Synthetic opioids are used for pain relief. The effect of synthetic opioids on the body is similar to that of other opioids. These drugs are opioid receptor agonists and act primarily on the brain and spinal cord. The efficacy of synthetic opioids is higher compared to other pain killers such as nonsteroidal anti-inflammatory drugs.
North America Synthetic Opioids Market is estimated to account for US$ 97.6 Bn in terms of value by the end of 2027.
North America Synthetic Opioids Market: Drivers
Increasing use of synthetic opioids for the treatment of cancer pain is expected to propel growth of North America synthetic opioids market over the forecast period. For instance, fentanyl is the most widely used synthetic opioid in medicine. Fentanyl patches make it to the World Health Organization’s List of Essential Medicines for cancer pain.
North America Synthetic Opioids Market: Opportunities
Enhancing business operations is expected to offer lucrative growth opportunities for players in the market. Market players can focus on expanding their business through strategic investments, licensing agreements, and acquisitions. Branded players have the opportunity to optimize their R&D programs and launch novel drugs with enhanced formulations and generic manufacturers have the opportunity to expand their portfolio.
North America Synthetic Opioids Market: Restraints
Stringent regulations and laws to curb the use of synthetic opioids are expected to hinder growth of the market. For instance, in April 2019, China announced to ban all variants of fentanyl. China is considered as a major source of fentanyl and has led to several deaths in the U.S.
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The semi synthetic opioids segment in North America synthetic opioids market was valued at US$ 75.0 Bn in 2019 and is expected to reach US$ 90.1 Bn by 2027 at a CAGR of 2.3% during the forecast period. Increasing use of synthetic opioids for the treatment of cancer pain is expected to assist the growth of the market.
The pain management segment held dominant position in North America synthetic opioids market in 2019, accounting for 65.9% share in terms of value during the forecast period. Increasing prevalence of cancer in the region is expected to assist the growth of the segment during the forecast period.
There is a ban on use of fentanyl analogues in the U.S. In February 2018, the Drug Enforcement Administration imposes a “class-wide” ban on any and all fentanyl analogues.
Researchers are focused on developing approaches to improve the safety of opioids. For instance, in August 2019, researchers from Scripps Research Institute reported discovery of a biological system that manages cells’ response to opioid drug exposure.
Food and Drug Administration (FDA)
The mission of FDA’s Center for Drug Evaluation and Research (CDER) is to ensure that drugs marketed in U.S. are safe and effective
It has responsibility for both prescription and nonprescription or over-the-counter (OTC) drugs
In response to the current opioid crisis, the FDA has established a far-reaching action plan to reassess the agency’s approach to opioid medications. The plan focuses on policies aimed at reversing the epidemic, while still providing patients access to effective therapies for pain management.
In March 2016, the FDA issued a draft guidance titled “General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products.” This guidance recommends studies a generic applicant should conduct so FDA can evaluate the abuse deterrence of certain generic opioid drug products and help ensure that generic versions of approved opioids with abuse-deterrent formulations (ADFs) are no less abuse-deterrent than the brand named drug.
North America Synthetic Opioids Market: Competitive Landscape
Major players operating in North America synthetic opioids market include, Purdue Pharma LP, Pfizer Inc., Janssen Pharmaceuticals, Inc., Teva Pharmaceuticals, Endo International plc, West-Ward Pharmaceuticals, Mallinckrodt Pharmaceuticals plc, Mylan N.V., Impax Laboratories, Inc., and Indivior Plc.
North America Synthetic Opioids Market: Key Developments
September 2019: Purdue Pharma L.P. announced that the company has reached an agreement in principle on a framework for settling the U.S. opioid litigation
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