Cancer immunotherapy is one of the most exciting fields of research in oncology. Successful drug development in this space offers a highly lucrative opportunity for drug developers. Most excitement centers on immune checkpoint inhibitors; the 2014 approvals of the programmed cell death-1 (PD-1) inhibitors nivolumab (Bristol-Myers Squibb/Ono Pharmaceutical’s Opdivo) and pembrolizumab (Merck & Co.’s Keytruda) mark a significant milestone in the history of cancer immunotherapies, and the two agents are the focus of broad and ambitious clinical development programs. Developers are vying to bring new cancer immunotherapies to the market and are forging collaborations to get an edge in this increasingly competitive field. This drug development frenzy is driving rapid expansion of the pipeline across a wide range of oncology indications.

Questions Answered in This Report:

  • We forecast impressive annual growth of the cancer immunotherapy market over the ten-year forecast period (2013-2023). Which cancer immunotherapies currently in Phase III development will launch? Which indications will be driving this growth? Which cancer immunotherapy will be the most commercially successful?

  • Extensive R&D efforts are under way for current and emerging immune checkpoint inhibitors across multiple oncology indications. What are the most promising immune checkpoint inhibitors undergoing development? Which indications and patient populations are immune checkpoint inhibitors most likely to penetrate? How do interviewed experts perceive current and emerging immune checkpoint inhibitors? What notable combinatorial approaches are being pursued with agents from this drug class?

  • Programmed death-ligand 1 (PD-L1) overexpression is being evaluated as a predictive biomarker for response to the PD-1/PD-L1-targeted agents. What are multidisciplinary experts’ perceptions of PD-L1 overexpression as a predictive biomarker? What are the advantages and disadvantages of this potential biomarker? What hurdles will developers face in incorporating PD-L1 overexpression testing in routine practice?

  • Several therapeutic vaccines are in late-phase development for oncology. Which therapeutic vaccines are most promising, according to interviewed experts? Which indications or patient populations do experts consider the most appropriate for these cancer immunotherapies? Which therapeutic vaccines will launch over the forecast period?

  • Multiple cancer immunotherapies belonging to a variety of drug classes are in early-phase clinical development. In which drug classes is early-phase clinical development ongoing? Which cancer indications are being targeted by developers? Which are the most promising early-phase therapies to watch?

Scope:

Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.

Primary research: 27 country-specific interviews with thought leaders.

Epidemiology: Newly diagnosed incident cases and recurrent cases in select patient populations for malignant melanoma, non-small-cell lung cancer (NSCLC), renal cell carcinoma, glioblastoma multiforme, prostate cancer, gastric cancer, bladder cancer, squamous-cell carcinoma of the head and neck (SCCHN), and breast cancer, by country.

Population segments in market forecast: Malignant melanoma (resectable [stage II-III]; first-, second- and third-line unresectable/metastatic); NSCLC (newly diagnosed stage III; first-, second-, and third-line advanced/metastatic); renal cell carcinoma (first-, second-, third-, and fourth-line metastatic); glioblastoma multiforme (first, second, and third line); prostate cancer (first-line metastatic castrate-resistant); gastric cancer (second- and third-line metastatic); bladder cancer (muscle-invasive; second-line metastatic; SCCHN (first-, second-, and third-line recurrent/metastatic); breast cancer (first-line metastatic hormone-receptor-negative/HER2-negative [triple-negative]).

Emerging therapies: Phase I/II: 42 drugs; Phase III/PR: 33 drugs; registered: 11 drugs.

Market forecast features: We forecast drug-treatable population sizes and drug sales for all patient segments annually through 2023.

Author(s): Khurram Nawaz, M.Sc.