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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.


For Additional Information:

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.


For More Information:

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.


For More Information:

Closed System Drug Transfer Devices

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Biosimilars Slow to Crack the Erythropoiesis Stimulating Protein Market

Each year, an estimated 1.2 million cancer patients undergo cytotoxic chemotherapy in the United States alone; and approximately 800,000 (67%) will become anemic. Hematopoietic agents stimulate the bone marrow to increase the production of red blood cells and have been shown to result in a clinically significant improvement of anemia associated with chemotherapy.

Neutropenia is a major indication for erythropoiesis stimulating protein market (ESP). Neutropenia is a decrease in circulating neutrophils in the peripheral blood. The absolute neutrophil count (ANC) defines neutropenia. ANC is found by multiplying the percentage of bands and neutrophils on a differential by the total white blood cell count. An abnormal ANC is fewer than 1500 cells per mm3. African Americans have a lower normal ANC value of 1000 cells per mm3 but have a normal total neutrophil content. The severity of neutropenia is categorized as mild with an ANC of 1000-1500 cells per mm3, moderate with an ANC of 500-1000 cells per mm3, and severe with an ANC of fewer than 500 cells per mm3. The risk of bacterial infection is related to the severity and duration of neutropenia. Recurrent infections typically occur with neutropenia, but neutropenia per se is not necessarily a disease.

In 2007, five biosimilar ESPs were approved by the EU EMA.  In spite of these competitors, this market continues to be dominated by established protein drugs.  In 2015, the total global revenue for this class of recombinant proteins was $5.6 billion (ex-manufacturer basis). But eight years after EMA approval, the five biosimilars (Abseamed, Binocrit, Epoetin Alfa Hexal, Retacrit, Silapo), accounted for only $385 million of the market (6.8 percent).

Erythropoiesis Stimulating Protein Market

.Source: Greystone Research Associates

Biosimilar uptake has to date been highly country-specific. This indicates that at least two factors are at play. The first is country-to-country regulatory variability and the element of risk this represents for practitioners. The second is traditional physician-patient relationships, particularly when the condition is potentially life threatening and the biological therapeutic is known to have significant side effects.

Going forward, we expect ESP biosimilar uptake to continue to trail expectations due to the difficulty of prescribers to reach an adequate level of confidence in prescribing an alternate version of a powerful drug.

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The EU Market for Therapeutic Protein Manufacturing

From a geographic perspective, the European Union (EU) s a highly diverse and heterogeneous market for recombinant protein manufacturing. As the EU continues to outpace the US in terms of the type and number of biosimilars that have received marketing authorization, the increasing activity surrounding biosimilars is having a secondary effect on the EU recombinant protein ecosystem.

As is the case in the U.S. the majority of suppliers in the region are captive – divisions, subsidiaries or business units of the labeling company. Not surprisingly, smaller labelers are most likely to contract for protein manufacturing services outside their own organization.

Top Level EU Recombinant Protein Manufacturers

Recombinant Protein Manufacturing

 

Activity in biosimilars is also allowing selected companies who have several proteins in their manufacturing portfolio to enhance their manufacturing resumes. Since the shortest path to biosimilar approval lies in outsourcing not only the functional activity, but the knowledge base and existing art as well, biosimilar labelers in Europe are most often contacting with contact manufacturers with previous clients for the same API.

API Suppliers to Recombinant Protein Manufacturers in the EU

Therapeutic Protein Manufacturing

 

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The Growth of Recombinant Enzymes

The quiet growth of recombinant enzymes is a success story that has yet to be widely recognized. Taken in the aggregate, this drug class has become an important segment within the biotech sector.

Recombinant enzymes span several therapeutic segments, including fibrinolytics, antineoplastics, acid α-glucosidase deficiency, and even one (Jetrea) that acts as an adhesion inhibitor. But the majority of recombinant enzymes are approved for indications that can be grouped under the heading of enzyme therapy and which are indicated for orphan diseases.

There are currently 10 recombinant enzymes in the enzyme therapy class that have received marketing authorization from the FDA and/or the EMA – 13 if drug products approved with identical trade names are considered separately (Elaprase, Naglazyme, Strensiq). These drugs had  total revenue of $3.2 billion on an ex-manufacturer basis in 2015.

Enzyme Therapy – Recombinant Enzymes Global Revenue (2015)

enzyme-pie-2015-revenue

 

The supply chain for these drugs is diverse and global. Not surprisingly, the top level supply chain (e.g., API manufacturing and final manufacturing) is most often comprised of captive suppliers – divisions or subsidiaries of the labeler. Notable exceptions are for smaller labelers who have contracted with recombinant drug manufacturers with significant experience.

Recombinant Enzymes Indicated for Orphan Diseases – Top Level Supply Chain

Enzyme therapy recombinant enzyme suppliers

Source: Recombinant Drug Market SourceFile (Greystone Research Associates)

Looking ahead, we expect recombinant enzymes that target orphan diseases to continue to proliferate, as market participants take advantage of the market opportunities associated with this class of indications.

AUTHOR’S NOTE: This data was taken from the Recombinant Drug Market SourceFile, a user-interactive information resource created and made available by Greystone Research Associates. For more information, please visit greystoneassociates.org