Plasma Fractionation: An Indispensable Component for Plasma-derived Therapies Manufacturing

Plasma fractionation, a critical process in the field of medical science, involves the separation of various components present in blood plasma to create valuable therapeutic products. This intricate procedure has gained significant recognition due to its ability to provide essential treatments and to address various medical indications. The success of plasma fractionation companies hinges upon the precise isolation and purification of specific proteins and molecules from plasma. Notably, the technology used in this process plays a pivotal role in determining the quality and efficacy of the resulting therapeutic products. Over time, technological advancements incorporated by plasma fractionation companies have enabled researchers to enhance the efficiency of the process, resulting in improved yields of vital plasma-derived medications. Further, the continuous evolution of plasma fractionation companies and the techniques employed has led to the emergence of novel methods that offer improved selectivity and precision in isolating specific plasma components with enhanced purity. As the demand for plasma-derived therapies continues to grow, the plasma fractionation market is poised to experience substantial expansion in the foreseeable future.

It is worth mentioning that recently third-party service providers or contract plasma fractionators are becoming more popular alternative than establishing in-house plasma fractionation facilities. This trend can be attributed to the fact that employing third-party plasma fractionation services is more cost effective. In the absence of a local plasma fractionation company or facility in a country, the plasma products can be made available using contract fractionation in a shorter time frame. To ensure the highest quality standards, third-party service providers require strict supervision from regulatory authorities for both the plasma suppliers and contract fractionators.

Plasma Fractionation Companies: Current Market Landscape

Currently, over 85 plasma fractionation facilities are established by more than 35 plasma fractionation companies to offer a wide range of highly efficacious plasma-derived therapies in order to cater to the rising population diagnosed by rare and chronic diseases. The below figure presents the distribution of plasma fractionation companies, based on the company size:

Plasma Fractionation Market Company Size

It is worth highlighting that the majority (74%) of the plasma fractionation companies are large companies, with more than 500 employees. This can be attributed to their extensive plasma fractionation facilities and their ability to establish a strong presence in multiple key locations, enabling them to effectively meet the growing demand. Notable examples of such plasma fractionation companies include (in alphabetical order, no specific selection criteria) ADMA Biologics, Biotest, GC Biopharma, and Hualan Biological. Additionally, we came across small plasma fractionation companies with less than 50 employees accounting for 6% of the overall plasma fractionation companies.

It is worth highlighting that the plasma fractionation companies are involved in fractionating blood plasma to manufacture therapeutic plasma proteins. The below figure presents the distribution of plasma fractionation companies, based on type of plasma-derived therapeutic products manufactured:

Distribution by Type of Plasma derived therapeutic products

Over 95% of the plasma is fractionated to produce immunoglobulins, this is followed by albumins (94%) and coagulation factors (86%). It is worth highlighting that over 80% of the plasma fractionation companies are involved in fractionating blood plasma for the development of all of these aforementioned plasma-derived therapeutic products; examples of such plasma fractionation companies include (in alphabetical order, no specific selection criteria) China National Biotec Group (CNBG), Intas Pharmaceuticals, Merck KGaA, and Oryx Bio-Tech.

The Escalating Interest in this domain is also reflected in Partnership Activities

Over the past few years, there has been a steady increase in partnership activity within this domain, growing at a steady pace during the given period (2018-2023), depicting the growing interest of plasma fractionation companies in plasma fractionation to manufacture safe and effective plasma-derived therapies. For this purpose, mergers and acquisitions, product development and manufacturing agreements, technology / product licensing agreements, supply agreements, service agreements, product development and commercialization agreements, joint ventures, product distribution agreements and others have been reported in this market, as plasma fractionation companies strive to become one-stop-shops, to cater to the diverse needs for their clientele.

Plasma Fractionation Partnership Model

It can be inferred from the figure that mergers and acquisitions are the most popular type of partnership model being adopted by over 45% of the plasma fractionation companies, with maximum activity being reported in 2021. It is worth highlighting that the majority (70%) of the industry stakeholders have partnered to consolidate their raw plasma collection potential for fractionation and are actively adopting other partnership models to enhance their capabilities.

The partnerships signed within this domain were analyzed based on whether they were signed between companies based in the same continent (intracontinental agreements) or those having headquarters in different continents (intercontinental agreements).

Plasma Fractionation Intercontinental Agreements

It is worth mentioning that nearly 65% of the deals signed in this domain are intercontinental agreements. The majority of these deals were signed by plasma fractionation companies based in Europe. A similar trend was observed during the establishment of intracontinental deals, where over 15% of the agreements were signed by plasma fractionation companies based in Europe. This is followed by intracontinental agreements signed by plasma fractionation companies based in Asia-Pacific and the rest of the world.

Several Expansion Activities have been reported to attain sufficiency in plasma domain

Over the past few years, several recent expansions (since 2018) have been undertaken by various plasma fractionation companies in order to augment their respective plasma collection and fractionation capabilities. We were able to identify more than 60 expansions wherein companies engaged in plasma fractionation have expanded their existing facilities / capabilities through various strategies, including new facility, new plant and capacity expansion.

Recent Expansion Year wise

During our research, we came across various types of expansion initiatives that were reported in 2022. Majority of expansions in this year were related to the establishment of new facility (30%), in order to accommodate the growing demand for plasma therapies and increasing extent of outsourcing activity in the industry, followed by initiatives taken for the establishment of a new plant (5%). Example of plasma fractionation companies that establishment new plants to enhance their plasma fractionation capabilities in 2022 include (in reverse chronological order) LFB (November 2022), Grifols (September 2022), and Takeda Pharmaceutical (September 2022) in France, Canada, and Belgium, respectively.

Comprehensive Analysis of the Plasma Fractionation Market Reveals Promising Opportunities

In-depth market research conducted by our team has revealed a thriving landscape for the plasma fractionation market, growing at an annualized rate of ~10%. Our findings indicate that the market opportunities are diverse and well-distributed across various market segments, including type of company, scale of operation, types of plasma-derived therapeutic products manufactured, therapeutic area of plasma-derived products, demand across key geographical regions and supply across key geographical regions. The growing demand for different types of plasma-derived therapeutic products is anticipated to drive the growth of plasma fractionation market; Asia-Pacific is anticipated to be the fastest growing region with respect to both demand and supply side of the plasma fractionation market. A closer examination of the market reveals that immunoglobulins and albumins account for the majority share of the total market. This trend is expected to continue in the foreseeable future, the plasma fractionation market is poised to experience steady growth over the coming years.

Concluding Remarks

Owing to the increasing popularity of albumins and immunoglobulins, combined with the attempts to lower the plasma manufacturing cost, we believe that this market will experience significant growth in the near future. Further, driven by the continuous technological innovations, this domain is anticipated to witness steady growth; contract fractionation is expected to gain significant traction in the near future.

For detailed insights about this domain, check out our report on Plasma Fractionation Market, 2023-2035