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Pharma trends translate into increased need for not only external partners, but those will capabilities that can help advance today’s drug development and manufacturing challenges.
There is growing demand for “CDMOs” in both pharmaceutical product development and manufacturing. Several major trends are driving this growing demand-small and specialty companies with limited infrastructure are playing a bigger role in innovation and early stage product pipelines. Big and mid-sized Pharma continue to tighten their focus on core discovery and commercialization activities, and thereby align with external partners to advance their promising compounds. Patient-centric and more specialized medicines are driving the need for more complex formulation and processing capabilities. These trends translate into increased need for not only external partners, but those will capabilities that can help advance today’s drug development and manufacturing challenges.
Outsourcing continues to be an important aspect of drug development and manufacturing. This year (2017) was marked by major acquisitions involving huge transactions in billions of dollars, such as Lonza’s acquisition of Capsugel and the acquisition of Patheon by Thermo Fischer Scientific. A notable trend is the expansion of CDMOs to become full-service providers that offer end-to-end capabilities. While Big Pharma remains the least penetrated, with only 20% of their new drug applications (NDAs) being outsourced, most small companies are already outsourcing 80% of their activities, said Jim Miller, president of PharmSource, a GlobalData company, in his presentation at the 2017 CPhI Preconnect Congress (1).
“Business models are changing,” says Christian Dowdeswell, senior director of commercial development at Lonza, who notes a change in client base in pharma. “Small specialty companies are increasing in numbers, and they need a development and manufacturing partner, especially given the increasing complexity of molecules with solubility and bioavailability challenges as well as APIs that are highly potent. These molecules require specialized formulations, but drug development needs to be phase appropriate.”
“It is crucial to start with understanding the molecule and what the target profile is,” explains Jim Coward, global head, market development, Bio/Pharmaceuticals, Lonza. “Designing appropriate feasibility studies requires depth in technology in order to develop a formulation that is fit for purpose.” Time to market is a crucial factor, but Coward points out that speed is not just about getting it fast. “The goal is to achieve optimal design, so that you reduce the need for rework,” he says.
Coward observes that the oral solid-dosage form market continues to grow, specifically, the multiparticulates because they offer flexibility for the different populations, such as paediatrics and geriatrics. “There is a demand for more patient-centric formulations, and multiparticulates are advantageous as they can be developed into fixed-dose combinations, or designed to have controlled-release profiles. You can also do drug layering or taste masking,” he adds. Coward notes that existing molecules are also being reformulated for new indications and to offer convenience. “Repositioning existing molecules using the FDA NDA 505(b)2 pathway or equilavent in Europe makes up approximately 40% of approvals,” he says.
According to Miller, the contract manufacturing space continues to see strong performance in 2017, with APIs leading the way, driven by the high-value products and broad outsourcing activities (1). For Saneca Pharma, business is growing in the opiate division, says Anthony Sheehan, chief executive officer of the Slovakia-based CDMO. Saneca currently manufactures 15 opiate API products under cGMP. “We are looking to launch new drug master files (DMFs) and certificates of suitability (CEPs) in the near future,” Sheehan told Pharmaceutical Technology.
Saneca is also moving into custom synthesis of APIs, driven by the growth in the company’s API business. “API manufacturing is moving back to Europe from Asia,” Sheehan observes. “Eastern Europe, in particular, is a growing market.” He adds that Saneca is also expanding its finished dosage forms development services, starting with non-sterile liquids. “What we notice is that customers want regulatory support and support with tech transfer,” says Sheehan. “Tech transfer can be a challenge, especially with old products, which in some cases, may have to be reformulated, or perhaps the process has to be optimized.”