US Cancer Vaccine Pipeline Analysis
Cancer vaccines are a viable option for treating many types of cancers which in the present day do not have effective treatments. With the approval of the expensive prostate cancer vaccine, Provenge by Dendreon, the field of cancer vaccines has received an unprecedented boost. Consequently, many companies are expected to enter this emerging and highly profitable field of preventing, treating, and potentially curing cancer. Merck’s Gardasil, a Prophylactic cancer vaccine, along with GSK’s Cervarix are some of the first vaccines to have gained attention globally with their blockbuster status.
The market for cancer vaccine is in its growth stage in the US and has great opportunities for entry. Constituting almost 50% of the global pie, the US cancer vaccine market was estimated to be worth USD 14 Billion in 2012. With close to 1.5 million Americans being diagnosed with cancer every year, this market is expected to o reach USD 20 billion by 2020.
“US Cancer Vaccine Pipeline Analysis” by PNS Pharma gives comprehensive insight on the various vaccines being developed for the treatment of various cancers. Research report covers all vaccines being developed in various development phases. This report enables pharmaceutical companies, collaborators and other associated stake holders to identify and analyze the available investment opportunity in the US cancer vaccine market based upon development process.
Following parameters for each orphan designated drug profile in development phase are covered in “US Cancer Vaccine Pipeline Analysis” research report:
- Drug Profile Overview
- Alternate Names for Drug
- Active Indication
- Phase of Development
- Mechanism of Action
- Brand Name
- Patent Information
- Orphan Designation by Indication, Country & Organisation
- Country for Clinical Trial
- Owner / Originator/ Licensee/Collaborator
- Administrative Route
- Drug Class
- ATC Codes
- Research: 2
- Preclinical: 38
- Clinical: 2
- Phase-0: 1
- Phase-I: 35
- Phase-I/II: 19
- Phase-II: 32
- Phase-II/III: 2
- Phase-III: 17
- Marketed: 5
2. US CANCER VACCINE MARKET REGULATIONS
2.1 Considerations for Both Early and Late Phase Clinical Trials
2.2 Considerations for Early Phase Clinical Trials
2.3 Considerations For Late Phase Clinical Trials
3. CANCER VACCINE DEVELOPMENT CLINICAL PHASE: RESEARCH
3.1 Overview
3.2 Cancer Vaccine Profile in Clinical Phase
4. CANCER VACCINE DEVELOPMENT CLINICAL PHASE: PRECLINICAL
4.1 Overview
4.2 Cancer Vaccine Profile in Clinical Phase
5. CANCER VACCINE DEVELOPMENT CLINICAL PHASE: CLINICAL
5.1 Overview
5.2 Cancer Vaccine Profile in Clinical Phase
6. CANCER VACCINE DEVELOPMENT CLINICAL PHASE: PHASE-0
6.1 Overview
6.2 Cancer Vaccine Profile in Clinical Phase
7. CANCER VACCINE DEVELOPMENT CLINICAL PHASE: PHASE-I
7.1 Overview
7.2 Cancer Vaccine Profile in Clinical Phase
8. CANCER VACCINE DEVELOPMENT CLINICAL PHASE: PHASE-I/II
8.1 Overview
8.2 Cancer Vaccine Profile in Clinical Phase
9. CANCER VACCINE DEVELOPMENT CLINICAL PHASE: PHASE-II
9.1 Overview
9.2 Cancer Vaccine Profile in Clinical Phase
10. CANCER VACCINE DEVELOPMENT CLINICAL PHASE: PHASE-II/III
10.1 Overview
10.2 Cancer Vaccine Profile in Clinical Phase
11. CANCER VACCINE DEVELOPMENT CLINICAL PHASE: PHASE-III
11.1 Overview
11.2 Cancer Vaccine Profile in Clinical Phase
12. MARKETED
12.1 Overview
12.2 Marketed Cancer Vaccine Profile
Each Drug Profile has Tables Representing Following Information:
- Alternate Names
- Originator & Owner
- Collaborator
- Technology Provider
- Licensee
- Highest Development Phase
- Indications
- Class
- Mechanism of Action
- ATC code
- Designated Brand Name & Orphan Designation
Cancer vaccines are a viable option for treating many types of cancers which in the present day do not have effective treatments. With the approval of the expensive prostate cancer vaccine, Provenge by Dendreon, the field of cancer vaccines has received an unprecedented boost. Consequently, many companies are expected to enter this emerging and highly profitable field of preventing, treating, and potentially curing cancer. Merck’s Gardasil, a Prophylactic cancer vaccine, along with GSK’s Cervarix are some of the first vaccines to have gained attention globally with their blockbuster status.
Market Overview
The market for cancer vaccine is in its growth stage in the US and has great opportunities for entry. Constituting almost xx% of the global pie, the US cancer vaccine market was estimated to be worth USD 12.8 billion in 2010. With close to xx million Americans being diagnosed with cancer every year, this market is expected to grow at a CAGR of xx% to reach USD xx billion by 2018.
Therapeutic cancer vaccines and Prophylactic cancer vaccines are the two broad segments into which the cancer vaccines market is categorized. The Therapeutic vaccines segment currently accounts for approximately xx% share of the US cancer vaccine market. However, with an increasing focus on developing therapeutics for other types of cancer, this segment is expected to become very important by 2016.
Owing to increasing incidence rates of cancer in the US, and the urgent need to control the spread of the disease, the cancer vaccines are becoming a very popular area of research. Currently, the prophylactic vaccines available to the patients include Merck's Gardasil, GSK's Cervarix, and several other Hepatitis B vaccines, while the only therapeutic vaccine in the market is Provenge released by Dendreon. USA’s Dendreon is the first company to have introduced a therapeutic cancer vaccine to the market.
The first therapeutic cancer vaccine, Provenge (sipuleucel-T), for metastatic castrate resistant prostate cancer, is presently marketed in the USA only.
With the launch of Merck & Co’s Gardasil (human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant) and Cervarix (human papillomavirus bivalent (types 16 and 18) vaccine, recombinant) from GlaxoSmithKline, the prophylactic cancer vaccines market experienced high growth in the previous years. By 2015, with the expected launch of Merck’s first-in-class vaccine, which is an improved version of Gardasil V503 in 2014, it is most likely that the prophylactic cancer vaccine market would grow significantly and would account for xx% share in the overall cancer vaccines market.
A major portion of the developments in the field of cancer vaccines in the US are substantially backed by funding and support from the government and private players. There are significant opportunities in both the prophylactic and therapeutic vaccines segment in the US. Specifically, the support from the government has proved to be a remedy for the high death rate among females due cervical cancer. Owing to the large number of candidates in clinical trials, the segment of therapeutic cancer vaccines offers great potential in the future.
With regards to the competitive landscape, it is most likely that the market would continued to be dominated by both Merck and GSK. Additionally, owing to the significant and rapid growth in the US cancer vaccines market, an increased number of M&A activities is on the cards which would lead to a handful of players dominating the market.
Currently, there are three cancer vaccines approved in other countries, but the regulatory scenario in the US is very strict and conservative with patient safety occupying utmost importance. Such a stringent regulatory landscape has resulted in long approval processes as the FDA ensures that the drugs are safe and efficacious. Thus, the commercial approval of cancer vaccines is one of the most eagerly anticipated progressions in modern health care in the US. There is a huge opportunity in the country as it has a population of more than eight million and healthcare professionals are always looking to innovate and invent novel ideas which could increase the chances of survival and improve the quality of life for cancer-stricken patients.
Future Scenario
There is high unmet need in the prophylactic and therapeutic cancer vaccines market in terms of there being more vaccines needed for different types of cancer. In the prophylactic cancer vaccines market, there are only two vaccines available for the prevention of cervical cancer and precancerous conditions. For other types of cancers, there are only two vaccines in the pipeline: one is for cervical cancer and the other for breast cancer. In order to satisfy this high demand for vaccines, there is an urgent need for the pharmaceutical companies to increase their research activities and develop new preventive medicines.
The second leading cause of death buy illness in the USA has been observed to be cancer. It is expected that in the future, cancer would become the leading cause of mortality. As the cancer vaccines have the potential to become a significant force in future cancer treatments, this segment is most likely to become a major player in the global vaccine market.
The process of developing cancer vaccines is in addition with other cancer treatments such as chemotherapy, radiation, or surgery. This implies that these cancer vaccines would be given to each and every patient if they have been proved to be efficacious. This incremental benefit encourages the adjunctive use and significantly expands the cancer therapeutic market.
It is expected that over the next few years, many vaccines are likely to be over a range of indications including the commonly diagnosed lung and colorectal cancer types. All of these vaccines have proved to be efficient by improving patient survival, by a few months, or years. However, the high expected prices of these vaccines would be a barrier of market growth.