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.
Statistics:
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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Key Takeaways:
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.
Market Trends
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.
Regulations
U.S.
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
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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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