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2 PLASMA FRACTIONATION MARKET By Product (Albumin, Immunoglobulin, Factor VIII, Protease Inhibitors), Application (Neurology, Immunology, Hematology, Critical Care), End-user (Hospitals, Clinical Research Laboratories) GLOBAL FORECAST TO 2019 It s a ll a b o u t m a r k e ts MARKETSANDMARKETS sales@marketsandmarkets.com sales@marketsandmarkets.com

3 MarketsandMarkets is a global market research and consulting company based in the U.S. We publish strategically analyzed market research reports and serve as a business intelligence partner to Fortune 500 companies across the world. MarketsandMarkets also provides multi-client reports, company profiles, databases, and custom research services. MarketsandMarkets covers fourteen industry verticals, including aerospace and defence, advanced materials, automotives and transportation, biotechnology, chemicals, consumer goods, energy and power, food and beverages, industrial automation, medical devices, pharmaceuticals, semiconductor and electronics, and telecommunications and IT. Copyright 2015 MarketsandMarkets All Rights Reserved. This document contains highly confidential information and is the sole property of MarketsandMarkets. No part of it may be circulated, copied, quoted, or otherwise reproduced without the approval of MarketsandMarkets. 1

4 1 EXECUTIVE SUMMARY FIGURE 1 NORTH AMERICA DOMINATED THE GLOBAL PLASMA FRACTIONATION MARKET IN , , , % 1,175.4 Market Share = CAGR = % Market Share = CAGR = CAGR (%) % Market Share = CAGR = North 0.0America Academic Institutes Market Share Hospitals = Military Organizations Europe CAGR = Asia-Pacific Rest of the World *Flags represent the top 5 fastest-growing countries In 2013, North America accounted for the largest share of the global plasma fractionation market, followed by Europe (), Asia-Pacific (), and the RoW (). The market in Asia-Pacific is expected to grow at the highest CAGR of during the forecast period, largely driven by the rapid growth in the aging population, increasing use of albumin and immunoglobulin, and increasing number of hemophilic patients. On the other hand, the market in the Rest of the World region is poised to grow at a CAGR of during the forecast period owing to the growing number of hemophilic patients and increasing use of immunoglobulin for the treatment of immune diseases in this region. 2

5 2 PREMIUM INSIGHTS 2.1 GROWTH POTENTIAL OF THE PLASMA FRACTIONATION MARKET FIGURE 2 ATTRACTIVE GROWTH OPPORTUNITIES IN THE GLOBAL PLASMA FRACTIONATION MARKET Million Million ATTRACTIVE MARKET OPPORTUNITIES The global plasma fractionation market is expected to reach $ million by 2019, at a CAGR of from 2014 to 2019 Market growth is mainly attributed to the growing use of immunoglobulin in various therapeutic areas; rising aging population across the globe; and the growing prevalence of emphysema and AATD, which in turn drives the uptake of alpha-1-antitrypsin Emerging economies such as India, China, Brazil, South Korea, and Thailand offer significant growth opportunities Rising focus on geographic expansions in emerging markets and increasing number of hemophilic patients across the globe offer lucrative opportunities for the market players in the next five years

6 2.2 PLASMA FRACTIONATION MARKET: GEOGRAPHIC GROWTH OPPORTUNITIES FIGURE 3 THE U.S. COMMANDED ABOUT ONE-THIRD SHARE OF THE GLOBAL PLASMA FRACTIONATION MARKET Canada U.K. Germany U.S. Spain France Middle East and Africa India China Japan Latin America > CAGR (Healthy Growth) CAGR (Moderate Growth) < CAGR (Weak Growth) Note: The percentages in the bubbles indicate market shares (2013) of the respective country/region in the global plasma fractionation market. Note: Rest share belongs to Rest of APAC and RoE. 4

7 2.3 NORTH AMERICA DOMINATES THE PLASMA FRACTIONATION MARKET DURING THE FORECAST PERIOD Market Size ($Million) 30,000.0 CAGR% ( ) 25, ,000.0 CAGR 15, , , North America Europe Asia-Pacific RoW 2.4 PLASMA FRACTIONATION MARKET: DEVELOPED VS. DEVELOPING COUNTRIES FIGURE 4 CHINA TO REGISTER THE HIGHEST GROWTH IN THE FORECAST PERIOD Market Size ($Million) CAGR% ( ) China India Latin America U.S. Germany Japan 5

8 2.5 PLASMA FRACTIONATION MARKET, BY END USER: GEOGRAPHIC MIX FIGURE 5 NORTH AMERICA DOMINATES THE PLASMA FRACTIONATION MARKET IN ALL THE END-USER SEGMENTS IN 2014 Market Share (%) Asia-Pacific $ Million $ Million $ Million Total = $ Million RoW (Latin America and Middle East and Africa) Asia-Pacific Europe North America Hospitals and Clinics Clinical Research Laboratories Academic Institutes 6

9 3 GLOBAL PLASMA FRACTIONATION MARKET, BY PRODUCT 3.1 ALBUMIN Albumin is a low molecular protein that is responsible for colloidal pressure, transportation of metabolites, volume expansion of blood, and anti-oxidant properties. It is used to treat various conditions including hypovolemia, shock, surgical blood loss, burns, trauma, acute respiratory distress syndrome, hemorrhage, acute liver failure, hypoalbuminemia, and chronic liver disease. It is also used in various medical treatments such as cardiopulmonary bypass, hemodialysis, and resuscitation. Globally, the rising demand for Immunoglobulin (Ig) is resulting in the increase in its production. This in turn is resulting in an increase in the production of albumin as the production of Ig and albumin are linked together. Albumin is produced from Ig fractioned blood plasma as it must be produced from the same blood for fractionators to make a profit. With the growing demand for Ig, the production of albumin will also increase. This in turn will reduce the price of albumin. This will help drive the market for albumin in developing countries which prefer low-cost products. The growing demand for albumin as an antioxidant and volume expander in severe conditions, such as burns, trauma, and liver diseases is expected to propel the growth of this market. However, the irrational use and adverse reactions associated with albumin are expected to restrain the growth of this market to a certain extent. In 2013, albumin accounted for a share of of the global plasma fractionation market. This segment is poised to reach $ million by 2019 from $ million in 2014, at a CAGR of during the forecast period. The major players in this market are Baxter International, Inc. (U.S.), Grifols International S.A. (Spain), CSL Ltd. (Australia), Octapharma AG (Switzerland), Kedrion (Italy), Bio Product Laboratory (U.K.), Beijing Tiantan Biological Products Co., Ltd. (China), China Biologic Products, Inc. (China), Shanghai RAAS Blood Products Co., Ltd. (China), Green Cross (Korea), Sanquin (Netherlands), and Biotest (Germany). TABLE 1 GLOBAL ALBUMIN MARKET SIZE, BY REGION, ($MILLION) Country/Region CAGR ( U.S. Canada Germany France U.K. Italy Spain China Japan India Latin America 7

10 Middle East and Africa Others Total China accounted for the largest share of of the global albumin market in This regional segment is expected to reach $ million by 2019 from $ million in 2014, at a CAGR of during the forecast period. 3.2 COAGULATION FACTOR CONCENTRATES Coagulation factors are plasma proteins which act as enzymes on activation. These activated factors result in the production of thrombin, followed by fibrin, which together with platelets prevent the loss of blood after blood vessel injuries. Coagulation factor concentrates include factor VIII, factor IX, factor XIII, Prothrombin complex concentrates, von Willebrand factor, and fibrinogen concentrates. These concentrates are used in hemostatic management of patients with excessive bleeding in trauma, in surgeries, and for the treatment of diseases such as hemophilia. A number of factors such as the increasing number of hemophilic patients, growing preference for prophylactic treatment for hemophilia, and rising rate of diagnosis of hemophilia are expected to drive the growth of this market. Newer recombinant coagulation factors are penetrating the plasma-derived products market. The use of recombinant products is gaining importance in the U.S. and Europe, as the supply of these products is stable. Moreover, these products do not carry the chance of cross infections in donors. The rising demand of recombinant coagulation factors which are used as an alternative to plasma-derived coagulation factor concentrates is expected to restrain the coagulation factor concentrates market in developed countries. However, in developing countries, the market is expected to grow mainly due to the reducing prices of coagulation factor concentrates. In 2013, coagulation factor concentrates accounted for a share of of the global plasma fractionation market. This segment is poised to reach $ million by 2019 from $ million in 2014, at a CAGR of during the forecast period. The major players in this market are Baxter International, Inc. (U.S.), Grifols International S.A. (Spain), CSL Ltd. (Australia), Octapharma AG (Switzerland), Kedrion (Italy), Bio Product Laboratory (U.K.), Sanquin (Netherlands), and Biotest (Germany). 8

11 FIGURE 6 FACTOR VIII WILL CONTINUE TO DOMINATE THE COAGULATION FACTOR CONCENTRATES MARKET IN THE FORECAST PERIOD Market Size ($Million) 2, , CAGR (%) 1, , Factor VIII Factor IX PCC Fibrinogen Concentrates Factor XIII Von Willebrand Factor 9

12 4 GLOBAL PLASMA FRACTIONATION MARKET, BY APPLICATION 4.1 INTRODUCTION The global plasma fractionation market by application is segmented into neurology, hematology, immunology, critical care, and other applications. Plasma-derived products are obtained from fractionation of plasma. These products, including albumin, immunoglobulin, and coagulation factor concentrates are used in various clinical specialties settings such as neurology, hematology, immunology, and nephrology. Among these plasma products, immunoglobulin has wider applications in various therapeutic areas. It is primarily used in neurology, hematology, and immunology. Coagulation factor concentrates are mainly used in hematological disorders; albumin is mainly used in liver disease, burns, and trauma, while other products such as fibrin sealants are used as alternative to sutures for maintaining hemostasis. Major players in the global plasma fractionation market are Baxter International Inc. (U.S.), Grifols International S.A. (Spain), CSL Ltd. (Australia), Octapharma AG (Switzerland), Kedrion (Italy), Bio Product Laboratory (U.K.), Sanquin (Netherland), Laboratoire Français du Fractionnement et des Biotechnologies (France), Bharat Serums and Vaccines Limited (India), Shanghai Institute of Biological products (China), China Biologic Products Inc. (China), and Biotest (Germany). FIGURE 7 NEUROLOGY SEGMENT WILL CONTINUE TO DOMINATE THE GLOBAL PLASMA FRACTIONATION MARKET IN THE FORECAST PERIOD Market Size ($Million) 12, , CAGR (%) 8, , , , Neurology Immunology Hematology Critical Care Others 10

13 5 GLOBAL PLASMA FRACTIONATION MARKET, BY END USER 5.1 INTRODUCTION The plasma fractionation market is categorized into three end-user segments, namely, hospitals and clinics, clinical research laboratories, and academic institutes. In 2013, the hospitals and clinics segment held the largest share of of the plasma fractionation market. This segment is expected to dominate the market by 2019, growing at a CAGR of during the forecast period. Globally, the increase in incidence of diseases such as immune deficiency disorders and bleeding disorders is playing a major role in the increasing adoption of plasma products in hospitals and clinics. In addition, the growing number of research activities on off-label use of immunoglobulins in hematological and neurological disorders is also expected to propel the growth of this market. Currently, albumin, immunoglobulins, and other plasma products are being evaluated for various diseases in clinical trials; the increasing number of trials on plasma products is further propelling the growth of this market. However, the growing use of SCIg, which is self-administered by patients at home, and strict regulatory requirements for clinical trials are expected to hamper the growth of the market to a certain extent. FIGURE 8 HOSPITALS AND CLINICS SEGMENT WILL CONTINUE TO DOMINATE THE GLOBAL PLASMA FRACTIONATION MARKET IN THE FORECAST PERIOD Academic Institutes Clinical Research Laboratories CAGR (%) Largest and Fastest-growing End-user Segment Hospitals and Clinics , , , , , , Market Size ($Million) 11

14 6 GLOBAL PLASMA FRACTIONATION MARKET, BY GEOGRAPHY 6.1 INTRODUCTION FIGURE 9 GEOGRAPHIC SNAPSHOT ( ) RAPID GROWTH MARKETS ARE EMERGING AS NEW HOT SPOTS Canada U.K. Germany U.S. France Italy China Japan Spain India Latin America Middle East & Africa < Growth Growth Growth > Growth FIGURE 10 CHINA OFFERS HIGH GROWTH POTENTIAL FOR ALL PRODUCT CATEGORIES Product Type U.S. China Germany India Japan Immunoglobulin Plasma Fractionation Market Albumin Coagulation Factor Concentrates Protease Inhibitors Others CAGR (%) from 2014 to 2019 Low Medium High < > Note: Others include fibrin sealants and cryoprecipitate. 12

15 6.2 NORTH AMERICA FIGURE 11 NORTH AMERICAN PLASMA FRACTIONATION MARKET SNAPSHOT: INCREASING USE OF LABEL AND OFF LABEL USE OF IMMUNOGLOBULIN TO DRIVE MARKET GROWTH North America holds prominent market share in the Global Plasma Fractionation Market of global plasma fractionation market Expected to grow at a CAGR ( ) of U.S. commands ~ share of North American market Plasma fractionation Market Size, 2014 ($Million) Market Size: $ Million CAGR: U.S. North American Plasma Fractionation Market Market Size: $ Million CAGR: U.S. Canada U.S. Canada North American Plasma Fractionation Market, by End-user (2013) CANADA Factors supporting the growth of Plasma fractionation market in North America Growth of aging population Clinical Research Laboratories Academic Institutes Increasing use of Label and off label use of immunoglobulin Increasing prophylaxis treatment, Wider product availability, financial access to therapies, presence of insurance coverage Hospitals & Clinics dominated the market in 2013 Hospital & Clinics 13

16 6.3 EUROPE FIGURE 12 GERMANY IS THE MAJOR MARKET FOR PLASMA FRACTIONATION IN EUROPE Rest of Europe U.K. Germany France Spain Italy Plasma Fractionation Market Share (2013) TABLE 2 EUROPE: PLASMA FRACTIONATION MARKET SIZE, BY COUNTRY, ($MILLION) Country CAGR ( Germany France U.K. Italy Spain Rest of Europe Total In 2013, Germany accounted for the largest share of of the plasma fractionation market in Europe. This market is poised to reach $ million by 2019 from $ million in 2014, at a CAGR of during the forecast period. 14

17 6.4 ASIA-PACIFIC TABLE 3 ASIA-PACIFIC: PLASMA FRACTIONATION MARKET SIZE, BY COUNTRY, ($MILLION) Country CAGR ( China Japan India Rest of APAC Total In 2013, China accounted for the largest share of of the plasma fractionation market in the Asia- Pacific. This market is poised to reach $ million by 2019 from $ million in 2014, at a CAGR of during the forecast period. TABLE 4 ASIA-PACIFIC: PLASMA FRACTIONATION MARKET SIZE, BY PRODUCT, ($MILLION) Product CAGR ( ) Albumin Immunoglobulin Coagulation Factor Concentrates Protease Inhibitors Other Plasma Products Total In 2013, the albumin segment accounted for the largest share of of the plasma fractionation market in the Asia-Pacific. This market is poised to reach $ million by 2019 from $ million in 2014, at a CAGR of during the forecast period. 15

18 7 COMPETITIVE LANDSCAPE 7.1 MARKET SHARE ANALYSIS The global plasma fractionation market includes high-capacity fractionators, which provide plasma products across the globe, and small to medium fractionators that cater to the demands of domestic markets. The market was dominated by five to six major players in 2013, together accounting for a share of -. On the other hand, there are several smaller players in the market are based across developing countries, such as China, Singapore, Brazil, and Korea. China itself has more than 25 plasma fractionators. Baxter International, Inc. (U.S.), Grifols International S.A. (Spain), CSL Ltd. (Australia), Octapharma AG (Switzerland), Biotest (Germany), and Laboratoire Français du Fractionnement et des Biotechnologies (France), were the major players in the market, accounting for - of the market share in FIGURE 13 GLOBAL PLASMA FRACTIONATION MARKET SHARE ANALYSIS, BY KEY PLAYER, 2013 CSL Ltd Grifols International S.A. Baxter International Inc. Octapharma AG Biotest LFB Others Source: Distributor Presentations, Expert Interviews, and MarketsandMarkets Analysis 16

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