Envisioning an Essential Diagnostics List (EDL) and Its IVD Market Impact

Envisioning an Essential Diagnostics List (EDL) and Its IVD Market Impact

Kalorama Information offers relevant market research in the areas of molecular point-of-care (POC) diagnostics, traditional POC diagnostics, and physician office laboratory (POL) test markets. Market information in this post was drawn from the associated reports.

In a recent article of the New England Journal of Medicine (NEJM), health and medical experts convincingly argued for the establishment of an Essential Diagnostics List (EDL) modeled on the existing Essential Medicines List (EML). The globally applicable EDL would have its greatest impact in the development of markets for in vitro diagnostic (IVD) products within the least developed healthcare systems. Accessibility and coordination of care is still desperately lacking in the developing world and has been addressed only in part by the World Health Organization’s (WHO) establishment of essential medicines for distribution to resource-limited healthcare systems. Effective use of EML therapies, including the stewardship of distributed antibiotics, would be encouraged through the equal availability of diagnostics. In this post, Kalorama Information identified several core EDL test categories outlined by the NEJM article’s authors that are represented by currently marketed physician office laboratory (POL) and point-of-care (POC) diagnostics. While the potential to address future EDL-driven markets through existing IVD products exists, significant cost improvements will be necessary.

Several global healthcare challenges - burden of hepatitis and HIV infections; surveillance of Zika and Ebola viruses; mounting antimicrobial resistance; glycemic control - can be combated through the greater availability and accessibility of effective testing services in neglected regions. An EDL administered by a global body such as WHO could be one of the most cost-effective vehicles for improving care in the developing world. Relatively small investments in diagnostics could help more efficiently manage both human resources and medicine by avoiding misdiagnoses and enabling more timely intervention. Benefits of global investment in EDL-listed diagnostics would also extend to the developed world through improved disease surveillance and mitigation of development in antimicrobial resistance.

The working EDL proposed by the NEJM authors identified key test categories each essential to the “effective and safe use of at least 10 [EML-listed] medicines”. Cost synergies are evident in the proposed EDL, both in terms of the repeated role of certain tests across multiple therapies and the minor subset of tests identified overall that guide the majority of clinical decision making. In the United States, the authors noted, only 2% of laboratory tests represent 80% of testing volume, which underscores the reasonable scope of core EDL tests. The following are the most highly referenced test categories under EML-related treatments and were included as candidates for an EDL by the article’s authors:

  • Complete Blood Count (CBC) - The developed world (or little more than 15% of the global population) accounts for 32% of the estimated global volume for this routine hematology test. The automated CBC is the most-performed lab test in the United States. Near-patient or POL CBCs represent a global IVD market in excess of $250 million. However, current impedance- and flow-based hematology analyzers remain infeasible for wide deployment in the developing world both in terms of cost and lab requirements.
  • Liver Enzymes - Liver enzyme tests are commonly performed in the core lab on clinical and integrated chemistry analyzers. The global POL market for clinical chemistry is close in size to the POL CBC market. Relevant POL chemistry analyzers such as the Abaxis Piccolo are costly, but could find limited markets in low-resource regions with large-scale, negotiated procurement programs for EDL tests.
  • Renal Function - Also commonly performed as part of clinical chemistry panels from venous samples, renal function can also be assayed from urine samples using low-cost urinalysis strips and analyzers.
  • Urinalysis - The multi-parameter testing of urine samples using urinalysis strips represents one of the most readily accessible tests available to the developing world. Automation of urinalysis testing is increasingly common in the developed world, but market-displaced manually interpreted strips could find new markets with very affordable bulk-negotiated prices as EDL-listed diagnostics.
  • Molecular Microbiology - Significant innovation in recent years has made low-complexity, near-patient molecular testing for infections a reality. In the U.S. market, rapid molecular testing outside of hospital and independent labs is possible for influenza, respiratory syncytial virus (RSV),  strep A, hospital-acquired infections (HAIs) and common STIs such as chlamydia and gonorrhea (CT/NG). Additional systems cater to near-patient HIV testing in the developing world including the Alere q and Diagnostics for the Real World’s (DRW) SAMBA II. However, molecular diagnostics’ relatively high assay costs and the availability of cheaper alternative, non-molecular tests for HIV and hepatitis virus testing are anticipated by Kalorama Information to keep the combined molecular POC market for HIV and hepatitis far short of its +$1 billion total market potential in 2020. Cost sensitivity is even more of an issue for malaria tests, where molecular tests would be hard-pressed to edge out current rapid malaria tests procured for under $1 each. While easy-to-use, high-specificity and high-sensitivity molecular tests for the Ebola and Zika viruses would be invaluable to disease surveillance efforts, serology-based tests for these dangerous diseases remain a priority in assay development. It is also uncertain whether Zika and Ebola would be included under a potential EDL.
  • Electrolytes - Electrolytes can be assayed as part of urinalysis or clinical chemistry. While urine-based electrolyte testing is already feasible as part of an EDL, automation of chemistry testing remains an expensive proposition for routine patient care in the developing world.
  • Microbiologic Culture - High barriers exist to the introduction of culture-based microbiology testing in routine clinical care for resource-poor regions. Personnel are lacking for intensive and complex manual culturing. Automated solutions for culturing and susceptibility testing are prohibitively expensive for extensive deployment in healthcare settings. Rapid serology and molecular tests for markers of microbial resistance to antibiotics could represent a lower level of investment for decentralized near-patient testing in low-income countries, but assay costs again outstrip likely available resources. Even in the developed world, rapid antimicrobial susceptibility testing (AST) assisting effective antibiotic stewardship persists as a challenge.

The developing world and its emerging markets have long been targets for market expansion by IVD companies. Inconsistent and slow growth in the world’s developed economies and cost pressures on their established healthcare systems have checked growth in IVD spending.  Other global IVD targets - China, Brazil, Russia, India (once-fabled BRIC market) - have cooled down or failed to launch. Remaining low-income markets in Africa, Asia and Latin America could experience dramatic IVD market growth, but require bulk procurement facilitated by negotiation and co-financing between international organizations and recipient governments and guided by an EDL or similar standard. The distribution of listed tests could succeed at the same level as rapid HIV and malaria tests broadly distributed using procurement organization and assisted funding by the Clinton Foundation HIV/AIDS Initiative, Roll Back Malaria, UNAIDS, United States President’s Emergency Plan for Aids Relief (PEPFAR), the Global Fund to Fight AIDS, and Tuberculosis and Malaria, and the World Health Organization. Large-scale procurement and continued IVD innovation are able to work in concert to lower the costs of tests and introduce them into mainstream clinical usage, but also require clearly defined objectives as provided in global campaigns against diseases such as HIV, tuberculosis, and malaria.