Recently, a number of domestic pharmaceutical companies have successively announced that they have made key progress in the research and development of Riociguat raw material, which indicates that the localization process of this core raw material drug for treating pulmonary hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) has been accelerated. Insiders pointed out that with the approaching patent expiration window and the increasing demand for generic drug declaration in China, Riociguat API Powder market is welcoming a new round of development opportunities.
1. Technological breakthrough: optimization of synthesis process promotes industrialization.
Riociguat, as the first soluble guanylate cyclase (sGC) agonist, has become an important targeted drug in the treatment of pulmonary hypertension since it was approved for marketing in the United States in 2013. However, its raw material medicine synthesis process is complex and technical barriers are high, which has long been mainly mastered by Bayer Company, the original research enterprise. According to public information, Riociguat molecular structure contains multiple chiral centers and complex heterocyclic systems, and the synthetic route involves multiple key reactions, which requires extremely high intermediate purity and impurity control.
Recently, many domestic API enterprises have achieved technological breakthroughs through process innovation. A person in charge of research and development of a pharmaceutical company in Jiangsu revealed to reporters that the continuous flow microreaction technology route developed by his team has raised the total yield of key intermediates to over 65%, and the control level of related substances is better than ICH Q3A standard, and the purity of some batches of products has reached over 99.5%. The technology has passed the pilot test, and it is expected that large-scale production can be realized in the second half of 2026.
Another API company located in Shandong successfully reduced the discharge of three wastes by 30% through the transformation of green chemical process, and at the same time controlled the production cost at about 60% of the original research process. The person in charge of the company said that its products have passed the quality verification of many pharmaceutical companies, providing a stable supply of raw materials for the subsequent declaration of generic drugs.
2. Market driven: Dual benefits of patent expiration and demand growth
Market analysis shows that the growth of demand for raw materials of Riociguat is mainly driven by two factors. On the one hand, because Riociguat powder's core compound patent is about to expire, many domestic imitation enterprises have already laid out in advance, resulting in a substantial increase in the demand for raw material procurement. According to industry statistics, at present, more than 10 companies in China have submitted Riociguat imitation application materials, and it is expected that there will be a peak of imitation listing in 2027-2028.
On the other hand, the number of patients with pulmonary arterial hypertension continues to expand. According to the registration and research data of pulmonary arterial hypertension in China, the number of PAH and CTEPH patients has exceeded 80000, and about 5000 new confirmed cases are added every year. With the improvement of diagnostic technology and the coverage of medical insurance policies, the usage rate of Riociguat preparations has been increasing year by year. In 2023, the domestic market size has reached 120 million yuan, a year-on-year increase of 15%. As the upstream of the industrial chain, the demand for active pharmaceutical ingredients is growing synchronously.
It is worth noting that the Riociguat API market exhibits a clear "quality stratification" feature. GMP grade raw materials are mainly used for formulation production and have relatively high prices; Reagent grade products are used for scientific research and laboratory studies. The prices of products with different specifications and purity levels vary greatly, and the purchaser needs to choose according to the specific purpose.
3. Challenges and Opportunities: Balancing Supply Chain Security and Compliance Requirements
Despite the acceleration of localization, the Riociguat API industry still faces multiple challenges. Firstly, there are intellectual property barriers. The original research enterprise has implemented a patent portfolio strategy to provide comprehensive protection for key intermediates, crystal forms, formulation processes, etc. Domestic enterprises need to avoid patent risks during the replication process. Secondly, the GMP certification cycle is long, usually taking 24-36 months from process development to on-site inspection by drug regulatory authorities, which requires a high level of financial strength and technological accumulation from the enterprise.
In addition, environmental protection and safety production pressures cannot be ignored. The synthesis process of Riociguat API powder involves multiple organic solvents and metal catalysts, and the cost of treating the three wastes is relatively high. Recently, environmental policies in many regions have become stricter, and some small and medium-sized enterprises are facing production capacity limitations due to insufficient investment in environmental protection.
However, policy support also brings opportunities for industry development. The national "14th Five Year Plan" for the development of the pharmaceutical industry clearly proposes to enhance the core competitiveness of the active pharmaceutical ingredient industry and promote the localization of high-end active pharmaceutical ingredients and key intermediates. Some local governments provide tax incentives and financial support to API projects that meet GMP standards. At the same time, with the revision and implementation of the Drug Administration Law, the quality requirements for active pharmaceutical ingredients have become stricter, which is conducive to regulating market order and eliminating outdated production capacity.
4.Future Outlook: Domestic Substitution and Internationalization Parallel
Industry insiders predict that the next three years will be the key window for the localization of Riociguat APIs. With the maturity of technology and the release of production capacity, the market share of domestic APIs is expected to increase from less than 30% to more than 50%. Some enterprises with international certification capabilities have begun to lay out overseas markets. At present, some enterprises have passed the EDQM (European Drug Quality Administration) certification, and their products are exported to the European market, accounting for 28% of the total exports. In the long run, Riociguat API industry will show the development trend of "quality improvement, cost reduction and application expansion". On the one hand, with the process optimization and large-scale production, the cost of APIs is expected to be further reduced, providing space for the price reduction of generic drugs; On the other hand, the research on new indications and the development of combined medication schemes may bring new market growth points. In addition, the application of artificial intelligence assisted drug design and green synthesis technology will promote the transformation of the industry to high quality and sustainable development.
Why choose our Riociguat API powder?
Choosing our 98% purity Riociguat API Powder is mainly based on the comprehensive consideration of the following core advantages:
1. Advantages of quality system and compliance: Our company has passed GMP certification, has a complete quality document system (COA, MSDS, DMF/EDMF, etc.), the product purity is stable at ≥99.5%, and the impurity control is strict (single impurity is ≤0.5%, total impurity is ≤1.5%), which meets the standards of China Pharmacopoeia, USP, EP and other countries and can meet the declaration and export of preparations.
2. Technical process and stability guarantee: Our company adopts an optimized synthetic process route, with high yield of key intermediates and good stability between batches. The product can be valid for 24 months under the condition of sealed storage at 2-8℃, which reduces the risk of supply chain.
3. Supply capacity and cost competitiveness: we have large-scale production capacity, can provide stable supply from kilogram to ton, and the price is competitive among similar suppliers, and can provide ladder quotation according to the purchase volume to support long-term cooperation agreements.
4. Perfect service support system: We can provide complete technical documentation package, registration support, customized packaging specifications, timely technical response and after-sales support, and can cooperate with customers to complete key links such as process verification and stability research.
5. Market response and delivery efficiency: At present, our spot inventory is sufficient, the delivery cycle is short, and we support multiple logistics channels, which can quickly respond to urgent orders and reduce the risk of customer production interruption.
On the whole, Xi'an Faithful BioTech Co., Ltd Company has formed systematic advantages in terms of quality controllability, supply stability, cost-effectiveness and supporting services, and can provide your pharmaceutical enterprises with a full-cycle Riociguat raw material solution from R&D to commercial production, which is the core value of choosing our products.
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