Summary

U.S. Intravenous Immunoglobulin Market Growth & Trends

The U.S. intravenous immunoglobulin market size is expected to reach USD 10.24 billion by 2028, according to a new report by Grand View Research, Inc. It is expected to expand at a CAGR of 6.8% from 2021 to 2028. Robust pipeline, approval and launch of novel products, and increasing government initiatives are expected to be the major factors driving the market.

Robust pipeline and increasing approvals and launches of novel products are anticipated to support the market growth over the forecast period. For instance, in April 2019, U.S.-based ADMA Biologics, Inc. received U.S. FDA approval for its new drug Asceniv. It is an IVIG drug indicated for the treatment of primary humoral immunodeficiency disease. Similarly, in December 2019, CSL Behring announced receiving orphan drug exclusivity for Hizentra from the U.S. FDA to treat Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP). In another instance, in February 2021, Biotest AG announced that it was the first in Germany to manufacture an investigational hyper immunoglobulin from plasma protein for the COVID-19 treatment.

Furthermore, increasing initiatives by various government organizations to boost the development of novel products are expected to support market growth over the forecast period. For instance, in January 2018, the National Institutes of Health (NIH) awarded a grant of USD 3 million to the U.S.-based GigaGen Inc. to develop novel recombinant intravenous immunoglobulin for patients with primary immunodeficiency diseases.

However, the manufacturing of IVIG requires a well-developed production facility and high capital investments, thereby leading to the high cost of the final product. Hence, this factor is anticipated to restrain the market growth. In addition, IVIG products undergo stringent regulations pertaining to safety and handling, which is another factor expected to impede the market growth. For instance, in 2018, the U.S. FDA delayed the approval of GC Pharma’s intravenous immunoglobulin product and demanded additional data related to the drug’s manufacturing process.

U.S. Intravenous Immunoglobulin Market Report Highlights

• By application, immunodeficiency diseases dominated the market in 2020 owing to the rising number of cases and the growing adoption of IVIG for the treatment of these diseases

• The multifocal motor neuropathy application segment is expected to register the fastest growth rate over the forecast period due to the high effectivity of IVIG in its treatment

• Based on distribution channel, hospital pharmacy held the largest share in 2020 owing to a large number of hospital pharmacies and the easy availability of products in the hospitals

• Market leaders are involved in the development of new plasma collection centers and other collaborative strategies to expand their geographical reach and widen their product portfolio

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Table of Contents

Table of Contents

Chapter 1 Methodology and Scope
1.1 Market segmentation & scope
1.2 Market definition
1.3 Information procurement
1.3.1 Purchased database
1.3.2 GVR’s internal database
1.3.3 Secondary sources & third party perspectives
1.3.4 Primary research
1.4 Information analysis
1.4.1 Data analysis models
1.5 Market formulation & data visualization
1.6 Data validation & publishing
Chapter 2 Executive Summary
2.1 Market Outlook
2.2 Segment Outlook
2.3 Competitive Insights
Chapter 3 U.S. Intravenous Immunoglobulin (IVIG) Market Variables, Trends & Scope
3.1 Market Lineage Outlook
3.1.1 Parent Market Outlook
3.1.2 Ancillary Market Outlook
3.2 Penetration and Growth Prospect Mapping
3.3 Market Dynamics
3.3.1 Market driver analysis
3.3.1.1 Rising number of immunodeficiency disease cases
3.3.1.2 Rising adoption of immunoglobulin replacement therapies
3.3.1.3 Approval and launch of novel products
3.3.1.4 Increasing R&D investments
3.3.2 Market restraint analysis
3.3.2.1 Cost-intensive nature of immunoglobulin replacement therapy
3.3.2.2 Stringent regulations pertaining to production and approval
3.3.3 Industry opportunity
3.4 U.S. Intravenous Immunoglobulin (IVIG) Market Analysis Tools
3.4.1 Industry analysis - Porter’s
3.4.1.1 Supplier Power
3.4.1.2 Buyer Power
3.4.1.3 Substitution Threat
3.4.1.4 Threat from new entrants
3.4.1.5 Competitive Rivalry
3.4.2 PESTEL Analysis
3.4.2.1 Political Landscape
3.4.2.2 Environmental Landscape
3.4.2.3 Social landscape
3.4.2.4 Technology landscape
3.4.2.5 Legal Landscape
3.4 COVID-19 Impact on U.S. Intravenous Immunoglobulin (IVIG) Market
Chapter 4 U.S. Intravenous Immunoglobulin (IVIG) Market - Competitive Analysis
4.1 Recent Developments & Impact Analysis, by Key Market Participants
4.2 Vendor Landscape
4.2.1 List of key distributors and channel partners
4.3 Public Companies
4.3.1 Company market position analysis
4.3.2 Competitive dashboard analysis
4.4 Private Companies
4.4.1 List of key emerging companies
4.4.2 Company market position analysis
Chapter 5 U.S. Intravenous Immunoglobulin (IVIG) Market: Application Estimates And Trend Analysis
5.1 Definition & Scope
5.2 Application Market Share Analysis, 2020 & 2028
5.3 Segment Dashboard
5.4 Market, by Application, 2016 to 2028
5.5 Market Size & Forecasts and Trend Analyses, 2016 to 2028
5.5.1 Hypogammaglobulinemia
5.5.1.1 Market Estimates and Forecasts, 2016 to 2028 (USD Million)
5.5.2 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
5.5.2.1 Market Estimates and Forecasts, 2016 to 2028 (USD Million)
5.5.3 Immunodeficiency Diseases
5.5.3.1 Market Estimates and Forecasts, 2016 to 2028 (USD Million)
5.5.4 Congenital AIDS
5.5.4.1 Market Estimates and Forecasts, 2016 to 2028 (USD Million)
5.5.5 Chronic Lymphocytic Leukemia
5.5.5.1 Market Estimates and Forecasts, 2016 to 2028 (USD Million)
5.5.6 Myasthenia Gravis
5.5.6.1 Market Estimates and Forecasts, 2016 to 2028 (USD Million)
5.5.7 Multifocal Motor Neuropathy
5.5.7.1 Market Estimates and Forecasts, 2016 to 2028 (USD Million)
5.5.8 ITP
5.5.8.1 Market Estimates and Forecasts, 2016 to 2028 (USD Million)
5.5.9 Kawasaki Disease
5.5.9.1 Market Estimates and Forecasts, 2016 to 2028 (USD Million)
5.5.10 Guillain-Barré Syndrome (GBS)
5.5.10.1 Market Estimates and Forecasts, 2016 to 2028 (USD Million)
5.5.11 Others
5.5.11.1 Market Estimates and Forecasts, 2016 to 2028 (USD Million)
Chapter 6 U.S. Intravenous Immunoglobulin (IVIG) Market: Distribution Channel Estimates And Trend Analysis
6.1 Definition & Scope
6.2 Market Share Analysis, 2020 & 2028
6.3 Segment Dashboard
6.4 Market, by Distribution Channel, 2016 to 2028
6.5 Market Size & Forecasts and Trend Analyses, 2016 to 2028
6.5.1 Hospital Pharmacy
6.5.1.1 Market Estimates and Forecasts, 2016 to 2028 (USD Million)
6.5.2 Specialty Pharmacy
6.5.2.1 Market Estimates and Forecasts, 2016 to 2028 (USD Million)
6.5.3 Others
6.5.3.1 Market Estimates and Forecasts, 2016 to 2028 (USD Million)
Chapter 7 Company Profile
7.1 Company Profiles
7.1.1 Biotest AG
7.1.1.1 Company overview
7.1.1.2 Financial Performance
7.1.1.3 Product benchmarking
7.1.1.4 Strategic initiatives
7.1.2 Octapharma AG
7.1.2.1 Company overview
7.1.2.2 Financial Performance
7.1.2.3 Product benchmarking
7.1.2.4 Strategic initiatives
7.1.3 LFB Biotechnologies
7.1.3.1 Company overview
7.1.3.2 Financial Performance
7.1.3.3 Product benchmarking
7.1.3.4 Strategic initiatives
7.1.4 China Biologics Products, Holdings, Inc.
7.1.4.1 Company overview
7.1.4.2 Financial Performance
7.1.4.3 Product benchmarking
7.1.4.4 Strategic initiatives
7.1.5 Grifols, S.A.
7.1.5.1 Company overview
7.1.5.2 Financial Performance
7.1.5.3 Product benchmarking
7.1.5.4 Strategic initiatives
7.1.6 Kedrion Biopharma, Inc.
7.1.6.1 Company overview
7.1.6.2 Financial Performance
7.1.6.3 Product benchmarking
7.1.6.4 Strategic initiatives
7.1.7 CSL Behring
7.1.7.1 Company overview
7.1.7.2 Financial Performance
7.1.7.3 Product benchmarking
7.1.7.4 Strategic initiatives
7.1.8 McKesson Corporation
7.1.8.1 Company overview
7.1.8.2 Financial Performance
7.1.8.3 Product benchmarking
7.1.8.4 Strategic initiatives
7.1.9 Takeda Pharmaceutical Company (Shire plc)
7.1.9.1 Company overview
7.1.9.2 Financial Performance
7.1.9.3 Product benchmarking
7.1.9.4 Strategic initiatives
7.1.10 Bio Products Laboratory Ltd
7.1.10.1 Company overview
7.1.10.2 Financial Performance
7.1.10.3 Product benchmarking
7.1.10.4 Strategic initiatives
7.1.11 ADMA Biologics, Inc.
7.1.11.1 Company overview
7.1.11.2 Financial Performance
7.1.11.3 Product benchmarking
7.1.11.4 Strategic initiatives
7.1.12 Pfizer Inc.
7.1.12.1 Company overview
7.1.12.2 Financial Performance
7.1.12.3 Product benchmarking
7.1.12.4 Strategic initiatives

List of Tables

Table 1 List of key distributors and channel partners
Table 2 List of key emerging companies’/technology disruptors/innovators
Table 3 Primary interview details, by source
Table 4 List of secondary data sources
Table 5 List of abbreviation
Table 6 U.S. intravenous immunoglobulin (IVIG) market, by application, 2016 - 2028 (USD Million)
Table 7 U.S. intravenous immunoglobulin (IVIG) market, by distribution channel, 2016 - 2028 (USD Million)


List of Figures

Fig. 1 U.S. intravenous immunoglobulin (IVIG) market segmentation
Fig. 2 Market research process
Fig. 3 Information procurement
Fig. 4 Primary research pattern
Fig. 5 Market research approaches
Fig. 6 Value chain based sizing & forecasting
Fig. 7 QFD modelling for market share assessment
Fig. 8 U.S. intravenous immunoglobulin (IVIG) market snapshot (2020)
Fig. 9 U.S. intravenous immunoglobulin (IVIG) market: Segment snapshot (2020)
Fig. 10 Competitive Insights (2020)
Fig. 11 Parent market outlook
Fig. 12 Related/ancillary market outlook
Fig. 13 Penetration and growth prospect mapping
Fig. 14 U.S. intravenous immunoglobulin (IVIG) market driver impact
Fig. 15 U.S. intravenous immunoglobulin (IVIG) market restraint impact
Fig. 16 U.S. intravenous immunoglobulin (IVIG) market industry challenges
Fig. 17 Porter’s Five Forces Analysis
Fig. 18 SWOT Analysis, By Factor (Political & legal Economic and technological)
Fig. 19 Strategic alliance analysis
Fig. 20 Recent developments & impact analysis, by key market participants
Fig. 21 Company market position analysis
Fig. 22 Definition and scope, by application
Fig. 23 Application market share analysis, 2020 & 2028
Fig. 24 Segment dashboard
Fig. 25 U.S. intravenous immunoglobulin (IVIG) market, by application, 2016 - 2028 (USD Million)
Fig. 26 Hypogammaglobulinemia market size & forecasts and trend analysis, 2016 to 2028 (USD Million)
Fig. 27 CIDP market size & forecasts and trend analysis, 2016 to 2028 (USD Million)
Fig. 28 Immunodeficiency Diseases market size & forecasts and trend analysis, 2016 to 2028 (USD Million)
Fig. 29 Congenital AIDS market size & forecasts and trend analysis, 2016 to 2028 (USD Million)
Fig. 30 Chronic Lymphocytic Leukemia market size & forecasts and trend analysis, 2016 to 2028 (USD Million)
Fig. 31 Myasthenia Gravis market size & forecasts and trend analysis, 2016 to 2028 (USD Million)
Fig. 32 Multifocal Motor Neuropathy market size & forecasts and trend analysis, 2016 to 2028 (USD Million)
Fig. 33 ITP market size & forecasts and trend analysis, 2016 to 2028 (USD Million)
Fig. 34 Kawasaki Disease market size & forecasts and trend analysis, 2016 to 2028 (USD Million)
Fig. 35 Guillain-barre Syndrome market size & forecasts and trend analysis, 2016 to 2028 (USD Million)
Fig. 36 Others market size & forecasts and trend analysis, 2016 to 2028 (USD Million)
Fig. 37 Definition and scope, by distribution channel
Fig. 38 Distribution channel market share analysis, 2020 & 2028
Fig. 39 Segment dashboard
Fig. 40 U.S. intravenous immunoglobulin (IVIG) market, by distribution channel, 2016 - 2028 (USD Million)
Fig. 41 Hospital pharmacy market size & forecasts and trend analysis, 2016 to 2028 (USD Million)
Fig. 42 Specialty pharmacy market size & forecasts and trend analysis, 2016 to 2028 (USD Million)
Fig. 43 Others market size & forecasts and trend analysis, 2016 to 2028 (USD Million)