10 July 2000 00:00 [Source: ICB Americas]By Feliza Mirasol
The market for pain management drugs remains a substantial growth area for pharmaceutical companies, as they continue their efforts to maintain significant growth margins by tapping into markets of major unmet medical needs. Although an old venue in many respects, the pain management market still offers singular opportunities for new products in the pipeline as well as older, more established drugs.
The market for pain management, which consists broadly of two sectors--pharmaceuticals and devices--is valued at an estimated $18 billion in the US in 2000, according to a new study from Norwalk, Conn.-based Business Communications Company Inc. that will be released next month. It is expected to reach $32 billion by 2005, growing at an average annual rate of 12 percent in the next five years.
Pain management devices make up 3 percent, or $458.2 million, of the total market this year. This segment is expected to lose market revenue position despite technological advancements and a gradually declining cost structure, says BCC. Average annual growth is estimated at 9 percent in the 2000-2005 forecast period, and the segment is expected to reach $719.2 million by 2005.
The pharmaceutical segment, which comprises the bulk of the total pain management market, is expected to account for approximately 97 percent, or $17.8 billion, of the market through 2005. The average annual growth of this sector is predicted at 12 percent during the 5-year forecast period, reaching $30.9 billion in 2005.
The primary goal in pain management is the prevention of pain, notes the BCC report, which classifies pain into two general categories: acute and chronic. Because there are many differences between the two, the approaches to pain relief are usually different.
"Acute pain can be modulated and removed by treating its cause. Chronic pain is distinctly different and more complex. The source of the pain is often known but cannot be eliminated," states BCC. "The urge to do something to relieve the pain often makes some patients drug-dependent. Chronic pain may be one of the most costly health problems in the United States."
In the US pain management market, sales of drugs in the seizure disorders category, the largest category by dollar sales, totaled roughly $2.9 billion for the year through to March, almost a 26 percent increase from the same period last year when sales were $2.3 billion, according to IMS Health.
The robust growth was due to the strong performance of the category's leading products, namely Neurontin (gabapentin), the anti-convulsant drug from Warner-Lambert's Parke-Davis division. Neurontin's sales jumped a phenomenal 72 percent to $960.6 million, as of March this year, from $558.3 in the same period last year, states IMS.
"Part of the increase of Neurontin use is associated with increased utilization of the drug for neuropathic pain disorders. Anti-convulsants have a beneficial effect in the treatment of neuropathic pain disorders, because, we believe, the underlying physiological paths of neuropathic pain and of seizure disorders have significant commonalities," says Stephen Lande of Interactive Forums Inc., a Bala Cynwyd, Pa.-based strategic marketing and medical education company that provides services to the pharmaceutical industry.
"The increased use of Neurontin is timely with research coming out on neuropathic disorders. There is more recognition that neuropathic pain is a subcategory of pain that doctors need to attend to, to diagnose and to treat differently from the way other chronic pain disorders are treated. I think Parke-Davis has been doing a very good job in helping to support education about its diagnosis and treatment," he adds.
In contrast, sales of well-established products in the anti-arthritis category waned over the past year, due mainly to the strong competition of the newer players on the field, the COX-2 inhibitors, says IMS. Total US sales of the anti-arthritis category were $1.6 billion as of March this year, down almost 23 percent from $2.1 billion in the same period last year. Combined sales of Celebrex (celecoxib) and Vioxx (rofecoxib) for this year through to March were $2.3 billion, up from the combined $204 million that they earned after their launch in 1999.
Other IMS-designated categories in the pain management market include codeine and combinations (injectable and non-injectable) with $1.4 billion (up 33 percent), anti-migraine with $1.3 billion (up 13 percent), and morphine/opiates (injectable and non-injectable) with $643.5 million (up 20 percent). Morphine/opiate injectables totaled $100 million (up 10 percent), and injectable codeine plus combinations totaled $314,000 (up 4 percent).
AMPHOTERICIN B--Fujisawa Healthcare Inc. and Gilead Sciences Inc. received Food and Drug Administration approval for their antifungal drug AmBisome (amphotericin B liposome for injection) for the treatment of cryptococcal meningitis in HIV-infected patients. Fujisawa submitted a supplemental new drug application for AmBisome in July 1999 seeking a label expansion for the new indication.
APOMORPHINE--TAP Pharmaceutical Products Inc. withdrew its new drug application for Uprima (apomorphine HCl tablets) for erectile dysfunction, which it submitted to FDA in June 1999. The company says it withdrew the NDA because it has additional data and ongoing studies that could further establish the drug's safety and efficacy profile. TAP expects to resubmit the NDA at a later date.
DOXORUBICIN--Alza Corporation and its marketing partner Schering-Plough Corporation received a recommendation for approval in the European Union for Caelyx (pegylated liposomal doxorubicin) for the treatment of advanced ovarian cancer in women who have failed a first-line, platinum-based chemotherapy regimen. The European Commission is expected to issue a marketing determination for the drug in approximately three months. Alza markets the product in the US as Doxil.
GLAXO WELLCOME and SmithKline Beecham are expected to complete their previously announced merger on August 21. The merger will create Glaxo SmithKline, which will lead the pharmaceutical industry in terms of sales with a global market share of an estimated 7 percent.
HEPARIN--DuPont Pharmaceuticals Company, a wholly owned independent subsidiary of E. I. du Pont de Nemours & Co., entered an alliance with Emisphere Technologies Inc. for the development and marketing of oral formulations of heparin and low molecular weight heparin using Emisphere's proprietary drug delivery technology. Emisphere will retain development rights to its oral liquid formulation of heparin that is currently in Phase III clinical trials.
POLY 1:POLY C12U--Hemispherx Biopharma Inc. signed a licensing and marketing agreement with Vienna, Austria-based AOP Pharmaceuticals for facilitating product introduction of Ampligen (poly 1:poly C12U), a potential chronic fatigue syndrome treatment, in response to the growing market demand of CFS patients. The agreement covers segments of both the Western and Eastern European markets. Ampligen is a member of the nucleic acid class of drugs. AOP is well established for new pharma product introduction in a territory that includes Austria, Czechoslovakia, Poland and Hungary.
PROTEIN C--Eli Lilly and Company has stopped enrollment in a Phase III clinical trial investigating the therapeutic potential of recombinant human protein C in the treatment of severe sepsis. The product will be marketed as Zovant if it receives regulatory approval. Lilly's stock soared 17 percent on June 29 following its report of positive findings from the drug's study.
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