The aim of personalized medicine is to match the right drug to the right patient. It focuses on identifying which approach will be effective for individual patients based on the predispositions written into your genome at birth.
In part two of our Q&A series with Kelly Scientific, we look at the biggest challenges facing the personalized medicine industry, how it will integrate into the global healthcare market and more.
Don’t forget to check out part one, which discussed the key trends influencing the cancer immunotherapy market in 2017.
Q. In your opinion, what are the three biggest challenges facing the personalized medicine industry in 2017? How will these changes influence the industry and how will market players respond?
Applying genetics research into functional clinical applications is a major challenge. Clinical populations need to be stratified according to age, racial background and environmental conditions such as diets and lifestyle. To that end, correlating genomic mutations to functional molecular profiles with clinical relevance is an R&D obstacle.
Regulatory concerns are also a challenge, specifically with regards to data sampling, analytical procedures, coding systems, statistical methods, clinical utility and validity requirements. Results and patient background data needs to be standardized as does data protection. Furthermore, international agreement and valuation of clinical bioinformatic data analysis is a major challenge to the industry. One of the main obstacles of the personalized medicine space has always been the analysis of large volumes of complicated heterogeneous datasets and results.
Q. What have been the most important technological developments in the personalized medicine industry over the last decade?
The development of a number of fields have propelled the industry including:
- Single Base Primer Extension (SBE)
- Primer Based Base Extension
- Hybridization Based SNP Analysis
- Ligation Based Approach
- New-Generation Sequencing Technologies
- Ultra-High Throughput Sequencing
Ultra-High Throughput Sequencing (UHTS) is possible the most important technology to the advancement of personalized medicine. UHTS has transformed genetic research by allowing investigators to examine a number of genes simultaneously. Another major advantage of this technique is its ability to quickly sequence whole genomes at a low cost that will propel the personalized medicine industry. In the future UHTS technology will be widely adopted by clinical diagnostic laboratories. The development of assays with high probe coverage has also been instrumental in driving the industry. For example, some assays can use around 30,000 probes in are of increased disease association and will detect heterozygosity absence over 5-10Mb.
GLOBAL HEALTHCARE SYSTEM
Q. How will the personalized medicine market integrate into the global healthcare market?
The application of sequencing the entire human genome to medicine has revolutionized and challenged the current healthcare system. This phenomenon not only has allowed healthcare to continue its vertical momentum, aided by continuous companion diagnostic development. This new healthcare application will meet the needs of patients who are currently suffering from cancer and other genetic based diseases and also from adverse drug reactions and sub-therapeutic clinical effects. It will also transform health economics and reimbursement strategies. However, it will take a number of years before personalized medicine has truly integrated into the global healthcare system.
Currently oncology, infectious disease, cardiovascular and neurodegenerative based products are driving the personalized medicine market, however areas such as immunology, and metabolic disorder products are becoming more prevalent. Areas that will see significant development in the future include metabolic pathways, disease mechanisms and predisposition, pathogenesis, signal transduction, regulatory circuits and regeneration. More specifically market leaders are targeting signaling pathways in apoptosis, Jak/Stat pathways and PI3-kinase for future drug targets/diagnostic tests.
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