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Research PREVIEW for
A Product and Pipeline Analysis of the Opioid Therapeutics and Drug Delivery Market
Drug Abuse Triggers Regulations to Push the Development of Tamper-Resistant
Opioid Formulations for Pain Management
Executive Summary
• The increasing global aging population, rising incidence of cancer, and
increasing number of surgeries, especially in the developed regions, spur the
usage of opioids.
• Moderate to severe chronic pain therapeutics market is the most mature one
and the largest opioid market segment, holding nearly 47.0% of the market
share.
• Prevalence is highest for acute and post-operative pain affecting nearly 1
billion people globally, compared to other pain segments.
• With the patent expiry of oxycodone in 2014, there is a gap in the chronic
pain market. The Food and Drug Administration (FDA), however, refuses to
approve any generics due to safety concerns.
• Patent expiration of Oxycontin and bad press for Purdue Pharma will boost
sales of the newly-approved Zohydro ER drug for chronic pain.Source: Frost & Sullivan analysis.
3
Executive Summary (continued)
J&J
J&J competes strongly both in the transdermal patch space and orals.
• Nucynta’s immediate release and extended-release (ER) formulations had combined US sales of $266 million in 2013. J&J is currently conducting clinical trials to show the abuse-deterrence of Nucynta ER to provide a label update in 2015 or early 2016.
• Ultram ER US sales peaked in 2009 with $129.1 million. However, 2013 sales have declined to $3.4 million due to entry of generic competition.
4
Source: Frost & Sullivan
Many of the drugs used 100 years ago are the same as today and belong to the opioid or non-steroidal, anti-inflammatory drugs (NSAIDs) class of therapies.
– In the past 2 decades, improvements in formulations have been achieved such as extended-release and tamper-resistant formulations.
– Pfizer’s COX-2 is a recently-developed NSAID.
The 2 most common descriptions of pain are chronic and acute:
– Acute pain: Short bursts of pain. Acute pain is also defined as a pain that lasts for several days, increasing in intensity over time. It can also occur intermittently and is usually caused by post-op pain or injury such as a fracture.
– Chronic pain: Long-term and typically defined if it lasts for more than 3 months. It is more subjective and not as easy to clinically characterize as acute pain and includes psychological effects. This kind of pain usually affects a person's life by adding unnecessary stress and also compromises their functionality and overall lifestyle.
In the US, 10% of adults, or approximately 24 million individuals, suffer from moderate to severe pain.
Introduction
Source: Frost & Sullivan
5
Physician Guidelines to Opioid Therapy—Moderate to Severe Chronic Pain
The primary reason for the prescription of opioids by physicians was due to their ability to relieve pain and the prolonged effectiveness of pain relief.
Many studies conducted show that Tapentadol ER (Nucynta ER) was effective in the management of moderate to severe chronic pain when compared to Oxycodone HCl CR.
Less side effects were also observed when looking at the efficacy of Nucynta ER.
OxyContin, Fentora, Nucynta ER, Butrans
• Popular first-line options
Fentanyl Transdermal patch
• Popular second-line option
Ultram, Zohydro ER
• Popular third-line options
Current Moderate-Severe Chronic Pain Treatment Paradigm, US, 2013
Note: Popularity was determined by the number of prescriptions for 2013
Note: Does not account for all chronic pain and these treatments are dependent on age, severity, and location of pain
Note: The popularity of the drug used as first-line option depends on prescribers and the type of pain
Source: Express Scripts, Bloomberg, and Frost & Sullivan
The Full Analysis Features the Following Content
Section Slide Numbers
Methodology and Scope 3
Executive Summary 5
Introduction 13
US Opioid Therapeutics Market Overview 19
Competitive Landscape 30
Timeline Transparency 53
Late-stage Development—Product Dashboards 58
The Last Word 65
The Frost & Sullivan Story 68
Key Questions the Analysis Answers
Is the market growing, how long will it continue to grow, and at what rate?
Are the existing competitors structured correctly to meet customer needs?
Will these companies and products continue to exist in the next decade?
How will the structure of the market change with time? Is it ripe for acquisitions?
Who are the new entrants and how are they changing the market dynamics?
Are manufacturers finding opportunities outside the US where regulations are more lenient?
Source: Frost & Sullivan analysis.
Interested in Full Access? Connect With Us
Kayla BelcherCorporate Communications
210.247.2450
Research Authors
Aish Vivekanadan
Industry AnalystLife Sciences
Divyaa RavishankarSr. Industry
AnalystLife Sciences
Jennifer LazarGlobal Program
DirectorLife Sciences
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