Global Plasma-Derived Therapeutics Market - 2024-2031

Overview

The Global Plasma-Derived Therapeutics Market reached US$ 20.16 billion in 2023 and is expected to reach US$ 30.24 billion by 2031 growing with a CAGR of 5.2% during the forecast period 2024-2031.

Plasma-derived therapeutics are medicinal products manufactured from human plasma, the liquid portion of blood that contains vital proteins. These therapies are uniquely formulated to treat a wide range of serious and frequently rare diseases, particularly those stemming from deficiencies or malfunctions of plasma proteins. Plasma-derived therapies are indispensable for managing conditions such as immune deficiencies, bleeding disorders like hemophilia, and other genetic disorders caused by missing or dysfunctional proteins.

The production of plasma-derived therapeutics involves intricate processes that extract and purify specific proteins from donated plasma. This manufacturing timeline can span several months and necessitates rigorous safety protocols to guarantee the quality and effectiveness of the final products. Given their distinctive biological characteristics, these therapies are classified as sole-source biologics, meaning they cannot be substituted with other medications, and it is essential for patients to have reliable access to their specific treatments.

Market Dynamics: Drivers

Increasing prevalence of rare diseases

The demand for the global plasma-derived therapeutics market is driven by multiple factors. The rising incidence of rare diseases is a key factor contributing to the growth of the plasma-derived therapeutics market. These rare conditions, such as primary immunodeficiency disorders, hemophilia, and autoimmune diseases, frequently necessitate specialized treatments that are commonly delivered through plasma-derived therapies.

According to Pfizer, news release in 2024, more than 7,000 recognized rare diseases impact around 400 million individuals globally. Approximately 80% of these diseases have genetic origins, and 50% of those affected are children. Together, individuals living with rare diseases constitute one of the largest underserved patient populations worldwide, with only 5% of known rare diseases having one or more approved treatments available.

Moreover, key player strategies such as partnerships & collaborations, and the rising number of clinical trials would drive this market growth. For instance, in October 2022, Takeda partnered with the United Nations Institute for Training and Research (UNITAR) to launch a global educational initiative aimed at addressing plasma shortages. This collaboration seeks to establish a neutral platform under the UN framework where various stakeholders can come together to develop solutions for the shortfall in plasma and plasma-derived therapies.

Also, in February 2024, Grifols is gearing up for significant advancements in its plasma-derived medicines portfolio in 2024, as outlined by Chief Scientific Officer Jorg Schuttrumpf in a recent interview with Pharmaceutical Technology. The company is set to release Phase III results for its long-term albumin treatment aimed at improving survival rates in patients with decompensated cirrhosis and ascites. This treatment is part of the Preciosa trial, which focuses on patients awaiting transplants.

In addition, government initiatives & support, product launches, and approvals would propel this market growth. For instance, in July 2023, Kedrion Biopharma announced that its human Albumin product from BPL has been approved by China's National Institutes for Food and Drug Control (NIFDC) for release in the Chinese market. This milestone marks the first-ever approval for a BPL product in China.

Similarly, in October 2021, MilliporeSigma introduced the Viscosity Reduction Excipient Platform aimed at protein-based therapeutics. This platform is designed to lower viscosity while preserving protein stability, assisting therapeutic candidates in overcoming formulation challenges associated with highly concentrated protein solutions.

Also, in March 2021, OrganaBio launched its HematoPAC-HSC-CB CD34+ hematopoietic stem cells (HSCs) are sourced from fresh cord blood shortly after birth. Each HematoPAC-HSC-CB product is accompanied by a comprehensive quality data package that details donor characteristics, including HLA expression, as well as information on cell viability, purity, and immunophenotyping profiles for every manufactured cell lot.

Furthermore, with ongoing investment from pharmaceutical companies in the research and development of plasma-derived therapies, the market is well-positioned for sustained growth in the years ahead. This trend ensures that patients suffering from rare diseases will have improved access to vital and transformative treatments that can significantly improve their quality of life.

Restraints

Factors such as the high costs of plasma-derived therapies, strict regulations for the handling of plasma protein products, supply chain challenges, and limited awareness among individuals, are expected to hamper the market.

Market Segment Analysis

The global plasma-derived therapeutics market is segmented based on product type, application, end-user, and region.

The hemophilia segment accounted for approximately 56.3% of the global plasma-derived therapeutics market share

The hemophilia segment is expected to hold the largest market share over the forecast period. Hemophilia is a rare genetic disorder characterized by the body's inability to form blood clots effectively. This condition is primarily caused by deficiencies in specific clotting factors, which are proteins essential for the blood clotting process. The most common types of hemophilia are Hemophilia A, caused by a deficiency of factor VIII, and Hemophilia B, resulting from a deficiency of factor IX.

Plasma-derived therapeutics are essential in the treatment of hemophilia, a genetic bleeding disorder marked by a deficiency in certain clotting factors. Plasma-derived therapies are made up of clotting factor concentrates obtained from human plasma. These concentrates supply the essential clotting factors needed to manage and prevent bleeding. For individuals with severe hemophilia, consistent infusions of these therapies are typically necessary to sustain sufficient levels of clotting factors in the blood.

Moreover, key players in the industry more focus on R & D, rising number of clinical trials and product approvals propel this market growth.

For instance, in December 2022, Pfizer Inc. announced encouraging top-line findings from the Phase 3 BENEGENE-2 study, which assesses fidanacogene elaparvovec, an experimental gene therapy, for treating adult males with moderately severe to severe hemophilia B.

Also, in July 2024, Pfizer Inc. announced positive top-line results from the Phase 3 AFFINE study which evaluated giroctocogene fitelparvovec, an investigational gene therapy for adults with moderately severe to severe hemophilia A.

Similarly, in April 2024, Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved BEQVEZ a gene therapy aimed at treating adults with moderate to severe hemophilia B. This treatment is specifically for those who are currently undergoing factor IX (FIX) prophylaxis therapy, have experienced life-threatening hemorrhages, or suffer from frequent serious spontaneous bleeding episodes. Additionally, eligible patients must not have neutralizing antibodies to the adeno-associated virus serotype capsid, as confirmed by an FDA-approved test.

Market Geographical Share

North America accounted for approximately 43.9% of the global plasma-derived therapeutics market share

North America region is expected to hold the largest market share over the forecast period owing to the rising number of patients with rare diseases significantly driving the demand for plasma-derived therapeutics. These conditions, such as hemophilia and primary immunodeficiency diseases, often require lifelong treatment with specific therapies derived from human plasma, including immunoglobulins and coagulation factors.

These genetic disorders compromise the immune system, rendering patients extremely vulnerable to infections. There are more than 150 identified types of primary immunodeficiency diseases (PID), and treatment typically involves immunoglobulin therapy to supply the essential antibodies that the body is unable to produce sufficiently. Government efforts to enhance healthcare access and establish reimbursement policies for advanced treatments are driving market growth.

North America's robust healthcare system fosters extensive research and development in plasma-derived therapies, enabling rapid innovation and the introduction of new treatments to the market. This well-established infrastructure enhances treatment options for patients by facilitating the discovery of novel plasma-derived products and therapies.

Moreover, key player's strategies such as partnerships & collaborations, and government initiatives drive this market growth in this region. For instance, in September 2022, Grifols announced a groundbreaking long-term agreement with Canadian Blood Services, the national blood authority of Canada. This partnership aims to significantly boost the country's self-sufficiency in immunoglobulin (Ig) medicines, which are vital plasma-protein therapies used to treat various immunodeficiencies and other medical conditions.

Also, in September 2022, LFB Plasma, a plasma collection company based in the U.S. and a subsidiary of the LFB Group, announced its membership in the Plasma Protein Therapeutics Association (PPTA). This organization is dedicated to establishing standards for quality and safety in plasma collection and manufacturing. LFB Plasma currently operates collection centers in Greenacres and Fort Pierce, Florida, High Point, North Carolina, and Florence, South Carolina, with plans to open new centers in Pueblo, Colorado, and Anniston, Alabama.

In addition, a major number of key player's presence, well-advanced healthcare infrastructure, and product launches & approvals would drive this market growth. For instance, in January 2024, Pfizer Canada ULC announced that Health Canada has approved BEQVEZ a gene therapy utilizing an adeno-associated viral (AAV) vector. This treatment is intended for adults aged 18 and older who have moderately severe to severe hemophilia B, which is characterized by a congenital deficiency of Factor IX (FIX). Eligible patients must also be negative for neutralizing antibodies to the variant AAV serotype Rh74.

Also, in February 2024, GC Biopharma Corp., a major pharmaceutical company in South Korea, aims to increase sales of its immunoglobulin product Alyglo, which has been approved by the U.S. Food and Drug Administration (FDA), by six times over the next five years. The company is targeting sales of $300 million by 2028, up from an expected $50 million this year. Alyglo, a treatment for primary humoral immunodeficiency, is set to launch in the U.S.

Similarly, in April 2024, Kedrion Biopharma Inc. announced that patients in the U.S. with plasminogen deficiency type 1 (PLGD-1) now have access to RYPLAZIM.

Market Segmentation

By Product Type

Protein

Immunoglobulin

Albumin

Fibrinogen

Prothrombin

Antithrombin

Coagulation Factors

Others

By Application

Hemophilia

Idiopathic Thrombocytopenic Purpura (ITP)

Primary Immunodeficiencies

Others

By End-User

Hospitals & Specialty Clinics

Ambulatory Surgical Centers

Homecare Services

Others

By Region

North America

The U.S.

Canada

Mexico

Europe

Germany

U.K.

France

Spain

Italy

Rest of Europe

South America

Brazil

Argentina

The rest of South America

Asia-Pacific

China

India

Japan

South Korea

Rest of Asia-Pacific

Middle East and Africa

Market Competitive Landscape

The major global players in the plasma-derived therapeutics market include Takeda Pharmaceutical Company Limited, Johnson and Johnson (DePuy Synthes), Octapharma AG, Arthrex, Inc., Grifols, S.A., ADMA Biologics, Inc., CSL, Evolve Biologics Inc., Kamada Pharmaceuticals., and Bio Products Laboratory Ltd among others.

Key Developments

In June 2024, Grifols announced that its subsidiary, Biotest, received its first FDA approval for Yimmugo, an innovative intravenous immunoglobulin (Ig) therapeutic designed to treat primary immunodeficiencies (PID). This approval marks a significant milestone for Biotest, as Yimmugo is the first product in its portfolio to gain clearance from the FDA.

In May 2024, LFB announced the acquisition of Amber Plasma, a company operating 12 plasma collection centers in the Czech Republic, through its affiliate Europlasma. This strategic move significantly enhances LFB's plasma collection network in Central Europe, bringing the total number of centers operated by Europlasma to 24, with 15 in the Czech Republic and 9 in Austria.

In December 2023, PlasmaGen Biosciences raised ₹225 crore (approximately $27 million) in a funding round. The round was led by UK-based Artian Investments and included prominent public market investor Ashish Kacholia, pharmaceutical entrepreneurs Anurag Bagaria and Dushyant Patel, and other notable high-net-worth individuals (HNIs). Existing investors Eight Roads Ventures and F-Prime Capital also participated in the fundraising.

In May 2023, PlasmaGen Biosciences officially opened a new manufacturing facility for blood plasma-derived protein therapeutics in Kolar, Bengaluru, marking a significant advancement for the company and the biopharmaceutical landscape in India. This facility, which spans 8 acres, is notable for being the first dedicated plasma manufacturing site in India operated by a company solely focused on blood plasma products.

In March 2023, Takeda Pharmaceutical Company announced a significant investment of approximately $765 million (100 billion Japanese yen) to construct a new plasma-derived therapies (PDTs) manufacturing facility in Osaka, Japan. This investment marks Takeda's largest manufacturing expansion in its 241-year history and reflects the company's commitment to enhancing its production capabilities in this vital area of healthcare.

In December 2021, Evolve Biologics Inc. announced the innovations of its first manufacturing facility in Sachse, Texas, which is set to be a pivotal development in the production of plasma-derived therapeutics. This state-of-the-art facility will utilize Evolve's proprietary PlasmaCap EBA technology, marking a significant innovation in the biopharmaceutical industry.

Why Purchase the Report?

To visualize the global plasma-derived therapeutics market segmentation based on product type, application, end-user, and region and understand key commercial assets and players.

Identify commercial opportunities by analyzing trends and co-development.

Excel data sheet with numerous plasma-derived therapeutics market data points with all segments.

PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.

Product mapping is available in Excel consisting of key products of all the major players.

The global plasma-derived therapeutics market report would provide approximately 62 tables, 54 figures, and 183 pages.

Target Audience 2024

Manufacturers/ Buyers

Industry Investors/Investment Bankers

Research Professionals

Emerging Companies