Cancer diagnostics market on track for $215B by 2035

For years, cancer diagnostics were seen as routine steps in care, while treatment decisions drew the spotlight. Mounting evidence that earlier detection can save lives is now pushing diagnostics into a central role.

Genetic sequencing, AI-enhanced imaging, and blood-based assays are fueling this shift. These tools don’t just catch cancers earlier; they guide treatment choices, track disease progression, and tailor therapies over time to embed diagnostics at the core of precision medicine.

The market surrounding these advances is following suit. The global cancer diagnostics sector is projected to nearly double, reaching $215 billion by 2035, according to Vantage Market Research. That growth brings challenges as well as promise, pressing health systems to manage surging volumes of complex data, fold digital tools into already-strained workflows, and ensure that new tests deliver measurable improvements for patients.

Diagnostics step into the spotlight

Several structural factors are shaping the trajectory of the cancer diagnostics market. Cancer incidence is climbing globally, particularly as populations age, which means more patients are entering care pathways and creating higher demand for both initial screening and follow-up tests. At the same time, technological momentum is fueling innovation. Deep learning models are increasingly applied to pathology slides and imaging, improving both speed and accuracy, while multiparametric imaging and molecular assays allow clinicians to classify tumors more precisely and align treatments with individual patient profiles.

Another key factor is the growing shift toward less invasive testing. Liquid biopsies, which detect fragments of tumor DNA circulating in the blood, are among the fastest-growing areas. Easier to administer than traditional biopsies, they hold the promise of earlier detection and real-time monitoring of how tumors evolve, with companies like Guardant Health and Grail pushing development forward.

Policy and reimbursement trends are also adding momentum. Governments are investing in screening initiatives, and payers are increasingly supportive of early detection as a way to curb downstream costs. In lower-resource regions, there are efforts to design affordable diagnostic tools that could broaden access and create impact even where healthcare infrastructure is limited.

A rising tide lifts all risks

The rapid growth of cancer diagnostics also raises hurdles that reach beyond the lab:

Evidence and validation. Many emerging tests still need proof that they improve survival or quality of life. Regulators and insurers are demanding clinical utility data, not just analytical accuracy.

Access and cost. Advanced diagnostics are expensive and often concentrated in high-income settings. Ensuring equitable access across geographies is a persistent challenge.

Regulatory complexity. Oversight varies widely across markets. In the U.S., for example, diagnostic tests can fall under different regulatory frameworks depending on how they are developed, slowing adoption and complicating commercialization.

Data and interoperability. New diagnostic platforms generate enormous amounts of digital data. Without interoperability between EHRs, lab systems, and imaging platforms, the insights can remain siloed. Ensuring that diagnostic information flows smoothly into clinical decision-making is an ongoing obstacle.

Cybersecurity risks. Diagnostics data has become a prime target for cyberattacks, with healthcare already the most frequently breached critical infrastructure sector. The growth of connected diagnostic tools could widen vulnerabilities.

All forecasts indicate sunny skies

Vantage’s projection of a 6.35 percent annual growth rate is relatively conservative. Roots Analysis has forecast growth closer to 10 percent annually, while other firms fall somewhere in between. Grand View Research, for instance, estimates 6.14 percent growth through 2030, with the U.S. market alone reaching nearly $60 billion by that year.

These differences reflect uncertainty around adoption rates, reimbursement policies, and the pace of technological change. But across forecasts, the trend line is clear: diagnostics are expanding, and their influence on oncology is deepening.

How to become indispensable

If cancer diagnostics grow to the scale analysts predict, the implications for healthcare are significant. Diagnostics would no longer be secondary to therapies but a defining force in oncology care, shaping clinical decisions, reimbursement strategies, and research priorities.

For patients, better cancer diagnostics promise earlier detection, more precise treatment choices, and more effective monitoring. For health systems, they hold out the possibility of lower costs by avoiding late-stage interventions. Investors and companies are responding as well. Qiagen has publicly identified diagnostics as central to its future growth, while Grail is betting heavily on multi-cancer blood testing.

Integration is the key in cancer diagnostics market

Forecasting markets a decade ahead is inherently uncertain, but the broad trajectory for cancer diagnostics is unmistakable. Whether the market lands at $215 billion or higher, diagnostics are poised to become a defining feature of oncology, not just an adjunct to treatment.

The challenge will be ensuring that growth in tests translates into growth in outcomes. That means proving clinical value, securing equitable access, and building the digital infrastructure to support diagnostics at scale.

In that sense, the future of cancer diagnostics is not just a story about new tests, but about how health systems integrate those tests into care. The next decade will show whether diagnostics can move from promise to practice in reshaping the fight against cancer.