BUDESONIDE INHALER MARKET ANALYSIS

Budesonide is a medication that is used to prevent symptoms of asthma. It is a corticosteroid or steroid (cortisone-like medicine). The medication prevents inflammation in the lungs to decrease the severity of asthma attack. Inhaled budesonide may be used with other asthma medicines such as bronchodilators, which are also used to open up narrowed breathing passages in the lungs. Budesonide is available in several forms such as powders, suspensions, and tablets. In powder form, the medication can be inhaled by mouth using an inhaler. It can also be used as suspension to inhale by mouth using a special jet nebulizer (machine that turns medication into a mist that can be inhaled). Some of the trade names under which budesonide is sold are Pulmicort, Rhinocort, and Entocort.

Global budesonide inhaler market size was valued at US$ 6,899.6 Million in 2022 and is expected to witness a CAGR of 6.0% over the forecast period (2022 – 2030).

Figure 1.Global Budesonide Inhaler Market Share (%), by Product Type, 2022

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Increasing number of launches in generic version of budesonide inhaler is expected to drive growth of the budesonide inhaler market over the forecast period.

Increasing number of launches in generic version of budesonide inhaler is a major driving factor for growth of the budesonide inhaler market growth. For instance, in April 2020, Cipla Limited, a pharmaceutical company, announced that it received final approval for its Abbreviated New Drug Application (ANDA) for Albuterol Sulfate Inhalation Aerosol 90mcg (base)/actuation, from the U.S. Food and Drug Administration (FDA). Cipla’s Albuterol Sulfate Inhalation Aerosol 90mcg (base)/actuation, is AB-rated (a product approved by a regulatory agency that has determined the product to be bioequivalent to an existing or already-approved product identified as an Approved Product Concept.) generic therapeutic equivalent version of Merck Sharp & Dohme Corp’s Proventil HFA Inhalation Aerosol. It is used for treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms.

Figure 2. Global Budesonide Inhaler Market Share (%), by Region, 2022

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Increasing prevalence of chronic obstructive pulmonary disease and asthma in the U.S. is expected to boost the growth of global budesonide inhaler over the forecast period.

Increasing prevalence of chronic obstructive pulmonary disease and asthma in the U.S. is expected to boost the growth of budesonide inhaler market. For instance, on August 19, 2022, according to the reports published by Center Of Disease Control And Prevention, National Center of Health Statistics published a 2020 report which stated that, 5.0% of the U.S. population have been diagnosed with chronic obstructive pulmonary disease (COPD), emphysema, or chronic bronchitis, 4.1% of visits to office-based physicians with (COPD) chronic obstructive pulmonary disease indicated on the medical record in 2018.

Moreover, according to the same source, on August 16, 2022, according to the 2020 report, percent of adults aged 18 and over who currently have asthma is 8.4% and 5.8% of children under age 18 years who currently have asthma in the U.S. Whereas, 5.8 million was the annual number of office visits for asthma in 2020.

Global Budesonide Inhaler Market– Impact of Coronavirus (COVID-19) Pandemic

Since the COVID-19 virus outbreak in December 2019, the disease has spread to over 100 countries across the globe and the World Health Organization had declared it a public health emergency on January 30, 2020.

The sudden outbreak of COVID-19 has bought the world to a standstill. The whole world is fighting this pandemic with increased burden on hospitals and healthcare professionals. In April, 2020, University of Oxford, published a report on Asthma drug budesonide shortens recovery time in non-hospitalized patients with COVID-19, which reported that early treatment with inhaled budesonide shortens recovery time by a median of three days in patients with COVID-19 who are at higher risk of more severe illness, whereas Inhaled budesonide is a safe, relatively inexpensive and readily available corticosteroid commonly used around the world in inhalers to treat asthma and chronic obstructive pulmonary disease. The results showed that estimated median time to self-reported recovery for inhaled budesonide was 3.011 days shorter compared to usual care.

Thus, impact of covid-19 has driven the growth of global budesonide inhaler market during the pandemic.

Global Budesonide Inhaler Market: Key Developments

• In August 2020, Lupin Limited (Lupin), a pharmaceutical company, announced that it received approval from the U.S. Food and Drug Administration (FDA) for its Albuterol Sulfate Inhalation Aerosol, 90 mcg (base)/actuation, a generic version of ProAir HFA (Albuterol Sulfate Inhalation Aerosol). Lupin’s generic Albuterol Sulphate MDI had been manufactured at its Indore (Unit III) facility in India. ProAir HFA (Albuterol Sulfate Inhalation Aerosol) is the registered trademark of Teva Branded Pharmaceutical Products R&D, Inc. (Teva) and is indicated for the treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms
• For instance, in December 2018, Lupin, a pharmaceutical company, announced the receipt of the Establishment Inspection Report (EIR) for its Pithampur (Unit 3) facility. The inspection at the site was conducted between June 12, 2017 and June 16, 2017. This was a pre-approval inspection for Albuterol Sulfate Inhalation product. Lupin’s Pithampur (Unit 3) facility manufactures dermatological products, dry product inhalers and metered dose inhalers. The validation will help the company to maintain highest standards in quality and compliance across the facilities.
• For instance , in February 2020, Perrigo Company plc, a pharmaceutical company and its partner, Catalent Pharma Solutions, a pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has approved Perrigo’s abbreviated new drug application for generic albuterol sulfate inhalation aerosol, the first AB-rated generic version of ProAir HFA. Perrigo had launched a limited quantity of generic albuterol sulfate inhalation aerosol and, in collaboration with its development and manufacturing partner Catalent, to meet future demand in production.

Budesonide Inhaler Market Restraints

The major restraining factor for budesonide inhaler market growth is the side effects shown by budesonide such as

• runny or stuffy nose,
• sneezing,
• coughing,
• sore throat,
• dry throat,
• nosebleed,
• nausea,
• vomiting,
• diarrhea,
• stomach pain,
• white patches or sores inside the mouth or on lips,
• headache,
• hoarseness,
• voice changes,
• Bad taste in the mouth

Moreover, product recall is the major factor which hinders the growth of global budesonide inhaler market over the forecast period. For instance, in September 2020, Perrigo Company plc, a Pharmaceutical company, announced a voluntary U.S. nationwide recall of albuterol sulfate inhalation aerosol to the retail level after halting production and distribution. The actions were been taken out of an abundance of caution as a result of complaints that some units may not dispense due to clogging.  Perrigo's generic albuterol sulfate inhalation aerosol was developed in partnership with and manufactured by Catalent Pharma Solutions, a pharmaceutical company.

Key Players

Key players operating in the global budesonide inhaler market include Pfizer Inc., Cipla Limited, Lupin Limited, Cosmo Pharmaceuticals, Takeda Pharmaceutical Company Ltd., Manus Aktteva Biopharma LLP, Abbott Laboratories, Lunan Better Pharmaceutical, Novartis International AG (Sandoz), Mylan N.V., Skyepharma, AstraZeneca Plc., Chiesi Farmaceutici S.p.A, Orion Corporation, Santarus Inc., Synmosa Biopharma Corporation, and Shanghai Sine Pharmaceutical Laboratories Co. Ltd.