Precision Medicine: Who Captures the Value?

Precision medicine is moving from clinical promise to commercial reality.

Genomic sequencing, companion diagnostics, blood-based biomarkers, engineered cell therapies and personalised vaccines are making drug development more selective and more dependent on identifying the right patient groups.

The greater challenge is turning more precise targeting into treatments that can be paid for, delivered at scale and supported by evidence.

In this week’s Market Watch: Pharma, Biotech & Healthcare, we examine how precision medicine is reshaping drug development, strategy and market access.

Visiongain Top Takeaways

Biomarker testing is becoming a market-access gatekeeper, not a late-stage clinical add-on.
Precision medicine is shifting value beyond the molecule, towards diagnostics, evidence, delivery and reimbursement.
Cell and gene therapies will be judged as much on manufacturing capacity, logistics and payment models as on clinical promise.
Personalised vaccines are moving vaccine economics closer to patient-specific advanced therapy supply chains.
Advantage will sit with companies that can connect patient selection, treatment delivery and outcomes evidence into a reimbursable model.

Precision Oncology: Biomarkers Move to the Centre of the Market

Oncology is where precision medicine has moved furthest from scientific promise into market reality.

Therapy selection is increasingly guided by companion diagnostics, next-generation sequencing and liquid biopsy. The question is no longer only where the cancer is found, but which mutation, receptor status or immune marker is driving it.

The outcome is not simply more testing. Better patient selection can mean fewer trial-and-error prescriptions, stronger response rates, more targeted use of premium therapies and a clearer reimbursement case.

Regulators are moving in the same direction. Biomarker-defined patient groups are now embedded in many oncology approval pathways. Even a strong oncology asset can underperform if the testing pathway is slow, inconsistently reimbursed or poorly embedded in routine care.

Visiongain Insight: In precision oncology, the value of a therapy increasingly depends on the testing pathway around it. Companion diagnostics are becoming central to access, formulary positioning and clinical differentiation.

Cell & Gene Therapy: One-Time Treatment, Long-Term Value

Cell and gene therapy takes precision medicine from patient selection into patient-specific treatment.

CAR-T and TCR-engineered therapies use a patient’s own cells, or matched donor material, to create a tailored therapeutic product. Gene therapies aim to replace, silence or modify defective genes.

The business model is harder than the clinical promise suggests: fewer repeat prescriptions, higher upfront costs and a greater dependence on durable outcomes evidence.

Visiongain’s Cell & Gene Therapy Market Report projects the global market to grow from US$25.78bn in 2026 to US$126.86bn by 2036, at a CAGR of 17.3%.

The category is expanding beyond its original oncology and haematology base. CRISPR-edited therapies for sickle cell disease, TCR therapies for solid-tumour sarcomas and AAV-based gene therapies for inherited disorders have widened the precedent for high-value, single-administration treatment.

Scale remains the constraint. Manufacturing capacity, cold-chain reliability, quality control, vein-to-vein turnaround times, outcomes-based payment models and specialist treatment infrastructure will determine how quickly these therapies move into broader clinical use.

That creates opportunity beyond therapy sponsors, particularly for CDMOs, logistics providers and specialist manufacturing platforms that can reduce cost, complexity and turnaround time.

Visiongain Insight: Cell and gene therapy will be judged as much on delivery, capacity and payment design as on clinical promise. Curative intent will not be enough unless companies can prove durable value and make treatment workable for payers and health systems.

Alzheimer’s Biomarkers: Diagnosis Becomes the Market Gatekeeper

Alzheimer’s diagnosis is moving from cognitive assessment towards molecular confirmation.

As disease-modifying therapies enter the market, identifying the right patient at the right stage has become a clinical and market-access necessity. Blood-based biomarkers, including p-tau217 and beta-amyloid ratios, are moving into the diagnostic pathway and could reduce reliance on costly PET imaging and invasive cerebrospinal fluid testing.

Companies including Fujirebio and C2N Diagnostics are helping to build a market where molecular evidence supports earlier diagnosis, treatment eligibility and patient monitoring.

This matters because anti-amyloid therapies depend on patient selection. Treat too late and the clinical value may be limited. Treat the wrong population and payers will challenge the cost.

Visiongain’s Alzheimer’s Therapeutics Market Report 2026-2036 tracks how disease-modifying therapies and biomarker-led patient selection are becoming increasingly linked.

Visiongain Insight: Alzheimer’s diagnostics are becoming central to anti-amyloid market access. Drug uptake will depend on whether health systems can identify eligible patients quickly, credibly and at a cost payers will support.

Personalised Vaccines: From Population Protection to Patient-Specific Immunity

Vaccines have historically meant broad protection, manufactured at scale. Personalised cancer vaccines move that model closer to patient-specific therapy.

mRNA platforms allow vaccines to be designed around tumour neoantigens, with candidates being developed in melanoma and other solid tumours. Moderna and Merck’s intismeran autogene programme, in combination with Keytruda, remains the most visible example, while BioNTech is also advancing a broad oncology pipeline.

Visiongain’s mRNA Vaccines Market Report 2026-2036 forecasts the global market to grow from US$9.7bn in 2026 to US$34.7bn by 2036, at a CAGR of 13.6%, driven by an expanding pipeline of clinical candidates and platform partnerships.

The investment case is not settled. Larger confirmatory data, reimbursement and manufacturing scale will determine whether these products can move beyond compelling science into repeatable treatment models.

The operational test is demanding: tumour profiling, antigen selection, manufacturing, quality control and delivery all need to happen within clinically relevant timeframes. That makes the economics closer to cell therapy than traditional immunisation.

Visiongain Insight: Personalised vaccines will be judged on the full biopsy-to-dose chain, not immunogenicity alone. Patient-specific manufacturing will need to be fast, reliable and reimbursable.

Rare Disease Therapies: Small Populations, Larger Stakes

Rare disease was once a difficult fit for large pharma: small patient populations, fragmented diagnosis, high development costs and uncertain returns.

Gene therapy, enzyme replacement therapy, targeted biologics and orphan drug incentives have changed the calculation. Patient populations may be small by condition, but collectively they represent a large unmet need.

The World Health Organization estimates that rare diseases affect more than 300 million people globally across roughly 7,000 identified conditions. Most still have no approved treatment.

Visiongain’s Rare Diseases Market Report forecasts strong revenue growth through to 2034, driven by an expanding pipeline of gene therapies, enzyme replacement therapies and targeted biologics.

Regulatory incentives have helped move rare disease into mainstream pharma strategy. In the U.S., the FDA’s Office of Orphan Products Development has granted more than 6,340 orphan drug designations since the programme began.

The opportunity is attractive: high unmet need, defined patient groups, regulatory support and potential pricing power. The constraint is harder: diagnosis remains slow, patient identification is difficult, and payers will expect durable evidence to support high-cost therapies in small populations.

Visiongain Insight: Rare disease has become a mainstream market-entry route, but orphan status is not enough. Value will depend on finding patients, proving durable benefit and defending access under growing pricing scrutiny.

Commercial Landscape: Precision Medicine Becomes the Operating Model

Across oncology, cell and gene therapy, Alzheimer’s biomarkers, personalised vaccines and rare disease, precision medicine is moving from scientific category to commercial infrastructure.

Visiongain forecasts the global precision medicine market to grow from more than US$150bn in 2025 to US$644.76bn by 2035, as targeted therapies, companion diagnostics and genomic sequencing move further into mainstream care.

Competitive advantage is shifting beyond the molecule towards the ability to integrate diagnostics, manufacturing, clinical evidence and reimbursement into a single commercial model. Biomarker strategy needs to start earlier, companion diagnostics must be available and reimbursed, and manufacturing must support more flexible, small-batch and patient-specific models.

Diagnostics companies such as Roche’s Foundation Medicine and Guardant Health show how genomic profiling and liquid biopsy are becoming part of the infrastructure around precision therapies. CDMOs such as Lonza are also moving closer to the value chain as advanced therapies require more specialist production and delivery.

Payers face a harder value equation: better-targeted treatment, but often higher upfront costs, longer evidence horizons and reimbursement models that do not fit conventional per-dose pricing. Outcomes-based contracts will matter more where companies can prove durable value.

Visiongain Insight: Precision medicine is shifting advantage to companies that can make testing, evidence, delivery and reimbursement work together. The therapy still matters, but the model around it is becoming harder to separate from the product itself.

Market Outlook: Value Moves Beyond the Molecule

Precision oncology, cell and gene therapy, Alzheimer’s biomarkers, personalised vaccines and rare disease all point to the same shift: the broad indication is losing ground to the molecularly defined patient subgroup as the basic unit of commercial strategy.

For payers and health systems, precision medicine offers the prospect of better-targeted spend, improved outcomes and fewer trial-and-error prescriptions. The risk is that many therapies bring high upfront costs, longer evidence horizons and reimbursement models that do not fit neatly into conventional pricing systems.

Visiongain Insight: In precision medicine, value is no longer created by the therapy alone. The next generation of pharmaceutical leaders will be those that can integrate diagnostics, treatment, evidence generation and reimbursement into scalable precision medicine ecosystems.

From Visiongain

Visiongain’s healthcare, pharma and biotech reports help organisations assess where precision medicine is creating value, where adoption barriers remain and which companies are best positioned as diagnostics, advanced therapies and patient selection reshape the market.

The following reports examine markets where targeted treatment, biomarker strategy, manufacturing complexity and market access are becoming central to market performance:

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