Large Cell Neuroendocrine Carcinoma (LCNEC) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033

Large Cell Neuroendocrine Carcinoma (LCNEC) Market Outlook and Forecast

Large Cell Neuroendocrine Carcinoma (LCNEC) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033

Published Date : 2023-05-16

Updated On : 2024-04-22

Pages : 157

Large Cell Neuroendocrine Carcinoma (LCNEC) Market Outlook

Thelansis’s “Large Cell Neuroendocrine Carcinoma (LCNEC) 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 Large Cell Neuroendocrine Carcinoma treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

Large Cell Neuroendocrine Carcinoma (LCNEC) Overview

Large Cell Neuroendocrine Carcinoma (LCNEC) is a distinct subgroup of high-grade neuroendocrine neoplasms, exhibiting a rare occurrence throughout the human body. Although the lung is identified as the most prevalent primary site, LCNEC has been reported in the gastrointestinal tract and an array of other locations, including the cervix, uterus, kidney, bladder, prostate, pharynx, larynx, and numerous other primary sites. Its aggressive nature and rapid growth characterize LCNEC, drawing parallels with Small Cell Lung Cancer (SCLC). The majority of LCNEC cases originate in the lungs, with pulmonary LCNEC accounting for 2 to 3.5% of all lung cancer cases. LCNEC is a high-grade carcinoma that exhibits neuroendocrine architectural features, including the formation of rosettes, trabeculae, organoid nests, or perilobular palisading patterns, more than 10 mitoses per 2 mm2, and the expression of neuroendocrine immunohistochemical markers. The current World Health Organization (WHO) criteria for LCNEC diagnosis encompass:

  1. Neuroendocrine morphology (trabeculae, palisading, organoid nesting, and/or rosette formation)
  2. A high proliferation rate (>10 mitoses per 10 high-power fields)
  3. Extensive geographic necrosis
  4. Immunohistochemical (IHC) expression of at least one neuroendocrine marker (chromogranin-A, synaptophysin, NCAM/CD56)

The cytological diagnosis of LCNEC and its differentiation from SCLC can pose significant challenges. However, two critical clinical distinctions from SCLC include (i) a higher likelihood of presenting with early-stage disease (~25% of cases) and (ii) a greater propensity for primary lesions to be peripheral. Despite LCNEC distinction from other subtypes of Non-Small Cell Lung Cancer (NSCLC) or SCLC, no standard of care (SOC) currently exists.

Geography Covered:

North America- the United States and Canada

Europe- EU5 (Germany, France, Italy, Spain, and the United Kingdom)

Other countries- Japan & China

Study Period: 2023-2033

Current Clinical Practice and Treatment Algorithm

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.

KOL Insights:

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

Market Forecast: Patient Based Forecast Model (MS. Excel Based Automated Dashboard)

- 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

NPV/ IRR Calculator-

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.

Competitive Landscape:

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.

Clinical Trial Assessment-

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.

Unmet Medical Needs Overview-

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.

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Large Cell Neuroendocrine Carcinoma (LCNEC) Competitive Landscape

S. no Asset Company Stage
1 ABD-147 Abdera Therapeutics Phase 1
2 SNC115 Shanghai Simnova Biotechnology Co.,Ltd. Phase 1
3 Atezolizumab Roche Pharma AG Phase 2
4 FZ-AD005 Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. Phase 1
5 LB2102 Legend Biotech USA Inc Phase 1
6 PEN-221 Tarveda Therapeutics Phase 1/2
7 Nivolumab Bristol-Myers Squibb Phase 2
8 PT217 Phanes Therapeutics Phase 1

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

Large Cell Neuroendocrine Carcinoma (LCNEC) Market Forecast: Patient Based Forecast Model (MS. Excel Based Automated Dashboard)

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.

Large Cell Neuroendocrine Carcinoma (LCNEC) Market Forecast

1.  Large Cell Neuroendocrine Carcinoma (LCNEC) – 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. Large Cell Neuroendocrine Carcinoma (LCNEC) market scenario 2023
                     1.2.2. Large Cell Neuroendocrine Carcinoma (LCNEC) market scenario 2028
                     1.2.3. Large Cell Neuroendocrine Carcinoma (LCNEC) market scenario 2033

2. Large Cell Neuroendocrine Carcinoma (LCNEC) 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 Large Cell Neuroendocrine Carcinoma (LCNEC)
         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. Large Cell Neuroendocrine Carcinoma (LCNEC) 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 Large Cell Neuroendocrine Carcinoma (LCNEC) management
         2.16.  Market Opportunity for Large Cell Neuroendocrine Carcinoma (LCNEC)
         2.17. KOL Comments on current and upcoming/expected treatment practices in Large Cell Neuroendocrine Carcinoma (LCNEC)

3.       Epidemiology

         3.1.    Epidemiology Overview
         3.2.    Epidemiology by Geography
                     3.2.1. Large Cell Neuroendocrine Carcinoma (LCNEC) Epidemiology in US (2023-2033)
                             3.2.1.1.              Incidence of Large Cell Neuroendocrine Carcinoma (LCNEC)
                             3.2.1.2.              Diagnosed cases
                             3.2.1.3.              Treatable Patient Pool
                             3.2.1.4.              Epidemiology Trends
                     3.2.2. Large Cell Neuroendocrine Carcinoma (LCNEC) Epidemiology in EU-5 (2023-2033)
                             3.2.2.1.              Incidence of Large Cell Neuroendocrine Carcinoma (LCNEC)
                             3.2.2.2.              Diagnosed cases
                             3.2.2.3.              Treatable Patient Pool
                             3.2.2.4.              Epidemiology Trends
                     3.2.3. Large Cell Neuroendocrine Carcinoma (LCNEC) Epidemiology in Japan (2023-2033)
                             3.2.3.1.              Incidence of Large Cell Neuroendocrine Carcinoma (LCNEC)
                             3.2.3.2.              Diagnosed cases
                             3.2.3.3.              Treatable Patient Pool
                             3.2.3.4.              Epidemiology Trends
                     3.2.4. Large Cell Neuroendocrine Carcinoma (LCNEC) Epidemiology in China (2023-2033)
                             3.2.4.1.              Incidence of Large Cell Neuroendocrine Carcinoma (LCNEC)
                             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 Large Cell Neuroendocrine Carcinoma (LCNEC) 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 Large Cell Neuroendocrine Carcinoma (LCNEC) 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 Large Cell Neuroendocrine Carcinoma (LCNEC) 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 Large Cell Neuroendocrine Carcinoma (LCNEC) 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 Large Cell Neuroendocrine Carcinoma (LCNEC) 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 Large Cell Neuroendocrine Carcinoma (LCNEC) 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 Large Cell Neuroendocrine Carcinoma (LCNEC) 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 Large Cell Neuroendocrine Carcinoma (LCNEC) 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 Large Cell Neuroendocrine Carcinoma (LCNEC)
                                      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 Large Cell Neuroendocrine Carcinoma (LCNEC) 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 Large Cell Neuroendocrine Carcinoma (LCNEC)
         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 Large Cell Neuroendocrine Carcinoma (LCNEC) 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