Biological therapies such as those which use patient's own cells are considered to be personalized medicines. Vaccines are prepared from individual patient's tumor cells. Individualized therapeutic strategies using monoclonal bodies can be directed at specific genetic and immunologic targets. Ex vivo gene therapy involves the genetic modification of the patient's cells in vitro, prior to reimplantation of these cells in the patient's body.
Various technologies are integrated to develop personalized therapies for specific therapeutic areas described in the report. Examples of this are genotyping for drug resistance in HIV infection, personalized therapy of cancer, antipsychotics for schizophrenia, antidepressant therapy, antihypertensive therapy and personalized approach to neurological disorders. Although genotyping is not yet a part of clinically accepted routine, it is expected to have this status by the year 2020.
Several players are involved in the development of personalized therapy. Pharmaceutical and biotechnology companies have taken a leading role in this venture in keeping with their future role as healthcare enterprises rather than mere developers of technologies and manufacturers of medicines.
Ethical issues are involved in the development of personalized medicine mainly in the area of genetic testing. These along with social issues and consideration of race in the development of personalized medicine are discussed. Regulatory issues are discussed mainly with reference to the FDA guidelines on pharmacogenomics.
Increase in efficacy and safety of treatment by individualizing it has benefits in financial terms. Information is presented to show that personalized medicine will be cost-effective in healthcare systems. For the pharmaceutical companies, segmentation of the market may not leave room for conventional blockbusters but smaller and exclusive markets for personalized medicines would be profitable. Marketing opportunities for such a system are described with market estimates from 2015-2025.
Profiles of 318 companies involved in developing technologies for personalized medicines, along with 575 collaborations are included in the part II of the report. Finally the bibliography contains over 750 selected publications cited in the report.The report is supplemented by 80 tables and 34 figures.
Key Topics Covered:
Part I: Scientific & Commercial Aspects
1. Basic Aspects
2. Molecular Diagnostics in Personalized Medicine
5. Role of Pharmacoproteomics
6. Role of Metabolomics in Personalized Medicine
7. Personalized Biological Therapies
8. Personalized Non-pharmacological Therapies
9. Personalized Medicine in Major Therapeutic Areas
10. Personalized Therapy of Cancer
11. Development of Personalized Medicine
12. Ethical, Legal and Regulatory Aspects of Personalized Medicine .
13. Commercial Aspects of Personalized Medicine
Part II: Companies
14. Companies Involved in Developing Personalized Medicine