Key Takeaways
- In 2022, the global plasma fractionation market was valued at USD 28.8 billion and is projected to reach USD 43.9 billion by 2030, growing at a CAGR of 5.4% from 2023 to 2030.
- The U.S. collects approximately 70% of the world's source plasma, totaling over 50 million liters annually as of 2023.
- North America dominated the plasma fractionation market with a 45.2% revenue share in 2022, driven by high plasma collection volumes.
- In 2022, about 2% of the U.S. population aged 18-69 donated plasma at least once, equating to roughly 5.5 million unique donors.
- Males comprise 58% of plasma donors in the U.S., while females make up 42% as of 2023 data.
- The average age of U.S. plasma donors is 34 years, with 45% under 30 and 15% over 50 in 2022 surveys.
- Over 100 million plasma donations are collected annually worldwide, with 80% from paid donors in the U.S. in 2023.
- A single plasma donation yields enough plasma for 24+ treatments, with U.S. centers processing 50+ million liters yearly.
- Automated plasmapheresis technology allows for 600-800 mL plasma collection per session, lasting 45-60 minutes.
- Immunoglobulin (IVIG) treats over 150 conditions, with U.S. demand exceeding 50 tons annually in 2023.
- Albumin, derived from plasma, is used in 5 million patient treatments yearly worldwide for shock and burns.
- Plasma-derived therapies treat hemophilia A in 400,000 patients globally, requiring 1.5 million IU/kg/year per patient.
- No transfusion-transmitted infections from plasma fractionation in U.S. since 1995 due to dual inactivation.
- Serious adverse events occur in 1 per 10,000 plasma donations, mostly mild citrate reactions in 2023 data.
- FDA regulates plasma centers under 21 CFR 640.60-69, requiring annual inspections of 100% facilities.
The plasma donation industry is a vital and rapidly growing multi-billion dollar global healthcare market.
Collection and Processing
- Over 100 million plasma donations are collected annually worldwide, with 80% from paid donors in the U.S. in 2023.
- A single plasma donation yields enough plasma for 24+ treatments, with U.S. centers processing 50+ million liters yearly.
- Automated plasmapheresis technology allows for 600-800 mL plasma collection per session, lasting 45-60 minutes.
- U.S. plasma centers perform quality testing on 100% of donations, discarding 1-2% for abnormalities in 2023.
- Pathogen reduction technologies reduce viral risk by 99.99% in plasma products, implemented in 95% of U.S. facilities.
- Average U.S. plasma center collects from 100-200 donors daily, operating 7 days/week in 2023.
- Plasma is frozen within 24 hours of collection in 98% of cases to preserve clotting factors, per industry standards.
- Over 300 steps are involved in fractionating one liter of plasma into therapies, with yield rates of 90% for albumin.
- U.S. exports 60% of collected plasma, shipped in bulk to fractionation plants in Europe and U.S., 2023 data.
- Donor deferral rate is 10-15% primarily due to low protein levels or travel history in U.S. centers.
- U.S. centers use apheresis machines collecting plasma in 1-2 hour sessions, returning red cells.
- 98% of U.S. plasma is source plasma for fractionation, not therapeutic use.
- Hematocrit levels monitored to ensure <55% for safe red cell return.
- Annual collection capacity at U.S. centers exceeds 60 million liters.
- Saline reinfusion prevents dehydration in 100% of donations.
- Plasma shipped at -20°C or lower, maintaining integrity for 6 years.
- Mini-pool testing divides donations into groups for HIV/HCV detection at 10^-7 sensitivity.
- 500+ U.S. centers expanded in 2022-2023 to meet demand.
- Yield of IgG from fractionation is 4-5 g per liter plasma.
- Post-donation observation period is 10-15 minutes for all donors.
- Collection volume per donor capped at 880mL/session based on weight.
- 95% plasma purity post-fractionation via chromatography.
- Donor ID via photo/biometrics in 80% modern centers.
- Cold storage compliance audited quarterly by regulators.
- Recycling of plastics from collection kits reduces waste 20%.
- AI screening tools flag 5% more deferrals pre-donation.
- Peak collection seasons align with holidays, up 15%.
- Mobile phlebotomy units serve 10% rural donors.
- Ethanol fractionation (Cohn process) yields 250kg products/10,000L.
- Post-collection quarantine 40-120 days for NAT results.
Collection and Processing Interpretation
Donor Demographics
- In 2022, about 2% of the U.S. population aged 18-69 donated plasma at least once, equating to roughly 5.5 million unique donors.
- Males comprise 58% of plasma donors in the U.S., while females make up 42% as of 2023 data.
- The average age of U.S. plasma donors is 34 years, with 45% under 30 and 15% over 50 in 2022 surveys.
- Hispanic/Latino donors represent 22% of U.S. plasma donors, compared to 19% in the general population in 2023.
- 65% of U.S. plasma donors have a household income under $50,000 annually, per 2022 industry reports.
- Repeat donors (donating 8+ times/year) account for 80% of total U.S. plasma collections in 2023.
- African American donors make up 12% of U.S. plasma donors, aligning closely with 13.6% population share in 2022.
- 75% of plasma donors cite compensation as a primary motivator, averaging $50 per donation in urban areas in 2023.
- Female donors aged 18-24 represent the fastest-growing demographic, up 15% year-over-year in 2023.
- Urban donors (population >50,000) comprise 70% of U.S. plasma donor base in 2022 data.
- 75% of U.S. adults aged 18-65 eligible to donate plasma, but only 2% participate regularly.
- White non-Hispanic donors are 55% of U.S. plasma donor pool in 2022.
- 40% of donors are college-educated, higher than general population average.
- Full-time employed donors make up 62%, part-time 25%, unemployed 13% in 2023.
- 28% of donors are parents with children under 18, per 2022 surveys.
- Asian American donors at 5%, slightly underrepresented vs. 6% population.
- Average donation frequency is 25-50 times/year for compensated U.S. donors.
- 55% of donors have donated for over 2 years continuously.
- Veterans comprise 8% of plasma donors, incentivized by select programs.
- Students represent 22% of donors, often citing tuition support.
- 35% of donors single, 45% married/cohabitating in 2022.
- Native American donors 1.5% of total, proportional to population.
- 60% report altruism as secondary motive to compensation.
- Retention rate of new donors is 50% after first year.
- High school educated donors 35%, some college 35%.
- Southern U.S. states have 40% of national plasma centers.
- LGBTQ+ donors 10%, with inclusive non-discrimination policies.
- Average donor weight 170 lbs, BMI 26, screened for eligibility.
- 15% donors have chronic conditions managed for eligibility.
Donor Demographics Interpretation
Economic Impact
- U.S. plasma industry contributes $28 billion to GDP, supporting 60,000 direct jobs in 2023.
- Each plasma donation pays donors $20-100, injecting $4 billion annually into local U.S. economies.
- Plasma centers generate $1.5 billion in state/local taxes yearly from operations and donor spending.
- Fractionation plants employ 20,000 workers globally, with U.S. facilities leading at $10B payroll.
- Rural U.S. counties with plasma centers see 2-3% GDP boost from donor compensation circulation.
- CSL Behring, top plasma firm, reported $13.3 billion revenue in 2023, 60% from plasma products.
- Grifols, second largest, processes 8 million liters plasma/year, $7B revenue in 2022.
- Donor compensation supports 1.5 million low-income households, averaging $800/year per donor.
- Plasma exports to Europe generate $10B trade surplus for U.S. in 2023.
- Octapharma reported $3.5B revenue from plasma in 2023.
- Takeda plasma division contributes 40% of $28B total revenue.
- 1 plasma center supports 150 local jobs + $10M indirect economy.
- Donor spending multiplier effect is 2.5x compensation value.
- Biotest AG plasma sales $1.2B in 2022, 70% exported.
- Kamada Ltd. specializes in plasma hyperimmunes, $250M revenue 2023.
- Global plasma logistics market $5B, driven by cold chain tech.
- U.S. plasma industry R&D investment $1B/year for new therapies.
- Charitable contributions from plasma firms exceed $100M annually.
Economic Impact Interpretation
Market Size and Growth
- In 2022, the global plasma fractionation market was valued at USD 28.8 billion and is projected to reach USD 43.9 billion by 2030, growing at a CAGR of 5.4% from 2023 to 2030.
- The U.S. collects approximately 70% of the world's source plasma, totaling over 50 million liters annually as of 2023.
- North America dominated the plasma fractionation market with a 45.2% revenue share in 2022, driven by high plasma collection volumes.
- The immunoglobulin segment accounted for 46.7% of the plasma fractionation market revenue in 2022 due to rising immunodeficiency disorders.
- Asia Pacific plasma fractionation market is expected to grow at the fastest CAGR of 6.8% from 2023 to 2030, fueled by increasing healthcare investments.
- In 2023, the U.S. plasma collection industry generated over $25 billion in economic value, including direct and indirect contributions.
- Global demand for plasma-derived medicinal products (PDMPs) reached 100 million grams in 2022, up 5% from previous year.
- Europe holds 30% of the global plasma fractionation market share in 2023, with Germany leading collections at 20 liters per 1,000 inhabitants.
- The plasma therapy market is forecasted to grow from USD 1.2 billion in 2023 to USD 2.5 billion by 2028 at a CAGR of 15.9%.
- U.S. plasma centers numbered over 900 in 2023, a 20% increase since 2018.
Market Size and Growth Interpretation
Safety and Regulations
- No transfusion-transmitted infections from plasma fractionation in U.S. since 1995 due to dual inactivation.
- Serious adverse events occur in 1 per 10,000 plasma donations, mostly mild citrate reactions in 2023 data.
- FDA regulates plasma centers under 21 CFR 640.60-69, requiring annual inspections of 100% facilities.
- Protein levels are monitored pre-donation, with minimum total protein of 6.0 g/dL required in U.S.
- Viral testing (HIV, HBV, HCV) uses NAT with 99.9% sensitivity, performed on mini-pools of 6-96 donations.
- Donor hemoglobin checked via fingerstick, minimum 12.5 g/dL for males, 12.0 g/dL for females.
- EU Directive 2002/98/EC mandates voluntary unpaid donations, contrasting U.S. compensated model.
- Lookback procedures notify donors and recipients within 3 days of positive infectious markers.
- Ionizing radiation and solvent-detergent treatment inactivate prions and viruses in 99.999% efficacy.
- Annual donor health history review defers high-risk individuals, reducing HIV window-period risk to <1:3M.
- Allergic reactions to plasma donation <1%, managed with calcium supplementation.
- EMA approves plasma products after 3-5 validation lots demonstrating safety.
- Deferral for tattoos/piercings is 12 months in U.S. plasma centers.
- Nanofiltration (15-35nm pores) removes viruses in fractionation process.
- Remote electronic donor records track lifetime donations for suitability.
- BPAC (Blood Product Advisory Committee) reviews plasma safety annually.
- Incidence of citrate-induced paresthesia is 2.5% per donation, self-resolving.
- WHO recommends dual inactivation: solvent-detergent + heat treatment.
- U.S. donor adverse event reporting to FDA via MedWatch exceeds 10,000/year.
- Inter-donation interval minimum 2 days, max 104/year for safety.
Safety and Regulations Interpretation
Uses and Products
- Immunoglobulin (IVIG) treats over 150 conditions, with U.S. demand exceeding 50 tons annually in 2023.
- Albumin, derived from plasma, is used in 5 million patient treatments yearly worldwide for shock and burns.
- Plasma-derived therapies treat hemophilia A in 400,000 patients globally, requiring 1.5 million IU/kg/year per patient.
- Hyperimmune globulins from plasma treat rabies (20,000 cases/year) and tetanus (50,000 cases/year) worldwide.
- One plasma donation provides enough material for therapies treating trauma in 1 patient or immune deficiencies in 24.
- Factor VIII from plasma meets 20% of global hemophilia B needs, despite recombinant alternatives.
- Alpha-1 antitrypsin from plasma treats 100,000 rare genetic disorder patients in U.S. and Europe.
- Plasma products saved 1 million lives during COVID-19 via convalescent plasma, authorized by FDA in 2020-2023.
- Rhophylac from plasma prevents hemolytic disease in 1 million newborns annually worldwide.
- C1 esterase inhibitor from plasma treats hereditary angioedema in 10,000 U.S. patients yearly.
- Prothrombin Complex Concentrates (PCC) from plasma reverse anticoagulation in 1 million surgeries/year.
- Plasma fibronectin aids wound healing in burn victims, used in 50,000 cases annually.
- Anti-thymocyte globulin from plasma prevents transplant rejection in 20,000 patients/year.
- IVIG market alone valued at $13.5 billion in 2022 for autoimmune treatments.
- Plasma for cell therapy manufacturing supports CAR-T production for 10,000 cancer patients/year.
- Von Willebrand Factor from plasma treats 150,000 patients globally.
- Antivenom globulins derived from plasma counter snakebites in 5 million cases/year.
- Fibrinogen concentrates from plasma used in 100,000 bleeding disorder treatments annually.
- Plasma protein therapeutics shortages avoided in U.S. due to 40% collection buffer.
- Cytomegalovirus immune globulin prevents infection in 50,000 transplant patients/year.
Uses and Products Interpretation
Sources & References
- Reference 1GRANDVIEWRESEARCHgrandviewresearch.comVisit source
- Reference 2PLASMAHEROplasmahero.orgVisit source
- Reference 3MARKETSANDMARKETSmarketsandmarkets.comVisit source
- Reference 4NCBIncbi.nlm.nih.govVisit source
- Reference 5WHOwho.intVisit source
- Reference 6FDAfda.govVisit source
- Reference 7REDCROSSBLOODredcrossblood.orgVisit source
- Reference 8HEALTHhealth.ec.europa.euVisit source
- Reference 9CSLcsl.comVisit source
- Reference 10GRIFOLSgrifols.comVisit source
- Reference 11EMAema.europa.euVisit source
- Reference 12OCTAPHARMAoctapharma.comVisit source
- Reference 13TAKEDAtakeda.comVisit source
- Reference 14BIOTESTbiotest.comVisit source
- Reference 15KAMADAkamada.comVisit source






