Synthetic opioids are used forpain relief. The effect of synthetic opioids on the body is similar to that ofother opioids. These drugs are opioid receptor agonists and act primarily onthe brain and spinal cord. The efficacy of synthetic opioids is higher comparedto other pain killers such as nonsteroidal anti-inflammatory drugs.
Statistics:
NorthAmerica Synthetic Opioids Market is estimated to account for US$ 97.6 Bn interms of value by the end of 2027.
North America Synthetic OpioidsMarket: Drivers
Increasing use of syntheticopioids for the treatment of cancer pain is expected to propel growth of NorthAmerica synthetic opioids market over the forecast period. For instance,fentanyl is the most widely used synthetic opioid in medicine. Fentanyl patchesmake it to the World Health Organization's List of Essential Medicines forcancer pain.
North America Synthetic OpioidsMarket: Opportunities
Enhancing business operations isexpected to offer lucrative growth opportunities for players in the market.Market players can focus on expanding their business through strategicinvestments, licensing agreements, and acquisitions. Branded players have theopportunity to optimize their R&D programs and launch novel drugs withenhanced formulations and generic manufacturers have the opportunity to expandtheir portfolio.
North America Synthetic OpioidsMarket: Restraints
Stringent regulations and laws tocurb 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 deathsin the U.S.
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Key Takeaways:
The semi synthetic opioidssegment in North America synthetic opioids market was valued at US$ 75.0 Bn in2019 and is expected to reach US$ 90.1 Bn by 2027 at a CAGR of 2.3% during theforecast period. Increasing use of synthetic opioids for the treatment ofcancer pain is expected to assist the growth of the market.
The pain management segment helddominant position in North America synthetic opioids market in 2019, accountingfor 65.9% share in terms of value during the forecast period. Increasingprevalence of cancer in the region is expected to assist the growth of the segmentduring the forecast period.
Market Trends
There is a ban on use of fentanylanalogues in the U.S. In February 2018, the Drug Enforcement Administrationimposes a “class-wide” ban on any and all fentanyl analogues.
Researchers are focused ondeveloping approaches to improve the safety of opioids. For instance, in August2019, researchers from Scripps Research Institute reported discovery of abiological system that manages cells' response to opioid drug exposure.
Regulations
U.S.
Food and Drug Administration(FDA)
The mission of FDA's Center forDrug Evaluation and Research (CDER) is to ensure that drugs marketed in U.S.are safe and effective
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It has responsibility for bothprescription and nonprescription or over-the-counter (OTC) drugs
In response to the current opioidcrisis, the FDA has established a far-reaching action plan to reassess theagency’s approach to opioid medications. The plan focuses on policies aimed atreversing the epidemic, while still providing patients access to effectivetherapies for pain management.
In March 2016, the FDA issued adraft guidance titled “General Principles for Evaluating the Abuse Deterrenceof Generic Solid Oral Opioid Drug Products.” This guidance recommends studies ageneric applicant should conduct so FDA can evaluate the abuse deterrence ofcertain generic opioid drug products and help ensure that generic versions ofapproved opioids with abuse-deterrent formulations (ADFs) are no lessabuse-deterrent than the brand named drug.
North America Synthetic OpioidsMarket: Competitive Landscape
Major players operating in NorthAmerica 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., ImpaxLaboratories, Inc., and Indivior Plc.
North America Synthetic OpioidsMarket: Key Developments
September 2019: Purdue PharmaL.P. announced that the company has reached an agreement in principle on aframework for settling the U.S. opioid litigation
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