Vietnam Pharma Market: Your Growth Blueprint

2 min read

The pharmaceutical market in Vietnam is one of the fastest-growing in Southeast Asia, presenting compelling opportunities for pharmaceutical companies in Vietnam and global firms seeking to expand in the region.

Vietnam Market Overview

Vietnam’s pharmaceutical industry continues to expand robustly. In 2024, Vietnam pharma market size was approximately USD 7.44 billion, and it is projected to more than double to USD 14.07 billion by 2033, driven by a compound annual growth rate (CAGR) of 7.34 %. Other estimates indicate a growth from around USD 7.6 billion in 2024 to USD 12.12 billion by 2030, with a CAGR of 7.96 %.

Statista projects a rise in pharmaceutical revenue from USD 2.42 billion in 2025 to USD 3.11 billion by 2030, at a CAGR of 5.14 %.

Growth Drivers:

Chronic disease burden & aging population: With non-communicable diseases accounting for over 80% of deaths, demand for cardiovascular, metabolic, and oncology treatments is surging.
Healthcare investment & insurance expansion: Government initiatives like the “National Strategy for Pharmaceutical Industry Development” and insurance reforms are improving access and local self-sufficiency.
Demographics: By 2035, nearly 20% of Vietnam’s population will be over 60, further fueling demand for chronic care medications.
Digital transformation & e-pharmacies: The rise of e-pharmacy platforms, along with e-health and telemedicine technologies, is reshaping drug distribution and accessibility, especially in remote areas.

Registration Process in Vietnam

The Vietnam drug registration pathway is managed by the Drug Administration of Vietnam (DAV) under the Ministry of Health. Key steps in the registration process include:

Local Representation: Foreign manufacturers must appoint a locally registered entity as the Marketing Authorization Holder (MAH)
GMP Compliance: Manufacturing sites must meet PIC/S GMP or equivalent standards
Dossier Preparation & Submission: Documents must be aligned with ASEAN Common Technical Dossier (ACTD) guidelines
Review & Responses: The DAV may issue queries requiring prompt clarification
Approval & Licensing: Successful submissions lead to Marketing Authorization, enabling distribution and sale within Vietnam

Foreign pharmaceutical companies looking to enter the Vietnam pharmaceutical market must understand these Regulatory requirements to ensure compliance and accelerate market entry.

Basic Regulatory Requirements

GMP Certification from recognized bodies
Clinical Data for new chemical entities (NCEs); bioequivalence studies for generics
Labeling & Packaging in compliance with local regulations and language requirements
Product Monograph outlining composition, dosage, usage, and safety
Local MAH engagement for Regulatory interface

Freyr’s Case Study: Supporting a Korean-Based Pharmaceutical Client in Vietnam

Client Overview:

A leading South Korean pharmaceutical company sought Freyr’s Regulatory support to assess the status of its submitted product and evaluate viable registration options in Vietnam.

Project Highlights:

Strategic Engagement with DAV: Organized and participated in meetings with the Drug Administration of Vietnam (DAV) to discuss the current submission status and explore drug registration in Vietnam pathways.
Strategic Recommendations: Based on DAV interactions, Freyr outlined feasible options for proceeding with registration.
Documentation Review: Ensured all dossier components complied with DAV and ASEAN guidelines.
Meeting Report: Compiled and submitted a comprehensive report summarizing the discussion outcomes and next steps.

Outcome:

Freyr’s proactive engagement facilitated clarity on the Regulatory status, streamlined decision-making, and positioned the client for an accelerated and informed market entry into Vietnam pharma market.

Ready to Enter Vietnam’s Growing Pharmaceutical Market?

Vietnam’s pharmaceutical market is poised for substantial growth, but navigating its evolving Regulatory landscape demands local expertise, strategic planning, and robust documentation. Partnering with Freyr ensures: