By the PharmaTradz BD Team. Published November 2026.
Plasma-derived medicines are unlike any other product a pharmaceutical buyer handles. Their supply depends on people donating plasma, it takes seven to twelve months to turn a donation into a released vial, and no factory can switch to making more immunoglobulin on short notice. When demand rises faster than donations, hospitals feel it first.
This guide is for importers, hospital and tender buyers, and health ministries that buy immunoglobulin, albumin and clotting factors. It explains how the market works, why supply stays tight, and what to check before you commit to a source.
How the plasma market works
Plasma is collected from donors, pooled in large volumes and split by fractionation into several proteins. One litre of plasma yields a fixed amount of each, so the products are linked.
- Immunoglobulin (IVIG and SCIG) is the main driver of demand. It treats primary and secondary immunodeficiencies and a growing list of immune and neurological conditions.
- Albumin is produced from the same plasma. Its supply follows immunoglobulin production rather than albumin demand.
- Clotting factors (factor VIII, factor IX, fibrinogen, prothrombin complex) and hyperimmune products such as anti-D, hepatitis B, rabies and tetanus immunoglobulin come from smaller, specialised streams.
According to industry figures presented in 2025, about 90 million litres of plasma for fractionation were collected worldwide in 2024, up about 6% on the year before. Roughly two-thirds came from North America, almost all of it from the United States. Europe collected more than 10 million litres but still imported about a quarter of the immunoglobulin it used.
Why supply stays tight
- Concentrated collection. Most countries rely on plasma from a small number of markets, mainly the US. Policy or logistics changes there affect everyone.
- Long lead times. Collection, testing, inventory hold, fractionation and batch release take most of a year.
- Rising immunoglobulin use. New indications and better diagnosis keep demand growing. In 2024 the European Medicines Agency reported immunoglobulin shortages in 14 European countries.
- Regulation. The EU's new Substances of Human Origin (SoHO) Regulation, published in July 2024, applies from August 2027. It aims to strengthen donor protection and collection across Europe, which will shape European supply over the next few years.
What to check before you buy
A plasma product is only as good as its documentation. Ask every supplier for:
- Plasma origin. Where the plasma was collected and under which regulatory system. In Europe this is documented in a Plasma Master File (PMF) certified by the EMA.
- Approval status. Registration of the product with a stringent authority (EU, US or similar) and in your own country, or the import route you will use if it is not registered locally.
- Batch release. Plasma products usually need an official lot release certificate from a control laboratory, such as an EU Official Control Authority Batch Release (OCABR) certificate. Many importing countries also run their own lot release testing.
- Viral safety. The screening of donations, the virus inactivation and removal steps, and the testing of plasma pools.
- Product details. Concentration (5% or 10% IVIG, 20% or 25% albumin), IgA content, storage temperature and remaining shelf life at delivery.
- Supply chain. Proof that the goods come from the authorisation holder or a licensed wholesaler, with GDP-compliant cold chain records.
Be careful with offers that look too cheap. Immunoglobulin and albumin are high-value targets for diversion and falsification, and an unclear chain of custody is a serious warning sign.
Contract fractionation: turning domestic plasma into medicines
Many countries collect plasma through their blood services but cannot fractionate it themselves. Much of that plasma is discarded. Contract fractionation, also called toll fractionation, solves this: a country sends its plasma to a licensed fractionator abroad and receives finished immunoglobulin, albumin and clotting factors made from it. Australia has used this model for decades, and WHO has published guidance on how low- and middle-income countries can do the same.
A contract fractionation programme needs:
- plasma collected and tested to the fractionator's standards, usually requiring an upgrade of blood-centre quality systems;
- a plasma supply agreement and a quality agreement covering testing, look-back procedures and traceability;
- regulatory permission to export plasma and import the resulting products;
- volume planning, since a minimum annual quantity of plasma is needed to make the programme worthwhile.
For health ministries and blood services this can reduce dependence on imports and the cost of the medicines. For companies, it is a growing area for partnerships and technical services.
Practical tips for tender buyers
- Plan for the long lead times. Award contracts early and allow for partial deliveries.
- Accept more than one presentation. Allowing both 5% and 10% IVIG, or several pack sizes, widens the supplier pool.
- Ask about allocation. In tight markets suppliers ration by customer. A long-term agreement usually ranks above spot orders.
- Specify shelf life at delivery and who carries the cost of cold-chain failures.
How PharmaTradz helps
We help importers, hospitals and public buyers find plasma-derived medicines from authorised sources, with the documents regulators ask for, and we support plasma programmes looking for fractionation partners.
- Browse plasma products, including IVIG and human albumin.
- Check current shortages by country on our drug shortage radar.
- Bidding on a public tender? Browse open pharma tenders.
- Have a requirement? Send your RFQ.
The bottom line
Plasma-derived medicines will stay tight for the foreseeable future because supply grows only as fast as donations. Buyers who plan early, insist on full documentation from plasma origin to lot release, and build long-term supplier relationships will be supplied first. Countries with their own plasma collection should look seriously at contract fractionation.
This article is general business information, not medical, legal or regulatory advice. Requirements differ by country; check the current position with the relevant authority or a qualified adviser.
Frequently Asked Questions(FAQs)
What are plasma-derived medicinal products?
Medicines made by fractionating pooled human plasma, mainly immunoglobulin (IVIG and SCIG), albumin, clotting factors and hyperimmune immunoglobulins such as anti-D, hepatitis B and rabies immunoglobulin.
Why is immunoglobulin often in short supply?
Demand keeps growing while supply depends on plasma donations, most of which come from a few countries, and production takes seven to twelve months from donation to release.
What is a Plasma Master File?
A dossier certified by the European Medicines Agency describing the plasma used for a product: collection centres, donor screening, testing and traceability.
What is contract fractionation?
An arrangement in which a country sends domestically collected plasma to a licensed fractionator and receives finished plasma medicines made from it. It reduces reliance on imports.
What documents should an importer ask for?
Product registration or the import authorisation, the lot release certificate, the batch certificate of analysis, the GMP certificate, plasma origin information and cold chain records.
