Albany, NY -- (ReleaseWire) -- 12/24/2012 -- "The combination of government incentives to develop drugs for rare diseases and the promise of commercial opportunity will continue to fuel the industry’s interest in orphan drugs; and provide hope to patients with debilitating conditions and high unmet medical needs. In addition, the fast track approval system allows companies to enter the market faster and more cost-effectively with the potential to extend indications.
Significant unmet clinical need
While orphan diseases are rare, patients with rare diseases are numerous. There are up to 7,000 identifiable rare diseases, affecting an estimated 622 million people around the world. There is a clear need to provide rare disease patients with the same quality of care as other patients, and governments have provided incentives to companies developing orphan drugs to address a significant public health need. As effective diagnostics play a greater role in accurately diagnosing orphan diseases, the addressable patient population will expand.
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Companion diagnostics: a game changer?
One of the biggest challenges for rare disease patients is obtaining the correct diagnosis, which can be extremely difficult and can take years, or even decades. An increasing number of companies developing drugs for rare diseases are working with diagnostic companies, or their own diagnostic divisions, to establish biomarkers and develop companion diagnostics for patient selection. Companion diagnostics can assist with identifying patients for clinical trials of a novel drug, and may be approved simultaneously as part of a conditional drug approval.
A comprehensive overview of orphan drugs and their strategic importance is provided in this valuable new report
Market conditions – provides an analysis of the orphan drug market, detailing the drivers for recent growth, prevalence and scientific advances
Regulatory landscape – provides an in-depth analysis of current regulations in major markets (US, EU, Australia and Japan) along with pricing and reimbursement information and orphan drug approvals
Company activity – summarises leading and emerging companies and their established orphan drug products and pipelines
Targeted diseases – summarises diseases being targeted such as Duchenne muscular dystrophy, amyotrophic lateral sclerosis, leukaemia and pulmonary hypertension
Research – innovative areas of research such as antisense therapy, gene therapy, and cellular therapy in which orphan drugs are playing a key role.
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