Globally, antivenom markets are broken and unreliable, plagued by sky-high prices, severe shortages and the constant drop-out of producers from the market. In India, however, antivenoms are cheap and widely available.
So, how is India producing so much antivenom at such a low cost?
The Indian government has price controls on antivenom, such that no company can domestically sell the vials for more than 420 rupees (about $5 USD) each. Keep in mind that antivenom in the US usually costs around $10,000 to $20,000 per vial. In other countries, a vial will set you back a few hundred USD. So, how can Indian antivenom manufacturers are able to meet (and sometimes even undercut) this $5 price cap.
There are two principal reasons:
1.) Economies of Scale in Production Quantity
India has a large market for antivenom. Why? The country is densely populated, yet most areas are still exposed to wildlife. Agricultural work is conducted in a rustic manner, with farmers often going barefoot and picking with their hands. Many communities remain mired in poverty, with poor housing that may allow snakes to slither under doors or through cracks in the walls. These factors make India the world’s “snakebite capital,” with a million cases of envenoming estimated per year. Since so many people get bitten by venomous snakes across India, there is a high demand for antivenom, such that manufacturers can produce at scale.
2.) Economies of Scale in the Quantity of Products
Besides the high demand, there is a lot of bureaucracy involved in pharmaceutical operations: permits, legal proceedings, sales and marketing of the antivenom, etc. For a company that produces other pharmaceutical products besides antivenom, they are already engaging each state health ministry to sell pharmaceuticals. So, they can lean on these same salesmen, lawyers and experts to push antivenom through the drug acquisition system.
Insights from India’s Largest Antivenom Producer
ViNS is India’s largest antivenom manufacturer in terms of vial production; they produce about 2 million vials of Indian Polyvalent ASV annually, and another 500,000 vials for export. While this large company is a well-established antivenom supplier, all ASV manufacturers face fluctuating demand.
Domestically, states may supply ASV from different companies depending on the quoted prices. In addition, the quantity of snakebites each year is hard to estimate. Data is sparse, and most health facilities don’t currently report snakebites. Even if they did, the number of bites per year will fluctuate depending on factors such as rainfall and temperature. Unreliable demand is a big problem for manufacturers, given that antivenom supply is not so flexible.
Challenges to Production:
After getting the forecast, ViNS estimates that they need 9 months to one year to even begin producing that ASV. According to the forecast, manufacturers may have to acquire horses, which then require 6 months to slowly gain immunity to the venom. If a company produces more than one antivenom product, the WHO does not recommend switching a horse from one venom scheme to another (e.g. Indian venom to African venom).
There are many production factors that are outside of companies’ control but affect production. During the rainy season, horse farms are more likely to experience waves of infections. Sick horses cannot be used for antivenom production, according to WHO guidelines.
VINS claims that its biggest current hurdle is venom quality. The Irular Co-Operative is currently the only licensed venom producer in India but offers an impure product. Low quality venom must be filtered, contributing to some loss of venom. So, ASV producers must buy even more venom to make the same quantity of antivenom. At the same time, poor quality venom makes a less effective product (since some toxins will be degraded, and no amount of filtration can bring them back).
How Tenders Work in India:
Nationally, the Indian demand for antivenoms hovers around 4 million vials, and this is likely to increase over the coming years as the National Action Plan for Snakebite (NAPSE) increases awareness of proper first aid and improves access to healthcare. Improved data systems will also give state governments a better sense of local ASV needs. 90-95% of VINS’s antivenom sales go to the public sector through a “tender” system. How does this work?
State health ministries “float a tender,” which is basically a reverse auction. The health ministry stated how much ASV they want to buy, and companies compete to give the lowest price, called “filing for the tender”. The company that quotes the lowest price wins the tender. In this way, companies must compete to sell their products.
Some critics argue that this system can create a sort of “race to the bottom,” such that companies must cut corners in production to meet such low prices. Indeed, Indian antivenom has a poor reputation internationally for its quality. Researchers have cited dwindling protein concentrations in many of the largest manufacturers.
Outsourcing Serum Production to Simplify Business
In most of the world, antivenom producers keep their own horse farm and produce ASV from venom to vial. In India, however, the production chain is more fragmented. ASV manufacturers are shifting more and more serum production to 3rd party companies. Why?
This eliminates the need to constantly test venom quality and challenges of maintaining an equine farm: deciding how many ponies to immunize against which venoms, outbreaks, venom quality issues, stalled venom deliveries, the need for permits and lawyers, etc.
Takeaways
- Antivenom is expensive to produce
- It is a biological product with many moving parts
- Antivenom demand fluctuates and is difficult to forecast
- Antivenom supply is inflexible
- There are price caps on antivenoms in India, keeping prices very low
What does all this mean?
Antivenom is not an attractive market. Existing players may leave at any time, and current manufacturers are not interested in investing more than they currently do. Dialogue is going on between ASV manufacturers, the WHO and Indian government. India hopes to produce regional venoms and antivenoms, improve antivenom quality, and get approved by the WHO “Pre-Qualification Programme” (PQP), a certificate which would give them a stamp of WHO approval.
While global snakebite funds seem to be taking a hit, things are moving quickly in India. The 2024 release of the National Action Plan for the Prevention and Control of Snakebite Envenoming (NAPSE) triggered a cascade of action, and many states are now working on state action plans. Venom production centers are popping up across the country and wading through the bureaucracy to gain licenses and permissions. Policy is giving more legitimacy and resources to civil society actors, and, despite many remaining challenges, the future currently looks bright.
Want to learn more? Check out these links:
Venom, Antivenom Production and the Venomous snakes of India
Biological E. Antivenom Products
MoU Signed between Vins Bioproducts, India, and Atlantic Lifesciences, Ghana!
In India, a Need for New Antidotes to Curb Deadly Snakebites