CATEGORY
Large Molecule Drug Substance CDMO
The global large molecule DS CDMO market is valued to be around $11.5 billion in 2022 and is expected to reach $19.5 billion in 2028, with a growth rate between 8 percent and 9 percent
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Large Molecule Drug Substance CDMO Global Market Outlook
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The global large molecule DS CDMO market is valued to be around $11.5 billion in 2022 and is expected to reach $19.5 billion in 2028, with a growth rate between 8 percent and 9 percent.
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Cost-of-goods for a large molecule API is higher than that of drug product because of the technically challenging and capital-intensive nature of the API development and manufacturing process
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Biologic drugs are high value, high margin products and hence pharma companies are particularly focused on security of supply
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Another major concern for outsourcing biologic drugs is the lack of security of supply, ensuring quality, IP protection, etc. thus driving companies to keep biologic drugs substance manufacturing in-house
Large Molecule Drug Substance Market Overview - North America
Some major biologic CDMOs have increased their investments in the region. The global inflation has impacted the category to low-medium level.
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North America large molecule DS CDMO market is valued to be $3,335 million at 2022 and is expected to grow at a CAGR between 8 percent and 9 percent
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North America has highest market share in terms of value in biopharmaceutical CMO market.
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Though the demand is high North America market share for large molecule DS CDMO is lesser compared to Asia-Pacific and Europe share, since APAC and Europe region has large-scale capacities. The growth is also high, due to low cost for manufacturing of drug substance in APAC region
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The region is highly matured with high demand for biologics drugs for various indications
Porter’s Five Forces Analysis on Large Molecule Drug Substance
Supplier Power
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Ample suppliers/ CDMOs are available in the market for manufacturing large molecule drug substance. Since the industry is booming and the need for capacity increases suppliers are constantly expanding their capacities
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Supplier power is medium since most suppliers posses all the required technical and regulatory capabilities that pharmaceutical companies are looking for in a CDMO
Barriers to New Entrants
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New entrants may face heavy competition as there are several established players in the market
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In order to compete in this market suppliers should look at providing large capacities with single-use options, end to end support including analytical testing, fill finish, etc.
Intensity of Rivalry
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Since there are several large molecule drugs in pipeline there is intense competition within the CMOs
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As there is need for large capacities, CMOs with bioreactor capacities above 2000 L are preferred
Threat of Substitutes
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There are several substitutes available in the market for large molecule drugs like therapeutic monoclonal antibodies
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Biosimilars may be another alternate or substitute when the drug faces patent expiration
Buyer Power
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Most pharmaceutical buyers have in house manufacturing capacities, hence they may not be completely dependent on external manufacturers for their manufacturing operations
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Buyer power is moderate since they might have to engage with CDMOs for some technical capabilities or in order to achieve the required titers
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