. Market Progression (Futuristic) |
4.6.2. Market Trends and Expectations |
4.6.2.1. Worst case scenario |
4.6.2.2. Base Case Scenario |
4.6.2.3. Best Case Scenario |
4.6.3. Drivers and Barriers |
4.7. Japan Diabetic Peripheral Neuropathic Pain (DPNP) Market Forecast 2023-2033 |
4.7.1. Market Progression (Futuristic) |
4.7.2. Market Trends and Expectations |
4.7.2.1. Worst case scenario |
4.7.2.2. Base Case Scenario |
4.7.2.3. Best Case Scenario |
4.7.3. Drivers and Barriers |
4.8. China Diabetic Peripheral Neuropathic Pain (DPNP) Market Forecast 2023-2033 |
4.8.1. Market Progression (Futuristic) |
4.8.2. Market Trends and Expectations |
4.8.2.1. Worst case scenario |
4.8.2.2. Base Case Scenario |
4.8.2.3. Best Case Scenario |
4.8.3. Drivers and Barriers |
4.9. Key Expected Milestones (world-wide) Impacting the Market |
5. Competitive Landscape |
5.1. Pipeline Therapies Overview |
5.1.1. Phase III Therapies |
5.1.1.1. Current Status |
5.1.1.2. Trial details, results |
5.1.1.3. Approval Timeline |
5.1.1.4. Likelihood of approval |
5.1.1.5. Expected Product Positioning |
5.1.1.2. All other Phase III Therapies ….. |
5.1.1.3. Attribute Analysis of Phase III molecules |
5.1.2. Phase II and Phase I/II Therapies |
5.1.2.1. Current Status |
5.1.2.2. Trial details, results |
5.1.2.3. Approval Timelines |
5.1.3. List of active Pre-clinical Therapies |
5.1.3.1. Status in Diabetic Peripheral Neuropathic Pain (DPNP) |
5.1.3.2. Company positioning |
5.1.3.2. All other pre-clinical therapies |
5.1.4. List of Inactive/discontinued assets |
5.1.4.1. Business impact of discontinuations on current pipeline |
5.1.5. Potential winners from Diabetic Peripheral Neuropathic Pain (DPNP) Pipeline |
5.1.5.1. Potential Blockbusters across the pipeline |
6. Regulatory/Approval Scenario |
6.1. Regulatory/Approval Framework in US |
6.1.1. Policy Framework |
6.1.2. Payer Expectations |
6.2. Regulatory/Approval Framework in UK |
6.2.1. Policy Framework |
6.2.2. Payer Expectations |
6.3. Regulatory/Approval Framework in France |
6.3.1. Policy Framework |
6.3.2. Payer Expectations |
6.4. Regulatory/Approval Framework in Germany |
6.4.1. Policy Framework |
6.4.2. Payer Expectations |
6.5. Regulatory/Approval Framework in Italy |
6.5.1. Policy Framework |
6.5.2. Payer Expectations |
6.6. Regulatory/Approval Framework in Spain |
6.6.1. Policy Framework |
6.6.2. Payer Expectations |
6.7. Regulatory/Approval Framework in Japan |
6.7.1. Policy Framework |
6.7.2. Payer Expectations |
6.8. Regulatory/Approval Framework in China |
6.8.1. Policy Framework |
6.8.2. Payer Expectations |
7. Clinical Trial Assessment – Current and Future Paradigm |
7.1. Distribution of Primary Endpoints across trials |
7.2. Distribution of Secondary Endpoints across trials |
7.3. Evolution and acceptance of surrogate endpoints |
7.4. Key Investigator initiated trials |
7.5. Attrition analysis |
7.5.1. Suspended/Discontinued Assets |
7.5.2. Failed Trials, Reasons and Business Impact |
7.5.3. Terminated Trials, Reasons and Business Impact |
7.5.4. Withdrawn Trials, Reasons and Business Impact |
7.6. Trial enrollment scenario and challenges |
7.7. Clinical Trial Guidance (across geographies) |
8. Thelansis Commentary |
8.1. Key Unmet needs in Diabetic Peripheral Neuropathic Pain (DPNP) |
8.2. Possible Best-case Clinical Trial Strategies |
8.3. Possible Best Case Targeted Product Profile (TPP) |
8.4. Possible Best-case Market positioning strategies |
8.5. Possible Best-case Market Access Strategies |
8.6. Possible Best-case LCM Strategies |
8.7. Overall View on Diabetic Peripheral Neuropathic Pain (DPNP) Market in Dollar Value |
9. Report Methodology |
9.1. Secondary research |
9.2. Primary research |
9.3. Data collation |
9.4. Insight Generation |
10. About Thelansis |
10.1. Our Capabilities |
10.2. Our Services |
10.3. Our Contacts |
10.4. Disclaimer |