Pharmaceutical and medical device companies conduct tests to detect bacterial contamination in injectable drugs, vaccines, and medical devices. While the industry historically relied on blood extracted from horseshoe crabs to conduct such tests, approved and readily available synthetic alternatives are now available. Abbott continues using horseshoe crab blood despite pressure on a keystone species whose eggs provide critical food for at least 11 species of migratory shorebirds and fish species.[1] A decline in horseshoe crabs threatens the entire Atlantic coastal ecosystem. For example, the red knot shorebird population has plummeted 75% since the 1980s,[2] from approximately 50,000 to 13,000 birds, due to horseshoe crab egg depletion.[3]

Declining Crab Population

The biomedical industry harvests blood from millions of horseshoe crabs annually, with morality rates of 15 - 30%.[4] Population declines, tightening harvest regulations, and ongoing environmental litigation are compounding supply-chain vulnerability and elevating regulatory and reputational exposure for companies dependent on this input.[5],[6]

Synthetic Testing Is Now a Cost-Effective and Feasible Replacement

Synthetic alternatives offer more reliable and cost-effective testing for contamination.[7] They avoid quality and supply issues tied to horseshoe crab blood and deliver more consistent results.[8] With new U.S. Pharmacopeia standards taking effect in May 2025, these synthetic alternatives are now fully recognized by regulators – removing the primary adoption barrier.[9]

Abbott is Falling Behind Industry Leaders and Its Competitors

Industry leaders including Eli Lilly (which secured FDA approval for recombinant Factor C-tested drugs in 2018), GSK, Amgen, and Sanofi have adopted synthetic contamination testing, citing reduced costs, quality improvements, and enhanced supply chain security.[10],[11]

Failure to Transition Amid Tightening Regulations and Reduced Supply Poses Material and Reputational Risk

State legislatures are increasingly restricting horseshoe crab harvesting. In 2025, New York banned both commercial and biomedical collection, and similar measures are underway in Connecticut and New Jersey.[12] New regulations are tightening the already limited supply of horseshoe crab blood. Abbott’s continued reliance on horseshoe crab blood exposes the Company to escalating supply, regulatory and reputational risks. Abbott's 10-K highlights that such disruptions can result in "increased costs, lost revenue, [and] damage to customer relations."[13]

Without disclosure on testing methods or a strategy to adopt synthetic alternatives, shareholders cannot assess Abbott’s exposure to regulatory tightening, supply instability, or rising costs. Greater transparency is needed to evaluate how the Company is safeguarding operational continuity and investor returns.

[1] https://www.horseshoecrab.org/nh/eco.html

[2] https://www.usgs.gov/publications/effects-horseshoe-crab-harvest-delaware-bay-red-knots-are-harvest-restrictions-working

[3] https://www.usgs.gov/publications/red-knot-stopover-population-size-and-migration-ecology-delaware-bay-usa-2021

[4] https://whyy.org/articles/delaware-bay-female-horsehoe-crabs-spared-commercial-harvest-2023/

[5] https://www.mass.gov/news/regulatory-updates-2024-q1-and-q2

[6] https://biologicaldiversity.org/w/news/press-releases/maryland-court-orders-release-of-hidden-horseshoe-crab-mortality-data-2025-03-20/

[7] https://pmc.ncbi.nlm.nih.gov/articles/PMC6200278/

[8] https://pmc.ncbi.nlm.nih.gov/articles/PMC6200278/

[9] https://www.mbl.edu/news/us-pharmacopeia-oks-synthetic-alternatives-horseshoe-crab-blood

[10] https://reviverestore.org/eli-lily-sets-the-gold-standard-for-sustainable-endotoxin-testing/

[11] https://pharmascore.org/

[12] https://www.nysenate.gov/legislation/bills/2025/S4289 ; https://portal.ct.gov/governor/news/press-releases/2023/08-2023/governor-lamont-signs-legislation-banning-the-harvesting-of-horseshoe-crabs?language=en_US; https://www.littoralsociety.org/protect-horseshoe-crabs.html

[13] https://www.abbottinvestor.com/static-files/2b75fde0-1c65-4b0e-b0b6-ea78d31cb652