Blood and Organ Banks (U.S.) — Industry Primer

NAICS 2022 code 621991. A Histometrics primer for public- and private-market investors.

NAICS = North American Industry Classification System, the U.S. government's standard for grouping businesses by primary activity.

1. Overview

This industry collects, tests, processes, stores, and distributes human biological materials — whole blood and its components, source plasma, organs for transplant, and specialty banks (cord blood, sperm, eggs, embryos, eye/tissue). It is the plumbing between donors and the hospitals, drug makers, and patients who need the material. It is an essential service, not a single investable business.

Two things make it unusual. First, it is split down the middle by ownership and profit motive. The whole-blood and organ side is almost entirely nonprofit — the American Red Cross, community blood centers, and federally designated organ procurement organizations run on cost recovery, not margin. The source-plasma side is for-profit and fast-growing, feeding a multibillion-dollar plasma-derived-medicines business. Second, the material itself is a gift or a lightly paid donation, not a mined or manufactured commodity, so the binding constraint is almost always donor supply, not customer demand.

For a general investor the practical takeaway is: you cannot buy "the blood banks." The nonprofit core is not investable at all. Public-market exposure is mostly indirect — through the plasma-and-plasma-medicines complex (CSL, Grifols, Takeda, and smaller ADMA Biologics), plus makers of collection equipment/diagnostics (Haemonetics) and organ-preservation technology (TransMedics, XVIVO). Private-market money has flowed mostly into for-profit plasma collection and cord-blood storage.

Reported federal receipts for the industry were about $19.9 billion (2022) [1]. That figure understates the true economic system, for reasons explained in Section 3.

2. What it is and how it's structured

The Census index places these activities in 621991 [2]:

• Blood banks and blood donor stations — whole-blood and platelet/plasma collection for transfusion.
• Plasma collection services and plasmapheresis centers — "source plasma" collected (usually from paid donors) as raw material for medicines.
• Organ banks and organ donor centers — recovery, preservation, and storage of deceased-donor organs.
• Eye banks, sperm banks, egg/ova banks, embryo storage, placenta/cord-blood banks — specialty biological banking.

What it excludes (and where those dollars land instead):

• Turning plasma into drugs — the fractionation and manufacture of immunoglobulin (IG), albumin, and clotting factors — is pharmaceutical manufacturing, NAICS 325414 (Biological Product Manufacturing), not this code [2]. This matters enormously: most of the value and virtually all of the profit in the plasma chain sit in 325414, one step downstream of the collection centers counted here.
• Blood and infectious-disease testing labs are NAICS 621511 (Medical Laboratories) [2].
• Transfusion services and transplant surgery run inside hospitals are captured under NAICS 622 (Hospitals), not here [2].
• Other outpatient/ambulatory functions may fall in NAICS 621999 [2]. Because NAICS classifies an establishment by its primary activity, a single health system can run blood-bank or transplant functions without reporting them as separate 621991 establishments.

Ownership is the structural dividing line. Whole-blood collection is dominated by large national and regional nonprofits; America's Blood Centers members alone supply close to 60% of the U.S. blood supply [3]. Organ procurement organizations (OPOs) operate as federally designated, nonprofit or hospital-affiliated entities, not open-market businesses. Source-plasma collection and cord-blood storage are overwhelmingly for-profit — including the U.S. collection subsidiaries of global drug makers and a handful of private-equity-backed operators.

3. How big it is

Our ground-truth federal figures for NAICS 621991 combine the 2022 Economic Census (receipts, firms, concentration) with 2023 County Business Patterns (CBP: establishments, employment, payroll). The code was unchanged across these vintages, but the years and survey programs differ [1][4].

(CRn = the combined revenue share of the n largest firms. HHI = the sum of squared market shares; a lower number means less concentrated. SBA = U.S. Small Business Administration.)

The concentration data describe a barbell: an HHI of 573.6 (well below the 1,500 "unconcentrated" threshold) with a CR4 of 41.5% means a small group of large operators captures most revenue while a long tail of local and specialty operators dilutes the overall index. Roughly 2,110 establishments run by only 371 firms confirms the big operators run many sites each [1][4].

Undercount and scope caveats — read these before quoting the $19.9B:

1. The profit lives next door. The high-value activity — making IG and other medicines from collected plasma — is booked in NAICS 325414, not here. Counting only 621991 captures the collection and processing layer, not the drug economics it feeds. Global plasma-derived-therapy sales are far larger, headed toward roughly $58 billion by 2028 [6].
2. Cost recovery, not market price. Nonprofit blood centers price blood to recover costs, so their receipts reflect processing fees, not the clinical value of the product. Organ recovery is reimbursed at cost, so OPO "revenue" is not profit.
3. Coverage gaps. CBP and the Economic Census count employer establishments with paid staff; they exclude most government employees and government-owned establishments, and hospital-embedded transfusion sits inside hospital accounts (NAICS 622), invisible here [7].
4. No fine-grained splits. Our federal data give no separate blood-versus-organ breakout, capacity utilization, unit pricing, product-outdate rate, or operating margin. None should be inferred; where a value is suppressed we do not state one.

Treat ~$19.9B as the size of the collection-and-banking layer, with the real economic system materially larger once the downstream medicines are added.

4. The investable universe

There is no pure public play on U.S. blood or organ banking — the Red Cross, community blood centers, and OPOs are nonprofits and cannot be bought. Public exposure is indirect. Figures below are recent reported scale, not recommendations. An American depositary receipt (ADR) is a U.S.-traded certificate representing shares of a foreign company; OTC = over-the-counter (traded off the main exchanges).

Plasma and plasma-derived medicines (collection networks fall in 621991; profits are downstream in 325414):

Collection equipment, diagnostics, and organ-preservation technology (they sell into the industry rather than operating banks):

Private and nonprofit owners dominate collection. On the blood side: the American Red Cross (about 40% of the U.S. blood supply), plus independent community centers — Vitalant, OneBlood, New York Blood Center Enterprises, Versiti, LifeSouth — that together supply the rest [3][16]. Private plasma collectors include family-owned Octapharma and Kedrion/KedPlasma, and independent contract collector ImmunoTek [17][18][19]. Organ recovery runs through 56 nonprofit OPOs under federal designation [20]. For private-market investors, the accessible assets are for-profit plasma collection networks and cord-blood operators — both areas where private equity and strategic fractionators have been active; nonprofit blood centers and OPOs offer no ordinary common-equity ownership.

5. How the money works

Three genuinely different business models sit under one code.

A. Community blood banking (nonprofit, volunteer donors). Donors give free. Revenue is a per-unit cost-recovery fee charged to hospitals for each processed component — a unit of red blood cells, platelets, or plasma — plus testing, transfusion services, grants, and philanthropy. The median U.S. hospital paid about $226 per unit of leukoreduced red cells in 2023 [21]. Contracts run 3–5 years, often on consignment (the hospital pays when a unit is used), so prices are sticky and reset only at renewal [22]. The economics are hard: fixed costs of donor recruitment and testing are high, blood is perishable (red cells last ~42 days, platelets ~5–7), and transfusion volume has fallen structurally. The Department of Health and Human Services (HHS) has described many blood centers as running on narrow or negative margins [23]. Key operating levers: units collected per drive, product yield, wastage/outdate rate, and cost per unit — this is a scale-or-merge business, not a growth one.

B. Source plasma → medicines (for-profit, paid donors). This is the growth engine. Donors are compensated (commonly $50–$120 per visit) and may donate up to twice weekly, which is why the U.S. — with ~4% of world population — collects roughly 70% of the world's source plasma across 1,200+ centers, exporting billions in plasma-derived products (~$6.2B in 2024) [24]. The unit economics are those of a raw-material feedstock: liters collected per center per day, donor compensation + labor + testing cost per liter, and the grams of IG yielded per liter — then finished IG is sold as a high-margin medicine. IG demand (immune deficiency plus a widening list of neurological and autoimmune conditions) has grown double digits and is the profit center of the whole chain [6][8]. Vertical integration — owning collection and manufacturing — is the winning structure.

C. Organ procurement (nonprofit, cost-reimbursed). The 56 OPOs are effectively geographic monopolies, each assigned a donation service area, paid through a "standard acquisition charge" billed to transplant hospitals for each organ recovered and ultimately reconciled through Medicare cost reports [20][25]. Selling organs for transplant is a federal crime under the National Organ Transplant Act (NOTA), which permits only reasonable payment for procurement, transport, preservation, quality control, and storage [26]. Performance is measured on organs recovered and transplanted per eligible donor, not dollars.

D. Cord-blood banking (subscription-like). Private banks charge parents an upfront fee (often ~$1,350) plus annual storage (~$100–175) to preserve a newborn's cord blood — a recurring-revenue storage model in a market worth ~$6.8B in 2022, roughly 97% private [15].

6. What drives demand

• Blood: surgery, trauma, childbirth, cancer/chemotherapy, and chronic transfusion needs (e.g., sickle-cell disease). The CDC counts roughly 7 million U.S. donors and 14M+ units transfused a year, with daily demand near 29,000 red-cell units, ~5,000 platelet units, and ~6,500 plasma units [27]. An aging population lifts baseline need, but patient blood management (transfusing less per procedure) has cut usage: the 2023 National Blood Collection and Utilization Survey (NBCUS) estimated 11.586M whole-blood/red-cell units collected and 10.328M transfused — down from 2021 but described as broadly stabilizing after a long secular decline [28]. The real swing factor is donor turnout; the Red Cross and blood-community groups warned of critical national shortages in 2024 [16][29].
• Plasma: structural growth driven by IG demand — expanding diagnosis of immunodeficiencies and new/growing indications in neurology (e.g., chronic inflammatory demyelinating polyneuropathy, CIDP) and autoimmune disease — plus albumin and clotting factors. Supply, not demand, is usually the ceiling: throughput per center and donor availability [6][24].
• Organs: demand far exceeds supply. The waiting list stood at 103,223 people in a September 2024 snapshot, and about 17 people die each day waiting [30]. The U.S. performed a record 48,149 transplants in 2024 (up ~3.3%), supported by 16,988 deceased and 7,030 living donors [31]. Growth comes from more donors and from organ-preservation technology that keeps more organs usable.
• Cord blood: birth rates and marketing to expectant parents, plus any expansion in proven stem-cell therapies [15].

7. Regulation

• FDA / Center for Biologics Evaluation and Research (CBER) is the primary regulator of the blood and plasma supply. Rules live in Title 21 of the Code of Federal Regulations (CFR), Parts 600–680 — covering current good manufacturing practice (Part 606), donor testing (610), product standards (640), and blood-establishment registration (Part 607) [32]. Source-plasma operators need an FDA biologics license. FDA sets donor eligibility, mandatory infectious-disease testing, and recall/lookback rules; a 2023 shift to individual donor risk assessment (replacing some time-based deferrals) expanded the eligible pool [32].
• Human cells, tissues, and cellular/tissue-based products (HCT/Ps) — including cord blood, eye/tissue, and reproductive tissue — are regulated under 21 CFR Part 1271; public cord-blood units for transplant require FDA licensure [32].
• AABB (Association for the Advancement of Blood & Biotherapies) provides voluntary accreditation whose standards meet or exceed FDA rules and are a de-facto industry requirement [33].
• Organs are regulated separately from blood. FDA does not regulate the transplantation of vascularized organs (kidney, liver, heart, lung); that sits with the Health Resources and Services Administration (HRSA), which runs the Organ Procurement and Transplantation Network (OPTN) — long operated under contract by the United Network for Organ Sharing (UNOS) [26]. OPOs must also meet Centers for Medicare & Medicaid Services (CMS) Conditions for Coverage (42 CFR Part 486) to be paid, and since 2020 face tougher performance metrics that can lead to decertification [25]. Congress in 2023 moved to break UNOS's long-standing monopoly on the OPTN contract, opening the system to new contractors [26].

The net effect is a high-compliance industry with overlapping federal, state, hospital, laboratory, privacy, and payer requirements.

8. Competitive dynamics and consolidation

• Blood is local but consolidating hard. Donor trust, local brand, hospital contracts, emergency coverage, and collection density all matter; America's Blood Centers members run more than 700 collection sites across 1,100+ communities [3]. But declining volume against fixed costs is forcing mergers into a few national nonprofits — the five largest community centers collected 66.3% of U.S. whole-blood/red-cell units in 2023 [28]. Recent deals: Versiti agreed to acquire Dayton's Solvita (2024), and San Diego Blood Bank agreed to merge into Vitalant (announced Jan 2026) [34]. Centers also pool testing and back-office to survive. Expect the count of independents to keep shrinking.
• Plasma is a global oligopoly favoring scale and vertical integration. Four companies — CSL, Grifols, Takeda, Octapharma — dominate world collection and fractionation, competing on center footprint, donor recruitment, yield, and manufacturing scale; barriers include licenses, donor databases, quality systems, and working capital [6][24]. Grifols' acquisition of Interstate Blood Bank illustrates consolidation from independent collection into an integrated plasma chain [9]. ADMA Biologics is a smaller, growing U.S. entrant [11]. Financial stress is a live theme: Grifols spent 2024 managing high leverage and a short-seller challenge [9].
• Organs resemble regulated regional franchising. Each of the 56 OPOs holds a designated service area; CMS oversight makes competition a matter of keeping your federal designation and hitting performance metrics rather than winning customers [20][25].

9. Risks

• Chronic donor shortages on the blood side — an aging donor base and post-pandemic turnout lows have produced repeated emergency shortages [16][29].
• Structural volume decline in transfusion meeting high fixed costs — a solvency risk for smaller nonprofit centers and the engine of consolidation [22][23].
• Reliance on paid plasma donation — the U.S. model is ethically contested and could face policy or reputational change; donor supply also moves with the economy (recessions tend to raise plasma turnout, expansions lower it) [24].
• IG demand/pricing cycles and leverage — plasma medicines are capital-intensive; oversupply or pricing pressure, plus company-specific balance-sheet stress (Grifols), are real [6][9].
• Safety and recall — any transfusion-transmitted-infection scare, contamination, testing failure, or FDA action hits trust and volumes across the board [32].
• Hospital pricing power — consolidated health systems can squeeze blood-center pricing and reimbursement [23].
• Technology substitution — pathogen reduction, recombinant/synthetic therapies, better blood-management practices, and new preservation methods can shift value between operators.
• Supply-chain concentration — collection bags, testing inputs, specialized equipment, cold-chain, and transport can become bottlenecks.
• Organ-system overhaul — OPO decertification, the OPTN restructuring, and equity/oversight scrutiny create policy uncertainty for that segment [25][26].
• Public-company mismatch — a stock may look like blood/organ exposure while most earnings come from unrelated pharmaceuticals, diagnostics, or devices; separate the relevant segment before valuing it.

10. How to invest and the outlook

Public-market routes. Start with the subsegment:

• Direct plasma exposure: CSL (ASX/OTC), Grifols (Nasdaq: GRFS), Takeda (NYSE: TAK), and — as the closest U.S.-listed pure-play — ADMA Biologics (Nasdaq: ADMA) [8][9][10][11].
• Collection tools and diagnostics: Haemonetics (NYSE: HAE) [12].
• Organ preservation and logistics: TransMedics (Nasdaq: TMDX) and XVIVO (Nasdaq Stockholm: XVIVO) [13][14]; plus small-cap cord-blood name Cryo-Cell (OTC: CCEL) [15].

Understand what you're buying: the plasma names are biologics manufacturers whose collection centers happen to fall in NAICS 621991 — the thesis is IG demand and manufacturing yield, not blood banking as such. Review segment revenue, collection volumes, donor retention, center productivity, product mix, customer concentration, regulatory inspections, capital spending, working capital, debt, and currency — and use share prices, dividend yields, and valuation multiples only after separating the relevant business from the parent. The nonprofit blood-center and OPO core generates no equity exposure; the only capital-markets touchpoint is the occasional tax-exempt bond issued by a large blood center or health system.

Private-market routes. Accessible assets are for-profit plasma collection networks and cord-blood storage businesses — both have drawn private-equity and strategic buyers, with plasma feedstock especially prized by fractionators seeking supply security. Diligence should center on FDA licensing, donor economics, hospital contracts, service-area rights, product outdates, collection cost, staffing, compliance history, working capital, and exit options. Nonprofit blood centers and OPOs can hold meaningful revenue and assets but do not offer ordinary common-equity ownership; they combine through nonprofit mergers.

Outlook (editorial judgment). A bifurcated picture. Blood demand stays essential and defensive but grows slowly at best, keeping the nonprofit core in a slow-declining, consolidating mode as transfusion volumes stay soft and hospital pricing bites. The visible commercial growth is in vertically integrated plasma, organ utilization/preservation, and logistics rather than conventional blood banking: IG demand should keep pulling plasma volumes higher, and record transplant activity plus organ-perfusion technology support the organ-tech segment [6][31]. The main swing factors are donor supply, hospital pricing, regulatory intervention (paid-plasma scrutiny and the multi-year restructuring of the federal organ-transplant system), company-level leverage in plasma, and technology substitution.

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Sources

1. U.S. Census Bureau, 2022 Economic Census — Concentration of Largest Firms, NAICS 621991 (receipts, firms, CR4/CR8/CR20/CR50, HHI). https://data.census.gov/table/ECNSIZE2022.EC2200SIZECONCEN
2. U.S. Census Bureau, 2022 NAICS: 621991 Blood and Organ Banks — index and scope (adjacent codes 325414, 621511, 622, 621999). https://www.census.gov/naics/?details=621991&input=621991&year=2022
3. America's Blood Centers, About / America's Blood Supply (members ~60% of U.S. supply; 700+ sites across 1,100+ communities). https://americasblood.org/about/
4. U.S. Census Bureau, County Business Patterns 2023 — NAICS 621991 (establishments, employment, annual and Q1 payroll). https://www.census.gov/data/datasets/2023/econ/cbp/2023-cbp.html
5. U.S. Small Business Administration, Table of Size Standards (NAICS 621991 = $40 million), 2023. https://www.sba.gov/document/support-table-size-standards
6. ResearchAndMarkets / Businesswire, Plasma Derived Therapies Market — Insights & Forecast 2024–2028 (~$58.26B by 2028; IG growth), 2024. https://www.businesswire.com/news/home/20240613282301/en/
7. U.S. Census Bureau, Economic Census — Understanding NAICS / coverage (employer establishments; excludes most government). https://www.census.gov/programs-surveys/economic-census/year/2022/guidance/understanding-naics.html
8. CSL Limited, FY2024 Results / Annual Report (group revenue ~US$14.8B; CSL Behring ~$10.6B; CSL Plasma 200+ U.S. centers), 2024–2025. https://investors.csl.com/annualreport/2025/
9. Grifols, S.A., Form 20-F for Fiscal Year 2024 (revenue ~€7.2B; leverage; Interstate Blood Bank; diagnostics), 2025. https://www.sec.gov/Archives/edgar/data/1438569/000110465925034245/grfs-20241231x20f.htm
10. Takeda Pharmaceutical Co., Plasma-Derived Therapies / Form 20-F FY2024 (BioLife plasma centers), 2024–2026. https://www.takeda.com/science/areas-of-focus/pdt/
11. ADMA Biologics, Preliminary Full-Year 2024 Revenue (~$417–425M; ~10 plasma centers + IG manufacturing), Jan. 2025. https://ir.admabiologics.com/news-releases/news-release-details/adma-biologics-announces-preliminary-full-year-2024-revenue-and
12. Haemonetics Corporation, Annual Report FY2025, U.S. SEC, 2025. https://www.sec.gov/Archives/edgar/data/313143/000110465925000041/hae-20250605.htm
13. TransMedics Group, Fourth Quarter and Full Year 2025 Financial Results (Organ Care System), 2026. https://investors.transmedics.com/news-releases/news-release-details/transmedics-reports-fourth-quarter-and-full-year-2025-financial/
14. XVIVO Perfusion, Investor Relations, 2026. https://investor.xvivogroup.com/
15. Grand View Research, U.S. Cord Blood Banking Services Market (~$6.83B 2022; ~97% private; pricing), 2023. https://www.grandviewresearch.com/industry-analysis/us-cord-blood-banking-services-market
16. American Red Cross, Blood Shortage Explained (Red Cross share of supply; shortages), 2024–2026. https://www.redcrossblood.org/local-homepage/news/article/blood-shortage-explained-rcbs.html
17. Octapharma, Who We Are, 2026. https://www.octapharmausa.com/about-us/who-we-are
18. Kedrion Biopharma, About Us, 2026. https://www.kedrion.com/about-us/
19. ImmunoTek Plasma, About Us, 2026. https://www.immunotek.com/about/
20. Association of Organ Procurement Organizations / organdonor.gov, OPO oversight; 56 U.S. OPOs, 2024–2026. https://aopo.org/opo-oversight/
21. Statista / American Journal of Hematology, U.S. blood pricing — median paid per unit of leukoreduced RBC (~$226, 2023). https://www.statista.com/statistics/1204177/donated-blood-products-median-amont-paid-by-hospitals-us/
22. C. Bhardwaj et al., The fundamental economics of the blood service industry in the United States, Journal of Blood Service Economics (Emerald), 2023. https://www.emerald.com/insight/content/doi/10.1108/jbse-10-2022-0003/full/html
23. U.S. Department of Health and Human Services, ACBTSA Recommendations (blood-center margins), 2025. https://www.hhs.gov/oidp/advisory-committee/blood-tissue-safety-availability/acbtsa-recommendations/index.html
24. P. Jaworski / Cornell SC Johnson, The Global Plasma Economy (U.S. ~70% of world source plasma; 1,200+ centers; ~$6.2B exports 2024), 2025. https://business.cornell.edu/article/2025/05/the-global-plasma-economy/
25. Centers for Medicare & Medicaid Services, Organ Procurement Organizations — Conditions for Coverage (42 CFR Part 486), 2025. https://www.cms.gov/medicare/health-safety-standards/conditions-coverage-participation/organ-procurement-organizations-opo
26. HRSA / OPTN, About the OPTN; NOTA; OPTN modernization, 2024–2026. https://www.hrsa.gov/optn/about
27. Centers for Disease Control and Prevention, Blood Safety Basics (~7M donors; 14M+ units; daily red-cell/platelet/plasma demand), 2024. https://www.cdc.gov/blood-safety/about/index.html
28. Free et al., Have We Reached a New Baseline for Blood Collection and Transfusion in the United States? (2023 NBCUS: 11.586M collected, 10.328M transfused; top-5 centers 66.3%), 2025. https://pmc.ncbi.nlm.nih.gov/articles/PMC12623064/
29. American Hospital Association, Red Cross, America's Blood Centers, AABB Say U.S. Faces Critical Blood and Platelet Shortages, Aug. 2024. https://www.aha.org/special-bulletin/2024-08-07-red-cross-americas-blood-centers-aabb-say-us-faces-critical-blood-and-platelet-shortages
30. organdonor.gov, Organ Donation Statistics (waitlist 103,223, Sept. 2024; 17 deaths/day), 2025. https://www.organdonor.gov/learn/organ-donation-statistics
31. HRSA / UNOS, U.S. Surpassed 48,000 Organ Transplants in 2024 (48,149; 16,988 deceased + 7,030 living donors; +3.3%), 2025. https://www.hrsa.gov/optn/news-events/news/organ-transplants-exceeded-48000-2024-33-percent-increase-transplants-performed-2023
32. U.S. Food and Drug Administration, Regulation of the Blood Supply; Biologics Establishment Registration; HCT/Ps (21 CFR 600–680, Part 607, Part 1271; individual donor risk assessment), 2024–2026. https://www.fda.gov/vaccines-blood-biologics/blood-blood-products/regulation-blood-supply
33. Association for the Advancement of Blood & Biotherapies (AABB), Standards and Accreditation, 2025. https://www.aabb.org/
34. Versiti, Versiti to Acquire Solvita Blood Center (Nov. 2024); AABB, Vitalant, San Diego Blood Bank Announce Merger (Jan. 2026). https://versiti.org/newsroom/press-releases/2024/versiti-blood-center-of-ohio-to-acquire-solvita-blood-center