Antibody Drug Conjugates Contract Manufacturing Market

Antibody Drug Conjugates Contract Manufacturing Market Outlook 2031

The global antibody drug conjugates contract manufacturing market size was USD 11.07 Billion in 2022 and is likely to reach USD 25.80 Billion by 2031, expanding at a CAGR of 12.9% during 2023–2031. The market growth is attributed to the high demand for contract manufacturing.

Increasing collaboration of biopharmaceutical companies with contract manufacturing organizations (CMOs) is propelling the demand for antibody drug conjugates contract manufacturing market. Manufacturing antibody drug conjugates (ADCs) is a complicated process. CMOs have technical knowledge in linker and conjugation creation as well as in solid platforms.

Partnering with CMOs reduces the time for ADCs to reach the market, as they handle all stages such as scale-up, conjugation, saving time in testing and scheduling, commercial production, and ADC fill-finish production. CMOs are continuously trying to expand their manufacturing and bioconjugation capabilities to offer high-quality ADCs.

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• In October 2022, Lonza collaborated with Singzyme to provide a high-speed, integrated, precision bio-manufacturing platform for ADCs and other bioconjugates to accelerate the development of Bioconjugates. The innovative bioconjugation platform permits the expansion of novel targeted drugs for personalized medicine applications including cancer treatment.

The market report finds that the COVID-19 pandemic hampered the antibody drug conjugates contract manufacturing market. A favorable and cautious approach to the expansion of monoclonal antibodies (mAbs) and other ADCs brought into the focus as potential treatments for COVID-19 patients. The pandemic sparked a strong and rapid response from scientists working to produce medicines and vaccines for the government and industries. Demand for effective drugs to treat COVID-19 resulted in an expansion in the antibody-drug conjugates, the production of vaccines, and other pharmaceuticals.

Artificial Intelligence Impact on Antibody Drug Conjugates Contract Manufacturing Market

Artificial intelligence (AI) technologies are expected to fuel the antibody drug conjugates contract manufacturing market during the forecast period. AI is used in the development of ADCs through machine learning (ML) algorithms that predict the efficiency of antibody-drug combinations. These ML algorithms examine large datasets of proteomic and genomic information to detect possible target antigens for exact cancers.

Using AI in the development of ADCs through the use of generative models, which rapidly generate a large number of potential antibody candidates for a specific antigen is another method of using AI. These generative models use deep learning models to create new antibody systems that are projected to have high binding specificity and affinity for the target antigen.

• In June 2023, Lantern Pharma Inc. introduced its leverages AI platform, RADR in collaboration with Bielefeld University to develop antibody drug conjugates with high therapeutic and antitumor potential. This collaboration is expected to pave the way for next-generation ADCs and other drug conjugates that are designed by using AI and are developed with potentially higher efficacy, at a faster pace, and with significantly reduced costs.

Antibody Drug Conjugates Contract Manufacturing Market Dynamics

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Major Drivers

Increasing demand for antibody drug conjugates for cancer treatment is expected to boost the antibody drug conjugates contract manufacturing market during the forecast period. ADCs help to reduce some of the complications and enable the delivery of a particular medication dosage to a specific site of interest. The main purpose of ADCs is to enhance the efficacy of anticancer drugs by reducing systemic drug delivery and targeting specific cells.

Existing Restraints

High cost of medicine manufacturing and development is expected to hamper the antibody drug conjugates contract manufacturing market. ADCs are complex molecules that require specialized manufacturing processes which drives up the cost. There are concerns about the manufacturing and stability of ADCs. The process of bioconjugation is complex. Numerous factors affect the stability of the final product, which impacts the efficacy and safety of ADCs, which is likely to hinder the antibody drug conjugates contract manufacturing market.

Emerging Opportunities

Increasing new development of antibody drug conjugates is expected to create lucrative opportunities for the market players. Developments of ADCs include payloads with new mechanisms of action, novel target antigens, and new linker conjugation techniques that provide better therapeutic indicators and new forms of vectors and antibodies.

• In July 2022, WuXi XDC, a global leading contract research, development, and manufacturing organization partnered with AbTis for the development and manufacturing of ADCs. Under the partnership, AbTis has access to WuXi XDC’s integrated services for linker and payload manufacturing, ADC formulation, ADC conjugation process development, and drug product manufacturing process development.

Scope of Antibody Drug Conjugates Contract Manufacturing Market Report

The market report includes an assessment of the market trends, market segments, and regional markets. Overview and dynamics have also been included in the report.

Antibody Drug Conjugates Contract Manufacturing Market Segment Insights

Application Segment Analysis

Based on application, the antibody drug conjugates contract manufacturing market is segmented into lymphoma, myeloma, breast cancer, and others. The myeloma segment is expected to expand at a significant pace during the projection period. ADCs are a new type of therapy for multiple myeloma and they provide important cancer-killing drugs straight to myeloma cells and help the immune system damage the cancer. They are made of monoclonal antibodies chemically linked to a cytotoxic drug.

The lymphoma segment is anticipated to hold a key share of the market in the coming years. Monoclonal antibodies (MABs) such as obinutuzumab and rituximab, designed to specifically bind to an antigen on the cancer cell, have proven to play an important role in lymphoma treatment. With the expansion of MAB technologies, ADCs consisting of MAB linked to a small molecule cytotoxic payload via a covalent linker, have evolved as a new class of promising immunotherapy in lymphoma. For Instance,

• According to the American Cancer Society, in 2023, around 80,550 individuals (35,670 females and 44,880 males) were diagnosed with non-Hodgkin lymphoma (NHL)including children and adults. Around 20,180 individuals died from NHL cancer (8,400 females and 11,780 males).

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Linker Segment Analysis

On the basis of linker, the global market is bifurcated into cleavable linker and non-cleavable linker. The cleavable linker segment is projected to register a considerable CAGR during the forecast period, as it offers in certain circumstances to deliver the drug to the target cell. Cleavable linker uses the essential properties of tumor cells to release cytotoxins from ADCs and they are steady in the blood circulation for a long period. The process involves three types of mechanisms are used such as pH sensitivity, protease sensitivity, and glutathione sensitivity.

The non-cleavable linker segment is anticipated to account for a major market share in the coming years, as it offers the possibility to explore a completely different mechanism of action. ADCs with non-cleavable linkers are more determined by the biology of target cells as compared with cleavable linkers. The most important advantage of non-cleavable linker is the increased safety of non-cleavable ADCs, as they release their toxic cargo only upon digestion, thus reducing the risk of off-target toxicity and bystander effects.

Phase Segment Analysis

Based on phase, the antibody drug conjugates contract manufacturing market is divided into commercial and clinical. The clinical segment is expected to register a robust growth rate during the forecast period. ADCs are presently in clinical trials to evaluate whether they are efficacious treatment options for patients in diverse clinical settings. Cleavable and non-cleavable linkers are most applied in clinical settings.

• According to recent research published on March 2023, between 2019 and 2022, eight antibody drug conjugates were approved by the Food and Drug Administration (FDA).  In 2022, around a 90% increase was seen as compared to 2021, as 57 new ADCs entered in Phase 1 clinical trials. In addition, 249 clinical trials evaluating ADCs were started in 2022, a 35% rise was observed as compared to 2021.

Regional Analysis

In terms of region, the global antibody drug conjugates contract manufacturing market is classified as Asia Pacific, North America, Latin America, Europe, and Middle East & Africa. Asia Pacific is expected to dominate the market during the projection period, owing to the high burden of cancer. The increasing number of cancer cases is likely to increase the demand for targeted therapies such as ADCs for treatment, thus supporting its demand for manufacturing. Thus, in turn, is likely to drive the antibody drug conjugates contract manufacturing market in the region.

The market in North America is anticipated to expand at a rapid pace in the coming years, due to the rising number of pharmaceutical companies. The increasing incidence of cancer and the better spending ability for novel therapeutics are boosting the demand for ADCs, which increased the investment in the manufacturing and development of ADCs, which is expected to boost the antibody drug conjugates contract manufacturing market in the region.

• According to the report published by the National Institutes of Health (NIH), on May 2021, the US Food and Drug Administration (FDA) has accepted ten ADCs such as Kadcyla, Trodevy, Adcetris, Padcev, Mylotarg, Besponsa, Blenrep, Polivy, Enhertu, and Zynlonta as combinational therapy or monotherapy for breast cancer, myeloma, lymphoma, urothelial cancer, and acute leukemia.

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Segments

The global antibody drug conjugates contract manufacturing market has been segmented on the basis of

Application

• Lymphoma
• Myeloma
• Breast Cancer
• Others

Linker

• Cleavable Linker
• Non-cleavable Linker

Phase

• Commercial
• Clinical

Region

• Asia Pacific
• North America
• Latin America
• Europe
• Middle East & Africa

Key Players

• WuXi Biologics
• Sterling
• Sartorius AG
• Samsung Biologics
• Recipharm AB
• Piramal Enterprises Ltd
• Merck KGaA
• Catalent, Inc
• Cambrex Corporation
• AbbVie Inc

Competitive Landscape

Key players competing in the global antibody drug conjugates contract manufacturing market are WuXi Biologics; Sterling; Sartorius AG; Samsung Biologics; Recipharm AB; Piramal Enterprises Ltd; Merck KGaA; Catalent, Inc; Cambrex Corporation; and AbbVie Inc

These key players adopt various strategies including mergers, acquisitions, collaboration, partnerships, product launches, and production expansion to expand their consumer base globally.

• In September 2020, Merck KGaA announced an expansion of Euro 59 million antibody-drug conjugate (ADC) manufacturing and high-potent active pharmaceutical ingredient (HPAPI) manufacturing capacity and capabilities at its facility near Wisconsin, Madison, and the USA. This investment allows large-scale manufacturing of gradually potent compounds for the therapies that are likely to treat cancer.