U.S. Plasma Fractionation Market Size, Share & COVID-19 Impact Analysis, By Product (Albumin, Immunoglobulin [Intravenous Immunoglobulin {IVIG}, Subcutaneous Immunoglobulin {SCIG}], Coagulation Factors [Factor IX, Factor VIII, Prothrombin Complex Concentrates, Fibrinogen Concentrates, and Others], Protease Inhibitors, and Others), By Application (Immunology & Neurology, Hematology, Critical Care, Pulmonology, and Others), By End-user (Hospitals & Clinics, Clinical Research Laboratories, and Others), and Country Forecast, 2023-2030

The U.S. plasma fractionation market size was worth USD 15.64 billion in 2022 and is projected to grow at a CAGR of 7.5% during the forecast period.

The plasma fractionated products are biologic drugs that efficiently treat conditions such as burns, shocks, immunological disorders, congenital metabolic deficiencies, and other life-threatening disorders. The growing incidence of these conditions in the country is likely to increase the demand for plasma fractionation and plasma-derived products.

• For instance, according to the data published by the Centers for Disease Control and Prevention (CDC) in 2022, the incidence of hemophilia A is about one birth per 5,167 male births and one birth per 19,283 male births for hemophilia B.

To cater to this increasing demand for plasma products, market players are engaging in research and development activities to develop innovative products for the treatment of approved indications. The players are also conducting clinical trials to establish the efficiency of these products in the treatment of various other conditions. These factors, coupled with the rising launch of campaigns by the government to increase awareness regarding the importance of blood donation and plasma, are promoting the U.S. plasma fractionation market growth in the forthcoming years.

The U.S. market witnessed slow growth during the COVID-19 pandemic due to decreased plasma donation and collection volume.

LATEST TRENDS

Advanced Plasma Collection and Fractionation Technology by Key Players  

The plasma fractionation process comprises breaking down the plasma protein into components such as albumin, coagulation factors, immunoglobulins, and others. Leading players such as SL Behring, Octapharma, and others rely on company-owned collection centers. Currently, the companies are shifting their focus to developing advanced plasma fractionation technology and integrated systems with features to improve the efficiency of the plasma collection process with minimal errors and donor safety.   

• For instance, in March 2022, the U.S. FDA approved TERUMO BCT, INC's new plasma collection technology system, “Rika Plasma Donations System.” The system provides comfort and safety to the donors and completes plasma collection in less than 35 minutes. The system will be used for the first time in CSL plasma centers in the U.S.

DRIVING FACTORS

Rising Incidence of Immunodeficiency Disorder to Augment the Product Demand

The rising burden of immunodeficiency disorders is surging the demand for plasma-derived therapies such as immunoglobulins. Immunodeficiency disorders are characterized by autoimmune responses, recurrent chronic infections, inflammation, and allergy. Plasma-derived immunoglobulin therapy is used to treat these disorders.

• According to the National Organization for Rare Disorders (NORD) 2022 data, the incidence of Immune Thrombocytopenic Purpura (ITP) among the U.S. adult population is around 3.3 per 100,000/year.

Similarly, the rising incidence of human immunodeficiency virus (HIV) infection causes secondary immunodeficiency, acquired immunodeficiency syndrome (AIDS), is further surging the demand for plasma-derived products.

• For instance, according to the Centers for Disease Control and Prevention, approximately 36,136 people in the U.S. were diagnosed with HIV in 2021, which was 18.0% higher than in 2020.

Thus, the rising incidence of immunodeficiency disorders among the U.S. population is anticipated to raise the demand for plasma-derived products in the forthcoming years.

According to the report published by the Federal Deposit Insurance Corporation, the number of plasma centers in the U.S. increased from approximately 500 in 2015 to about 1,000 in 2021. Additionally, the top four companies accounted for 85% of the total plasma centers in 2021.

RESTRAINING FACTORS

Availability of Recombinant Therapies to Limit the Adoption of Plasma-Derived Therapies

Currently, patients are gradually shifting their preference toward recombinant therapies. These products are comparatively less immunogenic than plasma-derived products. Furthermore, recombinant products prevent the transmission of blood-borne infectious diseases. Such benefits are increasing the demand for these products among patients.

Additionally, in order to meet the growing demand for these products, companies are shifting their focus to develop recombinant products as an alternative to plasma-derived products for various conditions.

• For instance, in February 2023, Sanofi received U.S. FDA approval for ALTUVIIIO, a recombinant factor VIII replacement therapy indicated for treating children and adults with hemophilia A.

Thus, the presence of alternative recombinant products in the market is likely to impede the plasma-derived product market growth.

SEGMENTATION

By Product Analysis

Based on product, the market is segmented into albumin, immunoglobulin, coagulation factors, protease inhibitors, and others. The immunoglobulin segment accounted for the largest share in 2022 and is projected to continue its dominance during the forecast period. The rising prevalence of primary and secondary immune deficiency disorders is increasing  the demand for plasma-derived immunoglobulins. Moreover, the rising prevalence of autoimmune disorders such as myasthenia gravis, systemic lupus erythematosus (SLE), and others is increasing the demand for immunoglobulins therapy.

• For instance, according to the data published by the Centers for Disease Control and Prevention (CDC) in 2021, approximately 204,295 people in the U.S. are suffering from Systemic Lupus Erythematosus (SLE).

By Application Analysis

Based on application, the market is categorized into hematology, critical care, pulmonology, immunology & neurology, and others. The pulmonology segment is projected to grow significantly in the upcoming years owing to the rising prevalence of lung disorders such as chronic obstructive pulmonary disorders (COPD), emphysema, and chronic bronchitis, among others. Moreover, the key players operating in the market are seeking approval for the plasma derived drugs used to treat the condition.

• For instance, in April 2019, CSL Behring received the U.S. FDA approval for 4gm and 5gm vial sizes of plasma-derived Alpha-1 proteinase inhibitor, Zemaira, as a maintenance therapy for adults with AAT deficiency.

By End User Analysis

Based on end user, the market is segmented into hospitals & clinics, clinical research laboratories, and others. The clinical research laboratories segment is anticipated to grow lucratively in the forthcoming years. The growth is due to the rising research and development activities to develop and launch new plasma-derived medicinal products, and growing demand for plasma therapy for rare diseases, and others. Additionally, increasing collaborations between plasma companies and clinical research institutes to improve the treatment for a plethora of rare diseases such as hemophilia, inflammatory and autoimmune disorders, and others are bolstering segment growth. 

• For instance, in February 2020, CSL Behring partnered with the University City Science Center and awarded a research grant of USD 250,000 for developing new plasma-derived biotherapies.

KEY INDUSTRY PLAYERS

This market is highly consolidated, with a few players that held  the majority of the U.S. plasma fractionation market share in 2022. Grifols, S.A., CSL, and Octapharma AG are some of the companies leading the market in terms of revenue. The continuous efforts by these players to increase the manufacturing capacity of plasma-derived products to cater to the rising demand for these products in the country, significant investments in launching new products, and growing inorganic activities to expand their presence are a few factors to strengthen their market presence.

• For instance, in March 2021, Grifols, S.A. acquired 25 plasma donation centers from BPL Plasma Inc. under USD 370 million. Through this acquisition, the company aimed to increasing the country's geographical footprint.

LIST OF KEY COMPANIES PROFILED:

• CSL (Australia)


• Grifols, S.A. (Spain)


• Takeda Pharmaceutical Company Limited (Japan)


• Kedrion S.p.A (Italy)


• Octapharma AG (Switzerland)


• Bio Products Laboratory Ltd. (U.K.)


• LFB (France)

KEY INDUSTRY DEVELOPMENTS:

• April 2023- CSL Behring received the U.S. FDA clearance for a prefilled syringe, Hizentra, a subcutaneous immunoglobulin (Human) intended for treating people suffering from Primary Immunodeficiency (PI) or Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).


• April 2023 - Takeda Pharmaceutical Company Limited received the approval from the U.S. FDA for extended use of Hyqvia, immunoglobulin 10% (Human) with recombinant human hyaluronidase to treat children aged 2-16 years suffering from Primary Immunodeficiency.


• August 2021- Octapharma USA received seven years of market exclusivity for Octagam 10% (intravenous immunoglobulin
  ) from the U.S. FDA’s Office of Orphan Products Development.

REPORT COVERAGE

The U.S. plasma fractionation market report provides a detailed analysis and focuses on key aspects such as the overview of the types of plasma fractionated products, regulatory scenario in the country, reimbursement scenario in the country pipeline analysis, number of plasma collection centers in the country, prevalence of chronic diseases in the U.S., pricing analysis of plasma products, distribution of plasma fractionation throughput. Additionally, it includes an overview of new product launches/approvals, the market forecast, porter s five forces analysis, competitive landscape, and the impact of COVID-19 on the U.S. market. Besides these, the report offers insights into U.S. market trends and highlights key strategies by market players. In addition to the aforementioned factors, the report encompasses several factors that have contributed to the growth of the market in recent years.

Report Scope & Segmentation