This report delivers an in-depth understanding of the SCLC, historical and forecasted epidemiology as well as the SCLC market trends in the United States, EU5 (Germany, France, Italy, Spain, and United Kingdom) and Japan.
The report provides current treatment practices, emerging drugs, SCLC market share of the individual therapies, current and forecasted SCLC market size from 2017 to 2030 segmented by seven major markets. The report also covers current SCLC treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate best of the opportunities and assesses underlying potential of the market.
Small Cell Lung Cancer Epidemiology
The Small Cell Lung Cancer epidemiology division provide the insights about historical and current Small Cell Lung Cancer patient pool and forecasted trend for each seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the report also provides the diagnosed patient pool and their trends along with assumptions undertaken.
Total incident cases of SCLC in the 7MM was assessed to be 85,540 in 2017, and are expected to increase during the study period. The increase is partly credited to the rising trend in incidence in the 7MM, combined with underlying demographic changes in the respective markets. Furthermore, the total incident cases of SCLC patients were found to be more in males than in females in 7MM during the study period, i.e., 2017-2030.
The disease epidemiology covered in the report provides historical as well as forecasted Small Cell Lung Cancer epidemiology [segmented as Total Incident Patient Population, Gender-specific Incident Patient Population, Age-specific Incident Patient Population, Stage-Specific Incident Population, and Line-wise Treatment of Extensive-Stage SCLC (first-line, second-line platinum sensitive, second-line platinum refractory, and third-line and above] scenario of Small Cell Lung Cancer in 7MM covering United States, EU5 countries (Germany, France, Italy , Spain, and United Kingdom), and Japan from 2017 to 2030.
Among the European 5 countries, Germany had highest incident population of SCLC, followed by the United Kingdom and France. On the other hand, Spain had the lowest incident cases of SCLC.
Drug chapter segment of the Small Cell Lung Cancer report encloses the detailed analysis of Small Cell Lung Cancer marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the Small Cell Lung Cancer 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.
Opdivo (Nivolumab): Bristol-Myers Squibb
Opdivo (Nivolumab) by Bristol-Myers Squibb is a human immunoglobulin (Ig) G4 monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed death-1 (PD-1, PCD-1) with immune checkpoint inhibitory and antineoplastic activities. It is a prescription medicine used to treat people with unresectable or metastatic melanoma, metastatic non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), advanced renal cell carcinoma, classical Hodgkin lymphoma, recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN), urothelial carcinoma, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer and hepatocellular carcinoma. It is not known if Opdivo is safe and effective in children younger than 18 years of age. This drug is approved under accelerated approval based on overall response rate and duration of response for patients with metastatic small cell lung cancer with progression after platinum-based chemotherapy and at least one other line of therapy. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Keytruda (Pembrolizumab): Merck
Keytruda, also known as pembrolizumab, is a programmed death receptor-1 (PD-1)-blocking antibody. It is mainly used for cancers that are advanced, have spread to other parts of the body (metastatic) or are not responding to other treatments. In some cancers, it is only given to patients whose tumors produce high levels of a protein known as PD-L1. This drug is also used to help prevent the cancer from coming back after patients had surgery to remove melanoma (adjuvant therapy).
Small Cell Lung Cancer Emerging Drugs
Imfinzi +/- tremelimumab: AstraZeneca
Imfinzi (Durvalumab) also known as medi4736 with or without tremelimumab, is under development by AstraZeneca. It is administered intravenously after completing a combination of chemotherapy and radiation therapy (CRT) given at the same time, also known as concurrent CRT. Imfinzi may also attack healthy cells. It binds to a protein called PD-L1, which is found on some cancer cells and may block this protein and help the immune system kill cancer cells. It is a type of monoclonal antibody and a type of immune checkpoint inhibitor.
In 2017, AstraZeneca initiated a phase III, randomized, multicenter, open-label, and comparative study to determine the efficacy of durvalumab or durvalumab and tremelimumab in combination with platinum-based chemotherapy for the first-line treatment in patients with extensive stage SCLC (CASPIAN). In addition to this, the company also initiated a phase III, randomized, double-blind, placebo-controlled, multi-center, international study of durvalumab or durvalumab and tremelimumab as consolidation treatment for patients with limited-stage SCLC who have not progressed following concurrent chemoradiation therapy
Lurbinectedin (PM01183): PharmaMar
Lurbinectedin (Zepsyre, PM1183) by PharmaMar, is a compound in clinical research that belongs to the RNA polymerase II enzyme inhibitors family, which is essential for the transcription process. By inhibiting transcription, the compound reduces the expression of certain factors that are involved in tumor progression and blocks the DNA repair system called NER. This eventually induces the death of tumor cells. The antitumor efficacy of PM1183 (lurbinectedin) is being investigated in several types of tumors. Currently it is in phase III clinical developmental trial for SCLC.
EpicentRx is developing its lead program RRx-001, which is among a portfolio of immunotherapeutic compounds that normalize the tumor microenvironment, activate the tumor associated macrophages (TAMs) of the innate immune system, and sensitize solid tumors to standard therapies in small cell lung cancer (SCLC), glioblastoma, colorectal cancer and additional cancers. It is a next generation, small molecule anticancer immunotherapeutic that down regulates the CD47/SIRP axis and repolarizes TAMs and other immunosuppressive cells in the tumor microenvironment to an immunostimulatory phenotype. RRx-001 is designed to be used either as a monotherapy or in combination with chemotherapy, radiation therapy or immunotherapy. It has been granted Orphan Drug Designation from the US FDA and EMA for the treatment of patients with small cell lung cancer.
The management of SCLC is problematic due to the aggressive nature of this type of cancer. Another reason behind the complex treatment of SCLC is frequent substantial comorbidities caused by smoking, and impaired performance status, which make it more challenging for the patients with SCLC to receive appropriate treatment. As previously mentioned, SCLC has two stages. Among those, LS-SCLC is typically treated with a combined modality therapy of radiation therapy and chemotherapy. The recommended systemic chemotherapy is the combination of etoposide and cisplatin, administered concomitantly with thoracic irradiation.
There may also be a role for surgery in the management of patients with very early-stage SCLC, generally without nodal involvement. Besides this, the combination of radiotherapy and cisplatin-based chemotherapy is the standard of care for LS-SCLC. Three anti-PD-1 antibodies, Atezolizumab (Tecentriq; Hoffmann-La Roche - Genentech), Nivolumab (Opdivo; Bristol-Myers Squibb) and Pembrolizumab (Keytruda; Merck Sharp & Dohme Corp), have been approved for the treatment of SCLC. They block the inhibitory receptor on tumor-infiltrating T cells and regulate the adaptive immune system to exert antitumor response.
Among all the above-mentioned Immunotherapies, atezolizumab (Tecentriq; Bristol-Myers Squibb) is the only one which is approved in the US, Europe, and Japan [US: (March 2019) - EU: (September 2019) - JP: (August 2019)] for initial treatment of ES-SCLC.
According to the publisher, Small Cell Lung Cancer market in the 7MM is expected to change in the study period 2017-2030. The therapeutic market of Small Cell Lung Cancer in seven major markets is expected to generate USD 337 million in 2017 and will increase in the study period 2017-2030.
In 2017, the revenue generated in Second line platinum sensitive extensive SCLC was around USD 64 Million. Furthermore, the revenue of Second line platinum resistant extensive SCLC was around 15% of the overall market size.
The United States Market Outlook
Among the 7MM countries, the United States had the highest market size of SCLC in 2017.
EU-5 Countries: Market Outlook
The total Small Cell Lung Cancer market Size and market Size by therapies in Germany, France, Italy, Spain and the United Kingdom is provided in this section.
Japan Market Outlook
Like other 7MM countries, at present, the therapeutic landscape for SCLC in Japan is dependent on current treatment regimens. Assessments show the market size is likely to propel by the end of 2030, starting with USD 54 million in 2017.
Currently, market is mainly driven by chemotherapeutic agents as SCLC patients in the US mostly receive Platinum plus etoposide combination therapy. And within the regimen, combination of carboplatin plus etoposide is the gold standard treatment across the US, EU5 and JP, cisplatin plus etoposide was more common in the EU5 compared with the US or Japan. Tecentriq (atezolizumab) and Imfinzi (durvalumab) expected to dominate the market in future due to targeting of broader pool of patients (i.e. first line treatment setting) and expected less completion in first line setting
Small Cell Lung Cancer Pipeline Development Activities
4. Dinutuximab (Unituxin): United Therapeutics: Phase II/III
1. In March 2020, AstraZeneca's Imfinzi has been approved in the United States as a 1st-line treatment for adult patients with ES-SCLC in combination with standard-of-care (SoC) chemotherapies, etoposide plus either carboplatin or cisplatin (platinum-etoposide) (AstraZeneca, 2020). Imfinzi is currently under clinical investigation for Limited and extensive-stage SCLC and not yet approved in any markets outside of the United States.
2. In December 2019, the company submitted to NDA to the US FDA in the United States for lurbinectedin for the treatment of patients with SCLC who have progressed after prior platinum-containing therapy, under the accelerated approval regulations.
3. In November 2019, EpicentRx Initiated dosing in phase III trial of immunotherapy RRx-001 for third-line small cell lung cancer. REPLATINUM is EpicentRx's first Phase III study of RRx-001, a small molecule immunotherapy targeting CD47 - SIRP.
In January 2020, the National Institute for Health and Care Excellence (NICE) proposed that Tecentriq in combination with carboplatin and etoposide shouldn't be made available for untreated extensive-stage SCLC in adults.
According to the guidance, it was noted that clinical data show that Tecentriq plus chemotherapy could help people to live longer without their disease progressing, and to live for longer compared with chemotherapy alone. Also, the agency said that the cost-effectiveness estimates for atezolizumab with chemotherapy are higher than what is considered a cost-effective use of NHS resources. So, it should not be available for SCLC via the Cancer Drugs Fund - which provides a backup route for patient access to drugs while new evidence is being generated - although NICE notes that Roche did not express an interest in the treatment being considered for funding via the CDF.
To keep up with current market trends, we take KOLs and SME's opinion working in Small Cell Lung Cancer domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps to understand and validate current and emerging therapies treatment patterns or Small Cell Lung Cancer market trend. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.
Competitive Intelligence Analysis
The publisher performs Competitive and Market Intelligence analysis of the Small Cell Lung Cancer Market by using various Competitive Intelligence tools that includes - SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies etc. The inclusion of the analysis entirely depends upon the data availability.
Scope of the Report
The report covers the descriptive overview of Small Cell Lung Cancer, explaining its causes, signs and symptoms, pathophysiology and currently available therapies
Comprehensive insight has been provided into the Small Cell Lung Cancer epidemiology and treatment in the 7MM
Additionally, an all-inclusive account of both the current and emerging therapies for Small Cell Lung Cancer are provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape
A detailed review of Small Cell Lung Cancer market; historical and forecasted is included in the report, covering drug outreach in the 7MM
The report provides an edge while developing business strategies, by understanding trends shaping and driving the global Small Cell Lung Cancer market