Immunoglobulin sustainability in the United Kingdom

This report characterises the current and future challenges to immunoglobulin (Ig) sustainability in the UK, assesses the implications for patients, services and cost, and sets out prioritised policy responses. The findings draw on a targeted literature review, economic modelling and a multi-stakeholder expert roundtable.

What is Ig sustainability?

Ig sustainability refers to the ability of the UK health system to secure long-term patient access to Ig while also managing affordability and avoiding unsustainable pressure on NHS capacity. The UK currently secures reliable access to Ig at a controlled cost, but this position is under increasing pressure.

Why Ig sustainability matters?

Ig is a plasma-derived medicinal product used across more than 50 clinical indications. For a substantial proportion of patients there is no therapeutic substitute. Around half of total use is accounted for by immunology conditions requiring lifelong replacement therapy. 

What are the Ig sustainability challenges?

Three interrelated pressures will intensify over the next decade.

• Volume pressure: UK demand grew by around 30% between 2015 and 2024 and is projected to continue to grow. Growth is driven by improved diagnosis, widening eligibility and secondary antibody deficiency arising from bispecific antibody and CAR-T therapies. Approximately 80% of supply is imported, manufactured predominantly from US-sourced plasma, exposing the UK to global competition and external shocks. National shortage alerts occurred in 2010/11, in the late 2010s and in 2020/21.
• Economic pressure: Ig ex-factory price has grown by 14% after accounting for inflation during the period between 2007 to 2025. NHS procurement practices help in deferring exposure to international price growth, but rising costs will influence future negotiations. 
• Health system pressure: Intravenous administration of Ig dominates in the UK and is associated with substantial delivery costs and resource use. Infusion and workforce capacity are already constrained. 

These combined effects are likely to impact patients in the future through delayed or reduced treatment, changes of Ig product or changes to alternative therapies, with potential clinical and psychological risks, especially where such changes are not medically driven.

What are available policy responses?

Four solutions were assessed, spanning levers that increase the volume of Ig available, secure access to existing volume, and/or reduce the volume required. Their effects are complementary rather than interchangeable.

1. NHS procurement secures price and supply for a defined term. Protection is limited by contract duration, but this policy solution has achieved stable prices and secure supply. 
2. Clinical stewardship has been implemented successfully and is internationally regarded as a UK strength. It has inherent limits too, and changes to dose or therapy can also lead to patient and system harm if evidence-based guidance is applied inconsistently. Patient equity can be a concern if there are uneven standards of clinical stewardship across the UK and patient subgroups. 
3. Alternative therapies have the potential to reduce Ig demand and release Ig volume for indications where no alternative exists. There is a need to invest in clinical research, development, and access of such therapies in the long term.
4. Domestic Ig supply is a well-established response to import dependence. There is a need to invest in raising domestic supply in line with NHSBT targets through donor retention and plasma collection capacity. 

Which solutions should be prioritised? 

Procurement and stewardship are quick wins: operational, funded from existing budgets, and capable of immediate benefit, but with limited remaining headroom given the success that has already been achieved via these means. Alternative therapies and domestic supply expansion are strategic responses requiring sustained investment and longer lead times, with correspondingly greater potential impact. The preference of multi-stakeholder experts for a focus on alternative therapies and domestic supply expansion therefore reinforces the case for shifting attention towards these longer-term levers, where the greatest potential for additional impact lies.

In conclusion, each of the policy tools at our disposal can support a different component of a sustainable Ig system, with their effects complementary rather than interchangeable. A resilient and sustainable UK Ig system will therefore require a coordinated approach across all four.

Job code: UK-NON-26-00006