For more than 100 years, the mainstay of primary treatment for snakebite has been the administration of antivenoms. Antivenoms work by boosting our immune response after a snakebite. They are made by immunizing donor animals such as horses or sheep with snake venoms. These animals have robust immune systems, and produce powerful antibodies that can bind to snake venom components, enabling our own immune defences to eliminate these toxins. Antivenoms are obtained by harvesting and then purifying the antibodies from plasma produced by the donor animal. Good-quality antivenoms can literally make a difference between life and death.

However, the potential of antivenom treatment to significantly contribute to effectively controlling the burden of snakebite morbidity, disability and mortality has been limited by a number of factors:

• Poor regulatory frameworks for antivenoms, an absence of appropriate reference standards, and a lack of expertise and capacity within national drug control laboratories;
• Inadequate investment in research and development that would lead to improved product safety, efficacy and clinical effectiveness;
• Absence of minimum specifications for neutralization of overall lethality and specific toxic activities of antivenoms that reflect clinical effectiveness definitions in defined markets;
• Traditional belief systems that associate snakebite envenoming with supernatural, rather than health-related events;
• Sustained erosion of confidence in antivenom products due to poor training of health workers, marketing of poor quality, unsafe or ineffective products, and other factors;
• Health system weaknesses, inadequate infrastructure and inefficient distribution of antivenoms;
• A cycle of consequences driven by low investment in procurement, poor quality and specificity of some antivenoms which erodes sales, drives down production, curtails profitability, driving up prices and driving down accessibility – which perpetuates market decline and drives manufacturers out of the antivenom supply sector.

The consequence of these and other issues has been most dramatic in Sub-Saharan Africa, where local manufacturing of antivenoms has always been inadequate to the needs of the continent. Major multinational antivenom producers have cited competition from inferior (and sometimes less expensive) products as the reason for their abandonment of production for Sub-Saharan Africa. The loss of effective products and their replacement with both poor quality products, and products that have not been adequately evaluated prior to market penetration, has compounded the collapse of confidence in the use of antivenoms among health workers. Furthermore, poor data on the number and type of snake bites, and difficulty in accurately establishing forward needs assessments for specific antivenom products in each country, further discourages the participation of mainstream pharmaceutical manufacturers.