Prior to the launching of Yervoy, the five-year survival rate for patients with early stage melanoma was 98%; but the five-year survival rate for late-stage melanoma was just 16%. Yervoy has been reported to have a survival rate of 25% when tested alone. When tested as part of a combination therapy treatment with Bristol’s nivolumab, the two-year survival rates rose to 88% for patients with late-stage cancer. Increase in patient survival rates brought about by cancer immunotherapy treatment is similar to that seen when bone marrow transplantation changed our conception on how blood cancer was treated.
Therefore, it is no wonder that in 2013, most science journals hailed cancer immunotherapy as the breakthrough treatment of the year. Conceivably, what makes advancements in cancer immunotherapy research even more dramatic is the fact it has the potential to treat a wide range of tumor types. If the present trends continue, cancer immunotherapy drugs will have a market value of about $80 billion in 2020. A single drug, Bristol-Myers Squibb’s Yervoy, for example has earned revenues of about $960 million in 2013 and it is expected to have a market value of $1,775.2 million in 2020.
Recently, a new class of anti-cancer agents called checkpoint inhibitors has hit the market. In the first week of September 2014, Bristol-Myers Squibb and Ono Pharmaceutical launched their PD-1 (programmed cell death-1) inhibitor Opdivo (nivolumab) in Japan for unresectable melanoma. Later, Merck got FDA clearance for PD-1 inhibitor Keytruda (pembrolizumab) for unresectable melanoma following the treatment with Yervoy (ipilimumab).
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In the U.S., Opdivo was granted approval in 2015 for renal carcinoma, non-small-cell lung cancer (NSCLC) and previously treated advanced melanoma. In May 2016, Opdivo was granted FDA approval for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT).
Keytruda (pembrolizumab), another PD-1 inhibitor was granted FDA approval in October 2015 for advanced NSCLC, and was granted EMA approval for melanoma in July 2015. Both Keytruda and Opdivo have six figure price tags in the market. Keytruda will cost $12,500 a month and Merck says the median usage is 6.2 months, which works out to a $77,500 price tag, or $150,000 on annualized basis. In Japan, Opdivo costs about $143,000 a patient. Industry experts have predicted that Keytruda and Opdivo will generate sales revenues of $2.9 billion and $4.3 billion respectively in 2019.
Another area of anticancer therapy is cancer vaccines. There are two different types of cancer vaccines: prophylactic vaccines to prevent cancers from occurring, and therapeutic vaccines to treat pre-existing cancers. A few prophylactic vaccines for viral-associated cancers have had significant success, such as the human papillomavirus vaccine that helps prevent cervical cancer. On the other hand, therapeutic vaccines have proven much more elusive and a string of failures bred significant skepticism. Ultimately, in 2010, perseverance paid off and the first therapeutic vaccine sipuleucel-T for the treatment of metastatic prostate cancer was approved by the FDA: In spite of its financial restructuring efforts, Dendreon earned $303.8 million in 2014 which was $20.1 million more than its 2013 sales revenue.
The CAR-T industry is addressing unmet needs in specific relapsed cancers, however does early clinical trial data support a blockbuster status for this upcoming therapy? Some patients do indeed show long term activity and high remission rates, but there is a large proportion of patients with toxicities such as cytokine release syndrome and neurotoxicity. The main players within the CAR-T market are Juno Therapeutics, Kite Pharma, Novartis and Cellectis. The market is moving ahead, backed by years of R&D, from both academia and industry, investors capitol and small clinical studies. From 2017, Kelly Scientific forecasts that CAR T therapy will become more streamlined, with faster manufacturing times as advances in technologies take hold and clinical trials provide more robust evidence that this immunotherapy is robust. These factors, plus strategies to reduce adverse reactions and toxicities and larger players like Novartis taking stage will push CAR T therapy ahead. However, recent deaths in the Juno ROCKET trial are creating questions amongst investors. How will the CAR T space influence the total immunotherapy industry going forward? This comprehensive report scrutinizes the total market and provides cutting-edge insights and analysis.
This report provides a comprehensive overview of the size of cancer immunotherapy market, the segmentation of the market, key players and the vast potential of therapies that are in clinical trials. Oncologic therapeutics cannot cure cancer and yet in 2014, the overall market for cancer therapeutics stood at about $84.3 billion. Any drug that can provide a reasonable survival of more than five years for cancer patients can achieve a blockbuster status. Within cancer therapeutics, immunotherapeutic drugs have gained worldwide acceptance, because they are targeted drugs targeting only cancer cells. Today, cancer immunotherapy drugs have captured nearly 50% of the overall oncology drugs market, generating about $41.0 billion in 2014 alone. This report describes the evolution of such a huge market in 20 chapters supported by over 180 tables and figures in 317 pages.
• An overview of cancer immunotherapy that includes: monoclonal antibodies, cancer vaccines and non-specific cancer immunotherapies and CAR T therapies.
• Focus on current trends in cancer immunotherapies that include: anti-PD-1 drugs, Dendritic cell vaccines, T-cell therapies and cancer vaccines.
• Insight into the challenges faced by drug developers, particularly about the success vs. failure ratios in developing cancer immunotherapy drugs.
• Descriptions of more than 23 cancer immunotherapeutics approved and used as targeted drugs
• Insight into the various immunotherapeutics available for specific cancer types.
• Description and data for the prevalence of cancer types that are addressed by cancer immunotherapeutics.
• Overall global cancer therapeutics market, leading market players and the best selling cancer drugs.
• Detailed account of the market for cancer immunotherapeutics by geography, indication, company and individual drugs.
• Profiles, marketed products and products in the pipeline of 79 companies that are mostly located in the U.S. and Europe.
• Summary table to identify the category of immunotherapy drug offered by the 79 companies.
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1.2 Key Questions Answered in this Report
What is the global market for cancer immunotherapeutics by product class such as MAbs, vaccines and non-specific immunotherapies, through 2020?
• What is the global market for cancer immunotherapeutics by geography, through 2020?
• What is the global market for cancer immunotherapeutics by indication, through 2020?
• What is the global market for MAbs by type such as naked MAbs and ADCs, through 2020?
• What are the market values for Herceptin, Avastin, Erbitux, Yervoy, Mabthera, Adectris, and Keytruda?
• What is the global market for cancer vaccines?
• What is the global market for cytokines in cancer immunotherapy?
• The projected market values for Nivolumab, RG7446, DCVax-L, MEDI4736 etc.?
• What immunotherapies were approved between 1986 and 2016?
• What monoclonal antibodies (MAbs) were approved by the FDA to treat different types of cancers?
• What are naked MAbs and how many of them have been approved by the FDA?
• What are antibody-drug conjugates (ADCs) and how many of them are available in the market?
• What are the common cytotoxic “wareheads” used in ADCs?
• What are the important clinical assets in ADCs?
• How many bispecific MAbs are in late-stage development?
• What are the common side effects of MAbs in cancer immunotherapy?
• What are cancer vaccines and how many of them have been licensed to be marketed?
• How many cytokines have been approved for being used in cancer immunotherapy?
• What are the major checkpoint inhibitors in clinical development?
• What is the current status of anti-PD-1 drugs, dentritic cell therapies, T-cell therapies and cancer vaccines?
• What are the most valuable R&D projects in cancer immunotherapy and what would be their approximate sales revenues in 2020 Number of melanoma drugs approved between 1998 and 2016?
• Number of lung cancer drugs approved between 1998 and 2016?
• Number of brain cancer drugs approved between 1998 and 2016?
• What is CAR T Therapy?
• What are the main challenges associated with CAR T therapy?
• When will the first CAR T therapeutics be approved?
• What are the current regulations for immunotherapies in USA, Europe & Japan?
• What are the main manufacturing steps in CAR T therapy?
• What challenges lie ahead for CAR T production?
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