The pharmaceutical injectables market is gaining more traction as vaccines and the development of biological drugs such as cell and gene therapies grow. Multiple new therapy areas have emerged and proliferated the sector in recent years due to new advanced parenteral modalities. From mRNA vaccines for Covid-19 to GLP-1 agonists for obesity alongside the cell and gene therapy revolution, the current landscape for injectables manufacturing is expansive.
Manufacturers are having to respond to keep up—and fast. “Injectables manufacturers are under intense pressure to establish and be able to quickly pivot within an increasingly sophisticated production capacity mix in ever-shorter timelines,” Christian Lavarreda, Global Product Manager at Syntegon, told Pharmaceutical Technology.
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Although biologics make up only a tiny fraction of all prescription drugs sold by volume, Lavarreda stated, they make up more than half of all revenue. “It is on these products where manufacturing is, by far, the most important strategically and adds the most value,” Lavarreda said.
During Covid-19, vaccinations became even more synonymous with preventative healthcare, laying the foundations for an increase in injectable drugs manufacturing. In the post-pandemic landscape, manufacturers are tapping into the drug method to respond to the globe’s ageing population and prevalence of chronic illnesses. Sterile injections are also receiving approval quicker compared to other drug types, which helps their growth.
“In today’s (bio-)pharma environment, particularly given the tightening cGMP regulations around aseptic processing, supply chain sophistication has become integral to meeting core time-to-market business objectives,” says Lavarreda.
In August 2023, the European Union’s (EU) new Annex 1 of the EU Good Manufacturing Practices (GMP) for producing sterile medicinal products entered the sector, placing more extensive requirements on manufacturers to ensure optimal sterile production processes.
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By GlobalData“Manufacturers that have invested accordingly in their operations and achieved this level of sophistication are doing very well, given the substantial new markets that the new therapy areas have opened,” Lavarreda says. “But those that haven’t are struggling to keep up,” adds Lavarreda.
Push for vaccination adoption
On 10 October 2024, the World Health Organization (WHO) said that more investment in vaccinations and the better use of vaccines could prevent deaths resulting from antimicrobial resistance (AMR), decrease antibiotic use and save on the costs required to treat resistant infections.
While some vaccines for 24 pathogens identified by the WHO are available, it stated many are underused. Increasing investment and education promoting their use could lower the amount of antibiotics required by almost a quarter (22%) or 2.5 billion defined daily doses globally annually. And that’s just the potential in the field of AMR.
Travelling through the regulatory approval system and getting to market as fast as possible also delivers big wins for manufacturers as well as public health. It enables them to offer flexibility, shorter delivery times and a more efficient route to profitability. Sped up regulatory processes also suggests significant opportunities for the industry, evolving beyond more familiar parenteral drug manufacturing.
Creating injectable systems
Today, manufacturers are drawing on the backdrop of calls for convenience, flexibility and efficiency by creating intuitive and comprehensive systems to manufacture injectable drugs.
Pharma packaging solutions and process technology company Syntegon developed a modular platform for small-volume parenteral (SVP) pharma processing systems. Syntegon uses fully standardised platforms designed from off-the-shelf functional modules. The pharma company chose modularisation on the basis that the manufacturing equipment’s functionality depends on the drug product type. Modularisation enables equipment to achieve both process flexibility and shorter delivery times.
The company adopts a prefabricated integrated cleanroom design with its peripheral technology sitting outside the cleanroom in a technical skid. Syntegon states the SVP is ideal for GMP-based manufacturing and is suitable for a wide range of aqueous solutions, suspension and emulsion products.
The core advantage of systems that manufacture parenteral drugs using a modular system is their ability to provide efficient flexibility with peace of mind. “When properly developed and fully integrated and automated, modular systems are highly efficient at providing full functionality for a range of products while facilitating compliance to the respective cGMPs,” said Lavarreda.
However, modularisation (which these systems are built on) can only be effectively leveraged if customisation is carefully managed and contained. Going from an engineer-to-order to a configure-to-order solution only improves efficiency while maintaining flexibility if the extent of customization required is limited.
“The main challenge, therefore, lies in correctly assessing, ahead of time, exactly where and how much customisation is really needed,” Lavarreda added.
Drug delivery decisions: beyond cost
“Driven by this unprecedented dynamism in the therapies space, leading pharmaceutical companies have long stopped seeing their supply chain organisations as mere cost centers,” said Lavarreda.
Increasingly, manufacturers recognise that to achieve maximum profitability in the new medicines they bring to market, considering both time and scale, they need to focus on the value they provide. “Manufacturing organisations need to be elevated to full strategic partners in today’s environment,” Lavarreda added.
To sustain its prominent position, the injectables market needs to retain its dynamism and ensure its speciality medicines remain the industry’s most significant drivers of revenue growth. This is particularly true for biologics, primarily formulated as parenteral.
The R&D process behind these systems requires appropriate subject matter expertise and systematic product development outside of the order fulfillment process. These skills are crucial for successfully implementing modular hardware or automation frameworks in off-the-shelf solutions.
In these systems, comprehensive functional module libraries covering the full spectrum of necessary functions for the application, are developed entirely before order intake. Each function comprises not just the design, but every aspect of the project, down to every single deliverable associated with that function. This includes drawings, technical documentation, automation code, testing protocols and commercial information to capture the entire process.
The next phase of injectables development
Catering to advancements in the control strategies required for efficiency and scalability is at the core of anticipating how these systems will evolve. Pharma companies are increasingly implementing modular hardware and automation solutions to modernise and add flexibility to their production capacities.
“This is because they facilitate the implementation of the kinds of advanced control strategies that are necessary for efficient scale-up via improved process characterisation and successful tech transfer,” Lavarreda noted.
“The availability and uptake of modular systems can only be expected to continue growing for an expanding set of advanced therapy applications,” Lavarreda shared.
