세계의 재조합 혈장 단백질 치료제 시장(2024-2031년)

Overview

The global recombinant plasma protein therapeutics market reached US$ 34,774.78 million in 2023 and is expected to reach US$ 56,267.88 million by 2031, growing at a CAGR of 6.2% during the forecast period 2024-2031.

Products made from human plasma using chromatographic and other fractionation processes are known as plasma derivatives. Many therapeutic proteins, including coagulation factors, anticoagulants, immunoglobulins, and albumin, which are vital for treating severe congenital or acquired bleeding or immunological disorders, have only been conceivably obtained from human plasma. With the advent of technology and the introduction of recombinant technologies, a variety of modified versions of plasma proteins are generated, whereby the gene is inserted into an expression system to make the required plasma protein. Since then the market for recombinant plasma proteins has paced up and has been extensively studied for multiple indications.

Factors such as rising research and development activities, and rising prevalence of hematological conditions are expected to drive the market growth in the forecast period.

Market Dynamics

Drivers

Rising research and development activities and product approvals

The recombinant plasma protein therapeutics market growth is largely driven by rising research and development activities and product approvals by regulatory authorities. Major pharmaceutical companies have been constantly investing in R&D activites in recombinant plasma proteins therapeutics to enhance treatment options for rare diseases such as hematological conditions. These approvals are not only expected to provide multiple treatment options to the patients, and contributing to their growing adoption. This dynamic landscape of innovation and regulatory endorsement is propelling the market positively.

For instance, on November 9, 2023, the U.S. FDA has approved ADZYNMA developed by Takeda Pharmaceutical Company Limited. ADZYNMA is a human recombinant A disintegrin and metalloproteinase with thrombospondin motifs 13 ADAMTS13 (rADAMTS13) indicated for prophylactic or on-demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP). On May 30, 2024, the Committee for Medicinal Products for Human Use (CHMP) in the EU, has recommended the grant of of a marketing authorisation for ADZYNMA.

On February 23, 2023, the U.S. FDA has approved ALTUVIIIO a recombinant antihemophilic factor developed by Sanofi for the treatment of hemophilia patients to control bleeding episodes and also post-operative management. ALTUVIIIO is given as once-weekly dose and has the capability significantly reduce bleeding episodes.

Likewise several innovators have been actively investing to develop therapies, which are anticipated to get launched in the market in the forecast period.

Restraints

The high cost of recombinant plasma protein therapeutics is one of the restraining factors that may hinder market growth. Affordability plays a crucial role, especially for patients who need long-term treatment. Moreover, low-middle-income nations may not have access to these advanced drug-delivery devices. In addition, patient compliance and adherence issues may pose a significant challenge to the market growth which may cause lower adoption to plasma protein therapeutics.

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Segment Analysis

The global recombinant plasma protein therapeutics market is segmented based on type, expression system, application, route of administration and region.

Hemophilia in the application segment accounted for approximately 73.2% of the global recombinant plasma protein therapeutics market share

Hemophilia is a bleeding disorder in which the blood clot formation does not happen, as a result, the patient may experience excessive blood loss during any injury. This occurs as a result of mutations of the genes that replicate the proteins involved in the clotting cascade. There are several types of hemophilia such as Hemophilia A, B,, and C. Hemophilia A is the most common type in which factor VIII is missing. Hemophilia B is associated with Factor IX deficiency and Hemophilia C is associated with Factor X deficiency.

Hemophila is one of the most prevalent bleeding disorder, accounting for majority of cases. For instance, As per the World Federation of Hemophilia Report published in October 2023, there are approximately 454,690 patients suffering from bleeding disorders in the world, of which the hemophilia cases accounted for almost 60% of the cases.

Fig 1: Bleeding Disorder Total Cases (1992-2022)

Source: World Federation of Hemophilia Annual Global Survey Report 2022 (Published in October 2023)

Moreover, the majority of the recombinant plasma protein manufacturers focus on hemophilia treatment, considering the severity of the condition and disease burden.

For instance, below is the list of top-selling recombinant plasma proteins are their indications.

Recombinant Plasma Protein Manufacturer Product Indication

Takeda Pharmaceuticals RIXUBIS Hemophilia B

ADVATE Hemophilia A

Pfizer Inc. BeneFix Hemophilia B

Novo Nordisk A/S. NovoSeven(R) RT Hemophilia A & B

Rebinyn Hemophilia B

Sanofi ELOCTATE Hemophilia A

ALPROLIX Hemophilia B

Bayer AG Kogenate Hemophilia A

Geographical Analysis

North America is expected to dominate the market with a 47.6% share in the global recombinant plasma protein therapeutics market

North America is well known for its advancements in the healthcare industry. The major countries in the region such as the U.S. and Canada are well known for their investments in healthcare. The favorable yet stringent regulatory policies, favorable environment for research and development activities, higher demand for advanced therapeutics, and high investments in the industry are the factors that are contributing to the region's dominance. Moreover, the market leaders have stronghold position in the region, and are generating majority of their revenues from here, especially from U.S.

For instance, below is the top manufacturers of recombinant plasma protein therapeutic products are their geographic revenue share.

Manufacturer Product Total Revenue in 2023 (USD Million) NA Share

Sanofi ELOCTATE 519 72.45%

ALPROLIX 595 81.51%

ALTUVIIIO 175 97.71%

Novo Nordisk A/S. NovoSeven(R) RT 1178 52.38%

Total Rare Blood Disorders Portfolio 1743 45.38%

Market Segmentation

By Type

• Coagulation Factors
• Anticoagulants
• Immunoglobulins
• Albumin
• Colony Stimulating Factors
• Others

By Expression System

• Mammalian Cells
• Microorganisms

By Application

• Hemophilia
• Anemia
• Hypovolemia
• Hereditary Angioedema
• Others

By Route of Administration

• Subcutaneous
• Intra-Muscular

By Region

• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • Germany
  • U.K.
  • France
  • Spain
  • Italy
  • Rest of Europe
• South America
  • Brazil
  • Argentina
  • Rest of South America
• Asia-Pacific
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Middle East and Africa

Competitive Landscape

The major players in the recombinant plasma protein therapeutics market include Takeda Pharmaceuticals, CSL, Pfizer Inc., Novo Nordisk A/S., Pharming Healthcare, Inc., Amgen Inc., Sanofi, Bayer AG, Octapharma USA Inc., and Janssen Global Services, LLC among others.

Why Purchase the Report?

• To visualize the global recombinant plasma protein therapeutics market segmentation based on type, expression system, application, route of administration and region as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development
• Excel data sheet with numerous data points of recombinant plasma protein therapeutics market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.

The global recombinant plasma protein therapeutics market report would provide approximately 62 tables, 54 figures, and 187 Pages.

Target Audience 2024

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies

Table of Contents

1. Methodology and Scope

• 1.1. Research Methodology
• 1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

• 3.1. Snippet by Type
• 3.2. Snippet by Expression System
• 3.3. Snippet by Application
• 3.4. Snippet by Route of Administration

4. Dynamics

• 4.1. Impacting Factors
  • 4.1.1. Drivers
    • 4.1.1.1. Rising research and development activities and product approvals
    • 4.1.1.2. Rising prevalence of hematological conditions
  • 4.1.2. Restraints
    • 4.1.2.1. High cost of recombinant plasma protein therapeutics
  • 4.1.3. Opportunity
  • 4.1.4. Impact Analysis

5. Industry Analysis

• 5.1. Porter's Five Force Analysis
• 5.2. Supply Chain Analysis
• 5.3. Pricing Analysis
• 5.4. Regulatory Analysis
• 5.5. Unmet Needs
• 5.6. PESTEL Analysis
• 5.7. Patent Analysis
• 5.8. SWOT Analysis

6. COVID-19 Analysis

• 6.1. Analysis of COVID-19
  • 6.1.1. Scenario Before COVID
  • 6.1.2. Scenario During COVID
  • 6.1.3. Scenario Post COVID
• 6.2. Pricing Dynamics Amid COVID-19
• 6.3. Demand-Supply Spectrum
• 6.4. Government Initiatives Related to the Market During Pandemic
• 6.5. Manufacturers Strategic Initiatives
• 6.6. Conclusion

7. By Type

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
  • 7.1.2. Market Attractiveness Index, By Type
• 7.2. Coagulation Factors*
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 7.3. Anticoagulants
• 7.4. Immunoglobulins
• 7.5. Albumin
• 7.6. Colony Stimulating Factors
• 7.7. Others

8. By Expression System

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Expression System
  • 8.1.2. Market Attractiveness Index, By Expression System
• 8.2. Mammalian Cells*
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 8.3. Microorganisms

9. By Application

• 9.1. Introduction
  • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 9.1.2. Market Attractiveness Index, By Application
• 9.2. Hemophilia*
  • 9.2.1. Introduction
  • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 9.3. Anemia
• 9.4. Hypovolemia
• 9.5. Hereditary Angioedema
• 9.6. Others

10. By Route of Administration

• 10.1. Introduction
  • 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 10.1.2. Market Attractiveness Index, By Application
• 10.2. Subcutaneous*
  • 10.2.1. Introduction
  • 10.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 10.3. Intra-Muscular

11. By Region

• 11.1. Introduction
  • 11.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
  • 11.1.2. Market Attractiveness Index, By Region
• 11.2. North America
  • 11.2.1. Introduction
  • 11.2.2. Key Region-Specific Dynamics
  • 11.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
  • 11.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Expression System
  • 11.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 11.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 11.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 11.2.7.1. The U.S.
    • 11.2.7.2. Canada
    • 11.2.7.3. Mexico
• 11.3. Europe
  • 11.3.1. Introduction
  • 11.3.2. Key Region-Specific Dynamics
  • 11.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
  • 11.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Expression System
  • 11.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 11.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
    • 11.3.6.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 11.3.6.2. Germany
    • 11.3.6.3. UK
    • 11.3.6.4. France
    • 11.3.6.5. Italy
    • 11.3.6.6. Spain
    • 11.3.6.7. Rest of Europe
• 11.4. South America
  • 11.4.1. Introduction
  • 11.4.2. Key Region-Specific Dynamics
  • 11.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
  • 11.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Expression System
  • 11.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 11.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
    • 11.4.6.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 11.4.6.2. Brazil
    • 11.4.6.3. Argentina
    • 11.4.6.4. Rest of South America
• 11.5. Asia-Pacific
  • 11.5.1. Introduction
  • 11.5.2. Key Region-Specific Dynamics
  • 11.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
  • 11.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Expression System
  • 11.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 11.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
    • 11.5.6.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 11.5.6.2. China
    • 11.5.6.3. India
    • 11.5.6.4. Japan
    • 11.5.6.5. South Korea
    • 11.5.6.6. Rest of Asia-Pacific
• 11.6. Middle East and Africa
  • 11.6.1. Introduction
  • 11.6.2. Key Region-Specific Dynamics
  • 11.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
  • 11.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Expression System
  • 11.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 11.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration

12. Competitive Landscape

• 12.1. Competitive Scenario
• 12.2. Market Positioning/Share Analysis
• 12.3. Mergers and Acquisitions Analysis

13. Company Profiles

• 13.1. Takeda Pharmaceuticals
  • 13.1.1. Company Overview
  • 13.1.2. Product Portfolio and Description
  • 13.1.3. Financial Overview
  • 13.1.4. Key Developments
• 13.2. CSL
• 13.3. Pfizer Inc.
• 13.4. Novo Nordisk A/S.
• 13.5. Pharming Healthcare, Inc.
• 13.6. Amgen Inc.
• 13.7. Sanofi
• 13.8. Bayer AG
• 13.9. Octapharma USA Inc.
• 13.10. Janssen Global Services, LLC

LIST NOT EXHAUSTIVE

14. Appendix

• 14.1. About Us and Services
• 14.2. Contact Us