|Fastest Growing Market:||Asia-Pacific|
|Largest Market:||North America|
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The antibody drug conjugates contract manufacturing market is projected to register a CAGR of 12.5% during the forecast period.
COVID-19 pandemic has had an enormous influence on the healthcare domain, significantly disrupting the whole supply chain, from raw materials to production and delivery. The covid-19 pandemic has assessed in general optimistic and conscious approach to the development of monoclonal antibody and disrupting supply chains not only for those antibodies deemed most promising before a year, but also for others antibody-drug conjugate (ADC) that have been driven into the spotlight as a potential treatment for COVID-19 disease. The pandemic has created a sturdy and quick reaction from scientists working in government, and industries to produce medicines and vaccines. As a consequence of the growing demand for effective medicines for the treatment of COVID-19, the global production of antibody-drug conjugates, vaccines, and other pharmaceuticals is anticipated to expand. Besides, as ADCs are more complex to manufacture, this is likely to create more demand for CMOS.
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 the disease-associated cells while minimizing the off-target toxicity.
Notably, with the time and advancements in the research, scientists have further improved the design and development process for these therapies. This has resulted in the approval of four new ADCs in 2019 and 2020. To date, the United States of Food and Drug Administration has approved 12 ADCs and 100 are in development.
Also, as per the ADC Review, a considerable amount around 70% of ADC projects are outsourced to the contract development and manufacturing organizations (CDMOs) and with the continued expansion of the pipelines, this trend is likely to endure. As more commercial products reach the market, there is an acute need for CDMOs that know the way to execute the late-stage studies to support the filing strategy. CMOS with plans to support commercial-scale ADC manufacturing are setting up processes to handle the challenging supply chains and investing in facilities and processes to ensure security, quality, efficiency. Hence, given the anticipated growth in the demand for ADCs, the contract manufacturing market for ADC is also expected to witness significant growth in the coming years.
Scope of the Report
As per the scope of this report, antibody drug conjugates are a class of biopharmaceuticals designed for cancer treatment that comprise an antibody that specifically targets a tumor antigen and a cytotoxic compound associated with a chemical linker. They are intended to allow the precise targeting of the cytotoxic compound to kill tumor cells while having a limited effect on healthy tissue. As ADCs are a novel class of biopharmaceuticals, the production of such complex products requires both chemical and biological know-how. Contract manufacturing organization provides technical knowledge in conjugation and linker creation, as well as solid platforms. The antibody-drug conjugates contract manufacturing market is segmented by Linker (Cleavable Linker, and Non-cleavable Linker), Application (Myeloma, Lymphoma, Breast Cancer, and Others), Phase (Clinical, and Commercial), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America).
Key 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 ADC 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 ADC. Even though the ADC linkers can be non-cleavable, the majority of ADCs in clinical development have specific release mechanisms to allow controlled linker cleavage at the target site and are thus termed 'cleavable'. The cleavable linkers are the major class of ADC linkers. The main feature of cleavable linkers is that they are cleaved by the environmental differences and particular lysosomal enzymes in response to extracellular and intracellular environments. As per the article on “The Analysis of Key Factors Related to ADCs Structural Design” published in April 2019, about 2/3 ADCs used cleavable linkers in the current clinical trials. As per the article on Antibody-drug conjugates: Recent advanced in linker chemistry, more than 80% of the clinically approved ADCs employ cleavable linkers.
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North America is Expected to Hold a Significant Share in the Market and Expected to do Same in the Forecast Period.
The favorable government support in the United States related to the approval of antibody-drug conjugates (ADCs) is driving the market growth. As of May 2021, the United States Food and Drug Administration (FDA) has approved ten ADCs for breast cancer, urothelial cancer, myeloma, acute leukemia, and lymphoma.
Besides, the increase in the prevalence of cancer in the United States and demand for novel therapeutics is creating more demand for the ADCs which in turn is leading to increased investment in the development and manufacturing of ADC. As per the Centers for Disease Control and Prevention (CDC), in 2018, there were 1,708,921 new cancer cases reported in the United States and 599,265 people died of cancer. For every 100,000 people, 436 new cancer cases were reported and 149 people died of cancer. Increasing awareness about current therapies, the high prevalence of cancer, significant R&D expenditure, and the presence of major players is supporting the market growth in the region. For instance, MilliporeSigma has deep expertise in the relevant capabilities including monoclonal antibodies, linkers, highly potent compounds, and conjugation technologies, and continues to build on its end-to-end capabilities. The company is also excited to increase the number of commercial products produced at their U.S.-based facility, the first CDMO site approved for commercial ADC manufacturing in the U.S.
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The antibody drug conjugates contract manufacturing market is fragmented competitive and consists of several major players. Some of the companies which are 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 towards expanding their capabilities and, 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.
· In July 2021, Lonza Group has extended collaboration with the major biopharmaceutical industry client for the supply of an antibody-drug conjugate against hard-to-treat cancers, the Swiss contract drugmaker.
· In September 2020, Merck announced a EUR 59 million expansion of its ADC and HPAPI manufacturing capabilities at its facility near Wisconsin, USA. This investment is likely to allow large-scale manufacturing of increasingly potent compounds for therapies that have the potential to treat cancer.
Table of Contents
1.1 Study Assumptions
1.2 Scope of the Study
2. RESEARCH METHODOLOGY
3. EXECUTIVE SUMMARY
4. MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Increasing burden of Cancer Cases
4.2.2 Increasing R&D Activities Pertaining to Antibody Drug Conjugates
4.2.3 Growing Demand for Biologic Therapy
4.3 Market Restraints
4.3.1 R&D and Production Challenges
4.4 Porter's Five Force Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5. MARKET SEGMENTATION
5.1 By Linker
5.1.1 Cleavable Linker
5.1.2 Non-Cleavable Linker
5.2 By Application
5.2.3 Breast cancer
5.3 By Phase
5.4.1 North America
188.8.131.52 United States
184.108.40.206 United Kingdom
220.127.116.11 Rest of Europe
18.104.22.168 South Korea
22.214.171.124 Rest of Asia-Pacific
5.4.4 Middle-East and Africa
126.96.36.199 South Africa
188.8.131.52 Rest of Middle-East and Africa
5.4.5 South America
184.108.40.206 Rest of South America
6. COMPETITIVE LANDSCAPE
*List Not Exhaustive
6.1 Company Profiles
6.1.1 Lonza Group
6.1.2 Piramal Pharma Solutions
6.1.3 Abbvie, Inc.
6.1.5 Merck KGaA
6.1.6 Cambrex Corporation
6.1.8 Thermo Fisher Scientific, Inc.
6.1.9 Cerbios-Pharma SA
6.1.10 Sterling Pharma Solutions
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
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Frequently Asked Questions
What is the study period of this market?
The Global Antibody Drug Conjugates Contract Manufacturing Market market is studied from 2018 - 2026.
What is the growth rate of Global Antibody Drug Conjugates Contract Manufacturing Market?
The Global Antibody Drug Conjugates Contract Manufacturing Market is growing at a CAGR of 12.5% over the next 5 years.
Which region has highest growth rate in Global Antibody Drug Conjugates Contract Manufacturing Market?
Asia-Pacific is growing at the highest CAGR over 2021- 2026.
Which region has largest share in Global Antibody Drug Conjugates Contract Manufacturing Market?
North America holds highest share in 2020.
Who are the key players in Global Antibody Drug Conjugates Contract Manufacturing Market?
Lonza Group, Abbvie, Inc., Merck KGaA, Cambrex Corporation, Recipharm are the major companies operating in Global Antibody Drug Conjugates Contract Manufacturing Market.