When biopharmaceutical companies start development of a new parenteral product, their strategic manufacturing partners often encourage them to follow one key dictum: start with the end in mind.

Recently, however, the ends these companies must plan for have undergone considerable shifts. Major global medication trends are driving a sea change in the lifecycle goals that companies must plan for when developing a new parenteral product. Many of these trends are already leading to a major realignment of priorities for new drug products, including the way they need to evolve across their lifecycle.

While the potency and efficacy of the drug substance itself remain vital, shifting patient needs and expectations are now driving the need to further improve the patient-friendliness of every product attribute—in ways that not only support product efficacy, but also the safety, convenience, compliance, and market differentiation of new injectable products.   

Growing market, changing goals
Parenteral products are a major growth engine in today’s surging global biopharma market. Their share of the global market is expected to grow from 52% in 2019 ($604bn) to 55% in 2026 ($1,206bn), outpacing other routes of administration.¹ On average, more than 40% of the medications approved by the FDA are injectable, with subcutaneous and intramuscular products making up a growing percentage of those approvals.^2,3 

Even in this fast-growing market, though, successful new parenteral medications need more than a promising molecule and a validated therapeutic target. They need a clear, complete picture of the clinical, commercial, logistic, and operational factors that define the product’s pathway to success. Specified, agreed-upon market requirements, target product attributes, and commercial goals are as critical as the drug substance and its mechanism of action—not to mention the injectable delivery system that will be used to administer that new treatment.

Defining these parameters at the start has always been a critical first step in creating a truly integrated, efficient, and resilient drug development and manufacturing process. It’s an increasingly vital step today. Not because these critical success factors have changed—it’s as important as ever to define a product’s key attributes and requirements from the very beginning—but because many of the end goals have. The key features of the roadmap remain the same. But for many high-value parenteral medications, the potential destinations have shifted dramatically.

Market-shaping trends
A new injectable biopharma product that enters the pipeline today will launch into a market that’s evolving rapidly, in ways that are quickly redefining the typical use cases for new parenteral drugs and their delivery systems.

There are four major global trends that are driving this transformation: Chronic disease, development costs, at-home-care and COVID-19 (see Figure 1).

Chronic disease
Conditions like diabetes, heart disease, Alzheimer’s, and COPD are rapidly growing in both global prevalence and economic impact. As the incidence of these diseases continues to increase, the sustained, intensive treatment patients require will place increasingly significant demands on the resources of the global health system.

Development costs
Demand for specialized, targeted, and personalized treatments—as well as the complex processes and often much smaller batch sizes they require—continues to spike the level of investment needed to bring new treatments to market. As more and more sensitive, highly customized biologics enter the global pipeline, their biopharma owners are under growing pressure to optimize costs and shorten timelines wherever possible.

At-home care
One major cost-saving strategy has become increasingly important: shifting patient care out of resource-intensive clinical settings and into patients’ homes. At-home care lightens provider workloads, reduces demand for expensive clinical services, and offers greater convenience for patients and caregivers. Not surprisingly, many biopharma companies have begun to proactively target this valuable use case in their product development strategies.

COVID-19
All of these trends have been accelerated by the global pandemic. Flooded by COVID cases, many thinly stretched health systems are now ever-more focused on remotely managing as many conditions as possible—while patients themselves are increasingly eager to stay home as much as possible. Both the challenges and opportunities produced by this shift are further increasing the pressure on biopharma companies to not only launch new treatments faster and more efficiently than ever, but also enhance those new products with features that make self-administered treatment as safe, effective, and convenient as possible. 

Together, these trends are shaping a transformative new reality for the biopharma market. The target profile for tomorrow’s high value injectable has changed: from an efficacious molecule with a familiar, go-to injection method, to a complex, customized treatment with a delivery system optimized for convenient, long-term self-delivery at home.

Delivery innovations for changing demands
For today’s injectable drug owners, “starting with the end in mind” no longer means simply planning for a successful initial commercial launch. Today’s market is thirsty for products that not only deliver therapeutic benefits, but that are also designed to provide an easy, safe, adherence-supporting delivery experience. To create such a product, drug owners need to think far beyond the molecule, its therapeutic target, and launch configuration. New injectables now need to hit the market with a full-lifecycle development plan to continually enhance the product’s convenience and patient-friendliness.

One key to that ongoing enhancement is often the product’s packaging and delivery system. Today’s drug development plans can already factor in a rapidly growing range of innovations in these areas. Several of these products have already shown that they can deliver significant value-adding differentiation of a parenteral product’s user experience:

Prefilled syringes
Prefilled syringes are a user-friendly option that makes it easy and safe to deliver each dose—a significant differentiating value. Drug products in this ready-to-inject format offer patients a simple, comfortable administration process with predefined volumes, often also resulting in improved compliance.

Pens and autoinjectors
Convenient, compact, and easy to handle, these secondary packaging innovations can be a useful way to facilitate long-term self-administration – especially for patients whose condition may compromise their physical dexterity.

Wearables
Numerous treatments that require a specific, uniform amount of medication can be delivered via innovative clip- and stick-on parenteral delivery systems. These convenient devices enable consistent dosing of large product volumes, while also fitting discretely into a patients’ outfit and lifestyle.

Connected smart devices
Pharma 4.0 is driving the convergence of injection systems and information systems, including a new generation of connected autoinjectors, infusion pumps, and other drug delivery technologies that combine personalized dosing with data capture and reporting capabilities. These delivery systems not only simplify dosing, but also offer providers and patients a new level of digital visibility and insight into each course of treatment. 

These diverse innovations have a common benefit. They’re designed to make long-term injectable treatments simpler, more convenient, and more manageable for the patients who need them, and who are likely to be administering their treatment themselves. As global trends continue to accelerate the shift toward products optimized for patient-friendliness, we anticipate that innovations like these will play an increasingly important goal in product lifecycle plans developed for new injectables. A successful launch in a vial may only be a first step, one that may often be followed by many future evolutions designed to optimize patients’ administration experience.   

Increasing value of strategic partners
New parenteral products can factor a variety of different delivery innovations into the product’s lifecycle. But while these solutions can contribute significant value to a product’s market profile, they also add another dimension that’s equally important to consider and solve: production complexity. 

The global shift toward patient-friendly delivery systems has increased the level of manufacturing sophistication required to sustain the continual evolution of a product’s market profile. A high-quality fill-and-finish plan is only one step in the production of a high-value parenteral product. The same development plan must now also show a clear pathway to several different evolutions of the product’s secondary packaging, each with its own regulatory requirements, quality standards, and manufacturing specifications.

For biopharma companies and their injectable products, this new paradigm means that the right strategic production partners are now more valuable than ever. Today’s clinical and commercial teams need far more than a service provider who can handle drug product manufacturing. They need production experts who can provide multifaceted technical expertise, solution customization, and market foresight—not just prior to and at launch, but across the product lifecycle. These vital partners will not simply encourage biopharma companies to start with the end in mind. They’ll be there to help those companies navigate the continuing, dynamic evolution of those ends, as patient needs and market drivers continue to reshape the highest-value goals for new injectable products.

Summary
A new generation of high-value injectable products is already taking shape in response to major concurrent trends in the global biopharma market. These products not only deliver safe, efficacious, long-term treatment, but are also setting new standards for safe, accurate, convenient self-administration.

These advanced injectables will create both new opportunities and new challenges for their owners. As chronic conditions become more prevalent and patient care increasingly shifts from the clinic to the home, meeting the needs of this changing market will require drug owners to deliver new injectable products that combine both clinical efficacy and differentiating administration experiences. It’s time for biopharma companies to factor this significant added complexity into their product development plans. The first step: finding the right development and manufacturing partners. Ones with proven experience in putting new injectables on a path to success from the start. 

References

1. Global Data Sales Analytics, 24 June 2020
2. FDA.gov
3. ibid

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Peter Soelkner has been a Managing Director of Vetter Pharma-Fertigung GmbH & Co. KG since June 2008. In 2009, he was also appointed Managing Director of Vetter Pharma International GmbH, the company’s marketing and sales organization. Soelkner graduated from the University of Dortmund, Germany, in 1992 with a degree in chemical engineering and earned an MBA from Columbia University, New York, in 2001. Before joining Vetter, he held positions in Germany and North America at Sartorius AG and Sartorius North America Inc., in R&D, marketing, key account management, and general management roles. At Vetter, from 2003 to 2007, Soelkner managed the company’s key account program and global end-to-end supply chain. He left the company for a year to serve as Vice President of global key account management at Sartorius Stedim Biotech (USA) before returning to Vetter in 2008.