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レポート概要
| 本調査資料は、世界の血漿蛋白製剤市場について調査し、イントロダクション、調査手法、エグゼクティブサマリー、市場動向、製品別（免疫グロブリン、アルブミン、血漿由来因子Viii、その他）分析、用途別（血友病、特発性血小板減少性紫斑病、原発性免疫不全症、その他）分析、地域別分析、競争状況、市場機会/将来の見通しなどを徹底分析したものです。 ・イントロダクション ・調査手法 ・エグゼクティブサマリー ・市場動向 ・世界の血漿蛋白製剤市場規模：製品別（免疫グロブリン、アルブミン、血漿由来因子Viii、その他） ・世界の血漿蛋白製剤市場規模：用途別（血友病、特発性血小板減少性紫斑病、原発性免疫不全症、その他） ・世界の血漿蛋白製剤市場規模：地域別 ・競争状況 ・市場機会/将来の見通し |
The plasma protein therapeutics market studied has been projected to grow with a CAGR of nearly 5.3% over the forecast period 2021-2026.
The COVID-19 pandemic is expected to have a significant impact on the global market. In the context of the COVID-19, government organizations in various countries, research institutes, and many biotech and pharmaceutical firms are focusing on effective and rapid technologies for the fast diagnosis of COVID-19 and to develop vaccines and new therapeutics to overcome the current situation. The COVID-19 is also affecting the global economy in three main ways, by directly affecting production and demand, by creating supply chain and market disruption, and by its financial impact on the firms and financial markets. The current COVID-19 pandemic has also temporarily impacted plasma donation, globally, which may affect the plasma protein therapeutics market. However, researchers are focusing on plasma-based therapeutics to identify whether these therapies have any promising role in treating the COVID-19 virus. For instance, in April 2020, Kamada Ltd. and Kedrion Biopharma, two biopharmaceutical companies specialized in plasma-derived protein therapeutics entered a global collaboration for the development, manufacturing, and distribution of a human plasma-derived Anti-SARS-CoV-2 (COVID-19) polyclonal immunoglobulin (IgG) product as a potential treatment for COVID-19 patients.
In April 2020, the Indian Council of Medical Research (ICMR) pursued participation of researchers for conducting clinical trial of convalescent plasma therapy, to treat critically ill COVID-19 patients and floated a protocol for it. In May 2020, BioAegis Therapeutics started researching on its lead product, recombinant human plasma gelsolin therapy (rhu-pGSN), believing it as a viable therapeutic option for patients suffering from severe lung injury due to COVID-19.
The major factors that are leading to the growth of the market include the increasing prevalence of autoimmune disorders, immune deficiency disorders, neurological and bleeding disorders. Along with these factors, the rise in geriatric population across the globe is a major reason for marketbgrowth as elderly people are more prone to neurological disorders.
Furthermore the growing investements in research and development programs by the biotechnology and pharmaceutical companies is boosting the market growth. The current happening research and development in the plasma protein segment are anticipated to drive its use through several applications. The increase in usage of therapeutic protein drugs in the treatment of a wide range of clinical symptoms are projected to generate unique growth opportunities for this market in forthcoming years.
However, the stringent regulations for the handling of plasma protein products, and the lack of proper reimbursement policies are the major drawbacks that are hindering the market growth.
Key Market Trends
Albumin Segment is Expected to be the Fastest Growing Segment over the Forecast Period
Hemophilia is a unique bleeding disorder of genetic origin that prevents the normal clotting of blood. The major symptom of this disorder is uncontrolled and often causes spontaneous bleeding in different areas of the body. The amount of bleeding depends on the severity of hemophilia. According to the World Federation of Hemophilia report 2019, the number of people identified with Hemophilia increased from 78,629 in 1999 to 210,454 in 2018. Additionally, as per the Global Hemophilia Care 2019 report, more than 1,125,000 men around the world have an inherited bleeding disorder, and 418,000 of those have a severe version of the most undiagnosed disease. Hemophilia A is the most prevalent type of the condition, with an incidence rate of 1 in 4,000 to 1 in 5,000 males, worldwide, who are born with this disorder. Hemophilia B occurs in approximately 1 in 20,000 newborn males across the world. The increasing prevalence of hemophilia and the huge patient pool are expected to trigger market growth, during the forecast period. Moreover, the increasing R&D research on the development of new therapeutics and product launches are expected to boost the segment growth, over the forecast period. For instance, in October 2018, the United States Food and Drug Administration (FDA) approved Roche’s Hemlibra for routine prophylaxis, to prevent or reduce the frequency of bleeding episodes in adults and children, newborn and older, with hemophilia A without factor VIII inhibitors. The increasing geriatric population is also expected to boost demand for plasma protein therapeutics.
North America Dominates the Market and Similar is Expected Over the Forecast Period
North America is expected to dominate the overall plasma protein therapeutics market, throughout the forecast period. The market growth is due to factors like increasing prevalence and incidence of autoimmune and neurological diseases. the United States is expected to be the largest market in this region.
The presence of the well-established healthcare infrastructure focused market players on R&D for plasma protein therapeutics, coupled with recent product launches, and the rising burden of autoimmune disorders are primary growth factors for the market in the United States. According to the Centers for Disease Control and Prevention (CDC) in 2018, about 70% of people with hemophilia in the United States receive multidisciplinary, comprehensive care in a network of federally funded hemophilia treatment centers. According to the United States Arthritis Foundation, arthritis is the leading cause of disability among adults in the country. By conservative estimates, about 54 million adults were diagnosed with arthritis and almost 300,000 children are suffering from arthritis or rheumatic condition (as of 2017-2018). According to a study published by Derek Weycker, in October 2019, the annual incidence of immune thrombocytopenia (ITP) in the United States was 6.1 per 100,000 persons, higher among females versus males (6.7 vs. 5.5), and highest among children aged between 0 and 4 years (8.1) and adults aged 65 years and above (13.7). Furthermore, there has been increased focus on convalescent plasma therapy for the treatment of COVID-19 in the United States. In April 2020, Johns Hopkins got FDA approval to test blood plasma therapy to treat COVID-19 patients. The United States Food and Drug Administration issued guidance to provide recommendations for investigational convalescent plasma therapy. Thus, the market for plasma protein therapeutics is projected to have significant growth in the United States
Increasing geriatric population in this region also increases the patient pool like the old age people are more prone to neurological diseases. Furthermore, beneficial government initiatives, escalating awareness levels among the blood donors, existence of advanced protein fractioning procedures, greater per capita income in the developed countries, increase in the number of research partnerships are some of the drivers expected to increase the market growth in the region.
Competitive Landscape
The plasma protein therapeutics market is moderately competitive and consists of several major players. Some of the companies which are currently dominating the market Takeda Pharmaceutical Company Ltd, Octapharma USA Inc., Grifols, S.A., CSL Behring, Biotest AG, Baxter, and China Biologic Products Holdings, Inc.
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1 INTRODUCTION
1.1 Study Assumptions and Market Definition
1.2 Scope of the Study
2 RESEARCH METHODOLOGY
3 EXECUTIVE SUMMARY
4 MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Increasing Incidence of Autoimmune and Neurological Diseases
4.2.2 Rise in Research and Development in the Plasma Protein
4.3 Market Restraints
4.3.1 Strict Regulations for the Handling of Plasma Protein Products
4.4 Porter’s Five Force Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5 MARKET SEGMENTATION
5.1 By Product
5.1.1 Immunoglobulin
5.1.2 Albumin
5.1.3 Plasma Derived Factor Viii
5.1.4 Others
5.2 By Application
5.2.1 Hemophilia
5.2.2 Idiopathic Thrombocytopenic Purpura
5.2.3 Primary Immunodeficiencies
5.2.4 Others
5.3 Geography
5.3.1 North America
5.3.1.1 United States
5.3.1.2 Canada
5.3.1.3 Mexico
5.3.2 Europe
5.3.2.1 Germany
5.3.2.2 United Kingdom
5.3.2.3 France
5.3.2.4 Italy
5.3.2.5 Spain
5.3.2.6 Rest of Europe
5.3.3 Asia-Pacific
5.3.3.1 China
5.3.3.2 Japan
5.3.3.3 India
5.3.3.4 Australia
5.3.3.5 South Korea
5.3.3.6 Rest of Asia-Pacific
5.3.4 Middle East and Africa
5.3.4.1 GCC
5.3.4.2 South Africa
5.3.4.3 Rest of Middle East and Africa
5.3.5 South America
5.3.5.1 Brazil
5.3.5.2 Argentina
5.3.5.3 Rest of South America
6 COMPETITIVE LANDSCAPE
6.1 Company Profiles
6.1.1 Takeda Pharmaceutical Company Ltd.
6.1.2 Octapharma USA Inc.
6.1.3 Grifols, S.A.
6.1.4 CSL Behring
6.1.5 Biotest AG
6.1.6 Baxter
6.1.7 China Biologic Products Holdings, Inc.
6.1.8 Kedrion S.p.A
6.1.9 Shire Plc
6.1.10 Bio Products Laboratory
6.1.11 ADMA Biologics, Inc.
7 MARKET OPPORTUNITIES AND FUTURE TRENDS