Director Zhang, the patient's blood pressure is 30/15mmHg and lactate is 6.8mmol/L. Rapid expansion is needed! ”In the alarm sound of the operating room monitor, the anesthesiologist's voice was urgent. The chief surgeon didn't lift his head and said, 'Push Sodium Lactate Green, give 1000ml first, monitor blood gas!'! ”This is a daily scene in emergency surgery at a tertiary hospital - as one of the most commonly used balanced salt solutions in clinical practice, the effect of Sodium Lactate Green Injection (hereinafter referred to as "Ruge Liquid") has long been deeply embedded in every key node of emergency and critical care.
--1、 Industry Overview 1 Definition and Category: According to the Classification and Code of Chemical Drug Injections (2023 edition) issued by the National Medical Products Administration, Sodium Lactate Green Injection belongs to the category of "electrolyte balance regulating drugs" (classification code: XJ05B). It is a compound electrolyte solution containing sodium lactate, sodium chloride, potassium chloride, and calcium chloride, with an osmotic pressure similar to plasma (about 273mOsm/L) and a pH value of 6.5-7.5. It can supplement body fluids, electrolytes, and regulate acid-base balance through lactate metabolism. Its core function is different from the single electrolyte supplementation of 0.9% sodium chloride injection (physiological saline), and it is more suitable for fluid supplementation in metabolic acidosis or those with acidosis tendencies.
The industry segmentation areas mainly include: ① Conventional preparations (standard specifications such as 500ml, 1000ml, etc.); ② Special packaging (such as multi chamber bags, soft bags); ③ Special population preparations (such as low concentration specifications for children). two The industrial chain structure of Ruge liquid follows the typical pharmaceutical industry logic of "raw materials formulation terminal": - Upstream: raw materials include sodium lactate (accounting for about 25% of the cost), sodium chloride (about 15%), potassium chloride (about 10%), calcium chloride (about 5%), and packaging materials (glass bottles/soft bags/PP bags, accounting for about 30%). Key raw material suppliers include Shandong Huihai Pharmaceutical (sodium lactate), China Salt Group (sodium chloride), Jiangsu Kelun Medical Plastic (soft bags), etc.

Midstream: Formulation production enterprises need to pass GMP certification and generic drug consistency evaluation. Leading enterprises include Kelun Pharmaceutical (32% market share), China Resources Shuanghe (21%), Otsuka Pharmaceutical (15%), Shisiyao Group (10%), etc.

-Downstream: Terminal coverage includes public medical institutions (75%), private hospitals (15%), retail pharmacies (5%), and emergency centers (5%).

---2. Market Status Analysis 1 According to the "2024 China Public Medical Institution Terminal Chemical Injection Market Report" by MiNet, the domestic milk gel liquid market reached 4.26 billion yuan in 2024, a year-on-year increase of 8.2% (compared to 2.87 billion yuan in 2020, with a compound annual growth rate of 9.8%). The main reasons for the growth are: ① an increase in the number of surgical operations (the national surgical volume will reach 68 million units in 2023, a year-on-year increase of 7%); ② Expansion of Emergency and Intensive Care Unit (ICU) capacity (by 2024, the number of ICU beds in second level and above hospitals will exceed 500000, an increase of 40% compared to 2020); ③ The demand for fluid replacement in primary healthcare institutions is increasing (the market size of county-level hospitals is growing by 12% annually).

2. Competitive landscape

Industry concentration is relatively high (CR5=83%), with significant advantages for top companies:

Enterprises
Kelun Pharmaceutical Co., Ltd., China Resources Shuanghe Otsuka Pharmaceutical Group, Shisiyao Group

Market share
32%, 21%, 15%, 10%

Core advantages
Full industry chain layout (raw materials+packaging materials+preparations), nationwide distribution network (covering 90% of tertiary hospitals), accumulation of original research technology (authorized by Japanese Otsuka patent), low-cost manufacturing (scale effect of Hebei production base)
The usage scenario is: Department distribution: Surgery (45%, especially general surgery and orthopedics), Emergency Department (25%), ICU (20%), Pediatrics (10%);

- Usage frequency: The daily average usage of 150-200 bags (500ml) in tertiary hospitals, 50-80 bags in secondary hospitals, and 10-20 bags in primary hospitals;
-Patient characteristics: Surgical patients (70%), severe diarrhea/burn patients (15%), sepsis patients (10%), and others (5%).
--3、 Technology and Trend Analysis 1 Core Technology Evolution
The core technology of Ruge Liquid focuses on "aseptic assurance" and "ingredient stability": - Aseptic filling technology: Domestic enterprises have upgraded from traditional glass bottles (contamination rate of 0.05%) to non PVC soft bags (contamination rate of 0.01%). Kelun Pharmaceutical's "Fully Automatic Blowing and Sealing (BFS)" technology, launched in 2023, reduces the contamination rate to 0.003%; -Osmotic pressure control: By precise proportioning (sodium lactate 3.10g/L, sodium chloride 6.00g/L, potassium chloride 0.30g/L, calcium chloride 0.20g/L), isotonic with plasma (error ± 2%) can be achieved. Otsuka Pharmaceutical's "dynamic titration technology" can reduce the error to ± 1%; -Consistency evaluation of generic drugs: As of 2024, 23 domestic enterprises have passed the evaluation (only 8 in 2020), and the compliance rate of key indicators (such as related substances and bacterial endotoxins) has increased from 85% to 98%. two Future trend prediction - policy driven: The National Health Commission's "Technical Operation Specification for Intravenous Infusion Treatment and Nursing (Revised in 2024)" clearly states that "balanced salt solution should be given priority". It is expected that by 2025, the proportion of milk grid solution in large infusion will increase from 18% in 2024 to 22% (only 12% in 2020); -Technological iteration: Multi chamber bag formulations (requiring temporary use of mixed sodium lactate and electrolytes) are expected to increase their market share from 5% to 15% by 2025 due to the reduction of compatibility contraindication risks (Otsuka and Kelun have already laid out); -Change in demand: With the increasing aging population (the proportion of people over 60 years old will reach 20% by 2025), the demand for perioperative fluid replacement continues to grow, and it is expected that the market size will reach 4.8 billion yuan by 2025 (an annual increase of 12.7%).

3. Emerging scenario analysis - emergency first aid extension: In 2024, the "China Severe Trauma Treatment Standards" recommended Ruge Liquid as the preferred fluid for hemorrhagic shock in trauma, promoting an increase in the number of emergency vehicles and community first aid stations (+30% in 2024 compared to 2023);
-Pediatric specific preparation: Wuhan Children's Hospital has collaborated with a pharmaceutical company to develop a "low sodium milk grid solution" (reducing sodium concentration by 10%). After pilot use in 2024, the incidence of hypernatremia in children has decreased from 8% to 3%;
-Tumor supportive therapy: Research has shown (Chinese Journal of Cancer, Issue 3, 2024) that Ruge liquid can improve metabolic acidosis in cancer patients after chemotherapy, and 500 cases have been enrolled in relevant clinical studies.
--4、 Challenge and Opportunity 1 Existing challenges - Fluctuations in raw material prices: Sodium lactate (accounting for 25% of formulation costs) is affected by corn prices (a 12% increase in corn prices in 2023 led to an 8% increase in sodium lactate costs), resulting in a decrease in the company's gross profit margin from 58% in 2022 to 52% in 2024;
-Pressure of medical insurance cost control: In the 2024 national medical insurance negotiations, the average price of Ruge liquid will be reduced by 15% (the winning bid price will decrease from 3.2 yuan/bag to 2.7 yuan/bag), and the annual profit of top enterprises will decrease by about 200-300 million yuan;
-Homogenized competition: Although CR5 has reached 83%, small and medium-sized manufacturers (such as a local pharmaceutical company) have seized the grassroots market through low price strategies (selling at 2.5 yuan/bag), resulting in a 2-3 percentage point decrease in the industry average profit margin. two Development opportunities - Accelerated import substitution: The market share of original research products (such as Otsuka "LeJia") has decreased from 25% in 2020 to 15% in 2024, and domestic generic drugs have rapidly replaced them due to their cost-effectiveness advantage (20% lower price);
-Grassroots market expansion: The policy of graded diagnosis and treatment promotes the improvement of the capacity of county-level hospitals (the number of tertiary hospitals in counties will reach 480 by 2024, an increase of 120% compared to 2020), and the annual increase in the use of breast milk gel solution at the grassroots level is 15%;
-Green Production Transformation: Kelun Pharmaceutical's "Low Carbon Soft Bag Production Line" (reducing energy consumption by 30%), which will be put into operation in 2023, has been certified as a "Green Factory" by the Ministry of Industry and Information Technology. Policy subsidies and cost advantages are driving the company to accelerate technological upgrades. ---V. Suggestions and Prospects 1 Enterprise Strategy Suggestions - Leading enterprises (such as Kelun and CR Shuanghe): Focus on multi chamber bags and BFS sterile preparations with high technical barriers, while also expanding into international markets (such as FDA 510 (k) certification, Kelun has exported 5 million bags to the United States by 2024);
-Small and medium-sized enterprises (such as local pharmaceutical companies): deeply cultivate the grassroots market, develop small-sized (250ml), low-priced products (priced at 2.3-2.5 yuan/bag), and improve coverage through the three-level distribution network of "hospital township health center village health room";
-Innovative enterprise: Exploring compound formulations of "Ruge liquid+functional ingredients" (such as adding magnesium ions and glucose), referencing the successful experience of Otsuka's "LeJia-G" (containing glucose) in Japan (with a market share of over 30% in Japan). two Investment risk warning - Technology substitution risk: New electrolyte solutions (such as sodium acetate Ringer's solution) may seize some of the market due to faster metabolism (acetic acid metabolism half-life of 2 minutes vs lactic acid of 15 minutes), with an expected substitution rate of about 5% by 2025, resulting in a reduction of 200-300 million yuan in the market size of the Ringer's solution;
-Policy change risk: If the medical insurance payment standards are further lowered (such as by another 10% in 2025), the gross profit margin of enterprises may fall below 50%, and small and medium-sized enterprises face the risk of exit (it is expected that the industry clearance rate will reach 10% by 2025);
-Raw material supply risk: The main raw material for sodium lactate, corn, is affected by extreme weather conditions (such as a 5% reduction in global corn production due to North American drought in 2023), and price fluctuations may expand to ± 15%. Companies need to establish raw material inventories for at least 3 months.
--This bag of liquid may seem ordinary, but it is a 'life supply line' for rescue. ”The director of the pharmacy department of a tertiary hospital expressed his feelings at the forum "Progress of Infusion Therapy in China". From the operating room to the emergency department, from tertiary hospitals to village clinics, the role and efficacy of Sodium Lactate Green Injection are continuously expanding with the upgrading of medical needs and technological iterations. In the future, with the deepening of domestic substitution, activation of grassroots markets, and the launch of innovative formulations, this niche field may usher in a more stable growth cycle.