Breast cancer has become the most frequently diagnosed cancer in Vietnam, creating growing demand not only for treatment but also for accurate, specialised diagnostic services.
According to GLOBOCAN 2022, the country recorded an estimated 24,563 new breast cancer cases, representing approximately 13.6% of all newly diagnosed cancers. More recent GLOBOCAN 2024 estimates place the figure at 25,711 cases, confirming the substantial scale of Vietnam’s breast cancer burden.
However, the importance of breast cancer diagnostics extends beyond the number of patients.
Modern cancer treatment increasingly depends on understanding the biological characteristics of individual tumours. Identifying cancer cells under a microscope remains essential, but it is no longer sufficient to guide every treatment decision.
Pathologists must also assess biomarkers such as estrogen receptors (ER), progesterone receptors (PR), human epidermal growth factor receptor 2 (HER2), and, in selected settings, the proliferation marker Ki-67.
These findings help oncologists determine which treatments may be appropriate for individual patients.
For Vietnam’s pathology industry, this creates a significant development opportunity.
The value of cancer diagnostics is increasingly determined not simply by the ability to identify a tumour, but by the ability to produce reliable biological information that guides treatment.
A large Vietnamese study published in Annals of Oncology in 2024 illustrates why this distinction matters.
Breast Cancer Is Vietnam’s Most Frequently Diagnosed Cancer
The International Agency for Research on Cancer (IARC), part of the World Health Organization, estimated that Vietnam had approximately 180,480 new cancer cases in 2022.
Breast cancer accounted for 24,563 of those cases, ranking first among all cancer types by the estimated number of new diagnoses.
The same dataset estimated approximately 10,008 breast cancer deaths.
Updated GLOBOCAN 2024 estimates indicate 25,711 new breast cancer cases and 10,609 deaths in Vietnam.
These figures represent population-level estimates rather than a complete registry of individually confirmed cases. Differences between GLOBOCAN editions can also reflect changes in data sources and estimation methods, so they should not automatically be interpreted as a measured year-on-year growth rate.
Nevertheless, both datasets point to a substantial national disease burden.
That burden creates demand for a broad range of healthcare services, including imaging, tissue biopsy, surgery, systemic treatment, radiotherapy and follow-up care.
A critical component of this pathway is histopathology.
When a suspicious breast lesion is identified, tissue is commonly collected through a biopsy and examined by a pathologist.
The initial assessment establishes whether cancer is present and identifies important features of the tumour.
But for many patients, this represents only the first stage of diagnostic evaluation.
Further testing is necessary to identify molecular and protein characteristics that can influence treatment selection.
As a result, the demand for breast cancer pathology cannot be measured solely by counting the number of biopsies performed.
The increasing complexity of diagnostic evaluation is equally important.
Modern Breast Cancer Diagnosis Requires More Than Routine Histopathology
Traditional histopathology involves processing tissue samples, preparing microscope slides and examining cellular structures.
One of the standard techniques is hematoxylin and eosin staining, commonly known as H&E staining.
This allows pathologists to evaluate tumour morphology, tissue architecture and other important features.
However, tumours that appear similar under a microscope may behave differently and respond to different treatments.
Modern breast cancer diagnosis therefore frequently incorporates immunohistochemistry (IHC), a laboratory technique that uses antibodies to identify specific proteins in tissue.
Four commonly discussed biomarkers demonstrate how diagnostic requirements have evolved.
Estrogen Receptor (ER)
Estrogen receptor testing helps determine whether breast cancer cells express receptors that may make them responsive to endocrine therapy.
Under ASCO/CAP guidelines, validated ER testing is an important component of assessing invasive breast cancer.
Accurate interpretation is particularly important for tumours with low levels of receptor expression.
Progesterone Receptor (PR)
Progesterone receptor testing provides additional information about tumour biology and prognosis.
It is commonly evaluated alongside ER as part of the routine pathological characterisation of invasive breast cancer.
HER2
HER2 is a protein involved in cell growth signalling.
Some breast cancers demonstrate HER2 overexpression or gene amplification, making HER2 testing particularly important when considering HER2-targeted therapies.
Testing commonly begins with immunohistochemistry, with results reported using scores from 0 to 3+.
An IHC score of 3+ generally supports HER2-positive classification under established testing guidelines, while an IHC score of 2+ requires additional evaluation, typically using in situ hybridisation.
Ki-67
Ki-67 is a marker associated with cellular proliferation.
It can provide information about how actively tumour cells are dividing.
However, its interpretation requires standardisation, and its clinical utility is more limited than that of ER and HER2 testing. It should not independently determine treatment selection in every breast cancer case.
Together, these markers illustrate the changing role of histopathology.
A pathology laboratory is no longer responsible only for confirming the presence of cancer. It increasingly contributes information that helps determine how the cancer should be treated.
A Vietnamese Study Examined More Than 23,000 Breast Cancer Patients
A study presented in Annals of Oncology in December 2024 provides insight into breast cancer diagnostic practices in Vietnam.
Titled HER2-positive breast cancer in a low-middle income country (LMIC): Lack of pathology capability and the urgent need for targeted treatment, the research examined women treated at Vietnam National Cancer Hospital, also known as K Hospital.
The observational study covered the period from 2015 to 2023.
Researchers analysed a cohort of 23,318 women with histologically confirmed breast cancer.
Of these patients, 18,679 underwent immunohistochemistry-based subtype classification, approximately four in five women in the study population.
Among patients with IHC classification, the researchers reported:
- 28.3% had HER2 3+ expression, involving 5,324 patients.
- 13.7% had HER2 2+ results, involving 2,568 patients.
- Among the HER2 2+ group, only 673 patients, or 26.2%, underwent further FISH or Dual-ISH testing.
These results describe patients treated at one national referral cancer hospital. They should not be interpreted as representative of HER2 prevalence across all breast cancer patients in Vietnam.
Nevertheless, the study highlights an important practical challenge.
Even within a major oncology institution, completing the diagnostic pathway for certain breast cancer subtypes may be constrained by affordability and access to additional testing.
For healthcare providers, the findings show why advanced pathology services require more than basic laboratory equipment.
For investors, they demonstrate the importance of evaluating the entire diagnostic process rather than individual tests in isolation.
Why HER2 Testing Creates Additional Diagnostic Requirements
HER2 testing provides a particularly useful example of how breast cancer pathology has become more complex.
A standard tissue examination may identify invasive breast carcinoma.
Immunohistochemistry then provides information about HER2 protein expression.
However, not every IHC result produces a definitive HER2 classification.
Cases with an IHC score of 2+ generally require additional testing, most commonly fluorescence in situ hybridisation (FISH) or another validated in situ hybridisation method.
These techniques assess HER2 gene amplification and help clarify HER2 status.
In the Vietnam National Cancer Hospital study, 2,568 patients had HER2 2+ findings, but only 673 underwent further FISH or Dual-ISH testing.
The researchers associated this limited use of confirmatory testing with patients’ ability to afford subsequent anti-HER2 treatment.
This observation is important because it demonstrates the connection between diagnostic access and treatment affordability.
The clinical value of an advanced test depends partly on whether its findings can inform available treatment options.
Nevertheless, incomplete confirmatory testing can also leave clinicians with less definitive information about tumour biology.
The study does not establish that every patient who did not undergo further testing was denied clinically indicated treatment.
It does, however, identify a substantial gap between the number of patients with equivocal HER2 results and those receiving additional molecular confirmation.
That gap illustrates why expanding pathology capabilities must be accompanied by appropriate clinical pathways, financing arrangements and access to treatment.
The Economic Value of Breast Cancer Pathology Extends Beyond Biopsy Processing
For a pathology laboratory, breast cancer diagnosis can involve several distinct stages of testing.
A patient may initially require a tissue biopsy, followed by routine histological examination.
Depending on the findings, additional testing may include immunohistochemistry, confirmatory HER2 analysis or other molecular investigations.
Each stage requires different technical capabilities and professional resources.
From a business perspective, this creates several potential sources of diagnostic service demand.
Routine histopathology involves specimen processing, tissue embedding, sectioning, staining and microscopic interpretation.
Immunohistochemistry adds antibody-based staining, dedicated equipment, quality-control procedures and specialist assessment.
Advanced confirmatory testing may require additional instruments, reagents, interpretive expertise and validation.
Selected patients may also need molecular or genetic testing when clinically indicated.
These activities are related, but they should not be treated as interchangeable revenue streams.
Not every breast cancer patient requires every available test. Testing must remain appropriate to the patient’s diagnosis, clinical circumstances and applicable guidelines.
Nevertheless, greater diagnostic sophistication can increase the range of services a qualified pathology provider is able to offer.
The commercial opportunity lies in delivering a complete, reliable diagnostic service rather than simply increasing the number of basic tissue examinations.
This is particularly relevant to laboratories seeking to develop specialist oncology capabilities.
Why Advanced Pathology Is Difficult to Establish
Although sophisticated pathology services may offer higher-value diagnostic capabilities, they also present substantial barriers to entry.
A laboratory performing routine tissue processing cannot automatically introduce advanced immunohistochemistry or molecular testing without additional investment.
Technical requirements may include automated tissue processors, embedding stations, microtomes, staining systems, immunohistochemistry platforms and specialised analytical equipment.
The laboratory must also establish reliable specimen handling and fixation procedures.
These pre-analytical processes matter because poor tissue preparation can compromise subsequent biomarker testing.
Even when laboratories use the same commercial test kits, differences in tissue handling, staining protocols or interpretation may affect result quality.
The College of American Pathologists and American Society of Clinical Oncology have therefore established detailed recommendations for hormone receptor and HER2 testing.
Such guidance emphasises validated methods, appropriate quality controls and reliable interpretation.
For investors, these requirements create a fundamental difference between pathology and many other laboratory businesses.
In clinical chemistry, significant portions of testing can be highly automated.
Histopathology also benefits from automation, but expert medical interpretation remains central to many diagnostic decisions.
A specialised pathology business therefore depends on both technical infrastructure and the availability of qualified professionals.
The combination creates meaningful operating complexity.
Specialist Expertise Could Become a Competitive Advantage
As cancer treatment becomes more personalised, the demand for specialised diagnostic interpretation may become increasingly important.
A laboratory’s competitive advantage may no longer depend primarily on the number of specimens it processes.
It may also depend on its ability to provide consistent biomarker testing, complex case interpretation and timely diagnostic reporting.
For example, a pathology centre with validated HER2 testing and experienced breast pathologists could potentially support referring hospitals that lack certain specialised capabilities.
This creates opportunities for cooperation between independent laboratories, oncology hospitals and regional healthcare networks.
The model could also support centralisation of selected complex tests.
A hospital might continue collecting and processing specimens locally while sending eligible samples to a specialist reference laboratory.
Such arrangements can reduce the need for every institution to duplicate advanced equipment and highly specialised expertise.
However, centralisation does not automatically improve efficiency.
Transport time, specimen stability, turnaround requirements, service pricing and reporting responsibilities must be carefully managed.
The most effective arrangement will depend on clinical demand, geographic coverage and operational capacity.
Digital pathology may further support these networks by enabling authorised specialists to review digitised slides remotely.
Nevertheless, advanced imaging systems must be validated, and remote interpretation must remain subject to appropriate medical oversight.
What Investors Should Examine in Vietnam’s Pathology Market
The breast cancer evidence suggests that investment opportunities in Vietnamese histopathology should be evaluated through more than patient volumes alone.
A prospective laboratory investor should consider four central factors.
First, diagnostic complexity. The relevant question is not simply how many biopsies are performed, but what proportion requires immunohistochemistry, additional confirmatory tests or specialist interpretation.
Second, clinical referral relationships. Hospitals and oncology specialists need confidence in diagnostic accuracy, reliability and turnaround times. These relationships can take considerable time to establish.
Third, laboratory utilisation. Advanced diagnostic platforms require sufficient testing volume to justify capital investment, staffing, maintenance and reagent costs.
Fourth, affordability and reimbursement. The 2024 Vietnamese study demonstrates that the availability and uptake of diagnostic testing can be influenced by the cost and accessibility of subsequent treatment.
These factors make pathology investment different from a straightforward equipment-led expansion strategy.
A laboratory may possess sophisticated technology without generating sufficient testing volume to support it.
Conversely, a provider with strong clinical partnerships, reliable reporting and qualified specialists may have opportunities to expand services progressively.
Investors therefore need to examine actual referral demand, test mix, cost per case, achievable pricing and clinical quality indicators before estimating commercial returns.
The number of new cancer cases provides useful market context, but it does not directly establish the addressable market or revenue potential of a pathology business.
The Future of Breast Cancer Diagnostics in Vietnam
The evolution of breast cancer treatment is changing what hospitals require from pathology laboratories.
Accurate identification of cancer remains essential, but biological classification is now an important part of determining appropriate treatment.
As targeted therapies and personalised oncology become more established, validated biomarker testing and specialist interpretation will remain central to clinical decision-making.
Vietnam’s experience illustrates both the opportunity and the challenge.
GLOBOCAN estimates indicate a substantial breast cancer burden, while the 2024 Vietnam National Cancer Hospital study demonstrates the importance of immunohistochemistry and the practical limitations affecting further HER2 testing.
For healthcare providers, these findings support investment in stronger diagnostic systems, quality assurance and specialist expertise.
For pathology laboratories, they highlight opportunities to develop services beyond routine tissue processing.
For investors, they point toward a healthcare sector where technical capability, clinical credibility and access to specialist knowledge may become increasingly important sources of competitive differentiation.
However, commercial sustainability will depend on appropriate investment, patient affordability, clinical integration and sufficient testing demand.
As breast cancer treatment becomes more personalised, the value of pathology increasingly lies in providing the right diagnostic information to guide the right treatment.
The opportunity for Vietnam’s pathology industry is therefore not merely to process more biopsies.
It is to develop the expertise and infrastructure needed to deliver increasingly sophisticated cancer diagnostics at consistent quality and accessible cost.
That may ultimately prove more important than laboratory size alone.
References
- International Agency for Research on Cancer (IARC). GLOBOCAN 2022: Viet Nam Fact Sheet. Global Cancer Observatory. Historical country estimates for 2022.
- International Agency for Research on Cancer (IARC). GLOBOCAN 2024: Viet Nam Fact Sheet. Updated national cancer estimates. Official country report
- Hoang, T.H., & Phung Thi, H.T. (2024). HER2-positive breast cancer in a low-middle income country (LMIC): Lack of pathology capability and the urgent need for targeted treatment. Annals of Oncology, 35(Supplement 4), S1410. https://doi.org/10.1016/j.annonc.2024.10.035
- College of American Pathologists (2023). HER2 Testing in Breast Cancer: 2023 Guideline Update. Official guideline
- Allison, K.H., et al. (2020). Estrogen and Progesterone Receptor Testing in Breast Cancer: ASCO/CAP Guideline Update. Journal of Clinical Oncology, 38(12), 1346–1366. https://doi.org/10.1200/JCO.19.02309
- Nielsen, T.O., et al. (2021). Assessment of Ki67 in Breast Cancer: Updated Recommendations From the International Ki67 in Breast Cancer Working Group. Journal of the National Cancer Institute, 113(7), 808–819. https://doi.org/10.1093/jnci/djaa201