Although proteins and glycoproteins are the most common allergens, pure carbohydrates and low molecular weight metabolites also act as an allergen in rare circumstances. All foreign proteins are potential allergens in theory, but only few are confirmed as allergenic to the human body. It also depends on the individual body reaction to foreign particles, hence there is no identified distinguish between allergenic and non-allergenic proteins.  Allergen extracts are intended to be used in diagnostic testing and as a part of treatment regime for allergen specific allergy disease for use of hypersensitization or immunotherapy when prevention of specific allergens cannot be attained. Allergen extracts are used as adjunctive therapy along with pharmacotherapy including corticosteroids, antihistamines, and cromoglycate. The prime intention for allergenic extracts for therapeutic use is to determine the allergen to which the patient is allergic or has any history of exposure. Allergen extracts are administered by prick-puncture or intradermal routes for diagnosis purpose, while for immunotherapy injections they are administered subcutaneously. Allergen extracts are prepared using aqueous extraction of allergic material sources obtained from natural sources.

Market Dynamics

Center for Biologics Evaluations and Research (CBER), a part of U.S. Food and Drug Administration (FDA) which regulates allergenic products formed a committee in 2004 to review the scientific data about safety and efficacy of non-standardized allergen extracts. These extracts are classified into five categories based on the level of scientific information available to justify their usage. For instance, pollen comprises 451, 250, and 7 species in category 1, 4, and 5 respectively.  CBER also proposed to remove all the products classified in category 4 and 5 due to safety concerns. In Europe, the concept of ‘homologous groups’ proposed by Lorentz et al in 2009, to classify allergen sources is used. The concept uses similar biochemical composition and homology/cross-reactivity of allergen to group them. The allergen manufacturing companies are required to obtain quality data for representative allergen sources classified in the homologous group. The European regulatory agency has also proposed regulations that would further reduce the allergenic extracts in the market, which are similar to the concept proposed by CBER in US, but more rigorous as lesser number of allergen extracts are permitted as compared to US.

Rising awareness regarding allergies and growing incidence of allergies globally due to pollution are the leading factors for the growth of the market. Pollens are the leading reason for asthma and rhinitis in US and also other parts of the world. According to Canadian Allergy, Asthma and Immunology Foundation, allergic rhinitis affects around 20 to 25 percent of the population in Canada. The population who are hyper allergic are the ones suffer from allergic or seasonal asthma and rhinitis. Hence, it becomes difficult to treat such people without proper knowledge about the substances which can trigger immune anaphylaxis in the patient. Hence, allergen extracts are useful for diagnosis of patient’s hypersensitivity towards various allergen sources and proper immunotherapy can be administered.

Segment Analysis by Region

In 2019, North America held the largest share in the global allergen extracts market and is projected to continue to exhibit similar trend during the forecast period. Presence of large number of players operating in the region and high healthcare expenditure drives the region. The U.S. accounted for largest share in the North America market owing to high awareness towards allergies. Europe accounted for second largest share in the market owing to stringent guidelines and high demand for subcutaneous allergen extracts.  The market in Asia Pacific is expected to witness faster growth in the target market due to substantial increase in patients suffering from asthma and rhinitis due to rising air pollution in the region. In addition, major players approach towards enhancing the business in emerging economies through strategic merger is expected to boost the growth of regional market.

Competitive Landscape

The global allergen extracts market is high highly competitive due to presence of large number of players and innovative product offerings. In addition, business expansion activities through partnerships and agreements are factors expected to further increase the competition. The companies operating in the market include F. Hoffman La-Roche, Novartis AG, Merck & Co. Inc., ALK-Abello, Allergopharma, Shionogi & Co., and HollisterStier Allergy among others.

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Allergen Extracts Market Segment Analysis, 2019

The global allergen extracts market is segmented into treatment types and allergy types. The treatment type segment is bifurcated into subcutaneous allergen extracts, sublingual allergen extracts, and intradermal. The application segment is bifurcated into diagnostics and therapeutic applications. The allergy segment is divided into allergic asthma, allergic rhinitis, skin allergies, and others.

Market Segmentation

Market By Treatment Type
Subcutaneous Allergen Extracts
Sublingual Allergen Extracts
Intradermal

Market By Application
Diagnostics
Therapeutics

Market By Application
Allergic Asthma
Allergic Rhinitis
Skin Allergies
Others

Market By Geography

North America
•    U.S.
•    Canada

Europe
•    U.K.
•    Germany
•    France
•    Spain
•    Rest of Europe

Asia-Pacific
•    China
•    Japan
•    India
•    Australia
•    South Korea
•    Rest of Asia-Pacific

Latin America
•    Brazil 
•    Mexico
•    Rest of Latin America

Middle East & Africa
•    GCC
•    South Africa
•    Rest of Middle East & Africa