diagnostics product development projects · diagnostics product development projects . ... limited...
TRANSCRIPT
Page 0
Diagnostics product development projects
Smiljka de Lussigny Technical Officer, HIV
UNITAID
Copenhagen, 23 September 2013
Page 1
About UNITAID HIV diagnostics market UNITAID’s current investment in HIV diagnostics
1
2
3
Page 2
ABOUT UNITAID
1
Page 3
UNITAID Market Effects Framework for Public Health
UNITAID’s market impact framework
Page 4
Com
mod
ity B
irth
Line
Value Chain
R&D IP Issues
Market Entry
Quality Availa- bility
Price Country Intervention
Operational Research in country
- + ++ + ++ ++ +/- -
Delivery
+
UNITAID’s interventions
Page 5
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
Page 6
UNITAID’s implementers
Page 8
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
Page 9
HIV DIAGNOSTICS MARKET
2
Page 10
• 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
Page 11
• 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
Page 12
12.4 19.1
1.9 2.8
19.4
17.0
7.7 8.4
2.0 2.1 -
5
10
15
20
25
30
35
40
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
Page 13
Testing need increasing with scale up of ART
-
10
20
30
40
50
60
70
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
Page 14 Page 14
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
Page 15
Page 16
• 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
Page 17 Page 17
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
Page 18
UNITAID CURRENT INVESTMENTS IN DX
3
Page 19
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
Page 20
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
Page 21
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
Page 22 Page 22
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
Page 23
Thank you for your attention