Tuesday, April 07, 2009

The dynamic opioid analgesic segment continues to evolve – reformulation advances rapid acting and long duration analgesics

The treatment of pain continues to suffer significant unmet needs. One of the oldest classes of analgesics, the opioids, remains a large and dynamic one which has changed significantly over the past few years.

As described in today’s featured report, Forecast Insight: Opioids, the market value for opioids was reportedly worth $8.4 billion across the 7 major markets in 2007. Growth has continued at a CAGR of 4% and is expected to grow at this rate through to 2018 at which time the market is expected to be worth $11.9 billion. This is remarkable given current market pressures including price competition, generic availability, negative stigma, and the US Risk Evaluation and Mitigation Strategy.

One drug development concept central to the opioid class is reformulation. The development of new combination therapies and delivery forms is a relatively inexpensive development process thereby presenting accessible strategies to mid- and small sized drug delivery and development companies. The attractiveness of the class is amplified by the large patient base and comparatively low market entry barriers

Reformulation of established opioids offers a useful means of treating breakthrough pain (by developing formulation with a fast onset of action) or chronic pain (by developing extended release formulations).

OxyContin, Duragesic, Kadian, Avinza and Opana are all extended-release reformulations of opioids. Duragesic has suffered from product recalls as well as generic incursion and hence a decline in revenue. Generic equivalents of Duragesic have also suffered product recalls and so OxyContin is expected to enjoy a majority market share this year with sales of $3 billion expected across the 7 major markets.

Activity in the development of extended release formulations continues however and there is a current emphasis on reducing abuse potential, frequently through the incorporation of naltrexone, an opioid receptor antagonist. The launch of several oxycodone controlled release-based opioids with anti-abuse potential will erode OxyContin’s market share in the mid-term. Despite this it is unlikely that any individual anti-abuse opioid brands will gain blockbuster revenues. This reflects unclear demand from frontline stakeholders such as prescribers and patients, and the flood of brands set to enter the market. Moreover the development of anti-abuse opioids appears to be a US-specific trend in the pipeline.

Despite the fragmented nature of anti-abuse opioids, King Pharmaceutical’s anti-abuse opioid franchise does however look set to reach blockbuster levels with combined sales of Remoxy (oxycodone controlled-release), Embeda (morphine extended release and naltrexone) and the immediate-release opioid Acurox (oxycodone and niacin) forecast to generate around $1 billion per annum by 2018

Overall the long-acting opioids market is expected to grow from $5.0 billion in 2007 to $6.1 billion in 2018 across the 7 major markets.

Reformulations enabling rapid onset of analgesia have, like extended release formulation, also gained significant attention. In particular this is to satisfy the demand for improved treatments of breakthrough pain. Actiq and Fentora are fentanyl formulations with transmucosal and buccal routes of action respectively. Choices open to physician and patient are likely to grow as dissolvable and spray formulations advance through the pipeline.

While the current market for short- and rapid acting opioids is quite low ($771m in 2007), growth is expected with sales expected to reach $1.7 billion by 2018 in the 7 major markets, representing the strongest growth rate among the opioid market. This reflects new product entries in addition to an expected increase in Fentora sales should it receive approval for non-cancer pain. The FDA issued a complete response letter for this submission in September 2008.

Unlike the anti-abuse long-acting opioids, short- and rapid-acting opioids are being developed across all three major market regions (US, 5EU and Japan). Cephalon’s Fentora is expected to remain the market leading brand in the US, however experienced local marketing partners such as Meda (Onsolis, buccal fentanyl) and Nycomed (Instanyl, intranasal fentanyl) are expected to provide significantly more competition to Cephalon in what will become an increasingly fragmented European market

All in all the opioid market remains dynamic. Hopefully development will feed through to improved treatments of pain. This editorial is based on new data reported in our current feature: Forecast Insight: Opioids - Saturation limits the commercial potential of individual brands

Other recent market research and pipeline reports:


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