Antibody-Drug Conjugates Contract Manufacturing Market - Growth, Trends, COVID-19 Impact, and Forecasts (2023-2028)

The antibody-drug conjugates contract manufacturing market is projected to register a CAGR of 12.5% during the forecast period.

The COVID-19 pandemic had an enormous influence on the healthcare domain, significantly disrupting the whole supply chain, from raw materials to production and delivery. An optimistic and conscious approach to the development of monoclonal antibodies and other ADCs was driven into the spotlight as potential treatments for COVID-19. The pandemic created a sturdy and quick reaction from scientists working for governments and industries to produce medicines and vaccines. As a consequence of the demand for effective medicines for the treatment of COVID-19, the global production of antibody-drug conjugates, vaccines, and other pharmaceuticals expanded. Besides, ADCs are more complex to manufacture, which is likely to create more demand for contract manufacturing organizations.

Antibody-drug conjugates are complex, potent biologics that offer significant potential to address critical diseases, including cancer. The clinical potential of these therapeutics is attributed to their ability to effectively target disease-associated cells while minimizing off-target toxicity. Notably, with time and advancements in research, scientists have further improved the design and development process for these therapies. This has resulted in the approval of four new ADCs in 2020. To date, the USFDA has approved 12 antibody-drug conjugates, and 100 are in development.

Also, as per the ADC Review in 2021, around 70% of antibody-drug conjugate projects are outsourced to contract development and manufacturing organizations (CDMOs), and with the continued expansion of the pipelines, this trend is likely to endure further. As more commercial products reach the market, there is an acute need for contract development and manufacturing organizations that know the way to execute late-stage studies to support the filing strategy. CMOs, with plans to support commercial-scale antibody-drug conjugate manufacturing by setting up processes to handle challenging supply chains by investing in facilities and processes to ensure security, quality, and efficiency, are expected to contribute to the growth of the market over the forecast period. Hence, given the anticipated growth in the demand for antibody-drug conjugates, the contract manufacturing market for antibody-drug conjugates is also expected to witness significant growth in the coming years.

Antibody Drug Conjugates Contract Manufacturing Market Trends

The Cleavable Linker Segment is Expected to Hold a Major Market Share in the Antibody-Drug Conjugates Contract Manufacturing Market

The growth of the segment is largely attributed to the extensive use of cleavable linker technology in antibody-drug conjugates and a greater number of cleavable linker-based authorized products. ADCs are now recognized as a main class of therapeutics for the clinical treatment of cancer. The properties of the linker between the payload and the antibody are proven to be vital to the success of an antibody-drug conjugate. Even though the antibody-drug conjugate linkers can be non-cleavable, the majority of antibody-drug conjugates in clinical development have specific release mechanisms to allow controlled linker cleavage at the target site and are termed 'cleavable'. The cleavable linkers are the major class of antibody-drug conjugate linkers. The main feature of cleavable linkers is that they are cleaved by environmental differences and particular lysosomal enzymes in response to extracellular and intracellular environments.

As per an article published by NCBI in April 2020, about two-thirds of antibody-drug conjugates used cleavable linkers in clinical trials. As per the article, Antibody-drug conjugates: Recent advances in linker chemistry, more than 80% of the clinically approved antibody-drug conjugates employ cleavable linkers.

The above-mentioned factors are expected to drive the demand for the growth of the segment studied during the forecast period.

North America is Expected to Hold a Significant Share in the Market During the Forecast Period.

Favorable government support in the United States related to the approval of antibody-drug conjugates (ADCs) is driving the growth of the market. As of May 2021, the USFDA had approved ten antibody-drug conjugates for breast cancer, urothelial cancer, myeloma, acute leukemia, and lymphoma.

Besides, the increase in the prevalence of cancer in the United States and the country's greater spending capacity for novel therapeutics are creating more demand for antibody-drug conjugates, which, in turn, is leading to increased investment in the development and manufacturing of antibody-drug conjugates. According to the American Cancer Society, the estimated new numbers of cancer cases were 1.9 million in 2021 in the United States, and the same source projected that the new number of cancer cases would be 1.9 million in 2022.

Additionally, according to the National Cancer Institute, breast cancer is the most common cancer, with 290,560 new cases projected in the United States in 2022. Prostate cancer and lung cancer are the next most frequent cancers in the country. Increasing awareness about current therapies, the high prevalence of cancer, significant R&D expenditure, and the presence of major players are supporting the market growth in the region. For instance, MilliporeSigma has deep expertise in relevant capabilities, including monoclonal antibodies, linkers, highly potent compounds, and conjugation technologies, and it continues to build on its end-to-end capabilities. The company is also excited to increase the number of commercial products produced at its facility in the United States, the first CDMO site approved for commercial ADC manufacturing in the United States.

Additionally, the key market players' investments and strategies are expected to drive the growth of the market. For instance, in September 2020, Merck announced a USD 59 million expansion of its ADC and HPAPI manufacturing capabilities at its facility near Wisconsin, United States. This investment is likely to allow large-scale manufacturing of increasingly potent compounds for therapies that have the potential to treat cancer.

Thus the above-mentioned factors are expected to drive the growth of the market studied in this region during the forecast period.

Antibody Drug Conjugates Contract Manufacturing Market Competitor Analysis

The antibody-drug conjugates contract manufacturing market is fragmented in nature, with several regional as well as international players. Some companies currently dominating the market are Lonza Group, Piramal Pharma Solutions, Abbvie Inc., Novasep, Merck KGaA, Cambrex Corporation, Recipharm, Thermo Fisher Scientific Inc., Cerbios-Pharma SA, and Sterling Pharma Solutions.

To gain a competitive edge, companies are putting in noteworthy efforts and capital investments toward expanding their capabilities, thereby enhancing their respective service portfolios. Some firms have also established new facilities dedicated to the manufacturing of highly potent compounds. The field has also observed the establishment of various partnerships between drug developers and ADC manufacturers.

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