Media release from GlobalData

Drugs under development to treat those affected by acute spinal cord injuries are not expected to emerge within the current decade, leaving the market largely open to new entrants, according to a new report issued by pharmaceuticals intelligence provider GlobalData.

The new report* shows that there have been no treatment options approved for Acute Spinal Cord Injury (ASCI) by either the Food and Drug Administration (FDA) or the European Medicines Agency (EMA), so off-label generic drugs dominate the market.

Spinal Cord Injury (SCI) refers to damage to the spinal cord which results in the loss of mobility and feeling. SCI usually occurs due to a sudden traumatic blow to the spine that fractures or dislocates vertebrae, caused by injuries involving the head, pelvic fractures, penetrating injuries close to the spine, or injuries caused by a fall from a significant height. The classification of SCI into acute and chronic phases is based on the period of time the patient has suffered with the condition.

In USA, Methylprednisolone Sodium Succinate (MPSS) is prescribed as off-label drug used for treating inflammation in ASCI, acting to reduce swelling in the spinal cord. However, it is also associated with certain adverse effects, such as reduced immunity, infections and gastrointestinal bleeding, among others. This has led European physicians to prescribe other off-label drugs instead, including anticoagulants, proton pump inhibitors, antihypotensives, antidiabetic, Gamma Aminobutyric Acid (GABA) analogs and antibiotics. However, all these medications have their limitations in treating ASCI.

The absence of effective treatment options clearly signifies that current competition in the ASCI therapeutics market is weak. Therefore, significant opportunity exists for novel products that can provide better treatment, and lead to better recovery from injury. The current therapeutic landscape has no neuroprotective and neuroregenerative therapies, and so a product that can offer either of these mechanisms of action would expect to capture a significant share of the market and cater the unmet need of the market.

GlobalData's research indicates that there are 14 molecules in the pipeline, all of which are first-in-class. These new inventions aim to protect surviving nerve cells from further damage, and stimulate the regrowth and connection of axons, showing strong potential to offer better options for the treatment of SCI than those available presently. These include neuroregeneratives, neuroprotective molecules, stem cell therapies, synthetic basic fibroblast growth factors and neuroprotective molecules. However, they are all are also in early stages of the pipeline, and are therefore unlikely to enter the market during the forecast period.

The market is expected to register slow growth due to the lack of approved therapies, the early stages of all molecules in clinical development, and the indication by Key Opinion Leaders (KOLs) that the incidence of ASCI cases has remained stable in the immediate past, with this trend likely to continue into the near future.

GlobalData estimated the global ASCI therapeutics market to be worth $6m in 2011, and expects it to grow at a compound annual growth rate (CAGR) of approximately 1% to $6.5m in 2019.