US Allergy Therapeutics Market Analysis

US Allergy Therapeutics Market Executive Summary

US Allergy Therapeutics Market was valued at $9744 Mn in 2022 and is estimated to reach $13751 Mn in 2030, exhibiting a CAGR of 4.4% during the forecast period.

Allergies are immune system reactions brought on by the body's reaction to normally harmless environmental chemicals known as allergens. These allergens include dust mites, pollen, and mold, in addition to frequent dietary triggers including milk, eggs, soy, and almonds. Runny noses and stinging eyes are common signs of mild allergies. However, severe and perhaps fatal reactions, like anaphylaxis, can cause respiratory difficulty and coma. Approaches to managing allergies include immunotherapy, avoiding allergens, and using prescription drugs such as antihistamines and nasal corticosteroids.

Allergies are a prevalent health issue in the United States, impacting a vast number of people from various age groups and demographic backgrounds. Allergies affect more than 100 Mn Americans each year, making them the sixth most common cause of chronic illness in the nation. About 20 Mn individuals suffer from food allergies, which are a significant issue. Common allergens include milk, soy, eggs, wheat, peanuts, tree nuts, sesame, fish, and shellfish. Pollen from grass, weeds, and trees is the main cause of seasonal allergies, which impact 24.7% of adults between the ages of 18 and 44 and rise to 27.9% in those between the ages of 45 and 64. As people age, the prevalence of diagnosed eczema declines and is higher in women (8.9%) than in males (5.7%). Latex and insect sting allergies are less prevalent but nonetheless potentially dangerous. Allergies have an immense impact on people, causing everything from minor symptoms like runny nose, itchy eyes, and sneezing to severe, potentially fatal reactions.

In the process of the Phase 3 PEANUT2 trial, Aimmune Therapeutics' AR101 Peanut Oral Immunotherapy (OIT) achieved a noteworthy milestone. The trial effectively achieved its statistically significant primary endpoint, proving that AR101 is effective in lowering the incidence of peanut allergy responses in kids and teenagers. With this achievement, the company is expected to receive FDA approval by 2024. The trial's successful conclusion highlights AR101's potential as a strong treatment for peanut allergies, representing a significant breakthrough in the field of immunotherapy for allergic disorders affecting kids and teenagers.

Market Dynamics

Market Growth Drivers

Rising Prevalence of Allergies: Allergies affect about 100 Mn Americans, making them a major public health issue. 20 Mn people suffer from food allergies alone, and 4 Mn youngsters are especially affected by peanut allergies. Seasonal allergies are also common, impacting about 25% of people in the 18–44 age range. This rise in the number of patients suffering from allergies has led to an increase in demand for allergy treatment, which will drive the market’s expansion.

Increased Awareness and Diagnosis: Increased diagnostic capabilities and public awareness initiatives enabled earlier and more precise allergy identification, which encouraged people to seek treatment.

Aging Population: Allergy-related conditions such as allergic rhinitis and chronic sinusitis are becoming more common in the elderly population. This generates demand for allergy medicines by forming a new market group that needs specialist treatment alternatives.

Market Restraints

High Cost of Treatment: A considerable percentage of the population cannot afford many of the modern and successful allergy medicines, such as biologics and sublingual immunotherapy, due to their high cost. This may restrict patients access to the best possible care and market penetration.

Treatment Compliance and Adherence: For allergy treatments to work best, especially long-term regimens like immunotherapy, regular adherence is necessary. Low patient adherence brought on by expenses, inconveniences, or adverse effects might reduce the effectiveness of treatment and impede market expansion.

Regulatory Hurdles: Patients may not get timely access to innovative treatments if there is a delay in approval of new pharmaceuticals and therapies due to the rigorous regulatory procedures that must be followed.

Notable Recent Updates

January 2023, the FDA approved ALK's expanded use of ODACTRA, a sublingual immunotherapy tablet, for treating teenagers aged 12 to 17 who have allergic rhinitis caused by house dust mites.

October 2023, Astria Therapeutics, Inc. and Inchon's Sciences announced a license deal. The OX40 portfolio is covered by the agreement, with a special emphasis on STAR-0310 development as a possible treatment for atopic dermatitis (AD) and other allergic and immunological disorders.

Healthcare Policies and Regulatory Landscape

The U.S. Food and Drug Administration (FDA) is the main regulatory body in the United States that oversees the regulatory environment for allergy therapy medications. Pharmaceutical companies must submit New Drug Applications (NDAs) or Biologics License Applications (BLAs) to the FDA, which is in charge of overseeing the approval process for these treatments, in order to prove their products' safety and efficacy prior to going on sale. Biological allergy treatments are specially assessed by the FDA's Centre for Biologics Evaluation and Research (CBER). To avoid abuse, the Drug Enforcement Administration (DEA) also controls the chemicals found in these medications. The U.S. Patent and Trademark Office (USPTO) enables intellectual property protection, while state pharmacy boards oversee dispensing laws. Part of the National Institutes of Health (NIH), the National Institute of Allergy and Infectious Diseases (NIAID) may contribute to and finance projects pertaining to allergy therapies.

Competitive Landscape

Key Players

• Sanofi
• Novartis
• GlaxoSmithKline (GSK)
• AstraZeneca
• Merck & Co.
• Johnson & Johnson
• Roche
• Teva Pharmaceutical Industries
• ALK-Abelló
• Stallergenes Greer.