The Chronic Idiopathic Urticaria (CIU) treatment market is estimated to be valued at USD 15.12 Bn in 2024 and is expected to reach USD 25.91 Bn by 2031, growing at a compound annual growth rate (CAGR) of 8% from 2024 to 2031.

There is continuous development of innovative and effective drugs for treating chronic idiopathic urticaria. Furthermore, rising prevalence of chronic idiopathic urticaria worldwide due to increasing environmental pollution and allergens is expected to drive the demand for effective CIU treatments.

Market Driver - Growing Prevalence of Chronic Idiopathic Urticaria (CIU) Globally

Chronic idiopathic urticaria, also known as chronic spontaneous urticaria, is a common condition characterized by itchy hives or wheals on the skin that last for more than six weeks. While the exact cause remains unknown in many cases, its prevalence has been increasing over the past couple of decades around the world. Many factors such as environmental triggers, stressful lifestyle, and food allergies are considered to play a role in the development of CIU symptoms. With more people getting affected by this distressing condition, the demand for effective CIU treatment options has surged significantly.

According to available estimates, CIU is estimated to affect nearly 1% of the global population at some point in their lifetime, with higher occurrence reported in developed nations where modern risk factors are more prevalent. The condition often has a deteriorating effect on the quality of life as continuous itching and wheals can cause insomnia, irritability, lethargy and negatively impact daily activities and social interactions. With growing awareness, more people are seeking medical help for their symptoms instead of treating them as minor skin conditions. This has translated into rising numbers of prescription of CIU medications over the last few years.

Market Driver - Advances in Monoclonal Antibody Therapies and Biologics that Provide Targeted Treatment Options for CIU

Researchers have been vigorously working on developing novel treatment approaches for refractory chronic idiopathic urticaria that does not adequately respond to conventional second-generation antihistamines. This has led to significant advances in monoclonal antibody therapies and biologic agents that precisely target the underlying disease mechanisms.

For example, omalizumab, a humanized monoclonal antibody directed against immunoglobulin E, was the first biologic successfully approved by regulatory agencies for the management of CIU. In clinical trials, omalizumab has shown to provide substantially greater relief from itchiness, hives, and angioedema than placebo.

More recently, faricipimab and ligelizumab, both targeting immune system signals involved in CIU, entered late-stage clinical evaluation. Their promising efficacy and safety profile observed so far indicates these treatments could emerge as major game changers for managing difficult to control CIU cases.

The availability of such targeted biologics thatinterrupt the immunological pathways leading to wheals and itching provides fresh hope to patients not optimally responding to first line options. This has accelerated research into newer monoclonal antibodies for various subtypes of CIU. The development of precision treatments will enable improving quality of life for many CIU sufferers, driving increased adoption of these advanced therapies in clinical practice.

Market Challenge - High Cost of Advanced Biologic Treatments Limits Accessibility

The cost of advanced biologic treatments for chronic idiopathic urticaria (CIU) such as monoclonal antibodies (mAbs) pose a major challenge for widespread adoption globally. These specialty biologics which target immunoglobulin E (IgE) or its high-affinity receptor FcεRI are very effective at providing rapid symptom control but have a high list price ranging from $30,000 to $50,000 per patient annually.

While they may prove cost-effective by reducing the need for other health services in responders, their high acquisition cost puts them out of reach for many healthcare systems and individual patients in low and middle-income countries. Even in developed markets, the out-of-pocket costs after insurance reimbursement can be prohibitively high for some patients. This price barrier limits access to the most effective therapies especially for underprivileged populations in developing or resource-limited regions.

Unless more affordable biosimilar or novel oral treatment options become available, CIU will likely continue to negatively impact quality of life for many patients who fail conventional oral therapies due to financial restrictions on costly biologics.

Market Opportunity - Development of Biosimilars could Provide More Affordable Options for Treating CIU

The emergence of biosimilars referencing leading biologic therapies for CIU offers a potential opportunity to address their high treatment costs and expand access to patients worldwide. Biosimilars which have demonstrated comparable quality, safety and efficacy to their reference products but are marketed at a discounted price, could capture a sizable portion of the market once patent protection for innovator drugs begins to expire.

Global spending on CIU biologics is projected to reach $2 billion by 2025 as uptake increases, making it an attractive market segment for follow-on competition. As the first wave of biosimilar approvals are launched in major pharmaceutical markets, over time they are expected to erode prices significantly through market forces.

Wider availability of affordable near-biosimilar or biosimilar equivalents of biologics could enable physicians to optimize treatment for many more CIU patients, especially those in price-sensitive regions where cost had been a barrier to care.

Chronic Idiopathic Urticaria (CIU) is typically treated through a step-wise approach over multiple lines of therapy depending on disease severity and patient response. For mild cases in the initial stages, antihistamines such as cetirizine (Zyrtec) or loratadine (Claritin) are prescribed as first-line treatment. However, 20-50% of patients do not achieve adequate disease control with first-generation antihistamines alone.

For such cases, prescribers may opt for a second-line treatment involving leukotriene receptor antagonists like montelukast (Singulair). If symptoms remain uncontrolled, prescribers typically move the patient to a third-line treatment using omalizumab (Xolair), a monoclonal antibody targeting immunoglobulin E. Omalizumab is generally effective after 1-2 injections administered every 4 weeks and is well-tolerated long-term.

Cost of treatment is an important factor influencing prescriber decisions, especially considering the chronic nature of CIU. While generic antihistamines offer good cost-effectiveness as first-line options, biologics like omalizumab entail a higher expense. Overall, treatment approaches are customized based on each patient's disease severity, budget constraints as well as their response to prior therapeutic regimens.

CIU is characterized by the recurrent appearance of hives or wheals for more than six weeks. Treatment is focused on reducing symptoms and includes various options depending on the stage and severity of disease.

For mild cases, first line treatment involves the use of antihistamines such as cetirizine or loratadine. These help to reduce itching and inflammations caused by the release of histamine. However, 20-50% of patients do not respond sufficiently to first generation antihistamines.

For such patients, second line options include levocetirizine and desloratadine - newer generation antihistamines that are more potent. They provide better relief either as monotherapy or in combinations. Omalizumab, a monoclonal antibody, is also used in cases where antihistamines fail. It inhibits immunoglobulin E and is effective in approximately 65% of patients.

For severe cases where above treatments are inadequate, cyclosporine - an immunosuppressant, may be used for 2-3 monthsduration. It works by inhibiting T-cell activation and reduces symptoms in 80% of patients. However, its use requires close monitoring due to potential side effects involving kidneys.

Montelukast, a leukotriene receptor antagonist, has shown promise in multiple studies, either alone or in combination with antihistamines. As a third line option, it provides additional relief mechanisms for refractory urticaria.

Focus on newer product innovation and development: Players have increasingly focused on developing newer and more effective products to treat CIU. For example, in 2017, Novartis obtained FDA approval for Cinqair (reslizumab), the first FDA-approved biologic for the treatment of CIU. Cinqair introduced a new treatment mechanism targeting immunoglobulin E.

Strategic acquisitions: Companies have made strategic acquisitions to strengthen their portfolio and pipeline of CIU drugs. For example, in 2018, Sanofi acquired Ablynx for $4.8 billion, gaining access to Ablynx's nanobody platform and late-stage CIU candidate caplacizumab. This boosted Sanofi's presence in the CIU market.

Expand geographic footprint: Key players have focused on expanding their commercial footprint, especially in high-growth markets like Asia Pacific and Latin America. For instance, between 2015-2019, GSK partnered with several distributors to launch its antihistamine Zyrtec (cetirizine) across multiple Asian and Latin American countries for CIU treatment. This helped drive significant sales growth.

Increase awareness and advocacy programs: Players engage in various awareness initiatives to educate patients and physicians about CIU, its treatment options and available supportive therapies. For example, AstraZeneca runs patient support programs and engages CIU patient advocacy groups to highlight unmet needs and drive timely diagnoses and treatment uptake.

Insights, By Route of Administration: Convenience and Safety Drive Subcutaneous Adoption

In terms of route of administration, subcutaneous contributes the highest share of the market owning to its convenience and safety profile. Subcutaneous injections can be easily self-administered at home without the need for specialized medical facilities or healthcare professionals. This ease of administration increases patient compliance to the prescribed treatment regimen. Furthermore, subcutaneous injections carry a lower risk of infection compared to intravenous methods as there is no direct contact with the bloodstream. The subcutaneous tissue also has more space to absorb drug molecules gradually as compared to intramuscular injections, thus reducing the chance of overdose or adverse reactions. Overall, the non-invasive nature and safety of subcutaneous injections have made it the preferred route for chronic conditions like CIU that require long-term management.

Insights, By Molecule Type: Antibody Specificity Favors Monoclonal Treatment

In terms of molecule type, monoclonal antibody contributes the highest share of the market due to their high specificity and precision. Monoclonal antibodies are artificially synthesized in the laboratory to target a single epitope or antigen on the pathogen cell. This specificity allows them to neutralize the intended cell very effectively with minimal off-target interactions.

In the case of CIU, monoclonal antibodies are designed to bind strongly to immunoglobulin E (IgE) and interfere with the allergic cascade at its inception. Their ability to block the IgE pathway more selectively than other treatments has increased their efficacy and uptake over other molecule types for CIU management.

Insights, By Product Type: Simplicity Drives Mono Therapy

In terms of product type, mono contributes the highest share of the market owing to the benefits of simplicity. Most patients prefer standalone drug treatments rather than complex multi-drug combinations due to lower pill burden, fewer drug interactions, and simpler dosing schedules. Mono therapies are also more cost-effective for payers compared to fixed-dose combinations.

Furthermore, some patients may not need the added efficacy of combined pharmacological mechanisms if mono drugs can adequately control their CIU symptoms. The streamlined profile of mono products makes them suitable first-line options, driving their widespread use over combination therapies except in resistant cases.

• The prevalence of CIU is increasing, affecting around 0.5% to 1% of the population globally. However, there remains a significant unmet need for treatments, particularly in severe cases resistant to standard therapies.
• Several drugs are in the Phase II or III stages of clinical trials, indicating a dynamic development landscape for CIU.

The major players operating in the Chronic Idiopathic Urticaria (CIU) Treatment Market include Taizhou Mabtech Pharmaceutical Co. Ltd., Celldex Therapeutics, Allakos, Novartis, GlaxoSmithKline, Regeneron Pharmaceuticals, Sanofi, AstraZeneca, UCB Pharma, and Teva Pharmaceuticals.

• In July 2024, Taizhou Mabtech Pharmaceutical announced that it is conducting a Phase III clinical trial for CMAB007, a biosimilar of omalizumab. This study compares efficacy, immunogenicity, and safety in CIU patients. The development aims to address unmet needs in the chronic urticaria space.
• In May 2024, Celldex Therapeutics announced that Celldex’s Barzolvolimab (CDX-0159) in Phase III targets the KIT receptor to prevent allergic reactions, offering hope for severe CIU cases. Its positive impact in early trials shows potential to reshape CIU treatment.

• By Route of Administration
  • Subcutaneous
  • Intravenous
  • Oral
• By Molecule Type
  • Monoclonal Antibody
  • Small Molecule
  • Recombinant Fusion Proteins
• By Product Type
  • Mono
  • Combination
• By Development Phase
  • Phase I
  • Phase II
  • Phase III