Drugdu.com expert's response:

Development Trends in the Complex Formulation Industry

I. Complex formulation processes will gain broader development opportunities

Formulation innovation can extend the lifecycle of new molecular entities while enhancing the safety, efficacy, and patient compliance of existing products, making it a focal point of pharmaceutical R&D. For instance, conventional leuprolide formulations have gradually been phased out, whereas leuprolide microspheres remain a first-line treatment for prostate cancer and uterine fibroids. In 2022, the market size of leuprolide microspheres in China reached approximately RMB 4.8 billion, with steady year-on-year growth.

China’s 14th Five-Year Plan for the Pharmaceutical Industry emphasizes the need to prioritize the development of complex formulation technologies for chemical drugs, including high-selectivity, long-acting controlled-release injectables (e.g., microspheres) and oral formulations such as controlled-release and multi-particulate systems. Enterprises mastering innovative complex formulation processes are poised to stand out and secure greater profit margins.

II. Significant potential for import substitution by domestic products

Core technologies for complex injectables, such as microspheres, have long been dominated by pharmaceutical manufacturers in developed countries, with limited domestic alternatives available. However, recent breakthroughs by Chinese developers have led to milestones such as the approval of generic bupivacaine liposome injections and the submission of marketing applications or ongoing bioequivalence (BE) trials for generic risperidone microspheres.

As China transitions from "proportional reimbursement" to "equal payment for generic names" in its healthcare insurance system, the implementation of pharmaceutical separation policies will discourage hospitals and physicians from prescribing high-priced original drugs. Assuming equivalent efficacy, domestically produced complex injectables are expected to replace imported counterparts through cost advantages, creating vast import substitution opportunities as more domestic products enter the market.

III. Accelerated upgrading and iteration of product dosage forms

Long-acting complex injectables are evolving toward longer durations of efficacy and reduced dosing frequencies. For example, Johnson & Johnson’s paliperidone palmitate long-acting injection has undergone iterations from monthly to three-monthly and six-monthly administrations, while aripiprazole and its prodrug-based long-acting injectables have progressed from four-week to six-week and two-month regimens. Such upgrades enhance clinical advantages, enable developers to maintain market share, and extend product lifecycle.
Additionally, new technological variants of complex injectables for the same active pharmaceutical ingredient (API) are emerging, potentially reshaping China’s market landscape. A case in point is the rapid market penetration of paclitaxel albumin-bound nanoparticles, which have displaced paclitaxel liposomes.

IV. Growing emphasis on pharmaceutical quality

Drug quality directly impacts patient safety, physical and mental well-being, national healthcare expenditure efficiency, and population health levels. Consequently, pharmaceutical industries worldwide are subject to stringent regulatory oversight. China has reinforced quality assurance through measures such as formulating relevant regulations, advancing consistency evaluations for generic drugs, and establishing standardized systems for pharmaceutical excipients and packaging materials, thereby improving market competition environments.

For pharmaceutical enterprises, competitive edge now hinges not only on process optimization, equipment upgrades, and regulatory compliance but also on the adoption of advanced quality management philosophies. Integrating quality control elements during early-stage drug development significantly influences subsequent quality control standards, costs, and operational efficiency.