The full version of this personalised medicine feature can be read in the April issue of our digital magazine: http://www.pharmtech.com/ptedigital0410
"When the Wright Brothers took flight in 1903, few could imagine that in the space of less than 70 years a man would set foot on the moon," says the PwC report. "Similarly, we believe the 21st century will give rise to advances in genomic and proteomic science that cannot yet be envisioned, and will yield results on a similarly grand scale."The potential promise of personalised healthcare has been fuelled by recent advances in genomics and proteomics, which have improved our understanding of the variances between individuals' genetic profiles. This knowledge offers the opportunity to identify which individuals are susceptible to which health conditions, as well as the ability to match the right drugs to patients based on their genetic make up. According to the US Institute for Systems Biology, personalised medicine has four attributes:
According to Kalorama Information's report,2 Pharmacodiagnostics, the path to personalised medicine lies in pharmacodiagnostics — the pairing of a diagnostic test to a therapeutic. The report claims there are two new applications for this. "The first is to narrow the field of application for drugs in development. That is, not only will genomic and proteomic testing be used to identify targets, but also to identify subpopulations of individuals for selection in clinical trials. This was something that was unthinkable to pharmaceutical companies not long ago."
The second application is to select a therapeutic for a patient that will have the greatest efficacy and a lower probability of harmful side effects. This type of personalised treatment is already a reality for certain conditions, such as cancer. The diagnostic classification of cancer has historically been based on the organ or tissue location where it originated in the body. Now, however, it is possible to classify some cancers by the genes that are expressed, the tumour's cell surface proteins and other molecular attributes. Trastuzumab (Herceptin; Genentech), for instance, is only prescribed for patients whose genetic tests reveal an over-expression of the protein HER2 due to a gene mutation.
Barriers to adoption
Unfortunately, there are also numerous barriers hindering pharmacodiagnostics, including a healthcare financial system that is dependent on visible disease symptoms and gross clinical classifications. "Simultaneously, the ability to classify diseases into distinct molecular subcategories challenges traditional pharmaceutical business models that focus on "one-size-fits-all" drugs," says the Kalorama report.
The need for a change in traditional business models is also echoed by the PwC report, The new science of personalised medicine, which describes personalised medicine as a "disruptive innovation" because it will require new approaches, new relationships and new ways of thinking.
The PwC report estimates the core diagnostic and therapeutic segment of the personalised medicine market (comprising mainly pharmaceutical, medical device and diagnostic companies) to be worth approximately $24 billion in the US and expects it to grow by 10% annually to reach $42 billion by 2015. However, the biggest opportunities in personalised medicine lie outside of the traditional healthcare sector. The personalised medical care portion of the US market (including telemedicine, health information technology and disease management services) is estimated to rise from its current value of $4–12 billion to more than $100 billion by 2015. Meanwhile, the nutrition and wellness market (comprising retail, complementary and alternative medicines offered by consumer products, food and beverage, leisure and retail companies) will rise from $196 billion to more than $290 billion by 2015.
"As the boundaries between traditional healthcare offerings and wellness products and services blur, and as the trend towards consumer-focused healthcare accelerates, companies outside the health industry are finding new opportunities," says the report, which means that traditional pharma and biotech companies will need to be wary of new competitors entering the market. The report adds: "Companies from outside the traditional healthcare arena, from PepsiCo to Procter & Gamble, could be formidable competitors, due to their skills and experience in targeting consumers, who are contributing to the rapid growth of the wellness market."
In particular, the PwC report stresses that collaboration will be key in this new business model. "Unless regulatory and reimbursement models are aligned with the requirements of personalised medicine, the new science is not likely to advance far," says the report. "Pharmaceutical and diagnostic companies, payers and regulators can work together to create an economically viable, sustainable process for commercialising targeted diagnostics and therapeutics."
In light of the future expectations of personalised medicine, Pharmaceutical Technology Europe spoke with numerous experts to find out more about some of the latest developments and trends driving the sector.