DiaSorin Files IPO Prospectus Amid Dominance in TORCH Testing with Over 80% Market Share and Intensifying Competition with Chinese IVD Leaders

Currently, 80% of clinical disease diagnoses rely on in vitro diagnosis (IVD), known as the "eyes of physicians."

In Vitro Diagnostics (IVD) refers to products and services that obtain clinical diagnostic information by testing human samples (such as blood, body fluids, and tissues) outside the human body, thereby enabling the assessment of diseases or physiological functions. In China, the IVD industry is primarily segmented into three areas: biochemical diagnostics, immunodiagnostics, and molecular diagnostics. Among these, biochemical and immunodiagnostics constitute the market mainstream, collectively accounting for 60% of the market share. However, data indicates that the application field of molecular diagnostics is experiencing rapid growth. It has become the fastest-growing subsector of the global IVD industry, with significant market demand that cannot be overlooked.

Traditional multinational giants such as Roche, Siemens, Abbott, and Thermo Fisher are the major players in China’s in vitro diagnostics (IVD) market. Among them, DiaSorin has maintained its dominant position in certain niche segments of the IVD field, leveraging its unique test offerings in areas such as infectious diseases and bone metabolism.

DiaSorin was founded in Italy in 1968 and is one of the global leaders in the in vitro diagnostics market, primarily producing and selling in vitro diagnostic kits for immunoassay and molecular diagnostics to hospitals and private laboratories. In 2007, DiaSorin was listed on the Italian Stock Exchange (Borsa Italiana S.p.A.) and is a constituent of the FTSE Italia Mid Cap Index.

Today, DiaSorin, now over fifty years old, has accumulated extensive R&D expertise in the biomedical field. Its radioimmunoassay and enzyme immunoassay technologies enjoy high recognition across Europe and worldwide. Currently, DiaSorin operates six manufacturing plants, five research laboratories, and 27 subsidiaries, with a sales network spanning more than 100 countries and regions globally.

How Did DiaSorin Step by Step Become a Leader in the In Vitro Diagnostics Field? We May Glimpse the Answer from Its Development History.

DiaSorin’s history dates back to 1968, when it was merely an in vitro diagnostics division of Sorin Biomedica S.p.A. Two years later, DiaSorin successfully developed two products: RIA (Radioimmunoassay) and ELISA (Enzyme-Linked Immunosorbent Assay). Over the next three decades, the DiaSorin division continuously expanded into countries and regions outside Italy through acquisitions or by leveraging Sorin Biomedica S.p.A.’s partnerships.

In 1997, Sorin Biomedica S.p.A. decided to transfer all of its in vitro diagnostics-related businesses to Standard Diagnostics, Inc. in the United States, in order to refocus its operations on the field of cardiology.

Three years later, American Standard Companies adjusted its business strategy and decided to divest its healthcare assets. Senior executives of the division, including Gustavo Denegri, the current Chairman of DiaSorin, and Carlo Rosa, the current Chief Executive Officer, purchased all shares of DiaSorin from American Standard. After undergoing various twists and turns, DiaSorin S.p.A. finally achieved independence.

Following its independence, DiaSorin began to gain momentum. Through a series of acquisitions, the company rapidly expanded its product portfolio and scale.

In 2002, DiaSorin acquired BYC Sangtec, obtaining the rights to LIAISON, the DiaSorin Group’s first chemiluminescent immunoassay (CLIA) immunodiagnostic platform, and began transitioning tests developed using existing enzyme-linked immunosorbent assay (ELISA) technology to the latest automated CLIA format. During this phase, DiaSorin established the LIAISON brand with the intention of shifting towards CLIA. From 2007 to 2010, DiaSorin explored the potential of molecular diagnostics through various acquisitions and collaborations.

On July 19, 2007, DiaSorin successfully completed its initial public offering (IPO) in Italy. Three years later, DiaSorin was elevated to blue-chip status.

Meanwhile, DiaSorin has also entered into a non-exclusive licensing agreement with Eiken Chemical to utilize LAMP (Loop-mediated Isothermal Amplification) technology. This will enable DiaSorin to conduct global production and market testing, thereby entering the molecular diagnostics market. DiaSorin aims to leverage LAMP technology to develop an instrument platform capable of automating molecular diagnostic tests by 2011.

In 2008, after acquiring Biotrin and its parvovirus testing products, DiaSorin promptly paid Abbott $58 million to secure ownership of the Murex line of diagnostic products for HIV, HCV, and HBV.

DiaSorin stated that the addition of the Murex product line would help “add new depth to its product portfolio.” The company added, “This acquisition further strengthens DiaSorin’s leadership in the field of infectious diseases and opens the door to attractive growth opportunities in the future.”

In 2011, to launch the LIAISON XL platform, DiaSorin entered into multiple agreements, including an agreement with Precision System Science to develop molecular diagnostic analyzers for LAMP, and a renewed distribution agreement with Cardinal Health for the U.S. market.

In 2012, DiaSorin entered the Indian market, where the in vitro diagnostics sector was valued at approximately $500 million and the molecular diagnostics segment at around $165 million, by establishing a joint venture with Trivitron Healthcare called DiaSorin Trivitron Healthcare Private Limited. It also became the first company to introduce a CLIA (chemiluminescent immunoassay) platform in India.

In the same year, Biotrin, a subsidiary of DiaSorin, acquired the molecular business unit of NorDiag ASA, which included technologies related to nucleic acid (including DNA) extraction for molecular diagnostic applications, and officially launched the LIAISON IXT and LIAISON IAM molecular diagnostic systems.

In 2013, DiaSorin seized the momentum and reached an agreement with Roche to allow the LIAISON XL system to be connected to Roche’s cobas 8100, thereby opening the door to the Swiss market.

In 2015, DiaSorin and Beckman Coulter Diagnostics signed a distribution partnership agreement to commercialize DiaSorin’s hepatitis B, hepatitis C, and HIV assays in China on the DiaSorin LIAISON XL LAS, which is integrated with Beckman Coulter’s Power Express and Power Processor automated sample processing systems.

Through this collaboration, DiaSorin can continue to execute its strategy targeting large hospitals in China (approximately 8,000 Tier-3 and Tier-2 hospitals), while Beckman Coulter can provide comprehensive and efficient workflow solutions to its extensive customer base in China through integrated automation solutions. This agreement was extended to the U.S. market the following year.[lz1]

In March 2016, DiaSorin announced that it would acquire Quest Diagnostics’ Focus Diagnostics immunodiagnostic and molecular diagnostic product business for $300 million. The acquisition included Simplexa assays and ELISA immunoassay products for influenza, respiratory syncytial virus, herpes, and streptococcal infections, thereby expanding DiaSorin’s portfolio in molecular diagnostics.

In 2017, DiaSorin partnered with Qiagen to integrate DiaSorin’s LIAISON® series of fully automated analyzers into the QuantiFERON-TB diagnostic test, providing a fully automated solution for tuberculosis diagnosis. This enhancement enables customers of both companies to process QuantiFERON-TB Gold Plus (QFT-Plus) on the LIAISON® platform, which is the fourth-generation modern gold standard for detecting latent tuberculosis (TB).

This year, DiaSorin acquired the ELISA immunodiagnostic business portfolio and related assets from Siemens Healthineers. This acquisition granted DiaSorin access to a significant customer base in Europe, further expanding its global commercial footprint to facilitate the promotion and marketing of DiaSorin’s CLIA product menu.

Commenting on the acquisition, DiaSorin Group CEO Carlo Rosa stated, “We are pleased to acquire Siemens Healthineers’ ELISA business. We believe this transaction aligns perfectly with our long-term strategic objectives, which aim to leverage our extensive customer base to expand the CLIA specialty menu and the LIAISON platform.”

In 2018, DiaSorin entered into a strategic partnership with Meridian Bioscience to market the Helicobacter pylori stool antigen test for the automated LIAISON platform under the global Meridian brand in the United States and the United Kingdom.

On June 5, 2019, DiaSorin partnered with QIAGEN to develop an ultra-sensitive diagnostic test for Lyme disease based on QuantiFERON. The two companies planned to conduct multi-site clinical validation during the 2020 Lyme disease season and aimed to submit regulatory filings in the United States and Europe by the end of that year.

Both companies estimate that the current market for Lyme disease tests based on Toxoplasma IgG and IgM in the United States and Europe generates up to 20 million tests annually, although it will take time for the market to transition from existing standards.

DiaSorin primarily engages in the research, development, and manufacturing of instruments and reagents for fully automated chemiluminescent immunoassays. Currently, DiaSorin’s immunodiagnostic products enjoy a global reputation in the fields of infectious disease testing and vitamin D assessment. The company offers the LIAISON series of diagnostic analyzers, along with specialized testing panels for ToRCH (eugenics and healthy childbirth), hypertension, Epstein-Barr virus (EBV), and fecal examinations.

The LIAISON series is a chemiluminescent immunoassay platform and DiaSorin’s flagship product line, featuring a test menu of over 110 assays and comprising the LIAISON XL and LIAISON XS systems.

The LIAISON XL system is a fully automated chemiluminescent immunoassay analyzer, renowned for its high level of automation and rapid testing speed. The time to first result is only 17 minutes, with a throughput of 180 tests per hour, making it one of the fastest standalone fully automated chemiluminescent immunoassay analyzers currently available. It has obtained CE certification.

The LIAISON XS system enables faster and more efficient processing of specialized and routine tests at optimal throughput. This fully automated LIAISON XS system features a precise and comprehensive design, offering a new optimal solution for clinical testing. The LIAISON XS utilizes barcode-based sample tube identification technology to ensure process optimization and quality control during continuous loading. The sample area accommodates four racks, with a maximum sample capacity of 48 tubes. The system is currently pending regulatory registration.

Chemiluminescence is a key component of clinical laboratory operations. After decades of development, chemiluminescent assays have undergone four generations of reagent iteration. Notably, the first-generation reagents used isoluminol as the luminescent label and adopted the CLIA method, with DiaSorin being a representative company for this generation. Today, DiaSorin offers a portfolio of unique testing menus, including bone metabolism, infectious diseases, and chronic kidney disease (CKD).

Bone Metabolism Category:In 1985, DiaSorin pioneered the launch of its 25-OH Vitamin D assay. To date, 25-OH Vitamin D has become the recognized clinical gold standard. In 2011, DiaSorin’s 25-OH Vitamin D assay obtained registration approval in China. In 2014, DiaSorin exclusively introduced worldwide a chemiluminescent immunoassay kit for the detection of active 1,25-dihydroxy Vitamin D. This product has received FDA clearance and is still pending registration in China.

Infectious Diseases:Women’s and children’s health is a core strength of DiaSorin. DiaSorin’s ToRCH panel of assay kits commands a significant global market share, owing to their superior quality and comprehensive product range. In 2010, DiaSorin launched its chemiluminescent immunoassay kits for Parvovirus B19 (IgG/IgM), which were registered and introduced in the Chinese market in 2016.

Building on this foundation, DiaSorin has sequentially registered and launched a range of assay kits, including those for four Epstein-Barr virus (EBV) markers, varicella-zoster virus, Mycoplasma pneumoniae (IgG/IgM), measles (IgM) and mumps (IgM), Chlamydia pneumoniae (IgG/IgM), and pertussis. All of these pediatric viral tests can be performed on DiaSorin’s LIAISON XL chemiluminescence analyzer. To date, DiaSorin remains the only company worldwide offering chemiluminescent assays for parvovirus B19.

Notably, in 2017, when the Zika virus ravaged multiple countries, DiaSorin was commissioned and sponsored by the U.S. CDC to develop a chemiluminescent Zika virus IgM detection kit, which received Emergency Use Authorization from the FDA.

Chronic Kidney Disease, Hypertension:In 2006, DiaSorin launched its direct renin chemiluminescent assay kit in the European market, which can be used for the detection of secondary hypertension. Six years later, DiaSorin also launched its aldosterone chemiluminescent assay kit in Europe. Both products have received regulatory approval from the FDA and CFDA for marketing. To date, DiaSorin is the only international chemiluminescence manufacturer in China that can provide both of these chemiluminescent assay kits.

In May this year, DiaSorin registered and launched cortisol and adrenocorticotropic hormone (ACTH) assay kits in China, providing a comprehensive diagnostic solution for hypertension.

According to DiaSorin’s official website, its key clinical areas include infectious diseases, bone mineral metabolism, endocrinology, hypertension, oncology, stool diagnostics, and autoimmunity. DiaSorin is one of the companies with the most comprehensive immunoassay menus worldwide, currently offering more than 120 marketed tests.

Compared with large multinational corporations such as Abbott, Roche, and Siemens, which established their presence in the Chinese market at an early stage, DiaSorin entered China only in 2004 and founded its Chinese subsidiary in 2009, making it a latecomer. Although DiaSorin holds only a 2% share of the IVD market in China, it focuses on the infectious disease sector and commands over 80% market share in eugenics and prenatal care (TORCH) testing.

Since its independence in 2000, DiaSorin has established the Liaison® brand and begun its transition to chemiluminescence immunoassay. It has successively acquired chemiluminescence product lines from companies such as Biotrin and Murex, with chemiluminescence accounting for 74.4% of its business portfolio. In China, several companies are also deeply engaged in the chemiluminescence sector, including Snibe Diagnostics and Autobio Diagnostics.

Founded on December 15, 1995, Snibe Co., Ltd. has been dedicated to research in the field of chemiluminescence immunoassay (CLIA). In February 2010, Snibe successfully launched China’s first fully automated chemiluminescence immunoassay analyzer and its accompanying reagents. Four years later, its intelligent “modular biochemistry and immunoassay analysis system” entered the market, further enriching the company’s product portfolio.

Subsequently, Snibe achieved a series of breakthroughs. In July 2017, Snibe Biomedical passed the FDA 510(k) review and obtained market clearance, officially becoming the first Chinese manufacturer of chemiluminescence immunoassay systems to gain FDA approval. In 2018, Snibe Biomedical successfully launched the MAGLUMI X8, the world’s fastest fully automated chemiluminescence immunoassay system.

In August 2019, Autobio Diagnostics, the first in vitro diagnostics (IVD) manufacturer listed on China’s Main Board, released its 2019 semi-annual report. The company reported revenue of RMB 1.179 billion for the first half of the year, representing a year-on-year increase of 39.03%. According to analytical reports, Autobio Diagnostics is estimated to have installed more than 450 new chemiluminescence immunoassay (CLIA) systems in the first quarter of 2019, bringing its total installed base across China to over 3,500 units. Sales of CLIA reagents continued to achieve robust growth exceeding 45%, slightly surpassing market expectations.

During the same period, the interim report of Hotgen Biotech, the first in vitro diagnostics company listed on the STAR Market, also highlighted the significance of chemiluminescence in its business. The company’s up-converting phosphor technology-based product series serves as its distinctive offerings and a key pillar of its performance. Its chemiluminescence products are currently in a phase of rapid volume growth, generating RMB 24.44 million in revenue in the first half of 2019, and are poised to become a new driver of growth. Notably, the triple-marker assay for liver cancer demonstrates strong innovativeness and is expected to emerge as a unique competitive advantage for the company.

Given the vast market, there is certainly no shortage of players.

On the evening of September 29, Dirui Medical announced that its recent application for medical device registration of chemiluminescence immunoassay products had been accepted. On October 8, YHLO, a company specializing in in vitro diagnostics, received strategic investment from Sinopharm Capital and recently launched a fully automated open-track laboratory automation system, gradually positioning itself among the top tier of domestic chemiluminescence manufacturers.

Chemiluminescence immunoassay is one of the most important sub-sectors in the field of in vitro diagnostics. In 2017, the market size of chemiluminescence immunoassay in China was approximately RMB 26 billion. With a scale exceeding RMB 20 billion and a compound annual growth rate (CAGR) of over 20% in the past five years, it has become the largest segment within immunodiagnostics in China. After years of development, a number of outstanding domestic manufacturers of chemiluminescence immunoassays have emerged. However, the localization rate remains around 15%, indicating that import substitution still has a long way to go.