TB Diagnostics: Global Market Analysis and Potential

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1 TB Diagnostics: Global Market Analysis and Potential Madhukar Pai, MD, PhD McGill University, Montreal, Canada September 2012

2 Market analyses are important and necessary To support new product development To convince industries and investors about the need for investments in new TB tools To develop target product profiles (TPPs) that can guide product development and scale-up To inform donor/funder decisions 2

3 Global TB burden: how many people are screened for TB ever year? According to the World Health Organization, in 2010, there were ~9 million incident cases of TB Since ~7 people with TB symptoms need to be screened to detect one TB case, this means over 60 million people get tested for active TB every year In addition, there is testing for latent TB infection and MDR-TB 3 Source: WHO

Only one global TB market analysis has been done to date By FIND & TDR Published in 2006 4 Source: FIND

4 Only one global TB market analysis has been done to date By FIND & TDR Published in Source: FIND

Findings from this analysis showed Annually over US$ 1 billion is spent worldwide on TB diagnostics One third (US$ 326 million) of this money is spent out side of the established market

5 Findings from this analysis showed Annually over US$ 1 billion is spent worldwide on TB diagnostics One third (US$ 326 million) of this money is spent out side of the established market economies (EME),where 73% of TB diagnostic testing takes place In EME: latent TB testing (PPD) dominates In non-emes: active TB dominates (smears and chest x-rays) 5 Source: FIND/TDR, 2006

6 Potential market for new TB tests (global) The potential markets for improved tests to detect active disease are large: 80 million for point-of-care test (per year) 50 million for smear replacement (per year) 20 million tests for culture replacement tests (per year) 6 Source: FIND/TDR, 2006

7 This global analysis needs to be updated to account for Major recent changes in the TB dx landscape and policies Development of several new diagnostics that are replacing or supplementing older tests Shift from PPD skin testing to IGRAs in high income countries Donor-driven roll-out of new tools, especially molecular tests, in high burden countries Greater willingness of high burden countries (especially BRICS) to invest in new technologies and invest more in TB control 7

8 The recently published UNITAID TB Dx landscape provides a good snapshot of this evolving landscape 8

9 Old tools are being replaced/supplemented by new technologies Tuberculin IGRAs Conventional microscopy LED/FM microscopy Solid cultures Liquid cultures Conventional, phenotypic DST Molecular DST (LPA) Conventional PCR Cartridge-based NAATs 9

10 The policy environment is vastly different now 10 Source: WHO 2011

11 In high-income countries, there is a growing shift from tuberculin skin testing to IGRAs, or TST + IGRA T-SPOT.TB [Oxford Immunotec, UK] QuantiFERON-TB Gold In Tube [Cellestis Ltd, Qiagen] 11 Denkinger C et al. Clin Micro Infect 2011

sputum smears continue to be used As of August 2012: $9.

12 For the first time, a molecular TB test is being rolled out for active TB in high burden countries; while sputum smears continue to be used As of August 2012: $9.98 per cartridge for public sector in high burden countries 12

13 After GeneXpert, several fast-followers are rapidly emerging, aiming at decentralized deployment Source: Pai NP, Pai M. Discovery Med

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current Current and near term future Long term future (10-15 years+?

to result GeneXpert Next generation molecular Dx Molecular diagnostics Highly sensitive and specific Rapid

14 This image cannot currently be displayed. Molecular diagnostics improve upon current tools, providing a bridge to true point-of-care Dx Past and current Current and near term future Long term future (10-15 years+?) Expected health impact 14 Microscopy Very affordable Poor sensitivity Culture More expensive Slow time to result GeneXpert Next generation molecular Dx Molecular diagnostics Highly sensitive and specific Rapid time to results Affordability and accessibility increasing over time True point-of-care Dx (based on biomarker TBD) High performance Very affordable Accessible even to patients not reached by current Dx Source: BMGF

emerging economies (India and China, in particular) to

15 Need for regional market analyses and focus on BRICS Efforts are ongoing to engage industries and donors in emerging economies (India and China, in particular) to develop affordable Dx that can be scaled-up for TB and HIV 15

TB Diagnostics in India: Market Analysis Revised - Version 2

Minal Madhavankandi, MBA [Indian Institute of Management,

New Delhi] Madhukar Pai, MD, PhD* [McGill University, Montreal]

16 TB Diagnostics in India: Market Analysis Revised - Version 2 Shekhar Menon, MBA [Indian Institute of Management, Bangalore] Minal Madhavankandi, MBA [Indian Institute of Management, Bangalore] Mansi Chitalia, MBA [Clinton Health Access Initiative, New Delhi] Madhukar Pai, MD, PhD* [McGill University, Montreal] Full analysis is available at:

17 TB diagnostics that are currently in use in India Public sector (RNTCP) Refers to the testing facilities under the Revised National Tuberculosis Control Programme (RNTCP), the government tuberculosis programme Active TB: Sputum smear microscopy (direct ZN staining) Chest x-rays Drug resistant TB: Line probe assays Solid culture and DST Liquid culture and DST Latent TB and pediatric TB: Tuberculin skin test Private (non-rntcp) Includes all testing facilities in the private sector, government hospitals, medical colleges Active TB: Sputum smear microscopy (direct ZN and auramine staining) Chest x-rays Serological TB tests (ELISA and rapid tests) PCR (in-house or commercial) QuantiFERON-TB Gold In Tube Drug resistant TB: Line probe assays Liquid culture and DST Latent TB: Tuberculin skin test QuantiFERON TB Gold In Tube 17

18 Estimation of number of patients with suspected pulmonary TB Estimation of total pulmonary TB suspects (per year) National TB programme (RNTCP) Pulmonary TB suspects 1 7,550,522 Contribution of RNTCP to total pulmonary suspects 40% Contribution of Non RNTCP (private sector) to total pulmonary suspects 60% Non RNTCP Estimated number of pulmonary TB suspects 11,325,783 Total pulmonary TB suspects 18,876,305 Assumptions based on discussions with key stakeholders* We assumed the split of patients tested for pulmonary TB (pulmonary TB suspects) in RNTCP: Non-RNTCP sector to be 40: 60 based on discussions with various stakeholders* The split was applied to the pulmonary TB suspects in the RNTCP sector to calculate the number of pulmonary TB suspects in the Non-RNTCP sector Source: 1. RNTCP report: TB India 2011; Note: *Key stakeholders include RNTCP, WHO, BMGF, CHAI, FIND, GHS, private laboratory service providers, diagnostics manufacturers 18

19 Estimated RNTCP (public sector) spend on TB diagnosis TB test Volume Price per test 1 ($) Market value ($) Comments Sputum smear 15,101, ,752,610 Assumes two smear conducted microscopy 2 per suspect as per RNTCP diagnostic algorithm Line Probe Assay 13, ,333 (LPA) 3 Liquid culture 3 6, ,000 Total 15,121,044 38,025,943 Based on RNTCP reporting and data from stakeholders, we noted the volumes of TB tests conducted by the RNTCP (public) sector Using the unit cost per test, we calculated the total patient spend on the various pulmonary TB tests 19 Source: 1. Discussions with RNTCP and labs 2.RNTCP report: TB India 2011; 3. Data from FIND and BD Note: Exchange rate: 1USD = 50 INR

20 Estimated Non-RNTCP (private sector) spend on TB diagnosis TB test Volume Price per test 1 ($) Market value ($) Serology Rapid Card tests (lateral flow assays) 3,397, ,988,675 Serology ELISA (assumed 2 antibodies tested per 2,265, ,181,879 suspect) Sputum smear microscopy 2,831, ,078,614 Culture 1,132, ,375,084 PCR (in-house and commercial) 1,132, ,507,662 QuantiFERON-TB Gold In Tube 226, ,325,783 Line Probe Assay (LPA) 2, ,258 Total tests 10,988, ,570,955 Unit cost per test was used to calculate the total patient spend on pulmonary TB diagnosis in the Non-RNTCP sector 20 Source: : 1. Discussions with large lab chains Note: Exchange rate: 1USD = 50 INR

21 Total patient spend on TB diagnosis in India: ~$220 m TB testing in Volume Market value ($) RNTCP 15,121,044 38,025,943 Non RNTCP 10,988, ,570,955 Common tests (X-rays and TST) 15,274,290 45,649,624 Total tests 41,384, ,246,522 India accounts for about 25% of the global TB burden 21

22 WHO has discouraged commercial TB serological tests and India has recently banned these tests There is a substantial market now for a test that can replace TB serology 22

23 acement and usage scenarios to estimate essable market value Scenario (if a new TB test 1 were to ) Volume Price per test 2 ($) ote: 1USD = 50 INR No specific Target Product Profile (TPP) for the new TB test was assumed while developing the different scenarios Assumes that the new TB test will be imported Market value ($) Replace serology (rapid + ELISA) (capture 33%) 1,868, ,728,844 Test always prescribed for all suspects (Ideal) 11,325, ,051,637 Test prescribed for 70% of suspects (High) 7,928, ,536,146 Test prescribed for 30% of suspects (Medium) 3,397, ,515,491 Test prescribed for 10% of suspects (Low) 1,132, ,505,164 Replace smear (capture 33%) 4,983, ,877,995 Replace smear (capture 100%) 15,101, ,751,501 Replace culture (capture 33%) 2, ,281 Replace culture (capture 100%) 6, ,335

24 existing TPPs that need to be refined and integrated arket analyses to get at addressable market size a POC F/TAG/STP)* TPP for a simple and affordable molecular test TPP for a high throughput molecular test for centralized

25 ally, in the immediate term, we need an affordable molecular that can be used in health centers with a peripheral lab cess to Care by Infrastructure Category* ion Access to no infrastructure Access to minimal infrastructure Access to moderate/advanced infrastructure rica 25% 47% 28% ia 13% 29% 58% Potential Coverage 28% - 58% Current - Diagnostic Tools Potential Coverage 75% - 87% Mid Term Goal - POC Platform with Moderate Impact Potential Coverage 87% - 93%

26 e longer term, we need a simple POC test that can eployed in the community and health posts

lusions ough the exact size of the TB Dx

27 lusions ough the exact size of the TB Dx global market today is not known, definitely likely to be higher than $1 billion because of two major ds in the past few years: ncome countries uberculin IGRAs iddle income countries croscopy Molecular

28 lusions ever, since current versions of IGRAs and molecular tests are ensive and challenging to scale-up, there is an opportunity for panies to develop: More affordable IGRAs or next-generation assays for latent TB infection that are more predictive for future disease More affordable molecular tests or next-generation assays for active TB and MDR-TB Truly innovative, simple technologies for POC use in decentralized settings

29 ese companies are already making progress along e lines example: B-IGRAs by Beijing Wantai Haikou VTI Biological Institute B molecular assays by: Ustar Biotechnologies CapitalBio hese products need to be internationally validated for policy commendations and global uptake/adoption Regulatory approvals are required but not sufficient for policy and global scale-up

30 t evidence is needed for global policy? t are the challenges for global scale-up? 30 J Infect Dis 2012 Int J Tuberc Lung Dis 2012

31 k you! o financial/industry nflicts erve as a consultant to e Bill & Melinda Gates undation eceive grant support om the Bill & Melinda ates Foundation & rand Challenges Canada

Value chain in action: the story of TB serology in India

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