A pharmacist’s perspective on medications trends
As a pharmacist, I’m always watching to see how the market will harness new discoveries.
Ground-breaking new medication approvals derived through data-driven results continue to strengthen patient care and can initiate cures for chronic diseases that unfortunately we haven’t yet cured.
Looking at some recent drug approval trends sheds light on where the pharmaceutical industry is headed this year and beyond.
The Food and Drug Administration (FDA) saw a record-breaking year in 2018 for new drug approvals. Surprisingly, there were 59 new molecular entities (NMEs) and biologics, 19 of which were first-in-class therapies and 34 of which received orphan drug designation (ODD).1
First-in-class (FIC) medications are sometimes preferred by manufacturers due to lack of competition from similar medications for a certain period. Competitors, although reduced development risk, must differentiate their products when they look to design a more validated target with a “follow-on” drug.2
“ODD is granted to drug products that are used to treat a rare disease, defined by the Orphan Drug Act of 1983 as having a prevalence of less than 200,000 cases in the United States.”3 FIC and orphan medications can be one and the same or completely different.
The high numbers of FIC and ODD medications prove that there is an ongoing shift away from what is known as “me too” therapies.1
“Me too” therapies can be structurally similar to an already existing medication with slight differences. These often carry a negative connotation, but they also can create inventive competition and reduce cost for patients in some cases.4
Although they may take significant time to launch, newer approaches look to target unmet needs, have innovative mechanisms of action (MOA), and create more gene therapies.1 Ground-breaking new medications are launching at a median of about six months faster than they did in the previous five years.
These growth figures illustrate the significant investment made in medical innovation in 2018 by emerging biopharma companies:
Around 2015, there was about $10 billion in aggregate value-of-life science venture capital deals. That grew to more than $23 million in 2018.
We used to think of the big pharma players performing the bulk of the research and design for new drug development. Now, there has been a shift to smaller companies. Small biopharma accounts for about 72% of late-stage pipeline activity, mainly seen in the growing areas of oncology and orphan medications. Small pharma is no longer as dependent on partnering or selling rights through acquisitions to develop and commercialize their new drug therapies.5
Key oncology statistics:
- In 2018, 15 new active substance (NAS) oncology treatments launched with 17 indications.6
- To date, there are 57 new oncology therapeutics spanning 89 approved indications for 23 different tumor types.6
- Spending on oncology medicines hit its fifth consecutive year of double-digit growth reaching nearly $150 billion globally and $56 billion in the U.S. alone.6
- The average annual cost of new cancer treatment ranged between $90,000 and >$300,000 with a median of $149,000 in 2018.6
- By 2023 worldwide, total estimated oncology therapeutics spending is expected to be between $200 to $230 billion.6
- Since 2014, 31% of approved indications have been for hematologic cancers such as leukemia, lymphoma, and multiple myeloma.6
- Of the solid tumor indications, lung cancer had 12, breast cancer 7 and melanoma 6.6
- Of ~700 global companies with late-stage oncology drug development, 89% are emerging biopharma and 11% large biopharma. The mainstream activity within the pipeline is in immunotherapies, with almost 450 in clinical development.6
- A total of 1,170 oncology clinical trials were initiated last year with more than 100 next-generation biotherapeutics (cell, gene, and nucleotide therapies) focusing on 18 different MOAs.6
As you can see, there was a significant investment in medical innovation in 2018 by emerging biopharma companies.
It is so inspiring to be able to work with the patient data that makes drug trials possible and to be able to evaluate the trends that will change the healthcare landscape for generations to come.