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Diagnostics product development projects

Smiljka de Lussigny Technical Officer, HIV

UNITAID

Copenhagen, 23 September 2013

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About UNITAID HIV diagnostics market UNITAID’s current investment in HIV diagnostics

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ABOUT UNITAID

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UNITAID Market Effects Framework for Public Health

UNITAID’s market impact framework

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Com

mod

ity B

irth

Line

Value Chain

R&D IP Issues

Market Entry

Quality Availa- bility

Price Country Intervention

Operational Research in country

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Delivery

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UNITAID’s interventions

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HIV / AIDS 51 recipient countries

Malaria 29 recipient countries

Tuberculosis 76 recipient countries

> US$903 m > US$456 m

Cross-cutting programmes: US$ 129 m - WHO PQ of drugs, diagnostics and VMC devices US$ 31 m - Medicines Patent Pool

> US$291 m

UNITAID’s commitments 2006-2012 US$ 1,8 billion; 94 Countries receiving commodities

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UNITAID’s implementers

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1 Simple, point of care (POC) diagnostics

2 Affordable,

adapted paediatric medicine

3 Treatment of HIV/AIDS and co-infections

4 Treatment of

malaria (ACT)

5 Treatment of second-line tuberculosis

6 Preventatives

for HIV/AIDS, TB and malaria

STRATEGY 2013-2016 Six Strategic Objectives

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HIV DIAGNOSTICS MARKET

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• Initial diagnosis of HIV (including Early Infant Diagnosis)

• Patient staging (CD4 testing) • Patient monitoring

• 2013 WHO guidelines : viral load testing for treatment failure

• Laboratory-based and point of care

HIV diagnostic and monitoring tools

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• Unmet needs: <50% of PLHIV are aware of their serostatus <60% of PLHIV have access to CD4 testing <25% have access to VL testing <26% of the infants born to HIV positive mothers have access to Early

Infant Diagnostic (EID) testing.

• Changes in 2013 WHO guidelines will impact the “needs”: – Increased number of people eligible for ART: total of 25.9 million

(9.7 million are now on ART) – Preference of VL for monitoring of treatment failure over CD4,

• When? • What?

Demand side

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12.4 19.1

1.9 2.8

19.4

17.0

7.7 8.4

2.0 2.1 -

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10

15

20

25

30

35

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2012 2013 2012 2013 2012 2013

CD4 VL EID

Mill

ions

Unmet Need for HIV Diagostics

Number of Tests performed Additional Tests requiredTests

CD4 and VL coverage data based on country data collected by CHAI in 8 high HIV burden countries in SA. EID data based on kidstat testing numbers. Newer testing volumes were used where available.

Testing coverage far below need

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Testing need increasing with scale up of ART

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2012 2013 2014 2015 2016 2017 2018 2019 2020

Mill

ions

CD4, VL and EID testing need

CD4 Staging CD4 monitoring VL monitoring EID

Based on CHAI ART patient forecast and country guidelines for staging and monitoring. WHO guidelines were used where country guidelines were unavailable.

EID data is based on WHO reported number of HIV exposed infants

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Supply side – market shortcomings

• Availability: Limited POC CD4; no POC VL or EID tests available on market.

• Acceptability: existing tools too complex for all needs of resource limited settings (lab-based), especially remote settings

• Affordability: Traditional lab testing too expensive (CD4 US$25-90K for instrument; VL US$100-225K, plus test cost!). Recent POCs less expensive (ranges US$6-25K per device, US$6-12 per test).

• Quality: absence of information on quality of new POC; slow global and unclear, inconsistent, and costly national QA processes.

• Delivery: slow and insufficient uptake

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• Market entry definition: "completion of the marketing approval steps required to commercialize a product"

• Most significant market entry barriers: • Unclear, absent, and/or inconsistent regulatory

pathways to market, register, and use new diagnostics – each country has own requirements

• Slow global QA processes • Private funding (venture capital) hard to access

Discovery Development Evaluation Registration Market

Market entry barriers for HIV POC Dx

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Implications

• Delay in market entry of new products • Limited competition. First-to-market may capture market

share and block market entry of potentially improved and lower cost products in the pipeline

• Additional costs and resources needed to enter market may increase final price & limit extent of uptake

• Long term disincentives for continued innovation

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UNITAID CURRENT INVESTMENTS IN DX

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LSHTM

WHO PQ Diagnostics

Development Evaluation Market Approval

Landscape Analyses; Market Forums; Partner Coordination to align procurement practices &

policies

Developers - Market Entry

MSF

CHAI/UNICEF

legend: Projects Secretariat activity

Univ. Bern: CE

UNITAID’s HIV Dx approach

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Funding Project Aim CHAI UNICEF

1 year $20 million Phase 2 Dec 2013

POINT OF CARE DIAGNOSTICS FOR HIV Prepare the market for accelerated scale-up of POC HIV diagnostics including CD4, VL/EID in 7 countries.

MSF 3 years $28.6 million POINT OF CARE DIAGNOSTICS FOR HIV Operational research on introduction of PoC and adapted laboratory-based monitoring to understand how, where and when PoC fits in the mix of laboratory services available in health services in 7 countries.

FEI 1 year $2.4 million Phase 2 June 2014

OPEN POLYVALENT PLATFORMS FOR SUSTAINABLE AND QUALITY ACCESS TO VIRAL LOAD Improve access to viral load testing (VLT) and early infant diagnosis (EID) for adults and children living with HIV through the introduction of innovative Open Polyvalent Platforms (OPPs)

LSHTM

$2.9 million GLOBAL NETWORK TO IMPROVE ACCESS AND QUALITY OF HIV MONITORING

Market entry projects

$20.7 million envelope MARKET ENTRY Address Developers’ Market Barriers: 4 developers of CD4, VL and EID POCs

UNITAID’s recent investment

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Closed Platform

Open Platforms

Extraction Reagents

Real time thermocycler

• OPEN systems: different components can be provided by different suppliers

• POLYVALENT systems: may be used for multiple diagnostics

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http://www.fei.gouv.fr/index.php/a-la-une/613-procurement-notice-opp-era

http://www.dgmarket.com/tenders/np-notice.do~9461166

OPP-ERA call for tenders

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Thank you for your attention