In the pharmaceutical industry, pharmaceutical gelatin, as a key excipient, is widely used in a variety of pharmaceutical formulations, including capsules, tablet coatings, and suppositories. Its quality directly impacts the safety and efficacy of drugs. So, how is pharmaceutical gelatin manufactured? Let's delve deeper into the rigorous and complex manufacturing process.
Raw Material Selection and Pretreatment
The production of pharmaceutical gelatin begins with the selection of raw materials. The primary raw materials are animal skins and bones, such as cowhide and pighide, as well as cattle and pig bones. These raw materials must come from healthy, disease-free animals and meet strict hygiene and quality standards. After collection, the raw materials undergo pretreatment to remove impurities such as hair, fat, and residual meat scraps adhering to the surface. Animal skins are typically treated using either the lime or acid method. The lime method involves soaking the skin in lime milk. The alkaline environment breaks down and dissolves non-collagenous proteins in the skin, a process that typically takes several weeks. The acid method, on the other hand, uses an acid solution and is relatively quick. Animal bones are first mechanically crushed into smaller particles, then decalcified using dilute hydrochloric acid or other methods to dissolve the inorganic calcium salts in the bones, resulting in pure collagen, which paves the way for gelatin extraction.
Gelatin Extraction
After pretreatment, the raw materials enter the crucial gelatin extraction stage. The processed skin or decalcified bone is placed in an extraction device, an appropriate amount of water is added, and extraction is performed under certain temperature and pressure conditions. The temperature is generally controlled between 50 and 70°C, which promotes the conversion of collagen to gelatin while preventing degradation of the gelatin due to excessive temperatures. The extraction process is typically performed in multiple steps, and the quality and properties of the gelatin extracted will vary. The first extraction yields higher quality gelatin, while subsequent extractions gradually decrease in quality. After each extraction, the gelatin solution is separated from the solid residue by filtration, resulting in a relatively pure gelatin extract.
Concentration and Drying
The resulting gelatin solution is relatively low in concentration and requires concentration. A common concentration method is vacuum evaporation. Under vacuum, the boiling point of water is lowered, allowing it to evaporate rapidly at lower temperatures, thus preventing gelatin from deteriorating at high temperatures. After concentration, the gelatin solution's concentration is significantly increased, forming a viscous gelatin solution. The concentrated gelatin solution is then dried, primarily using spray drying and freeze drying. Spray drying involves spraying the gelatin solution into a mist, where the water evaporates rapidly in a stream of hot air, forming fine gelatin particles. Freeze drying involves freezing the gelatin solution into a solid state and then allowing the ice to sublime directly into a gaseous state under vacuum, resulting in a dried gelatin product. The dried gelatin exhibits excellent storage and usability.
Refining and Quality Inspection
The dried gelatin undergoes further refinement. Ion exchange and activated carbon adsorption are used to remove residual impurities, pigments, and odors, further enhancing its purity and quality. After refining, pharmaceutical gelatin undergoes rigorous quality inspections. Inspections include physical and chemical indicators (such as gel strength, freezing force, viscosity, and pH), microbiological indicators (total bacteria count, mold and yeast counts, and pathogenic bacteria such as E. coli), and heavy metal content. Only pharmaceutical gelatin that meets all indicators and relevant quality standards of the National Pharmacopoeia is approved for market entry and pharmaceutical production.
The production of pharmaceutical gelatin is a multi-step, high-standard process. From raw materials to finished product, every step is strictly controlled to ensure its safety and effectiveness, providing a reliable foundation for the development of the pharmaceutical industry.
In-depth Analysis of the Pharmaceutical Gelatin Market Prospects and Development Trends
As a core excipient in the pharmaceutical industry, the market structure and development trends of pharmaceutical gelatin have consistently resonated with the upgrading of the pharmaceutical industry. Driven by the rise of biopharmaceuticals, stricter regulatory policies, and accelerated technological innovation, the global pharmaceutical gelatin market is undergoing structural changes. This article combines industry data and policy developments to provide an in-depth analysis of its market prospects and development trends.
I. Market Status: Steady Expansion, China Becomes a Core Market
The pharmaceutical gelatin market has entered a period of steady growth, with China's position as a global production and consumption center becoming increasingly prominent. Data shows that China's pharmaceutical gelatin market size will be approximately RMB 1.56 billion in 2024 and is expected to exceed RMB 1.8 billion in 2025, a year-on-year increase of 15%. Long-term, the market is expected to continue expanding at a compound annual growth rate of 7.2% from 2025 to 2030, reaching a projected size of RMB 15.6 billion in 2030. Exports are also expected to climb to RMB 4.5 billion, demonstrating strong competitiveness in markets such as Southeast Asia and the Middle East. The market segments exhibit distinct structural characteristics: pharmaceutical-grade gelatin dominates, with a projected market share of 65% by 2030. Demand for high-value-added products such as hard capsule shells, enteric-coated capsule shells, and injectable excipients is growing fastest, exceeding 65% in the next five years. Food-grade and cosmetic-grade gelatin complement these segments, while medical-grade gelatin, driven by the development of biomedical materials, is becoming a new growth engine.
II. Core Drivers: Policy, Demand, and Technology Empowerment
1. Policy Regulation Strengthens Quality Thresholds
Strong policy regulation has established a "safety red line" for industry development while also accelerating market reshuffle. Following the implementation of the revised Drug Administration Law, quality standards for pharmaceutical excipients have been significantly tightened. Stringent regulations such as QB 2354-2005 "Pharmaceutical Gelatin" on protein content, heavy metal residues, and microbiological indicators have forced companies to increase R&D investment and upgrade equipment, leading to a continued increase in industry concentration. Furthermore, national support policies for the biopharmaceutical industry have provided a favorable policy environment for the expansion of pharmaceutical gelatin applications.
2. Downstream Demand Explodes in Multiple Areas
The escalating demand for pharmaceutical and healthcare products is the core driver of market growth:
In the biopharmaceutical sector, the large-scale production of vaccines and antibody drugs has significantly driven demand for injectable-grade gelatin. This high-purity gelatin, used as a stabilizer and matrix material, continues to create a widening market gap.
An aging society is driving the expansion of the health supplement market, and the application scenarios of pharmaceutical gelatin in functional foods are continuously expanding.
With the trend of pharmaceutical packaging upgrades, high-end products such as enteric-coated capsule shells are replacing traditional dosage forms, further unleashing demand for high-quality gelatin.
3. Technological Innovation Breaks Through Development Bottlenecks
Iterative upgrades in production technology are injecting new vitality into the industry. Traditional lime and acid processes are gradually being replaced by new technologies such as enzymatic hydrolysis and ultrafiltration, which not only increase production efficiency by over 30% but also reduce the risk of heavy metal residues. The widespread use of automated production lines and intelligent testing equipment has enabled comprehensive quality control from raw materials to finished products. The application of cutting-edge technologies such as nanotechnology and supercritical extraction has further expanded the application of pharmaceutical gelatin in high-end fields such as tissue engineering and drug delivery.
III. Development Trends: Raw Material Innovation and Green Manufacturing Go Hand in Hand
1. Diversification of Raw Material Structures
The long-standing focus on animal-derived raw materials, such as cowhide and pigskin, is changing. Driven by animal disease risks, environmental policies, and demand for vegetarian diets, plant-based gelatin has become a research and development hotspot, with its market share expected to gradually increase over the next five years. At the same time, raw material traceability systems are constantly improving, and high-quality, "traceable, disease-free" raw materials have become a core competitive advantage for companies, driving the industry towards standardization and regularization.
2. Green Production Becomes an Industry Consensus
Tightening environmental regulations are forcing companies to upgrade their production processes. The adoption of low-energy technologies such as vacuum evaporation and freeze-drying is increasing, and the application of wastewater treatment and solid waste recycling technologies has achieved emission and energy reductions. Green manufacturing not only demonstrates corporate social responsibility but also serves as a gateway to international market entry, driving China's pharmaceutical gelatin industry from a scale advantage to a quality advantage.
3. Dual Drive of High-End Product Development and Internationalization
High-end product development is the key to breaking through profit bottlenecks. Companies are increasing their R&D efforts in high-value-added products, with the market share of injectable-grade gelatin and customized excipients steadily increasing, gradually breaking their reliance on imports. International expansion is accelerating. While consolidating traditional markets like Southeast Asia, companies are actively exploring high-end markets in Europe and the United States through international certification and technical collaboration, promoting the upgrade of "Made in China" to "Made in China Intelligence."
IV. Challenges and Responses: Overcoming Development Challenges in the Context of Opportunities
The industry still faces multiple challenges: raw material price fluctuations impact cost control, increased environmental protection investment raises entry barriers, and international market competition is intensifying. To address this, companies need to build core competitiveness through "industry chain collaboration + technological innovation + brand building": expanding upstream to establish raw material bases to ensure stable supply; increasing R&D investment to overcome technical bottlenecks in plant-based gelatin and high-end medical gelatin; and enhancing brand influence through international certification and overseas collaboration.
Conclusion
The pharmaceutical gelatin industry is experiencing a golden period of development, fueled by favorable policies and market demand, and is expected to maintain steady growth over the next five years. Driven by raw material innovation, technological upgrades, and green manufacturing, the industry will gradually achieve high-quality development, and China is expected to further consolidate its core position in the global pharmaceutical gelatin industry. Only by grasping trends and focusing on innovation can companies seize the initiative in the fierce market competition.
Post time: Sep-24-2025