Emerging HIV Therapies

Pharmacor -- June 2007

  Introduction:

The human immunodeficiency virus (HIV) market is the largest antiviral market, and it has become increasingly competitive, with a range of effective and conveniently delivered antiretroviral (ARV) therapies. Nonetheless, the highly mutable nature of the virus and the emergence of ARV-resistant HIV strains, the rising prevalence of HIV infection, and the need for agents with better long-term safety will continue to fuel the demand for new ARV therapies. HIV has been one of the most active and well-funded areas of research and development among infectious diseases, yielding a pipeline with a wide range of product candidates, including a number of highly promising next-generation ARVs as well as two novel ARV classes in late-stage development. The new integrase inhibitors and CCR5 antagonists represent significant treatment advances and will be important market growth drivers as a number of key HIV therapies will lose patent protection.

  Questions Answered in This Report:

A number of integrase inhibitors are in development, with Merck’s raltegravir being the most advanced. How will these novel agents be positioned in the lines of HIV treatment over time? What is the commercial potential of the integrase inhibitor class? How can follow-on integrase inhibitors improve upon and compete with the first-to-market member of the class?

The first CCR5 antagonist, Pfizer’s maraviroc, is expected to enter the market by the end of 2007. Although key opinion leaders consider maraviroc an important clinical advancement, a number of questions have arisen regarding its future use. What do physicians consider the main hurdles that maraviroc has to overcome to enjoy wide use on the HIV market? How successful will the product be with the impending launch of Merck’s integrase inhibitor, raltegravir? Which patients will be the main users of this novel agent at launch and over time?

The HIV pipeline features a broad array of next-generation compounds from conventional classes, as well as entirely novel mechanisms directed at new viral and cellular targets. However, many steps in the viral life cycle and key drug targets remain unexploited. What do thought-leading physicians and basic science researchers consider the most promising targets and therapeutic approaches for drug development in the near- and long-term future? What potential advantages and disadvantages do these targets offer? What are the most important barriers in HIV research and drug development? What enabling technologies will propel HIV drug discovery and development over the next five to ten years?

A host of preventive and therapeutic vaccines based on different approaches are in various stages of development. What do vaccine experts say about the outlook for HIV vaccines? What is the likelihood that effective HIV vaccines will be developed? What are the requirements and expectations for a successful HIV vaccine?

  Scope:

Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.

Primary research: 41 country-specific interviews with thought-leading infectious disease specialists and 142 surveyed HIV scientists involved in HIV research across the globe.

Epidemiology: Total HIV prevalence; diagnosed prevalence, drug-treated population, and newly diagnosed HIV cases.

Emerging therapies: Preclinical development: 18 drugs; Phase I: 19 drugs; Phase II: 34 drugs; Phase III: 7 drugs; preregistration: 0 drugs.

Market: We provide a 15-year forecast by individual agent in each of the seven markets. Uptake of emerging classes and their use in combination with current ARVs are based on assumptions from interviewed thought leaders and market analogues.