Global Apheresis Market

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Global Apheresis
Market
Apheresis Market Size, And Share, by Product (Disposables and Devices),
by End User (Blood centers, Hospitals and Other end users), by
Component (Plasma, Platelets, RBCs, Therapeutic) and by Geography
(North America, Europe, APAC, RoW); Forecasts 2020-2028

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Table of Content
1. Global Apheresis Market Overview……………………………………..……………………………………………………………….………………………….05
a. Introduction to Apheresis
b. Market size and forecast
2. Global Apheresis Market Growth Drivers and Restraints……….…………………………………………………….........................................................09
a. Market Growth Drivers
i. Growing demand of different components of blood
ii. Favorable reimbursement policies and funding for Apheresis
iii. Increasing number of complex surgical procedures
iv. Rising cases of neurology, oncology and rare diseases and the growing demand of trauma and injury cases
v. Increasing demand of source plasma from biopharma companies
b. Market Restraints
i. High cost of apheresis devices and therapeutic apheresis procedures
ii. Fewer blood donations due to lack of awareness and sensitivity among individuals
iii. Stringent donor recruitment criteria
3. Global Apheresis Market Segmentation…………………………………………………………………………………………………….………………………..16
a. By Product
i. Disposables
ii. Devices

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Table of Content (continued)
a. By End User
i. Blood Collection Centers
ii. Hospitals and Transfusion Centers
iii. Other End users
c. By Component
i. Plasma (Plasmapheresis)
ii. Platelets (Plateletpheresis)
iii. RBC’s (Erythropheresis)
iv. Therapeutic Apheresis
d. By Geography
i. North America
ii. Europe
iii. Asia Pacific
iv. Rest of the World
4. Competitive Landscape ..………………………………………………………………………………………………………………………………….…………....24
a. Major Companies
b. Key Players Market Share
5. Key Company Profiles………………………………………………………………………….……………………………………………………………………...27
a. Fresenius Overview: Product, Services, Strategies and Financials

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Table of Content (continued)
b. Terumo Overview: Product, Services, Strategies and Financials
c. Haemonetics Overview: Product, Services, Strategies and Financials
d. Macopharma Overview: Product, Services, Strategies and Financials
e. Nigale Overview: Product, Services, Strategies and Financials
f. Scinomed Overview: Product, Services, Strategies and Financials
g. B-Braun Overview: Product, Services, Strategies and Financials
h. Asahi Kasei Overview: Product, Services, Strategies and Financials
i. Cerus Overview: Product, Services, Strategies and Financials
6. Access and Reimbursement Scenario…………………………………………………….……………………………………..…………………………………46
a. Key market access considerations
b. General reimbursement environment
7. Factors Driving Future Growth…………………………………………………………………………………………………………………………………...….49
a. Key Industry Developments of Apheresis Market
b. Ongoing clinical trials for Apheresis
8. Conclusion……………………………………………………………………………………………………………………………………………………………….52

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Global Apheresis Market Overview

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Apheresis is the process of separating blood into its components
▪ Apheresis involves removing whole blood from a donor or
patient by passing it through a medical device and
separating the blood into individual components so that
one particular component can be removed
▪ The remaining blood components then are re-introduced
back into the bloodstream of the patient or donor
▪ Used for collection of donor blood components and for
the treatment for certain medical conditions
▪ Process takes two to four hours and is similar to a regular
blood donation
▪ Involves laboratory medicine, clinical hematology
laboratory, pediatric hematology and oncology

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Apheresis has several applications across chronic diseases
Neurology Oncology Rare Diseases
Genetic
Disorders
Acute Guillain–Barré
syndrome
Chronic inflammatory demy-
-elinating polyneuropathy
Polyneuropathy associated
with paraproteinaemias
Breast Cancer
Colon Cancer
Leukemia
Lymphoma
Multiple Myeloma
Thymoma
Myasthenia Gravis
Thrombotic
thrombocytopenic purpura
Sickle Cell Disease

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Global Apheresis Market: Market Size and Forecast Overview
The Global Apheresis Market will experience sizable growth over the forecast period, increasing from $3.2 Bn in 2020 to over $xx
Bn in 2028 growing at a CAGR of 7.9%
Global Apheresis Market Size ($Bn) (2020-2028F)
▪ Growth in the market will be largely driven by the rising prevalence of
chronic diseases, growing number of trauma and injury cases,
increasing demand for source plasma and blood components and the
increasing number of complex surgical procedures
▪ Geographically, North America is accounted to hold a significant
market share in the global apheresis market, followed by Europe, Asia
Pacific, Latin America and the Middle East and Africa
Key Findings
2020 2021 2022 2023 2024 2025 2026 2027 2028
xx
xx
Key Players

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Global Apheresis Market Growth Drivers And
Restraints

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Snapshot of Market Growth Drivers And Restraints
Favorable
reimbursement
policies and
funding for
Apheresis
High cost of apheresis devices
and therapeutic apheresis
procedures
Impact
Impact
Market
Drivers
Market
Restraints
Increasing
number of
complex
surgical
procedures
Growing
demand of
different
components of
blood
Increasing
demand of
source plasma
from biopharma
companies
Rising cases of
neurology,
oncology and rare
diseases and the
growing demand of
trauma and injury
cases
Fewer blood donations using
apheresis due to lack of
awareness
Stringent donor recruitment
criteria

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Market Growth Drivers
1. Growing demand of different components of blood
The global demand for blood and blood components is on the rise. In the US alone, approximately 44,000 units of
blood are required every day in hospitals and emergency treatment facilities for the treatment of patients suffering
from accident/trauma-related injuries, cancer, and other diseases
Around 21 million units of blood components are transfused in the US every year; whereas, only 13.6 million units of
whole blood and red blood cells are collected yearly in the country
Content
Content

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Market Growth Drivers (continued)
Reimbursement policies governing apheresis procedures are quite favorable in developed countries such as the US,
Germany, Italy, and Japan
According to the Centers for Medicare and Medicaid Services (CMS) and American Society for Apheresis (ASFA),
the reimbursement for various apheresis procedures and devices was expected to increase by 5–7%
Content
Content
2. Favorable reimbursement policies and funding for Apheresis

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Over the years, the importance of blood components in treating certain diseases or conditions has been recognized.
Additionally, huge volume of blood and its components are required to manage major blood loss occurring due to
hemorrhages from trauma or surgery
Various chronic diseases have an associated risk of organ failure in affected patients. Such critical cases of organ
failure require organ transplant surgeries. The number of such surgeries is expected to increase in the coming years
as a result of the growth in the prevalence of chronic diseases. This, in turn, is estimated to increase the demand for
blood and blood components during the forecast period
Content
Content
3. Increasing number of complex surgical procedures

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Urbanization, changing lifestyles, and changing food habits have led to an increase in the number of
chronic diseases, such as oncology, cardiovascular disease (CVD), neurological disorders, diabetes, renal disorders,
digestive disorders, rare diseases, etc
According to the American Heart Association, the prevalence of CVD in the US increased from 36.9% in 2010 to
38.7% by 2020 and is further expected to increase to 40.5% by 2030
In cases of trauma and injury uncontrolled haemorrhage is one of the biggest reasons of death and Apheresis is
used to compensate the loss of blood which has a success rate of about 97%
Content
Sample
4. Rising cases of neurology, oncology and rare diseases and the growing demand of trauma and injury cases

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Source plasma is collected from healthy, voluntary donors through a process called plasmapheresis. Biopharma
companies produce plasma-derived products from collected raw plasma and these are used in the treatment of
various diseases such as hemophilia A and B, Von Willebrand Disease, and other bleeding diseases
In order to meet the growing demand for plasma-derived products, biopharmaceutical companies have increased
their processing/fractionation capacities in the past decade
Content
Content
5. Increasing demand of source plasma from biopharma companies

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High cost of apheresis devices & therapeutic
apheresis procedures
Fewer blood donations using apheresis due to lack
of awareness
▪ Despite the increasing demands for blood and
its products, some people, especially the youth,
have little interest in donating blood
▪ Globally, around 112.5 million units of donated
blood are collected every year.
▪ Nearly half of these are collected in high-
income countries and the average blood
donation rate is more than 9 times greater in
high-income countries than in low-income
countries.
▪ Particularly, Sub-Saharan Africa faces great
challenges not only in the shortage of blood but
also in the safety of blood
▪ For instance, in the United States, the cost of
an apheresis procedure is approximately USD
2500 per treatment, which is very high
▪ An investment of USD 19,000 to USD 32,000
for a blood cell separator is the initial cost for
setting up the machine and disposable sets
produced by manufacturers will vary between
USD 40 and USD 90 per treatment
▪ Replacement fluids (at an average volume of
2.8 litres), such as albumin or fresh frozen
plasma, make up the remainder of the costs,
running USD 125 to USD 600 per treatment
Market Restraints

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Global Apheresis Market Segmentation

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Snapshot of Apheresis Market Segmentation
Market Segmentation
By End User
By Product
Disposables Devices
By Component
Platelets
Leukocytes
Plasma
Therapeutic
Apheresis
Other End Users
Hospitals
Blood Centers

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Market Segmentation By Product: Disposables (Volume Market)
Globally xx million Disposables were utilized across different procedures for apheresis
Globally Volume of Disposables used for Apheresis (segregated by procedure type) in 2020
Total
xx
Platelet Apheresis
Red Blood Cell
Apheresis
Plasmapheresis
Therapeutic
Apheresis
▪ Key Insights
Sample
Hospitals
Dialysis Service Providers

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Market Segmentation By Product: Disposables (Value Market)
Globally $yy billions of revenue was generated from xx million units of disposables, which made up ~85% of
the global apheresis market
Platelet Apheresis
Red Blood Cell
Apheresis
Plasmapheresis
Therapeutic
Apheresis
Hospitals
Dialysis Service Providers
Total
xx
▪ Key Insights
Globally Revenue generated by Disposables used for Apheresis (segregated by procedure type) in 2020
Sample

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Market Segmentation By Product: Disposables (Geographical Split)
Apheresis Disposables Market Revenues (by Major
Regions) in $B, 2020
# of Apheresis Disposables Utilized Globally (by
Major Regions), 2020
Total
North America Europe APAC RoW
xx
Total
xx
▪ Key Insights
Sample
43% of the total global revenues from disposables is from North America

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Market Segmentation By Product: Devices (Volume Market)
Globally ~xx thousand devices / machines are
installed for performing apheresis
Total # Devices
Installed Globally
Total # Devices
Replenished in 2020
Globally
▪ Considering a 5 year lifecycle of an Apheresis
device, we assumed that only 20% of the total devices
will be actually replenished in any particular year
(2020) for the lifecycle of entire 5 years
▪ And, thus this 20% of replenished devices will only
contribute to the sales generated through devices
in that single year
▪ Therefore, as ~xx machines / devices were globally
installed for apheresis, only 20% of those were actually
replenished and generated sales
Key Assumptions

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Market Segmentation By Product: Devices (Volume & Value Geographical
Split)
Apheresis Devices Market Revenues (by Major
Regions) in $B, 2020
# of Apheresis Devices Installed Globally (by Major
Regions), 2020
Total
xx
Total
xx
▪ Key Insights
Sample
40% of the total global revenues from devices is from North America

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Total Global Apheresis Value Market Segmentation By Geography
▪ North America is a major market for apheresis, with
greater share coming from U.S., followed by Canada
▪ Europe contributes to one-third of the total market with major
markets being Germany followed by UK, France and Italy
▪ APAC regions contributes to around one-fifth of the global
market, with major markets being Japan, followed by China,
South Korea and India
▪ Rest of the world brings in 5% of global revenues, with Brazil
being a major contributor
▪ Anticipated growth rates for various geographies are as
follows:
▪ North America: 8.8% - 10.9%
▪ Europe: xx% - xx%
▪ APAC: xx% - xx%
▪ RoW: xx% - xx%
Key Highlights
Global Apheresis Market (by Major Regions) in $B, 2020
Total

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Competitive Landscape: Key Players Revenue (Current and Forecasted)
Major Market Revenue of Top Companies in the Apheresis Market ($Mn)
2020 2021F 2022F 2023F 2024F 2025F 2026F 2027F 2028F
Fresenius Kabi $xx - - - - - - - -
Terumo $996M - - - - - - - -
Haemonetics $988M - - - - - - - -
Macopharma $xx - - - - - - - -
Nigale $xx - - - - - - - -
Scinomed $xx - - - - - - - -
B-Braun $xx - - - - - - - -
Asahi Kasei $xx - - - - - - - -
Cerus $xx - - - - - - - -

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Competitive Landscape: Key Players Market Share
• Terumo has a significant global footprint owing to its strong
sales and distribution network. Additionally, strong after-
sale services such as maintenance and re-installation of
instruments gives the firm a competitive advantage over
other players in the apheresis market. The company’s
extensive R&D activities enable it to increase its depth of
capabilities in technologies. Moreover, significant
investments also assist the company in launching
innovative products in the market space
• Fresenius has maintained its leading position in the
market through its strong distribution networks across the
Asia Pacific, North America, Europe, Latin America, and
the Middle East and Africa
• It is strengthening its business operations by expanding its
presence in emerging markets
Key Insights
Major Market Share
Terumo
Fresenius
Haemonetics
Corporation
Others

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1. Fresenius Kabi
Company Name: Fresenius Kabi
Year of Establishment: 1912
Headquarter: Germany
Total Revenue: $x M
Revenue from Apheresis: $y M
Website: https://www.fresenius-kabi.com/
Business Overview
Sample
Company at a Glance

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1. Fresenius Kabi (continued)
Sample
Breakdown of revenue (%) by segment, 2020
Total Revenues ($Mn), 2020-2028
Recent News and Developments

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1. Fresenius Kabi (continued)
Sample
Key Strategies (organic and inorganic)
Key Products
Sample

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2. Terumo
Company Name: Terumo BCT, Inc
Headquarter: Japan
Total Revenue: $x M
Website: https://www.terumo.com/
Sample
Company at a Glance
Business Overview

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2. Terumo (continued)
Sample
Revenues ($Mn), 2020-2028

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2. Terumo (continued)
Sample
Key Products
Sample

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3. Haemonetics
Company Name: Haemonetics Corporation
Headquarter: US
Total Revenue: $x M
Website: https://www.haemonetics.com/
Sample
Company at a Glance
Business Overview

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3. Haemonetics (continued)
▪ In 2021, Haemonetics Corporation announced that it has entered into a definitive agreement to acquire privately-held Cardiva
Medical, Inc., (“Cardiva”) an industry leading manufacturer of vascular closure systems based in Santa Clara, California
▪ In June, 2020, Haemonetics Corporation, announced that it has entered into a definitive agreement to sell its Fajardo, Puerto Rico,
manufacturing operations to GVS, S.p. A, a leading provider of advanced filtration solutions for critical applications

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3. Haemonetics (continued)
Sample
Key Products
Sample

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4. Macopharma
Company Name: Macopharma
Headquarter: France
Total Revenue: $x M
Website: https://www.macopharma.com/
Sample
Company at a Glance
Business Overview

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4. Macopharma (continued)
Sample

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4. Macopharma (continued)
Sample
Key Products
Sample

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5. Nigale
Company Name: Sichuan Nigale Biomedical
Co., Ltd.
Headquarter: Sichuan, China
Total Revenue: $x M
Website: http://en.nigale.cn/
Sample
Company at a Glance
Business Overview

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5. Nigale (continued)
Sample

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5. Nigale (continued)
Sample
Key Products
Sample

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6. Scinomed
Company Name: Scinomed
Headquarter: UK
Total Revenue: $x M
Website: https://www.scinomed.com/
Sample
Company at a Glance
Business Overview

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6. Scinomed (continued)
Sample

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6. Scinomed (continued)
Sample
Key Products
Sample

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7. B-Braun
Company Name: B-Braun
Headquarter: Germany
Total Revenue: $xxMn
Revenue from Apheresis: $xxMn
Website: https://www.bbraun.com/en.html
Sample
Company at a Glance
Business Overview

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7. B-Braun (continued)
Sample

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7. B-Braun (continued)
Sample
Key Products
Sample

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8. Asahi Kasei
Company Name: Asahi Kasei Medical
Co., Ltd
Headquarter: Japan
Total Revenue: $x M
Website: https://www.asahi-kasei.com/
Sample
Company at a Glance
Business Overview

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8. Asahi Kasei (continued)
Sample

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8. Asahi Kasei (continued)
Sample
Key Products
Sample

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9. Cerus
Company Name: Cerus
Headquarter: California, US
Total Revenue: $x M
Website: https://www.cerus.com/
Sample
Company at a Glance
Business Overview

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9. Cerus (continued)
Sample

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9. Cerus (continued)
Sample
Key Products
Sample

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Access And Reimbursement Scenario

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Key Market Access Considerations
▪ Despite the emergence of new revenue channels for the apheresis market, there are numerous challenges present in the
landscape, which could inadvertently narrow growth prospects. A key barrier to growth is the lack of skilled professionals.
▪ Recent times have witnessed an epochal scale of technological changes, which has revolutionized the healthcare industry, and, in
turn, its operations.
▪ However, scarcity of expert operators leads to an increase in acquisition cost of well-informed resources, which adds up to the
already high cost of apheresis procedures.
▪ Healthcare expenses in developed regions such as North America and Europe are offset through government initiatives and
reimbursement programs.
▪ However, cost concerns in developing and underdeveloped regions could shrink opportunities for players in the apheresis market,
though these present highly lucrative, yet largely untapped markets.

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General Reimbursement Environment
▪ Governments of North America and Europe are diverting investments towards encouraging the adoption of quality healthcare
through various programs such as Medicare, Medicaid, employee insurance programs, and Veterans Health Administration, which
alleviates high-cost concerns regarding apheresis procedures
▪ Lack of regular blood donors is being countered by private blood collection centres that attract donors through paid plans
▪ In recent times, hospitals are increasing the adoption of apheresis equipment to collect and store required blood components, so as
to reduce dependency on private suppliers and blood collection centres
▪ Scope of coverage in Insurance– all conditions determined to be medically necessary – may vary by insurer, depending on their
methodology and rigor in establishing and updating their coverage policies
▪ Therapeutic apheresis services are often covered by insurers only if the patient meets certain additional laboratory, diagnostic,
and/or clinical criteria
▪ Preauthorization (physician) or precertification (hospital) is commonly required by commercial insurers (HMOs, PPOs, indemnity
plans, point-of-service plans) and Medicaid programs prior to performing therapeutic apheresis procedures
▪ Medicare claims contractors do not require prior authorization. Depending on the procedure and clinical indication, coverage may
variously be based on a Medicare National Coverage Determination (NCD) or a Local Coverage Determination (LCD), or may be
determined on an individual consideration basis

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Factors Driving Future Growth

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Key Industry Developments of Apheresis Market
▪ High technological prowess coupled with government aid supporting research & development activities is increasing the
concentration of manufacturers in North America
▪ Advancements in the healthcare sector and progressive improvements in the quality of services have been increasing patients’
reliance on hospitals and clinics
▪ Besides this, easy access to advanced apheresis products, on the backdrop of ongoing development initiatives undertaken by market
players, further expands the patient pool in the region
▪ Considering these drivers, North America is expected to lead the growth of the apheresis market, with the regional market registering
a CAGR of ~10% during the forecast period
▪ Among other regions, manufacturers in the apheresis market in Japan are taking the technological approach to foster innovation in
the development of apheresis products, which is anticipated to strengthen the Asia Pacific apheresis market
▪ Though reimbursement scenarios are likely to offer coverage in developing countries in future, it is imperative that market players
adopt a cost-competitive strategy to achieve better penetration rate of products in these regions

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Ongoing clinical trials for Apheresis
▪ According to guidelines for apheresis procedures as provided by the American Society for Apheresis (ASFA), there are over 87
diseases that can be treated using the apheresis procedure as the sole line or as supportive treatment
▪ Manufacturers of apheresis equipment are capitalizing on this opportunity to foster innovation in these products, and validate them
based on evidence to target novel applications
▪ Among other applications, evidence-based use of apheresis procedures for neurological applications is projected to create a
significant revenue stream for the apheresis market
▪ Moreover, increasing use of radiotherapy or chemotherapy and incidence of damaged bone marrow are likely to unlock profitable
avenues from apheresis procedures used for the treatment of cancer
▪ In order to carry out research procedures on the plasma or mononuclear components of blood, it is often necessary to obtain larger
quantities of plasma or mononuclear cells than can be safely obtained by simple phlebotomy. These components can be easily and
safely obtained using apheresis procedures
▪ More recently, results of the phase 2b/3 Alzheimer Management by Albumin Replacement (“AMBAR”) randomized controlled study
tested three plasma exchange treatment arms of albumin and intravenous immunoglobulin replacement compared with a sham
procedure in patients with mild-to-moderate Alzheimer’s disease. Patients treated with plasma exchange performed significantly
better on an Alzheimer’s Disease and had a trend toward better Alzheimer’s Disease Assessment Scale-Cognitive Scale

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Conclusion
1
2
3
5
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Increasing Demand
Growing demand of different
components of blood along
with rise in prevalence of
chronic disease and trauma and
injury cases are leading to
rising demands for apheresis
Initiatives to increase
Awareness
As there is a lack of awareness
among people for blood
donations, government and
hospitals are rolling out
schemes to attract donors like
paid donations
New Opportunities
New innovations in apheresis
technologies, research and
trials are already going on to
increase the scope of apheresis
in conditions like Alzheimer
Management
Government funding and
Reimbursement
Government of various countries
are funding more on the
healthcare services and
simultaneously increasing the
scope of insurance covers
New Developments
Manufacturing countries like North
America are already leveraging on
the government support to the
healthcare R&D. Countries like
Japan are fostering innovations in
the apheresis market which can
strengthen Asia Pacific market

Global Apheresis Market

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