USD 10 billion
Large Molecule Drug Substance CDMO Market Size, Share, Growth Analysis, By Service(Contract manufacturing and contract development), By Source(Microbial, mammalian, and other), By Region - Industry Forecast 2024-2031
Report ID:
SQMIG35I2127 |
Region:
Global |
Published Date: July, 2024
Pages:
278
|Tables:
61
|Figures:
75
Large Molecule Drug Substance CDMO Market Insights
Large Molecule Drug Substance CDMO Market size was valued at USD 10 billion in 2019 and is poised to grow from USD 10.86 billion in 2023 to USD 21 billion by 2031, growing at a CAGR of 8.6% in the forecast period (2024-2031).
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.
Market Snapshot - 2024-2031
Global Market Size
Largest Segment
Contract Manufacturing
Fastest Growth
Contract Manufacturing
Growth Rate
8.6% CAGR
Global Large Molecule Drug Substance CDMO Market ($ Bn)
Country Share for Asia Pacific Region (%)
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Large Molecule Drug Substance CDMO Market Segmental Analysis
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.
Global Large Molecule Drug Substance CDMO Market By Service
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Large Molecule Drug Substance CDMO Market Regional Insights
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.
Global Large Molecule Drug Substance CDMO Market By Region
- Largest
- Fastest
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Large Molecule Drug Substance CDMO Market Dynamics
Large Molecule Drug Substance CDMO Market Drivers
Increasing Biologics and Biosimilars Research and Development
- Numerous companies have made large expenditures in the development of biologics and biosimilar substances since the epidemic. Currently, about half of the potential therapeutic candidates are biologics at the discovery stage, such as peptides, proteins, and monoclonal antibodies. Numerous innovative biologics are either being developed or are in the pipeline as a result of the increased investment in research and development by biopharmaceutical companies. Therefore, each of these reasons contributes to the expansion of the market for CDMOs for large molecular drugs.
Expanding Cardiovascular Diseases (CVD) and Deaths due to CVD
- The number of individuals who die from cardiovascular disease (CVD) is constantly rising, according to a report that analyzed the overall severity of CVD burden and was published in the Journal of the American College of Cardiology. Additionally, one-third of all fatalities worldwide in 2019 are included in this total. The figures demonstrate the urgent need for countries to establish cost-effective public health programs that are aimed at reducing the risk of heart disease through modifiable habits.
Large Molecule Drug Substance CDMO Market Restraints
Strict Parameters and Regulations, Complex Analytical Characterization of Biologics
- Large molecules are particularly difficult to characterize. Characterization in the biopharmaceutical industry is required in a variety of contexts, such as stability, purity, and function. For effective structural validation of large molecules, a variety of low- and high-resolution approaches must be combined. Additionally, the recombinant synthesis approach results in the production of multiple post-translational modifications (PTMs) by big molecules. Therefore, the growth and development of the large molecule drug substance CDMO market are being aided by the increase in R&D and product development spending.
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Large Molecule Drug Substance CDMO Market Competitive Landscape
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
- Lonza
- Catalent
- Samsung Biologics
- WuXi Biologics
- Boehringer Ingelheim
- Cytiva (formerly GE Healthcare Life Sciences)
- Thermo Fisher Scientific
- AbbVie Contract Manufacturing
- Fujifilm Diosynth Biotechnologies
- AGC Biologics
- Merck KGaA
- Biogen
- GSK Contract Manufacturing
- Ajinomoto Bio-Pharma Services
- Novartis Contract Manufacturing
- Rentschler Biopharma
- Syngene International
- KBI Biopharma
- JHL Biotech
- Emergent BioSolutions
Large Molecule Drug Substance CDMO Market Recent Developments
- In October 2022, WuXi joined with Toregem BioPharma, a biotechnology business with headquarters in Japan, particularly to provide therapeutic compounds intended for creating dental regeneration drugs. The collaboration entails the development of TRG035, an antibody for the treatment of congenital dementia. The collaboration matches with WuXi's goal of assisting global partners in developing breakthrough biologics solutions for patients worldwide.
- In October 2022, FUJIFILM Diosynth Biotechnologies partnered with RoosterBio, a biotechnology business with headquarters in the US, particularly to offer stem cell products. The collaboration entails GMP manufacture of exosomes and cell treatments. The agreement enables FUJIFILM to provide its customers with comprehensive cell therapy CDMO services.
- In December 2021, WuXi partnered with ImmuneOncia, a South Korean biotechnology company, with the primary goal of producing immunotherapies for the treatment of various types of cancer. The collaboration will make use of WuXi's expertise in cell line creation, bioassay development, cell culture development, and biologics manufacturing to create bio-specific antibodies. The antibody specifically targets PD-L1 and Cluster of Differentiation 47 (CD47).
- In September 2021, Boehringer partnered with the synthetic biology business Twist Bioscience in the US. Through this partnership, Boehringer will be better able to serve its customers and patients by combining Twist's expertise in creating robust, varied therapeutic antibodies with its experience in drug discovery and development.
- In April 2021, Samsung Biologics collaborated with TG Therapeutics, a biotechnology business based in the United States. The agreement entails expanding contract manufacturing for TG Therapeutics' ublituximab, an antigen used in lymphoma, leukemia, and multiple sclerosis. This collaboration is consistent with Samsung Biologics' aim of better serving humanity by offering necessary medications to patients.
- In January 2021, Boehringer joined forces with Google, a worldwide technology firm headquartered in the United States. The collaboration entails combining Boehringer's expertise in computer-based drug design and silico modeling with Google's expertise in algorithms and quantum computers to work on research and development. The collaboration intends to boost R&D procedures, resulting in greater medical advancements.
Large Molecule Drug Substance CDMO Key Market Trends
- The development of large molecule biopharmaceuticals and their expansion are hastening the evolution of commercial-scale manufacturing. Many high-value biologics don't have the same quantities or batch sizes as small-molecule medications, which is one difference. The emergence of small molecule inhibitors and antibody-drug conjugates (ADCs), which are fostering a more focused approach to cancer therapy, could be compared to this. Innovative start-ups and smaller businesses that lack the resources to invest in manufacturing capabilities or access to the knowledge necessary to guide their product from development through to commercialization are also heavily represented in the biologics market. For some businesses, trial supply, tech transfer, and scale-up may be completely uncharted territory. Businesses need to reevaluate their capabilities and make investments in new machinery, lines, procedures, and operational strategies in order to keep up with the trend towards more tailored therapies. There is a substantial danger for solitary CDMOs here. Even while they will need to concentrate their efforts on achieving the same efficiencies, saving APIs, reducing loss, and increasing yield, they will need to adapt to more adaptable and dynamic working methods to suit the demands of small-scale production. For contract producers, the market for high-potency APIs presents additional difficulties. Oncology medications, hormone products, and substances to treat organ rejection are driving significant expansion, which is being accompanied by heightened regulatory scrutiny. Effective containment techniques are needed in high-potency manufacturing to safeguard both the health of employees and patients.
Large Molecule Drug Substance CDMO Market SkyQuest Analysis
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 billion |
| Market size value in 2031 | USD 21 billion |
| Growth Rate | 8.6% |
| Forecast period | 2024-2031 |
| Forecast Unit (Value) | USD Billion |
| Segments covered |
|
| 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 |
|
| Customization scope | Free report customization with purchase. Customization includes:-
|
| Historical Year | 2019 |
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Table Of Content
Executive Summary
Market overview
- Exhibit: Executive Summary – Chart on Market Overview
- Exhibit: Executive Summary – Data Table on Market Overview
- Exhibit: Executive Summary – Chart on Large Molecule Drug Substance CDMO Market Characteristics
- Exhibit: Executive Summary – Chart on Market by Geography
- Exhibit: Executive Summary – Chart on Market Segmentation
- Exhibit: Executive Summary – Chart on Incremental Growth
- Exhibit: Executive Summary – Data Table on Incremental Growth
- Exhibit: Executive Summary – Chart on Vendor Market Positioning
Parent Market Analysis
Market overview
Market size
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- SWOT Analysis
KEY MARKET INSIGHTS
- Technology Analysis
- (Exhibit: Data Table: Name of technology and details)
- Pricing Analysis
- (Exhibit: Data Table: Name of technology and pricing details)
- Supply Chain Analysis
- (Exhibit: Detailed Supply Chain Presentation)
- Value Chain Analysis
- (Exhibit: Detailed Value Chain Presentation)
- Ecosystem Of the Market
- Exhibit: Parent Market Ecosystem Market Analysis
- Exhibit: Market Characteristics of Parent Market
- IP Analysis
- (Exhibit: Data Table: Name of product/technology, patents filed, inventor/company name, acquiring firm)
- Trade Analysis
- (Exhibit: Data Table: Import and Export data details)
- Startup Analysis
- (Exhibit: Data Table: Emerging startups details)
- Raw Material Analysis
- (Exhibit: Data Table: Mapping of key raw materials)
- Innovation Matrix
- (Exhibit: Positioning Matrix: Mapping of new and existing technologies)
- Pipeline product Analysis
- (Exhibit: Data Table: Name of companies and pipeline products, regional mapping)
- Macroeconomic Indicators
COVID IMPACT
- Introduction
- Impact On Economy—scenario Assessment
- Exhibit: Data on GDP - Year-over-year growth 2016-2022 (%)
- Revised Market Size
- Exhibit: Data Table on Large Molecule Drug Substance CDMO Market size and forecast 2021-2027 ($ million)
- Impact Of COVID On Key Segments
- Exhibit: Data Table on Segment Market size and forecast 2021-2027 ($ million)
- COVID Strategies By Company
- Exhibit: Analysis on key strategies adopted by companies
MARKET DYNAMICS & OUTLOOK
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- Regulatory Landscape
- Exhibit: Data Table on regulation from different region
- SWOT Analysis
- Porters Analysis
- Competitive rivalry
- Exhibit: Competitive rivalry Impact of key factors, 2021
- Threat of substitute products
- Exhibit: Threat of Substitute Products Impact of key factors, 2021
- Bargaining power of buyers
- Exhibit: buyers bargaining power Impact of key factors, 2021
- Threat of new entrants
- Exhibit: Threat of new entrants Impact of key factors, 2021
- Bargaining power of suppliers
- Exhibit: Threat of suppliers bargaining power Impact of key factors, 2021
- Competitive rivalry
- Skyquest special insights on future disruptions
- Political Impact
- Economic impact
- Social Impact
- Technical Impact
- Environmental Impact
- Legal Impact
Market Size by Region
- Chart on Market share by geography 2021-2027 (%)
- Data Table on Market share by geography 2021-2027(%)
- North America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- USA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Canada
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Europe
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Germany
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Spain
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- France
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- UK
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Europe
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Asia Pacific
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- China
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- India
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Japan
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Korea
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Asia Pacific
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Latin America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Brazil
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of South America
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Middle East & Africa (MEA)
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- GCC Countries
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Africa
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of MEA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
KEY COMPANY PROFILES
- Competitive Landscape
- Total number of companies covered
- Exhibit: companies covered in the report, 2021
- Top companies market positioning
- Exhibit: company positioning matrix, 2021
- Top companies market Share
- Exhibit: Pie chart analysis on company market share, 2021(%)
- Total number of companies covered
Methodology
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.
Analyst Support
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:
Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.
Regional Analysis: Further analysis of the Large Molecule Drug Substance CDMO Market for additional countries.
Competitive Analysis: Detailed analysis and profiling of additional Market players & comparative analysis of competitive products.
Go to Market Strategy: Find the high-growth channels to invest your marketing efforts and increase your customer base.
Innovation Mapping: Identify racial solutions and innovation, connected to deep ecosystems of innovators, start-ups, academics, and strategic partners.
Category Intelligence: Customized intelligence that is relevant to their supply Markets will enable them to make smarter sourcing decisions and improve their category management.
Public Company Transcript Analysis: To improve the investment performance by generating new alpha and making better-informed decisions.
Social Media Listening: To analyze the conversations and trends happening not just around your brand, but around your industry as a whole, and use those insights to make better Marketing decisions.
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