Dengue Vaccines - Opportunity Analysis and Forecasts to 2020, New Report Launched

After the Launch of the First Dengue Vaccine in 2015, the Market is Projected to Experience Rapid Growth Through 2020

In 2015, Publisher projects the dengue vaccine market to be valued at $69.6m across the five pharmaceutical markets covered in this report: Brazil, India, Mexico, Singapore, and Thailand. Two of the earliest adopters of dengue vaccines, Brazil and Mexico, are together expected to account for well over 95% of the 2015 market share, with sales of $44.6m (64.1% market share) and $23.6m (34.0% market share), respectively. For the purposes of this report, Publisher defines the market as the sales of dengue vaccines in the countries of interest that are likely to incorporate these vaccines into their routine immunization programs.

By 2020, Publisher expects dengue vaccine sales to grow substantially and reach a combined $398.6m in Brazil, India, Mexico, Singapore, and Thailand, at a Compound Annual Growth Rate (CAGR) of 41.8%. This rapid uptake of dengue vaccines will be driven primarily by the inclusion of live-attenuated vaccines in national immunization programs. Brazil ($97.0m; 24.4% market share) and Mexico ($216.7m; 54.4% market share) are anticipated to continue their dominance of the market, although Publisher projects India ($58.6m; 14.7% market share), Singapore ($16.1m; 4.0% market share), and Thailand ($10.0m; 2.5% market share) to still experience solid growth from 2015-2020. Sales growth, however, will likely be hindered by the arrival of less expensive, publically-supplied vaccines in Brazil and India, which are expected to rapidly garner patient share from premium-priced vaccines.

Given their superior clinical and commercial positioning, Publisher anticipates that live-attenuated dengue vaccines — led by Sanofi’s CYD-TDV and Takeda’s DENVax — will dominate the market, with 2020 sales projected to reach $166.4m (41.8% market share) and $148.5m (37.3% market share) across the five pharmaceutical markets covered in this report, respectively. Despite being second to market, Publisher expects DENVax to seize significant market share from Sanofi’s first-to-launch vaccine due to its more convenient dosing schedule and a competitive pricing strategy. Despite their overall market dominance, Publisher projects both CYD-TDV and DENVax to lose market share to the domestically-produced live-attenuated vaccine, TV-003 ($80.2m; 20.1% market share), in Brazil and India by 2020, primarily because of its lower price. Publisher expects the earlier-stage pipeline vaccines — GlaxoSmithKline’s (GSK’s) TDENV-PIV and Merck’s DEN-80E — to garner less than 1% market share by 2020.

Publisher expects the major drivers of growth in the dengue vaccine market across Brazil, India, Mexico, Singapore, and Thailand to include:

- The launch of the first live-attenuated dengue vaccines, particularly Sanofi’s CYD-TDV and Takeda’s DENVax. These vaccines will be heralded by physicians, public health officials, and policymakers as a welcome relief to the growing global healthcare burden of dengue.

- Dengue’s growing socioeconomic and public health burden will lead countries to push for widespread immunization as a preventative measure. Specifically, the past failures of vector control initiatives to curtail the spread of the Aedes aegypti mosquito have left a glaring void in the prevention and landscape, which will hasten the uptake of vaccines.

- The integration of dengue vaccines into routine childhood immunization schedules. Taking into account the existing immunization program infrastructure and disease epidemiology, Publisher’s primary research indicates that targeting the pediatric population for vaccination will likely improve coverage rates and provide a sustained revenue source for vaccine manufacturers.

Publisher anticipates the formidable barriers to growth in the dengue vaccine market across Brazil, India, Mexico, Singapore, and Thailand to include:

- Formidable logistical and financial hurdles must be overcome in order to successfully assimilate a novel vaccine into the immunization program infrastructure of developing nations. Publisher projects the growth in these markets to be slowed by these barriers relative to novel vaccine adoption in the developed markets.

- Domestically-supplied vaccines — most notably, the Butantan Institute’s TV-003 in Brazil and Panacea Biotech’s/Biological E’s TV-003 in India — will stymie market growth due to their low cost relative to vaccines produced by privately-held foreign companies.

- The failure of current disease surveillance programs and vector control programs in developing nations may slow growth in the dengue vaccines marketplace, as key opinion leaders (KOLs) view the integration of vaccines into a holistic prevention program as the most promising approach to dengue control.

From a Barren to Competitive Market: Vaccine Developers Will Need to Leverage Innovative R&D Strategies to Differentiate Themselves from Their Rivals

Over the last several years, much progress has been made towards the development of safe and effective dengue vaccines. As of May 2014, six investigational vaccines were being studied in humans, and the leader of these pipeline candidates, Sanofi Pasteur’s CYD-TDV, is currently undergoing Phase III efficacy and safety studies. The desire to bring the first dengue vaccines to market has led companies to utilize a variety of different research and development (R&D) strategies, which include diverse approaches to antigen construction, vaccine formulation, and clinical trial design. Since 2008, Big Pharma has demonstrated its desire to penetrate this untapped market, increasing its stake in the marketplace through partnerships, licensing deals, and acquisitions. However, as the dengue vaccine marketplace becomes increasingly crowded over the forecast period (2015-2020), Publisher anticipates that firms will turn to innovative R&D strategies, in particular, the exploration of alternative approaches to early-stage clinical trial design, such as the dengue human infection model (DHIM), in order to increase developmental efficiency, minimize upfront risk, and gain a competitive advantage over their rivals.

High Unmet Need for Safe and Efficacious Dengue Vaccines Expected to Facilitate Rapid Uptake of Pipeline Agents

Publisher classifies the overall level of unmet need in the global dengue vaccines marketplace as high. As the morbidity and mortality associated with dengue continue to climb, KOLs agree that the absence of a safe and efficacious dengue vaccine represents the greatest unmet need across the five markets covered in this report: Brazil, India, Mexico, Singapore, and Thailand. The failure of vector control to limit the spread of the virus’ mosquito vectors has further boosted the importance of vaccines as an additional disease prevention tool. Publisher expects that the high level of unmet need in the marketplace will lead to the rapid incorporation of live-attenuated dengue vaccines into routine childhood immunization programs, with Brazil, Mexico, Singapore, and Thailand quickly achieving ≥90% coverage rates within the projected target age cohort of two years by 2017. Slowed by poor disease surveillance and a weak immunization program infrastructure relative to the other four markets, Publisher projects India to more gradually incorporate novel dengue vaccines into its childhood vaccination schedule, with coverage rates only topping 60% by 2020.

Opportunities for Current and Future Players to Exploit Gaps in the Treatment Landscape Will Exist Throughout the Forecast Period and Beyond

While Publisher expects several dengue vaccines with solid clinical profiles, led by Sanofi Pasteur’s CYD-TDV and Takeda’s DENVax, to receive licensure during the forecast period, opportunities will still exist for later entrants to compete with these first-in-class products. Experts revealed to Publisher that vaccine developers should focus their efforts on evaluating more convenient vaccine dosing schedules, gaining an improved understanding of dengue immunity, identifying more robust immunological correlates of protection, exploring novel approaches to clinical trial design, and improving animal models in order to best position their respective pipeline products.

From a commercial perspective, Publisher contends that companies must prioritize engaging healthcare policymakers and other stakeholders in order to expedite the launch of new dengue vaccines. Historically, vaccine launches in the developing world have taken several years, so early planning is essential for the rapid adoption of new dengue vaccines. Dengue vaccine developers must adopt a country-specific approach to planning for vaccine adoption, as this strategy represents an attractive opportunity for positioning a vaccine for rapid adoption in multiple countries once it receives regulatory approval. KOLs also indicated that one of the most important issues that must be addressed pre-launch is vaccine pricing, a factor that will heavily influence the rate and extent of uptake in low- and middle-income nations. Developers will also need to consider that healthcare policymakers will take into account how vector control and disease surveillance spending will influence a country’s ability to afford mass dengue immunization programs.

Live-Attenuated Vaccines, Led by Sanofi’s CYD-TDV, are Expected to Dominate the Dengue Vaccine Marketplace from 2015-2020

While the dengue vaccine pipeline possesses a high level of diversity in terms of vaccine class and technological approach, Publisher expects the live-attenuated vaccines, which include Sanofi Pasteur’s CTD-TDV, Takeda’s DENVax, and the US National Institute of Health’s (NIH’s) TV-003 (licensed to the Butantan Institute in Brazil and Panacea Biotech/Biological E in India), to rule the marketplace for the duration of the forecast period. Despite lingering questions regarding their safety and ability to provide balanced short- and long-term protection against the four dengue virus (DENV) serotypes, KOLs interviewed by Publisher cited live-attenuation as the most promising technological approach to dengue vaccine R&D. While the other vaccine classes in clinical development — inactivated virus, subunit, and deoxyribonucleic acid (DNA) vaccines — may theoretically minimize the chance of viral interference and could be perceived as safer by patients, KOLs overwhelmingly viewed them as inferior to live-attenuated vaccines and cited their need for adjuvants and late arrival to the marketplace as key weaknesses. Publisher projects live-attenuated dengue vaccines to account for over $395m in sales by 2020, with a CAGR of 41.5% from 2015-2020.

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