Primary Immune Deficiency Market

Market Overview:

The 7 major primary immune deficiency markets reached a value of US$ 5.7 Billion in 2023. Looking forward, IMARC Group expects the 7MM to reach US$ 9.4 Billion by 2034, exhibiting a growth rate (CAGR) of 4.61% during 2024-2034.

The primary immune deficiency market has been comprehensively analyzed in IMARC's new report titled "Primary Immune Deficiency Market: Epidemiology, Industry Trends, Share, Size, Growth, Opportunity, and Forecast 2024-2034". Primary immune deficiency refers to a group of rare genetic disorders that impair the normal functioning of the immune system. These conditions are characterized by a weakened or absent immune response, making individuals more susceptible to infections, autoimmune diseases, and other health complications like cancer. The ailment can manifest in various ways, depending on the specific defect in the body's defense mechanism. The most common symptoms of the illness are recurrent, severe, or unusual infections that can affect different body systems, including the respiratory tract, skin, and gastrointestinal tract. Children suffering from this ailment may also experience growth problems, failure to thrive, developmental delays, etc. Primary immune deficiency is typically diagnosed through a combination of clinical feature evaluation, medical history review, and a physical examination. The healthcare provider may further conduct genetic testing to identify specific gene mutations causing the underlying indications in patients. Numerous laboratory tests and blood workups, such as functional assays, lymphocyte subsets, complete blood counts, etc., are also performed to assess and indicate any abnormalities within the immune system.

The increasing cases of genetic variations that can either be inherited from one or both parents or occur spontaneously are primarily driving the primary immune deficiency market. In addition to this, the rising incidences of phagocytic cell disorders, in which the immune system's ability to ingest and kill microorganisms through neutrophils and monocytes is impaired, are further bolstering the market growth. Moreover, the widespread adoption of hematopoietic stem cell transplantation, since it helps to improve immune function and provide protection against infections, is also creating a positive outlook for the market. Apart from this, the inflating application of granulocyte colony-stimulating factor (G-CSF) therapy that encourages the bone marrow to produce and release white blood cells, thereby significantly enhancing the quality of life for patients, is further augmenting the market growth. Additionally, the escalating popularity of gene therapy, which is intended to address the underlying genetic cause of the ailment and potentially reduce the need for frequent treatments, is expected to drive the primary immune deficiency market during the forecast period.

IMARC Group's new report provides an exhaustive analysis of the primary immune deficiency market in the United States, EU4 (Germany, Spain, Italy, and France), United Kingdom, and Japan. This includes treatment practices, in-market, and pipeline drugs, share of individual therapies, market performance across the seven major markets, market performance of key companies and their drugs, etc. The report also provides the current and future patient pool across the seven major markets. According to the report, the United States has the largest patient pool for primary immune deficiency and also represents the largest market for its treatment. Furthermore, the current treatment practice/algorithm, market drivers, challenges, opportunities, reimbursement scenario, unmet medical needs, etc., have also been provided in the report. This report is a must-read for manufacturers, investors, business strategists, researchers, consultants, and all those who have any kind of stake or are planning to foray into the primary immune deficiency market in any manner.

Recent Developments:

• In June 2024, Takeda Canada Inc. announced that Health Canada had expanded the marketing authorization (NOC) for HyQvia (normal immunoglobulin [human] 10% and recombinant human hyaluronidase solution for subcutaneous infusion) as a replacement therapy for primary and secondary humoral immunodeficiency in pediatric patients aged 2 and above. HyQvia is the only SCIG infusion that can be given every three or four weeks.
• In June 2024, Grifols stated that Biotest, a Grifols Group company, had obtained FDA approval for Yimmugo, a novel intravenous immunoglobulin therapy used to treat primary immunodeficiencies.
• In December 2023, GC Biopharma Corp reported that the U.S. FDA had approved ALYGLO (immune globulin intravenous, human-stwk) 10% Liquid, formerly known as "GC5107," for the treatment of adult patients aged 17 years and older with primary humoral immunodeficiency.

Key Highlights:

• Primary immunodeficiencies have an overall frequency of about 1 in 10,000 people.
• Primary immunodeficiency disorders affect around one in every 2000 people in the United States.
• According to Jeffrey Model Foundation data, 57% of primary immunodeficiencies are identified in men and 43% in women.
• The most common age range for primary immunodeficiencies is 5 to 19 years old (38%).
• Only 5% of primary immunodeficiency diagnoses are made in children under the age of one year.

Drugs:

HYQVIA is a liquid drug delivered under the skin (subcutaneously) to treat primary immunodeficiency in people two years and older, as well as chronic inflammatory demyelinating polyneuropathy in adults. HYQVIA involves derived from human plasma. Immunoglobulins are antibodies that help to sustain the immune system.

GC5107 is a liquid solution for intravenous infusion that contains 10% immunoglobulin G (100 mg/mL) and is made from combined human plasma from donors in the United States. The manufacturing process is divided into three parts with the goal of reducing the likelihood of virus transmission. These include fractionation, solvent/detergent treatment, and nanofiltration. GC5107 additionally uses its revolutionary cation exchange chromatography in the production process to lower FXIa to undetectable levels.

BPX-501 is a genetically engineered T-cell treatment developed by Bellicum Pharmaceuticals to address primary immunological deficiencies. The medication is derived from donor T cells that have been genetically altered to include Bellicum's CaspaCIDe safety switch.

Time Period of the Study

• Base Year: 2023
• Historical Period: 2018-2023
• Market Forecast: 2024-2034

Countries Covered

• United States
• Germany
• France
• United Kingdom
• Italy
• Spain
• Japan
   

Analysis Covered Across Each Country

• Historical, current, and future epidemiology scenario
• Historical, current, and future performance of the primary immune deficiency market
• Historical, current, and future performance of various therapeutic categories in the market
• Sales of various drugs across the primary immune deficiency market
• Reimbursement scenario in the market
• In-market and pipeline drugs

Competitive Landscape:

This report also provides a detailed analysis of the current primary immune deficiency marketed drugs and late-stage pipeline drugs.

In-Market Drugs

• Drug Overview
• Mechanism of Action
• Regulatory Status
• Clinical Trial Results
• Drug Uptake and Market Performance
   

Late-Stage Pipeline Drugs

• Drug Overview
• Mechanism of Action
• Regulatory Status
• Clinical Trial Results
• Drug Uptake and Market Performance
   

*Kindly note that the drugs in the above table only represent a partial list of marketed/pipeline drugs, and the complete list has been provided in the report.

Key Questions Answered in this Report:

Market Insights

• How has the primary immune deficiency market performed so far and how will it perform in the coming years?
• What are the markets shares of various therapeutic segments in 2023 and how are they expected to perform till 2034?
• What was the country-wise size of the primary immune deficiency market across the seven major markets in 2023 and what will it look like in 2034?
• What is the growth rate of the primary immune deficiency market across the seven major markets and what will be the expected growth over the next ten years?
• What are the key unmet needs in the market?
   

Epidemiology Insights

• What is the number of prevalent cases (2018-2034) of primary immune deficiency across the seven major markets?
• What is the number of prevalent cases (2018-2034) of primary immune deficiency by age across the seven major markets?
• What is the number of prevalent cases (2018-2034) of primary immune deficiency by gender across the seven major markets?
• How many patients are diagnosed (2018-2034) with primary immune deficiency across the seven major markets?
• What is the size of the primary immune deficiency patient pool (2018-2023) across the seven major markets?
• What would be the forecasted patient pool (2024-2034) across the seven major markets?
• What are the key factors driving the epidemiological trend of primary immune deficiency?
• What will be the growth rate of patients across the seven major markets?
   

Primary Immune Deficiency: Current Treatment Scenario, Marketed Drugs and Emerging Therapies

• What are the current marketed drugs and what are their market performance?
• What are the key pipeline drugs and how are they expected to perform in the coming years?
• How safe are the current marketed drugs and what are their efficacies?
• How safe are the late-stage pipeline drugs and what are their efficacies?
• What are the current treatment guidelines for primary immune deficiency drugs across the seven major markets?
• Who are the key companies in the market and what are their market shares?
• What are the key mergers and acquisitions, licensing activities, collaborations, etc. related to the primary immune deficiency market?
• What are the key regulatory events related to the primary immune deficiency market?
• What is the structure of clinical trial landscape by status related to the primary immune deficiency market?
• What is the structure of clinical trial landscape by phase related to the primary immune deficiency market?
• What is the structure of clinical trial landscape by route of administration related to the primary immune deficiency market?