To the good fortune of patients, treatment for the vast majority of conditions is significantly beyond where things were at just 40 years ago. Therapies have progressed from small molecules to include biologics, heart disease deaths have dropped significantly, targeted therapies for cancer have become a true reality, combination therapies for HIV have extended life by multiple-decades post-diagnosis, conditions like HCV now essentially have “cures”, cell and gene therapies have reached the bedside, and the innovations go on and on…
HCPs, patients, and payers generally have a broad assortment of therapeutic options to consider – so much so that for several conditions a new brand might go largely unnoticed. Not every brand has the deep pockets and risk appetite to invest hundreds of millions into head-to-head trials vs the latest therapeutic innovation, but does that mean they don’t deserve to exist? Can these brands still bring value to patient outcomes, and be meaningful players for HCPs and payers to consider? How can a “challenger” brand make a mark, and ultimately win at launch, when plagued by difficulties like: being late to market, entering a crowded landscape, having limited data to distinguish its profile, facing competition with more “novel” MOAs, not having the big commercial bucks and infrastructure to rival competition, etc.?
Listen in to hear a dynamic roundtable discussion (or download our white paper) exploring:
- What has helped some “challenger” brands win, versus those that lose?
- How does a brand get noticed in a crowded market, with limited distinctive data?
- How have organizations with limited infrastructure and funding for particular disease areas managed to nonetheless launch successfully in key markets?
- When you only have X dollars to spend – where should you spend it to move the needle?
Our seasoned panel of experts includes a mix of Ipsos Healthcare specialists and industry leaders:
- Anuj Hasija, Novartis, VP Global Oncology Lifecycle and Established Medicines
- Bill Gibson, Eisai, Senior Director & US Commercial Launch Lead, Alzheimer's Disease
- Bill Renzo, Ascendis Pharma, US & Global Lead - Pricing, Contracting & Distribution
- Pablo Lapuerta, 4M Therapeutics, CEO
- Steve Girling, Ipsos Healthcare NA, President
- Neil Kairen, Ipsos Healthcare Advisory Commercial Strategy Executive Leader
Stakeholders now often have a multitude of therapeutic options to consider for most conditions—which presents a conundrum for biopharma manufacturers.
Therapeutic advances in the last several decades include…
- Progression from being solely small molecule to also include recombinant DNA technology, or biologics— the first approval of which was in 1982 (Humulin).
- Since 1980, heart disease deaths have dropped by over 50% in the U.S.
- Targeted therapies for cancer—both heme and solid tumor—have become a true reality.
- Since the late 1990s, new classes of antiretroviral therapies (ART) for HIV have extended life post-diagnosis by 50+ years.
- Since 2014, conditions like Hepatitis C now essentially have “cures.”
- Cell therapy hit a breakthrough in 2006 with induced pluripotent stem cells, and 2017 saw the first gene therapy reaching the bedside with CAR-Ts (Kymriah for ALL—acute lymphoblastic leukemia). … and the innovations go on and on!
As wonderful as this is for patients, and society—for most conditions, stakeholders often have so many therapeutic options to consider that a new brand might go entirely unnoticed! It’s a conundrum for biopharma manufacturers.
To that end—how can a pharma “challenger” brand make a mark, and WIN at launch despite these challenges?
When thinking about market maturity or saturation vs brand or portfolio position—there are some important considerations.
Whether a market is very immature, or very mature— a biopharma manufacturer might encounter significant challenges in either case. Being closer to the middle on the horizontal / X-axis is generally easier.
We’re all familiar with a number of disease areas that fall across this spectrum…
- On the low maturity side would be many rare disease areas, several genetic conditions, unknown viruses— such as Covid-19 back in early 2020!
- More mature markets would include CV / Metabolic, Diabetes, RA, Antipsychotics, etc.
- Disease areas that are generally in more of that sweet spot include much of Oncology, Neurology, Immunology, Opthalmology, Infectious Disease, etc.
- Not surprisingly, this is where most of R&D spend in the sector is focused today.When considering brand or portfolio position, being above the illustrated line is really ideal.
Particularly above the line and in the blue zone is preferred. In this white paper, we focus on addressing pretty much EVERYTHING ELSE! With that, consider some scenarios.
S c e n a r i o # 1:
A pharma brand is late to market, and/or in a highly competitive space...
a. Also, with little to no profile distinction
b. Let’s go above brand—say these are portfolio concerns
When late to a competitive market—as suggested, to differentiate it’s really about finding your niche... You need to know your strengths and how to use them!
• Whether that be data-based, biomarker, patient subgroup, standard of care head-to-head, etc.
• Via dosing / administration, QoL measures, etc. (if not better on efficacy / safety profile).
• Via execution by reaching the right stakeholders better—those important ones that are missed, or otherwise not being targeted effectively.
• Through DTC, digital, patient support services (PSP), other channels.
• Considering regional payers / formulary positioning, key prescribing HCPs that more often switch / cycle Rx, etc.
• Via pricing by strategically figuring out the right entry point.
• If you price strategically, the leaders won’t drop immediately, and you can earn your place on formulary and in market share.
• Or via stakeholder positioning and knowing WHO to target and with WHAT message.
• Even without specific data, you can still identify a profile you want your brand to resonate with and market to… if they’re important and not effectively targeted by others, it’s yours to win.
... these are all ways you can still win
Scenario #1: (continued)
a. With little to no profile distinction…
Sotagliflozin team found a place… all other studies were outpatient, so they moved to an inpatient setting.”—Pablo Lapuerta
You have to consider corporate strength, disease area leadership (TL relationships, your FF, portfolio). Can these things help?
- You might want to consider alternative indications, combinations, or market entry strategy.
- Sometimes it is worthwhile to look outside of your category or even industry for inspiration!
- How does Hershey’s do it, in the land of chocolate bars, for example…?
- Nonetheless, even with all of this—sometimes you’ve got a dog. You have to realize when you’re better off cutting your losses and selling, perhaps to someone better positioned to find value from it.
b. If these are portfolio or corporate considerations…
S c e n a r i o # 2 :
Think you’ve got something special in terms of an asset, but not sure yet!
This is a situation where you really need next level research and analysis to identify where to invest.
- Look for key stakeholder perspectives—ad boards, and other PMR are all fair game.
- Build a valuation model and evaluate it—consider the forecast, cost of investment, PTRS, etc.
- Set thresholds and consider metrics to help inform go / no-go, invest more or less, etc.
This is clearly an area where competitive intelligence becomes key—particularly to understand “how your brand stands out” at a granular level
Also, always be aware of brand team-bias—things aren’t always as amazing externally, or with PTRS, etc. as they might seem internally. Inform your hypotheses and make decisions objectively. When late to a competitive market—as suggested, to differentiate, it is about finding your niche. You need to know your strengths and how to use them.
S c e n a r i o # 3 :
Facing competition with more novel MOAs...
a. Say you’re already in market
b. Now let’s say you enter after them
Novel means less precedence, and therefore it’s more speculative and risky—leverage that! It also might mean more expensive—draw attention to that.
Similar to any product category, it’s your narrative. Own it. Tell the story you want people to know—about the problem, your brand, the novel competitor. Don’t let the novel entrant own the story—preempt it ideally
Draw that category map for key stakeholders...tell them where your brand fits, and how they should consider using the more novel MOA.
Finally, better execution can go a long way—contracting, patient assistance group engagement, TL relationships and patient services can all make a difference.
Let’s now consider a less mature market where you’re entering
a market that is underdeveloped, or even unknown.
It’s pretty much all about market building... disease awareness, symptom characterization, finding and partnering with patients and PAGs, finding TLs / mapping them / forming relationships, HCP and payer education, diagnostic establishment, etc.
Limited commercial dollars or infrastructure to rival competitors
a. You say it’s an Alliance brand…?
There are a few things to consider when commercial dollars / infrastructure is tight:
- You’ve got to optimize spending on what will really move the needle.
- Running an eNPV model on commercial / clinical options and looking at sensitivity analysis (like a tornado chart) can help you identify the highest ROI initiatives.
- Figure out your strengths and how you can amplify those despite less resources.
- Consider analogues that have won in similar circumstances... what did they do?
- Of course—partnering is clearly an option to consider here! Make it worth their while…
- Upfront milestones can cover nearly all downside risk... regulatory milestones then restore upside potential.
For an Alliance brand—ensure CLEAR alliance roles and communication / alignment checkpoints on the regular. KPIs should also be evaluated VERY regularly at senior levels... over-communicating is your friend in this instance.
Only so much money to spend, and want to maximize return on investment:
When you want to maximize ROI on the dollar:
- It’s worth considering ROI benchmarks on different marketing and promo tactics.
- PTRS (probability of technical and regulatory success) benchmarks of course too.
- One useful method for this is quantifying eNPV (expected net present value) of options, and plotting that out on a probability vs NPV distribution.
- If you consider this at the portfolio level, you can really pinpoint whether you should invest in the asset or in other areas of the portfolio based on eROI. Is eROI of the portfolio better with or without this asset?
- Analogues are worthwhile to consider here again—particularly with regards to forecast impact and
- Finally, that sensitivity analysis again can pinpoint what will drive the most value. Assess the big drivers from a tornado chart, for example, and invest there!