Rising demand for human biologics cannot be fulfilled by currently used mammalian cell culture production platforms, as these platforms are highly expensive and have limited scalability. However, recent developments in plant expression vectors, downstream processing, and glycoengineering have established plants as a superior alternative to biologics production. Plants not only offer the traditional benefits of proper eukaryotic protein modification, but also have the potential to develop biologics at a lower cost with high scalability. They increase the production of biologics at unprecedented speed and also helps in controlling potential pandemics such as covid-19, Ebola and others for better efficacy or safety.
Plant-based biologics is expected to be the next major commercial development in the field of biotechnology. Some of the advantages offered by plant-based biologics in terms of product safety, production scale and economy, ease of storage, and distribution cannot be fulfilled at same time by any other current commercial system. Plant-based biologics also provide the opportunity to supply low-cost drugs and vaccines to the emerging economies such as Argentina, Brazil, China, India, Indonesia, Mexico, and others.
Plant-based Biologics Market – Impact of Coronavirus (Covid-19) Pandemic
The rapid spread of Covid-19 infection has positively impacted the plant-based biologics market as it has increased the demand of plant-based vaccines for prevention of Covid-19 infection. Rapid development of novel diagnostics, therapeutics, and vaccines is needed to mitigate spread of the SARS-CoV-2 virus and prevent future reoccurrences. Moreover, establishment of safe, efficacious vaccine platforms will be critical to develop a stronger level of preparedness for future outbreaks. Multiple vaccine technology platforms are being employed by companies such as iBio Inc., PlantForm to address the COVID-19 pandemic. More traditional approaches are based on live or killed viruses, while newer solutions rely on recombinant DNA or messenger RNA (mRNA). AstraZeneca, Pfizer, Moderna, and CureVac, among many others, are progressing new vaccines at an accelerated pace, with some already in late-stage clinical trials with tens of thousands of participants.
The plant-based biologics market is estimated to be valued at US$ 19.4 million in 2020 and is expected to exhibit a CAGR of 3.4% during the forecast period (2020-2027).
Figure 1. Plant-based Biologics Market Share (%) Regional Analysis, 2027
Robust pipeline of plant-based biologics are expected to boost growth of the plant-based biologics market
Major players in the market have a number of biopharmaceuticals products in clinical trials, or products that are awaiting approval from regulatory authorities. Thus, the robust pipeline of biopharmaceutical products is expected to significantly drive growth of the global plant-based biologics market in near future. For instance, Protalix Biotherapeutics’s, a global plant based biologics drug manufacturing company one major plant-based drug candidates in their pipeline – Pegunigalsidase alfa is designed to be a plant cell culture-expressed and a chemically modified version of the recombinant alpha-Galactosidase-A protein. In clinical research, pegunigalsidase alfa has exhibited a favorable circulatory half-life with targeted enzyme activity in organs affected by Fabry disease. The product is in phase 3 clinical trial.
Furthermore, iBio, Inc. is a plant–based biologics manufacturing company, which manufactures monoclonal antibodies, antigens, bioinks, and other recombinant proteins using FastPharming technologies has three plant-based biologics, which are in preclinical stage. In terms of human disease, IBIO-100 targets fibrosis, a leading cause of organ failure worldwide. IBIO-200 is a virus-like particle (VLP) vaccine designed as a rapid medical countermeasure solution to the COVID-19 outbreak. IBIO-201 is a vaccine targeting COVID-19 using the patented LicKM platform. Hence, such product developments are expected to positively impact the global plant-based biologics market growth.
|Base Year:||2019||Market Size in 2020:||Over US$ 19.4 Mn|
|Historical Data for:||2017 to 2019||Forecast Period:||2020 to 2027|
|Forecast Period 2020 to 2027 CAGR:||3.4%||2027 Value Projection:||Over US$ 24.9 Mn|
Leaf Expression Systems, Zea Biosciences, Planet Biotechnology Inc., InVitria, PlantForm Corporation, IBIO, Inc., Mapp Biopharmaceutical, Inc., Pfizer Inc., Ventria Bioscience Inc., Medicago Inc., Eleva GmbH, Kentucky Bioprocessing, LLC, Solarvest Bioenergy Inc., and Byondis B.V.
|Restraints & Challenges:||
Plant-based Biologics Market – Restraints
The stringent regulatory guidelines for the production of plant-based biologics is one of the major factors that is expected to restrain growth of the plant-based biologics market over the forecast period. Moreover, concerns regarding contamination and environmental risks is another factor that is expected to hinder growth of the market. For instance, ProdiGene, Inc. Texas, a U.S.-based company introduced large-scale production of transgenic maize that produces trypsin. However, the U.S. Department of Agriculture (USDA) discovered that plant remnants from a previous ProdiGene trial had contaminated a nearby conventional field. ProdiGene was fined US$ 250,000 and US$ 3 million to cover the cleanup operation of mishandling the field test. The punitive action forced ProdiGene into bankruptcy. This event represented a significant setback to the commercial use of plant molecular farming (PMF).
Plant-based Biologics Market – Regional Analysis
On the basis of region, the global plant-based biologics market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa.
North America is expected to be the most lucrative region in the plant-based biologics market over the forecast period. This is owing to the presence of various private and government research organizations focused on R&D activities to develop plant-based biologics in this region. For instance, Fraunhofer Center for Molecular Biotechnology completed phase I clinical trials for the study of safety and immunogenicity of plant-derived recombinant protective antigen (Biological: PA83-FhCMB) for anthrax vaccine in healthy adults in the year 2015. Furthermore, key players in North America are focused on conducting clinical trials to develop plant-based biologics for the treatment of various chronic diseases, which is further expected to drive growth of the plant-based biologics market in this region.
In addition, Latin America plant-based biologics market is expected to witness significant growth during the forecast period, owing to launch and construction of manufacturing facilities for plant-based biologics. For instance, in June 2017, Brazil-based Axis Biotec Brasil announced the construction of tobacco leaves-based biopharmaceutical expression and manufacturing facility in Brazil for the development of biosimilar and protein and biobetter drugs for the Brazilian market.
Figure 2. Plant-based Biologics Market Value (US$ Mn) & Y-o-Y Growth (%), 2016-2027
Plant-based Biologics Market - Competitive Landscape
Key players operating in the global plant-based biologics market include Leaf Expression Systems, Zea Biosciences, Planet Biotechnology Inc., InVitria, PlantForm Corporation, IBIO, Inc., Mapp Biopharmaceutical, Inc., Pfizer Inc., Ventria Bioscience Inc., Medicago Inc., Eleva GmbH, Kentucky Bioprocessing, LLC, Solarvest Bioenergy Inc., and Byondis B.V.
Plant-based biologics are biologic drugs that are manufactured by using plant molecular farming. They are also known as plant-made biologics (PMB). The applications and advantages of plant-based biologics have stretched beyond the traditional boundaries of vaccines and therapeutic proteins. For instance, bacterial colicins derived from plants in 2015 were recently proven effective as food additives for controlling pathogenic bacteria in food products. These colicins are highly effective (even when used in lower concentrations) to fight against all the pathogenic Escherichia coli strains that cause food poisoning. Moreover, it costs around US$ 1.00 for manufacturing one gram of purified colicins, which is commercially viable.
The increasing demand for biologics for various chronic diseases and rising investments in R&D for the production of biologics are expected to contribute significantly to the growth of plant-based biologics market. For instance, according to the Biotechnology Innovation Organization (BIO) 2015, over 250 biologic therapies and vaccines have changed the lives of hundreds of millions of patients. Moreover, according to the same source, over 900 biologics are currently (2018) under the stage of development for over 100 diseases in the U.S. Furthermore, according to the Pharmaceutical Research and Manufacturers of America (PhRMA), 2016, member companies invested around US$ 58.8 billion in research and development in 2015, of which, majority of the investments was made by all the biopharmaceutical companies in the U.S. for the treatment of rare diseases.
Many biopharmaceutical companies are focused on developing plant-made pharmaceuticals using various plants such as tobacco, duckweed, moss, alfalfa, and other plants, which is expected to propel growth of the plant-based biologics market. For instance, in September 2015, LeafBio, Inc., the commercial partner of Mapp Biopharmaceutical, Inc. (Mapp), was granted fast track designation by the U.S. Food and Drug Administration (FDA) for their plant-made drug ZMapp for the treatment of Ebola virus disease.
However, stringent regulatory guidelines for the production of plant-based biologics is one of the major factors restraining growth of the plant-based biologics market. Moreover, concern regarding contamination and environmental risks is another factor restraining growth of the market.
Key features of the study:
“*” marked represents similar segmentation in other categories in the respective section.
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