Contract Small Molecule API Manufacturing Industry by the Numbers – 2021 Edition
According to the Global Data’s Drugs database, it indicates that maximum of the marketed drugs is found to be small molecules, despite many of the prominent contract manufacturing organizations (CMOs) investing in advanced therapy medicinal product (ATMP) capabilities in recent years and an increasing use of biologic APIs in both the pipeline and among marketed drugs. With the increase in high potency small molecule APIs, has been driven by the rise of oncology pipeline drugs coupled with small or virtual pharma companies being unable to acquire or access containment capabilities in-house, means that the demand for innovative specialized small molecule capabilities will remain high.
This report analyzes 2,787 small molecule API contract manufacturing facilities. Of those, 935 (34%) small molecule API facilities offer containment capabilities, while 256 facilities (9%) offer controlled substance capabilities.
In terms of geographic distribution of small molecule API manufacturing facilities, China has the largest number, followed by India and then the US. China and India’s greater volume of small molecule facilities is to be expected, as most API in US-marketed drugs come from China and India.
What are the market dynamics in the contract small molecule API manufacturing industry?
The main trends that have affected small molecule CMOs in recent years are shown below. These trends are classified into three categories: increased CMO appetite for specialist capabilities, geographic distribution, and small molecule API’s value to drug production.
There has been a major decline in the number of small molecule API facilities. One-third of small molecule API facilities that offer containment capabilities, and less than one-tenth offer-controlled substance capabilities. Containment and controlled substance capabilities are specialty offerings provide barriers between the active substance and its surroundings or manufacturing staff. CMOs can charge more for containment and controlled substance services because they are rare and in demand.
China has the smallest molecule API manufacturing facilities, followed by India, and the US. The API production costs in these countries can be 30% cheaper than in more developed markets, driving CMOs to acquire or construct facilities in these countries.
Despite industry excitement and investment in large molecule drugs, there is still significant demand for small molecule API manufacture. With the increase in high potency small molecule APIs, and the rise of oncology pipeline drugs coupled with small or virtual pharma companies unable to acquire or access this capability in-house, means that demand for innovative specialized capabilities will remain high.
What is the geographic distribution of public small molecule API dedicated contract CMOs?
In terms of geographic distribution of small molecule API manufacturing facilities, China has the largest number, followed by India and then the US. China and India’s greater volume of small molecule facilities is to be expected, as most API in US-marketed drugs come from China and India. API production costs in these countries can be 30% cheaper than in more developed markets, driving CMOs to acquire or construct facilities in these countries.
Geographic distribution of public small molecule APIs
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Who are the major market players in the contract small molecule API manufacturing industry?
The largest CMOs (both Excess Capacity and Dedicated) often have the highest number of small molecule API facilities. Excess Capacity companies such as Teva and Merck own the largest number of small molecule API contract manufacturing facilities. The Excess Capacity CMOs shown are some of the largest pharmaceutical companies globally, often with the biggest marketed drug portfolios. However, Dedicated Contract CMOs have the most controlled substance facilities. Six of the top seven controlled substance CMOs have a Dedicated Contract model. The list of controlled substance CMOs includes some of the top API CMOs in the industry: BASF, Cambrex, Curia, Johnson Matthey, and Siegfried Holding.
Top CMOs by small molecule API manufacturing facilities, by key players
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Market report scope
| Top CMOs by Small Molecule API Manufacturing Facilities | Teva, Merck, Curia Inc., Sun Pharmaceuticals, Sanofi, Viatris Inc. Pfizer Inc. |
Scope
- This 53-page report gives important, expert insight you won’t find in any other source. 31 tables and figures throughout the report illustrate major points and trends. This report is required reading for:
- CMO executives who must have deep understanding of the small molecule API marketplace to make strategic planning and investment decisions.
- Sourcing and procurement executives who must understand crucial components of the supply base in order to make decisions about supplier selection and management.
- Private equity investors that need a deeper understanding of the market to identify and value potential investment targets.
Reasons to Buy
- Overview of contract small molecule API facilities and the proportion of containment and controlled substance specialist capabilities
- Detailed view of the geographic distribution of small molecule API facilities
- Establishing which CMOs are most involved in contract small molecule API industry by facility count
- Analysis of M&A activity related to small molecule API facilities
Key Players
Table of Contents
List of Tables
List of Figures
Frequently Asked Questions
In terms of geographic distribution of small molecule API manufacturing facilities, China has the largest number, followed by India and then the US.
Teva, Merck, Curia Inc., Sun Pharmaceuticals, Sanofi, Viatris Inc. Pfizer Inc. are the top CMOs by small molecule API manufacturing facilities.
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