This Market Spotlight report covers the Small Cell Lung Cancer (SCLC) market, comprising key marketed and pipeline drugs, recent events and analyst opinion, probability of success, clinical trials, upcoming and regulatory events, a 10-year disease incidence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.

Key Takeaways

• Datamonitor Healthcare estimates that in 2019, there were 317,500 incident cases of small cell lung cancer (SCLC) worldwide, and forecasts that number to increase to 334,700 incident cases by 2028.
• Northern America is estimated to have the highest disease incidence of SCLC (10.43 per 100,000 people), while Africa has the lowest incidence (0.47 per 100,000 people).
• Approved drugs for SCLC focus target DNA, cyclin dependent kinase, topoisomerase I, programmed death-1 receptor/programmed death ligands (PD-L1 and PD-L2), and the immune system. These drugs are administered via the oral or intravenous routes.
• The majority of industry-sponsored drugs in active clinical development for SCLC are in Phase II. Therapies in development for SCLC focus on a wide variety of targets. The majority of drugs in development for SCLC are administered via the intravenous route, with the remainder being oral, intratumoral, inhaled, or subcutaneous formulations.
• High-impact upcoming events for drugs in the SCLC space comprise topline Phase I/II trial results for HPN328, topline Phase II/III trial results for Onivyde, topline Phase III trial results for Imfinzi and tiragolumab, and the expected initiation of Phase II trials for SHR3162 and SHR-1701.
• The overall likelihood of approval of a Phase I solid tumors asset is 5.3%, and the average probability a drug advances from Phase III is 42.3%. Drugs, on average, take 9.7 years from Phase I to approval, compared to 9.6 years in the overall oncology space.
• The distribution of clinical trials across Phase I–IV indicates that the vast majority of trials for SCLC have been in the early and mid-phases of development, with 88% of trials in Phase I–II, and only 12% in Phase III–IV.
• The US has a substantial lead in the number of SCLC clinical trials globally. Spain leads the major European markets, while China has the top spot in Asia.
• Clinical trial activity in the SCLC space is dominated by completed trials. Bristol Myers Squibb has the highest number of completed clinical trials for SCLC, with 47 trials.
• Bristol Myers Squibb leads industry sponsors with the highest overall number of clinical trials for SCLC, followed by AstraZeneca and Pfizer.