The pharmacogenomics (PGx) market is heating up, with new entrants popping up around the globe—especially in North America, Europe, and parts of Africa and Asia. PGx testing is no longer just a research tool. It’s becoming a cornerstone of personalized medicine in oncology, psychiatry, cardiology, and primary care.
But there’s a catch.
The path to clinical market penetration is murky, highly regulated, and full of choices that can make or break a PGx Startups. One of the biggest strategic dilemmas new PGx companies face is this:
Should we build our own testing infrastructure and go solo, or should we partner with established labs, platform providers, or health systems?
This blog unpacks the pros, cons, and context behind each strategy—helping new PGx startups make informed, evidence-based decisions.
Understanding the unique challenges faced by PGx Startups is crucial for navigating this complex landscape.
Key Takeaways:
- If your strength is scientific innovation and you have strong funding—build.
- If you’re great at clinical integration or consulting—partner.
- If your edge is software and service design—license and scale.
What Are PGx Startups Up Against?
Before making a strategic decision, it’s critical to understand the current landscape.
- Market Size & Growth: The global pharmacogenomics market is projected to grow at a CAGR of 8.6%, reaching $7.6 billion by 2030 (Grand View Research, 2023).
- Payer Pressure: Reimbursement remains patchy. CMS in the US covers PGx testing under specific conditions, but private payer adoption varies.
- Clinical Demand: Over 90% of patients carry at least one actionable pharmacogenomic variant, yet fewer than 20% of providers know how to use PGx in practice.
- Regulatory Complexity: CLIA, CAP, FDA, HIPAA—all must be navigated if you want to go clinical.
This means most startups entering the space are not just selling a test. They’re building systems for education, interpretation, payer negotiation, and clinical integration.
Option 1: Build Your Own Lab, Platform, and Services (Go Solo)
Pros:
- Full Control: From assay design to data analytics to clinical reporting, you’re in charge.
- Stronger IP Ownership: A proprietary platform can increase your valuation and differentiation.
- Vertical Integration: Capture more value across the testing chain (collection, analysis, reporting, interpretation).
Cons:
- High Burn Rate: Establishing a CAP/CLIA-certified lab can cost $1–3 million upfront, not including staff or licensing.
- Longer Time to Market: Building infrastructure delays entry and revenue.
- Compliance Burden: Solo startups bear the full weight of regulatory audits, quality assurance, and HIPAA compliance.
Ideal If:
- You have access to deep capital, seasoned lab operations leadership, and plan to sell directly to physicians or employers.
Option 2: Partner with an Existing Laboratory or Platform Provider
Many PGx startups have succeeded by leveraging what others have already built. Think of RxOptimization working alongside existing labs or Corriel Life Sciences helping clients launch branded PGx programs without building infrastructure from scratch.
Pros:
- Faster Launch: Leverage existing CLIA/CAP labs and go to market quickly.
- Shared Risk: Partners help shoulder regulatory and operational burdens.
- Network Access: Established labs often have payer, provider, or health system relationships.
Cons:
- Revenue Sharing: Margins may be thinner due to partnership splits.
- Less Control: You depend on the partner for test quality, TAT, and compliance.
- Brand Dilution: You may be one of many under a larger lab’s umbrella.
Ideal If:
- You have a strong go-to-market strategy (e.g., provider education or payer alignment), but lack the infrastructure or capital to build a lab.
Option 3: License Tests or White-Label an Existing PGx Platform
Rather than building or partnering with a lab, some startups take a software-first approach—licensing a validated PGx panel or interpretation engine and focusing on delivery.
Pros:
- Capital Efficient: No need for wet-lab setup.
- Focus on Differentiation: Build services around UI/UX, education, payer strategy, or integration into EHRs.
- Scalable: You can serve clients across geographies without logistical complexity.
Cons:
- Limited IP: Your valuation may depend more on distribution than innovation.
- Dependency Risk: Licensing terms may change or expire.
- Need Strong Differentiator: You must still carve out a clear niche.
Ideal If:
- You aim to become a PGx SaaS company or are focused on digital health integration, not wet-lab operations.
What Are Other Startups Doing?
Let’s look at real-world examples from the PGx space:
| Startup | Strategy | Notes |
| UGenome AI | Build + AI Platform | Built their own genomic platform and personalized reference genome tech |
| Peregrine WORx | SaaS + Subscription Model | Offers wellness subscriptions with PGx insights—white-labeled testing |
| RxOptimization | Partner with Labs | Pharmacist-led consulting using external test results |
| Telos PGx | Direct + Partnership Mix | Focuses on senior care, partners with care networks and labs |
| Corriel Life Sciences | Enable Others to Build | Helps others launch branded PGx programs with existing infrastructure |
Questions Every PGx Startup Should Ask Before Choosing
- What is our core strength? (Science, software, distribution, education?)
- How much capital do we have—or can we raise?
- Do we want to serve patients directly or through providers/payers?
- How fast do we need to go to market to gain traction or show ROI?
- How important is owning the IP and infrastructure long-term?
Final Thoughts
The best approach depends on your capital, competencies, timeline, and target market. Some of the most successful PGx startups started lean with partnerships and later built their own infrastructure. Others focused entirely on software and integration without ever touching a test tube.
In 2025 and beyond, the winning PGx companies will be those that know when to build, borrow, or buy—and how to adapt as the market evolves.
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