Biotech Disease and Market Assessments: Why Early Action is Crucial for Early Stage Biotechs

As an Early Stage Biotech executive, your focus is often consumed by scientific research, preclinical data, and the pursuit of new therapies. Your time is heavily invested in research parameters, securing funding, and navigating early-stage drug development as your next step is to enter the clinic. Commercialization may seem distant, a task for "later," once the science and clinical data is solid.

But what if your science and clinical trial design requires input from this "later" task?

AI-Powered: Disease and Market Landscapes, TPP Analysis, Patient Journey & Forecasts Starting at $425

Early-stage actions shape your biotech's success, including crafting a strong commercial narrative that addresses market needs. This narrative attracts early investors by demonstrating a clear path to market and exits, vital for discerning venture capitalists and in a period of declining non-dilutive funding.

Have you started to articulate this path? Even if you are not launching your innovation, do you know the landscape it will be entering?

Early commercial planning isn't premature marketing. It's about gaining market understanding now. Who are your competitors? What specific unmet needs are you addressing? What is your drug's unique value, as a solution for patients and the healthcare system? Have you answered these questions?

Early planning means identifying key stakeholders: physicians, pharmacists, payers, and regulatory bodies. Building relationships and gathering insights early shapes your commercial strategy.

Are you engaging with these stakeholders, even indirectly, to understand their perspectives?

Ultimately, early commercial assessment guides decisions on which products bring the most value under high uncertainty. It anticipates roadblocks, informs strategic choices, and provides evidence for future transactions and funding. Can you navigate this complex journey without that guidance?

The Benefits of Early Market Analysis

Ignoring the market during the early stages is like building a ship without knowing the waters. Early market analysis offers significant benefits:

• Understanding the Competition: Who else will be treating the same patients? Are they ahead or behind your timeline?

• Defining Your Target Patient Population: What are their needs, demographics, and treatment journeys? Are you connected to the realities of your target patients?

• Anticipating Barriers to Market Entry: What prescribing hurdles, payer skepticism or adoption challenges might your lead candidate face? Are you proactively strategizing around obstacles?

Are you considering payer perspectives in your studies?

Early market understanding helps anticipate payer responses. Developing a strong value proposition for reimbursement requires understanding their priorities and potentially tailoring clinical trial designs.

Researching the future market is critical. Early insights help prioritize resources and maximize impact and revenue. While disruptions occur, early knowledge allows for effective pivots.

Are you looking beyond your current lead candidate to understand the future market?

Early market insights help guide research, development, and licensing. Early knowledge facilitates adaptation to market changes.

How Early Commercial Insights Inform Critical Decisions

Early commercial opportunity assessment informs today's decisions. As you build your biotech venture, envision the entire journey and destination, even if it involves a strategic alliance or exit.

AI-Powered: Disease and Market Landscapes, TPP Analysis, Patient Journey & Forecasts Starting at $425

What key commercial considerations should shape your business decisions now?

• For the Translational Scientist: How does market understanding inform your Target Product Profile (TPP)? Failing to understand the competitive landscape early can hinder patient recruitment, or even worse, the indication you were targeting no longer has a high unmet need.

• For the Startup Founder: What is the depth and defensibility of your commercial opportunity? Investors want a clear understanding of your target segment and unique approach. This helps prove that you have cognitive diversity.

• For the Biotech Executive: How do early commercial considerations influence your company strategy regarding partnering, licensing, or acquisition? If you lack a forecast, investors will likely question your timelines. This uncertainty may lead to undervalue your company or extend their expected timeline, ultimately diminishing your attractiveness.

What key commercial considerations should shape your clinical decisions ?

Early commercial opportunity assessment should influence your Phase 1 go/no-go decision. Even at the pre-IND or preclinical stage, ask:

• Have we assessed the disease area strategic opportunity and recommended target indications/patient populations, considering the competitive landscape and unmet needs?

• Have we performed initial market and competitive evaluations to identify potential challenges in recruitment given the existing and emerging therapies?

• Has our preliminary demand forecast identified any potential manufacturing constraints that could impede timely trials or limit market share uptake?

Lastly, ignoring the commercial landscape now doesn't make it disappear. It means navigating without a vital map, potentially undervaluing assets or missing opportunities. Start charting your course with the destination in mind.

How Can We Partner?

Our deep understanding of funding and commercialization in drug development comes from direct, hands-on experience, and with TheraAIsight, our AI-powered tool, we build custom disease and market landscapes, patient journeys, Target Product Profiles, and revenue forecasts faster and more affordably than any of our competitors. Embark on your journey of discovery into the disease and market landscapes early – without the burden of substantial financial investment.

Additionally, our partnership with SerGene Biosciences expands our offering with risk-adjusted net present value (rNPV) assessments, equipping early-stage biotech companies for funding or licensing. Early rNPV assessment strengthens licensing negotiations and partnership discussions. It mitigates risks, optimizes resource allocation, streamlines development, and facilitates informed decisions.

When is Commercial Assessment and rNPV Analysis Necessary?

You need it if you can't answer these questions:

1. Market Potential

   • What is the patient population size?

   • What is the potential market share?

   • What is an appropriate price point?

2. Development Costs and Timelines

   • What are the development costs?

   • What are the clinical development timelines?

   • What is the probability of success at each stage?

3. Financial Viability

   • What are the projected future cash flows?

   • What is the rNPV?

   • Does the rNPV justify the investment?

4. Strategic Considerations

   • How does the treatment fit in the current and future market?

   • Are there partnership or licensing opportunities?

   • How does this drug compare to alternative investments?

Early commercial insights are essential for biotech ventures to navigate the market and achieve success. Don't risk building a product without understanding the market; proactively chart your course and ensure your voyage leads to success.

Ready to navigate the complexities of biotech commercialization with a clear course? Contact us today!

References:

1. Viscadia. Optimizing Early-Stage Commercial Assessments. Viscadia. https://viscadia.com/wp-content/uploads/2024/09/Viscadia_Whitepaper_Optimising-Early-Stage-Commercial-Assessments.pdf    

2. Syneos Health. Accelerating Biotech Success: Early-Stage Development Strategies to Secure Funding. Syneos Health. https://www.syneoshealth.com/insights-hub/accelerating-biotech-success-early-stage-development-strategies-secure-funding    

3. P360 The Importance of Early Commercialization Planning for Pharmaceutical Startups. P360. https://www.p360.com/newsroom/early-commercialization-pharma-startups/    

4. Forbes Business Council. (2024, June 25). The Importance Of Early Commercialization Planning For Pharmaceutical Startups. Forbes. https://www.forbes.com/councils/forbesbusinesscouncil/2024/06/25/the-importance-of-early-commercialization-planning-for-pharmaceutical-startups/    

5. Hinton II, B., & Humphries, C. (n.d.). Key Benefits of Early Market Access Planning. MMIT. https://www.mmitnetwork.com/thought-leadership/key-benefits-early-market-access-planning/

6. The Lean startup. (2011) ISBN: 0307887898 Wikipedia (https://en.wikipedia.org/wiki/The_Lean_Startup)

7. Svennebring and Wikberg. (2013). Net present value approaches for drug discovery. SpringerPlus. (2) 140. https://doi.org/10.1186/2193-1801-2-140