FDA’s push for abuse-resistant opioid formulations will disrupt the pain market, say analysts Frost & Sullivan.
The opioid market is currently dominated by non-tamper resistant formulations (TRFs), but FDA’s promotion of TRF therapies “could well result in the departure of non-TRF therapies from the market and shake up its structure.”
Unless FDA mandates TRF therapies, further genericization and lack of novel mechanism of actions (MOAs) will ensure opioids are unrepresented in the top 50 by 2018.
However, according to Frost & Sullivan’s Competitive Analysis of the Global Opioid Therapeutics Market, a large opportunity remains for tamper resistant technologies, as well as combination therapies to minimize side effects from opioid products. Purdue’s Oxycontin leads this category, generating $2.77 billion in sales in 2012.
“Another outcome of the FDA’s endorsement of TRFs is the flooding of the pain therapy pipeline with new TRF opioid-based therapies,” said Frost & Sullivan Life Sciences Global Research Director Jennifer Lazar Brice. “In this scenario, Pfizer has significant opportunity to grow, with its broad pipeline of oral (TRFs), transdermals and IV candidates.”
Brice added: “Overall, the future of the pain market is heavily dependent upon the FDA’s decision to remove non-TRF generic therapies from the market. This move will create a huge opportunity for new TRF therapies to remain branded.”