QYOBO API1000 Price Index

API prices were highly volatile over the past year, shaped by a complex mix of market forces. The QYOBO platform tracks these trends across 5,000+ substances – APIs, excipients, and key starting materials. In QYOBO’s API1000 Index, covering 1,000 of the most commonly traded APIs, 54% declined, 34% increased, and 12% remained stable (Figure 1).

Differences in quality frameworks, reflected in pharmacopeial standards, and their global adoption, create distinct price baselines, while upcoming patent expiries reshape markets well before exclusivity ends.

Pharmacopeial standards set different price baselines

Pharmacopeial standards are legally recognized reference documents for pharmaceutical ingredients, issued by regulatory bodies such as the Japanese Pharmacopoeia (JP), European Pharmacopoeia (EP), United States Pharmacopeia (USP), and Indian Pharmacopoeia (IP). Differences in quality, testing, and control requirements, as well as market adoption and manufacturing scale, influence API pricing.

To illustrate how these frameworks impact cost structures, QYOBO analyzed a smaller sample of 12 APIs with abundant data across the four major compendia – JP, EP, USP, and IP – comparing their average market price levels (Figure 2):

JP: On average, +87% above the global market price across all 12 substances (ranging from +9% for Tacrolimus to +186% for Terbinafine).
EP: +22% vs. the global market average (–19% for Tacrolimus to +128% for Rabeprazole).
USP: –8% vs. the global market average (–30% for Diclofenac to +29% for Ursodeoxycholic Acid).
IP: –26% vs. the global market average (–66% for Diclofenac to +24% for Flurbiprofen).

While both the U.S. Pharmacopeia (USP) and European Pharmacopoeia (EP) are globally recognized, USP specifications tend to be adopted more broadly, which supports larger production runs and wider supplier bases (Figure 3). The Japanese Pharmacopoeia (JP) and Indian Pharmacopoeia (IP) are more regional in application, with JP typically pricing higher and IP lower, most likely reflecting differences in documentation scope and quality requirements.

Patent expiry shifts API prices ahead of time

The patent for the monohydrate phosphate salt of Sitagliptin, held by Merck & Co. (known as MSD outside of the U.S. and Canada) and covering the active ingredient in JANUVIA, will expire on November 24, 2026, with pediatric exclusivity extending to May 24, 2027 (Merck). The co-formulation of Sitagliptin and Metformin (JANUMET) is protected by a separate Merck & Co. patent expiring on January 21, 2029, with pediatric exclusivity extending to July 21, 2029 (Merck).

Ahead of these patent expirations, the QYOBO platform shows a substantial price decrease over the past 5 years for Sitagliptin, reflecting intensifying competition in the market (Figure 4).

A total of 47 API manufacturers have already submitted a USDMF for Sitagliptin (Figure 5, QYOBO platform), and 20 ANDAs have received tentative FDA approval.

Interestingly, Zydus Lifesciences has already entered the market using the sitagliptin free base rather than the patented phosphate salt, a strategic move under a 505(b)(2) NDA pathway allowing earlier market entry (FDA).

Up-to-date, granular market data available on the QYOBO platform

The QYOBO platform continuously updates price insights across thousands of APIs (small molecules and biologics), excipients, intermediates, and OTC ingredients. In this blog post, you can explore how prices evolve across these categories for a set of spotlight substances – and on the platform, dive deeper into current trends, regional variations, and detailed pricing data that power data-driven decisions across the pharmaceutical value chain.