Immunoglobulin Market Size, Share and Industry Analysis By Route of Administration (Intravenous (IV), Subcutaneous (SC)), By Indication (Primary Immunodeficiency, Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Guillain-Barre Syndrome (GBS), Immune Thrombocytopenic Purpura (ITP), Multifocal Motor Neuropathy (MMN)), By Form (Liqui, Lyophilized), By End User (Hospitals, Clinics, Homecare), and Regional Forecast 2018-2025

The global immunoglobulin market size stood at USD 10,750.0 Million in 2017 and is projected to reach USD 18,378.0 Million by 2025 exhibiting a CAGR of 7.0% in the forecast period (2018-2025).

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Immunoglobulins are the glycoprotein molecules manufactured by the plasma or the white blood cells. Immunoglobulins form a very critical line of defense of the immune system by specially recognizing and binding itself to particular antigens such as bacteria and viruses and aid in their destruction. In many of the individuals, the immunoglobulins have to be specially administered through a variety of route of administration for the body to be able to fight a number of immune diseases.

Due to increasing awareness and increasing number of diagnoses due to greater efficiency in diagnostic methods, there has been a greater demand for immunoglobulins as a treatment option. This, coupled with its proven efficiency as an effective treatment option for a number of diseases such as primary immunodeficiency and chronic inflammatory demyelinating polyneuropathy (CIDP) is also positively driving the market growth.

Some of the other factors which are also contributing to the immunoglobulin market growth are its immunomodulation and anti-inflammatory properties. The introduction of new and advanced immunoglobulins such as CUVITRU and BIVIGAM by Shire (Takeda Pharmaceutical Company Limited) and ADMA Biologics Inc., respectively is expected to drive the growth of the immunoglobulins market in developed as well as emerging countries, during the forecast period 2018-2025.

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"Increasing adoption of immunoglobulins for the treatment of critical immunological and rare diseases are driving the market demand, resulting in newer product launches."

The adoption of immunoglobulin therapy as the first line of treatment for the primary immunodeficiency and other rare immunological and neurological diseases. This is one of the most prominent factors that are responsible for the growth of the global immunoglobulins market in 2017. Intravenous (IV) segment is estimated to have the largest market share among route of administration segment. The intravenous (IV) segment accounted for the largest market share in 2017 and is expected to decline during the forecast period. Increasing focus towards the diagnosis of immune disorders and the subsequent treatment based on the individual case and training of the patient, in most cases the patient is not adept in self-administration, is also driving the intravenous segment.

The subcutaneous (SC) segment is estimated to grow at a faster CAGR during the forecast period. This is attributed to the increasing number of product launches especially in the subcutaneous (SC) segment. Currently, there is an increasing adoption of the subcutaneous in the markets in the developing nations due to improved patient advantages such as no need of venous access, and this is expected to contribute to the growth of the market at higher CAGR during the forecast period. The recent product launches such as CUVITRU and BIVIGAM by Shire (Takeda Pharmaceutical Company Limited) and ADMA Biologics Inc., respectively is also anticipated to drive the growth of the immunoglobulin market.

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Market Segmentation

On the basis of route of administration, the global immunoglobulin market segments include intravenous (IV), and subcutaneous (SC). The intravenous (IV) segment accounted for a major global immunoglobulin market share in 2017.

On the basis of indication, the global immunoglobulins market segments include primary immunodeficiency (PI), chronic inflammatory demyelinating polyneuropathy (CIDP), Guillain-Barré syndrome (GBS), immune thrombocytopenic purpura (ITP), multifocal motor neuropathy (MMN), and others. On the basis of form, the global market segments include liquid, and lyophilized. On the basis of end user, the market segments include hospitals, clinics, and homecare.

Regional Analysis

"Increasing diagnosis of immunodeficiencies due to greater awareness, along with increasing adoption expected to result in the highest CAGR in the Asia Pacific"

North America generated an immunoglobulin market revenue of US$ 6,291.5 Mn in 2017 and is anticipated to account for a dominant share in the global immunoglobulins market during the forecast period. The primary driving factor for the significant and strong growth of the Immunoglobulin market is the fact that the first line of treatment for a number of critical immune disorders. With the increase in contributing factors of such as the increasing number of patients and the efficiency, is expected to give rise to a significant demand for this product. In developed countries, the adoption of advanced immunotherapies is growing alongside the greater adoption of subcutaneous immunoglobulins.

India and China in the Asia Pacific region are experiencing growth in the immunoglobulins due to increased diagnosis of immunodeficiences in the population. In terms of the dominance of route of administration, intravenous (IV) is the most dominating type in these developing regions. However, in countries like Japan, there is increased adoption and expenditure towards advanced immunoglobulins and Japan holds significant revenue shares. The Latin America immunoglobulin market is estimated to increase in market size and in Middle East & Africa, South Africa is estimated to experience growth.

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Key Market Drivers

"Key market players such as Grifols S.A., CSL Behring and Shire (Takeda Pharmaceutical Company Limited) are anticipated to be the leading players in global immunoglobulins market"

Grifols, S.A., emerged as the leading player with the highest market share in 2017, as the company has a number of product offerings in the immunoglobulins market across a wide range of indications and in the commonly used route of administration, and these product offerings dominate a substantial portion of market share. The company accounts for the highest immunoglobulin market shares from regions such as North America and Europe. In addition, other market players are also getting product approvals such as Shire (Takeda Pharmaceutical Company Limited). The company received regulatory approvals for the immunoglobulin product offering of CUVITRU. Other players operating in the Immunoglobulin market are CSL Behring, Grifols, S.A., Kedrion S.p.A, Octapharma, Bio Products Laboratory Ltd., Biotest AG, China Biologic Products Holdings, Inc., LFB SA and Shanghai RAAS Blood Products Co., Ltd.

List of Companies Profiled

• Shire (Takeda Pharmaceutical Company Limited)


• CSL Behring


• Grifols, S.A.


• Kedrion S.p.A


• Octapharma


• Bio Products Laboratory Ltd.


• Biotest AG


• China Biologic Products Holdings, Inc.


• LFB SA


• Shanghai RAAS Blood Products Co., Ltd.

Report Coverage

An Infographic Representation of Immunoglobulins Market

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Immunoglobulins, also referred to as antibodies, are the glycoprotein molecules manufactured by the plasma or the white blood cells. Immunoglobulins form a very critical line of defense of the immune system by specially recognizing and binding itself to particular antigens such as bacteria and viruses and aid in their destruction. In certain individuals, these products have to be administered for the treatment and management of diseases such as primary immunodeficiency (PI). However, comparatively high product costs and the associated adverse effects, are some of the major factor projected to restrain the adoption of these products in emerging countries.

The report provides qualitative and quantitative insights on immunoglobulin industry trends and detailed analysis of market size & growth rate for all possible segments in the market. The immunoglobulin market segments include route of administration, indication, form, and end user. On the basis of indication, the market is categorized into (primary immunodeficiency, chronic inflammatory demyelinating polyneuropathy (CIDP), Guillain-Barré syndrome (GBS), immune thrombocytopenic purpura (ITP), multifocal motor neuropathy (MMN) and others).

On the basis of route of administration, the market is categorized into intravenous (IV) and subcutaneous (SC). On the basis of form, the market can be segmented into liquid and lyophilized. On the basis of end user, the market can be segmented into hospitals, clinics and homecare. Geographically, the market is segmented into five major regions, which are North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. The regions are further categorized into countries.

Along with this, the report analysis comprises of market dynamics and competitive landscape. Additionally, the report offers insights on the pipeline analysis, overview of regulatory scenario by key regions, key industry developments, number of primary immunodeficiency (PI) patients by key countries and reimbursement scenario.

SEGMENTATION

Key Industry Developments

• In May 2019, the FDA approved the prior approval supplement (PAS) for ADMA Biologics, Inc.’s product offering of BIVIGAM and subsequently ADMA announced that it will begin the commercial sales of the product


• In April 2019, a novel intravenous immunoglobulin by ADMA Biologics, Inc. to be utilised for the treatment of primary immunodeficiency called Asceniv (Immune Globulin Intravenous, Human – slra 10%, Liquid), received the FDA approval


• In May 2018, Kedrion S.p.A and Kamada announced that KEDRAB, an immunoglobulin aimed at the treatment of rabies, was ready for commercial distribution and shipping