Vietnam Oncology Drugs Market

The Vietnam oncology drugs market is witnessing dynamic growth driven by multiple interrelated factors shaping both demand and supply sides. Rising cancer prevalence, fueled by aging demographics, lifestyle transitions, and environmental factors, increases the need for early diagnosis and effective treatments, propelling demand for oncology pharmaceuticals. Healthcare reforms by the government, including expanded health insurance coverage and investments in oncology centers, are improving patient access to advanced cancer therapies such as chemotherapy, targeted drugs, immunotherapies, and biologics. Pharmaceutical companies, both domestic and multinational, are capitalizing on improving regulatory pathways and faster drug approvals, enabling broader availability of innovative therapies. Strategic collaborations between local distributors and global manufacturers also ensure a diverse portfolio of oncology medications in Vietnamese healthcare facilities. The rising middle class and awareness about early cancer detection further amplify demand for specialized medicines, contributing to market expansion. On the supply side, Vietnam's pharmaceutical industry is undergoing transformation with increasing focus on self-sufficiency through domestic drug production and reducing import dependency, supported by government initiatives and favorable policies. Production capabilities certified with WHO-GMP and EU-GMP standards are expanding, thereby improving manufacturing quality and competitiveness. However, market development is influenced by infrastructural disparities, with advanced oncology services concentrated in urban centers while rural areas face access challenges. Pricing and reimbursement complexities, as well as regulatory stringency, present ongoing challenges alongside the opportunity presented by biosimilars and affordable generics. FIGURE 2 VIETNAM ONCOLOGY DRUGS MARKET: MARKET GROWTH AFFECTING FACTOR ANALYSIS (2019-2035) Source: MRFR Analysis Copyright © 2025 Market Research Future 34

4.2.1 RISING CANCER INCIDENCE & PREVALENCE According to the Global Cancer Observatory (IARC/WHO) and recent population-based cancer registries in Hanoi and Ho Chi Minh City, Vietnam is projected to experience more than 180,400 new cancer cases and over 120,000 cancer-related deaths annually in 2025 a figure that has nearly tripled since the 1990s. This surge is largely attributed to demographic shifts, lifestyle changes, and increased longevity across the nation. For e e, n H no nd Ho Mn en on’s o os o o s r n en ers n er n den e rose s r fro 28,506 cases in 2020 to a projected 36,333 cases in 2025, with lung, colorectal, breast, thyroid, and liver cancers representing 67% of all new diagnoses. Among men, lung cancer prevalence is especially high, while breast and thyroid cancers are notably common among women. Younger populations are increasingly affected as risk factors such as tobacco use, urban pollution, sedentary lifes e, nd d e r s n rev en e n on e or r so e Ur n en ers d s so e of e o n r ’s es n dence rates, but virtually all regions report climbing numbers, requiring urgent expansion of oncology services. The real-world impact of these trends is reflected in hospital oncology wards, where continuous patient loads strain medical infrastructure and demand for advanced therapies accelerates. For instance, the age-standardized rate for breast cancer more than doubled, rising from 15.2 per 100,000 women in 1991 to over 40 per 100,000 in 2020, and is still increasing. This mounting burden compels a consistent upgrade in oncology drugs supply, regulatory support for expedited therapy approvals, and investments in healthcare services that enable the timely procurement and deployment of new cancer treatments throughout Vietnam. FIGURE 3 VIETNAM ONCOLOGY DRUGS MARKET: VIETNAM CANCER STATISTICS AT A GLANCE, 2022 Category Males Females Both sexes Population 49,411,162 49,542,373 98,953,535 Incidence Number of new cancer cases 95,358 85,122 180,480 Age-standardized incidence rate 177.1 132.3 150.8 Risk of developing cancer before the age of 75 years (cum. 18.8 13.7 16 risk %) 1. Liver 4. Breast 7. Breast Top 3 leading cancers (ranked by cases) 2. Lung 5. Lung 8. Liver 3. Stomach 6. Colorectum 9. Lung Mortality Number of cancer deaths 71,385 48,799 120,184 Age-standardized mortality rate 132.6 72.7 99 Risk of dying from cancer before the age of 75 years (cum. 14.3 8 10.9 risk %) Liver, Lung, Liver, Lung, Top 3 leading cancers (ranked by deaths) Breast, Lung, Liver Stomach Stomach Prevalence 5-year prevalent cases 189,429 219,715 409,144 Source: WHO 4.2.2 EXPANDING HEALTH INSURANCE COVERAGE & REIMBURSEMENT REFORMS B M 2 25, V e n ’s e ns r n e over e re ed n n re eden ed 96 5% of e o on about 97 million residents— well ahead of the national target set for 2025. This near-universal coverage includes patients from diverse socioeconomic backgrounds, ensuring that even the poor and vulnerable have access to high-cost oncology treatments. Copyright © 2025 Market Research Future 35 Vietnam's Ministry of Health has made comprehensive reforms to reimbursement policies, culminating in the amended Law on Health Insurance and new circulars that took effect in January 2025. These reforms guarantee that health insurance participants are now entitled to 100% coverage for medical examinations and inpatient treatments at both basic and specialized hospitals including cancer centers regardless of administrative boundaries or referral facilities. Rare and critical illnesses, such as cancer, are allowed direct access to high-level hospitals without complex referral procedures, addressing previous gaps in care delivery for urgent cases. In practice, oncology patients benefit from standardized reimbursement rates of 80%, 95%, or even 100% for most anticancer drugs and services, depending on status and income bracket. For breast cancer, for instance, the majority of drugs are included in social health insurance reimbursement, dramatically lowering out-of-pocket payments, which previously caused catastrophic health expenditures for over 65% of cancer-affected households. Special policy groups such as the poor, near-poor, ethnic minorities, war veterans, and children qualify for zero or minimal co-payments, further inclusive measures that widen drug access. With millions of annual healthcare visits funded by the insurance system and tens of thousands of oncology cases treated at major hospitals, these reforms actively drive demand for registered oncology drugs, increase market volumes for specialty therapies, and improve health outcomes across Vietnam. 4.2.3 RAPID GROWTH OF VIETNAM’S PHARMA & BIOPHARMA MARKET R d ro nVe n ’s r e nd o r se ors s ron dr ves de nd nd nnov

4.4.1 LOCAL MANUFACTURING / TECH TRANSFER Local manufacturing and technology transfer present significant opportunities for the Vietnam oncology drugs market by enabling increased self-sufficiency, reduction of import dependency, and greater access to high- n er er es V e n ’s N onal Strategy for Developing the Pharmaceutical Industry to 2030 (Vision 2045) specifically targets technology transfer for at least 100 original pharmaceuticals, vaccines, and biological products, aspiring for domestic drugs to cover 80% of market volume and 70% of market value by 2030. Leading policy reforms and investments s s e ons r on of I e r ’s ne $58 on n 46 R&D ro e s, nd As r ene ’s re en $ on o en underscore growing capacity for innovation and biologics production at home. The opening of a large-scale pharmaceutical- o o r nT Bn rov n e nves en VND 3 8 r on ref e s V e n ’s Copyright © 2025 Market Research Future 39 strategic priority to enter advanced manufacturing, especially for biopharmaceuticals, biosimilars, and cancer therapeutics, breaking new ground away from reliance on chemical generics. As of 2025, Vietnam operates 238 pharmaceutical factories certified with WHO-GMP and 17 with EU-GMP standards. Most transfers have focused on conventional biologics, but the regulatory environment is evolving to encourage local production of high-value oncology drugs, including incentives for tax, R&D, licensing, and preferential procurement policies for drugs clinically trialled and manufactured domestically. Recent legal changes to the Law on Pharmacy further streamline approvals for originator drugs and biosimilars, enhancing market entry for new therapies produced under tech transfer agreements. For example, the Russian pharmaceutical company Medsintez and Vietnam's VNVC Vaccine and Biopharmaceutical Manufacturing Plant signed a comprehensive technology transfer agreement to produce biopharmaceuticals and advanced drugs in Vietnam, expanding domestic capabilities for oncology and vaccine manufacturing. This is expected to not only improve access and affordability for cancer patients but also elevate Vietnam's competitiveness in regional and global pharmaceutical supply chains. 4.4.2 PUBLIC–PRIVATE PARTNERSHIPS & CAPACITY BUILDING Ven ’s M n s r of He s ve ever n PPPs o onne overn en r v e se or e er se nd funding, following national mandates and regulatory frameworks such as the 2020 PPP Law. Over the past two decades, Vietnam has signed 336 PPP contracts in health and related sectors, helping bridge funding, infrastructure, and service gaps. For instance, high-profile PPPs involving Novartis and AstraZeneca have resulted in enhanced capacity for healthcare worker training, infrastructure upgrades, diagnostic technology access, and expansion of primary and specialty care models for non- communic e d se ses, n d n on o o Nov r s’s r ners e M n s r of He de ons r es s ro n ves that provide diagnostics, affordable medicines, and advanced training for rural health staff, directly addressing workforce and access inequities in cancer management. On the technological front, Vietnamese tech giants such as FPT have teamed with global pharmaceutical leaders to plan AI-powered clinical trials, digital health solutions, and rapid drug discovery platforms ro e s de fe s e PPP ode s nd V e n ’s e talent pool, which is set to exceed one million IT specialists by 2030. These collaborative efforts drastically reduce the cost and time associated with new drug development and enable remote, data-driven cancer care. Add on , PPPs f e nfr s r re deve o en for n er os s, s reen n n ves, nd “ e ond-the- ” support services such as home nursing and tele-oncology, enhancing the comprehensiveness and holistic nature of cancer services. S o n effor s re r n ddress n V e n ’s d s r es n re nd re on ess, e dn s s ainable market for advanced oncology drugs and innovation-driven treatment models. 4.4.3 BIOSIMILARS & AFFORDABLE GENERICS B os rs nd fford e ener s resen or o or n for V e n ’s on o o dr s r e ddress n e ress ng need for cost-effective cancer therapies while supporting broader access for all patient groups. With cancer drug costs being a m or f n n en e, V e n ’s re or or es ve oved o s f nd e er e e rov of os rs and ener on o o dr s T e M n s r of He ’s r r No 2 2 25 TT-BYT, effective from July 1, 2025, introduces a more principles-based approach to drug classification and registration, mandating that biosimilars meet rigorous bioequivalence and s fe r er efore o rov Ven ’s ne fr e or s so ned n ern on s nd rds, e n re s ration dossiers based on prior approval in countries with Stringent Regulatory Authorities (e.g., EMA, FDA), which streamlines market entry for affordable versions of high-cost biologics. Biosimilars biologic drugs shown to be highly similar to already-approved originators offer significant price reductions compared to innovator biologics, making treatments like trastuzumab, bevacizumab, or rituximab far more accessible to Vietnamese cancer Copyright © 2025 Market Research Future 40 patients. Regulatory changes also encourage domestic and foreign manufacturers to engage in technology transfer and contract manufacturing for biosim

4.3.1 PROLIFERATION OF COUNTERFEIT AND SUBSTANDARD DRUGS The Drug Administration of Vietnam has repeatedly warned about the presence of fake cancer drugs in the market, reporting cases where these counterfeit medicines, lacking active ingredients or containing harmful substances, have been distributed widely through pharmacies and hospitals. For instance, a notorious scandal involving VN Pharma saw over 600,000 boxes of counterfeit cancer drugs sold illegally, generating illicit profits of around VND 31.5 billion and endangering thousands of patients. Copyright © 2025 Market Research Future 37 Statistics show that in 2023 alone, Vietnamese authorities detected over 160 cases related to counterfeit drug production and trafficking, leading to arrests and sanctions. In Ho Chi Minh City, a major hotspot for counterfeit pharmaceuticals, the number of seized counterfeit samples rose from 5 in 2022 to 40 in 2024, with many lacking the proper active ingredients or being adulterated with synthetic drugs. This alarming trend complicates effective cancer management because counterfeit drugs fail to deliver therapeutic benefits, allowing disease progression and resistance development. Counterfeiters employ increasingly sophisticated methods such as fake QR codes, forged labels, and mixing genuine with fake drugs—making detection difficult even for regulators and healthcare professionals. Though hospitals reportedly avoid counterfeit drugs by ensuring clear provenance, these illicit products continue circulating in less regulated channels, including online platforms and informal markets. The consequences of counterfeit oncology drugs include delayed treatment, increased mortality risk, and eroded confidence in Ven ’s r e s se . 4.3.2 DEPENDENCE ON IMPORTS FOR HIGH -VALUE BIOLOGICS Dependence on imports for high-v e oo s re ns r res r n for V e n ’s on o o dr s r e , re n s v ner es, fford en es, nd ess rr ers for dv n ed n er er es W e V e n ’s do es pharmaceutical industry has made progress in generic drug manufacturing, it still faces major hurdles in producing complex biologics largely due to high technological requirements, limited R&D, and a shortage of skilled biomanufacturing personnel. Over 90% of raw pharmaceutical ingredients are imported, with more than half sourced from mainland China, reinforcing the o n r ’s re n e on o s ns for r er s nd f n s ed oo dr s sed n on o o e dn er es including monoclonal antibodies, checkpoint inhibitors, and targeted biologics crucial to the treatment of cancers like breast, lung, and lymphoma are supplied primarily by international companies such as Roche, Novartis, and Pfizer, due to the absence of domestic alternatives. This import dependence means that any disruption such as trade tensions, COVID-19-related delays, or currency fluctuations can quickly result in shortages and price spikes that hit both hospitals and patients. Vietnamese authorities have recognized these risks: national strategies now aim to boost local biopharma capacity so that by 2030, 80% of essential drugs are produced domestically, yet progress in biologics remains slow. Regulatory frameworks for technology transfer and biosimilar approvals have been introduced, but local firms still lag behind in the necessary quality standards (i.e., EU GMP, PI S GMP for oo s n f rn Re en e s “f -f n s ” ro ess n where import biologics are packaged locally offer limited cost relief but do not address production or innovation gaps. The practical impact is clear, many cancer patients depend on expensive imported biologic medicines, with costs frequently exceeding annual incomes and limited insurance reimbursement. 4.3.3 UNEVEN ACCESS ACROSS REGIONS Comprehensive cancer care including advanced diagnostics like PET/CT, radiotherapy, specialist consultations, and access to the latest oncology drugs is concentrated in a handful of major hospitals in Ho Chi Minh City, Hanoi, and other larger provinces. As of the In 2016 data, only three comprehensive cancer centers and 45 oncology departments exist nationwide, and 2010 survey stating that 10 of 63 provincial hospitals cannot offer any cancer services at all. Access to degree-qualified pharmacists and regulated drug outlets is also dramatically better in urban centers; in rural and poor districts, many outlets lack registered staff and appropriate oversight, raising concerns about the quality and safety of medicines, including oncology drugs. Even with an average of 102 drug outlets per 100,000 people among the highest densities in Vietnam, pharmacies in remote areas may be poorly stocked or rely on non-specialist staff, exacerbating inequities. Copyright © 2025 Market Research Future 38 Modern radiotherapy and nuclear medicine equipment shortages further limit timely treatment for cancer patients outside metropolitan regions. Hospital overcrowding is endemic; in leading urban cancer hospitals, bed occupancy often exceeds 150%, while patients from remote areas are forced to travel long distances and wait weeks or months for appointments and specialized therapies. In fact, 70–80% of cancer patients in Vietnam present at late stages due to poor access to screening and early intervention services, with provincial cancer capacity estimated to only meet 30–40% of actual demand. The gap in cancer care infrastructure means rural and economically disadvantaged groups have delayed, incomplete, or even unaffordable access to effective oncology drugs and treatments hindering equitable cancer outcomes nationwide. FIGURE 5 VIETNAM ONCOLOGY DRUGS MARKET RESTRAINT: IMPACT ANALYSIS Source: MRFR Analysis

4.5.1 REIMBURSEMENT COMPLEXITY AND PRICING NEGOTIATIONS Ven ’s e ns r n e s s e , over n over 93.4% of the population as of 2024, operates under a complex drug re rse en fr e or re ed e M n s r of He ’s r r No 37 2 24 TT-BYT, effective from January 1, 2025. This circular establishes detailed principles and criteria for drug inclusion on the reimbursement list, considering treatment cost, clinical efficacy, and budget impact assessments, but also introduces multi-layered administrative procedures requiring extensive documentation and negotiations for price and reimbursement rates. Pricing negotiations for oncology drugs are often protracted due to high costs and the need for balancing innovation incentives with public affordability. Drugs like trastuzumab used for HER2-positive breast cancer receive partial reimbursement with rates between 48-60%, while others such as pertuzumab are not yet covered under social health insurance, forcing patients to bear out- of-pocket costs that can exceed their annual income. This reimbursement gap means many patients must decide between expensive life-saving therapies and financial hardship. The fragmented nature of reimbursement coverage further complicates access, as some innovative immunotherapies and targeted therapies remain excluded from the basic social health insurance package, relying instead on private insurance or out-of-pocket payments. While private insurance providers add some flexibility, their uptake remains limited, and reimbursement limits can cap en s o er eve s Add on ,V e n ’s n s en He Te no o Assess en HTA s s e , r for ev den e-based pricing decisions, is still developing, resulting in slower assessments and delays in drug listing. These complexities extend to administrative burdens on providers and pharmaceutical companies, with frequent policy updates requiring continuous adaptation. 4.5.2 STRINGENT GOVERNMENT REGULATIONS With the implementation of Circular No. 12/2025/TT-BYT by the Ministry of Health in July 2025, drug registration requirements underwent significant revision to align more closely with international standards while maintaining rigorous safety and efficacy assessments. Although this newer framework offers some regulatory streamlining—like accepting a single Certificate of Pharmaceutical Product (CPP) from a Stringent Regulatory Authority (SRA) country and requiring submission of Vietnamese registration applications within five years after approval by SRAs it also introduces strict limits on supplemental dossier rounds, reducing the opportunities to address deficiencies to two rounds unless critical issues arise. This restricts flexibility for manufacturers and heightens pressure to prepare entirely compliant applications upfront. Moreover, compliance with evolving pharmaceutical laws, such as Law No. 44/2024/QH15 effective July 2025, mandates adherence to quality standards akin to EU-GMP and Japanese GMP standards that few local producers currently meet. These regulatory Copyright © 2025 Market Research Future 41 burdens mean that many domestic firms face high costs upgrading manufacturing and quality assurance systems, constraining their ability to compete with imports or scale production of innovative oncology biologics and biosimilars. Furthermore, regulations tightly control drug pricing, advertising content, and shelf-life requirements at customs clearance, adding layers of administrative complexity. While intended to protect public health and ensure quality, these policies increase market entry barriers for new oncology drugs, delay patient access, and complicate strategic partnerships and technology transfers critical for market development. While V e n ’s overn en re ons re odern n nd n ern on n , e r s r n en nvo ves o er on , f n n , nd procedural challenges that require pharmaceutical companies to invest heavily in compliance and quality, posing a restraint on the rapid availability and affordability of new oncology drugs in the Vietnamese market. Copyright © 2025 Market Research Future 42