Malaria Vaccines: Commercial Prospects and Landscape Analysis

  • ID: 1279161
  • Report
  • 350 Pages
  • Beremans Limited
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Malaria vaccines have reached the late-phase clinical trials stage. The analyst has undertaken a robustly independent and realistic assessment of the market landscape and commercial prospects of these vaccines. The analyst is not linked to or affiliated with any organisation with any interest in promoting malaria vaccines, whether commercial or not-for-profit; there were no conflicts of interest which could have affected our findings.

The report includes:

- an examination of the clinical need for a vaccine (nature of disease, independent estimation of global incidence, identification and quantification of at-risk populations worldwide); an outline of the scientific / technological background (including key issues in malaria vaccine development);

- an assessment of the competitive environment, including the competitive positioning of clinical-stage vaccine candidates, and brief notes on commercial and non-commercial bodies linked to malaria vaccine development;

- quantification and 2020 projections of total potential end-users of a malaria vaccine (namely, travellers from less than 20 developed economies to regions of malaria transmission;

- private sector users in malaria transmission regions;

- public sector users in malaria transmission regions; and a provisional outline analysis of the military market);

- likely prices for a malaria vaccine in different markets;

- and 2020 revenue projections for a malaria vaccine, broken down by private sector sales in the developed world, private sector sales in the developing world, and public sector sales in the developing world.

This report provides an independent assessment of the market landscape and market size for a hypothetical malaria vaccine applicable to all age groups (paediatric and adult), in both endemic countries and the developed world.

We first assessed and summarised the state of knowledge regarding malaria disease transmission, pathophysiology and prevention, by reference to peer-reviewed publications. We then collected publicly available data on reported malaria cases worldwide, and used this to assess the global incidence from 2004-2008, and to derive an estimate of clinical cases worldwide. These data also permitted us to categorise the geographical distribution of falciparum malaria. The above exercise allowed us to gain a clear idea of the clinical need associated with malaria.

We then reviewed the technical challenges and types of technical approach relevant to malaria vaccine development. This enabled us to provide background detail which is helpful in discussing the various different candidate malaria vaccines that have reached the clinic. Similarly, we examined broad features of the malaria vaccine market, particularly in terms of significant stakeholders, and their influence on the procurement and pricing of some vaccines. This provides useful background to later chapters presenting detailed revenue projections for malaria vaccines.

Next, we identified the main candidate malaria vaccines, focusing on those in clinical development, and summarised the publicly disclosed clinical trials for each vaccine. We also identified and outlined the commercial and non-commercial organisations linked to clinical-stage malaria vaccines. In addition, we analysed the different clinical-stage malaria vaccine candidates, facilitated by positioning them on a competitive landscape matrix.

Importantly, we undertook a major exercise to quantify the different populations that might be appropriate for malaria immunisation, namely total populations in endemic countries (subsegmented by infants, women of child-bearing age, and girls reaching child-bearing age), urban populations in endemic countries (subsegmented by infants, WOCBA, and GRCBA), and traveller populations visiting endemic countries. For traveller populations, we exploited our model of international travel which we constructed using numerous manipulations, corrections and adjustments of raw travel data to provide defensible estimates of actual traveller numbers from each of 21 different developed countries to each of over 100 developing countries. In our opinion, this is the most comprehensive and accurate model of international travel available.

In addition, we provide a provisional outline assessment of the potential market for malaria vaccines among the military. We also projected relevant population numbers to 2020, to provide a base for revenue projections.

We then identified key data which allowed us to make defensible assumptions in order to derive malaria vaccine revenue projections. These assumptions (e.g. price, maximum market penetration, rate of market penetration, roll-out per country, etc.) enabled an estimation of the market for:

(i) a private sector vaccine in the developed world (i.e. a travel vaccine);
(ii) a private sector vaccine in the developing world; and
(iii) a public sector vaccine in the developing world.

We also provide a provisional outline rage of values for the military malaria vaccine market. Finally, we interviewed key experts in the field to obtain third-party views on aspects of the market for malaria vaccines. The report is lengthy, but contains, in addition to the Executive Summary, an extended Summary at the end of each Section. The busy reader may identify all key points by reference to the Summaries, and supplement this as necessary by reference to the text in the main body of each Section. Additional background information is contained in the Appendices.
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Table of Contents SYNOPSIS

1. Executive Summary

2. Clinical need
2.1 Overview
2.2 Disease
2.2.1 Causative agents
2.2.2 Symptoms
2.2.3 Pathophysiology
2.3 Malaria transmission
2.4 Populations at risk
2.4.1 Current distribution of malaria endemicity
2.4.2 Risk factors for endemic residents
2.4.3 Trends in global distribution of malaria
2.4.4 Potential for future spread or re-emergence of endemicity
2.6 Worldwide malaria incidence: endemic country residents
2.6.1 Previous estimates of incidence in endemic country residents
2.6.2 Beremans’ estimates of incidence in endemic country residents
2.6.3 Trends in incidence in endemic country residents
2.7 Malaria incidence in travellers from developed economies
2.7.1 Historical estimates of malaria incidence in non-military travellers
2.7.2 Trends in incidence of malaria in non-military travellers
2.7.3 Risk factors for travel-related malaria
2.7.4 Military travel
2.8 Current treatment and prevention options
2.8.1 Treatment
2.8.2 Prevention
2.8.3 Trends
2.9 Current clinical need
2.10 Summary

3. Science / technology background
3.1 Overview
3.2 Host factors
3.2.1 Environmental influences
3.2.2 Genetic influences
3.2.3 Immune response
3.3 Parasite factors
3.3.1 Antigen pool for vaccine development
3.3.2 Stage-specific antigens
3.3.3 Stage-transcending antigens
3.3.4 Species-transcending antigens
3.3.5 Parasite strategies to evade immunity
3.4 Key issues in malaria vaccine development
3.4.1 Concept of malaria vaccine
3.4.2 Vaccine objectives and vaccine design
3.4.3 Immune correlates of protection
3.4.4 Parasite immune-evasion strategies and vaccine development
3.4.5 Adjuvants
3.4.6 Clinical trial design for malaria vaccines
3.4.7 Process / production issues
3.5 Early stage approaches to malaria vaccine development
3.5.1 Early stage pre-erythrocytic candidates
3.5.2 Erythrocytic-stage vaccine approaches in pre-clinical development
3.5.3 Transmission-blocking vaccines
3.5.4 Stage-transcending approaches in pre-clinical development
3.5.5 Other approaches
3.5.6 Commercial bodies active in preclinical development
3.6 Summary

4. Malaria vaccine market – general features
4.1 Overview
4.2 Main stakeholders in vaccine development and procurement
4.2.1 National governments
4.2.2 Non-governmental organisations
4.2.3 Commercial /academic entities involved in vaccine development
4.2.4 Health care providers and healthcare professionals
4.2.5 End-users – vaccinees
4.3 Vaccine purchase and procurement
4.3.1 Public sector vaccine purchase: developed economies
4.3.2 Public sector vaccine purchase: developing economies
4.3.3 Private sector vaccine purchase: developed economies
4.3.4 Private sector vaccine purchase: developing economies
4.4 Legal, regulatory, and manufacturing issues
4.4.1 Legal
4.4.2 Regulatory
4.4.3 Manufacturing
4.5 Recent trends
4.6 Summary

5. Malaria vaccine market – competitive environment
5.1 Overview
5.2 Clinical phase malaria vaccine candidates
5.2.1 Malaria vaccine candidates in clinical trials 2005-2010
5.2.2 Current status of malaria vaccine candidates
5.3 Outline of candidate vaccines in active clinical development
5.3.1 Pre-erythrocytic vaccines
5.3.2 Erythrocytic-stage vaccines
5.3.3 Transmission blocking vaccines
5.3.4 Stage-transcending vaccines
5.4 Competitive positioning of active clinical-stage malaria vaccine programme
5.4.1 Pre-erythrocytic vaccine candidates
5.4.2 Erythrocytic phase vaccine candidates
5.4.3 Transmission-blocking vaccines
5.4.4 Stage-transcending vaccines
5.4.5 Competitive landscape analysis
5.5 Outline of organisations linked to active clinical stage programmes
5.5.1 Commercial bodies with active clinical malaria vaccine programmes
5.5.2 Non-commercial bodies with active clinical malaria vaccine programmes
5.8 Non-vaccine competition
5.8.1 Malaria chemoprophylaxis
5.8.2 Vector control strategies
5.9 Summary

6. Malaria vaccine market – potential end-user numbers
6.1 Overview
6.2 Potential end-user numbers: public vaccine
6.3 Potential end-user numbers: private vaccine
6.3.1 Private sector purchase within falciparum-endemic countries
6.3.2 Non-military travellers from developed economies to endemic countries
6.3.3 Military travel to falciparum-endemic regions
6.4 Future growth in potential end-user numbers
6.4.1 2020 public sector projections
6.4.2 2020 private sector projections: residents of falciparum transmission regions
6.4.3 2020 private sector projections: relevant travellers
6.4.4 Military travel
6.5 Summary

7. Market penetration and revenue projections
7.1 Overview
7.2 Market penetration: public sector vaccine
7.2.1 Countries wishing to introduce a public sector malaria vaccine
7.2.2 Countries able to introduce a public sector malaria vaccine
7.2.3 Appropriate population segments for a public sector malaria vaccine
7.2.4 Coverage estimates
7.3 Timing considerations: public sector vaccine
7.3.1 Market entry
7.3.2 Vaccine roll-out per country
7.3.3 Comparison with another vaccine introduction
7.4 Market penetration: private sector vaccine
7.4.1 Private sector vaccine: market penetration in endemic countries
7.4.2 Private sector vaccine: market penetration in developed countries (non-military)
7.4.3 Market penetration among military travellers
7.5 Vaccine pricing
7.5.1 Cost-effectiveness studies
7.5.2 Price benchmarking
7.6 Revenue projections
7.6.1 Key assumptions: non-military markets
7.6.2 Malaria vaccine revenue projections to 2020: private sector, developed world
7.6.3 Malaria vaccine revenue projections to 2020: private sector, developing world
7.6.4 Malaria vaccine revenue projections to 2020: public sector, developing world
7.6.5 Revenue projections for vaccine sold to the military
7.6.6 Conclusions: Beremans estimate of total 2020 market for malaria vaccines
7.6.7 Comparison of Beremans estimates with third-party data
7.7 Summary

8. Expert interviews
8.1 Overview
8.2 Expert interviews
8.3 Summary


Appendix 1: Countries at risk of falciparum malaria – third-party assessment
Appendix 2: Malaria incidence by country, 2000-2008 (WHO data)
Appendix 3: Global incidence of malaria – Beremans assessment
A3.1 Caveats and data anomalies
A3.1.1 Problems with collection of raw data on apparent malaria incidence
A3.1.2 Problems with presentation of raw malaria incidence data
A3.1.3 Problems with estimates of real malaria incidence
A3.2 Methodological notes: Beremans estimate of worldwide malaria incidence
A3.3 Adjusted data: global incidence of clinical malaria, 2000-2008
A3.4 Adjusted data: global incidence of clinical falciparum malaria, 2000-2008
Appendix 4: Transcripts of expert interviews
A4.1 Dr. Ashley Birkett, PATH-MVI
A4.2 Dr. Stephen Hoffman, Sanaria Inc
A4.3 Jessica Milman, Gates Foundation
Appendix 5: Clinical trials of falciparum malaria vaccine candidates, 2005-2010
Appendix 6: Methodology behind population estimates / projections
Appendix 7: International travel data: correction and adjustment methodology
Appendix 8: DTP3 coverage rates (%) for possible adopters of malaria vaccine
Appendix 9: Summary of recent malaria-relevant WTP studies
Appendix 10: Terms and conditions under which this report has been purchased
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