Pain as a major health care problem Pain is a significant, costly, and growing health care issue. In the United States, 76.5 million Americans (26% of adults age 20 or older) reported a problem with pain lasting for more than 24 hours. The majority of adults in the United States (57% or 170 million) have experienced chronic or recurrent pain in the past year. The economic cost of pain, including health care costs as well as lost productivity due to pain, is estimated at $100 billion annually in the United States. Some $61 billion of this amount is lost productivity attributable to pain, with an average loss of five hours per week for workers experiencing reduced performance or work absences. Among pain conditions, headache is the primary reason for lost productive time.
The market for pain management products is large. According to BBC Research, the pharmaceutical segment of the pain-management market was valued at $29 billion in 2007 and will be worth $38 billion by 2012. Five of the top 50 prescription drugs ranked by worldwide sales in 2006 were pain medications.
Recent developments regarding the dangerous side effects of certain non-steroidal anti-inflammatory drugs (NSAIDs), including the removal of several COX-2 inhibitors from the market, and the FDA’s subsequent attention to the matter, has created a significant market opportunity for alternative pain therapy medications and has generated a heightened consumer caution and wariness of current marketed products. Similarly, potential for abuse of some existing prescription medications for moderate-to-severe pain, such as opioid-based analgesics, establishes a need among consumers for medications with less risk for addiction.
We believe that as recognition of the importance of pain diagnosis and treatment becomes greater, and as the FDA continues to issue health advisories and tighten restrictions on marketed NSAIDs, the increasing need for effective pain medications with fewer side effects and less dependency concerns will create significant market opportunities for new products.
Several trends in the pain management market are also expected to drive growth and create opportunities for new products for osteoarthritis and rheumatoid arthritis pain, headache pain including migraine, cluster, tension-type and chronic daily headache; neuropathic pain and cancer pain.
Aging of the population The populations in the United States, Europe, and Japan are aging rapidly. By 2025, it is estimated that in the United States, one in four people will be 60 years of age or older (versus one in six in 2000). In Europe and Japan, the aging of the population is expected to be even more pronounced. As people age, they tend to be afflicted with more chronic pain conditions and to undergo more surgical procedures which require postoperative pain control.
Greater recognition of the importance of pain diagnosis and treatment Medical and health care practitioners are increasingly aware of the importance of diagnosing and treating pain. Whereas pain may have once been considered a natural or inevitable consequence of aging or certain medical conditions, it is now considered a patient’s “fifth vital sign,” which is essential to monitor and treat. The Joint Commission on Accreditation of Healthcare Organizations has established standards that require health care facilities to assess and treat pain.
Significant unmet medical needs in pain management Almost 50% of those surveyed said their pain is not under control. More than 75% of those surveyed strongly agreed that new options are needed to treat their pain. Even among those patients who do receive treatment for pain, many do not achieve significant relief. In fact, one survey found that respondents were so dissatisfied with the efficacy of their prescription and over-the-counter (OTC) pain control medications that 78% were willing to try new treatments, and 43% said they would spend a substantial portion of their financial resources on a treatment if they thought it would work.
Unfavorable side effect profiles of existing pain medications Some commonly used pain medications have side effects that render them unsuitable for significant segments of the affected population. For instance, NSAIDs that are commonly used to treat osteoarthritis, including the COX-2 inhibitors, have gastrointestinal, renal, and cardiovascular side effects. In the past two years, several of the COX-2 inhibitors have been withdrawn from the market because of these safety concerns, such as Vioxx® and Bextra®. Triptans, used to treat migraine pain, have cardiovascular cautions in their labeling. Opioid medications, used to treat a variety of painful conditions, often cause constipation and have significant addiction potential.