A separate path for Vietnam’s biopharmaceutical industry

SKĐS – Vietnam needs to lay the foundation for the biopharmaceutical industry by leapfrogging in technology and promoting innovation, this was the general consensus of experts attending the Vietnam Biopharmaceutical Industry Development Discussion recently held in Hanoi.

Over the past 25 years, Vietnam has become a significant player in global markets and supply chains in many sectors such as textiles, footwear, electronics, and other manufactured products. This increasing participation in supply chains has been coupled with domestic economic growth and development, as well as improved local skills and capabilities. However, Vietnam still lags behind many countries in the region and globally in the development of biopharmaceuticals – one of the key areas of the 21st century.

The term “biopharmaceuticals” indicates that the traditional pharmaceutical field is being transformed by new technologies, driven by advances in biotechnology, including biological products and increasingly advanced technologies such as gene therapy , cell therapy, and gene editing. Vietnam has made significant efforts over the past three decades to catch up with its Southeast Asian neighbors and participate in global trade, thus offering many reasons for optimism about its potential to become a leading nation in the field of biopharmaceuticals.

In the context of the Politburo’s issuance of Resolution 57 on breakthroughs in national science, technology, innovation, and digital transformation, and the amended Law on Pharmaceuticals coming into effect in July 2025, the implementation of appropriate policies will be a catalyst for the development of this extremely young field.

According to Associate Professor Dr. Nguyen Lan Hieu, Director of Hanoi Medical University Hospital, in the field of biopharmaceuticals, Vietnam has begun to deploy vaccines; however, the medical and pharmaceutical industry currently faces many difficulties in infrastructure to form a biopharmaceutical ecosystem. Regarding product quality, more and more biological drugs are entering Vietnam, but there are no quality control standards, making product quality assessment difficult. In terms of research and clinical trials, Vietnam’s research capacity is still low, lacking animal testing laboratories; therefore, it is essential to establish research centers located in hospitals and universities.

Associate Professor Dr. Nguyen Lan Hieu shared about the high costs of conducting clinical trials on animals in Thailand and Singapore, and expressed his hope for investment in this field in Vietnam in the near future.

From a research perspective, Professor Huy Bui of McGill University (Canada) emphasized the role of the state and government in funding basic research in the biomedical field. According to the professor, businesses are often only interested in investing in clinical trials when they are relatively certain about the economic viability of the product; therefore, the development of research in an academic environment needs to be spearheaded by the state.

“With limited resources, Vietnam should focus on research with high applicability, directly related to the needs of the people, in order to attract social investment,” Professor Huy Bui shared.

From a clinical trial perspective, Ms. Tran Minh Huyen, Director and Head of Clinical Trial Research at AstraZeneca Vietnam, stated that Vietnam possesses many favorable conditions to become a regional clinical trial center: new policies with numerous incentives, a large population, diverse disease patterns, reasonable costs, and the increasing number of internationally accredited research facilities.

To realize that potential, Vietnam needs to continue investing in research infrastructure, standardizing processes, training human resources, and expanding cooperation with global partners. Vishal Doshi, CEO of AUM Biosciences (Singapore), also stated that Vietnam needs to ensure three key factors to become a serious candidate for global clinical trials: a rapid patient recruitment rate (an average of 3 months), favorable policy infrastructure, and the capacity to train doctors and specialists.

Sharing insights from practical production, Dr. Sundar Ramanan, Quality Director of Enzene Company (India), introduced the FCCM™ model for continuous and fully interconnected biosimilar drug production, which reduces processing costs by up to 50% and increases productivity nearly tenfold compared to traditional methods.

He emphasized two core technological elements: high-performance cell culture techniques and a horizontal production expansion strategy that allows for the parallel operation of multiple production lines, enhancing flexibility and ensuring product stability.

In particular, from a strategic perspective, Joseph Damond – former Chief Negotiator of the Vietnam-US Trade Agreement and President of Life Sciences at Crowell Global Advisors – emphasized Vietnam’s potential to become a global destination for biopharmaceutical production and research collaboration. Speaking at the discussion, Damond noted that key trends in the global biopharmaceutical industry include enhanced supply chain security, control of healthcare costs, and risks from new US tax policies. According to him, to actively participate in the global value chain, Vietnam needs to overcome limitations in market size and technological expertise – two advantages currently possessed by more developed countries.

Based on that, he proposed that Vietnam pursue a “third path” to enhance its position in the value chain: focusing on specialized niche segments, leveraging existing advantages in cost and quality, applying digital technology and artificial intelligence in production and research, and building a clear cooperation plan with international partners. Mr. Damond particularly appreciated the amended Pharmaceutical Law, effective from July 2025, which will be the legal foundation to create momentum for innovation and attract foreign investment in this field. “In the context of converging policy factors, technology, and international cooperation, Vietnam has every opportunity to break through and become a reliable partner in the global biopharmaceutical value chain,” Mr. Damond observed.

With a special affection for Vietnam and a desire to support Vietnam in its journey to enhance the global biopharmaceutical industry’s capacity, since the end of 2022, Mr. Joseph Damond, former Head of the Vietnam-US Trade Agreement negotiating team, senior consultant in the field of biopharmaceuticals and trade policy, together with Edelman Company, has launched the Vietnam Biopharmaceutical Industry Globalization Initiative.

As part of this initiative, in May 2023, Joseph Damond completed the Draft White Paper on Globalization of the Biopharmaceutical Industry in Vietnam, researching and analyzing the policy and legal environment for biopharmaceuticals in major East Asian economies and offering practical policy suggestions for developing the biopharmaceutical industry in Vietnam.

In June 2023, a Vietnamese delegation led by the Permanent Deputy Minister of Health, Do Xuan Tuyen, attended the International Bio Convention in Boston, USA. Notably, in September 2023, in New York, in the presence of Prime Minister Pham Minh Chinh, the Vietnam Pharmaceutical Corporation, the Biotechnology Innovation Organization, and Edelman Global Advisory signed a Memorandum of Understanding to establish a strategic partnership aimed at promoting the development of the biopharmaceutical industry in Vietnam.

According to statistics from the Ministry of Health, domestically produced medicines are currently mainly generic drugs. The number of facilities producing biological and biotechnological drugs is still modest, with 6 vaccine manufacturing plants, 1 biotechnology drug manufacturing facility, and 2 facilities in the research and development phase. Biological products mainly focus on a few vaccines produced using conventional technology; there are not many highly effective biological products used in the treatment of specialized, critical diseases or emerging epidemics. The research and development capacity of enterprises is still limited, failing to keep up with and apply modern biotechnologies.

Source : https://suckhoedoisong.vn/