Emerging CRO Aisulai Secures Over 100 Clients Including Novartis and Roche Within First Year of Operation, Files IPO Prospectus

The CRO markets in Europe and the United States had already matured by the 1990s. According to Frost & Sullivan’s statistics and forecasts, the global CRO market size is projected to reach $95.2 billion by 2023. In the 21st century, with the global expansion of CRO giants and the rise of economy and technology in Asia, the CRO industry has gradually shifted toward Asia.

China, South Korea, Singapore, India, and other countries are experiencing a rapid rise in their pharmaceutical industries, with R&D expenditures growing swiftly. China enjoys a cost advantage, as its research expenses across all stages of preclinical and clinical trials amount to only 30% to 60% of those in developed countries.

According to Frost & Sullivan data, the size of China’s CRO market grew from $2.1 billion in 2014 to $5.9 billion in 2018, representing a compound annual growth rate (CAGR) of 29.2% from 2014 to 2018. The market is projected to reach $21.4 billion by 2023.

Global and China CRO Market Size

(Image source: Sun Pharma’s prospectus; data source: Frost & Sullivan; unit: billion USD)

Against the backdrop of rapid industry development, a number of multinational and large domestic CRO companies have emerged in China’s CRO market.

Large multinational CRO companies or their domestic branches, which possess strong R&D capabilities and substantial financial resources, offer services covering both preclinical and clinical trial research. Examples include Parexel, IQVIA, Covance, and WuXi AppTec. Domestic CRO companies are represented by firms such as ChemPartner, Pharmaron, and Joinn Laboratories, which primarily focus on preclinical CRO services, as well as Tigermed and Boji Medicine, which mainly provide clinical CRO services.

Amidst a赛道 crowded with industry giants, how can domestic startups carve out a niche in this vast market?

Large enterprises typically offer broad and comprehensive services, covering not only CRO operations but also expanding into CDMO businesses. Their scope essentially encompasses the entire suite of preclinical processes, characterized by substantial market capitalization and production capacity, as well as rapid growth. In this context, startups can focus on a specific niche, achieving specialized expertise within a particular CRO segment, and then expand their industrial footprint based on this foundation.

Emerging CRO Jiangsu Aisulai Biotechnology Co., Ltd. (hereinafter referred to as “Aisulai”) has prioritized quality research in its development strategy, delivering impressive results: “Our laboratory officially commenced operations in early 2021. Over the subsequent year, we have served more than 100 clients, including major domestic and international companies such as Novartis, Roche, Baxter Healthcare, Borui Medicine, Taizhou Dongyao Pharmaceutical, and Kelun Group,” Dr. Zhang Yi, Chief Scientist at Aisulai, told VCBeat News.

Aisulai has achieved such rapid growth since the commencement of its operations for three reasons.

First, in terms of hardware facilities and supporting systems.Aisulai is a compliant pharmaceutical quality and safety laboratory accredited by CMA/CNAS (ISO/IEC 17025), operated in accordance with cGMP guidelines, and certified with GMP Compliance Certification issued by the Suzhou Pharmaceutical Association. Currently, Aisulai has an analytical laboratory area of 5,600 m² and stability sample storage space of 3,600 m³. The company owns instruments and equipment valued at RMB 70 million, including 18 sets of high-end biomedical research instruments each worth over RMB 1 million, such as the QE HF-X, QE Plus, Biacore T200, and microCal DSC. These instruments cover all aspects of quality research.

Secondly, in terms of team building.Jiangsu Aisulai Biotechnology Co., Ltd. boasts three specialized teams in quality, project management, and science. The quality team members include former authorized signatories for renowned third-party laboratories and QA professionals from well-known European and American pharmaceutical companies, possessing extensive experience in CDE/FDA regulatory submissions and on-site inspections by the FDA/EMA. The head of project management brings 15 years of industry experience, having overseen more than 50 CDE/FDA registration projects and managed over 10 urgent deficiency response projects. The core members of the scientific team have previously worked for globally recognized pharmaceutical companies, with over a decade of research experience in their respective fields. They demonstrate strong R&D capabilities and extensive instrument operation expertise in stability studies, impurity profiling, packaging material compatibility studies, degradation impurities, genotoxic impurities, and impurity preparation and purification.

Most importantly, since its inception, Jiangsu Aisulai Biotechnology Co., Ltd. has targeted a niche with substantial demand and limited domestic competition.Dr. Zhang Yi stated, “Aisulai primarily focuses on quality analysis in the biopharmaceutical sector, including quality research, impurity studies, and stability testing of biologics. Among these, stability testing is Aisulai’s distinctive specialty. Market research indicates that CRO services for drug stability studies and storage are well-established in Europe, the United States, and Japan, with a market size of approximately USD 1 billion.”

“In China, many pharmaceutical companies choose to build their own stability chambers for related research and storage. There are three disadvantages to pharmaceutical companies independently constructing such systems: first, the high cost; second, the need for corresponding supporting equipment and personnel for regular validation and maintenance; and third, if a company has few samples, building a stability system results in significant resource waste. Recognizing these pain points, Jiangsu Aisulai Biotechnology Co., Ltd. invested over 20 million yuan in developing its stability program, creating the largest stability sample storage facility in China, with a total volume of 3,600 cubic meters, and plans to further expand its capacity.”

The team, equipment, and systems have provided the foundation and momentum for Aisulai’s rapid development, while its strategic positioning in blue-ocean markets has offered ample space for its swift growth.

Based on the aforementioned foundation, Aisulai has currently established eight service sectors centered on drug quality research.

1. Stability Study Services.Stability studies are a signature service offering and a key business segment of Jiangsu Aisulai Biotechnology Co., Ltd. (Aisulai). Guided by ICH, WHO, and ChP guidelines, Aisulai adheres to the concept of “compliant shared storage spaces for stability studies” and has established the largest stability storage facility in China. Equipped with first-tier stability chambers from Weiss and Espec, along with an RMS online temperature and humidity monitoring system, Aisulai provides domestic and international clients with high-quality, highly secure, and cost-effective stability storage and research services.

2. Quality Research and Characterization Analysis Services for Biologics.This business segment is led by Dr. Zhang Yi, Chief Scientist at Aisulai, who brings over 10 years of experience in the field of macromolecule project research. Leveraging its CMA and CNAS accreditations, Aisulai operates in strict compliance with the cGMP quality system, enabling it to conduct stability studies for biologics, microbiological testing, and more, thereby providing customers with “one-stop” quality research services for biological drugs.

“One-Stop” Quality Research Services for Biologics

3. Impurity Research Services.In accordance with relevant regulations from the NMPA, ICH, FDA, EMA, and WHO, Jiangsu Aisulai Biotechnology Co., Ltd. is capable of conducting studies on genotoxic impurities, elemental impurities, ionic impurities, ordinary impurities, specific impurities, and unknown impurities. To date, the company has undertaken more than 20 impurity research projects and over 10 urgent deficiency response projects.

Based on the three key areas mentioned above, Jiangsu Aisulai Biotechnology Co., Ltd. has gradually established service offerings for microbiological research and testing, raw material and excipient testing, physical and chemical testing and transportation testing of packaging materials, and packaging compatibility (seal integrity) studies. Furthermore, in response to market demand, the company has expanded its services to include testing of GMP utility systems.In accordance with GMP, ChP, USP, EP, and other relevant regulations, Jiangsu Aisulai Biotechnology Co., Ltd. can perform GMP utility system testing for cleanrooms/laboratories, purified water/water for injection/steam systems, and compressed air/nitrogen systems. The company can develop validation protocols and plans based on customer URS (User Requirement Specifications) and execute PQ (Performance Qualification).

Dr. Zhang Yi told VCBeat New Medicine: “Aisulai is based in Suzhou, which inherently provides a geographical advantage. In recent years, Suzhou’s biopharmaceutical industry has developed rapidly, with new pharmaceutical manufacturing facilities continuously rising from the ground. To be applied to product research and development and production in the pharmaceutical field, these facilities must undergo rigorous GMP utility system testing. In response to market demand, Aisulai has rapidly deployed its strategic layout in this area.”

Based on its eight core service modules, Jiangsu Aisulai Biotechnology Co., Ltd. is committed to providing comprehensively optimized research and testing services for innovative R&D and manufacturing enterprises in the pharmaceutical industry. The research and testing services provided by Aisulai are strictly implemented in accordance with client requirements, adhering to current standard methods such as ICH, FDA, ChP, USP, EP, JP, ISO, GB, and YBB. The resulting data and reports are suitable for new drug applications in China and globally.

When discussing Aisulai’s current development and future plans, Dr. Zhang Yi stated, “This year marks the first year of Aisulai’s official commercial operations. We will fully leverage our geographical advantages in Suzhou to gradually expand our quality research services across China and globally. While supporting the safe development of every drug, Aisulai will continue to advance at a rapid pace.”

With a clear objective in place, all that is needed is the passage of time. We look forward to Aisulai emerging as a premier pharmaceutical quality analysis laboratory, validated by time, and contributing to the development of safe medications for the pharmaceutical industry.