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US Cancer Vaccine Pipeline Analysis

January 2014 | 300 pages | ID: UB9DA88116CEN
PNS Pharma

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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
US Cancer Vaccine Pipeline by Clinical Phase:
  • 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
1. US CANCER VACCINE MARKET OVERVIEW

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.



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