Neuropathic pain is a type of chronic pain defined by the International Association for the Study of Pain (IASP) as pain “initiated or caused by a primary lesion or dysfunction in the nervous system”. Neuropathic pain, therefore, refers to the dysfunction or damage to the somatosensory system.

Any lesion of the central or peripheral nervous pathways leads to the damage of sensory nerves, typically resulting in impairment or loss of pain sensation. Neuropathic pain can have considerable social, psychological and functional consequences, which are very severe and disabling.

The neuropathic pain market is forecast to show significant growth

The global neuropathic pain market is set to be worth $4.8bn during the 2010s and is expected to grow at a compound annual growth rate (CAGR) of approximately 9.6% from $4.8bn in 2010 to $10bn in 2018.

This significant growth is primarily attributed to the:

– Increasing patient pool for neuropathic pain due to the increase in the prevalence of co-morbid conditions, such as herpes zoster, multiple sclerosis, trigeminal neuralgia, diabetes and migraine.
– Clinical development and preferential uptake of newer disease modifying agents, such as Zenvia (AVP-923) and AS-3201 (ranirestat), which are expected to positively impact and change the future treatment paradigm for neuropathic pain.

Competition in the current neuropathic pain market is strong

“Current competition in the neuropathic pain market is strong, led by Pfizer‘s Lyrica and Eli Lilly’s Cymbalta.”

Current competition in the neuropathic pain market is strong, led by Pfizer’s Lyrica and Eli Lilly’s Cymbalta. There are only five drugs that are approved by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) for the treatment of neuropathic pain: Lyrica (pregabalin), Cymbalta (duloxetine), Neurontin (gabapentin), Lidoderm (lidocaine 5% patch) (approved under the trade name Versatis in Europe) and more recently Qutenza (capsaicin 8% patch).

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Lyrica, Cymbalta, Lidoderm and Qutenza currently have a significant presence in the market. Moreover, the presence of gabapentin and other generic drugs has intensified the competition.

Pfizer remains the market leader in the neuropathic pain market, followed by Eli Lilly. There is competition between Lyrica and Cymbalta in the treatment of pain associated with diabetic peripheral neuropathy (DPN).

Therapies that can target the underlying cause are in demand

The treatment of neuropathic pain relies on a limited number of therapies. The currently available therapies provide partial pain relief to the patient instead of eradicating the underlying cause of the pain.

Although the current market is reasonably well served, the market still needs disease modifying therapies offering better results in terms of safety and efficacy, as well as a cure for the underlying cause of the pain. Achieving these objectives will address the existing unmet need in the market.

Current treatment options are only moderately successful

The available treatment options are moderately successful in meeting the market demand. Although the current neuropathic pain therapeutics market has FDA approved drugs such as SNRIs (serotonin-norepinephrine re-uptake inhibitors) and tricyclic antidepressants (TCAs), these drugs only have moderate efficacy and safety profiles.

The current therapies are competing to provide a greater than or equal to 50% reduction in pain. A greater than or equal to 30% reduction in pain is considered to be clinically significant. Providing partial relief (a greater than or equal to 50% reduction in pain) has been the target endpoint for products in the market.

However, there is a need for a product that can be more efficacious in reducing the pain, offering long term pain relief with better safety. There is potential in the market for any new entrant that will cater to these unmet needs and there is enormous opportunity for any drug that can offer better long-term efficacy and safety.

Transdermal patches such as Lidoderm and Qutenza have applications in a wide range of co-morbid neuropathic pain indications other than traditional neuropathic pain, such as osteoarthritis pain or lower back pain. Neuropathic pain has various etiologies and a new entrant has diverse sections of the patient population to target. This broad patient population increases the scope for any new entrant to become the ‘first of its kind’ for a particular type of neuropathic pain.

Newer therapies in pipeline are expected to increase the competition

A pipeline analysis shows there are 116 molecules in the various stages of development for neuropathic pain. Nucynta ER, long acting Oxymorphone HCl and Fentora (fentanyl-buccal) are the pipeline candidates in the regulatory filing stage waiting for approval.

“Pfizer remains the market leader in the neuropathic pain market, followed by Eli Lilly.”

AS-3201 and AVP-923 (Zenvia) are in Phase III of clinical development. These are all first-in-class therapies and differ from the existing therapies in terms of their mechanism of action, as do most of the molecules in Phase II. These molecules are likely to offer better efficacy and safety than the existing therapies.

The development pipeline for neuropathic pain contains 85 first-in-class molecules and many disease modifying mechanisms of action, such as N-Methyl-D-Aspartate (NMDA) receptor antagonists, NaV 1.7 inhibitors, cannabinoid receptor modulators, cathepsin S/K inhibitors, ZFP-TF (Zinc-Finger Protein – Transcription Factor), VEGF-A upregulators, alpha-2 receptor agonists and protein kinase inhibitors, representing novel (first-in-class) mechanisms of analgesic activity and improving the overall functioning of the patient. These drugs may offer better efficacy and safety and benefit the patient population who cannot tolerate the currently available drugs. The newer therapies may intensify the existing competition, which could result in a price war.


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