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In Search of Relief

The pain management therapeutics market is expected to continue its rapid growth over the coming years as a result of ageing populations and new treatments in the pipeline.

Pain is a universal human experience and is one of the most common reasons for people to seek medical advice. The World Health Organization recognises pain as a global healthcare problem, and with the release of pain management standards by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), there is growing tendency among the medical community to accord pain the status of a vital sign, on par with pulse, temperature and blood pressure. According to a household survey conducted by the International Association for the Study of Pain, an estimated 36 per cent of households in Europe and 43 per cent in the US have chronic pain patients. Chronic pain alone affects about 116 million American adults, which is more than diabetes, cancer and heart disease combined (1). Direct healthcare costs and loss of productivity due to chronic pain is expected to cost the US economy a staggering $635 billion annually (2). Common pain conditions such as arthritis, back pain and headaches account for a national economic loss of about $60 billion annually in the US due to the associated reduced productivity levels. About 80 per cent of initial physician visits in the UK complain of pain as the primary symptom and analgesics constantly rank amongst the top prescriptions by volume (3).

Pain is generally classified based on the location, frequency, duration, intensity and underlying aetiology. Clinicians prefer to use most of these classifications on a case-by-case basis. The American Academy of Pain Medicine has classified pain on a neurobiological basis as eudynia (nociceptive pain) and maldynia (neuropathic pain). Nociceptive pain refers to the pain due to tissue damage caused by visceral or somatic lesions, while neuropathic pain refers to the pain caused by damage to the central or peripheral nervous tissue (4). Pain which lasts for less than 30 days is regarded as acute pain, while pain which lasts for more than six months is considered chronic pain. Subacute pain is used to describe pain which falls between these two categories.

Market for Pain Management Therapeutics

The ‘Pain Management Therapeutics Market to 2017’ report covered the pain therapeutics market for osteoarthritis, rheumatoid arthritis, fibromyalgia, migraine, neuropathic pain, cancer pain, lower back pain and postoperative pain. The report indicates that the market, in spite of patent expiries and generic substitution, is exhibiting a moderate growth rate. The rapid growth of elderly populations, associated with an increasing incidence of painful conditions such as cancer and arthritis, is driving the growth of this segment.

Pain therapeutics consists of four classes of drugs:

  • Opioids, including drugs such as morphine, codeine, hydrocodone, oxycodone, and so on
  • Non-opioids, including nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin and acetaminophen
  • Adjuvant analgesics, including medications such as anticonvulsants and antidepressants, which are primarily developed for other purposes but used to relieve pain in specific conditions
  • Others include medications used to treat other associated conditions as a part of pain management programme, such as anxiolytics and sedatives

In 2010, the global pain management market was worth approximately $28.6 billion, representing a compound annual growth rate (CAGR) of 5.3 per cent between 2002 and 2010. The approval of Lyrica (pregabalin) for several pain indications other than neuropathic pain contributed the most to this growth.

In 2017, the global pain management market is expected to generate sales of $35.1 billion, representing a CAGR of three per cent between 2010 and 2017. The annual cost of treating pain is forecast to decline, resulting in slower market growth. Nevertheless, blockbuster sales of Lyrica and Cymbalta (duloxetine), coupled with improved diagnosis of pain indications such as fibromyalgia and neuropathic pain, are expected to augment market revenues. The neuropathic pain market is expected to grow fastest, followed by cancer pain. The market share of osteoarthritis, fibromyalgia and the migraine segments are expected to shrink from their 2010 levels. In 2017, the post-operative pain market will continue to be the largest segment.

Unmet Need

The current level of competition in the chronic pain therapeutics market is strong. The market is dominated by drugs such as morphine sulfate, methadone, fentanyl, oxycodone, tramadol, duloxetine, pregabalin, gabapentin, bupivacaine, diclofenac potassium, celecoxib, ibuprofen and others. Physicians prescribe a wide array of drugs that aim to reduce pain and treat the underlying condition. But almost none of the marketed products are specific to any one condition, and hence the level of pain relief is not satisfactory. The products, in addition, have intolerable and harmful side effects that in most cases outweigh the benefits. For maximum pain relief and reduced side effects, the active pharmaceutical ingredients have to be delivered to the specific site of inflammation and in a controlled manner, indicating a need for novel drug delivery mechanisms in pain management.

R&D Pipeline

In 2010, around 280 programmes were in progress for pain management. Nevertheless, barring a few products, the pipeline does not look set to present great competition to the drugs currently being marketed. The pipeline is a mix of ‘first-in-class’ and ‘me-too’ products. The growth of the market is highly dependent on the success of the ‘first-in-class’ molecules. Nearly half of all programmes are involved in research on neuropathic pain. Post-operative pain and cancer pain are two other dynamic areas of research.

With the role of nerve growth factor (NGF) in acute and chronic pain conditions being established, several drugs are currently being developed that aim to antagonise NGF. Pfizer is in the lead with tanezumab (PF-4383119), a humanised monoclonal antibody, which would be the first drug to be specifically indicated for lower back pain. However, the worldwide trials for tanezumab for osteoarthritis were discontinued following increased incidence of damage and necrosis in the knee joints of patients undergoing trials. The other trials from major players which includes SAR164877/ REGN475 (Sanofi-Aventis/Regeneron), JNJ-42160443/AMG403 (Johnson & Johnson/Amgen) and MEDI578 (MedImmune/Astra Zeneca) and are either on hold, or terminated as recommended by the FDA when experts spotted some problems with the class of NGF-targeting antibodies. However, these companies are cautiously optimistic about the risk-benefit ratio of the drugs in development and are hoping that the trials would be allowed to proceed. Other promising drugs in development include PG-110, GRT6005, GRT6006, ABT-602 and CNV2197944. Since pain is caused by multiple interacting factors, only combination therapies that target key pain modulating pathways can relieve pain satisfactorily, and these are currently being researched actively.

Strategic Partnerships

With the upcoming patent expiries of some blockbuster drugs such as Lyrica, Cymbalta and Oxycontin, manufacturers are looking to acquire smaller players to boost their R&D activities, as well as to enter the generics market. Biovail’s acquisition of Valeant Pharmaceuticals and Teva’s acquisition of Cephalon are among the major deals that have been made recently. Pfizer expanded its pain products portfolio by acquiring King Pharma in 2010.

REMS and the Pain Therapeutics Market

Despite having several undesirable side effects, opioid analgesics are effective in clinical situations where non-opioids fail to provide adequate pain relief. Opioids are the most powerful pain relievers and are often misused, which leads to fatal outcomes. In an effort to minimise the risk of misuse, abuse, addiction and overdose, opioids are made available through the risk evaluation and mitigation strategies (REMS) programme in the US. Pharmacies, distributors and medical care providers are required to enrol in the REMS programme before dispensing, distributing and prescribing opioid drugs. With about four million US patients receiving long-acting or extended-release opioids every year, REMS for opioids will affect more people than any existing REMS for other high-risk medications.

Conclusion

With rising life expectancy associated with a concomitant increase in pain conditions and increasing awareness among patients and physicians, the demand for safe and effective pain relieving drugs is expected to rise. With the most promising trials being put on hold or terminated, the market will not be able to sustain the growth rates witnessed in the last few years in the pain management market. The implementation of the REMS programme for opioids is expected to reduce the number of prescriptions with a net negative impact on the pain therapeutics market, notwithstanding the other positive factors. With prevailing high unmet need in pain management, research on novel drug delivery mechanisms and combination therapies is expected to garner more momentum in the future and would be the key growth component in the market.


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Swapna Soni is an Analyst in the Healthcare practice at GBI Research, and has authored numerous strategic reports in major therapeutic sectors and established markets. As a frequent lead author, Swapna has analysed and presented on a variety of topics and themes shaping the global pharmaceuticals market. Prior to joining GBI Research, she worked with Global Industry Analysts, Inc at its Hyderabad office as a senior research analyst for five years.
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