Aegros is a leader in the development of novel plasma fractionation technology. Aegros is a global organisation with operations in Singapore, USA, Israel and a head office in Sydney, Australia. Below is some general information on the Therapeutic Plasma Market.
THE THERAPEUTIC PLASMA
Therapeutic plasma products represent a US$19.7B global market of which 70% is in the US and Europe. The rest of the world is undersupplied, for example, Asia represents 21% of the world market while accounting for 61% of the world population.
There are three critical drivers of therapeutic plasma products in emerging markets:
- α Plasma Supply,
- β Fractionation Process and
- γ Regulatory Controls.
α Plasma Supply
Human plasma (the liquid component of Human blood) is the critical raw material from which all therapeutic plasma products are manufactured. Plasma is controlled at the country level and many emerging countries discard their plasma resulting in an estimated 5.8m litres of plasma wasted each year. Further, only US plasma can be used to manufacture products sold into the US market. This restriction is pressuring supply and pricing as the US collects 64% of the world’s plasma. In addition to discarded plasma, there is a continuous supply of partially processed plasma which the existing fractionators are unable to use.
Using its unique CyMES (Cylindrical Membrane ElectroSeparation) (patent pending), Aegros can fractionate both the discarded and partially processed plasma to supply emerging markets.
β Fractionation Process
Existing fractionators use antiquated manufacturing processes which are capital intensive, low yielding and sensitive to raw material (plasma) quality. Using existing processes, the minimum economically viable plant size is 300,000L pa. To put this in perspective, most emerging countries collects less than 100,000L of plasma pa.
Raw materials account for 5% of most Pharma products, whereas they account for 43% in the case of Therapeutic Plasma products. This disparity is driven by both the cost of plasma and the low production yields, making any process which reduces this cost a Therapeutic Plasma game changer.
By comparison, CyMES significantly increases process yield, decreases process steps, increases product safety, providing a higher quality, lower cost product.
Further, plasma fractionation is capital intensive with a typical capital cost around US$150 – $200m for a 300,000L facility. The restrictions of plasma supply and capital cost have precluded countries from setting up their own fractionation facilities. This conflicts with the World Health Organisation (WHO) mandate that all countries should become self-sufficient in therapeutic plasma products.
γ Regulatory Controls
As therapeutic plasma products are derived from human blood the entire production process from blood collection to finished product shipment is subject to stringent regulatory controls.
Existing processes cannot completely eliminate pathogen contaminations. For this reason, the regulators, such as FDA and EMA, enforce stringent controls and will not allow fractionators to process plasma from countries which do not meet their standards. In part these concerns can be addressed using disposable manufacturing process eliminating batch to batch contamination.
The regulators control the manufacturing process by licensing fractionation facilities under a regulation called ‘current Good Manufacturing Process’ (cGMP). Further, the finished products require country specific ‘Marketing Approval’ before they can be sold. This generally involves undertaking clinical trials which are capital, time and resource intensive. A number of emerging countries, including India, have less restrictive regulations. It is these emerging countries which Aegros will initially target.
HISTORY OF THE THERAPEUTIC
Therapeutic Plasma products were first used in WWII. Over 70 years the industry has evolved into a capital intensive, oligopolistic market similar to the oil industry. Today the industry is on the flat section of the cost curve, focused on reducing costs by fractions of a percent. Currently, CSL is the industry leader, manufacturing up to 6 products from a litre of plasma.
The defining moment for the therapeutic plasma market was the AIDS contamination of the blood supply in the early 1980s. Following this the regulators restructured the industry over a 10 year period through regulatory changes and manufacturing shutdowns. These ‘consent decrees’ led to a consolidation as the industry built high capital automated production processes to meet the higher safety levels.
Existing players are constrained by these historic approvals as any changes to a product affect product approvals further down the manufacturing cascade. See the existing fractionator manufacturing processes in Aegros Plasma Fractionation webpage for more details. This regulatory constraint means adopting new systems could require expensive regulatory approvals, and for most products, is cost prohibitive.
The first new process to be approved since these more stringent regulations and US ‘consent decrees’ was the Singapore Health Sciences Authority (HSA) approval of PrIME Biologics tangential flow electrophoretic process in July 2016.