The Food and Drug Administration regulates blood collection, preparation, and testing (FDA). Whole blood is collected from volunteer donors and separated into components such as red blood cells, platelets, plasma, and cryoprecipitate. Granulocytes and other white blood cells, while occasionally transfused, are not FDA-approved products (but they generally are collected using aphaeresis in FDA-registered facilities). Platelets, red blood cells, and plasma can also be collected using apheresis, which involves passing the blood through a machine that separates blood components and returns uncollected components to the donor. Plasma can be prepared from whole blood or collected by aphaeresis for transfusion or further processing into plasma protein derivatives such as albumin (human), clotting factor concentrates, and Immune Globulin Intravenous (IGIV). Plasma proteins are derived from plasma collected specifically for the purpose of manufacturing these derivatives or from whole blood plasma. Plasma protein derivatives are created by pooling plasma from multiple donors and separating the desired proteins, such as immune globulins and clotting factors, through a fractionation process.

COVID-19 impact on blood plasma derivatives market

Convalescent plasma therapy, according to a report released by the Mayo Foundation for Medical Education and Research (MFMER), uses blood from people who have recovered from illness to help others recover. The Food and Drug Administration (FDA) of the United States has granted emergency approval for convalescent plasma therapy with high antibody levels to treat COVID-19. It may be used for some hospitalized COVID-19 patients who are either in the early stages of their illness or have weakened immune systems. Blood donated by COVID-19 survivors contains antibodies to the virus that causes it. Blood cells are removed from donated blood, leaving behind liquid (plasma) and antibodies. These can be given to people who have COVID-19 to help them fight the virus. People with COVID-19 who are in the hospital and are early in their illness or have a weakened immune system may be given convalescent plasma therapy. Convalescent plasma therapy may aid in the recovery of COVID-19 patients. It may lessen the severity of the disease or shorten its duration. Furthermore, data from several clinical trials, studies, and a national access program suggest that when given early in the disease or to those with weakened immune systems, convalescent plasma with high antibody levels may lessen the severity or shorten the duration of COVID-19 in some people. 

Market Drivers

Rising prevalence of life-threatening disorders, especially hemophilia have gained significant attention for the global blood plasma derivatives market

Due to the rapid introduction of a number of new hemophilia treatment products, the hemophilia markets in high-income countries have seen more changes in the last 5 years than in the previous 30 years. The first notable change occurred in 2014 when Biogen (now Bioverativ) introduced the first extended half-life factors VIII and IX products. Shire, CSL Behring, and Novo Nordisk have all introduced extended half-life factor products since then, with several more in late-stage development. In addition, in November 2017, Roche received FDA approval for the first novel, non-factor therapy to treat hemophilia patients with inhibitors.  This is the first monoclonal antibody to be used to treat hemophilia patients, as well as the first therapy to be administered subcutaneously. As IgG production has increased over the last few decades, so has the demand for more plasma.  From approximately 16.4 million liters in 1990 to 33.6 million liters in 2010, the global supply of plasma for fractionation (source and recovered) reached an estimated 51.2 million liters in 2016. Two-thirds of this was made up of total plasma from the United States. In 2016, the United States supplied 74% of the world's source plasma. Because the FDA allows individuals to donate plasma more frequently and at a higher annual volume than any other country, this country is able to generate a higher volume of source plasma than other countries. While donor compensation is significant, it is not the primary reason for the United States' dominance in this field. The commercialization of new plasma-derived therapies is expected to skyrocket in the coming decade.

Increasing awareness about blood & plasma donation bolster the growth of global blood plasma derivatives market

According to a World Health Organization (WHO) report, 40% of the 118.5 million blood donations collected globally are collected in high-income countries that account for 16% of the world's population. In low-income countries, children under the age of five account for up to 54% of all blood transfusions, whereas in high-income countries, the most frequently transfused patient group is over 60 years old, accounting for up to 75% of all transfusions. Furthermore, to raise awareness of blood and plasma derivatives “WHA63.12” urges Member States to establish, implement, and support a nationally coordinated, efficiently managed, and sustainable blood and plasma program based on available resources, with the goal of achieving self-sufficiency. Individual governments are responsible for ensuring a sufficient and equitable supply of plasma-derived medicinal products, such as immunoglobulin’s and coagulation factors, which are required to prevent and treat a wide range of serious conditions that occur around the world. During the year, approximately 25.6 million liters of plasma from 39 reporting countries were fractionated for the production of PDMP. This includes approximately 47 % of the plasma recovered from whole blood donations.

Market Segmentation

The global blood plasma derivatives market is segmented based on type, application, and end-user. By type, the market is segmented as albumin, factor 8, factor 9, immunoglobulin, hyperimmune globulin, and others. Based on application, the market is segmented as hemophilia, hypogammaglobulinemia, immunodeficiency diseases, von Willebrand's disease (VWD), and other applications. Further, end-user is segregated as hospitals, clinics, and other end-users.

Regional Framework

The global blood plasma derivatives market is expected to be dominated by North America. The market in North America is being driven by rising awareness about the use and availability of plasma derivatives for the treatment of infectious diseases. Asia Pacific, on the other hand, is expected to have the fastest growing CAGR during the analysis period. The high population base, increase in disposable income, and improvement in patient awareness of plasma derivatives are the major factors driving the global blood plasma derivatives market.

Competitive Landscape

The prominent players of the global blood plasma derivatives market involve Grifols, S.A., SK Plasma, Fusion Healthcare, Biotest AG, GC Pharma [Green Cross Corporation], Baxter International Inc., LFB S.A., Octapharma AG, CSL Limited, Shire plc, and among others

Market Segmentation

Market By Type

Albumin
Factor 8
Factor 9
Immunoglobulin
Hyper Immune Globulin
Others

Market By Application

Hemophilia
Hypogammaglobulinemia
Immunodeficiency Diseases
Von Willerbrands Disease (VWD)
Other Applications

Market By End-User

Hospitals
Clinics
Other End-Users

Market By Geography

North America
•    U.S.
•    Canada

Europe
•    U.K.
•    Germany
•    France
•    Spain
•    Rest of Europe

Asia-Pacific
•    China
•    Japan
•    India
•    Australia
•    South Korea
•    Rest of Asia-Pacific

Latin America
•    Brazil 
•    Mexico
•    Rest of Latin America

Middle East & Africa
•    GCC
•    South Africa
•    Rest of Middle East & Africa