Fast Growth in Real and “Virtual” Biobanks May be Revenue Opportunity for Clinical Pathology Laboratories
Biobanking is now a $7.9 billion industry and demand for specimens is skyrocketing
Biobanking is going big time! VisionGain estimates that biobanking is now a $7.9 billion industry. That’s a revenue number that should interest pathologists and clinical laboratory managers, since their organizations access large volumes of patient specimens every year.
As one source of human specimens, both clinical laboratories and anatomic pathology groups have an opportunity to participate in biobanking activities. At this stage in the market, however, few medical laboratories formally participate in biobanking activities. Experts believe that is likely to change.
The world’s largest biomedical database now contains tissue specimens gathered from more than 500,000 middle-aged Britons. It is the U.K. Biobank, which recently made its resources available to researchers. This biobank is backed by the U.K.’s Medical Research Council and the Wellcome Trust charity. Each tissue sample also has more than 1,000 pieces of health-related and genetic data associated with it.
Researchers and pharmaceutical companies have an enormous need for access to large quantities of human tissue samples, especially if they can be pre-screened for specific disorders and diseases. For example, many research studies would benefit from having access to as many as 2,000 tissue samples from men and women diagnosed with the same type of cancer.
The challenge is that few clinical trials or institutions have the depth and breadth of materials to fulfill such requests. However, genomic screening technologies are now inexpensive enough to make biobanking possible.
Opened in 2009 by Princess Anne, the UK Biobank is considered the world’s largest bio-repository. It contains a huge freezer that is designed to hold 10 million samples of blood and urine from 500,000 people aged 40 to 69, for the next 30 years. (Photo by RTS-Group.com.)
The biobanking industry is exploding and a number of different types of repositories are appearing, including such business models as:
- Physical (or “real”) biobanks
- Virtual biobanks
- Matchmaking services
- Tissue banks
- Population banks (typically regional in nature and comprising biomaterials with associated phenotypic, lifestyle, clinical, genetic, and environmental information)
Large biobanks, or “virtual biobanks” that draw materials from other biobanks, have the power to assemble large numbers of specimens that fit the criteria of specific research projects, observed Margaret Clotworthy, Director of Human Focused Testing. “Researchers rely on tissue repositories to access samples essential to their work… Scientists will go wherever they know that they can obtain quality, ethically sourced tissues.”
A recent article in Genetic Engineering & Biotechnology News looked at this rapidly expanding industry, which ranges from individual research labs and hospitals to academic centers and commercial biobanks. In fact, the industry is not only growing, it appears to be specializing.
Biobanks are being set up that specialize in specific types of tissues or specific medical conditions, observed Ann Cooreman, COO at Tissue Solutions. “Commercial biobanks do not tend to bank unusual samples; hospitals have no particular bias and often bank with fewer commercially sensitive restrictions,” she said.
Significant Ethical Considerations for Biobanks
Biobanks present certain ethical problems. If, for instance, a researcher uses a tissue sample and in the course of their research discovers that the patient has an undiagnosed condition, are they obligated to inform the patient? This is one question asked by Susan Wolf, JD, McKnight Presidential Professor of Law, Medicine and Public Policy at the University of Minnesota, and head of an NIH www.nih.gov/ working group in charge of creating recommendations for ethical issues related to genetic information.
Wolf published 10 recommendations in Genetics in Medicine. One of those recommendations was for more biobanks to be set up.
Wolf writes in the paper, “Yet biobanks—a term we use broadly here to cover a range of structured collections, including biorepositories and databases—are now crucial engines of large-scale genetic and genomic research. They are the central part of what we will call a ‘biobank research system,’ comprising primary research or collection sites, the biobank, and secondary research sites accessing biobank data or samples for further research.”
Another recommendation, however, is that the researchers be responsible for telling patients about their findings. Robert Green, M.D., of Boston University, was quoted in a 2011 Science article, as indicating that most researchers are ill-equipped and untrained for providing patients with medical counseling. “Biobanks would have to reach out to the hundreds of thousands of people who have already shared DNA samples and inquire whether they might want information back; currently, virtually all biobank consent forms say that genetic results will not be returned.”
Clinical Laboratories and Biobanks
If the biobanking industry is growing, what does that mean to clinical laboratories? Are clinical laboratories and pathology group practices sitting on a gold mine of marketable tissue samples?
The answer is maybe. Clearly there’s money involved. As noted above, Visiongain estimates the global biobanking market at $7.88 billion and predicts that it will expand. And the expenses of a major biobanking enterprise are significant and might require government backing. The UK Biobank cost almost $160 million (U.S.) to plan and develop.
Quality of samples, sample integrity, and risk management are growing concerns. Martin Frey, PhD, Senior Product Manager of Storage Technologies at Swiss-based Hamilton Bonaduz says, “We are finding that scientific journals are now asking for proof that all samples in a study have been tracked and that temperature profiles have been maintained.”
Despite the costs and the ethical and technical complications, biobanking is a fast-growing sector of healthcare. Yet the U.S. appears to be lagging significantly behind. Reports indicate that the Netherlands and Northern Europe are leaders in the industry and China is in the process of setting up its own biobanks.
It remains to be seen how quickly the United States can establish its own biobanks that can grow to tens of thousands of specimens. Advances in healthcare informatics may make it easier for local clinical laboratories and pathology groups to participate in biobanking activities—in return for reimbursement that makes the effort worthwhile.
—By Mark Terry