The internal or female condom (IC) is a valuable barrier method offering dual protection against unintended pregnancy and sexually transmitted infections. Users often observe a significant price difference compared to the male condom (MC), where the internal version can cost three to four times more commercially. This disparity is a direct result of several compounding economic and logistical factors, including the physical complexities of the product, the economics of scale, and the specific regulatory pathways required for market entry.
Manufacturing Complexity and Materials
The fundamental physical design of the internal condom contributes substantially to its higher unit manufacturing cost. Unlike the simple, tube-like structure of the male condom, the internal condom incorporates a sheath with two rings: a flexible inner ring for insertion and an outer ring that remains outside the body. This complex structure requires a multi-step, intricate assembly process that is more difficult to fully automate compared to the continuous, high-speed dipping process used for standard male condoms.
The material used in production represents another significant cost driver, as internal condoms often rely on specialized, non-latex polymers. While most male condoms are made from inexpensive natural rubber latex, internal versions typically use materials like nitrile or polyurethane. Polyurethane, a synthetic elastomer, can cost 10 to 20 times more to produce than standard latex. Nitrile, another common non-latex material, also carries a higher raw material cost than latex.
The finished internal product requires a larger surface area of these more expensive materials compared to a standard male condom. Although advances in automation have helped reduce manufacturing costs for newer generations, the production process remains relatively costly. The combination of a multi-component design and reliance on higher-cost synthetic materials establishes a higher baseline price for every unit produced.
Market Size and Production Volume
The vast difference in global production volume between the two product types severely limits the ability of internal condom manufacturers to benefit from economies of scale. The global market is overwhelmingly dominated by the male condom segment, which accounts for over 95% of the total market share. The market for internal condoms is comparatively small, meaning that fixed costs are distributed across a far smaller number of units.
Manufacturers of male condoms can spread the high fixed costs of research and development, factory tooling, and machinery across billions of units annually, resulting in a minimal overhead cost per unit. For example, in 2023, one major global health organization distributed nearly 270 million male condoms but only 1.9 million internal contraceptives. This low consumer adoption prevents internal condom manufacturers from achieving the same cost-saving efficiencies of mass production.
When production volume is low, the initial investment in specialized equipment and quality control systems is disproportionately high for each unit manufactured. The market remains in a cycle where high manufacturing cost contributes to low consumer demand, which keeps production volume low and prevents major price reduction. This lack of market competition and mass-scale production volume is a primary economic barrier to affordability.
Regulatory Hurdles and Distribution Costs
The process of gaining regulatory approval for a new internal condom design is historically a much more rigorous and expensive endeavor than it is for the male version. For many years, the U.S. Food and Drug Administration (FDA) classified the internal condom as a Class III medical device, the most stringent category requiring lengthy and costly Pre-Market Approval (PMA). Male condoms were classified as Class II devices, which require the less burdensome 510(k) clearance.
Although the FDA reclassified the internal condom to Class II in 2018, reducing some regulatory burden, new devices must still undergo specific, expensive clinical trials. Due to the unique design and placement of the internal condom, regulators often require dedicated contraceptive effectiveness studies, adding significant time and expense to the approval process. This systemic cost of gaining market authorization acts as a high barrier to entry for potential competitors, limiting the number of available products.
The distribution system also contributes to the high final price, as the market is heavily reliant on public health programs and subsidized channels. The majority of internal condoms are procured by governments, non-governmental organizations (NGOs), and international funders for free or low-cost distribution. This reliance on public sector sales, rather than high-volume commercial retail, introduces logistical complexities and procurement overheads. Navigating these specialized, subsidized distribution chains adds systemic costs that are ultimately reflected in the retail price.