アメリカの癌ワクチン市場動向

◆英語タイトル:US Cancer Vaccine Market Outlook 2020
◆商品コード:RNCS507155
◆発行会社(リサーチ会社):RNCOS
◆発行日:2015年7月
◆ページ数:130
◆レポート形式:英語 / PDF
◆納品方法:Eメール
◆調査対象地域:米国
◆産業分野:製薬・医療
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【レポートの概要】

In the face of an alarmingly rising incidences of cancer and limited treatment options, physicians are being forced to look for precautionary vaccines beyond the conventional treatments. Hence, many research institutes and companies are now investing in developing prophylactic and therapeutic vaccines to curb this deadly disease. Amongst the various cancers, those of the respiratory system, digestive system, lymph nodes, prostate and breast are the leading cancers among Americans. The US represents the most promising market for cancer vaccines across the globe, accounting for over 58% share in 2014.

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 Outlook 2020” provides an analysis of the current market size for these vaccines along with the future estimations. In depth, a 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 undisputed market leaders in the prophylactic cancer vaccine segment as the launch of a new cancer vaccine is unlikely in the next 3-4 years. The research and innovation for cancer vaccines is highly robust and several candidates are being studied for their roles 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 GSK1572932A and GV1001 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. Therapeutic vaccines currently account only for about 12% share in the US cancer vaccine market, but this share can be expected to increase post 2018 with a high focus on developing therapeutics for various cancer types.

In particular, the report is an outcome of an extensive research and prudent analysis of the cancer vaccine market in the world and in the US. It provides an effective analysis of the market drivers, current market size and future estimates. It also provides the key constraints faced by the aforementioned cancer vaccine products that can hinder the market’s growth in future. Further, the report provides an in-depth analysis of the pipeline cancer vaccines in phase 1-4 clinical stages of most prevalent cancers in the 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.

Furthermore, the report highlights the competitive landscape of the US cancer vaccine market, describing the business, financials, strengths and weaknesses, and recent developments of major industry players. This will help the reader to gain crucial insight into the key market players’ performances and strategies for growth. Holistically, the research provides all the prerequisite information for clients looking to make a debut in this industry and facilitates them to formulate schemes while going for an investment/partnership in the US cancer vaccine market.

【レポートの目次】

1. Analyst View
2. Research Methodology
3. Cancer Statistics by Demographics
3.1 Prevalence, Incidences and Mortality (2008-2014)
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 Children Cancer Incidence
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 & Comvax
4.2.3.2.3 Pediarix/ Infanrix
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 & 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
7.4 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 Galena Biopharma
7.7.1 Business Description
7.7.2 Key Strategy Analysis

List of Figures:

Figure 3-1: Cancer Incidences (Million), 2008-2014
Figure 3-2: Cancer Mortality (‘000), 2008-2014
Figure 3-3: Incidences by Type of Cancer (%), 2014
Figure 3-4: States with Highest Cancer Incidences, 2014
Figure 4-1: Global – Cancer Vaccine Market (Billion US$), 2014-2020
Figure 4-2: Cancer Vaccine Market (Billion US$), 2014-2020
Figure 4-3: Share of US in Global Cancer Vaccine Market (2014)
Figure 4-4: Cancer Vaccine Market by Product Type (%), 2014
Figure 4-5: Provenge Market (Million US$), 2012-2014
Figure 4-6: Global – Gardasil Market (Million US$), 2012-2014
Figure 4-7: Gardasil Market (Million US$), 2012-2014
Figure 4-8: Share of US in Global Gardasil Sales (2014)
Figure 4-9: Global – Cervarix Market (Million US$), 2012-2014
Figure 4-10: Cervarix Market (Million US$), 20102-2014
Figure 4-11: Share of US in Global Cervarix sales (2014)
Figure 4-12: Global – Hepatitis B Vaccine Market (Billion US$), 2012-2014
Figure 4-13: Hepatitis B Vaccine Market (Million US$), 2012-2014
Figure 4-14: Global – Engerix-B and Twinrix Market (Million US$), 2012-2014
Figure 4-15: Engerix-B and Twinrix Market (Million US$), 2012-2014
Figure 4-16: Global – Recombivax Market (Million US$), 2012-2014
Figure 4-17: Recombivax Market (Million US$), 2010-2012
Figure 4-18: Global – Pediarix/Infanrix Market (Billion US$), 2012-2014
Figure 4-19: Pediarix/ Infanrix Market (Million US$), 2012-2014
Figure 5-1: Therapeutic Cancer Vaccines in Clinical Trials by Cancer Site (%), 2014

List of Tables:

Table 3-1: Top 10 Cancer Incidences in Males (2014)
Table 3-2: Top 10 Cancer Incidences in Females (2014)
Table 3-3: Top 10 Cancer Incidences in Children (Ages 0-14), (2014)
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 Clinical Trials
Table 5-3: Therapeutic Cancer Vaccines in Clinical Trials
Table 5-4: Prostate Cancer Therapeutic Vaccines in Phase-3 Clinical Trials
Table 5-5: Prostate Cancer Therapeutic Vaccines in Phase-2 Clinical Trials
Table 5-6: Prostate Cancer Therapeutic Vaccines in Phase-1 and 1/2 Clinical Trials
Table 5-7: Breast Cancer Therapeutic Vaccines in Phase-3 Clinical Trials
Table 5-8: Breast Cancer Therapeutic Vaccines in Phase-2 Clinical Trials
Table 5-9: Breast Cancer Therapeutic Vaccines in Phase-1 and 1/2 Clinical Trials
Table 5-10: Lung Cancer Therapeutic Vaccines in Phase-3 Clinical Trials
Table 5-11: Lung Cancer Therapeutic Vaccines in Phase-2 and 2/3 Clinical Trials
Table 5-12: Lung Cancer Therapeutic Vaccines in Phase-1 and 1/2 Clinical Trials
Table 5-13: Colorectal Cancer Therapeutic Vaccines in Phase-3 Clinical Trials
Table 5-14: Colorectal Cancer Therapeutic Vaccines in Phase-2 Clinical Trials
Table 5-15: 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: Bavarian Nordic – Cancer Vaccines in Pipeline
Table 7-4: Celldex Therapeutics – Cancer Vaccines in Pipeline
Table 7-5: KAEL-GemVax – Cancer Vaccines in Pipeline
Table 7-6: Galena Biopharma – Cancer Vaccines in Pipeline



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