Additional InformationGBI 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.
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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