Plasma Fractionation Market Size, Share & COVID-19 Impact Analysis, By Product (Immunoglobulin, Albumin, Coagulation Factors, 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 Regional Forecast, 2021-2028

The global plasma fractionation market size was USD 29.10 billion in 2020. The global impact of COVID-19 has been unprecedented and staggering, with plasma fractionation products witnessing a positive demand shock across all regions amid the pandemic. Based on our analysis, the global market exhibited a significant growth of 14.4% in 2020. The market is projected to grow from USD 32.45 billion in 2021 to USD 51.83 billion in 2028 at a CAGR of 6.9% in the 2021-2028 period. The sudden fall in CAGR is attributable to this market’s demand and growth, returning to pre-pandemic levels once the pandemic is over.

Plasma fractionation has always ignited curiosity among researchers and industrialists alike. The therapeutic efficacies of blood plasma to treat and manage immunodeficiency diseases have helped the growth of the market. Cryo precipitation and ethanol fractionation are the major processes carried out to separate therapeutic protein components from whole blood in the plasma fractionation equipment. Protein components such as prothrombin complex, thrombin, fibrinogen, and others play a major role in managing diseases. These fractionation plasma products have therapeutic efficiencies in treating diseases such as congenital metabolic deficiencies, trauma, immunological disorders, and other life-threatening diseases.

Use of Plasma Therapy in COVID-19 Patients to Boost Market Potential

The outbreak of COVID-19 has urged scientists to experiment with plasma therapy on affected people. According to the New York Times, there were over 70,000 new cases of COVID-19 on 29 March 2021 in the U.S. alone.  In the initial phases of the outbreak, the patients were administered blood plasma for recovery as there was no specific treatment medicine or vaccine against the disease. The U.S. FDA is yet to approve the use of plasma therapy for the treatment of COVID-19. Plasma from the infected individual is studied as an investigational drug product among COVID-19 positive individuals. The promising results shown by plasma therapy in disease management and recovery will spur lucrative growth opportunities for the plasma fractionation industry.

LATEST TRENDS

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Shift Towards Advanced Treatment Options to Boost Market Growth

The rising demand for plasma products globally has enabled manufacturers to dedicate manufacturing units to produce plasma proteins. This was significantly witnessed in countries like China. China is among the largest producers and consumers of plasma-derived products. According to the journal Annals of Blood, nearly 7 million liters of plasma gets collected in China per year. According to the data published in the National Institute of Health research paper, 40,000 kg of intravenous immunoglobulin and 500,000 kg of human albumin are produced each year worldwide. Therefore, the increasing focus on developing advanced treatment solutions is expected to favor the growth of the global market of plasma fractionation in the forthcoming years.

DRIVING FACTORS

Increasing Adoption of Immunoglobulin to Bolster Market Growth

One of the most predominant and crucial factors for the growth of the market is the increasing adoption of immunoglobulin for the management, treatment, and diagnosis of metabolic diseases worldwide. Thus, the high utilization of immunoglobulin will magnify its dominance and improve market prospects. Immunoglobulin is glycoprotein molecules that are derived through plasma and act as antibodies. There has been constant research and development to cognize the efficacy and therapeutic nature of immunoglobulin to treat complex diseases such as Alzheimer’s and other autoimmune disorders. These factors cumulatively are anticipated to drive the plasma fractionation market growth.

Establishment of GLP Compliant Facilities to Augment Market Growth

The growing focus on establishing advanced plasma fractionation plants by key market players is likely to augment the growth of the market. For instance, in February 2019, Kedrion Biopharma announced that the company received FDA approval for establishing a plasma fractionation facility in Melville that would be dedicated to producing plasma proteins. Such facilities are of utmost importance to carry out the process in a sterile micro-organism-free environment. Additionally, in light of the 2019-2020 global pandemic, such facilities will play a crucial role in maintaining the supply-demand cycle of plasma derivatives worldwide. This has, in turn, accelerated the growth of the market

RESTRAINING FACTORS

Stringent Regulatory Policies to Restrain Market Growth

As the plasma fractionation products are derived from whole blood, the products are stringently regulated by regulatory bodies. Stringent regulations on the manufacturing facility, source of whole blood, isolation process, among others can restrain the growth of the market. Such rigorous policies could impact the development and manufacturing time of the product. Additionally, the development of vaccines to inhibit the spread of the COVID-19 could also impact the sales of these products in the forthcoming years.

SEGMENTATION

By Product Type Analysis

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Protease Inhibitor Segment to Witness Significant Growth during Forecast Duration

Based on product type, the global market is categorized into albumin, immunoglobulin (intravenous immunoglobulin and subcutaneous immunoglobulin), coagulation factors (Factor IX, Factor VIII, prothrombin complex concentrates, fibrinogen concentrates, and others), protease inhibitors, others. Immunoglobulin dominated the market followed by coagulation factors. The dominant position of immunoglobulins is attributable to the rapid demand in the product owing to its wide range of applications in the treatment of autoimmune disorders.

Due to its efficacy in preventing viral infections, protease inhibitors are projected to witness the highest growth in the coming years. Protease inhibitors are widely used as antiviral agents. Increasing incidences and outbreaks of viral outbreaks are estimated to propel the segment growth over the forecast duration. Also, the increasing demand for coagulation factor concentrates is driving the growth of the product type.

By Application Analysis

Immunology and Neurology to Witness Highest CAGR

Based on the application, the global market is segmented into immunology & neurology, hematology, critical care, pulmonology, and others.

The immunology and neurology segments are projected to grow at a higher growth rate during the forecast period. This is attributed to the extensive use of plasma proteins such as coagulation and immunoglobulin in neurology R&D and treatment procedures. Additionally, immunoglobulin has shown promise in treating complex disease indications such as myasthenia gravis, Alzheimer’s, bleeding disorder among others. Combined with this, there is numerous plasma-based protein under development and clinical trials for neurology and immunology applications.

The prevalence of genetic disorders such as hemophilia is predicted to fuel the demand for coagulation factors in the coming years. The hematology segment has captured a considerable market share in 2020.

By End-user Analysis

Hospitals to Register a Higher CAGR over the Forecast Duration

In terms of end-user, the market is categorized into hospitals & clinics, research laboratories, and others (academic institutes).

The dominant revenue is generated by the hospitals & clinics segment based on market trends. This is attributed to the high need for plasma fractionated products in advanced clinical settings to treat complex diseases. In addition to this, the rising number of in-patients would boost the market growth.

REGIONAL INSIGHTS

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North America stood at USD 12.55 billion in 2020 and is estimated to dominate the global plasma fractionation market during the forecast period. The dominance is attributable to the increasing number of research and development in the field combined with highly developed infrastructure. Favorable government regulations and recent FDA-approved therapies are projected to further augment the growth of the market in the coming years. In light of the COVID-19 pandemic, the U.S. FDA has encouraged the survivors of the disease to actively participate in plasma donations.

Europe, on the other hand, secured the second position in terms of market share. This is due to the rising prevalence of rare disease, and increasing investments in plasma fractionation systems are augmenting the market growth in the region.

High investment in drug discovery and evolving healthcare research infrastructure in countries like India and China are expected to drive the market growth in Asia Pacific.

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Latin America and the Middle East and Africa are estimated to register comparatively slower growth during the forecast period owing to the lesser adoption of products for R&D activities coupled with lack of advanced laboratory infrastructure to carry out product developments.

KEY INDUSTRY PLAYERS

Product Launch by CSL to Strengthen its Market Position

The market is consolidated with major players such as CSL and Grifols, S.A., among others dominating the market. Higher spending in research and increased focus on manufacturing biologics are major factors that have led CSL to dominate the market. Grifols and CSL together hold around 45% in terms of global market revenue. Other plasma fractionation companies that are in the race to gain a significant share in the market are Baxter, Kedrion S.p.A, and the Shire among others. Continuous efforts in launching advanced products coupled with investments in RD are attributable to the penetration of the companies in the global market.

LIST OF KEY COMPANIES PROFILED:

• CSL (U.S.)


• Grifols, S.A (Spain)


• Baxter (U.S.)


• Kedrion S.p.A (Italy)


• Octapharma (Switzerland)


• Shire- Part of Takeda Pharmaceutical Company Limited (U.S.)


• Biotest AG (Germany)


• LFB (France)        

KEY INDUSTRY DEVELOPMENTS:

• January 2019 – Takeda Pharmaceutical Company Limited completed the acquisition of Shire, one of the leaders in the biopharmaceutical industry in Japan.


• March 2020 – One of the hospitals in Houston, U.S, became the first healthcare institute to test plasma therapy in a COVID-19. The treatment method is called convalescent serum therapy.

REPORT COVERAGE

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The market research report provides a detailed market share analysis and focuses on key aspects such as leading companies, product types, and leading product applications. Besides this, the report offers insights into the market trends, market dynamics, competitive landscape, highlights key industry developments, and the impact of COVID-19. In addition to the aforementioned factors, the report encompasses several factors that have contributed to the growth of the advanced market over recent years.

Report Scope & Segmentation