With the approval of new antibody-drug conjugates (ADC), the global market size for ADCs, valued at USD 4.3 billion in 2020, is expected to grow at a compound annual growth rate (CAGR) of 23.7% from 2021 to 2028.[1]

According to industry experts, major advancements in novel linker technology coupled with increasing investment in R&D are expected to drive the market. In addition, the increasing prevalence of cancer is expected another key factor driving the market over the forecast period.[2]

The Global Cancer Observatory (GCO), an interactive web-based platform presenting global cancer statistics to inform cancer control and cancer research, in 2020, confirmed that the incidence of cancer reached 19.3 million, and estimated deaths due to cancer were 9.96 million. The incidence is expected to reach 21.9 million by 2025 and 24.6 million by 2030.[2]

Antibody-drug conjugates, which combine the sensitive and unique targeting abilities of antibodies, which allow sensitive discrimination between cancer tissues and healthy tissues with the cell-killing ability of cytotoxic drugs, is among a growing class of targeted therapies that help improve treatment.

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Expanding capacity
MilliporeSigma, the U.S. and Canadian Life Science business of Merck KGaA, Darmstadt, Germany, a leading science and technology company has launched new technology and expanded capacity to advance ADC therapies.

These initiatives underscore MilliporeSigma’s continued investment in novel modalities and support the company’s efforts to double its ADC and high-potent active pharmaceutical ingredient (HPAPI) capacity in the near future.

Andrew Bulpin, Head of Process Solutions at the Life Science business of Merck KGaA, Darmstadt, Germany.

“ADCs have experienced remarkable growth, with commercially approved ADCs tripling in the past three years,” said Andrew Bulpin, Head of Process Solutions at the Life Science business of Merck KGaA, Darmstadt, Germany.

“We are a pioneer in this space, involved in 50 percent of the commercially approved ADCs on the market today. This latest innovation and additional capacity help bring novel treatments to cancer patients around the world and reinforce our commitment to shaping the future of these novel modalities,” Bulpin added.

ChetoSensar™ technology
With the launch of its ChetoSensar™ technology, MilliporeSigma is one of the front runners working to address the hydrophobicity of ADCs, in tandem with its CDMO services.  Many ADC candidates have poor aqueous solubility and MilliporeSigma estimates that more than 20 percent of ADC clinical terminations are caused by this issue. The company’s new ChetoSensar™ technology improves ADC solubility, therefore giving hope to ADCs that were previously terminated.

The payloads commonly used for ADCs are highly-complex molecules that take many steps to synthesize. Based on MilliporeSigma’s calculations, its new DOLCORE™ platform significantly reduces the development and manufacturing time required, increasing speed-to-market for a novel Dolostatin-based ADC payload by up to a year.

In addition, the company will enhance the ADC capabilities of its clinical manufacturing facility in St. Louis, Missouri in December. This facility will provide a larger footprint to enable large-scale production including chromatographic purification for early phase clinical supply. This follows last year’s announcement of a $65 million expansion of MilliporeSigma’s facility near Madison, Wisconsin, which will double its HPAPI kilo lab capacity and enable the company to expedite the manufacture of HPAPIs, ADC linker/payloads, and complex APIs.[3]

This innovation and additional capacity support the company’s ambition to accelerate growth through investments in the “Big 3”, including the Process Solutions business unit within the Life Science business sector as a key driver.

Experience
With 15 years of experience developing and manufacturing ADCs, MilliporeSigma offers unique CDMO services streamlined with a single, highly experienced provider.  The company leverages its global network and deep expertise to tailor each molecule’s unique journey while creating the dynamic client partnerships drug manufacturers need to help reach their critical milestones. MilliporeSigma integrates contract development and manufacturing with the industry’s broadest product offering across multiple modalities. Customers can also seamlessly integrate BioReliance®services from the company’s leading biosafety testing portfolio.

MilliporeSigma recently announced expansion projects in Darmstadt, Germany; Cork, Ireland; Buchs, Switzerland; Carlsbad, California, USA; Madison, Wisconsin, USA; Jaffrey, New Hampshire, USA; and Danvers, Massachusetts, USA. These expansions are part of an ambitious, multi-year program to increase the industrial capacity and capabilities of the Life Science business sector to support the growing global demand for lifesaving medications and to make significant contributions to public health.

Reference
[1] Antibody Drug Conjugate Market Size, Share & Trends Analysis Report By Application (Blood Cancer, Breast Cancer), By Technology (Cleavable Linker, Linkerless), By Region, And Segment Forecasts, 2021 – 2028
[2] Forcast. Global Cancer Observatory. Online. Last accessed on October 28, 2021
[3] Creating a New Single-digit Nanogram Containment Manufacturing Facility: MilliporeSigma Announces US $65 M Investment in ADC Manufacturing. ADC Review | Editorial Team, September 9, 2020. [Aricle]

Featured Image: Novel facilities at MilliporeSigma. Photo Courtesy: © 2021 MilliporeSigma. Used with permission.

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