Targeted Therapeutics- Advancement in Gene Therapy and Stem Cell Therapy will Drive the Market

GBI Research
February 10, 2011
100 Pages - SKU: XGBR6130342
Targeted Therapeutics- Advancement in Gene Therapy and Stem Cell Therapy will Drive the Market

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.


Additional Information

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 Researchs 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 Alzheimers 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.

Key Small Molecule Drugs, Global Sales ($m), 2007- 2009

Source: GBI Research, Company Annual Reports

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.

Definition of Advanced Therapy Medicinal Products by European Commission

Source: GBI Research, European Commission Website

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