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New therapies and tighter budgets challenge bio/pharma to think outside the industry.
In the past few years, therapies for orphan and rare diseases have been approved by FDA in increasing numbers. Personalized therapies made their mark in 2017 with three approvals of individualized patient treatments. In addition, several big-name blockbuster drugs are scheduled to go off patent in the next few years. Is the bio/pharma industry prepared to address the internal and external factors that will influence the types of drugs that are developed and how patients pay for these therapies?
In its Drugs to Watch 2018 report (1), Clarivate Analytics predicted a record number of blockbuster drugs would reach the market in 2018. The report forecasted 12 new drugs would achieve annual sales of $1 billion or more by 2022, up from a predicted eight blockbusters in 2017, and the most since the report was first issued in 2013. Three drugs-Hemlibra (Roche/Chugai), Biktarvy (Gilead), and Ozempic (Novo Nordisk)-are expected to exceed $3 billion in annual sales by 2022.
The prospective blockbusters are both large- and small-molecule drugs-including the first cannabidiol-based medicine for the US market-and treat a range of diseases including diabetes, endometriosis, epilepsy, HIV, hemophilia, migraine, opioid addiction, and shingles. Only one anticipated blockbuster is for cancer; in the 2017 projections, more than half of the anticipated blockbusters were for cancer treatment.
Through the first 11 weeks of 2018, FDA approved six new novel drugs, including two on Clarivate’s blockbuster list (Biktarvy and Johnson & Johnson’s Erleada). This overall drug approval rate is similar to the number approved in the first quarter of 2017 when a record-breaking 46 novel therapies were approved (2).
If the trends of recent years continue, however, a significant percentage of new drug approvals will address orphan or rare diseases, with small patient populations, and therefore smaller sales volume. A report from the IQVIA Institute (3) suggests that bio/pharma faces several “turning points” that may force companies to adjust to evolving business, regulatory, and technical factors from both inside and outside of the industry.
The IQVIA report noted that branded medicine spending will be flat in developed markets for 2018–2020 but specialty medicines will drive spending growth. Patent expirations, including biologics, will be 37% higher than the previous five years; new medicine growth will be slower in 2018–2022 than from 2013–2017. The report authors also project slower growth in China and other pharmerging markets.
The industry has reached a “breaking point,” said Graham Lewis, IQVIA’s vice-president, global pharma strategy, during a presentation at DCAT Week ‘18.
Payers are not willing-or in some cases able-to pay more for healthcare and medications. This price squeeze will impact developed and emerging markets for branded, generic, and specialty drugs; limited resources could slow the adoption of new therapies.
Lewis warned of trends in the transformative space that are not about drugs, and the pharma industry will need to look outside itself to embrace change. Factors to consider include: FDA’s adoption of real-world data to accelerate drug approvals, the use of mobile health apps and wearable sensors for patient treatment; and telehealth programs that replace the traditional doctor’s office visits; and more mainstream use of personalized biotherapeutics.
There are significant differences between a therapy that treats millions and a therapy that treats one patient. Both blockbusters and personalized therapies will be needed. The bio/pharma industry must be flexible enough to discover, develop, manufacture, and market therapies for both ends of the spectrum, and all patient needs in between.
1. Clarivate Analytics, Drugs to Watch 2018 (March 2018).
2. FDA, New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products.
3. M. Aitken, M. Kelinrock, and D. Nass, 2018 and Beyond: Outlook and Turning Points, IQVIA Institute (2018).
Vol. 42, No. 4
When referring to this article, please cite it as R. Peters, "When One Therapy No Longer Fits All" Pharmaceutical Technology 42 (4) 2018.