Vietnam Biosimilar Market Size, Share, Trends and Forecast by Molecule, Indication, Manufacturing Type, and Region, 2025-2033

Vietnam Biosimilar Market Overview:

The Vietnam biosimilar market size reached USD 106.00 Million in 2024. The market is projected to reach USD 747.04 Million by 2033, exhibiting a growth rate (CAGR) of 24.23% during 2025-2033. The market is evolving rapidly, fueled by rising demand for affordable biologic therapies, particularly in chronic, autoimmune, and oncology indications. Growing government backing, improving healthcare infrastructure, and shifts in manufacturing both in‑house and outsourced, are enabling broader access to biosimilars across the country. Patient and provider acceptance is increasing alongside regulatory improvements that favor biosimilar approvals. These dynamics point to stronger market performance and growing confidence in the Vietnam biosimilar market share.

Vietnam Biosimilar Market Trends:

Regulatory Streamlining and Harmonised Guidelines

Vietnam has recently made solid moves to simplify and clarify rules around biologics and biosimilars, which supports faster development and market entry. The Ministry of Health issued Circular 12/2025/TT‐BYT, effective from July 1, 2025, which revises several registration pathways, including for biologics. Key improvements include acceptance of a Certificate of Pharmaceutical Product from either the manufacturing country or from a recognized stringent regulatory authority, clearer documentation requirements for clinical data, and differentiated timelines for review depending on drug type or variation. These changes make it easier for biosimilar products to follow a reference biologic and reduce uncertainty for developers of similar biotherapeutic products. Also, new national guidelines, such as Decision 16/QĐ‐K2ĐT, establish frameworks for nonclinical and clinical studies specifically for similar biological medical products, aligning them with international norms for safety, quality, and efficacy. Together, these regulatory reforms help reduce duplication, speed up dossier evaluation, and provide more predictable approval pathways, which are essential for investment, manufacturing planning, and ensuring patient access to biosimilars. These developments strongly contribute to Vietnam biosimilar market growth.

Increased Market Entry and Product Approval Activity

The past year has seen more biosimilar products being approved or launched in Vietnam, reflecting rising confidence among applicants and regulators. In June 2025, a biosimilar for autoimmune disease was brought to market, and a treatment biosimilar for breast and stomach cancer followed in August 2025. These product launches underscore growing demand for therapies in chronic, autoimmune, and oncological areas, as clinicians and patients seek more affordable alternatives to originator biologics. Alongside mobilization of regulatory capacity, these approvals are supported by policy frameworks revising how biologics are evaluated and compared to reference drugs. Also, increased participation in clinical trials and licensing agreements regionally suggest Vietnam is becoming a more appealing biosimilar destination. As more biosimilar therapies gain authorization and enter tenders, both public and private health providers benefit from wider therapeutic choice. This pattern of approvals and rising utilization is helping define Vietnam biosimilar market trends.

Domestic Capability Building and Supportive Policy Environment

Vietnam is strengthening its domestic infrastructure and policy landscape to support biosimilar development and production. The national pharmaceutical sector development strategy by 2030 outlines aims such as increasing technology transfer for biologics, vaccines, and similar products and enhancing local manufacturing capacity to meet more of domestic demand. Legal reforms have been passed to improve health insurance reimbursement processes and to amend pharmaceutical laws so that domestically produced biologics can compete more fairly. The Drug Administration of Vietnam has issued guidelines to clarify quality, safety, and efficacy requirements for biosimilars (often called similar biotherapeutic products), including referencing recognized regulatory authority standards, aligning clinical study designs, and enhancing dossier transparency. Investment in regulatory training and laboratory capacity is also increasing, enabling better oversight and faster evaluation of biosimilar dossiers, which helps reduce time-to-market. These building‑blocks of human resources, governance, and infrastructure are fueling a more self-sufficient ecosystem for biosimilar supply and availability.

Vietnam Biosimilar Market Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the market, along with forecasts at the country and regional levels for 2025-2033. Our report has categorized the market based on molecule, indication, and manufacturing type.

Molecule Insights:

• Infliximab
• Insulin Glargine
• Epoetin Alfa
• Etanercept
• Filgrastim
• Somatropin
• Rituximab
• Follitropin Alfa
• Adalimumab
• Pegfilgrastim
• Trastuzumab
• Bevacizumab
• Others

The report has provided a detailed breakup and analysis of the market based on the molecule. This includes infliximab, insulin glargine, epoetin alfa, etanercept, filgrastim, somatropin, rituximab, follitropin alfa, adalimumab, pegfilgrastim, trastuzumab, bevacizumab, and others.

Indication Insights:

• Auto-Immune Diseases
• Blood Disorder
• Diabetes
• Oncology
• Growth Deficiency
• Female Infertility
• Others

A detailed breakup and analysis of the market based on the indication have also been provided in the report. This includes auto-immune diseases, blood disorder, diabetes, oncology, growth deficiency, female infertility, and others.

Manufacturing Type Insights:

• In-house Manufacturing
• Contract Manufacturing

The report has provided a detailed breakup and analysis of the market based on the manufacturing type. This includes in-house manufacturing and contract manufacturing.

Regional Insights:

• Northern Vietnam
• Central Vietnam
• Southern Vietnam

The report has also provided a comprehensive analysis of all the major regional markets, which include Northern Vietnam, Central Vietnam, and Southern Vietnam.

Competitive Landscape:

The market research report has also provided a comprehensive analysis of the competitive landscape. Competitive analysis such as market structure, key player positioning, top winning strategies, competitive dashboard, and company evaluation quadrant has been covered in the report. Also, detailed profiles of all major companies have been provided.

Vietnam Biosimilar Market News:

• August 2025: Vietnam-headquartered Sandoz has signed a licensing deal with Lupin Limited for marketing a biosimilar in several different markets. As per the agreement, Sandoz will take care of product commercialization in the European Union (excluding Germany), Switzerland, Norway, Australia, Hong Kong, Vietnam, and Malaysia. Lupin will oversee product manufacturing and making regulatory submissions. In most of the designated markets, Sandoz will have exclusive marketing rights, but in France, Australia, Vietnam, and Malaysia, the rights will be semi-exclusive.

Vietnam Biosimilar Market Report Coverage:

Key Questions Answered in This Report:

• How has the Vietnam biosimilar market performed so far and how will it perform in the coming years?
• What is the breakup of the Vietnam biosimilar market on the basis of molecule?
• What is the breakup of the Vietnam biosimilar market on the basis of indication?
• What is the breakup of the Vietnam biosimilar market on the basis of manufacturing type?
• What is the breakup of the Vietnam biosimilar market on the basis of region?
• What are the various stages in the value chain of the Vietnam biosimilar market? 
• What are the key driving factors and challenges in the Vietnam biosimilar market?
• What is the structure of the Vietnam biosimilar market and who are the key players?
• What is the degree of competition in the Vietnam biosimilar market? 

Key Benefits for Stakeholders:

• IMARC’s industry report offers a comprehensive quantitative analysis of various market segments, historical and current market trends, market forecasts, and dynamics of the Vietnam biosimilar market from 2019-2033.
• The research report provides the latest information on the market drivers, challenges, and opportunities in the Vietnam biosimilar market.
• Porter's five forces analysis assist stakeholders in assessing the impact of new entrants, competitive rivalry, supplier power, buyer power, and the threat of substitution. It helps stakeholders to analyze the level of competition within the Vietnam biosimilar industry and its attractiveness.
• Competitive landscape allows stakeholders to understand their competitive environment and provides an insight into the current positions of key players in the market.