US Cancer Vaccine Market Analysis

  • September 2012
  • -
  • RNCOS
  • -
  • 135 pages

Cancer vaccines are highly researched today owing to growing cancer incidences and an urgent need to control and prevent the massively penetrating disease. Amongst the highest incident cancers, prostate cancers are high in males and breast cancer in females. The introduction of Merck’s Gardasil bought great attention to cancer vaccines. US represents the most promising market for cancer vaccines across the globe, accounting for around 49% share.

The prophylactic vaccines currently available in the market include Merck’s Gardasil, GSK’s Cervarix, and several other Hepatitis B vaccines while the only therapeutic vaccine in the market is Dendreon’s Provenge. The report “US Cancer Vaccine Market Analysis”, in such a scenario provides an analysis of the current market size for these vaccines along with future estimations. In-depth perspective has been provided for the various factors that will govern the growth of each of these vaccines along with the constraints that limit them.

Merck and GSK are expected to continue to be undefeated market leaders in the prophylactic cancer segment as the launch of a new cancer vaccine is unlikely in the next 3 years. The research and innovation for cancer vaccines is highly robust and several candidates are being studied for their role in cancer. Trials are focusing more on the therapeutic vaccines and this segment can be expected to evolve greatly in the years to come. Amongst the various studies, a vaccine for lung cancer can be expected to come up soon with promising candidates, such as Lucanix and Stimuvax having entered phase 3 trials.

The report also covers the FDA's vaccine approval process and its guidance to the industry for developing therapeutic cancer vaccines. The therapeutic vaccines currently account only for about 15% share in the US cancer vaccine market but this share can be expected to increase drastically post 2016 with such high focus on developing therapeutics for other cancer types.

The report “US Cancer Vaccine Market Analysis”, is an outcome of an extensive research and prudent analysis of the cancer vaccine market in the world and in US. It provides an effective analysis of the market drivers, current market size, and future estimates. It also provides the key constraints faced by these cancer vaccine products that can hinder its market growth in the future. Further, the report provides an in-depth analysis on the pipeline cancer vaccines in phase 1-4 clinical stages for most prevalent cancers in US. The regulatory environment detailing the whole cancer vaccine approval process along with FDA's guidelines for clinical proceedings of cancer therapeutic vaccines has also been provided. The report also provides competitive analysis of the promising players in the market along with their key strategies to increase their penetration in the market.

Table Of Contents

1. Analyst View
2. Research Methodology
3. Cancer Statistics by Demographics
3.1 Prevalence, Incidences and Mortality (2008-2016)
3.2 Leading States by Incidence
3.3 Leading Cancers by Incidence
3.3.1 Male Cancer Incidences
3.3.2 Female Cancer Incidences
3.3.3 Age-Group
4. Cancer Vaccines Market Outlook
4.1 Market Analysis and Segmentation
4.2 Key Product Analysis
4.2.1 Provenge
4.2.1.1 Market Analysis
4.2.1.2 Restraints
4.2.2 HPV Vaccine
4.2.2.1 Gardasil
4.2.2.1.1 Market Analysis
4.2.2.1.2 Restraints
4.2.2.2 Cervarix
4.2.2.2.1 Market Analysis
4.2.2.2.2 Restraints
4.2.3 HBV Vaccines
4.2.3.1 Market Analysis
4.2.3.2 Market Restraints
4.2.3.2.1 Engerix-B and Twinrix
4.2.3.2.2 Recombivax HB and Comvax
4.2.3.2.3 Pediarix
5. Potential Cancer Vaccine Candidates: An Opportunity Assessment
5.1 Prophylactic Vaccine
5.2 Therapeutic Vaccine
5.2.1 Prostate Cancer
5.2.2 Breast Cancer
5.2.3 Lung Cancer
5.2.4 Colorectal Cancer
6. Regulatory Environment
6.1 Vaccine Approval Process
6.2 FDA Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines
6.2.1 Considerations for both Early and Late Phase Clinical Trials
6.2.1.1 Patient Population
6.2.1.2 Monitoring the Immune Response
6.2.1.3 Biomarkers as Evidence of Efficacy
6.2.1.4 Adjuvants Used to Stimulate Immune Response
6.2.1.5 Multi-antigen Vaccines
6.2.1.6 Disease Progression/Recurrence Immediately or Shortly after the Initial Administration of Cancer Vaccines
6.2.1.7 Concomitant and Subsequent Therapies
6.2.2 Considerations for Early Phase Clinical Trials
6.2.2.1 Starting Dose and Dosing Schedule
6.2.2.2 Booster and Maintenance Therapy
6.2.2.3 Dose Escalation
6.2.2.4 Single-arm versus Randomized Phase-2 Trials in Early Development
6.2.3 Considerations for Late Phase Clinical Trials
6.2.3.1 Safety Profile from Early Phase Clinical Trials
6.2.3.2 Endpoints
6.2.3.3 Statistical Issues
6.2.3.4 Control Issues
6.2.3.5 Delayed Vaccine Effect
6.2.3.6 Autologous Vaccine Trials
6.2.3.7 Accelerated Approval Regulations
7. Competitive Landscape
7.1 Merck and Co.
7.1.1 Business Description
7.1.2 Key Strategy Analysis
7.2 GSK
7.2.1 Business Description
7.2.2 Key Strategy Analysis
7.3 Dendreon
7.3.1 Business Description
7.3.2 Key Strategy Analysis
7.4 Bavarian Nordic
7.4.1 Business Description
7.4.2 Key Strategy Analysis
7.5 Celldex Therapeutics
7.5.1 Business Description
7.5.2 Key Strategy Analysis
7.6 Kael-GemVax
7.6.1 Business Description
7.6.2 Key Strategy Analysis
7.7 Oxford BioMedica
7.7.1 Business Description
7.7.2 Key Strategy Analysis
7.8 Galena Biopharma
7.8.1 Business Description
7.8.2 Key Strategy Analysis

List of Figures:

Figure 3-1: Cancer Prevalence (Million), 2008-2016
Figure 3-2: Cancer Incidences (‘000), 2008-2016
Figure 3-3: Cancer Mortality (‘000), 2008-2016
Figure 3-4: Incidences by Type of Cancer (%), 2012
Figure 3-5: Top Five States with Highest Cancer Incidences (‘000), 2012
Figure 3-6: Cancer Incidences by Age Group (%)
Figure 4-1: Global - Cancer Vaccine Market (Billion US$), 2010-2012
Figure 4-2: Cancer Vaccine Market (Billion US$), 2010-2012
Figure 4-3: Share of US in Global Cancer Vaccine Market (2012)
Figure 4-4: Cancer Vaccine Market by Product Type (%), 2012
Figure 4-5: Provenge Market (Million US$), 2010-2012
Figure 4-6: Global - Gardasil Market (Million US$), 2010-2012
Figure 4-7: Gardasil Market (Million US$), 2010-2012
Figure 4-8: Share of US in Global Gardasil Sales (2012)
Figure 4-9: Global - Cervarix Market (Million US$), 2010-2012
Figure 4-10: Cervarix Market (Million US$), 2010-2012
Figure 4-11: Share of US in Global Cervarix sales (2012)
Figure 4-12: Global - Hepatitis B Vaccine Market (Billion US$), 2010-2012
Figure 4-13: Hepatitis B Vaccine Market (Million US$), 2010-2012
Figure 4-14: Global - Engerix-B and Twinrix Market (Million US$), 2010-2012
Figure 4-15: Engerix-B and Twinrix Market (Million US$), 2010-2012
Figure 4-16: Global - Recombivax Market (Million US$), 2010-2012
Figure 4-17: Recombivax Market (Million US$), 2010-2012
Figure 4-18: Global - Pediarix Market (Million US$), 2010-2012
Figure 4-19: Pediarix Market (Million US$), 2010-2012
Figure 5-1: Therapeutic Cancer Vaccines in Phase-3 Clinical Trials by Cancer Site (%)

List of Tables:

Table 3-1: Top 10 Cancer Incidences in Males (2012)
Table 3-2: Top 10 Cancer Incidences in Females (2012)
Table 4-1: Adverse Effects of Gardasil
Table 5-1: Cancers with High Linkage to Virus and Bacteria
Table 5-2: Prophylactic Cancer Vaccines in Phase-4 Clinical Trials
Table 5-3: Prophylactic Cancer Vaccines in Phase-3 Clinical Trials
Table 5-4: Prophylactic Cancer Vaccines in Phase-2 Clinical Trials
Table 5-5: Prophylactic Cancer Vaccines in Phase-1 Clinical Trials
Table 5-6: Therapeutic Cancer Vaccines in Phase-3 Clinical Trials
Table 5-7: Prostate Cancer Therapeutic Vaccines in Phase-3 Clinical Trials
Table 5-8: Prostate Cancer Therapeutic Vaccines in Phase-2 Clinical Trials
Table 5-9: Prostate Cancer Therapeutic Vaccines in Phase-1 and 1/2 Clinical Trials
Table 5-10: Breast Cancer Therapeutic Vaccines in Phase-3 Clinical Trials
Table 5-11: Breast Cancer Therapeutic Vaccines in Phase-2 Clinical Trials
Table 5-12: Breast Cancer Therapeutic Vaccines in Phase-1 and 1/2 Clinical Trials
Table 5-13: Lung Cancer Therapeutic Vaccines in Phase-3 Clinical Trials
Table 5-14: Lung Cancer Therapeutic Vaccines in Phase-2 and 2/3 Clinical Trials
Table 5-15: Lung Cancer Therapeutic Vaccines in Phase-1 and 1/2 Clinical Trials
Table 5-16: Colorectal Cancer Therapeutic Vaccines in Phase-2 Clinical Trials
Table 5-17: Colorectal Cancer Therapeutic Vaccines in Phase-1 and 1/2 Clinical Trials
Table 7-1: Merck - Cancer Vaccines in Pipeline
Table 7-2: GlaxoSmithKline - Cancer Vaccines in Pipeline
Table 7-3: Dendreon - Cancer Vaccines in Pipeline
Table 7-4: Bavarian Nordic - Cancer Vaccines in Pipeline
Table 7-5: Celldex Therapeutics - Cancer Vaccines in Pipeline
Table 7-6: KAEL-GemVax - Cancer Vaccines in Pipeline
Table 7-7: Oxford BioMedica - Cancer Vaccines in Pipeline
Table 7-8: Galena Biopharma - Cancer Vaccines in Pipeline

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