Plasma Fractionation Market Size, Share & Trends Analysis Report By Product (Albumin, Immunoglobulins, Coagulation Factors, Protease Inhibitors, Others), By Application (Immunology & Neurology, Hematology, Critical Care, Pulmonology, Others), By End-user (Hospitals & Clinics, Clinical Research Laboratories, Others) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2022-2030

Market Overview

The global plasma fractionation market size was worth USD 20,551 million in 2021. It is expected to be valued at USD 36,223 million by 2030, growing at a CAGR of 6.5% during the forecast period (2022–2030). 

Fractionation is a way to separate a certain amount of a mixture using a machine. Plasma is the yellowish liquid part of blood that contains blood cells. Plasma fractionation separates high-quality proteins like albumin and immunoglobulins from the rest of the plasma. These products are called plasma derivatives because they are made by separating plasma. These products are also used in different areas of medicine like neurology, hematology, critical care, and immunology. Plasma products are also used in hospitals and labs that do clinical research.

The primary factor driving the market is the rise in the geriatric population, which is more susceptible to rare diseases that need plasma derivatives for treatment. The plasma fractionation market is also growing because immunoglobulins and alpha-1-antitrypsin are used more readily in medicine worldwide. Additionally, the spike in the number of plasma collection centers around the world is a significant factor in the growth of this market.

Plasma fractionation has always piqued the interest of both researchers and industrialists. Blood plasma's therapeutic effectiveness in managing immunodeficiency illnesses has expanded the market. The two main methods used in plasma fractionation equipment to separate therapeutic protein components from whole blood are cryo precipitation and ethanol fractionation. Prothrombin complex, thrombin, fibrinogen, and other protein components are crucial in treating illnesses. These fractionated plasma products effectively treat conditions including congenital metabolic deficits, trauma, immunological problems, and other serious illnesses.

Market Dynamics

What are the Driving Factors for the Global Plasma Fractionation Market in the Forecast Years?

• Improved Research and Development (R&D)

More people worldwide are contracting rare diseases, which has increased the demand for plasma fractionation products. Plasma derivatives are used to treat rare diseases like Guillain-Barré and myasthenia gravis. These diseases are rare and not well understood. Therefore, there is an increased emphasis on research and development of new therapies and drugs for rare diseases, stimulating the plasma fractionation market.

• Growing Geriatric Population

The growing geriatric population worldwide contributes to the market significantly. Older people are more susceptible to rare diseases. For example, Guillain-Barré syndrome is more prevalent in older people. Likewise, most people with thymoma get myasthenia gravis between the age of 50 and 60. This increases the demand for plasma fractionation. Consequently, the government and private organizations are working hard to inform patients about available and effective treatments, boosting market growth.

• Increased Use of Immunoglobulins

Immunoglobulin is an antibody present in the cells of the immune system. Immunoglobulins are used to treat conditions like immunodeficiency diseases, idiopathic thrombocytopenic purpura (ITP), Kawasaki disease, and nervous system disorders. Immunoglobulins are also used to treat lupus and vasculitis, which are both rare diseases. Immunoglobulins like IVIG are also used to treat diseases with no alternative treatment.

Furthermore, people with Guillain-Barré syndrome, multiple myeloma, myasthenia gravis, acquired factor VIII inhibitor syndrome, autoimmune neutropenia, post-transfusion purpura, and polymyositis/dermatomyositis are often advised to take immunoglobulins. Immunoglobulins can also treat primary immunodeficiency and secondary immunodeficiency, among other things. Therefore, the growing awareness and widescale adoption of immunoglobulins in medicine spur the plasma fractionation market.

• Rising adoption of PDMPs

Human plasma is used to produce plasma-derived medicinal products (PDMPs). Albumin, immunoglobulin, and coagulation factors are some of these products. Numerous PDMP drugs were listed in the model list of essential medications created by the World Health Organization (WHO). This initiative highlighted that these drugs are suitable for treating severe conditions while being safe. The high need for plasma-derived products increased the demand for these treatments, stimulating the expansion of the industry. For instance, immunoglobulin can treat primary immunodeficiency illnesses by making up for lost IgG serotype antibodies. However, coagulation factor replacement is necessary for hemophilia and Von Willebrand disease (VWD). Plasma therapies are demonstrated to be crucial for major deficits and play a significant role in both prenatal and acute care. Increased manufacture of plasma-derived products eventually helped the market growth due to the increased use of PDMPs for uncommon immunodeficiency diseases and numerous other neurological and hematological disorders.

Market Restraints

• High Costs of Plasma Derived Products

Plasma-derived products are made from donated human blood. Plasma or clotting proteins are separated from the blood and used to make clotting factor concentrates or fresh frozen plasma. Fractionation is an expensive process involving getting blood from many people and mixing it. These people go through screenings to find and prevent diseases that can be spread through plasma. Also, plasma-based products are tested again after they are made to kill any bacteria or viruses in them. Due to these steps, products made from plasma are expensive. Furthermore, products made from therapeutic plasma can cost more than USD 200,000. This slows the growth of the plasma fractionation market.

• Development of Recombinant Therapies as an Alternative to Plasma-Derived Medicines

Many recombinant substitutes have been created recently for various plasma-driven therapies. Recombinant products are preventive and less immunogenic than those made from plasma. There are other longer-acting replacement factors in the pipeline in addition to these. The products offer essential advantages such as less frequent administration and improved prophylactic performance. An important factor restricting the usage of plasma products is the growing use of recombinant factors and their rising use in preventive therapy.

Recombinant products, produced by the expression of identical proteins from the genetically modified cannula, are a safer alternative to plasma-derived products because they prevent the risk of infectious infections from being transmitted through the blood. Therefore, the benefit of such products makes them more dependable than items made from plasma, limiting market expansion.

What Are Future Growth Opportunities in the Plasma Fractionation Market Globally?

• High Growth Potential in Emerging Countries

The plasma fractionation business has immense potential in developing economies. The market in developing economies like Canada, Saudi Arabia, and others is driven by the ever-changing life science industry. Plasma fractionation is also used more in low-and middle-income countries to make medicines from plasma. For example, the World Federation of Hemophilia estimates that only 25% of people with hemophilia get the proper care worldwide. Additionally, the International Patient Organization for Primary Immune Deficiencies says immunoglobulin products are unavailable to 70% of patients with primary immune deficiencies. Therefore, the high unmet need for plasma fractionation will likely create good growth opportunities in the coming future.

Regional Analysis

The global plasma fractionation market share is segmented into North America, Europe, Asia-Pacific, and LAMEA.

Is North America Likely to Dominate the Global Plasma Fractionation Market?

North America holds the highest share of the plasma fractionation market and is expected to grow at a CAGR of 6.3% during the forecast period. This is because immunoglobulins and alpha-1-antitrypsin are readily used in medicines, plasma fractionation products are easily available, and many big companies offer these products. Furthermore, the government is raising awareness about plasma-derived products, propelling the market.

Significant key players in the sector, including Baxter International Inc., Emergent BioSolutions, KabaFusion, Biotest AG, and CSL Ltd, also contribute significantly to the market. Additionally, the rising incidences of rare diseases, a growing elderly population, and an increasing number of plasma collection centers further boost the demand for plasma fractionation.

Asia-Pacific is the fastest-growing region in the plasma fractionation market. It is expected to grow at a CAGR of 6.9% during the forecast period, accounting for USD 9,090 million. The presence of governmental agencies that oversee and control plasma collection, fractionation, and sales is primarily driving the market. Furthermore, hemophilia, primary & secondary immune deficiencies, and rising rates of severe fever with thrombocytopenia syndrome (SFTS) contribute to the market expansion.

In the European region, Germany, France, the UK, Italy, and Spain are looked at as some of the most important countries. In 2021, 14.4% of the global market for plasma fractionation was made up of sales in Europe. During the next few years, the European market is expected to grow steadily, owing to the growing demand for plasma fractionation products and a strong presence of key players in the industry. Another factor influencing the expansion of the plasma fractionation market is the numerous improvements made to plasma fractionation products by the leading manufacturers.

Due to the expansion of the target population, the surge in demand for plasma fractionation products, and improvements in the healthcare infrastructure, LAMEA is a rising market that is anticipated to offer lucrative growth possibilities for major players. Additionally, the rising prevalence of hemophilia and other medical diseases in LAMEA that call for the usage of plasma derivatives for therapy are increasing the use of plasma fractionation, fueling the market expansion.

Segmental Analysis

The global plasma fractionation market share is segmented by product and sector.

By Product Analysis

Product-wise, the global plasma fractionation market is classified into Albumin and Immunoglobulins.

Immunoglobulins hold the highest market share and are expected to grow at a CAGR of 6.4% during the forecast period. Immunoglobulins are made from donated human plasma. They are important biological parts used to treat many autoimmune and inflammatory diseases. The main thing that helps the immunoglobulin segment grow is that more immune deficiencies are being found and treated. The growth of the immunoglobulin plasma fractionation market is also supported by the increasing use of high-dose IgG products to treat autoimmune neurologic diseases.

Albumin is used more in medical situations like acute liver failure and cardiopulmonary bypass. Albumin is the most common plasma protein because it makes up more than 50% of serum protein in healthy people. It is also made by the liver and is chemically insoluble in water.

By Sector Analysis

Sector-wise, the global plasma fractionation market is classified into Public and Private Sectors.

The Private Sector holds the maximum share and is expected to grow at a CAGR of 6.7% during the forecast period. The private sector is run by businesses for profit. It includes all businesses that are not owned or run by the government. In the private sector, companies collect plasma in highly controlled settings by licensed and trained staff. Also, these private companies keep plasma in storage for 60 days before sending it to their factories. At the manufacturing sites, therapeutic proteins are taken out of the plasma and then purified, and viruses are killed to make the products safer for patients.

Public Sector companies pay for themselves and are owned by the government. The people who work in the public sector offer services that help everyone, not just those who use them. For example, the Korean Red Cross is a non-profit group in South Korea that works with plasma fractionation, which is part of the public sector. Likewise, the Japanese Red Cross works as a non-profit plasma fractionator in Japan.

The segment grew in 2022 as a result of an increase in the use of albumin in numerous applications, including the treatment of cirrhosis, sepsis, and cardiovascular illnesses. For instance, albumin is a popular treatment for severe liver illness in China, according to a 2019 article from BioSupply Trends Quarterly. 28 million patients are thought to need therapy, and 7 million people with severe liver disease need immediate, intensive care.

Impact of covid-19

Covid-19 had some profound adverse impacts on the global advanced ceramics market.

COVID-19 spread across the world from China, making the whole world stand still and to a complete lockdown situation. Covid-19 is an infectious disease that was caused by a newly discovered coronavirus. During the time, the fatality rate among the population above 40 was also high globally. The disease causes severe illness for people suffering from medical conditions like diabetes, cardiovascular disease, chronic respiratory disease, etc.

Considering the situation during that time, it was declared a pandemic which led to numerous countries, including the major economies like China, the United States, India, and others, implementing lockdowns which adversely affected the global economy.

In the first two quarters of 2020, the economic and industrial operations temporarily halted. Almost every manufacturing unit where advanced ceramics is used, such as electrical and electronics, transportation, industrial, chemical, and other End-user Industries (except medical), reduced their manufacturing capacities due to the lack of workers. The lockdown implemented put a halt to global supply chains. This resulted in repercussions in terms of both production and demand for advanced ceramics.

Market Recovery Timeline and Challenges

With time the lockdowns were uplifted, and relaxation was made to the public. Gradually, the economy picked up the pace and started its operations, bringing the demand in the global advanced ceramics market and increasing among various industries. As the situation improved during the initial months of 2021, the economies also strengthened their fiscal policies and initiated their development process; the end-user industries began their activities, bringing the overall ceramics market back on track.

Recent Developments

• In September 2022, Grifols and Canadian Blood Services signed an agreement to quicken Canada's transition to immunoglobulin self-sufficiency.
• In January 2023, Baxter Declares Strategic Initiatives to Boost Operational Efficiency, Speed Up Innovation for Patients, and Increase Shareholder Value.
• In December 2022, Etranacogene Dezaparvovec - Gene Therapy for Adults with Hemophilia B Received Positive CHMP Opinion from CSL