1. An Institutional Analysis of the Diagnosis and Monitoring Tests Market
Future Challenges to the Sustainability of the HIV/AIDS Responses in Southern Countries
An Institutional Analysis of the Diagnosis and Monitoring Tests Market
Preliminary Results
Cristina d’Almeida
CEPN - Université Paris 13 Nord
ANRS

2. Motivation
Strong impact on the sustainability of the HIV/AIDS Policies in Southern Countries
A highly specialized - “science-based” - market  lack of economic studies
Major Concerns:
Least Developed Countries: Access hindrances:high prices (namely VL) and viral diversity
Developing Countries: high prices, learning costs, technological dependency upon northern countries

3. Methodology
Institutional and Organizational Market Analysis by means of the Industrial Organization (IO) Theory
First step: Analysis of the Monitoring Tests Market: CD4, Viral Load (VL) and Genotyping
Study Case: Brazil
Interview with the most relevant stakeholders
Research on patents/ patent applications databases
In the near future: Approach Brazil/Cameroon

4. Main factors that impact the demand for HIV/AIDS monitoring tests
The introduction of new therapeutic regimens by means of evidence-based proofs
Viral resistance and therapeutic failures
Late introduction of HAART (monitoring of mortality and morbidity)
New therapeutic guidelines: precocious start for HAART
New monitoring technologies addressed to children: CD 45 counts
The ageing of the HIV+ population

5. Antibody detection (1-2 months)
The HIV/AIDS Dynamics
Source: WHO (2005)
Window Period 60
Antibody detection (1-2 months)
Viraemia
~200 CD4 cells/ml blood
>350 cells/ ml
blood
>500 cells/ ml
blood ?
? ? ?

6. WHO Guidelines for the use of HIV/AIDS Monitoring Tests
CD4
Viral Load
Assymptomatic patients
Every months/year
Every 3-4 months/year *
Every 3-4 months/year *
AIDS
“Naive” patients: 2-8 weeks after start of HAART
Every 3-4 months/year
Therapeutic failures
2-8 weeks after start of HAART
2-8 weeks after start of HAART
* Not recommended to LDC, due to the high costs
US Department of Health and Human Services (2008)

7. Technological Complexity Product differentiation
Market Structures
CD4
Viral Load
Technology
Flux Cytometry
(FCM)
RT-PCR
NASBA
b-DNA
Technological Complexity
Less complex
More complex
Product differentiation
Same technology but different wavelenghts readings
Different technologies, different principles
Nr of main competitors 3 4
Price
variation
Equip:USD20,000 – 35,000
Tests:USD 5-20
Equip:USD 70,000 – 80,000
Tests:USD

8. CD4 Tests Suppliers: International Activities
Rank intern. market
Priority markets
Costs * (USD)
Becton, Dickinson
1st
Europe
(32%)
Equipments: 20,000 (SP)
Reagents/Tests: 5-20
Beckman Coulter*
2nd
Americas
(38%)
Equipments: 22,000 (SP) Reagents/Tests: 5-8
* New investments: China and India
Partec GmbH
3rd
Equipments: 22,000 Reagents/Tests: 8-10
*Source: OMS (2007)

9. Viral Load Tests Suppliers: International Activities
Rank intern market**
Priority Market
Costs * (USD)
Roche Diagnostics
1st
Europe (35%)
Equipments: Reagents/Tests: 125
Abbott
Equipments: 33,500
Reagents/Tests: 20-70
2nd
Siemens Diagnostics
3rd
Europe + Middle East + Africa (35%)
Equipments: 40,000
Reagents/Tests: 28-90
bioMérieux
4th
Europe +Middle East +Africa (62%)
Equipments:
Reagents/Tests: 38-76
*Source: OMS (2005) **IVD general

10. The Intellectual Protection
Know-how (specific to each technology) – trade secrets
Reagents (biomarkers, devices) – patents
Equipments (owned or outsourced) - patents
Trademark

11. Preliminary Conclusions and Remarks
A Complementary Market to the ARV Market (association/repetition)
Cartel structures and high concentration (mergers and acquisitions)
Horizontal Intellectual Property, comparted to the ARV market
A market addressed to the needs of southern countries => inequities
Distinct product differentiation between the CD4 and the VL markets => different strategies

12. Preliminary Conclusions and Remarks(cont.)
Main hindrances to competition:
High technological specialization
The relevance of human resources capacitation
Information assymetries
Intellectual Property (royalties: ~20%)
Absence of local institutional mechanisms towards national production in southern countries
New technological trends: Real-time PCR (for VL)

13. Thank You!