Global Information Inc. would like to present a new market research report, "Acute Spinal Cord Injury (ASCI) Therapeutics - Pipeline Assessment and Market Forecasts to 2019" by GlobalData.
GlobalData estimated the global acute Spinal Cord Injury (SCI) therapeutics market to be worth $6m in 2011, and expects it to grow at a Compound Annual Growth Rate (CAGR) of approximately 1.0% to $6.5m in 2019. Key Opinion Leaders (KOLs) indicate that the incidence of acute SCI cases has remained stable over the past couple of years, and that this trend is likely to continue into the near future. The acute SCI therapeutics market has no approved treatment options. The treatment landscape is dominated by off-label generic drugs, which have their limitations due to adverse effects. Methylprednisolone Sodium Succinate (MPSS) is the only available treatment option for treating inflammation in acute SCI, but is associated with adverse reactions such as reduced immunity, infections, skin breakdown, and gastrointestinal bleeding among others. As suggested by the KOLs, MPSS is not preferred in Europe specifically due to these adverse reactions. Instead, other off-label drugs such as anticoagulants, proton pump inhibitors, antihypotensives, antidiabetic, Gamma Aminobutyric Acid (GABA) analogs and antibiotics are used to treat complications associated with acute SCI. The lack of approved therapies is a barrier to the growth of the market. The pipeline consists of molecules with neuroprotective and neuroregenerative mechanisms of action, all of which are in the early stages of development. The market is expected to register slow growth due to the lack of approved therapies, and the fact that potential neuroprotective and neuroregenerative molecules are still in the early stages of clinical development and are unlikely to enter the market during the forecast period.
The acute SCI therapeutics market has a high level of unmet need because there are no treatment options approved by either the Food and Drug Administration (FDA) or the European Medicines Agency (EMA). The currently used off-label options for treating associated complications have limitations due to adverse effects such as decreased immunity, infection, skin breakdown, and gastrointestinal bleeding, among others. Therefore, significant opportunity exists for novel products that can provide better treatment. This implies that the market is not well served by the current products and there is significant scope for the introduction of new therapeutic options which target better recovery from injury. The current therapeutic landscape has no neuroprotective and neuroregenerative therapies, and so a product that can offer either of these would capture a significant share of the market. None of the pipeline drugs are currently in Phase III, signifying that the acute SCI therapeutics market will continue to have a high level of unmet need during the forecast period to 2019.
GlobalDatas analysis reveals that the current competition in the acute SCI therapeutics market is weak, as it lacks a therapy that is approved by the FDA or EMA. Instead, the market is dominated by off-label generic drugs. MPSS, which reduces swelling in the spinal cord, is the only available treatment option, and is used off-label. However, it is also associated with certain adverse effects. The other classes of drugs, namely anticoagulants, GABA analogs, proton pump inhibitors, antihypotensives, and antibiotics are used off-label to treat complications associated with acute SCI. All have limitations in their usage for the treatment of acute SCI, and the absence of effective treatment options clearly signifies that current competition in the acute SCI therapeutics market is weak.
GlobalDatas research indicates that there are 14 molecules in the pipeline, all of which are first-in-class and in Phase II, Phase I, or the early stages of development. The pipeline molecules aim to protect surviving nerve cells from further damage and stimulate the regrowth and connection of axons. The molecules in the Phase I, preclinical, and discovery stages show strong potential to offer better options for the treatment of SCI. These include neuroregeneratives, neuroprotective molecules, and stem cell therapies. Phase II comprises synthetic basic fibroblast growth factors and neuroprotective molecules. As the potential molecules are only in Phase I and the early stages of the pipeline, they are unlikely to enter the market during the forecast period.
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