Analysis of the impact of technological changes in the plasma derivative industry on its two main products, normal serum albumin and antihemophilic factor in the United States
This study investigated, by written survey, the perceived impact of recent technological changes on the American plasma derivative industry as they affected its two major products, serum albumin and antihemophilic factor (AHF). Those surveyed included product manufacturers, distributors, researchers and end-users.
Survey responses were analyzed to determine which factors were considered most likely to affect the plasma derivative industry, and the degree of consensus or divergence of opinion among and between the various sectors of the industry.
Two factors were viewed as most likely to have an immediate impact on the industry: production of albumin and AHF by genetic engineering, which is nearing reality; and, the realization that despite efforts aimed at viral inactivation, viral infections can be transmitted through transfusion of blood products. Furthermore, there is no industry wide consensus regarding how these changes will affect production, safety, availability, and pricing of plasma products.
Responses indicated that because of the possibility of viral transmission via plasma-derived AHF, there is a perceived need for a genetically engineered substitute for AHF (but not for albumin) and an expectation that such a product will be available soon. Price is viewed as the most important factor for Albumin while safety was the most important factor for AHF. Price was the third most important factor for this product. Respondents generally agreed that higher prices for antihemophilic factor will be accepted if there are improvements in safety, but also in packaging, and distribution systems.
The study concluded that because safety issues were moot with regard to albumin, it and AHF were not viewed as closely similar products although both are derived from human plasma, and each is used in treating serious medical disorders.
Additional changes appear imminent, and the results of the survey reveal that distribution channels for these products are changing. It does seem apparent that the industry will have to develop joint ventures with genetic research companies, and this process is underway. Finally, to remain viable and profitable, manufacturers will have to focus on producing additional products from human plasma.