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It Takes Two To Tango: Combine Diagnostics And Drugs For Precision Medicine

This article is more than 8 years old.

Personalization is the New Name of the Game

“Precision medicine," also known as "personalized medicine," is a concept of combining a drug with a test that is modified to a person’s genetic disposition. The test has the ability to predict disease risk, diagnose disease and monitor therapeutic response. Given the huge problem of drug failure rates, the concept of “companion diagnostics” in the realm of precision medicine has gained huge momentum since 2010. Precision medicine involves the selection of diagnostic tests (companion diagnostics) that have the potential to identify changes in each patient's cells. The use of that knowledge may help prevent and treat diseases through the development of treatment strategies to target these specific molecular alterations. Ultimately, the goal of precision medicine is to improve patient outcomes.

Figure 1 shows the failure rates for drugs in several disease categories today. Personalized medicine can help save billions of dollars for the healthcare economy globally.

How Big is the Opportunity?

By 2020, the companion diagnostics market will experience a growth of 20.4 percent globally. In 2014, the market for test sales and test services alone was $2.4 billion and is expected to reach $6.9 billion globally.

Figure 2 shows the percentage distribution of partnerships by type of therapeutic area from 2011 to 2013. Companion diagnostics for oncology is obviously leading the way, but there are several other therapeutic areas, including neurology and cardiovascular, that have started to develop drug/diagnostics combo treatments.

The challenges in adopting personalized medicine are boundless. The first and foremost challenge affecting the precision medicine landscape is coordinating the timelines. Aligning the development of a drug and diagnostic design program requires a lot of careful planning. This also closely ties into the fact that the current regulations must be modified to support this idea. Current regulations and the three-tier approval process significantly drives up the cost of delivering drugs to market ($800 million – $2 billion per molecule) with times-to-market of seven to 10 years. This does not lend itself to driving the agility that is imperative for personalized medicine to become mainstream. A radical redesign of the drug approval process is imperative for personalized medicine to flourish.

As personalized medicine progresses, the blockbuster model will undergo gradual transformation to ensure the delivery of “targeted therapeutics” to very small patient populations for superior outcomes, while assuring profitability for pharmaceutical/devices/diagnostics. The pharmaceutical and biotechnology industry is set for a metamorphosis to be integrated and more efficient, and closely linked to biomarkers and diagnostics development.

At this very outset, it is also important that the lack of connectivity within the hospitals and across the healthcare value chain presents really daunting challenges. These include enabling collaboration among researchers, clinicians and the healthcare value chain to access, process and integrate clinical, genetic and genomic data from multiple, often heterogeneous and disconnected sources, and having the robust IT platforms (software and hardware) built on common industry standards to do so.

Precision Medicine Initiative – Who Should be More Attentive?

About $215 million was allocated for NIH, FDA and the Office of National Coordinator of Health Information Technology (ONC) to support precision medicine. This creates ample opportunities for several companies in this space and deploys precision medicine efforts at several levels. Figure 3 shows the ecosystem for precision medicine. Several sectors besides pharma and diagnostics will have a vital role to play. Figure 3 shows different sectors that could make use of the opportunity from the precision medicine initiative.

Pharmaceutical and Diagnostic Companies – It is obvious that pharmaceutical companies will certainly benefit immensely from this initiative. The very fact that the FDA is stressing the co-development of drug and diagnostics will initiate the molecular test developers such as Illumina and Nanostring to partner with pharmaceutical companies, since the future aims toward the provision of genetic testing at low costs. Over $130 million have been allocated to develop a database to genetically profile over 1 million individuals; the effect of this will directly flow through manufacturers and service provider companies, like 23andMe.

CROs, CDOs, Supply Chain Vendors, Biobanks – In order to outsource, pharma companies will contract their clinical trials to contract research organizations (CROs) and contract diagnostics organizations (CDOs). CDOs and CROs rely on high-quality samples from biobanks for biomarker discovery and validation studies. This requires the biobanks to provide samples with the highest quality to the research community, which means supply chain partners will play a key role in sample transport and delivery.

Healthcare IT Vendors – Healthcare IT vendors like Intel and IBM should look at this space more closely and contribute toward network security systems to ensure data privacy and data-sharing standards.

There are several variables that need to be addressed for personalized medicine to become a reality. The opportunities are many, the advantages are immense; however, there is a lot of work to be accomplished.

This article was written with contribution from Divyaa Ravishankar, Senior Industry Analyst with Frost & Sullivan’s global Healthcare and Life Sciences practice.