The Rise of Pharmacodiagnostics in the $10 Billion Global Cancer Diagnostics Market
Pharmacodiagnostics is swiftly emerging as a vital player in the global cancer diagnostics market, which soared to nearly $10 billion in revenue in 2024, according to Kalorama Information’s recent report, The World Market for Cancer Diagnostics, 2024-2029. This dynamic sub-segment is experiencing rapid growth, fueled by the increasing affordability of next-generation sequencing (NGS), which offers profound genetic insights into cancers.
The introduction of targeted and cytotoxic cancer drugs, along with efforts to enhance the efficacy and manage the costs of oncological therapies, is fueling the rise of pharmacogenetic testing. Advances in liquid biopsy techniques are also contributing to this growth by making it easier to extract tumor cells.
Pharmacodiagnostic products include predictive tests that determine whether a patient is likely to respond to a specific therapy. Although the development of molecular tests for personalized cancer treatment is still in its early stages, each cancer’s unique genomic aberration pattern offers distinct prognostic and therapeutic insights. Researchers are exploring the potential of next-generation DNA sequencing to gain a deeper genetic understanding of tumor activities, which could lead to more effective cancer diagnostics.
Several pharmacogenetic (PGx) tests have already been developed. For instance, mutations in the KRAS gene can distinguish between patients who will respond to anti-epidermal growth factor receptor (EGFR) monoclonal antibodies and those who will not. This significant finding, introduced in 2008, was quickly recognized by oncologists, professional groups, and regulatory agencies. The American Society of Clinical Oncology issued a Clinical Provisional Opinion recommending the use of the KRAS biomarker to select appropriate cancer patients for anti-EGFR antibody therapy.
The first cancer marker to receive prescribing information was the EGFR class of antibodies, including Amgen’s Vectibix (panitumumab) and ImClone’s Erbitux (cetuximab). The prescribing information for these drugs was updated to include gene mutation details, specifically advising against their use in colorectal cancer patients with these mutations. As a result, the demand for KRAS testing has surged, leading to the launch of nearly 20 KRAS/EGFR in vitro diagnostic (IVD) kits and services.
In addition to EGFR, other genetic biomarkers are now routinely tested in molecular pharmacodiagnostics. These include ALK for non-small cell lung cancer therapy, HER2 for breast cancer therapy, and BCR/ABL for monitoring chronic myelogenous leukemia (CML) and a type of acute lymphoblastic leukemia (ALL).
Cancer companion diagnostics is paving the way for similar developments in other medical fields. Nearly one-third of drugs in clinical development are associated with some form of genomic or proteomic marker. Between 25-40 percent of oncology trials incorporate defined biomarkers, and approximately 75 percent of licensing and partnership deals focus on oncology.
As we look ahead, pharmacodiagnostics stands ready to transform the global cancer diagnostics landscape, with Kalorama Information predicting significant growth in the coming years. As mentioned, the affordability of next-generation sequencing (NGS) and advancements in liquid biopsy techniques are key drivers, offering profound genetic insights and more precise cancer diagnostics. The rise of pharmacogenetic tests, such as those targeting KRAS and EGFR mutations, underscores the promise of personalized cancer treatments. With the routine testing of more genetic biomarkers, pharmacodiagnostics is set to lead the charge in delivering tailored and effective cancer therapies, enhancing patient outcomes worldwide. The future of cancer diagnostics is indeed promising, with pharmacodiagnostics spearheading this exciting evolution.
For more information, purchase, The World Market for Cancer Diagnostics, 2024-2029.
About the Report
Kalorama Information’s The World Market for Cancer Diagnostics, 2024-2029 delivers an authoritative and comprehensive analysis of the global cancer in vitro diagnostics (IVD) market, including industry-defining trends, market sizing, and growth opportunities.
This report offers an in-depth review of the cancer IVD market, including expert insights into significant segment markets:
- Oncology molecular assays (including companion diagnostics)
- Molecular screening for colorectal cancer
- Immunohistochemistry (IHC)
- Tumor marker immunoassays
- In situ hybridization (ISH/FISH)
- Human papillomavirus (HPV) tests
- Circulating tumor cell (CTC) assays
While focusing on these pivotal categories, the report provides limited coverage of imaging, hematology, clinical chemistry, flow cytometry, Pap smears, and traditional stains. Key developments, product launches, and regulatory announcements that shape the cancer IVD market are analyzed, along with forecasts for market growth from 2024 to 2029.