Neuropathic Pain: Pfizer attempting to hold on to market leadership

With Pfizer finally looking set to lose the patent protection of its current ‘gold standard’ drug gabapentin, the neuropathic pain market is poised for some serious changes. Coupling generic competition with numerous companies racing to enter this lucrative market with their inline and pipeline products, how long can Pfizer hold onto market leadership?

In its report 'Neuropathic Pain Insight Study: Life beyond gabapentin', Datamonitor aims to answer some key questions about neuropathic pain and to identify key commercial opportunities. This analysis is based upon a survey of 594 primary care physicians, surgeons, pain specialists, and neurologists across the seven major pharmaceutical markets.

Sizeable market

Unlike nociceptive pain, neuropathic pain is caused by damage to the nerve tissue and affects over 15 million people in the US alone. Successful treatment has long proved a challenge to physicians and, up until the launch of Pfizer’s gabapentin (Neurontin) in the 1990s, drugs used to treat neuropathic pain were limited by poor side effect profiles and unpredictable efficacy.

Gabapentin is the most widely used drug in the US market, and is frequently used off-label for the first-line treatment of many other neuropathic pain types, with the exception of fibromyalgia. To date, gabapentin is only approved for the treatment of post-herpetic neuralgia (PHN) in the US. In addition to proven efficacy, physician confidence to prescribe gabapentin for unapproved indications is bolstered by its favorable side effect profile and minimal drug-to-drug interactions when used in combination.

Indeed, following the success of Pfizer’s blockbuster, the interest in the neuropathic pain market by the pharmaceutical industry has grown exponentially. Not only does the market offer access to a large patient base and thus the potential for billion-dollar revenues, it also possesses a multitude of ‘first-to-market’ opportunities for companies with inline or pipeline products.

Diabetic neuropathic pain

Diabetic neuropathic pain (DNP) is a major medical problem, placing a substantial burden on the diabetic population. The condition often leads to ‘diabetic foot disease’, the most common functional difficulty associated with neuropathy, and potentially to ulcer formation, infection, and even amputation.

Companies looking to enter the neuropathic pain market will typically conduct controlled trials of their products for the treatment of DNP. Not only does this market benefit from relatively high awareness among sufferers and physicians alike, it also offers one of the largest patient populations, which is expected to continue growing with expanding obesity numbers.

Generic threat

Perhaps the greatest threat to those companies looking to enter the neuropathic pain market is the impending patent expiry of gabapentin in the US. Indeed the drug has already lost its protection in Europe.

Although Pfizer has so far successfully used legal proceedings to delay the impact of generic competition, the world's leading pharmaceuticals group cannot hold out for much longer. Generic gabapentin is expected to enter the US market in 2004. Given that gabapentin annual sales exceed $2bn, it is safe to assume that generic competition will seriously erode sales of Pfizer’s brand. The company, however, intends on maintaining market share with the launch of its follow- on drug pregabalin in mid-to-late 2004.

Pfizer has already begun laying the groundwork for pregabalin’s product lifecycle by using gabapentin to establish its position in a number of key markets. Pfizer’s strategy is to establish gabapentin in markets that pregabalin will be launched into, so the acceptance by physicians of the new compound is high. This has been approached either through an actual indication (e.g. neuropathic pain) or through the publication of clinical trial data to encourage off-label use.

Market prediction

Gabapentin does not however, benefit from FDA approval for the treatment of DNP, so the market remains open for the taking. Over the coming years, competition in the DNP market is expected to be fierce with the presence of all the major CNS players, including Pfizer, GSK, and Eli Lilly.

Datamonitor believes the global neuropathic pain market will grow substantially over the next few years, driven by the introduction of several new products, which are safer than older treatments and can improve patient quality of life. Increasing awareness of the disease in the public and medical community will also expand the size of the market, owing primarily to the launch of new drugs.

Over this period, Pfizer is likely to continue its reign as market leader courtesy of the upcoming release of pregabalin. However, Pfizer will lose market share to a growing number of emerging companies. Importantly, however, Datamonitor predicts that gabapentin will remain a popular treatment option over the next five to ten years.

If you found this week's Expert View useful, you may be interested in Datamonitor's reports:

• Neuropathic Pain Insight - Life Beyond Gabapentin - $78,000.00
• Stakeholder Insight: Neuropathic Pain - Comparative Overview of Treatment Preferences Across the Seven Major Markets - $20,400.00
• Pipeline Insight: Anticonvulsants - Drug Versatility Crucial for Market Success - $9,600.00

To order these reports contact peter.barfoot@bioportfolio.com or telephone +44 1300 321501 or +1 415 680 2472 and a representative will get back to you.

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