Abstract
GBI Research, the leading business intelligence provider, has released its
latest research, “Targeted Therapeutics- Advancement in Gene Therapy and
Stem Cell Therapy will Drive the Market.” It provides key data,
information and analysis on the main types of targeted therapeutics and their
key pipeline molecules. The report provides complete profile of key promising
therapies in the pipeline. The report provides comprehensive analysis of key
M&A and Licensing deals of key companies and analyses the outcome of the
respective deal. It also analyses the regulatory scenario with main focus on
gene therapy and stem cell therapy.
Key biotech and pharmaceutical companies are profiled along with their latest
deals involving targeted therapeutics.
It is built using data and information sourced from proprietary databases,
primary and secondary research and in house analysis by GBI Research’s
team of industry experts.
Failure of Conventional Therapies in Curing Chronic Diseases has Created
High-unmet Needs
Conventional therapies such as chemotherapy and hormone therapy, although
controlling progression of diseases, are often associated with potential
side-effects. For example side-effects due to chemotherapy in cancer range
from nausea and hair loss to thrombocytopenia and neutropenia. Patients often
succumb to death due to the side-effects and not the cancer. Chemotherapies do
not possess the selective target characteristics. Once administered, they
induce systemic action throughout the body leading to these potential side
effects.
Targeted therapies such as monoclonal antibodies have thus far shown better
efficacy and safety profiles compared to chemotherapies. However, they too do
not induce complete remission of the disease. They either reduce signs and
symptoms of the disease or slow down the growth of tumors. The inability of
these therapies to cure diseases has created significant unmet needs in
cancer, hepatitis, HIV and autoimmune diseases.
Expanded Indications Opens up New Potential Patient Group
Many marketed monoclonal antibodies such as Avastin, Rituxan, and Remicade are
being approved for multiple indications resulting in increased potential
patient pool for these products. Alemtuzumab, which is approved for b-cell
chronic lymphocytic leukemia, is in phase III clinical trials for multiple
sclerosis. Remicade is approved to treat plaque psoriasis, rheumatoid
arthritis, psoriatic arthritis, adult Crohn' s Disease, pediatric Crohn' s
disease, ulcerative colitis, and ankylosing spondylitis. Remicade is also in
Phase III clinical trials for the treatment of juvenile rheumatoid arthritis
and in Phase II clinical trials for the treatment of sarcoidosis, chronic
obstructive pulmonary disease (COPD), cachexia, and asthma. Enbrel, has been
approved for the treatment of rheumatoid arthritis, juvenile idiopathic
arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque
psoriasis
The same trend is also seen within the monoclonal antibody pipeline also. A
majority of pipeline molecules are researched for multiple indications to
maximize their patient base. Ocrelizumab is in phase III clinical trials for
rheumatoid arthritis and lupus nephritis; phase II clinical trial for
relapsing remitting multiple sclerosis
Furthermore, monoclonal antibodies are breaking grounds into new therapy areas
such as CNS disorders and metabolic disorders. Bapineuzimab is in clinical
trials for Alzheimer’s disease while teplizumab is in clinical trials
for diabetes.
Sales Value of Key Small Molecule Drugs for Targeted Therapeutics is
Increasing by Every Passing Year
The sales value of small molecule drugs such as Gleevec, Tarceva, Velcade and
others is increasing by every passing year because of their increased
penetration into the therapeutics segment. Pharmaceutical companies are
switching towards targeted therapeutics because of declining revenue generated
by conventional drugs.
TT is a lucrative sector in the pharmaceutical market to maintain competency
and revenue generation. Key promising drugs in the pipeline of small and
growing companies are attracting large pharmaceutical companies for licensing
and M&A deals. This has resulted into increased number of licensing and M&A
deals in TT market.
Regulatory Landscape for TT is Stringent Leading to Time Lag between Research
and Commercialization
The regulatory policies for TT are different from that of conventional
therapies. This is due to the ethical and social issues involved in some of
the targeted therapeutics such as gene therapy and stem cell therapy.
Different countries have established different regulatory agencies for TT in
general and gene therapy and stem cell therapy in particular.
The European Commission has considered Gene therapy, Somatic cell therapy and
tissue-engineered products under Advanced Therapy Medicinal Products (ATMP).
These regulations get modified with the advancing novel technology and
breakthroughs.
Summary
GBI Research, the leading business intelligence provider, has released its
latest research “Targeted Therapeutics- Advancement in Gene Therapy and
Stem Cell Therapy will Drive the Market”. The report provides in-depth
analysis of the major targeted therapeutics. The Market Drivers and Restraints
for all the types of Targeted Therapeutics (TT) are analyzed. The report
provides comprehensive assessment of key pipeline therapies in the TT segment.
The profiles of key promising molecules in the pipeline are mentioned. The
regulatory Landscape is analyzed with focus on European and the US scenario.
The regulatory landscape details about the major agencies for gene and stem
cell therapies. The report profiles all the key companies dealing in TT with
main focus on their deals involving M&A and licensing deals.
GBI Research finds that TT is the need of the hour for biotech and
pharmaceutical companies to recover from the loss of revenue by patent expiry
of conventional blockbuster drugs. Thus key pipeline molecules and key deals
will help the companies to make a better future strategy.
This report is built using data and information sourced from proprietary
databases, primary and secondary research and in-house analysis by GBI
Research’s team of industry experts.
The report gives insight about the key deals which have taken place between
biopharmaceutical companies and their influence. Reasons for considering
strategic consolidation as the main objective of the companies have been
mentioned. The major types of TT include small molecule drugs, protein/peptide
therapeutics, monoclonal antibody therapeutics, RNA interference, gene therapy
and stem cell therapy. The market drivers and restraints for these six classes
are mentioned. From a commercial perspective there is a huge unmet medical
need in difficult to treat diseases like cancer and autoimmune diseases. The
unmet need is due to the lack of effective and efficacious therapies based on
conventional mode of research. TT has the potential to satisfy this unmet need
by being more efficacious, effective and safe. The strategic M&A deals and
licensing deals of key companies such as Eli Lilly, Forest Laboratories,
Hoffmann La-Roche, Isis Pharmaceuticals, J&J, Pfizer , Biogen, Antisoma and
others are analyzed.
Scope
The scope of this report includes -
• Description of major types of
TT with key market drivers and restraints.
• Analysis of the leading
pipeline therapies which will define the future of TT market.
•
Factors driving small molecule drugs, peptide/protein drugs, MAbs, RNA
interference therapeutics, gene and stem cell therapy are analyzed.
•
Key Regulatory Landscape is detailed for understanding the approval procedure
of TT with main focus on gene and stem cell therapy.
• Major
companies dealing in TT are profiled and their M&A and Licensing deals are
mentioned.
• Key companies studied in this report are Eli Lilly,
Pfizer, J&J, Hoffmann La- Roche, Biogen, Isis Pharmaceuticals and Antisoma.
Reasons to buy
The report will enhance your decision making capability. It will allow you to
-
• Identify the advantages of TT and understand the potential that
it can capture.
• Align your product portfolio to the TT market
segment with high growth potential.
• Develop market-entry and market
expansion strategies by identifying the leading TT segments poised for strong
growth.
• Understand the key risks and issues which TT is facing and
key solutions in development to address these issues.
• Develop key
strategic initiatives by understanding the key focus areas with respect to
pipeline portfolio of leading companies.
• Exploit in-licensing and
out-licensing opportunities by identifying products that could fill portfolio
gaps and lead to revenue generation.
• Identify key players best
positioned to take advantage of TT market potential.
Table of Contents
1. Table of Contents
- 1.1 List of Tables
- 1.2 List of Figures
2. Targeted Therapeutics: Introduction
- 2.1 GBI Research Guidance
3. Targeted Therapeutics: Overview
- 3.1 Introduction
- 3.2 Targeted Therapy is the Need of the Hour
- 3.2.1 High Side Effects and Toxic Effects of Conventional Therapy
- 3.2.2 Variable Efficacy Rate of Conventional Drugs at the Affected Site
- 3.2.3 Resistance Developed to Conventional Drugs Used to Treat Infections
- 3.3 Targeted Therapeutics Market Drivers and Restraints
- 3.3.1 Targeted Therapeutics Market Drivers
- 3.3.2 Targeted Therapeutics Market Restraints
4. Targeted Therapeutics: Major Types of Targeted Therapeutics
- 4.1 Small Molecules
- 4.2 Innovative Small Molecule Therapeutics Market Drivers and Restraints
- 4.2.1 Small Molecule Therapeutics Market Drivers
- 4.2.2 Innovative Small Molecule Therapeutics Market Restraints
- 4.2.3 Profiles of Key Pipeline Molecules
- 4.3 Proteins/Peptide Drugs
- 4.4 Proteins/Peptide Drugs Therapeutics Market Drivers and Restraints
- 4.4.1 Peptides/Protein Drug Therapeutics Market Drivers
- 4.4.2 Peptides/Protein Drug Therapeutics Market Restraints
- 4.4.3 Profiles of Key Pipeline Molecules
- 4.5 Monoclonal Antibodies (MAbs) and Antibody Like Structures
- 4.6 Monoclonal Antibody Therapeutics, Market Drivers and Restraints
- 4.6.1 Monoclonal Antibody Therapeutics Market Drivers
- 4.6.2 Global Monoclonal Antibody Market Restraints
- 4.6.3 Profiles of Key Pipeline Molecules (MAb)
- 4.7 RNA Interference
- 4.8 RNA Interference Therapeutics Market Drivers and Restraints
- 4.8.1 RNA Interference Therapeutics Market Drivers
- 4.8.2 RNA Interference Therapeutics Market Restraints
- 4.8.3 Profiles of Key Pipeline Molecules (RNA)
- 4.9 Stem Cell Therapies
- 4.10 Stem Cell Therapeutics Market Drivers and Restraints
- 4.10.1 Stem Cell Therapeutics Market Drivers
- 4.10.2 Stem Cell Therapeutics Market Restraints
- 4.10.3 Profile of Key Late Stage Therapies
- 4.11 Gene Therapy
- 4.12 Gene Therapy Market Drivers and Restraints
- 4.12.1 Gene Therapy Market Drivers
- 4.12.2 Gene Therapy Market Restraints
- 4.12.3 Key Pipeline Candidates
5. Targeted Therapeutics: Regulatory Landscape
- 5.1 The US Regulatory Landscape Scenario
- 5.1.1 National Institute for Health (NIH)
- 5.1.2 FDA
- 5.2 EU Regulatory Landscape Scenario
- 5.2.1 Committee for Advanced Therapies (CAT)
6. Targeted Therapeutics: Competitive Landscape
- 6.1 Antisoma
- 6.1.1 Overview
- 6.1.2 Key Deals
- 6.2 AVI BioPharma
- 6.2.1 Overview
- 6.2.2 Key Deals
- 6.3 Biogen
- 6.3.1 Overview
- 6.3.2 Key Deals
- 6.4 Cephalon
- 6.4.1 Overview
- 6.4.2 Key Deals
- 6.5 Eli Lilly
- 6.5.1 Overview
- 6.5.2 Key Deals
- 6.6 Forest Laboratories
- 6.6.1 Overview
- 6.6.2 Key Deals
- 6.7 Genmab
- 6.7.1 Overview
- 6.7.2 Key Deals
- 6.8 Gilead Sciences
- 6.8.1 Overview
- 6.8.2 Key Deals
- 6.9 Hoffmann La- Roche (Genentech)
- 6.9.1 Overview
- 6.9.2 Key Deals
- 6.10 Isis Pharmaceuticals
- 6.10.1 Overview
- 6.10.2 Key Deals
- 6.11 Johnson and Johnson (J&J)
- 6.11.1 Overview
- 6.11.2 Key Deals
- 6.12 Mesoblast Limited
- 6.12.1 Overview
- 6.12.2 Key Deals
- 6.13 Pfizer
- 6.13.1 Overview
- 6.13.2 Key Deals
- 6.14 UCB
- 6.14.1 Overview
- 6.14.2 Key Deals
7. Targeted Therapeutics Market - Appendix
- 7.1 Market Definitions
- 7.2 List of Abbreviations
- 7.3 Research Methodology
- 7.3.1 Coverage
- 7.3.2 Secondary Research
- 7.3.3 Primary Research
- 7.3.4 Expert Panel Validation
- 7.4 Contact Us
- 7.5 Disclaimer
- 7.6 Sources
List of Tables:
- Table 1: Key Small Molecule Drugs Used For Targeted Therapeutics and Their
Indications, 2010
- Table 2: Key Small Molecule Drugs, Global, Sales Value ($m), 2007-2009
- Table 3: Key Protein/Peptide Drugs, Generic Names and Approved
Indications, 2010
- Table 4: Key Protein/Peptide Drugs, Global, Sales Value ($m), 2007-2009
- Table 5: Key Monoclonal Antibodies (MAbs) and Their Approved Indications
- Table 6: Key Monoclonal Antibodies, Global, Sales Value ($m), 2007-2009
- Table 7: List of Key EMA Directives and Guidelines for GTMPs
List of Figures
- Figure 1: Targeted Therapeutics, Global, Market Drivers and Restraints,
2010
- Figure 2: Key Small Molecule Drugs, Global Sales ($m), 2007- 2009
- Figure 3: Small Molecule Therapeutics, Global, Market Drivers and
Restraints, 2010
- Figure 4: Key Protein/Peptide Drugs, Global Sales ($m), 2007-2009
- Figure 5: Protein/Peptide Drug Therapeutics, Global, Market Drivers and
Restraints, 2010
- Figure 6: Key Monoclonal Antibodies, Global, Sales Value ($m), 2007-2009
- Figure 7: Monoclonal Antibody Therapeutics, Global, Market Drivers and
Restraints, 2010
- Figure 8: RNA Interference Therapeutics, Global, Market Drivers and
Restraints, 2010
- Figure 9: Types Of Stem Cells, Depending Upon Their Potential
- Figure 10: Stem Cell Therapeutics, Global, Market Drivers and Restraints,
2010
- Figure 11: Gene Therapy, Global, Market Drivers and Restraints, 2010
- Figure 12: Definition of Advanced Therapy Medicinal Products by the
European Commission
