Plasma Protein Therapeutics Market Size, Share, Industry, Forecast and outlook (2024-2031)

Global Plasma Protein Therapeutics Market is segmented By Product (Immunoglobulin, Albumin, Plasma Derived Factor Viii, Others), By Application (Hemophilia, Primary Immunodeficiency Disorder (PID), Idiopathic Thrombocytopenic Purpura (ITP), Others), and By Region (North America, Europe, South America, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2024-2031

Plasma Protein Therapeutics Market Overview

The Global Plasma Protein Therapeutics Market is estimated to reach at a high CAGR during the forecast period (2024-2031). 

Plasma protein therapy treats different medical conditions, restoring missing or inadequate proteins found in plasma to allow their receivers to lead healthier and more productive lives. The patients that rely upon plasma protein therapies generally require regular infusions for the duration of their lives.

Plasma Protein Therapeutics Market Summary

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Plasma Protein Therapeutics Market Dynamics

The plasma protein therapeutics market growth is driven by the growing prevalence of autoimmune disorders, immune deficiency disorders, neurological and bleeding disorders, the rising awareness about plasma donation is a major reason for market growth as elderly people are more prone to neurological disorders, growing investements in research and development programs by the biotechnology and pharmaceutical companies is boosting the market growth, the advancements in the plasma proteins.

The rising awareness about plasma donation, is expected to drive the global plasma protein therapeutics market growth

The awareness about plasma donation is increasing every year, more than 22 million liters of plasma are utilized to manufacture life-saving medicines to treat more than one million people worldwide. For instance, Baxter works closely with the Plasma Protein Therapeutics Association, or PPTA, to raise awareness of the importance of plasma donation to support a growing, global need for plasma-derived therapies. In 2011, Baxter received approval in Europe to use immune globulin to treat for multifocal motor neuropathy, a neurological disease that attacks the peripheral nerves, resulting in progressive limb weakness. In addition, Baxter also is in clinical trials exploring the use of immune globulin as a treatment for Alzheimer's disease.

Growing investments in research and development programs, is expected to drive the global plasma protein therapeutics market growth

The plasma protein industry players have been investing in the research and development of new plasma protein therapies (e.g., Ceruloplasmin, IgA, Plasmin), leading to innovative treatments for the benefit of patients. For instance, in March 2016, Grifols Biologicals, LLC invested US$ 360 Mn to extend production capabilities for plasma-derived therapies. This investment will increase the plasma fractionation capacity and purification of several proteins. This has also been evident from advancements such as the product presentations (e.g., subcutaneous IG, IVIG 10% concentration, and IVIG liquid presentation), manufacturing process (e.g., improvement of yield), added virus elimination technologies (e.g., nanofiltration), and development of new plasma proteins (e.g., protein C and purified factor V).

Stringent regulation and reimbursement issues threat is likely to hamper the growth of the market

The stringent regulation and reimbursement issues threat may restrict the market growth as plasma collection standards in emerging countries do not match those required by the fractionators. These regions follow stringent rules and regulations regarding the quality of their operations, starting with the quality of the raw material. Specific fractionators are designed for plasma. For example, the European health authorities require that the plasma pool for fractionation be tested for HIV, hepatitis A, B and C, and Parvovirus B. The blood collected by many centers is often unable to comply with these regulations, causing some recovered plasma to be unused.

Moreover, health budgets have been subjected to rising pressures. Funding through reimbursement pathways from private and public payers has come under inspection. It has drawn plasma protein therapies into the landscape of Health Technology Assessments (HTA), including the possible application of cost-utility analysis (CUA) to distribute reimbursement funds and, given the high cost of the therapies and the comparatively nascent nature of many indications, the application of these tools of health economics can constrain the supply of products for patients in genuine need.

In addition, regulatory and quality policies affect every step of the plasma protein therapy life cycle, including donor safety, quality and compliance, the biological license application process, therapy safety and efficacy, and pharmacovigilance. For example, licensing and inspecting plasma collection centers and plasma protein therapy manufacturing facilities can be tedious and time-consuming.

COVID-19 Impact Analysis on Plasma Protein Therapeutics Market

The COVID-19 outbreak is expected to have a major impact on the market. In the context of the COVID-19 pandemic, government organizations in various countries, research institutes, and many biotech and pharmaceutical firms are focusing on practical and rapid technologies for the fast diagnosis of COVID-19 and developing vaccines and novel therapeutics to overcome the current situation. It is also affecting the global economy in three main ways: by directly affecting production and demand, creating supply chain and market disruption, and its economic impact on the companies and financial markets. The present COVID-19 pandemic has also temporarily impacted plasma donation globally, affecting the plasma protein therapeutics market. However, researchers focus on plasma-based therapeutics to identify whether these therapies have any promising role in treating the COVID-19 virus. For example, in April 2020, Kamada Ltd. and Kedrion Biopharma, two biopharmaceutical companies specialized in plasma-derived protein therapeutics, entered into a global collaboration for the development, manufacturing, and distribution of a human plasma-derived Anti-SARS-CoV-2 (COVID-19) polyclonal immunoglobulin (IgG) product as a most potential treatment for COVID patients.

Moreover, in April 2020, the Indian Council of Medical Research (ICMR) pursued the participation of researchers for conducting a clinical trial of convalescent plasma therapy to treat critically ill COVID-19 patients and floated a protocol for it. In May 2020, BioAegis Therapeutics started researching its lead product, recombinant human plasma gelsolin therapy (rhu-pGSN), believing it as a viable therapeutic option for patients suffering from severe lung injury due to COVID-19.

Plasma Protein Therapeutics Market Segmentation Analysis

The Immunoglobulin segment is expected to hold largest share in this market segment

Many clinical indications for IG have been rapidly growing. Immuno globulins have become an important treatment option in many clinical indications beyond significant immunodeficiency, including autoimmune and acute inflammatory conditions and also, off-label prescribing has crossed over into almost every medical specialty. In addition, the chronic use of off-label prescribing in some indications, particularly for the treatment of some neurological illnesses, in addition to immune deficiencies, is increasing the demand for IGs.

Plasma-derived immunoglobulin is used for a wide range of autoimmune and inflammatory diseases. Increased recognition and treatment of immune deficiencies in the developing world have added to the global demand for IG. However, increased use of high-dose therapy, particularly in autoimmune neurologic diseases, is the primary reason for the continued strong demand for IG products.

Widespread off-label use of IG demonstrates the use of a large volume of plasma. Examples of the most common off-label uses for IVIG in the U.S include

• Multifocal motor neuropathy (MMN)
• Acute panautonomic polyneuropathy
• Hemolytic disease of the newborn
• Autoimmune mucocutaneous blistering diseases and
• Acute cardiomyopathy.

This clinical demand for medicines has increased in the past few years, and the trend is likely to continue due to constant improvement in diagnosis and improved life-expectancy.

For instance, in March 2018, the first immunoglobulin therapy received approval from the FDA is developed by CSL’s Hizentra. It is highly used in the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP).

The Hemophilia segment is expected to hold largest share in this market segment

Hemophilia, a unique bleeding disorder of genetic origin that prevents normal blood clotting holds large share of the market segment. The primary symptom of this disorder is uncontrolled and often causes spontaneous bleeding in distinct areas of the body. The amount of bleeding depends on the severity of hemophilia. For instance, according to the World Federation of Hemophilia report 2019, the number of people identified with hemophilia increased from 78,629 in 1999 to 210,454 in 2018. Additionally, as per the Global Hemophilia Care 2019 report, more than 1,125,000 men worldwide have an inherited bleeding disorder, and 418,000 of those have an extreme version of the most undiagnosed disease. Hemophilia A type is the most prevalent condition, with an incidence rate of 1 in 4,000 to 1 in 5,000 males worldwide born with this disorder. Hemophilia B occurs in approximately 1 in 20,000 newborn males across the world. The increasing prevalence of hemophilia and the vast patient pool are expected to trigger market growth during the forecast period.

Moreover, the increasing R&D research on developing new therapeutics and product launches is expected to boost the segment growth over the forecast period. For instance, in October 2018, the United States Food and Drug Administration (FDA) approved Roche’s Hemlibra for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children, newborns and older, with hemophilia A without factor VIII inhibitors. The increasing geriatric population is also expected to boost demand for plasma protein therapeutics.

Plasma Protein Therapeutics Market Geographical Share

North America region holds the largest market share of global plasma protein therapeutics market

The North American region is expected to serve a large share of the plasma protein therapeutics market due to factors like the rising prevalence of autoimmune diseases and neurological disorders. The United States is expected to have the largest share in this region.

The existence of the well-established healthcare infrastructure-focused market players on R&D for plasma protein therapeutics, coupled with recent product launches, and the rising burden of autoimmune disorders are major growth factors for the market in the United States. According to the Centers for Disease Control and Prevention (CDC), in 2018, about 70% of people with hemophilia in the United States receive multidisciplinary, comprehensive care in a network of federally funded hemophilia treatment centers. ​In addition, according to the United States Arthritis Foundation, arthritis is the leading cause of disability among adults. About 54 million adults were diagnosed with arthritis by conservative estimates. In addition, almost 300,000 children have arthritis or rheumatic condition (as of 2017-2018) and, according to a study published by Derek Weycker, in October 2019, the annual prevalence of immune thrombocytopenia (ITP) in the United States was 6.1 per 100,000 persons, higher among females than males (6.7 vs. 5.5), and the highest among children aged between 0 and 4 years (8.1) and adults aged 65 years and above (13.7).

Furthermore, there has been an increased focus on convalescent plasma therapy to treat COVID-19 in the United States. For instance, in April 2020, Johns Hopkins got FDA approval to test blood plasma therapy to treat COVID-19 patients. In addition, the US FDA issued guidance to provide recommendations for investigational convalescent plasma therapy. Hence, the market for plasma protein therapeutics is boosted to have major growth in the United States.

The increasing geriatric population in this region also increases the patient pool, like older people are more prone to neurological diseases. Furthermore, beneficial government initiatives, escalating awareness levels among the blood donors, advanced protein fractioning procedures, greater per capita income in developed countries, and increased research partnerships are some of the drivers expected to increase market growth in the region.

Plasma Protein Therapeutics Market Companies and Competitive Landscape

The global plasma protein therapeutics market is highly competitive with presence of global companies. Some of the key players which are contributing to the growth of the market include CSL Behring LLC, Octapharma AG, Grifols S.A., Shire Plc, Biotest AG, Kedrion S.P.A., China Biologics Products Holdings, Inc., Takeda Pharmaceutical Company Ltd., Baxter International Ltd, ADMA Biologics, Inc, Chengdu inst, Hualan Bio, Shuanglin Bio, Tiantan Bio, Shanghai RAAS Blood Products. The major players are adopting several growth strategies such as product launches, acquisitions, and collaborations, which are contributing to the growth of the market globally. For instance, In February 2021, Biotest became the first plasma protein manufacturer in Germany to produce an investigational hyper immunoglobulin preparation against COVID-19.

Plasma Protein Therapeutics Market Key Companies to Watch

Grifols S.A

Overview: Grifols is a global healthcare company that since 1909 has enhanced the health and well-being of people around the world. They are industry leader in producing plasma-derived medicines and transfusion medicine. They sell their products and services in more than 100 countries and regions and have subsidiaries in more than 30 of them. They have 24,000 employees work for a common goal to improve people's lives and well-being.

Product Portfolio: The company is focused primarily on Bioscience, Diagnostic, Hospital, and Bio Supplies.

Product: Plasmanate (Plasma Protein Fraction (Human) 5%, USP)

Protein solution comprised of approximately 88% normal human albumin, 12% alpha and beta globulins, and not more than 1% gamma globulin.

Indications: Plasmanate is indicated in the treatment of shock due to burns, crushing injuries, abdominal emergencies.

Key Development: On June 1st 2021, Grifols introduced HyperHEP B® (hepatitis B immune globulin [human]), a new formulation to treat patients exposed to hepatitis B.

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