Immunoglobulins Market Analysis | 2021-2026

Market Insights

"The immunoglobulin market is estimated to grow from USD 11.7 billion in 2020 to USD 16.8 billion by 2026 at a healthy CAGR of 6.3% during the forecast period."

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What is immunoglobulin?

Immunoglobulin, also referred to as an antibody, may be a protein synthesized by plasma cells and other lymphocytes. It's a posh entity that exerts its immunomodulatory effect on different components of the system. It's obtained from the blood via the method of fractionation and is purified for therapeutic and non-therapeutic applications.

Key Players

Key players operating in the immunoglobulins market are:

• Baxter international Inc. (US)
• CSL Ltd. (Australia)
• Grifols S.A (Spain)
• Octapharma AG (Switzerland)
• Kedrion Biopharma Inc. (US)
• LFB group (France)
• Biotest AG (Germany)
• China Biologics Products, Inc. (China)
• Shire (Baxalta) (US)
• Bayer Healthcare (Germany).

Market Dynamics

The rise in the geriatric population & the number of hemophilic patients improved immunoglobulin production due to the emergence of advanced technologies, and enhanced purification techniques, with better plasma yield, are some of the key factors bolstering the market growth. Also, the surge in prevalence of diseases such as chronic inflammatory demyelinating polyneuropathy (CIDP), hypogammaglobulinemia & others is likely to augment the industry growth. However, stringent government regulations about immunoglobulin products and the high risk of side effects due to the usage of immunoglobulin are anticipated to hinder the market growth.

Surge in the prevalence of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Disease:

Electrophysiological Findings of Classical CIDP

Electrophysiological studies, including Nerve Conduction Study (NCV), are useful in distinguishing between demyelinating and axonal processes. It's important to note that axonal processes can be either primary or secondary to demyelination and may not rule out CIDP. With 15 different diagnostic criteria available for CIDP, the European Federation of Neurological Societies and Peripheral Nerve Society (EFNS/PNS) 2010 criteria stand out with 83% sensitivity and 97% specificity. CIDP is then categorized into definite, probable, or possible groups according to this criterion.

According to a recent meta-analysis, the crude incidence rate of CIDP was found to be 0.33 per 100,000 patients. The overall prevalence ranges between 0.8 to 8.9 per 100,000 people and tends to increase with age, peaking between 40 to 60 years. However, due to the diversity of clinical presentations and diagnostic criteria used globally, the incidence and prevalence rates may vary. Furthermore, CIDP has a higher prevalence in males with a 2:1 ratio compared to females.

Surge in the prevalence of Hypogammaglobulinemia Disease:

X-Linked Agammaglobulinemia has a reported prevalence of approximately 1 in 379,000 live births (1 in 190,000 male births) according to a United States registry. Meanwhile, among primary immunodeficiencies, Common Variable Immunodeficiency (CVID) is the most common after selective IgA deficiency, with a high prevalence of 1 in every 10,000 to 50,000 live births.

The incidence of CVID is higher in those from northern Europe, with a reported frequency of 1 in 25,000 individuals. While the majority of pediatric CVID cases present after puberty, about 25% of all CVID patients present during childhood or adolescence, with a peak age of diagnosis at 8 years old. The male-to-female ratio for CVID is approximately 5 to 3.

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The COVID-19 outbreak positively influenced the growth of the Immunoglobulins market. The growing use of immunoglobulin in the treatment of COVID-19 infection can be effective in the management of the disease. In the US, the impact of COVID-19 on the immunoglobulin market is robust as there have been increasing research studies on immunoglobulins as an effective therapy in the treatment of COVID-19. For instance, as per the National Clinical Trial (NCT) Registry, as of 9th March 2021, in the US, there was around 50 immunoglobulin based ongoing clinical trials across different phases of development which shows a positive impact on the market as this can result to the development of new effective therapy for COVID-19 in the coming years.

Segment Analysis

Application Insights

"The hypogammaglobulinemia segment accounted for the largest market share."

The market has been classified into hypogammaglobulinemia, chronic inflammatory demyelinating polyneuropathy (CIDP), immunodeficiency disease, myasthenia gravis, and others. The hypogammaglobulinemia segment accounted for the largest market share in 2020. This is ascribed to the substantial rise in the prevalence of hypogammaglobulinemia disorder around the world over the years. For instance, hypogammaglobulinemia is the most common chronic immune defect in patients with lymphoproliferative disorders (LPDs). Its prevalence rate is ~2 per 100,000 population yearly, worldwide, which further boosts segment growth.

Regional Trends

"The market in North America accounted for the largest share."

The market in North America accounted for the largest share in 2020 and is projected to continue its dominance during the review period. This is mainly attributed to increasing healthcare expenditure, the growing inclination of clinicians towards immunodeficiency therapies, and the rising level of consciousness for the products involved in the treatment of immunodeficiency disorders. Moreover, beneficial government initiatives and a rise in the number of research partnerships further proliferate regional growth.

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Report Features

This report provides market intelligence in the most comprehensive way. The report structure has been kept such that it offers maximum business value. It provides critical insights into market dynamics and will enable strategic decision-making for existing market players as well as those willing to enter the market.

What deliverables will you get in this report?

Target Audience

Here is the list of the group of customers that the market hopes to have the greatest opportunity to convert:

• Distributors
• Suppliers
• Manufacturers
• Logistics organizations
• Government bodies

Research Methodology

This report offers high-quality insights and is the outcome of a detailed research methodology comprising extensive secondary research, rigorous primary interviews with industry stakeholders, and validation and triangulation with Stratview Research’s internal database and statistical tools. More than 1,000 authenticated secondary sources, such as company annual reports, fact books, press releases, journals, investor presentations, white papers, patents, and articles, have been leveraged to gather the data. We conducted more than 15 detailed primary interviews with market players across the value chain in all four regions and industry experts to obtain both qualitative and quantitative insights.

Customization Options

With this detailed report, Stratview Research offers one of the following free customization options to our respectable clients:

Company Profiling

• Detailed profiling of additional market players (up to three players)
• SWOT analysis of key players (up to three players)

Competitive Benchmarking

• Benchmarking of key players on the following parameters: Product portfolio, geographical reach, regional presence, and strategic alliances.

Custom Research: Stratview Research offers custom research services across sectors. In case of any custom research requirement related to market assessment, competitive benchmarking, sourcing and procurement, target screening, and others, please send your inquiry to sales@stratviewresearch.com.

Recent News & Developments

In March 2023, Takeda Pharmaceutical Company Limited unveiled its intention to allocate approximately USD 910.7 million towards the construction of a new production facility dedicated to plasma-derived therapies in Japan. This strategic move underscores Takeda's commitment to bolstering its manufacturing capabilities.

In March 2023, Advanced Infusion Care (AIC) forged a distribution partnership with Kendrion SpA to distribute GAMMAKED for the management of ITP in both adults and children, as well as CIDP in adults.

In January 2022, Octapharma AG expanded the approved uses for cutaquig, a subcutaneous immunoglobulin, within the European Union to include patients with secondary immunodeficiencies.

In January 2022, Kedrion S.p.A. and LFB entered into an industrial cooperation agreement to improve the availability of immunoglobulins for patients in France.

In 2022, Article titled "Patients Rising," patients typically receive 45 infusions per month, with an average monthly cost exceeding USD 40,000.

According to the Centers for Disease Control and Prevention (CDC), in 2021, 3,000 to 6,000 people in the US developed Guillain-Barre Syndrome, with individuals aged 50 and older being at a higher risk of developing this condition.

In November 2021, Biotest AG obtained marketing authorization for Intratect, their human IVIG preparation, in France, thus enhancing their product portfolio.

In July 2021, Octapharma AG secured approval from the U.S. FDA for Octagam 10%, an intravenous immunoglobulin, to treat adult dermatomyositis, a rare immune-mediated inflammatory disease.

In June 2021, Kedron Biopharma and Kamada Ltd. received approval from the U.S. FDA to update the label for KEDRAB (Rabies Immune Globulin [Human]) to expand their product offerings.

In June 2021, CSL Behring, a subsidiary of CSL Limited, gained approval from the Centers for Medicare & Medicaid Services (CMS) to include Hizentra in Medicare Part B, aiming to enhance product affordability.

In April 2021, CSL Behring received FDA approval for Hizentra (Immune Globulin Subcutaneous [Human] 20% Liquid) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).

According to a Frontiers Media S.A. article, IgG consumption increased from 40.4 gm per 1,000 population in 2010 to 94.6 gm in 2021 in Europe.

According to the Leukemia & Lymphoma Society, approximately 397,501 individuals in the US had leukemia or were in remission in 2021, while around 138,415 people were living with myeloma during the same year.
Furthermore, numerous research articles have reported that the geriatric population is more susceptible to autoimmune disorders. Consequently, the increasing geriatric demographic is leading to a larger patient population afflicted with these disorders, necessitating treatment.