The API industry has entered a new stage of development, presenting both opportunities and challenges for pharmaceutical equipment manufacturers.
Release Date:
2021-06-10 17:29
Active pharmaceutical ingredients, also known as APIs, are substances produced through chemical synthesis, plant extraction, or biotechnology; however, they cannot be administered directly to patients and typically require the addition of excipients and further processing before they can be formulated into finished dosage forms. Currently, China has emerged as one of the world’s major API markets. In recent years, accelerated reforms of China’s healthcare policies have led to a steady increase in the number of DMF registrations filed annually, while the scale of API exports has also expanded rapidly.
According to data from the National Bureau of Statistics, China’s output of active pharmaceutical ingredients (APIs) reached 2.769 million tonnes in 2019, representing a year-on-year increase of 20.2%; in 2020, API production totaled 2.734 million tonnes, up 2.7% from the previous year. In addition, the “In-Depth Research Report on China’s API Industry and Investment Prospects Forecast for 2020–2024” indicates that the size of China’s API market reached RMB 257.929 billion in 2019, a year-on-year growth of 6.4%.
Industry analysts believe that, over the medium to long term, China’s API market will continue to expand as API production capacity gradually shifts to the Asia-Pacific region and demand for APIs grows under centralized procurement. However, the domestic API industry still grapples with widespread issues such as fragmentation, disorder, and small-scale, unregulated operations, alongside persistent problems like cutthroat price competition, severe resource waste, and overcapacity. Against this backdrop, industry expectations are that the domestic API sector will soon enter a period of transformation and usher in a new phase of development. In this next stage, the industry anticipates that it will place even higher and more stringent demands on API companies regarding compliant operations and cost-control capabilities.
In fact, it is well known that the production of active pharmaceutical ingredients (APIs) frequently generates by-products such as wastewater, exhaust gases, and solid waste. In recent years, as the Chinese government has placed increasing emphasis on environmental protection, higher environmental standards have been imposed on the API industry. For instance, in 2018, the Environmental Protection Tax Law was officially implemented, and the introduction of the environmental protection tax, coupled with intensified environmental inspections and follow-up reviews, further increased pressure on API manufacturers. Nearly 70% of API producers were forced to suspend operations due to their inability to bear the substantial costs of compliance. Moreover, the issuance in 2019 of the Guiding Opinions on Promoting the Green Development of the API Industry accelerated the elimination of outdated production capacity and facilitated major industry consolidation.
Against this backdrop, industry experts believe that active pharmaceutical ingredients produced using environmentally friendly and green manufacturing processes will become a key priority for national industrial development. Consequently, the API manufacturing equipment sector is expected to benefit from increased growth opportunities, particularly as low-cost, high-efficiency, energy-saving, and eco-friendly pharmaceutical equipment sets new trends in API production.
According to available information, many domestic API equipment manufacturers have already been stepping up their efforts in the areas of environmental protection and energy conservation. For instance, one drying equipment manufacturer has continuously increased its R&D investment to develop API production equipment that is both environmentally friendly and energy-efficient. The company has established a dedicated environmental protection subsidiary along with a corresponding engineering testing center, and has defined core design principles for energy-saving, consumption-reducing, and eco-friendly products. Through these initiatives, it has actively pursued the R&D and production of green equipment, gradually achieving significant economic and social benefits.
Meanwhile, many other companies are integrating new technologies into the R&D and production of active pharmaceutical ingredient (API) equipment. For example, one company has developed a liquid-nitrogen freeze dryer that uses liquid nitrogen as a cold source to refrigerate the system; a novel sterilization process that leverages the existing vacuum system to convey gaseous water into the freeze-dryer pipelines for hydrogen-peroxide-based sterilization and disinfection; and a fully automated solid–liquid separation solution that reduces energy consumption, water usage, labor requirements, and wastewater treatment costs while increasing product recovery rates. In addition, another company has assembled an experienced technical team dedicated to heat-exchange equipment, with products designed to achieve energy savings and reduced resource consumption, thereby providing customers with effective solutions for cost reduction and efficiency improvement.
Overall, the latest technologies, equipment, and solutions being introduced by pharmaceutical equipment manufacturers are providing robust process support for API producers to achieve high-quality manufacturing. As the API industry enters a period of strong growth, the market for related API equipment is also expected to expand. However, it is important to note that opportunities are often accompanied by challenges. Therefore, while seizing these opportunities, API equipment companies must continuously adapt to evolving market needs and requirements, drive innovation in equipment and technology, and refine equipment design—in order to foster the sustained, higher-quality development of the innovative-drug API sector and deliver more and better services to customers.
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