LONDON, Oct. 17, 2016 /PRNewswire/ --
Cancer is an extremely complex disease and medical science is still trying to understand the numerous factors responsible for its origin, propagation, spread (metastasis) and relapse. In 2016, an estimated 1.7 million new cancer cases were reported in the US alone. Furthermore, as projected by the World Health Organization (WHO), the annual incidence of cancer worldwide is expected to rise to 24 million by 2035. Currently, there is a huge unmet need for advanced and efficient treatment interventions for cancer. Standard approaches that are currently employed to treat cancer include surgery, radiation therapy and chemotherapy. Although all the three approaches are recognized as the current standard of care in cancer treatment, there are some risks and drawbacks associated with these methods.
Many pharmaceutical companies are working on identifying ways to improve these treatment methods, as well as develop new cancer therapies. One of the current focus areas is immunotherapy; it makes use of the body's own immune system, or its components, to fight cancer. So far, antibody based therapeutics, including monoclonal antibodies (mAbs), bispecific antibodies (bsAbs) and antibody drug conjugates (ADCs), have had significant success as targeted anti-cancer therapies. Apart from antibody based therapies, there are other classes of immunotherapeutics that have been / are being developed to manage and treat cancer; these include immune checkpoint inhibitors (ICIs), therapeutic cancer vaccines and other whole cell based therapies.
The USFDA has approved cancer prevention vaccines (hepatitis B vaccine (HBV) and the human papillomavirus (HPV) vaccine) that prevent infection with cancer-causing viruses. Gardasil®, Gardasil 9® and Cervarix® are approved for the prevention of HPV-caused cancers whereas Engerix-B®, Recombivax HB®, Twinrix® and Pediarix® are approved for the prevention of chronic HBV infection. Although, preventive vaccines offer several benefits, the fact that viruses do not cause most cancers cannot be overlooked. Therefore, several companies are developing therapeutic vaccines that target specific cancers.
As of now, there are three marketed therapeutic cancer vaccines commercially available in different geographies; these are PROVENGE® (US), CreaVax-RCC® (South Korea) and TAPCells® (Chile). Despite the limited success of PROVENGE®, the first marketed dendritic cell vaccine, several stakeholders are actively engaged in the development of dendritic cell and tumor cell-based vaccines.
SCOPE OF THE REPORT
The Dendritic Cell and Tumor Cell Cancer Vaccines Market, 2016-2030 offers a comprehensive analysis of the current market landscape and future outlook of the growing pipeline of products in the therapeutic vaccines segment of the immuno-oncology domain. Currently, there are five types of such vaccines; these are dendritic cell vaccines, tumor cell vaccines, antigen / peptide vaccines, DNA vaccines and anti-idiotypic vaccines. This report is focused on the recent developments and the future potential of dendritic cell vaccines (dendritic cell loaded vaccines) and tumor cell vaccines (tumor cell loaded vaccines). Owing to the existing unmet demand for safe and effective cancer therapies and given the innate advantages of immunotherapies, we believe that dendritic cell and tumor cell cancer vaccines present lucrative opportunities for both therapy developers and investors alike.
During the course of our study, we identified a variety of dendritic cell and tumor cell cancer vaccines across various stages of development. More than 75% of these product candidates are currently in the clinical stages of development. With a rich development pipeline, this segment of the immunotherapy market has managed to capture the interest of several strategic investors and venture capital firms. During our research, we observed that over USD 1.5 billion has already been invested in this domain in past five years. Owing to the existing unmet demand for safe and effective cancer therapies and given the innate advantages of immunotherapies, we believe that dendritic cell and tumor cell cancer vaccines present lucrative opportunities for both therapy developers and investors alike.
One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. For this purpose, we took into consideration the following parameters:
- The dendritic cell and tumor cell vaccines pipeline, including marketed, clinical and preclinical therapies, in terms of phase of development, key players, type of donor and target indications.
- The existing and emerging technology platforms used for the development of innovative variants of cancer vaccines.
- The partnerships that have taken place in the recent past covering clinical trial collaborations, research collaborations, manufacturing and services agreements, license agreements specific to technology platforms and agreements related to the co-development and co-commercialization of promising candidates.
- Various investments and grants received by companies focused in this area including capital raised from IPOs and subsequent offerings.
- The performance of competing drug classes, complex manufacturing processes, batch-wise variability and other inherent threats to growth of the market in the short and long term.
The report offers comprehensive profiles highlighting developmental history, clinical trial details and key clinical results as well as the future market opportunity for marketed and late stage (phase III) candidates. This opportunity is linked to the target consumer segments, likely adoption rate and expected pricing. We have provided an estimate of the size of the market in the short-mid-term and long term for the period between 2016 and 2030. The base year for the report is 2016. To account for the uncertainties associated with the development of novel therapeutic classes and to add robustness to our model, we have provided three forecast scenarios portraying the conservative, base, and optimistic tracks of the market's evolution.
Most of the data presented in this report has been gathered through secondary research. For most of our projects, we also conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will shape up across different regions and wearable types. Where possible, the available data has been checked for accuracy from multiple sources of information.
The secondary sources of information include:
- Annual reports
- Investor presentations
- SEC filings
- Industry databases
- News releases from company websites
- Government policy documents
- Other analyst's opinion reports
While the focus has been on forecasting the market over the coming 14 years, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the market developed from various secondary and primary sources of information.
Chapter 2 provides an executive summary of the report. It offers a high level view on evolution of the dendritic cell and tumor cell cancer vaccines market in the mid to long term.
Chapter 3 provides information on the rising global burden of cancer and the various available therapeutic options. The chapter also includes a discussion on the emergence of immunotherapies and their advantages over current standard of care therapies.
Chapter 4 provides an introduction to cancer vaccines, including details on their history of development, respective mechanisms of action and the various challenges associated with their development and production. Further, the chapter includes brief overviews of the different types of cancer vaccines that are under development for the treatment of various oncological indications. It also includes a comprehensive compilation of the regulatory guidelines established to monitor, manage and regulate the development of therapeutic cancer vaccines.
Chapter 5 features a detailed and comprehensive analysis of the current market landscape of dendritic cell and tumor cell cancer vaccines. It includes information, such as the target indications, current phase of development, the type of donor and the type of vaccines, on the various marketed and pipeline therapies.
Chapter 6 contains a detailed discussion on dendritic cell cancer vaccines. The chapter includes detailed profiles of the marketed and phase III vaccines in this category. Each profile contains a brief discussion on the history of development of the particular therapy, its mechanism of action, dosage regimen, information on its clinical trials and key clinical insights. Further, the profiles provide details on the developer, including financial information, existing intellectual property, current product portfolio and manufacturing capabilities.
Chapter 7 provides a detailed discussion on tumor cell cancer vaccines. Similar to Chapter 6, the chapter also includes comprehensive profiles of the phase III tumor cell cancer vaccines. Each profile covers information such as the history of development of a particular therapy, its mechanism of action, dosage regimen, information on clinical trials and key clinical results. Further, it provides information about the developer as well, including details on financials, existing intellectual property, product portfolio and manufacturing facilities. In addition, this chapter consists of a case study on NewLink Genetics and its portfolio of products based on the HyperAcute® technology.
Chapter 8 includes a detailed discussion on the various technology platforms that are currently being used for the development of dendritic cell and tumor cell cancer vaccines.
Chapter 9 presents a detailed study of the investments made in this domain. The funding instances captured in the chapter include venture capital financing, public offerings, grants and other forms of equity / debt financing. The analysis highlights the growing interest of the VC community and other strategic investors in this segment of the immunotherapy market.
Chapter 10 features a comprehensive analysis of the collaborations and partnerships that have been forged between the players in this market. In the chapter, we have discussed the various types of partnership models that are employed by stakeholders in this domain. We have also categorized the deals / agreements, which we came across during our research, based on the aforementioned models and provided our reviewed the trend of partnerships over time.
Chapter 11 presents a detailed market forecast for dendritic cell and tumor cell cancer vaccines and a discussion on the overall financial opportunity that exists in this domain. It includes future sales projections for molecules in advanced stages of development. These projections took into account the target patient population, the existence of competing drugs or drug classes, likely adoption rate and the expected price of each individual therapy.
Chapter 12 provides a summary of the overall report. In this chapter, we present a list of key takeaways from the report and our independent opinion on the nature and potential of the cancer vaccines market. The insights presented in this chapter are based on the research and analysis described in the previous chapters.
Chapter 13 contains a collection of interview transcripts of discussions held with some of the key players in the industry.
Chapters 14 and 15 are appendices, which provide tabulated data and a list of companies mentioned in the report, respectively.
1. Over 60 dendritic cell and tumor cell cancer vaccines are currently in clinical / preclinical stages of development; 70% of the pipeline comprises of dendritic cell cancer vaccines.
2. 86% of the pipeline therapies are being developed as treatment options for solid tumors, including lung cancers, glioblastoma, prostate cancer and melanoma. In fact, two of the three marketed dendritic cell vaccines, PROVENGE® and TAPCells® (Chile), are approved for treatment of prostate cancer. In addition, a dendritic cell vaccine is also being developed as a first targeted therapy for the treatment of glioblastoma multiforme, the most common and aggressive form of brain cancer with poor survival rates.
3. The innovation in this emerging field is largely driven by smaller firms, specifically start-ups. Notable examples of small firms and start-ups include (in alphabetical order) Asterias Biotherapeutics, AVAX Technologies, DCPrime, Gradalis, Heat Biologics, ImmunoCellular Therapeutics, Immunicum, MolecuVax, Northwest Biotherapeutics, PDC*line Pharma, Pique Therapeutics, Regeneus, Tessa Therapeutics, Vaccinogen and XEME Biopharma. These companies have developed technology platforms that enhance the efficacy of therapeutic vaccines. Examples of some novel technology platforms include (in alphabetical order) AGGREGON™, DCOne®, ImPACT and Vigil®.
4. Several strategic investors and venture capitalists have strongly backed the potential offered by this domain. We identified over 125 instances of funding over the last few years. The total amount invested has been close to USD 2.0 billion; of this, USD 1.5 billion came during the last five years alone.
5. Several agreements have been inked amongst the stakeholders over past few years. We captured over 100 partnerships that are categorized across product development / commercialization agreement, manufacturing / supply agreement, service agreement, technology acquisition / licensing, clinical trial collaboration, research collaboration and others. Of these, clinical trial collaborations and technology acquisition / licensing together account for close to 50% share.
6. Prominent academic players, including (in alphabetical order) the Dana-Farber Cancer Institute, King's College London, Mary Crowley Research Cancer Center, MD Anderson Cancer Center, University of Chile, and University of Pennsylvania, have entered into research collaborations with industry players to conduct further research for the improvement of existing therapies and the development of novel technologies.
7. Overall, the dendritic cell and tumor cell cancer vaccines market is expected to grow at a healthy annual rate of 20.7% till 2030. Dendritic cell vaccines are likely to garner the most attention in near future. Post 2020, we expect tumor cell vaccines to begin to actively contribute to the market's revenues primarily driven by approval of Vigil®.
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