Specialty pharmaceuticals make up a significant part of the current drug market, and their impact is only going to grow over the next few years.
That’s according to an analysis of the specialty market and pipeline by Aimee Tharaldson, PharmD, senior clinical consultant of emerging therapeutics at Express Scripts, who spoke about specialty pharmaceuticals in development at the AMCP Nexus meeting in Orlando in October.
The specialty market made up 41% of the total drug spend in 2017. That number, Tharaldson said, is likely to increase. There will be a fifty-fifty split between specialty and traditional medications in the coming years, she said.
In total, the 2017 per-member per-year specialty spend was $444. Of that amount, the largest contributor was anti-inflammatory medications ($157), followed by oncology ($70), multiple sclerosis ($60), HIV ($45), and Hep C ($19).
Here are five things you should know about the specialty pharma pipeline:
1. The number of newly approved drugs is increasing every year.
The FDA is helping propel the specialty market forward. For at least the last eight years, the agency has approved more specialty drugs than traditional drugs. In 2017, the agency approved a record 36 specialty medications. In 2018, it has already approved 32, and more are on the way. Of those 32, 12 are for cancers, 10 for orphan conditions, five for HIV, three for thrombocytopenia, and two for inflammatory conditions.
The future of specialty medications, according to Tharaldson, will be defined by increased competition and a variety of high-impact indications.
2. The biggest competition factor will be biosimilar approvals
Through 2022, there will be a $54.4-billion potential for biosimilars as 71 specialty drug patents will expire, Tharaldson said. Biosimilars could provide “significant” cost savings, but they are not without their problems, she said.
Biosimilars face a variety of legal hurdles and will also struggle to gain market share.
3. The top two pipeline categories are cancer and orphan drugs
Tharaldson also covered several important categories that will be largely influenced by specialty medications in the coming years. The two biggest pipeline categories are oncology and orphan drugs, but other smaller indications could still play a significant role, she said.
Orphan drugs make up the largest slice of the specialty pipeline at 45%, with cancer drugs the second-largest class at 20%. According to Tharaldson, 30% of new orphan drugs will be blockbuster drugs.
4. NASH could see major drug developments in 2019.
One other notable treatment class is for nonalcoholic steatohepatitis (NASH). Currently, NASH has no treatment. But according to Tharaldson’s data, there are 10 medications in the pipeline, and one could be approved as early as the end of 2019. Some analysts expect this could be as much as a $35-billion-per-year industry, though Tharaldson said that number could be too high.
5. The Alzheimer’s pipeline is promising
In the even longer term, Tharaldson pointed out that the Alzheimer’s pipeline may be productive. Current treatments for Alzheimer’s are only symptom modifying, whereas new drugs could finally be disease modifying agents.
While these drugs—if they are even approved—won’t be available for years, they could significantly alter the Alzheimer’s treatment landscape.