Immunotherapy is forecast to become the oncology treatment of choice by 2026 with an estimated 60% of previously treated cancer patients likely to adopt immunotherapy in this timeframe. Multiple treatment lines, combination immunotherapy and the opportunity for repeat treatment are likely to accelerate fast growth. Cancer immunotherapy also expands into multiple indications and our analysis indicates that key immunotherapies including anti-PD-1 drugs, dendritic cell vaccines, T-cell therapies and cancer vaccines are all driving the market. The rising incidence and prevalence of numerous cancers globally is a significant accelerator of market growth. This is due to more sensitive early detection techniques, higher patient awareness and a growing aging population. Furthermore, the FDA’s pro-science attitude will accelerate development and regulatory approval for these immunotherapy drugs. To that end, the cancer immunotherapy market is forecast to hit $143 billion globally, with the USA, Europe, Japan and South Korea dominating by 2025 according to the latest research by Kelly Scientific’s Immunotherapy Market Report.
Strong Immunotherapy Market Growth Through Key Drug Approvals
Overall strong market growth rates are expected due to a significant unmet need and increasing trends of hematological cancers. Prior to the market launch 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. Other key therapeutic players in this market include Opdivo (nivolumab), Keytruda (pembrolizumab), Tecentriq (atezolizumab), Ibrance (palbociclib) the newly approved Bavencio (avelumab) and Imfinzi (durvalumab) and of course the first CAR-T therapies Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel).
Opdivo (nivolumab) from BMS is one of the most exciting agents in the immunotherapy market, and is indicated for melanoma, lung cancer, kidney cancer, blood cancer, head and neck cancer, and bladder cancer. It was given fast-track market approval on December 22, 2014. The majority of immunotherapy agents are anti-programmed death-1 (PD-1) monoclonal antibodies, which will certainly guide the market over the coming years. Projects that currently are valuable include combined immunotherapies on our knowledge of CD137 and PD-1/PDL1 mechanisms. A study on a novel effector activating monoclonal antibody known as IMAB362 for the treatment of solid cancers is also exciting. Other projects comparing CAR-T cell immunotherapy effectiveness against T-cells that target CD19 or mesothelin are interesting in a preclinical setting. Of course, Novartis gained the first CAR-T FDA approval for Kymriah (tisagenlecleucel, CTL019), in August 2017, for children and young adults with B-cell ALL. In October 2017, Yescarta (axicabtagene ciloleucel) from Kite Pharma for adult patients large B-cell lymphoma was also given FDA approval. This is a major boost for the global and US immunotherapy, and gene therapy markets.
What Are CAR-T Immunotherapies? How Will They Impact the Market?
CAR T (chimeric antigen receptor T) cells are engineered specificity using antibody fragments directed to the tumor cell, and also T-cell CD8/CD3 plasma membrane proteins that elicit specific activity towards the tumor cell, via intracellular signaling pathways. To date immunotherapy publications have revealed a number of effective intracellular molecules in the engineered T cell including CD28, 4-1BB (CD137) and CD3 zeta. These engineered immunotherapy T cells have numerous advantages including:
- Intracellular domain can be modified to increase efficacy and durability of CAR-T
- CAR-T are still subject to the same regulatory and tolerogenic constraints of natural T cells, including checkpoints, Treg, MDSC
- CAR-T can be engineered to express cytokines and chemokines that further enhance function and migration
- Can be modified to express suicide genes that limit CAR-T population if toxicity occurs
To date, the main challenges associated with the CAR T immunotherapy market includes manufacturing, regulations, pricing and toxicity in patients. Currently there are over 100 recruiting CAR-T clinical trials globally, mainly in the US, China and Europe. To date a number of CAR T Cells (autologous/allogeneic) trials are demonstrating clinical benefit to patients, but others have demonstrated toxicity such as cytokine release syndrome. In July 2017, an FDA advisory panel determined that the benefits of CAR T immunotherapies outperform the risks. Kymriah (tisagenlecleucel) by Novartis is indicated to treat children and young adults with acute leukemia and performed well in the ELIANA trial. The FDA’s Oncologic Drugs Advisory Committee (ODAC) recommended immunotherapy for approval and became the first CAR-T cell therapy on the US market. In October 2017, Yescarta (axicabtagene ciloleucel) from Kite Pharma for adult patients large B-cell lymphoma was also given FDA market approval and it has also been given market approval for indolent follicular lymphoma.
Key Drivers of the Cancer Immunotherapy Market
Immunotherapy is forecast to become the treatment of choice for cancer within a decade. This is helped by regulatory bodies such as the FDA and the EMA prioritizing immunotherapeutics and accelerating development and regulatory market approval for these drugs. Other key drivers of the immunotherapy market include:
- Cancer immunotherapy expanding into multiple indications.
- Multiple treatment lines, combination therapy and opportunities for repeat treatment are likely to accelerate fast growth.
- Drug candidates have the opportunity to command premium pricing.
- Key market drug drivers include Keytruda, Revlimid, Darzalex, Ibrance, Tecentriq and Opdivo
Cancer immunotherapy drugs offer significant improvements in the length of time cancer patients can expect to live, with relatively tolerable side-effects. Today, any medicine that can meaningfully extend the life of patients with melanoma, breast, or lung cancer is likely to generate more than $1 billion in revenue per year. In general, oncology medicines with proven efficacy advantages have increasingly been securing reimbursement of close to (and above) $100,000 on the basis of course of treatment in the industrialized nations.
Overall there is a significant drive within the R&D community to further investigate the following areas in order to propel immunotherapy breakthroughs:
- PD1 blockade investigation
- Identifying vaccine antigen targets
- Increased indications for current immunotherapies
- Using combination therapies
- Understanding the tumor microenvironment
- Identifying next generation T-cell therapies