The launches of sipuleucel-T (Dendreon’s Provenge) and ipilimumab (Bristol-Myers Squibb’s Yervoy) in 2010 and 2011, respectively, represented the first notable immunotherapy approvals in anticancer treatment since the advent of the cytokines. Their approvals dramatically altered the treatment landscape in their respective indications—prostate cancer and malignant melanoma—and laid the foundations for the re-emergence of immunotherapy as a key treatment strategy in oncology. A plethora of cancer immunotherapies are in development for multiple oncology indications and present a highly lucrative opportunity for immunotherapy developers.

Questions Answered in This Report:

  • We forecast impressive annual growth in the immunotherapies market over the ten-year forecast period (2012-2022). What factors are driving and constraining market growth? Which immunotherapies currently in Phase III development will launch? Which indications will be driving this growth?

  • The immune checkpoint inhibitors are the focus of extensive R&D across multiple oncology indications. What are the clinically and commercially most promising immune checkpoint inhibitors undergoing development? Which indications and patient populations are immune checkpoint inhibitors most likely to penetrate? How will these agents compete with drugs already on the market and with agents belonging to the same drug class? What notable combinatorial approaches are being pursued with agents of this drug class?

  • Programmed death-ligand 1 (PD-L1) overexpression is being evaluated as a predictive biomarker for response for the PD-1/PD-L1-targeted agents. What are multidisciplinary thought-leader perceptions of PD-L1 overexpression as a predictive biomarker? What do thought leaders consider to be the main hurdles that developers will face in incorporating PD-L1 overexpression testing in routine practice?

  • We anticipate the approval of several therapeutic cancer vaccines in multiple cancer indications. Which novel cancer therapy vaccines are slated to launch? Which indications and/or patient populations do experts consider the most appropriate for these vaccines? What are experts’ opinions of personalized versus off-the-shelf therapeutic vaccines?


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

Primary research: 23 interviews with thought leaders.

Epidemiology: Newly diagnosed incident cases and recurrent (or, for some indications, transformed)cases in select patient populations for malignant melanoma, non-small-cell lung cancer (NSCLC), renal cell carcinoma, glioblastoma multiforme, and prostate cancer, by country.

Population segments in market forecast: Malignant melanoma (resectable [stage II-III]; first-line unresectable/metastatic; second-line unresectable/metastatic; third-line unresectable/metastatic); NSCLC (newly diagnosed stage III; first-line advanced/metastatic; second-line advanced/metastatic; third-line advanced/metastatic); renal cell carcinoma (second-line metastatic; third-line metastatic; fourth-line metastatic); glioblastoma multiforme (first line; second line; third line); prostate cancer (first-line metastatic castrate-resistant).

Emerging therapies: Phase I/II: 50 drugs; Phase III/PR: 32 drugs; registered: 14 drugs.

Market forecast features: We forecast drug-treatable population sizes and drug sales for all patient segments annually through 2022.

Author(s): Khurram Nawaz, M.Sc.
Rachel Webster M.Sc., D.Phil.