Plasma Fractionation Market by Type of Company, Scale of Operation, Type of Plasma-derived Therapeutic Products Manufactured, Therapeutic Areas of Plasma-derived Products and Key Geographical Regions: Industry Trends and Global Forecasts, 2023-2035

INTRODUCTION

The global plasma fractionation market is estimated to be worth $ 5 billion in 2023 and is expected to grow at compounded annual growth rate (CAGR) of ~10% during the forecast period.

Over the past two decades, the number of patients affected with rare diseases have increased tremendously. In fact, over 410 million people are currently suffering from rare and chronic disorders. Given the growing prevalence of the aforementioned disorders, the demand for plasma derived therapies that have proven to be effective treatment option, has also observed an incremental hike. In order to cater to the rising demand for these plasma-derived therapies, an uninterrupted supply of blood plasma becomes imperative. Currently, the US is the hub of plasma donation centers, with ~80% of the world's plasma donation centers. In fact, the country alone supplies more than 70% of plasma to the plasma fractionator for the manufacturing of plasma-derived therapies after the process of plasma fractionation. It is worth mentioning that plasma fractionation is a crucial process to ensure separation and purification of key blood plasma components, such as immunoglobulins, albumins, anticoagulant factors and protease inhibitors. The refined blood plasma components / fractions then can be used for formulation of therapeutics. Recently, in April 2023, HYQVIA , a recombinant immunoglobulin was granted approval for its supplemental biologics license application (sBLA) regarding its expanded usage in the treatment of primary immunodeficiency in children (2-16 years). In fact, the plasma derived therapies hold immense significance as lifesaving treatments for patients worldwide, especially those afflicted with rare and complex diseases. Further, we believe that, as the need for these critical medicines rises, ongoing advancements in blood plasma fractionation and plasma manufacturing technology are anticipated to ensure timely access to those in need, in the foreseen future.

SCOPE OF THE REPORT

"The Plasma Fractionation Market - Distribution by Type of Company (In-house Manufacturers and Contract Service Providers), Scale of Operation (Preclinical, Clinical and Commercial), Type of Plasma-derived Therapeutic Products Manufactured (Albumins, Coagulation Factors, Immunoglobulins, Protease Inhibitors and Other Plasma derived Products), Therapeutic Areas of Plasma-derived Products (Hematological Disorders, Hepatic Disorders, Immunological Disorders, Neurological Disorders and Other Disorders) and Key Geographical Regions (North America, Europe, Asia-Pacific and Rest of the World): Industry Trends and Global Forecasts, 2023-2035" market report features an extensive study of the current market landscape, market size and future opportunities associated with companies having plasma fractionation capabilities, during the given forecast period. The market research report highlights the efforts of several stakeholders engaged in this emerging and rapidly evolving segment of the biopharmaceutical industry.

Key takeaways from the study of plasma fractionation market are briefly discussed below.

Rising Demand for Plasma Collection

In the US, Europe and Canada, over 1,000 specialized donation centers facilitate plasma donation through a process known as plasmapheresis. This automated procedure separates plasma from red blood cells and other cellular components, which are returned to the donor. However, the COVID-19 pandemic resulted in ~20% reduction in plasma donations, leading to shortage in raw material supply for plasma derived therapies. To address the decline in plasma collection volume, various stakeholders, including government agencies, patient advocacy groups and plasma fractionation companies, launched awareness campaigns to encourage plasma donation.

In 2022, the three largest plasma fractionation companies, namely CSL Behring, Grifols and Takeda Pharmaceutical, reported a substantial increase in plasma donations, with collection volumes returning to pre-pandemic levels. Despite this positive development, various challenges still persist, as the process from plasma donation to patient administration can take several months. In order to overcome these challenges, a number of commercial plasma fractionators have acquired / built their own network of plasma collection centers in the US and EU. Notably, the market is dominated by a few key companies that have undertaken several efforts to ensure the supply of plasma. For instance, Takeda acquired BioLife Plasma Services in 2019, which at the time of acquisition had more than 140 plasma collection centers across four countries. In January 2022, Grifols acquired Prometic Plasma Resources Inc's plasma donation center in Canada, the former company's first collection center in the region.

The plasma industry is actively exploring ways to enhance efficacy and reduce the cost of plasma-derived therapies through various measures, including adoption of new plasma fractionation technologies and increased automation. These efforts will aid to meet the rising demand for plasma-derived therapies and ensure patients' access to essential treatments. In April 2022, CSL Plasma adopted Rika Plasma Donation System, which claims to reduce the plasma donation procedure time by 30% while improving the donor experience. Such technological advancements in plasma collection are anticipated to assist in meeting the global demand for plasma, driving the plasma fractionation market during the forecast period.

Market Analysis: Current Plasma Fractionation Market Landscape

The plasma fractionation market features a mix of large, mid-sized and small companies, that have the required expertise to manufacture various types of plasma derived products. The market is consolidated, with the large commercial plasma fractionators acquiring the smaller regional industry players. In 2017, CSL Behring acquired Wuhan Zhong Yuan Rui De Biological Products, a China based plasma fractionator with one manufacturing facility and four plasma collection centers. Grifols also acquired a plasma fractionation facility in Canada, with 1.5 million liter annual capacity, from South Korea based GC Pharma in October 2020. There have been more such instances of mergers and acquisitions for market consolidation.

At present, more than 35 companies fractionate plasma in-house to manufacture plasma therapies. Takeda, being one such in-house plasma fractionator, announced its plans to set up a new plasma therapy manufacturing facility in Osaka, Japan in March 2023. The plant will be built with an investment of $ 754 million and will be capable of plasma fractionation and end-to-end manufacturing of plasma derived therapies.

In terms of geographical presence, we have identified more than 85 plasma facilities, through which these companies perform plasma fractionation. The majority of these facilities are located in Asia-Pacific, followed by Europe and North America. Further, nearly 20% of the plasma fractionation companies have the capability to operate at all the scales of operation from preclinical to commercial.

Market Drivers: Growing List of Plasma-derived Products

Human blood plasma contains more than 4,000 proteins, each having essential physiological functions and potential therapeutic benefits. However, ~30 such proteins are suitable for manufacturing various plasma-derived medicinal products to treat a wide range of indications. , List of plasma-derived products that received Biologics License Applications (BLAs) approval include alpha-1 proteinase inhibitor, antihemophilic factor, antithrombin, C1 esterase inhibitor, coagulation factors, fibrin, fibrinogen, immune globulins, protein C and thrombin. In addition to the aforementioned products, several other blood plasma products have also been approved by the USFDA. Examples of these include albumins, alpha antitrypsin, antihemophilic factor (recombinant), antihemophilic factor / von willebrand factor complex, anti-inhibitor coagulant complex, antithrombin (recombinant), corifact, profilnine SD - factor IX complex, kcentra (prothrombin complex concentrate, human), protein C concentrate, thrombin and von willebrand factor (recombinant).

Plasma Fractionation Market Size: Immunoglobulins Segment holds the Largest Market Share

The global plasma fractionation market is estimated to be worth around $ 5 billion in 2023. Driven by the rising demand for blood plasma therapies, along with advancement in fractionation technologies, the plasma fractionation market is anticipated to grow at a CAGR of 10%, during the forecast period 2023-2035. Currently, the global market for plasma manufacturing is dominated by plasma fractionation companies involved in fractionating immunoglobulins. This segment captures more than 45% of the market share and is likely to grow at a CAGR of 12% during the forecast period.

Demand Side: North America Holds the Majority Share in Plasma Fractionation Market

Presently, close to 45% of the demand is generated from North America. However, in the coming years, owing to the rising awareness about plasma derived products and high potency of plasma derived medicinal products, demand for blood plasma fractionates in Asia-Pacific region is likely to increase significantly at a much faster rate as compared to other geographies.

Supply Side: Asia-Pacific is the Fastest Growing Region in Plasma Fractionation Market

In terms of supply of plasma-derived therapies, the market potential of Asia-Pacific is anticipated to experience significant market growth in the coming years. In fact, the Asia-Pacific region is projected to grow at an annualized rate of over 11% by 2035. This incline can be attributed to the region's largest consumer base and the presence of manufacturers in China, India, Australia and South Korea.

Leading Plasma Fractionation Companies

Examples of key plasma fractionation companies (which have also been captured in this report) engaged in this industry include Baxter, Grifols, Kedrion, Octapharma, CSL and Takeda Pharmaceutical. This market report includes an easily searchable excel database of the companies involved in plasma fractionation worldwide.

Recent Developments in Plasma Fractionation Market

Several recent developments have taken place in the field of blood plasma fractionation. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that we've outlined in our analysis.

• In June 2023, GC Biopharma announced that it has obtained approval from the Indonesian Ministry of Health to build a plasma fractionation plant in Indonesia.

• In March 2023, Bio Products Laboratory (BPL) announced the establishment of a strategic partnership with CSI Pharmacy, which provided the latter company with limited distribution rights to BPL's immune globulin product Gammaplex.

The market report presents an in-depth analysis, highlighting the capabilities of various companies engaged in this industry, across different regions. Amongst other elements, the research report includes:

• An executive summary of the insights captured during our research, offering a high-level view on the current state of the plasma fractionation market and its likely evolution in the mid-long term.
• A general introduction to blood plasma fractionation, providing an overview of blood plasma and its components. It also provides information on plasma collection, screening and fractionation process, along with applications and challenges associated with plasma fractionation. Additionally, the chapter presents insights on outsourcing and the role of third party service providers in this domain. Further, it concludes with a discussion on future perspectives in this domain.
• A detailed assessment of the overall market landscape of plasma fractionation companies based on several key parameters, such as year of establishment, company size (in terms of number of employees), location of headquarters, type of company (in-house manufacturers, and in-house manufacturers and contract service providers), location of plasma fractionation facilities (North America, Europe, Asia-Pacific and Rest of the World), location of plasma collection facility (local plasma collection facility and international plasma collection facility), availability of patented / proprietary technology, additional fractionation capabilities (formulation, fill / finish, plasma testing and product testing), scale of operation (preclinical, clinical and commercial), type of plasma-derived therapeutic products manufactured (albumins, anti-coagulation factors, coagulation factors, immunoglobulins, protease inhibitors and other plasma-derived products), therapeutic areas of plasma-derived products (hematological disorders, immunological disorders, hepatic disorders, pulmonary disorders, neurological disorders, infectious diseases and other disorders) and end users (hospitals and clinics, biopharmaceutical and pharmaceutical industries, academic institutes and research laboratories, and others).
• A detailed competitiveness analysis of companies involved in plasma fractionation, which are based in North America, Europe, Asia-Pacific and rest of the world. The plasma fractionation companies considered in this analysis were segregated based on the type of company (in-house plasma manufacturers, and in-house plasma manufacturers / contract service providers) and scored based on multiple relevant parameters, such as company strength (in terms of years of experience) and portfolio strength (in terms of accreditation / certification of the fractionation facility, availability of in-house plasma collection centers, availability of patented / proprietary technology, additional fractionation capability, type of plasma-derived therapeutic products manufactured, scale of operation, therapeutic areas of plasma-derived products and end users).
• Tabulated profiles of key plasma fractionation companies based in North America, Europe and Asia-Pacific engaged in providing plasma fractionation services. Each company profile features a brief overview of the company, along with its financial information (if available), plasma fractionation portfolio, recent developments and an informed future outlook.
• An analysis of the recent partnerships and collaborations related to plasma fractionation, plasma-derived therapies and associated technology, established since 2018, based on several parameters, such as year of partnership, type of partnership (mergers and acquisitions, product development and commercialization agreements, licensing agreements, service agreements, product development and manufacturing agreements, joint ventures, manufacturing and supply agreements, and product distribution agreements), purpose of agreement (plasma collection, purification, plasma fractionation and others), type of plasma-derived therapeutic products manufactured (albumins, anti-coagulation factors, coagulation factors, immunoglobulins and protease inhibitors), type of partner (industry and non-industry) and most active players. It also provides the regional distribution of the companies involved in these agreements.
• A detailed analysis of the recent expansions (since 2018) undertaken by various companies in order to augment their respective plasma fractionation capabilities, based on several relevant parameters, including year of expansion, type of expansion (capacity expansion, new facility and new plant), type of facility (plasma collection / donation center and plasma fractionation facility), location of expanded facility, type of plasma-derived therapeutic products manufactured (albumins, coagulation factors and immunoglobulins) and most active players.
• A detailed analysis on the global fractionation capacity based on the information available in the public domain and insights generated via both secondary and primary research. The analysis highlights the distribution of the overall capacity by company size (small, mid-sized and large), type of plasma-derived therapeutic products manufactured (albumins, anti-coagulation factors, coagulation factors, immunoglobulins, protease inhibitors and other plasma-derived products), scale of operation (preclinical, clinical and commercial) and key geographical region (North America, Europe, Asia-Pacific and rest of the world).

One of the key objectives of this market report was to estimate the current opportunity and the future market growth potential of the global plasma fractionation market over the forecast period. We have provided an informed estimate on the likely evolution of the plasma fractionation market for the period 2023-2035. Our year-wise projections of the current and forecasted market have been further segmented based on relevant parameters, such as type of company (in-house manufacturers and contract service providers), scale of operation (preclinical, clinical and commercial), type of plasma-derived therapeutic products manufactured (albumins, coagulation factors, immunoglobulins, protease inhibitors and other plasma-derived products), therapeutic areas of plasma-derived products (hematological disorders, hepatic disorders, immunological disorders, neurological disorders and other disorders), demand across key geographical regions (North America, Europe, Asia-Pacific and Rest of the World) and supply across key geographical regions (North America, Europe, Asia-Pacific and Rest of the World). In order to account for future uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios, portraying the conservative, base and optimistic scenarios of the industry's evolution.

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this market report are in USD, unless otherwise specified.

RESEARCH METHODOLOGY

The data presented in this report was gathered via primary and secondary research. For all our projects, we conduct interviews / surveys with reputed industry experts (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Wherever possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include:

• Annual reports
• Investor presentations
• SEC filings
• Industry databases
• News releases from company websites
• Government policy documents
• Industry analysts' views

While the focus has been on forecasting the market till 2035, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

KEY QUESTIONS ANSWERED

Question 1: How big is the plasma market?

Answer: The global plasma therapies market is anticipated to be worth more than $ 28.5 billion and the global plasma fractionation market is estimated to be worth around $ 5 billion in 2023.

Question 2: What is the market value of plasma?

Answer: The market value of plasma therapy is around INR 15,000 - 20,000 if the symptoms are moderate.

Question 3: What is the fractionation process of blood?

Answer: Blood fractionation is the industrial process employed for the isolation of different components of blood, that have been harvested from donors.

Question 4: What is blood fractionation used for?

Answer: The blood fractionation is used to extract plasma, which can be utilized for the treatment of various indications, such as hematological disorders, hepatic disorders, immunological disorders, neurological disorders, pulmonary disorders, rheumatological disorders, infectious diseases and other disorders.

Question 5: What is the most commonly used plasma fractionation derivative?

Answer: Our estimates suggest that immunoglobulins and albumins are the most commonly used plasma fractionation derivatives.

Question 6: Which diseases / disorders are being treated by plasma-derived products, and has the largest share in the global plasma fractionation market?

Answer: The global plasma fractionation market is dominated by plasma proteins used for treating immunological disorders. This segment captures over 45% of the market share.

Question 7: Which are the biggest companies / organizations in the plasma fractionation market?

Answer: Presently, more than 35 companies are engaged in plasma fractionation market, worldwide. The top plasma fractionation companies engaged in this industry (which have also been captured in this report) include Baxter, Bio Products Laboratory (BPL), Biotest, CSL (CSL Behring), Grifols, Kedrion, LFB Plasma, Octapharma, Shanghai RAAS Blood Products and Takeda Pharmaceutical company.

Question 8: What is the future of plasma fractionation?

Answer: The global plasma fractionation market size is projected to grow at a CAGR of ~10% during the forecast period.

CHAPTER OUTLINES

• Chapter 1 is a preface providing an introduction to the full report, Plasma Fractionation Market, 2023-2035.

• Chapter 2 is an executive summary of the insights captured during our research, offering a high-level view on the current state of the plasma fractionation market and its likely evolution in the mid-long term.

• Chapter 3 provides a general introduction to blood plasma fractionation, featuring information on blood plasma and its components. It also provides information on plasma collection, screening and fractionation process, along with applications and challenges associated with plasma fractionation. Additionally, the chapter presents insights on outsourcing and the role of third party service providers in this domain. Further, it concludes with a discussion on future perspectives in this domain.

• Chapter 4 includes a detailed assessment of the overall market landscape of plasma fractionation companies based on several key parameters, such as year of establishment, company size (in terms of number of employees), location of headquarters, type of company (in-house manufacturers, and in-house manufacturers and contract service providers), location of plasma fractionation facilities (North America, Europe, Asia-Pacific and Rest of the World), location of plasma collection facility (local plasma collection facility and international plasma collection facility), availability of patented / proprietary technology, additional fractionation capabilities (formulation, fill / finish, plasma testing and product testing), scale of operation (preclinical, clinical and commercial), type of plasma-derived therapeutic products manufactured (albumins, anti-coagulation factors, coagulation factors, immunoglobulins, protease inhibitors and other plasma-derived products), therapeutic areas of plasma-derived products (hematological disorders, immunological disorders, hepatic disorders, pulmonary disorders, neurological disorders, infectious diseases and other disorders) and end users (hospitals and clinics, biopharmaceutical and pharmaceutical industries, academic institutes and research laboratories, and others).

• Chapter 5 presents a detailed competitiveness analysis of companies involved in plasma fractionation, which are based in North America, Europe, Asia-Pacific and rest of the world. The plasma fractionation companies considered in this analysis were segregated based on the type of company (in-house plasma manufacturers, and in-house plasma manufacturers and contract service providers) and scored based on multiple relevant parameters, such as company strength (in terms of years of experience) and portfolio strength (in terms of accreditation / certification of the fractionation facility, availability of in-house plasma collection centers, availability of patented / proprietary technology, additional fractionation capability, type of plasma-derived therapeutic products manufactured, scale of operation, therapeutic areas of plasma-derived products and end users).

• Chapter 6 features tabulated profiles of key plasma fractionation companies based in North America, Europe and Asia-Pacific engaged in providing plasma fractionation services. Each company profile features a brief overview of the company, along with its financial information (if available), plasma fractionation portfolio, recent developments and an informed future outlook.

• Chapter 7 highlights an analysis of the recent partnerships and collaborations related to plasma fractionation, plasma-derived therapies and associated technology, established since 2018, based on several parameters, such as year of partnership, type of partnership (mergers and acquisitions, product development and commercialization agreements, licensing agreements, service agreements, product development and manufacturing agreements, joint ventures, manufacturing and supply agreements, and product distribution agreements), purpose of agreement (plasma collection, purification, plasma fractionation and others), type of plasma-derived therapeutic products manufactured (albumins, anti-coagulation factors, coagulation factors, immunoglobulins and protease inhibitors), type of partner (industry and non-industry) and most active players. It also provides the regional distribution of the companies involved in these agreements.

• Chapter 8 presents a detailed analysis of the recent expansions (since 2018) undertaken by various companies in order to augment their respective plasma fractionation capabilities, based on several relevant parameters, including year of expansion, type of expansion (capacity expansion, new facility and new plant), type of facility (plasma collection / donation center and plasma fractionation facility), location of expanded facility, type of plasma-derived therapeutic products manufactured (albumins, coagulation factors and immunoglobulins) and most active players.

• Chapter 9 presents an estimate of the global fractionation capacity based on the information available in the public domain and insights generated via both secondary and primary research. The analysis highlights the distribution of the overall capacity by company size (small, mid-sized and large), type of plasma-derived therapeutic products manufactured (albumins, anti-coagulation factors, coagulation factors, immunoglobulins, protease inhibitors and other plasma-derived products), scale of operation (preclinical, clinical and commercial) and key geographical region (North America, Europe, Asia-Pacific and rest of the world).

• Chapter 10 features a comprehensive market sizing and opportunity analysis, highlighting the future potential of the market till 2035. Our year-wise projections of the current and forecasted opportunity have been further segmented based on key parameters, such as type of company (in-house manufacturers and contract service providers), scale of operation (preclinical, clinical and commercial), type of plasma-derived therapeutic products manufactured (albumins, coagulation factors, immunoglobulins, protease inhibitors and other plasma-derived products), therapeutic areas of plasma-derived products (hematological disorders, hepatic disorders, immunological disorders, neurological disorders and other disorders), demand across key geographical regions (North America, Europe, Asia-Pacific, and Rest of the World) and supply across key geographical regions (North America, Europe, Asia-Pacific, and Rest of the World).

• Chapter 11 is a summary of the overall report. The chapter provides the key takeaways from the report, and presents facts and figures described in the previous chapters. The chapter also highlights important evolutionary trends that were identified during the course of the study and are expected to influence the future of the plasma fractionation market.

• Chapter 12 is a collection of transcripts of interviews conducted with various stakeholders in the industry.

• Chapter 13 is an appendix, which contains tabulated data and numbers for all the figures included in this report.

• Chapter 14 is an appendix, which contains a list of companies and organizations mentioned in this report.