USD 10 billion
Report ID:
SQMIG35I2127 |
Region:
Global |
Published Date: July, 2024
Pages:
278
|Tables:
61
|Figures:
75
Large Molecule Drug Substance CDMO Market size was valued at USD 10.86 Billion in 2023 and is poised to grow from USD 11.79 Billion in 2024 to USD 22.81 Billion by 2032, growing at a CAGR of 8.6% during the forecast period (2025-2032).
Large molecule drug substance CDMOs are contract development and manufacturing organizations (CDMOs) that offer services for processing large molecules or biologics pharmacological substances. These are businesses that offer services and serve the pharmaceutical sector by assisting customers in the discovery of new drugs through production capabilities. The main drivers of the market are increase in large molecule drug approvals, particularly with the FDA, an increase in the prevalence of infectious diseases, a high demand for novel therapeutics, and higher capital investments by pharma and biotech firms in cutting-edge technologies for forming partnerships with CDMOs. Prior to the COVID-19 pandemic, there was an increase in investment in large molecule drugs due to the abundance of new therapeutic options it provides. The importance of biologics was made even clearer during the race to create treatments and vaccines against the SARS-CoV-2 virus. In particular, for CDMOs able to provide a broad range of COVID vaccination technologies and, to a lesser extent, therapeutic monoclonal antibody products, the demand for both high-volume and high-quality CGMP drug substance and drug product manufacturing services has increased rapidly.
However, new technologies were adopted and utilized in the production of vaccines, monoclonal antibodies, and diagnostic tests in order to combat the pandemic. The pandemic made it clear how crucial it is to have more regional, US-based contract pharmaceutical services and to work closely with universities, manufacturers, drug innovators, and regulatory bodies to provide patients with therapies. Large molecule (drug substance and drug product) production capacity and supply chain would then be constrained as CDMOs compete to develop COVID-19-related medicines in 2019. Drug substance (DS) development, which involves the creation of master and working cell banks, the development of manufacturing processes, and scale-up, and drug product (DP) development, which entails the placement of the drug substance into the primary container, are the two categories under which the development of large molecules drugs is divided. Like all regulatory bodies, the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) offers some guidance on how to characterize and evaluate the effectiveness and quality of medicines. Establishing requirements for DS and DP for novel chemical entities is the focus of ICH Q6.
It is challenging to create a large molecule pharmacological material that is affordable, quick to generate, and both effective and safe. The development of formulations is fraught with challenges because of the fragility and complexity of large molecule active substances. In the early stages of drug development, CDMOs have developed critical drivers that include overcoming obstacles and fulfilling deadlines. Encapsulation and the use of buffers are two revolutionary methods available to medication developers that help in the stabilization and protection of large molecular medicinal substances.
US Large Molecule Drug Substance CDMO Market is poised to grow at a sustainable CAGR for the next forecast year.
Global Market Size
USD 10 billion
Largest Segment
Contract Manufacturing
Fastest Growth
Contract Manufacturing
Growth Rate
8.6% CAGR
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Global large molecule drug substance CDMO market is segmented on the basis of service, source and region. By service, the market is segmented into contract manufacturing and contract development. By source, market is segmented into microbial, mammalian, and other. By region, the market is segmented into North America, Europe, Asia Pacific, Middle East and Africa, and Latin America.
Large Molecule Drug Substance CDMO Market Analysis by Service
In 2022, the contract manufacturing market segment held the majority of the market's revenue with a share of over 65.0%. Target identification and screening, target validation and functional informatics, lead identification and candidate optimization, and preclinical development make up the remainder of this sector. Due to recent quality-control monitoring, manufacturing standards have significantly improved. Indian pharmaceutical businesses have substantial experience in contract manufacturing.
The contract development segment is predicted to grow at the fastest CAGR of 10.9% throughout the forecast period. Cell line development and process development make up the remaining segments. The best CDMOs offer large molecule services such as upstreaming processing, downstream processing, and a variety of analytical techniques for protein characterization and bioassays.
Large Molecule Drug Substance CDMO Market Analysis by Source
In 2022, the mammalian source segment dominated the global market and represented more than 55.0% of total revenue. The mammalian sector is expected to grow the fastest during the forecast period. As more complicated biologics, such as bi- and tri-specific antibodies and antibody-drug conjugates, develop, this category will grow. Due to their efficiency in treating a range of illnesses, including cancer, mAbs, and their synthetic analogs have attracted a lot of investment. To treat illnesses like these, mAbs have historically been made from mammalian therapeutics.
The second-fastest CAGR is predicted for the microbiological source sector over the forecast period. Recombinant proteins are frequently made in microbial systems and exploited for medicinal purposes. Approximately 400 of the 650 protein therapeutics that have received global approval to date came from microbial recombinant technology. Additionally, microbial sources, which are predominantly exploited by CDMOs to manufacture cytokines, hormones, enzymes, and MABs, account for around one-third of the biologics that have been given manufacturing approval. These elements encourage segment growth.
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In 2021, Asia Pacific accounted for approximately 35.0% of global revenue, and it is expected to grow at the fastest rate (CAGR) during the projection period. The primary drivers of the regional market growth are a big patient base, lower total costs, a competent workforce, and changes in the regulatory environment. The region is thought to be the most desirable for contract manufacturing. Large patient populations and the opportunity for highly qualified medical personnel exist in the Asia Pacific region. When compared to western nations, the cost of producing and conducting a clinical trial is remarkably inexpensive. Additionally, organizations like Wuxi Biologics and Boehringer Ingelheim are always looking for ways to expand their services in this region. For instance, Wuxi Biologics established a biologics-integrated innovation hub in Hangzhou, China's Zhejiang province, in November 2020. This center will offer a variety of services, including manufacturing and process development.
North America is expected to grow in the next years as a result of considerable R&D investments in the United States. The Pharmaceutical Research and Manufacturers of America, for instance, claimed in 2022 that American pharmaceutical companies spent $102.3 billion on R&D in 2021, of which 79.6 billion were spent domestically and 22.7 billion were spent abroad. The USFDA had authorized 39 biosimilar medications as of September 2022. The market is further fueled by the participation of a sizable number of players, including Catalent, Cambrex Corporation, LabCorp Drug Development, and Fujifilm Diosynth Biotechnologies. For instance, Catalent said in April 2022 that it will invest USD 350 million over several years to expand its facility's capacity to produce large molecule therapeutic products and pharmacological substances.
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Large Molecule Drug Substance CDMO Market Drivers
Increasing Biologics and Biosimilars Research and Development
Expanding Cardiovascular Diseases (CVD) and Deaths due to CVD
Large Molecule Drug Substance CDMO Market Restraints
Strict Parameters and Regulations, Complex Analytical Characterization of Biologics
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The global large molecule drug substance CDMO market is fragmented and highly competitive. Key industry players are focused on product developments, new product launches, and geographical expansions to gain a significant amount of market share.
Large Molecule Drug Substance CDMO Market Top Player’s Company Profiles
Large Molecule Drug Substance CDMO Market Recent Developments
SkyQuest’s ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Co-relates and Analyses the Data collected by means of Primary Exploratory Research backed by the robust Secondary Desk research.
According to our global large molecule drug substance CDMO market analysis, drug compounds with a large molecule Contract development and manufacturing organizations, or CDMOs, provide services for handling big molecules, biologics, and pharmaceuticals. These are companies that provide services and benefit the pharmaceutical industry by enabling clients to discover novel medicines. By service, with a revenue share of more than 65.0% in 2021, the contract manufacturing market segment accounted for the majority of market revenue. By source, Mammalian sources dominated the market in 2021, accounting for more than 55.0% of total revenue. Asia Pacific was responsible for about 35.0% of global sales in 2021, and it is anticipated that during the projection period, it will expand at the quickest pace (CAGR). Due to significant R&D expenditures made by the United States, North America is predicted to rise over the coming years.
Report Metric | Details |
---|---|
Market size value in 2023 | USD 10.86 Billion |
Market size value in 2032 | USD 22.81 Billion |
Growth Rate | 8.6% |
Base year | 2024 |
Forecast period | 2025-2032 |
Forecast Unit (Value) | USD Billion |
Segments covered |
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Regions covered | North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA) |
Companies covered |
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Customization scope | Free report customization with purchase. Customization includes:-
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Executive Summary
Market overview
Parent Market Analysis
Market overview
Market size
KEY MARKET INSIGHTS
COVID IMPACT
MARKET DYNAMICS & OUTLOOK
Market Size by Region
KEY COMPANY PROFILES
For the Large Molecule Drug Substance CDMO Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:
1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.
2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Large Molecule Drug Substance CDMO Market.
3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.
4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.
Customization Options
With the given market data, our dedicated team of analysts can offer you the following customization options are available for the Large Molecule Drug Substance CDMO Market:
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Report ID: SQMIG35I2127
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