Currently, the two approved methods of Biopharmaceuticals manufacturing widely used in Europe are mammalian cell culture manufacturing and microbial fermentation. The high production and layout costs, bottlenecks in downstream processing, high vulnerability to microbial contamination, lengthy timescales and capacity constraints associated with these traditional manufacturing processes fuel the demand for innovative and cost-effective manufacturing alternatives such as the use of transgenic animals and plants for the production of biopharmaceuticals.
"Plant Molecular Farming (also referred to as Biopharming), which involves the use of transgenic plants as factories for the production of pharmaceuticals, is still in an infancy stage in Europe, as no Plant Manufacturing Pharmaceutical (PMP) for human use has been granted marketing authorization for market commercialization to date", explains Aiswariya Chidambaram, Research Analyst at Frost & Sullivan". With Europe having entered into the Biopharming industry at a relatively later stage compared to North America, most European companies appear to be in earlier stages of R&D activities."
Europe represents only 8 per cent of the field trials for Biopharming and holds 19 per cent of Biopharming patents worldwide. However, the public sector research activities, with regard to technology platforms and containment facilities, are on par with that of the United States. Within the European Union, Germany, the United Kingdom, France, Italy and Spain are the forerunners in Plant Molecular Farming public sector research.
Commercial players in this market are primarily of two types, namely technology providers, who develop proprietary technologies including expression systems and choice of crop and conduct feasibility analysis for other companies, and companies who develop their own PMPs for commercialization. The two major multionational companies in Europe are Bayer and BASF (Germany) through the acquisition of start-up companies like Icon Genetics (Germany) and CropDesign (Belgium) respectively.
The cost to build, equip and validate a bio manufacturing facility ranges anywhere between $300 million and $850 million, depending on the product manufactured, and requires four to five years to become completely operational. With Plant Molecular Farming, the capital costs can be reduced up to 80 per cent and potential production cost savings are generated as recombinant proteins can be produced at 0.1 per cent and 10 per cent of the cost of mammalian cell culture systems and microbial cell culture systems, respectively. Hence, Plant Molecular Farming could be a boon, particularly for low-cost developing countries with insufficient funding.
Although PMPs make a significant appeal in the ongoing biotechnology revolution in Europe in terms of scientific concept, costs benefits and higher production flexibility, many environmental, regulatory, technological and economic barriers restrict the approval of PMPs to be completely realized and be able to attract increased funding from Big Pharma companies. The key challenges of hazards to the food industry and environment need to be addressed satisfactorily. "The industry on the whole is striving to achieve this, and it is expected that the innovative strategies and novel technologies introduced by companies to overcome public and regulatory concerns would take the market to the next level," concludes Aiswariya Chidambaram.
If you would like to know more about Plant Molecular Farming, please send an email with your full contact details to Janique Morvan, Corporate Communications, at janique.morvan[.]frost.com.
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