Over the last decade or so, the life sciences have seen a seismic shift in where drug approvals are coming from. The emerging biotech market has become more adept at conducting and advancing trials and progressing molecules in therapeutic areas with unmet needs with oncology, orphan and rare disease indications being prime market areas. The upshot is more approvals and biotech products reaching patients. Of the 50 FDA approvals in 2021, 27 (54%) were first-in-class, 26 (52%) were approved to treat rare or “orphan” diseases.* 16 of the 50 were notably biologics – the most in any calendar year.
Start-up innovation is also exploding – since 2012 the total number of pharmaceutical companies with active R&D pipelines worldwide has doubled from 2,700 to 5,400.**
While excellent at product development and conducting trials, there remains untold opportunity among emerging biotech to realize the full value of their products when bringing them to market; this is where strategic commercial partners like Inizio are essential. We help bridge the gap between complex science and commercial success and inform decisions along the clinical development journey with better data and insights.
The ‘emerging biotech’ challenge – lean but full of potential
Emerging biotechs have a competitive edge when it comes to delivering biopharma innovation. They are invariably more agile when compared to traditional large pharma, giving them the flexibility to mobilize and ‘figure it out’ while developing drugs.
But, no two biotechs operate the same way. Their journeys through clinical development and biotech commercialization are unique and they face challenges that are similarly distinct. Start-ups, irrelevant of where their funding comes from are constantly watching the burn rate of their cash.
They can’t behave the same as large pharma, they don’t have the same resources and have to be innovative to be lean. They also need to constantly think about how to make themselves appealing to further investment while keeping costs down.
Realizing value with every opportunity
These businesses require support to generate and understand the value of their product from strategic partners at various clinical milestones and guidance to avoid underselling at the point of commercialization. What is often misunderstood is how early some of these value milestones are – emerging biotechs can start maximizing commercial potential by starting to craft a story around their product at the earliest clinical stages.
Four essential activities to conduct in this effort are:
- Future landscape assessment
- Opportunity assessment and prioritization
- KOL mapping and engagement
- Value, pricing, and access
So, the when and the what are vital elements. To achieve the full potential of any product, there are two things all emerging biotechs must think about:
1. Leveraging specialist biotech consulting services such as Inizio
There are so many resources and a lot of insight and support available in the space. Do due diligence and tap into the resources of a strategic commercialization partner that complements in-house skillsets and capabilities. Understanding and keeping the big picture in mind is vital – in the later stages of development, there are often inflection points where biotech companies don’t know what to do or where the value is in their product – and they’ve left it too late.
2. Starting early
For many emerging biotechs, the idea of spending money on anything other than product and trial delivery during phase II is daunting but the long-term pay-off is immense. 18 (36%) of the drugs approved by the FDA in 2021 received Fast Track status as they treat patients with unmet needs. Accelerated approvals need scalable MSL and sales teams in place quickly for these products.
Don’t go it alone
Generating these data early is essential to understanding the value of a product and evidencing this to prospective investors while removing the pressures of last-minute scrambles when a product starts to show promise in late-stage trials.
Importantly, these companies don’t have to go it alone – there are strategic and integrated biotech solutions partners like Inizio that understand the challenges and are skilled at generating value and supporting commercialization strategy and delivery.