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The global ADC contract manufacturing market size is estimated to be worth $1.79 billion in 2024 and expected to grow at a CAGR of 13% during the forecast period.
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The new research study consists of industry trends, detailed market analysis, service provider landscape, competitiveness landscape, recent expansions, partnerships and collaborations, capacity analysis, clinical trial analysis, likely partner analysis, demand analysis, value chain analysis, market impact analysis, and market forecast and opportunity analysis. The growth in the ADC contract manufacturing market size over the next decade is likely to be the result of anticipated increase in demand for antibody drug conjugates.
In recent years, antibody drug conjugates (ADC) have emerged as a potent class of therapeutics targeting a wide range of cancers including solid tumors and hematological tumors. These complex molecules consist of an antibody, which is attached to biologically active, cytotoxic agents through chemical linkers. ADC therapeutics possess enhanced stability, target specificity, tumor selectivity and pharmacokinetic properties. These properties have supported extensive research and development initiatives being undertaken for the advancement of ADC therapies to the market. In this context, the current ADC pipeline features the presence of over 260 candidates being evaluated in clinical trials, along with 23 ADC therapeutic programs that have already been approved by various regulatory agencies. The potential of such therapies in selectively targeting tumor cells, while limiting off target toxicities have paved the way for their success and widespread application in the healthcare industry.
However, the ADC manufacturing process is highly complex and is fraught with several challenges, including drug / linker side reactions, exposure to toxicity, contamination and up-scaling. Additionally, the manufacturing process requires significant expertise and use of cutting-edge technologies, which are highly cost intensive. Therefore, the ADC developers prefer outsourcing the manufacturing operations to ADC contract manufacturers. With an intent of cost saving, ADC therapy developers are continually utilizing the experience, capabilities and manufacturing facilities available with the contract manufacturing organizations in order to support their manufacturing operations. Further, it is worth mentioning that the CMOs engaged in ADC contract manufacturing are actively undertaking initiatives to become one-stop shops and mitigate the challenges associated with technology transfer and scale-up. Considering the increasing demand for ADCs and the increasing preference for outsourcing operations by drug developers, the ADC contract manufacturing market is likely to witness substantial market growth during the forecast period.
The market research report presents an in-depth analysis of the various companies that are engaged in the global ADC contract manufacturing market, across different segments, as defined in the table below:
|Key Report Attribute
|Market Size 2024
|Stage of Development
|Type of Payload
|Type of Linker
|Key Geographical Regions
|Key Companies Profiled
|15% Free Customization
|Excel Data Packs
One of the key objectives of this market report was to estimate the current market size, opportunity and the future growth potential for the ADC contract manufacturing market, over the forecast period. Based on multiple parameters, likely adoption trends and through primary validations, we have provided an informed estimate on the market evolution during the forecast period.
The ADC contract manufacturing market analysis also features the likely distribution of the current and forecasted opportunity within this market across various segments, such as stage of development (phase I, phase II, phase III and commercial), process component (antibody, HPAPI / cytotoxic payload, conjugation / linker and fill / finish), target indication (Solid Tumors, Hematological Tumors and others), antibody generation (second, third, fourth and next), antibody origin (humanized, chimeric, murine and others), antibody isotype (IgG1, IgG4 and others), type of payload (auristatin, camptothecin, DNA topoisomerase I inhibitor, maytansinoid and others), type of linker (Maleimide, SMCC, tetrapeptide-based linker, valine-citrulline and others), and key geographical regions (North America, Europe, Asia-Pacific and Rest of the World). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.
The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders in the ADC contract manufacturing market. In addition, the research report features detailed transcripts of interviews held with the following industry stakeholders (arranged on the basis of designation):
All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.
Based on the stage of development, the global ADC contract manufacturing market is categorized into phase I, phase II, phase III and commercial. The commercial segment occupies the highest share in 2023 and is expected to witness substantial growth in the coming years.
Based on the type of component, the global antibody drug conjugates contract manufacturing market is categorized into antibody, HPAPI / cytotoxic payload, conjugation / linker and fill / finish. The antibody segment occupies the highest share in 2023 in the overall ADC contract manufacturing market and this trend is expected to remain same during the forecast period. This can be primarily attributed to the fact that antibody manufacturing is a time and cost-intensive process, owing to the complex cellular or protein engineering requirements.
Based on the target indications, the global ADC contract manufacturing market is segmented into solid tumors, haematological tumors and others. With the anticipated approval of ADC therapeutics for their primary application in the treatment of solid tumors, this market segment is anticipated to occupy the largest market share in the overall antibody drug conjugates contract manufacturing market.
Based on the antibody generation, the antibody market is segmented into second generation, third, fourth and next generation. Presently, the market is dominated by revenues generated from manufacturing of third generation antibodies, followed by fourth generation antibodies. This can be attributed to the fact that at present, nearly 40 percent of approved antibody drug conjugates and majority of the clinical stage antibody drug conjugates have third generation ADC component. This trend is unlikely to change in the near future.
Based on the antibody origin, the antibody market is segmented into humanized, chimeric, murine and others. Currently, the market is primarily driven by ADCs utilizing human origin antibodies. This can be attributed to the fact that fully human origin antibodies have a low risk of generating immune reactions, as compared to murine or chimeric antibodies. It is worth mentioning that the market for chimeric origin ADCs is expected to grow at a relatively high CAGR, owing to their application in early stages of biotherapeutics research, as a more economical alternative to human or humanized antibodies.
Based on the type of antibody isotype, the antibody market is segmented into IgG1, IgG4 and others. Presently, the market is dominated by IgG1 antibody isotype. This can be attributed to the fact that IgG1 is the most common isotype available in the serum. Further, it is highly active in eliciting an immune response via the Fc medicated effector function, which is the primary mode of action for tumor targeting therapies.
Based on the type of payload, the HPAPI / payload market is categorized into auristatin, camptothecin, DNA topoisomerase I inhibitor, maytansinoid and others. Presently, the market is dominated by camptothecin as an ADC payload. This can be primarily attributed to the fact that camptothecin-based therapies possess the potential to avoid peripheral neuropathy, which is the most common adverse event associated with auristatin-based therapies. Further, these payloads have higher tolerability, allowing for the administration of higher doses of ADCs, leading to an enhanced therapeutic effect.
It is worth highlighting that the market share for maytansinoid-based ADCs is likely to grow at a higher CAGR in the near future.
Based on the type of linker, the conjugation / linker market is categorized into Maleimide, SMCC, tetrapeptide-based linker, valine-citrulline and others. Presently, the market is dominated by Maleimide as an ADC linker and this trend is unlikely to change in the future as well. This can be attributed to the fact that Maleimide linkers are uncharged and lipophilic, which confers additional stability to the ADC therapeutic.
This segment highlights the distribution of global ADC contract manufacturing market across various geographies, such as North America, Europe, and Asia-Pacific and rest of the world. According to our projections, the antibody drug conjugates contract manufacturing market in North America is likely to capture majority (46%) of the share, and this trend is unlikely to change in the future as well. It is worth highlighting that the market in Europe is expected to grow at a relatively higher CAGR (15%), during the period 2023-2035.
The “ADC Contract Manufacturing Market (6th Edition): Industry Trends and Global Forecasts, till 2035 – Distribution by Stage of Development (Phase I, Phase II, Phase III and Commercial), Type of Component (Antibody, HPAPI / Cytotoxic Payload, Conjugation / Linker and Fill / Finish), Target Indications (Solid Tumors, Hematological Tumors and Others), Type of Generation (Second, Third, Fourth and Next), Type of Antibody Origin (Humanized, Chimeric, Murine and Others), Type of Antibody Isotype (IgG1, IgG4 and Others), Type of Payload (Auristatin, Camptothecin, DNA Topoisomerase I Inhibitor, Maytansinoid and Others), Type of Linker (Maleimide, SMCC, Tetrapeptide-Based Linker, Valine-Citrulline and Others), and Key Geographical Regions (North America, Europe, Asia-Pacific and Rest of the World)” market report features an extensive study of the current market landscape, market size and future opportunities for the companies involved in the ADC contract manufacturers, during the forecast period. Further, the market report highlights the efforts of several stakeholders engaged in this rapidly emerging segment of the pharmaceutical industry. Key takeaways of the ADC contract manufacturing market report are briefly discussed below.
The ADC contract manufacturing market landscape features the presence of 30 large, mid-sized and small companies. Over 45% of the companies were established before 2000, demonstrating extensive experience and expertise in the contract manufacturing industry. Examples of companies, established before 1980 (in alphabetical order) include Lonza, MilliporeSigma, Sartorius and Sterling Pharma Solutions. Further, it is worth highlighting that 50% of the ADC contract manufacturers are based in North America. Within Europe, Switzerland emerged as the hub of ADC contract manufacturers. Notably, 43% of the companies offer all types of manufacturing services related to ADCs. Moreover, industry stakeholders are actively undertaking expansion initiatives for their product / service portfolios to become one-stop shops for mitigating the challenges associated with technology transfer and scale-up.
The growth of the ADC contract manufacturing market can be attributed to the ever-increasing demand for advanced therapeutic modalities, such as antibody drug conjugates. The ADC therapeutics domain features a rich pipeline of commercialized ADCs. Additionally, a number of ADCs are being evaluated in clinical trials, owing to the highly selective and specific nature of antibody drug conjugates in targeting tumor cells. This demonstrates the extensive development efforts being undertaken by stakeholders in this domain. The anticipated success of these drugs is likely to act as an impetus to the growth of overall ADC contract manufacturing market. It is important to note that ADCs are highly complex and unstable molecules, and require advanced technologies, expertise and manufacturing facilities for their production, which are available with contract manufacturers. Therefore, in recent years, an increased inclination of ADC developers towards outsourcing complex manufacturing operations has been observed, which is unlikely to change in the future.
Several stakeholders have been forging alliances with other industry / non-industry players in ADC contract manufacturing market for manufacturing antibody drug conjugates. It is worth highlighting that, since 2019, more than 30 partnerships have been inked in the industry. Further, the stakeholders are also acquiring other companies specializing in the manufacturing of various ADC components, in order to expand their existing capabilities and consolidate their product / service portfolio. In this context, in June 2023, Lonza acquired Synaffix in order to gain access to the company’s site specific linker technology platform and R&D capabilities.
Owing to the increasing outsourcing of ADC manufacturing process, several players in ADC contract manufacturing market have made significant investments in order to expand their existing facilities or establish new production plants. It is worth highlighting that over 35% of the expansions undertaken since 2019 have been inked in the last two years. Majority of the expansion instances reported in this domain were focused on expanding existing capabilities. Notably, ~91% of the expansions were being undertaken for offering ADC manufacturing services, followed by those being undertaken for offering analytical / development services for ADCs. Some examples of firms involved in the expansion initiatives include (in alphabetical order) Piramal Pharma Solutions and WuXi Biologics. It is interesting to note that more than 65% of the expansions were carried out in Europe, followed by those carried out in North America. As such, the ADC contract manufacturing companies in other regions are also expected to continue to carry out capacity expansions, driving the market growth for ADC contract manufacturing market.
The global market for ADC contract manufacturing is estimated to be worth $1.79 billion in 2024. Owing to the increase in the outsourcing of ADC manufacturing, the market growth is expected to increase at a CAGR of ~13.8% over the forecast period. It is worth highlighting that, in terms of process component, antibody is expected to capture the majority of the shares of the ADC contract manufacturing market during the forecast period. This can be attributed to the fact that antibody production requires complex protein engineering and cellular approaches, which is a cost and time intensive process.
Presently, North America and Europe capture more than 70% of the overall ADC contract manufacturing market size. In fact, in recent years, preference of ADC contract manufacturing in North America has witnessed a tremendous increase owing to the regulatory guidance and early approval for contract manufacturing applications by the Food and Drug Administration (FDA). It is worth highlighting that, in the coming years, owing to the anticipated increase in the establishment of ADC contract manufacturing facilities in Europe, this region is likely to grow at a higher CAGR as compared to other regions.
Examples of key ADC contract manufacturing organizations (CMOs) (which have also been profiled in this market report; the complete list of companies is available in the full report) include AbbVie Contract Manufacturing, Abzena, CARBOGEN AMCIS, Catalent Pharma Solutions, Cerbios-Pharma, Formosa Laboratories, GBI, Lonza, MabPlex, Millipore Sigma, Piramal Pharma Solutions, Sterling Pharma Solutions and WuXi Biologics. This market report includes an easily searchable excel database of all the ADC contract manufacturing organizations.
The ADC contract manufacturing market report presents an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this industry, across different geographies. Amongst other elements, the market research report includes:
Several recent developments have taken place in the field of ADC contract manufacturing. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall trends that have been outlined in our ADC contract manufacturing market analysis.
Author: Dhriti Gulati