Inhaled and Intranasal Products Contract Service Providers Market, 2020-2030

Overview

Over the past few decades, the prevalence of respiratory disorders has been increasing at an alarming rate. In fact, each year around 7 million deaths are attributed to respiratory disorders caused by air pollution, worldwide.Moreover, as per a Global Burden of Disease study, around 3 million fatalities are reported annually due to chronic obstructive pulmonary disorders (COPD). It is also important to note that, as of April 2020, an estimated 330 million individuals are suffering from asthma.Other causative factors responsible for respiratory diseases include smoking, climate change, low immunity, inappropriate development of lungs, and bacterial, viral and fungal infections.It is worth mentioning that the novel SARS-CoV2 viral strain is a respiratory pathogen.

Targeting the delivery of drugs directly into the lungs is deemed to be the most effective way to ensure optimal therapeutic benefits while treating pulmonary disorders. In addition, this route of administration has also been shown to be effective for drugs intended to treat a variety of other conditions, including various metabolic (460+ million adults estimated to be living with diabetes) , hormonal, autoimmune, infectious diseases/disorders and mental health conditions (260 million individuals estimated to be suffering from depression and around 50 million have epilepsy, worldwide). As a result, innovators in the pharmaceutical industry are engaged in efforts to develop the means to formulate and administer pharmacological interventions via inhalation and/or the intranasal route. Since 2019, the FDA has approved multiple inhaled and intranasal drug products, namely TOSYMRA™ (migraine), NUMBRINO™ (local anesthetic), GIMOTI™ (diabetic gastroparesis), VALTOCO® (epilepsy), NAYZILAM® (epilepsy), DUAKLIR® PRESSAIR® (COPD), PROAIR® DIGIHALER™ (asthma and COPD), AIRDUO® DIGIHALER™ (asthma), SPRAVATO® (depression).

Presently, several players are attempting to develop inhalable versions of different classes of drugs. In such endeavors, reformulating complex therapeutic molecules (such as biologics), novel drug classes (such as nanoparticle based medicine) and those intended for systemic delivery, present unique challenges.Further, the inhaled route of delivery itself has always been associated with several challenges, mostly related to ensuring the drug to its intended target. These concerns are further compounded by multiple physiological barriers, such as mucus hypersecretion/thickening, narrowing/collapse of airways, fibrosis and poor blood circulation. In order to navigate through the aforementioned challenges, innovators prefer to rely on specialty service providers with expertise in inhaled and intranasal nasal medicine. Such players, given their experience and niche expertise, enable innovator companies to not only expedite product development and production timelines, but also offer cost saving opportunities as well. Further, such service providers generally have the necessary infrastructure to scale-up operations in order to meet the evolving needs of a business across different stages of product development. Given the anticipated growth in demand for inhaled and intranasal drug products, the specialty contract services market catering to this segment of the pharmaceutical industry, is anticipated to witness substantial growth in the coming years.

Scope of the Report

The ‘Inhaled and Intranasal Products: Contract Service Providers Market (Focus on Drugs and Drug Delivery Systems), 2020 – 2030’ report features an extensive study of the current market landscape and future opportunities for the contract service providers focused on drugs and drug delivery systems. It features an in-depth analysis, highlighting the capabilities of various contract service providers engaged in this domain.

Amongst other elements, the report includes:

• A detailed assessment of the overall landscape of companies offering contract and custom services for the inhaled and Intranasal drug development and manufacturing, along with information on a number of relevant parameters, such as year of establishment, company size, type of service provider (contract manufacturing organization and contract research organization), scale of operation (preclinical, clinical and commercial), location of headquarters, location of manufacturing facilities, type of drug molecule (small molecule and biologic), type of inhaled and intranasal related primary service(s) offered (development, manufacturing, analytical testing/services, device selection/optimization and fill/finish and packaging), type of inhaled and intranasal related secondary service(s) offered (process development, pre-formulation development, formulation development, pre-formulation manufacturing, formulation manufacturing, particle engineering, product characterization, extractable and leachable studies, stability testing and plume geometry measurement), type of formulation (powder, aerosol and liquid), type of dosage form (metered dose inhaler, dry powder inhaler, nebulizer, soft mist inhaler, nasal spray, nasal drops, nasal powder and others), route of administration (oral and intranasal inhalation) and installed capacity and batch size (if available).
• A detailed assessment of the overall landscape of the companies offering contract services for the inhaled and intranasal drug delivery system manufacturing, along with information on a number of relevant parameters, such as year of establishment, company size, scale of operation (precommercial and commercial), location of headquarters, location of manufacturing facilities, type of inhaled and intranasal drug delivery system related service(s) offered (design, development, manufacturing, assembly, fill/finish and packaging), type of formulation (powder, aerosol and liquid) and type of drug delivery system used (metered dose inhaler, dry powder inhaler, nebulizer, nasal spray and others).
• A competitiveness analysis of inhaled and intranasal drug product contract service providers across key geographical areas, featuring a four-dimensional bubble representation, taking into consideration service strength (number of services offered, type of formulation(s) offered and route of administration), manufacturing strength (type of drug molecule, scale of operation, number of manufacturing facilities), supplier strength (company size and its experience in this field) and company size (small-sized, mid-sized and large).
• Tabulated profiles of some of the key contract manufacturers (shortlisted based on a proprietary criterion) that offer a diverse range of capabilities for the development, manufacturing and packaging of inhaled and intranasal drugs across North America, Europe and Asia-Pacific. Each profile features an overview of the company, along with information related to its financial performance (if available), service portfolio, products and intranasal related capabilities, type of drug molecule, type of dosage form, inhaled and intranasal products related manufacturing facilities, recent developments and an informed future outlook.
• An analysis of the various partnerships related to inhaled and intranasal contract service providers, which have been established since 2015, based on several parameters, such as year of agreement, type of partnership (development agreements, manufacturing agreements, merger and acquisition, licensing agreement, commercialization, research and development agreements, service alliance, joint venture and other agreements), scale of operation (preclinical, clinical and commercial), type of inhaled and intranasal related service(s) offered (development, manufacturing, analytical testing/services and fill/finish and packaging), type of dosage form (metered dose inhalers, dry powder inhalers, nebulizers and others) and most active players. It also provides the regional distribution of the players involved in the collaborations.
• A qualitative analysis highlighting the various factors that need to be taken into consideration by inhaled and intranasal product developers, while deciding whether to manufacture their respective products in-house or engage a contract service provider.
• An estimate of the global, inhaled and intranasal product demand, based on the type of product (inhaled and intranasal), type of drug delivery system used (metered dose inhalers, dry powder inhalers, nebulizers and nasal sprays) and key geographical regions (North America, Europe and Asia-Pacific).
• An insightful discussion on the impact of COVID-19 outbreak on the inhaled and intranasal service providers. In addition, it features various strategies that different companies have adopted/may adopt in order to mitigate the challenges affiliated to the current global crisis.

One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on parameters, such as overall pulmonary market, global intranasal drug market, cost of goods sold and outsourcing trends, we have provided an informed estimate of the likely evolution of the contract service providers market in the mid to long term, for the time period 2020-2030. Our year-wise projections of the current and future opportunity have further been segmented on the basis of [A] scale of operation (clinical, commercial and both), [B] type of product manufacturing services offered (API manufacturing, end product manufacturing and others), [C] type of drug delivery system used (metered dose inhaler, dry powder inhaler, nebulizer and nasal spray), [D] route of administration (orally inhaled and intranasal) and [E] key geographical regions (North America, Europe, Asia-Pacific and rest of the world). In addition, specific to intranasal service providers, the market has been segmented by the type of drug class (corticosteroids, decongestants, antiallergic, anti-infectives and other topical preparations) and for inhalation service providers, the market has been segmented by the type of disease indication (asthma, COPD, diabetes, cystic fibrosis and others). In addition to the market forecast for inhaled and intranasal drugs, we have also provided a 10-year forecast for inhaled and intranasal drug delivery systems, covering the market of metered dose inhaler, dry powder inhaler, nebulizer and nasal spray. In order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.

The opinions and insights presented in this study were also influenced by discussions held with senior stakeholders in the industry.

The report features detailed transcripts of interviews held with the following industry and non-industry players:

• Ben Forbes (Professor, King’s College London)
• Dries Cardoen (Team Leader of Study Directors, Nelson Laboratories)
• Neeraj Kumar (Honorary Secretary, The Indian Pharmaceutical Association)

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

Key Questions Answered

• Who are the leading contract service providers offering inhalable and intranasal products related services, across the world?
• In which regions are majority of the inhaled and intranasal product related manufacturing facilities located?
• What percentage of inhaled and intranasal manufacturing operations are outsourced?
• Which partnership models are commonly adopted by stakeholders in this industry?
• What is the impact of COVID-19 outbreak on inhaled and intranasal product services market?
• What is the current, global demand for inhaled and intranasal products?
• How is the current and future market opportunity likely to be distributed across key market segments?