Large Molecule Drug Substance CDMO

Large Molecule Drug Substance CDMO Global Market Outlook

• 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.

• 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

• Biologic drugs are high value, high margin products and hence pharma companies are particularly focused on security of supply

• 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.

• 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

• North America has highest market share in terms of value in biopharmaceutical CMO market.

• 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

• 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

• 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

• 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

• New entrants may face heavy competition as there are several established players in the market

• 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

• Since there are several large molecule drugs in pipeline there is intense competition within the CMOs

• As there is need for large capacities, CMOs with bioreactor capacities above 2000 L are preferred

Threat of Substitutes

• There are several substitutes available in the market for large molecule drugs like therapeutic monoclonal antibodies

• Biosimilars may be another alternate or substitute when the drug faces patent expiration

Buyer Power

• Most pharmaceutical buyers have in house manufacturing capacities, hence they may not be completely dependent on external manufacturers for their manufacturing operations

• Buyer power is moderate since they might have to engage with CDMOs for some technical capabilities or in order to achieve the required titers