The plasma industry is at a crossroads, with rising input costs but with revenues that struggle to cover them. While plasma acquisition costs play a large role in the overall expenditure incurred to produce plasma derived therapies, the manufacturing cost also plays a critical role, as billions are invested in fractionation and purification projects to expand and modernize plasma manufacturing plants around the world. Still, there is continued interest from veteran and new players alike in expanding the industry with new facilities, especially in countries which import all their products but wish to have their own domestic industry.

 This report is a comprehensive resource of information which provides a clear and broad understanding of the plasma manufacturing industry. It includes a detailed description of the plasma manufacturing process along with relevant data/benchmarking on immunoglobulin (IgG) production yields, key equipment pricing, and on the major vendors that support the industry.

 OBJECTIVES

 Companies are faced with important questions in relation to their position in this competitive industry, including:

• How and why have plasma fractionation costs risen and what components have mostly contributed to that change?
• How can companies respond to increasing customer demand while maintaining or even reducing manufacturing costs?
• How do companies compare on their efficiency in producing IgG from a liter of plasma, and what can they do to improve their performance?
• Which suppliers can help them improve process efficiency, reduce costs or increase automation?
• How much does key equipment, materials and certain services cost for new products or process development?
• What novel fractionation or production methods are in development that could affect the incumbent industry?

 This report answers these questions and many others, using multiple data, analysis and trends to help companies understand where they stand in the present and future competitive environment  and the key operational risks they face in this space. It also provides key benchmarks on yields that are of major importance for all organizations active in the plasma industry and suggests some general steps companies can take to improve their yields going forward. It is a first-of-its-kind report covering many aspects that have never been explored in this format and level of detail. Overall, this report is a key resource with a lot of insight across a wide range of aspects of the manufacturing of plasma proteins. It will be highly valuable to all stakeholders in involved in the plasma industry, or planning to invest in it.

METHODOLOGY

Experts Interviews. Over 60 interviews were conducted with industry experts experienced in every of the multiple aspect of plasma fractionations, as well as with engineering companies, suppliers of the equipment, supplies, services of fractionation facility.

MRB database: The Marketing Research Bureau has an extensive database covering over forty years of plasma fractionation industry operations. Some of the invaluable data and information have been included in this report, ensuring that it is not confidential and available to the general public.

REPORT CONTENTS (185 PAGES IN TOTAL)

The report begins with a broad background and history of plasma fractionation, including the key steps in the fractionation process, and how it influences the present environment. The current challenge of rising costs, especially since the beginning of the Covid19 pandemic are detailed, giving an impetus to the companies to make difficult and focused changes so as to improve their efficiency and maintain viability.

 IgG is the most important plasma protein and the focus of many companies at present. The report discusses how different processes and techniques used within the fractionation industry affect the IgG production yields. It also provides the estimated yields of all the major IgG brands, and the reasons of their differentiation.

Historical and current costs of key equipment used in plasma fractionation are provided, along with an analysis on the reason for inflation-adjusted changes. Other inputs, such as various energy costs are also explored, which are significant contributors to overall costs in this industry.

 The report also delves into trends in packaging, single-use systems, supply chain management, regulatory actions against plasma companies, automation trends and sustainability trends. Special attention is paid on how the Covid19 pandemic has affected, and continues to affect these areas of plasma products manufacturing. Key suppliers to the industry – engineering companies and others – are profiled, with descriptions of the ways they can bring plasma fractionation companies to higher levels of efficiency and rationality.

 This report will support companies in their understanding of their positioning across a broad range of manufacturing activities and serve as an essential comparison and cross-check tool for those which are currently active in the plasma fractionation space. It will help them understand some of the competitive strengths or weaknesses in this dynamic, but challenging industry. It will also highlight the capabilities of the main vendors to the plasma fractionation field, facilitate their assessment in regard to the customers’ requirements, and help them identify potential suppliers who may best contribute to efficiency enhancement or facility improvements in the future.