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Dry Powder Inhalers Market Snapshot

The search for improved routes of administration for therapeutic agents and the desire for noninvasive delivery methods for self-medication of chronic conditions have led to increased interest in pulmonary drug delivery systems. Recent developments, including ongoing research activity in powder formulations, advances in particle engineering, and novel device architectures are positioning dry powder inhalation as an attractive option for pharma and biotech product strategists in this age of direct-to-consumer marketing.

Inhalers for the treatment of upper respiratory ailments (URT) such as asthma and chronic obstructive pulmonary disease are arguably the most mission-critical drug delivery device class currently on the market. These combination products are relied upon by tens of millions of Americans and more than 300 million worldwide for the treatment of debilitating and life-threatening respiratory conditions. While accounting for nine out of every ten dollars spent on inhaled therapeutics, much of the recent activity for URT has focused on the rise of generics as patents expire and on COPD, a growing segment that continues represent significant unmet needs

Orally inhaled drug delivery is being transformed by recent developments in particle technology. Powder formulations predominantly used in commercial inhalers consist of coarse carrier particles blended with micronized drug particles. This approach can lead to significant variability in dose-to-dose drug administration. While improvements and enhancements in inhaler designs attempt to address these issues,

enabling technologies in the area of particle engineering are creating new opportunities for dry powder inhalation.

As aging population demographics and managed care initiatives drive growth in home health care and self-administration of drug therapies, inhaled medicine is increasingly being viewed as patient-friendly and cost-effective. Our analysis demonstrates that inhaled administration in general, and DPI in particular, are well positioned to take advantage of these trends and evolve into a significant factor in the future of pharmaceutical development and commercialization of therapeutic drugs.

While the market for inhaled drugs targeting upper respiratory diseases such as asthma and COPD is maturing technologically with most development activity now centering on expanded indications and combination drug inhalers, several participants in this sector are taking novel approaches that attempt to address underlying causes as opposed to treating disease symptoms. Many challenges remain, but as a group these candidates hold significant potential.


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Dry Powder Inhalers Market Report

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Patch Pump Drug Delivery Market Dynamics

Patch Pump Drug Delivery Sector Overview

The patch pump drug delivery segment is currently comprised of about a dozen players. The product strategies that are represented by these market segment participants range from simple mechanical, manually activated reservoir devices that adhere to the skin, to variations on existing external wearable drug pump products that are designed to be more user-friendly, ergonomic and in tune with active patient lifestyles.

 

Patch Pump Drug Delivery Product Segments

At the macro level, patch pumps – both commercially available and in development – can be grouped into electronic devices and mechanical devices. The electronic devices feature a microprocessor-based remote pump controller that can perform many of the functions incorporated into external insulin pump products.

The mechanical, wearable reservoir devices represent a rather unique product segment. While simple to use and inexpensive, these device offer only limited utility when compared to existing drug delivery devices such as insulin pens. Because of the low barriers to entry, we foresee growing competition for what might easily become a commodity product segment as the ability to differentiate a branded device from competitive products results in price competition for market share.

Mechanical patch pumps do not have microprocessors or other types of integrated circuits, delivery the drug via a mechanical force, and provide a constant, fixed basal insulin dosage. Electronic insulin patch pumps rely on a microprocessor for determining the rate of basal insulin administration, using algorithms and capturing user preferences for future use. Some models feature algorithms that support delivery of boluses in standard, dual-wave, and square-wave forms.

West Pharmaceutical Smart Dose Device

patch pump drug delivery

 

The Outlook for Patch Pump Drug Delivery

The patch pump product sector will be influenced by several macro trends that are affecting the therapeutic drug sector. In order to maintain the competitiveness of their proprietary drug candidates, large pharmaceutical companies seek delivery enhancements that will increase safety and efficacy, reduce side effects and make administration more convenient. Drug delivery companies can also apply their technologies to off-patent products to formulate their own proprietary products, which they often commercialize by seeking marketing collaborations with larger pharmaceutical companies that have greater capabilities and resources.


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Patch Pump Delivery Systems

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Closed System Transfer Device Market Dynamics

Closed system transfer device technology  is founded in the need to protect patients an caregivers from exposure to hazardous drugs. The risks of occupational exposure to hazardous drugs has been known since the 1970s. Since 1980, guidance documents from the American Society of Health-System Pharmacists (ASHP) and the National Institute for Occupational Safety and Health (NIOSH) have provided advice to healthcare providers who manage these agents, but many organizations have not taken the necessary steps to ensure safety. On February 1, 2016, United States Pharmacopeia (USP) General Chapter 800: “Hazardous Drugs: Handling in Healthcare Settings” was published, and will provide the first enforceable standards concerning hazardous drugs beginning on July 1, 2018.

 

The Lingering Role of Cytotoxics

The market for closed system transfer device (CSTDs) drug compounding and administration is dominated by a handful of companies that supply one or more approved closed system transfer device products. The primary application for these systems is oncology therapeutics, a disease sector that still relies heavily on cytotoxic drugs for the treatment of most cancers, in spite of the increasing promise of targeted antibody treatments based on tumor-specific biomarkers.  As a class cytotoxics include alkylating agents and antimetabolites drugs and chemicals that can also harm normal cells and their DNA, and these drugs are believed to represent a significant occupational exposure risk for hospital pharmacy and infusion center personnel.

Since a number of cytotoxic drugs are supplied in lyophilized form requiring reconstitution prior to administration, the cytotoxic drug delivery segment is closely aligned with the drug reconstitution segment, There are currently about a dozen important players in the drug reconstitution system market. While the barriers to entry are relatively low – particularly by proprietary drug standards – sales strategies and value messages suffer from the low-tech image associated with reconstitution devices.

 

The Competitive Landscape for Closed System Transfer Device Products

Although CSTDs do not guarantee 100% protection, they provide significantly more of it than without them. Many studies have been done to evaluate the use of a CSTD. These studies include assessing fluid and vapor leakage during preparation and administration, the impact of CSTDs on environmental contamination and personnel exposure, and the impact of CSTDs on workflow and staffing.

 

closed system transfer device

Source: Greystone from Published Sources

 

Material Selection Issues for Closed System Transfer Device Designs

In April 2015, the Institute for Safe Medication Practices (ISMP) and the FDA issued warnings that closed system transfer devices made out of polycarbonate plastic should not be used with chemotherapy agents containing the solvent N,N-dimethylacetamide. The ISMP cited bendamustine, amsacrine and busulfan as agents that when diluted with the solvent can melt or dissolve the polycarbonate plastic found in some CSTDs. Possible outcomes include spills and potential infusion of the dissolved plastic into the patient.

 

Oncology Drug Administration & Dosing

Balancing the benefits and risks of cancer therapies is critical in order to provide longer survival while maintaining or improving quality of life. For any drug dose, a range of beneficial and toxic effects can be anticipated that will vary based on the unique characteristics of each patient receiving the agent. An evaluation of recently approved oncology drugs reportedly demonstrated that many of these agents are labeled for use at doses that may be either too high or too low, at least for some patients.

For the clinician and caregiver at the point of care, this dynamic translates to variability in dosing and dose preparation. Variability in turn translates into complexity and higher risk of exposure. When every patient represents a unique drug preparation sequence, the probability of error increases. Because of the available infrastructure and experiential repetition, compounding antineoplastics in the pharmacy is considered a risk mitigating step that reduces the opportunity for error and accidental exposure.


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Closed System Drug Transfer Devices