Molecular imaging is becoming a very interesting growth area in drug discovery. There is considerable enthusiasm in the preclinical market to expand the use of molecular imaging and a more cautious approach in the clinical market. The size of the opportunity for suppliers of molecular imaging products and services is huge.
If the more than $12 billion spent annually by pharmaceutical companies for preclinical and Phase I drug discovery and the approximately $2.9 billion spent on translational research at academic and research institutions are combined, suppliers are competing for a share of a nearly $15-billion market.
Unusually, this huge market has limited technology risk since the imaging technologies are already well understood (Table). The development of additional molecular tracers/probes will require R&D but will not face hurdles in market acceptance. If instrument suppliers choose not to take the lead, there may well be an opportunity for other players such as contrast-agent suppliers and data-analysis software vendors to create integrated solutions that capture significant market share.
From a drug development perspective, molecular imaging can provide information on:
• Desirable or undesirable pharmacological effects of a drug on in vivo biochemistry and physiology
• Drug interactions with the desired target, including dose occupancy relationships and kinetic information
• The delivery of a drug to a specific target
• The absorption, distribution, metabolism, and elimination of a labeled drug candidate
We expect that the market for positron emission tomography (PET) techniques will grow at 15% over the next few years, with imaging agents growing even faster at 19%.
Spurred on by these robust growth rates, imaging equipment suppliers have been seeking new opportunities. Klaus Kleinfeld, former CEO of Siemens, predicted the increasing convergence of imaging, biotechnology, and IT would improve diagnosis and treatment of patients. Siemens’ commitment to this strategy was demonstrated by its acquisition of Bayer Diagnostics for $5.25 billion in 2006.
Two areas in which molecular imaging can have a significant impact on drug development are preclinical research and Phase I trials. Spending on these two areas accounted for nearly one-third of the total R&D spending across the pharmaceutical industry in 2006.
Not only are preclinical research and Phase I trials expensive, but inappropriate selection of compounds in these early phases can have disastrous consequences in later clinical trial phases. The story of drug development is also about failure. Out of a hypothetical 100 drug candidates that begin the process, only one will be successfully registered and available for patient care.
Between 30 to 40% of new drugs fail due to poor performance at the transition from animal to human trials (Phase I). Molecular imaging can play a role in completing the first successful toxicology in animal models to first in human testing in Phase I. Molecular imaging can impact between 8 to 22% of compounds in the later stages of preclinical research and Phase I trials. Even a modest improvement in these areas (e.g., 10–15%) could lead to a doubling of the number of compounds that successfully make it to market.