Published Date : 2023-04-17
Published Date : 2023-04-17
Updated On : 2024-01-12
Pages : 153
Thelansis’s “Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) 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 Chronic Inflammatory Demyelinating Polyneuropathy treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).
Chronic inflammatory demyelinating polyneuropathy (CIDP) is a neuropathic condition affecting peripheral nerves and nerve roots. It is acquired and mediated by the immune system, typically presenting with recurring or progressively worsening symmetrical weakness in both proximal and distal muscle groups. Clinically, CIDP is divided into two categories: "typical" and "atypical" cases. Typical CIDP manifests as a symmetrical polyneuropathy, equally impacting both proximal and distal muscles. In contrast, atypical CIDP includes conditions like 'distal acquired demyelinating symmetric' (DADS) and multifocal acquired demyelinating sensory and motor neuropathy (MADSAM), also known as Lewis-Sumner syndrome (LSS). DADS is characterized by a symmetrical, length-dependent sensory or sensorimotor neuropathy, often associated with an IgM paraprotein and significantly increased distal motor latencies. While these features resemble demyelinating neuropathy with antibodies against myelin-associated glycoprotein (MAG), anti-MAG neuropathy is excluded from CIDP according to EFNS/PNS criteria due to the presence of specific antibody presence and distinct treatment responses. LSS exhibits a multifocal distribution; a key electrophysiological feature is a conduction block. Additionally, pure motor and sensory CIDP variants have been documented, with some cases restricted to sensory nerve roots, referred to as chronic immune sensory polyradiculopathy. CIDP is diagnosed based on electrodiagnostic or pathological evidence of demyelination and a positive response to immunomodulatory therapies. The most common subtype is typical CIDP, accounting for at least 50 to 60 percent of all cases. Panzyga® (Immune Globulin Intravenous [Human] – 10 percent Liquid Preparation) treats adults with CIDP, a neurological disorder affecting the peripheral nerves.
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 | Efgartigimod alfa | argenx | Phase 3 |
2 | Batoclimab | Immunovant Sciences GmbH | Phase 2 |
3 | Panzyga | Octapharma | Phase 3 |
4 | SAR445088 | Bioverativ, a Sanofi company | Phase 2 |
5 | MD1003 | MedDay Pharmaceuticals SA | Phase 2 |
6 | Nipocalimab | Janssen Research & Development, LLC | Phase 3 |
7 | Rozanolixizumab | UCB Biopharma SRL | Phase 2 |
8 | TAK-771 | Takeda | Phase 3 |
9 | I10E | Laboratoire français de Fractionnement et de Biotechnologies | Phase 3 |
10 | Rituximab | Zenyaku Kogyo Co., Ltd. | 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. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) – 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. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) market scenario 2023 |
1.2.2. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) market scenario 2028 |
1.2.3. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) market scenario 2033 |
2. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) 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 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) |
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. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) 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 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) management |
2.16. Market Opportunity for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) |
2.17. KOL Comments on current and upcoming/expected treatment practices in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) |
3. Epidemiology |
3.1. Epidemiology Overview |
3.2. Epidemiology by Geography |
3.2.1. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Epidemiology in US (2023-2033) |
3.2.1.1. Incidence of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) |
3.2.1.2. Diagnosed cases |
3.2.1.3. Treatable Patient Pool |
3.2.1.4. Epidemiology Trends |
3.2.2. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Epidemiology in EU-5 (2023-2033) |
3.2.2.1. Incidence of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) |
3.2.2.2. Diagnosed cases |
3.2.2.3. Treatable Patient Pool |
3.2.2.4. Epidemiology Trends |
3.2.3. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Epidemiology in Japan (2023-2033) |
3.2.3.1. Incidence of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) |
3.2.3.2. Diagnosed cases |
3.2.3.3. Treatable Patient Pool |
3.2.3.4. Epidemiology Trends |
3.2.4. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Epidemiology in China (2023-2033) |
3.2.4.1. Incidence of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) |
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 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) 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 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) 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 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) 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 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) 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 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) 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 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) 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 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) 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 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) 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 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) |
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 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) 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 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) |
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 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) 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 |