Plant serves as an important source to produce cost-effective vaccine derivatives. Plant-based production of vaccine helps to reduce economic burden of infectious disease in emerging economies, owing to its large-scale production and cost-efficiency. Various clinical trials are focused on development of plant-based vaccines in therapeutic indications such as influenza, dengue, flu, and Ebola virus, which can be administered orally. Oral administration of these vaccines reduces the need of needles and syringes, which requires trained immunization staff and also reduces risk of Hospital Acquired Infections (HAIs).

The global plant-based vaccines market size is estimated to be valued at US$ 927.0 million in 2020 and is expected to witness a CAGR of 11.7% over the forecast period (2020–2026).

Existing key players and new entrants in the plant-based vaccines market are focused on extensive clinical trial studies to develop plant-based vaccines for numerous therapeutic applications.

For instance, Medicago Inc., a clinical-stage biotechnology company, which uses plant-based technologies to develop and produce novel vaccine and antibodies, is cultivating several tobacco plants (Nicotiana tabacum) at Durham's Research Triangle Park, North America, which will be used in testing and production of the flu vaccine. In March 2018, Medicago conducted phase III clinical trials to develop flu vaccine, which is expected to be launched in the market by 2020-21 influenza season. Furthermore, researchers require five to six weeks for production of plant-based vaccine, as compared to five to six month period to prepare the vaccine in chicken eggs, which is currently practiced by vaccine manufacturers.

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Besides cost-efficiency, plant-based vaccines offer several benefits over conventional egg-based vaccine production, in terms of production time and enhancing immune system of the patient. For instance, Medicago's Quadrivalent Influenza Vaccine (QIV) is produced using novel Virus-Like Particle (VLP) technology, which offers new approach in vaccine development and production. In VLP technology, vaccine mimics the native structure of viruses, allowing them to easily get penetrated into patient’s immune system. Moreover, the QIV vaccine lacks core genetic material, rendering them to become non-infectious and unable to replicate. This makes plant-based vaccine safe and effective in inducing immune response of patient similar to natural infection without infecting the patient.

Plant-based vaccine production offers better alternative over egg-based and cell-based vaccine production systems, by reducing lead time and increasing reliability and versatility. Furthermore, plant-based vaccine offers greater antigen specificity in disease treatment. Plant-based vaccine production enables manufacturers to create vaccine, which precisely matches the specific strain of influenza virus in patient’s circulation; as in case of flu infection, influenza virus mutates is constantly. For instance, according to Phase III clinical data study published by Medicago, in September 2017, Medicago's VLP vaccine during the phase II clinical trial stage showed higher antibody and Cell-Mediated Immunity (CMI) responses over comparator conventional vaccine.

However, several challenges in manufacturing of plant-based vaccines is expected to restrain growth of the market. Plant-based vaccine production is a new technology and involves complex manufacturing and regulatory process. In egg-based production, whole flu viruses are injected into eggs, which then replicate and form the basis for the vaccine. In plant-based vaccine production method, manufacturers use only specific gene, which codes for protein called hemagglutinin, which is responsible for triggering immune system and encodes it into the tobacco plant leaves. In this context, companies need to pursue the U.S. Food and Drug Administration (FDA) approval to state that not only plant-based vaccine is safe and effective, but also the hemagglutinin or other proteins, which can be extracted from the plant leaves are according to the mentioned standard and that the manufacturing process yields a uniform and reliable product.

Although various plant-based vaccines have been developed in various transgenic plants such as insulin in transgenic safflower, taliglucerase alfa in transgenic carrot, avian influenza vaccine in transgenic tobacco, and Ebola vaccine in transgenic tobacco, no plant-derived vaccine is yet approved for human consumption. Moreover, some of the challenges to develop effective vaccines from downstream processing to the implementation of the vaccines include, selection of antigen & plant expression host, uniformity of dosage, and manufacturing of plant vaccines according to Good Manufacturing Practice (GMP) procedures.

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