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Report Overview

Immunologic deficiency syndrome refers to conditions where the immune system fails to function properly, such as in HIV/AIDS. According to the World Health Organization (WHO), an estimated 39.9 million people were living with HIV in 2023. According to the immunologic deficiency syndrome pipeline analysis by Expert Market Research, the market is evolving with innovative immunologic deficiency syndrome therapeutics, including long-acting antiretrovirals and immune-boosting biologics. The growing focus on early diagnosis, targeted therapies, and government-backed health initiatives is expected to fuel market growth.

  • Major companies involved in the immunologic deficiency syndrome pipeline analysis include Takeda, Merck Sharp & Dohme LLC, and others.

  • Leading drugs currently in the pipeline include TAK-881, JSP191, ICVAX, and others.

  • The pipeline growth for immunologic deficiency syndrome drugs is driven by rising gene therapy advancements, increasing clinical trial activity, and strong R&D investments targeting rare genetic immunodeficiencies and antibody production disorders.

Report Coverage

The Immunologic Deficiency Syndrome Pipeline Analysis Report by Expert Market Research gives comprehensive insights into immunologic deficiency syndrome therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for immunologic deficiency syndrome. The immunologic deficiency syndrome report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The immunologic deficiency syndrome pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials, including their adverse effects on patients suffering from the condition, and alignment with immunologic deficiency syndrome treatment guidelines to ensure optimal care practices.

The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to immunologic deficiency syndrome.

Immunologic Deficiency Syndrome Pipeline Analysis By Drug Class

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Immunologic Deficiency Syndrome Pipeline Outlook

Immunologic deficiency syndrome refers to a condition where the immune system’s ability to fight infections is impaired or absent. It can be inherited (primary) or acquired (secondary), commonly resulting from infections like HIV or treatments such as chemotherapy. The syndrome leads to recurrent, severe infections and increased susceptibility to opportunistic pathogens.

Immunologic deficiency syndrome treatment focuses on addressing the underlying cause, boosting immune function, and managing infections. The treatment can be through antiretroviral therapy, immunoglobulin replacement, or stem cell transplantation, depending on the type and severity. In June 2025, Gilead Sciences received FDA approval for Yeztugo® (Lenacapavir), a twice-yearly injectable for HIV prevention. As an advanced HIV-1 capsid inhibitor, Yeztugo represents a significant therapeutic advancement in the immunologic deficiency syndrome drug pipeline.

Immunologic Deficiency Syndrome Epidemiology

According to the World Health Organization (WHO), an estimated 40.8 million people were living with Human Immunodeficiency Virus (HIV) in 2024, including 1.4 million children. Approximately 1.3 million new HIV infections were reported during the year. As reported by HIV.gov, in 2023, HIV prevalence included 20.8 million cases in Eastern and Southern Africa, 5.1 million in Western and Central Africa, 6.7 million in Asia-Pacific, and 2.3 million in Western and Central Europe and North America.

Immunologic Deficiency Syndrome – Pipeline Therapeutic Assessment

This section of the report covers the analysis of immunologic deficiency syndrome drug candidates based on several segmentations, including:

By Phase

  • Late-Stage Products (Phase 3 and Phase 4)
  • Mid-Stage Products (Phase 2)
  • Early-Stage Products (Phase I)
  • Preclinical and Discovery Stage Products

By Drug Class

  • Monoclonal Antibodies
  • Peptides
  • Polymers
  • Small Molecules
  • Gene Therapies

By Route of Administration

  • Oral
  • Parenteral
  • Others

Immunologic Deficiency Syndrome Pipeline Assessment Segmentation, By Phases

The report covers phase I, phase II, phase III, phase IV, and early-phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis, phase II covers a major share of the total immunologic deficiency syndrome clinical trials, with 39%, highlighting strong mid-stage development. Phase I follows with 27%, showing solid early-stage activity. Phase III holds 24.63%, indicating progress toward late-stage approvals. This balanced pipeline supports continued innovation and market expansion.

Immunologic Deficiency Syndrome Pipeline Assessment Segmentation, By Drug Classes

The drug molecule categories covered under the immunologic deficiency syndrome pipeline analysis include monoclonal antibodies, peptides, polymers, small molecules, and gene therapies. The immunologic deficiency syndrome report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for immunologic deficiency syndrome. Nucleoside reverse transcriptase translocation inhibitors are gaining prominence in the immunologic deficiency syndrome drug pipeline. For instance, Merck’s investigational combination therapy doravirine/islatravir, a once-daily, oral, two-drug regimen, is under FDA review. It has demonstrated non-inferior efficacy, and a favorable safety profile compared to three-drug regimens, offering a simplified treatment option for virologically suppressed HIV-1 patients.

Immunologic Deficiency Syndrome Clinical Trials – Key Players

The EMR report for the immunologic deficiency syndrome pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed immunologic deficiency syndrome therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in immunologic deficiency syndrome clinical trials:

  • Takeda
  • Merck Sharp & Dohme LLC
  • Jasper Therapeutics, Inc.
  • ViiV Healthcare
  • Pharming Technologies B.V.
  • Octapharma
  • Jiangsu Aidea Pharmaceutical Co., Ltd.
  • Bristol-Myers Squibb
  • AbbVie
  • GlaxoSmithKline
  • Gilead Sciences
  • Atara Biotherapeutics

Immunologic Deficiency Syndrome – Emerging Drugs Profile

This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for immunologic deficiency syndrome. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of immunologic deficiency syndrome drug candidates.

Biological: TAK-881

TAK-881 is currently being evaluated by Takeda in a Phase 3 trial to assess its long-term safety and tolerability in individuals with Primary Immunodeficiency Diseases (PIDD). The study is enrolling participants who completed the previous TAK-881-3001 trial. TAK-881 combines human normal immunoglobulin and recombinant hyaluronidase to enhance immune function and absorption. The trial is focusing on the drug’s extended use across adults and children.

Biological: JSP191

JSP191, developed by Jasper Therapeutics, Inc., is currently being evaluated in a Phase 1/2 trial for patients with Severe Combined Immunodeficiency (SCID). The study is assessing the safety, tolerability, and efficacy of JSP191 as an antibody-based conditioning agent before blood stem cell transplantation. By targeting CD117, a key receptor on blood-forming stem cells, JSP191 is depleting native cells to create space for donor stem cell engraftment, offering a gentler alternative to chemotherapy.

Biological: ICVAX

ICVAX, a therapeutic DNA vaccine for HIV, is being sponsored by Immuno Cure Holding (HK) Limited in a Phase I clinical trial. This study is evaluating the safety, tolerability, and immunogenicity of ICVAX in clinically stable HIV patients on ART. ICVAX is designed to induce broadly reactive, polyfunctional HIV-specific T cells to control the virus without ART, aiming for a functional cure.

*Please note that this is only a partial list; the complete list of drugs will be available in the full report.*

Key Questions Answered in the Immunologic Deficiency Syndrome Pipeline Insight Report

  • Which companies/institutions are leading the immunologic deficiency syndrome drug development?
  • Which company is leading the immunologic deficiency syndrome pipeline development activities?
  • What is the current immunologic deficiency syndrome commercial assessment?
  • What are the opportunities and challenges present in the immunologic deficiency syndrome pipeline landscape?
  • What is the efficacy and safety profile of immunologic deficiency syndrome pipeline drugs?
  • Which company is conducting major trials for immunologic deficiency syndrome drugs?
  • Which companies/institutions are involved in immunologic deficiency syndrome collaborations aimed at providing enhanced therapeutic alternatives for patients?
  • What are the geographies covered for clinical trials in immunologic deficiency syndrome?

Reasons To Buy This Report

The Immunologic Deficiency Syndrome Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for immunologic deficiency syndrome. It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into immunologic deficiency syndrome collaborations, regulatory environments, and potential growth opportunities.

Related Reports

Global Clinical Trials Market

Human Immunodeficiency Virus (HIV) Rapid Test Kits Market

Human Immunodeficiency Virus (HIV1) Infection Market

Human Immunodeficiency Virus (HIV 1) Infection Pipeline Analysis

*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*

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Please note that the figures mentioned in the description serve as estimates and may vary from the actual figures presented in the final report.

Scope of the Report

Details

Drug Pipeline by Clinical Trial Phase

  • Late-Stage Products (Phase III and Phase IV)
  • Mid-Stage Products (Phase II)
  • Early-Stage Products (Phase I)
  • Preclinical and Discovery Stage Products

Route of Administration

  • Oral
  • Parenteral
  • Others

Drug Classes

  • Monoclonal Antibodies
  • Peptides
  • Polymers
  • Small Molecules
  • Gene Therapies

Leading Sponsors Covered

  • Takeda
  • Merck Sharp & Dohme LLC
  • Jasper Therapeutics, Inc.
  • ViiV Healthcare
  • Pharming Technologies B.V.
  • Octapharma
  • Jiangsu Aidea Pharmaceutical Co., Ltd.
  • Bristol-Myers Squibb
  • AbbVie
  • GlaxoSmithKline
  • Gilead Sciences
  • Atara Biotherapeutics

Geographies Covered

  • North America
  • Europe
  • Asia Pacific
  • Others

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