OBJECTIVES: Consumers are shouldering an increasing percentage of health care expenditures through cost-sharing mechanisms embedded in benefit design structures.  As a result, many patients are paying out-of-pocket for some or all of the costs associated with diagnostic testing.  Traditionally, diagnostic companies have focused on demonstrating value to payers with the goal of achieving adequate pricing and reimbursement. Though this approach will remain necessary, patients are an increasingly critical stakeholder in determining whether a diagnostic’s value supports the resulting out-of-pocket costs. This study examined how out-of-pocket expenditures by individuals, national health expenditures (NHE) on diagnostics, and the price index for diagnostics grew between 2005 and 2011.  METHODS: A systematic review of published literature related to health care expenditure, health insurance coverage, diagnostic pricing, and benefit design was performed.  In follow-up, data from the Centers for Disease Control and Prevention, Bureau of Labor Statistics, Employer Benefits Health Survey, and diagnostic industry reports were reviewed to examine growth rates over the study period.  Basic statistical methods were employed to determine how average annual growth rates within each segment relate to other variables being considered.  RESULTS: The proportion of individuals in America with high-deductible health plans has increased 475% in the last six years. This correlates to over 25 million Americans responsible for at least $2000 in deductible costs in addition to coinsurance and co-pays.  During this period, pricing of diagnostics only rose at an average annual rate of 1.0%. Overall spending on health care increased while diagnostics expenditure remained consistent at 6% of NHE.  CONCLUSIONS: As health care continues to transform, the demand for high quality diagnostics will continue to grow. However, the increasing financial burden borne by individuals will lead to increased price sensitivity. Novel technologies will need to demonstrate value and clinical utility not only to payers, but to patients, to achieve pricing and reimbursement.