API CDMO Industry - Strategic Insights and Rapid Growth

Active Pharmaceutical Ingredient CDMO Industry Overview

The global active pharmaceutical ingredient CDMO market size was valued at USD 118.6 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 7.4% from 2024 to 2030. This growth can be attributed to factors such as increased investments in drug R&D, rising incidences of chronic diseases, expanding importance of generics, and an increasing consumption of biopharmaceuticals. Moreover, the rising adoption of development and manufacturing outsourcing services as an effective cost-containment mechanism further fuels market growth.

COVID-19 significantly impacted the supply chain of active pharmaceutical ingredients (API), causing some level of disruption in raw material supply and availability, shipping delays, and costs. However, the demand for new treatment options and an increase in approval rates of new drugs supported market growth during the pandemic. The growing burden of chronic diseases such as cancer, heart disease, and others is boosting the demand for new treatment options. This is expected to drive demand for new API in the coming years and hence support market expansion in the post-pandemic period.

Gather more insights about the market drivers, restrains and growth of the Active Pharmaceutical Ingredient CDMO Market

Furthermore, rising demand for generic drugs further propels overall market growth, Generic drugs enter the market after patent expiration of branded drugs and are available at a very economical price, which has led to an increase in their adoption. Countries such as China and India are currently hotspots for development and manufacturing of generic drugs. According to Healthline, China nearly controls the complete supply of generics in the U.S. and has control over critical supplies of drugs & drug companies. Healthline also reported that the U.S. market for generic drugs has moved offshore, especially to China, and nearly no company in the country manufactures generic drugs.

Forinstance, as of 2022, approximately 91% of prescriptions in the U.S were estimated to be fulfilled with generic drugs, and the FDA has approved over 32,000 generic drugs. Similarly, in 2020, generic drug program by the U.S. FDA approved or tentatively approved 948 generic drug applications (ANDAs), out of which 50 were original applications. In total, 72 first generic drugs were approved by the FDA in 2020. A generic drug costs 30-90% less than branded drugs because the cost and time required from development to commercialization of novel drugs are quite high.

Moreover, pharmaceutical companies have been steadily increasing the amount of discovery, development, and manufacturing work they outsource over the last couple of decades. However, the urge to outsource is not uniform in the biopharma industry. Small biotechnology companies frequently rely on a contract development and manufacturing organization (CDMO) to produce their development products as they go through the pipeline.

Key Companies profiled:

• Cambrex Corporation

• Recipharm AB

• Thermo Fisher Scientific Inc. (Pantheon)

• CordenPharma International

• Samsung Biologics

• Lonza

• Catalent, Inc.

• Siegfried Holding AG

• Piramal Pharma Solutions

• Boehringer Ingelheim International GmbH

Browse through Grand View Research's Category Medical Devices Industry Research Reports.

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Active Pharmaceutical Ingredient CDMO Market Segmentation

Grand View Research has segmented the global Active Pharmaceutical Ingredient CDMO market report on the basis of product, synthesis, drug, application, workflow, and region:

Active Pharmaceutical Ingredient CDMO Product Outlook (Revenue, USD Million, 2018 - 2030)

• Traditional Active Pharmaceutical Ingredient (Traditional API)

• Highly Potent Active Pharmaceutical Ingredient (HP-API)

• Antibody Drug Conjugate (ADC)

• Others

Active Pharmaceutical Ingredient CDMO Synthesis Outlook (Revenue, USD Million, 2018 - 2030)

• Synthetic

• Biotech

Active Pharmaceutical Ingredient CDMO Drug Outlook (Revenue, USD Million, 2018 - 2030)

• Innovative

• Generics

Active Pharmaceutical Ingredient CDMO Workflow Outlook (Revenue, USD Million, 2018 - 2030)

• Clinical

• Commercial

Active Pharmaceutical Ingredient CDMO Application Outlook (Revenue, USD Million, 2018 - 2030)

• Oncology

• Hormonal

• Glaucoma

• Cardiovascular disease

• Diabetes

• Others

Active Pharmaceutical Ingredient CDMO Regional Outlook (Revenue, USD Million, 2018 - 2030)

• North Americao U.S.o Canada

• Europeo U.K.o Germanyo Franceo Italyo Spaino Denmarko Swedeno Norway

• Asia Pacifico Chinao Indiao Japano Australiao Thailando South Korea

• Latin Americao Brazilo Mexicoo Argentinao Colombiao Chile

• Middle East & Africao South Africao Saudi Arabiao UAEo Kuwait

Key Active Pharmaceutical Ingredient CDMO Company Insights

Some key players operating in this market include Cambrex Corporation, CordenPharma International, and Recipharm AB

• Cambrex Corporation offers a wide range of technologies and capabilities, such as highly potent APIs, generic API manufacturing, custom API manufacturing, clinical API manufacturing, and analytical services.

• Recipharm AB offer a range of services, including pharmaceutical development and manufacturing, sterile fill and finish development and manufacturing, and development and GMP manufacture of ATMPs (Plasmid, xRNA, Viral vectors, Microbiome)

• Siegfried Holding AG and Piramal Pharma Solutions are some notable emerging market players in the Active Pharmaceutical Ingredient CDMO industry.

• Siegfried Holding AG offers a range of API CDMO services, including the development and manufacturing of active pharmaceutical ingredients (APIs), intermediates, and finished dosage forms.

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Recent Developments

• In November 2023, Hovione expanded its nasal drug delivery through a partnership with IDC (Industrial Design Consultancy), introducing innovative nasal powder devices for local, systemic, and nose-to-brain drug delivery. The partnership enhances Hovione's integrated nasal drug development and manufacturing services

• In May 2023, GHO Capital and Partners Group announced an investment in Sterling Pharma Solutions, a leading CDMO. The investment supports Sterling's global growth, production capacity expansion, and strategic acquisitions, with GHO remaining the majority shareholder

• In April 2023, Cognizant announced a strategic partnership with Boehringer Ingelheim, a prominent research-focused biopharmaceutical firm, with an aim to accelerate the pace and enhance the quality of medicinal therapy developments

• In March 2023, NAGASE and HALIX partnered to offer comprehensive contract development and manufacturing services for biopharmaceuticals and APIs in Japan. The collaboration leverages HALIX's expertise in biomanufacturing, expanding NAGASE's presence in the high-molecular pharmaceuticals space