Vietnam Biosimilar Market Size, Share, Growth and Forecast 2025-2033

The Vietnam biosimilar market size reached USD 106.00 Million in 2024 and is projected to grow to USD 747.04 Million by 2033, exhibiting a CAGR of 24.23% during 2025-2033. The market growth is driven by rising demand for affordable biologic therapies in chronic, autoimmune, and oncology indications, alongside government support and healthcare infrastructure improvements. Regulatory reforms and increased patient and provider acceptance are enhancing market access and confidence.

Study Assumption Years

• Base Year: 2024
• Historical Years: 2019-2024
• Forecast Period: 2025-2033

Vietnam Biosimilar Market Key Takeaways

• The Vietnam biosimilar market size was valued at USD 106.00 Million in 2024.
• The market is expected to grow at a CAGR of 24.23% during the forecast period 2025-2033.
• Market forecast for 2033 is USD 747.04 Million.
• The market is driven by increased demand for cost-effective biologic treatments for chronic, autoimmune, and oncology diseases.
• Regulatory reforms such as Circular 12/2025/TT-BYT and new national guidelines facilitate faster biosimilar approvals.
• Domestic manufacturing capacity and supportive legal frameworks are strengthening the biosimilar ecosystem.
• Rising participation in clinical trials and licensing agreements highlight Vietnam's emerging biosimilar market appeal.

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Market Growth Factors

The Vietnam biosimilars market is expected to see growth because of demand increasing for biologic medicines that are affordable to treat chronic, autoimmune diseases and oncology indications. These diseases will affect more patients, requiring treatment options with cost-effectiveness, for growth in the market.

One major area of anticipated regulation expansion is the introduction of Circular 12/2025/TT-BYT from the Ministry of Health. The Circular is to be enacted on 1 July 2025. The rule makes the registration process for biologics simple. The rule accepts Certificates of Pharmaceutical Product from manufacturing countries or major regulatory authorities. The rule includes clinical data requirements and timelines. Decision 16/QĐ-K2ĐT requires studies that are nonclinical and clinical to align with international standards that ensure safety, quality, and efficacy. It eases review of dossiers, reduces redundancy, accelerates approval processes, and encourages investment and market entry.

Increased domestic capacity and a favorable policy environment are also determinants of market growth in Vietnam. The national pharmaceutical development strategy 2020 aims for technology transfer and local production capacity in 2030. Legislative changes to ensure health insurance reimbursement and a level playing field for domestic biosimilars, and the Drug Administration of Vietnam aligning regulatory standards to international reference agencies, have been recently implemented within the system. Investing more in regulatory training and laboratory capacity can potentially improve how efficiently approvals proceed and supply becomes more self-sufficient.

Market Segmentation

Molecule Insights: The market is segmented by molecules including infliximab, insulin glargine, epoetin alfa, etanercept, filgrastim, somatropin, rituximab, follitropin alfa, adalimumab, pegfilgrastim, trastuzumab, bevacizumab, and others. This segmentation identifies specific biosimilar products available and their roles in treating various conditions.

Indication Insights: The market classification includes auto-immune diseases, blood disorder, diabetes, oncology, growth deficiency, female infertility, and others. This reflects the therapeutic areas where biosimilars are applied to address patient needs in Vietnam.

Manufacturing Type Insights: The biosimilar production is divided into in-house manufacturing and contract manufacturing. This distinction shows the manufacturing strategies adopted by companies operating in Vietnam.

Regional Insights

The report covers major regional markets including Northern Vietnam, Central Vietnam, and Southern Vietnam. Details about individual regional market sizes or dominant regions are not explicitly stated in the source.

Recent Developments & News

In August 2025, Vietnam-headquartered Sandoz signed a licensing deal with Lupin Limited for marketing a biosimilar across multiple markets including the EU (excluding Germany), Switzerland, Norway, Australia, Hong Kong, Vietnam, and Malaysia. Sandoz will manage product commercialization while Lupin will handle manufacturing and regulatory submissions. The agreement grants Sandoz exclusive marketing rights in most markets, with semi-exclusive rights in France, Australia, Vietnam, and Malaysia.

Key Players

• Sandoz
• Lupin Limited

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