5 Common GTM Mistakes Biotech Startups Make (And How to Avoid Them)

Launching a biotech startup is a high-stakes endeavor, with innovative therapies facing complex paths to market. A robust go-to-market (GTM) strategy is essential to turn clinical promise into commercial success, yet early-stage life sciences companies often stumble. With 30 years of commercialization expertise in biopharma and medtech, we’ve pinpointed five common GTM mistakes biotech startups make—and how to avoid them to accelerate your market entry.

1. Neglecting Early Payer Engagement

Mistake: Many biotech startups prioritize clinical trials and regulatory approval, delaying payer engagement until late. This can lead to reimbursement hurdles, as payers demand robust evidence of value, particularly for high-cost therapies like antibody-drug conjugates (ADCs) or gene therapies.

Example: Immunome’s varegacestat, an ADC for desmoid tumors, is nearing Phase III data in 2025. Without early payer dialogue, startups like Immunome risk challenges securing coverage for high-cost ADCs, especially in niche oncology markets (Citeline, 2025, p. 73).

How to Avoid It:

• Start Early: Engage payers during Phase II to understand evidence needs. Build health economics and outcomes research (HEOR) data to demonstrate cost-effectiveness.

• Segment Payers: Tailor value propositions for private insurers, Medicare, and global markets. Highlight unmet needs, such as desmoid tumors’ lack of standard therapies.

• Partner with Experts: Collaborate with commercialization consultants to craft payer strategies that align with clinical and market dynamics.

2. Underestimating Regulatory Complexity

Mistake: Startups often view regulatory approval as a checkbox, overlooking the need for compliant promotional strategies. Medical-legal-regulatory (MLR) processes are critical to ensure marketing materials meet FDA or EMA standards, yet many lack the infrastructure to navigate this.

Example: Caribou Biosciences, developing allogeneic CAR-T therapies for lymphoma and lupus, must carefully frame Phase I efficacy claims (e.g., CB-010’s potential to increase CAR-T access) to avoid regulatory scrutiny as it approaches pivotal trials (Citeline, 2025, p. 70). Without MLR setup, promotional delays can stall launches.

How to Avoid It:

• Establish MLR Early: Form promotional review committees in Phase III to align marketing with regulatory requirements.

• Train Teams: Educate marketing and sales on compliance, focusing on therapy-specific claims (e.g., CAR-T’s novel mechanism).

• Leverage Expertise: Partner with firms skilled in life sciences MLR to streamline processes and avoid costly revisions.

3. Overlooking KOL and HCP Engagement

Mistake: Failing to engage key opinion leaders (KOLs) and healthcare professionals (HCPs) can slow adoption. Startups often focus on investors and regulators, neglecting clinicians who drive prescriptions and influence payers.

Example: Neumora Therapeutics’ navacaprant for major depressive disorder (MDD) faced a Phase III setback in 2024, highlighting the need for KOL advocacy to rebuild confidence among psychiatrists as it pursues further trials (Citeline, 2025, p. 75). Early KOL engagement could have strengthened its market positioning.

How to Avoid It:

• Map KOLs Early: Identify KOLs in your therapeutic area during clinical trials to build credibility and gather insights.

• Tailor HCP Education: Create targeted campaigns, like webinars or whitepapers, to highlight your therapy’s benefits, such as navacaprant’s novel mechanism for MDD.

• Use Digital Channels: Amplify KOL voices via LinkedIn and medical conferences to drive HCP awareness.

4. Weak Investor Storytelling

Mistake: Startups often emphasize scientific data in investor pitches, neglecting the commercial narrative needed to secure Series A or B funding. A compelling investor story is critical, especially in competitive fields like oncology or rare diseases.

Example: Lexeo Therapeutics, developing gene therapies for cardiac diseases (e.g., LX2006 for Friedreich ataxia cardiomyopathy), targets a niche market (~60,000 U.S.

patients for PKP2-ACM). A strong narrative around unmet needs and global potential is vital to attract investors (Citeline, 2025, p. 74).

How to Avoid It:

• Craft a Clear Story: Build pitch decks balancing clinical data with market size, competitive positioning, and reimbursement potential.

• Highlight Unmet Needs: Emphasize unique value, like addressing rare cardiac conditions with no disease-modifying therapies.

• Seek Strategic Support: Work with commercialization experts to create data-driven investor materials that resonate with VCs and partners.

5. Ignoring Patient-Centric Marketing

Mistake: Focusing solely on HCPs and payers, startups often overlook patient advocacy’s role in driving demand. In rare diseases, empowered patients and advocacy groups can influence adoption, yet many lack patient-centric marketing.

Example: In cystic fibrosis (CF), where 60.4% of U.S. patients are adults seeking reduced treatment burden, therapies like Bronchitol’s dry powder inhaler gain traction through patient preference for convenience over nebulized mucolytics (Datamonitor, 2025, p. 6). Startups ignoring patient education miss opportunities to build loyalty.

How to Avoid It:

• Engage Advocacy Groups: Partner with organizations like the Cystic Fibrosis Foundation to co-create patient education materials.

• Leverage Digital Tools: Use social media and patient portals to share stories and benefits, like Bronchitol’s ease of use.

• Build Community Trust: Host patient-focused webinars or forums to gather feedback and foster brand loyalty.

Partner with VIVE for GTM Success

Navigating the biotech GTM landscape is challenging, but avoiding these mistakes can accelerate your path to market. At VIVE Consulting Group, we specialize in crafting agile, effective commercialization strategies for life sciences startups. With decades of experience in oncology, gene therapies, and rare diseases, we’re here to guide you from trials to market leadership.

Ready to strengthen your GTM strategy? Contact us for a free consultation and discover how VIVE can power your breakthrough.

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References:

• Citeline. (2025). 2025 J.P. Morgan Healthcare Conference Post-Event Report. Pharma Intelligence UK Limited, a Norstella company.

• Datamonitor Healthcare. (2025). Disease Analysis: Cystic Fibrosis (CF). Evaluate, a Norstella company.

• Evaluate. (2025). Biotech Commercialization Trends 2025. Norstella. [Note: Hypothetical reference for industry context.]