Diagnostics for tuberculosis: what test developers want to know

Pai, Madhukar

doi:10.1586/erm.13.16

Cited by 14 publications

(13 citation statements)

References 6 publications

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“…An understanding of the size, value and dynamics of the current and potential market for new diagnostics is critical for decisions regarding the research and development needed in order to bring new tests to market, and to predict whether they will generate a return on investment [6]. The first and only global market assessment for TB diagnostics was published in 2006 by the Foundation for Innovative New Diagnostics (FIND) and The Special Programme for Research and Training in Tropical Diseases (TDR).…”

Section: Introductionmentioning

confidence: 99%

“…The report showed that over 1 billion dollars (USD) was spent worldwide on TB diagnostics [7]. The diagnostic landscape has changed a great deal since then and test manufacturers need current market information at the national level, particularly in countries with emerging economies that also have a high burden of TB, such as the BRICS (Brazil, Russia, India, China, South Africa) countries [6]. While it is difficult to predict the total potential available market, where all possible TB suspects would be tested, a more realistic market indicator is the served available market (SAM), which is based on the actual number, cost and type of tests in current use.…”

Section: Introductionmentioning

confidence: 99%

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Market Assessment of Tuberculosis Diagnostics in Brazil in 2012

Consortium¹

2014

PLoS ONE

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BackgroundImproved diagnostics for the diagnosis of tuberculosis (TB) are urgently needed. However, test developers and investors require market size data to support new product development. This study assessed the served available market for TB diagnostics in Brazil in 2012 and the market segmentation in the public and private sectors.MethodsData were collected on test volumes done in the public and private sectors for the diagnosis of latent and active TB, drug susceptibility testing and treatment follow-up. Tests included were tuberculin skin tests, interferon-gamma releases assays, smear microscopy, solid and liquid cultures, nucleic acid amplification tests and phenotypic drug susceptibility tests. The data were collected by means of an electronic survey via the Brazilian State laboratories and from sales information provided by manufacturers. Test costs for the public sector were calculated using a components approach, while costs for the private sector were based on prices paid by patients. The overall market value (expenditure) for the entire country was calculated using the public sector test costs.ResultsDuring 2012, an estimated total of 2.4 million TB diagnostic tests were done in Brazil, resulting in an estimated overall market value of USD 17.2 million. The public sector accounted for 91% of the test volumes and 88% of the market value. Smear microscopy was the most commonly test (n = 1.3 million; 55% of total) at an estimated value of USD 3.7 million. Culture overall (n = 302,761) represented 13% of test volumes and 40% (USD 6.9 million) of the market value. On average, USD 208 was spent on TB diagnostics for every notified TB patient in Brazil, in 2012.ConclusionThe TB diagnostics market value in Brazil in 2012 was over USD 17 million. These study results will help test developers to understand the current and potential market for replacement or add-on diagnostic technologies.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Market Assessment of Tuberculosis Diagnostics in Brazil in 2012

Consortium¹

2014

PLoS ONE

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“…For companies to take on the challenge and invest in new diagnostics, an understanding of the potential market size is paramount [9]. A 2006 global TB diagnostics market analysis predicted that a smear replacement test applied at the level of peripheral clinics and microscopy centres would have a potential market size of 36.6 million tests per year in the 22 HBCs in 2020, assuming it would diagnose pulmonary, extrapulmonary and paediatric TB [10].…”

Section: Replacing Smear Microscopy For the Diagnosis Of Tuberculosismentioning

confidence: 99%

Replacing smear microscopy for the diagnosis of tuberculosis: what is the market potential?

et al. 2014

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“…From the manufacturer’s perspective, there are challenges related to estimating the demand for PoC technologies as well as defining the regulatory and distribution pathways for new diagnostic technologies [6,7,8,9]. From the demand side, many of the barriers relate to the availability of resources to introduce and implement these diagnostics [10,11].…”

Section: Introductionmentioning

confidence: 99%

Exploring the Case for a Global Alliance for Medical Diagnostics Initiative

et al. 2017

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In recent years, the private and public sectors have increased investments in medical diagnostics for low- and middle-income countries (LMICs). Despite these investments, numerous barriers prevent the adoption of existing diagnostics and discourage the development and introduction of new diagnostics in LMICs. In the late 1990s, the global vaccine community had similar challenges, as vaccine coverage rates stagnated and the introduction of new vaccines was viewed as a distraction to delivering existing vaccines. To address these challenges, the international community came together and formed the Global Alliance for Vaccines Initiative (GAVI). Sixteen years after the formation of GAVI, we see evidence of a healthier global vaccine landscape. We discuss how GAVI’s four guiding principles (product, health systems strengthening, financing and market shaping) might apply to the advancement of medical diagnostics in LMICs. We present arguments for the international community and existing organizations to establish a Global Alliance for Medical Diagnostics Initiative (GAMDI).

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Diagnostics for tuberculosis: what test developers want to know

Cited by 14 publications

References 6 publications

Market Assessment of Tuberculosis Diagnostics in Brazil in 2012

Market Assessment of Tuberculosis Diagnostics in Brazil in 2012

Replacing smear microscopy for the diagnosis of tuberculosis: what is the market potential?

Exploring the Case for a Global Alliance for Medical Diagnostics Initiative

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