Reports

Advitech's new project, within its business intelligence activities, is a collection of Reports focused on the active pharmaceutical ingredients (APIs) world: APIsTRENDS. The first issue of the APIsTrends collection is CDMO Benchmarking Report - Baseline analysis.

A Benchmarking study for the CDMO sector, starting with a baseline analysis of 2016 data where two main studies were planned:

  • A qualitative determination of the market value of small molecule APIs produced by CDMO;
  • Benchmarking of CDMO companies active in small molecule APIs.

New coming updated editions will enable to outline the main trends in this industrial sector, but this first CDMO Benchmarking Report will be an indispensable starting point to evaluate the market value of active pharmaceuticals ingredients (APIs) which is not so visible.

CDMO Benchmarking Report
Baseline analysis

Author:

The global contract development and manufacturing organization (CDMO) market is currently experiencing a constant growth and increasing interest in the healthcare world. The rise of CDMOs is a key aspect of the pharmaceutical industry's evolution over the past decades, where two-thirds of pharmaceutical manufacturing is outsourced. However, despite the wealth of information publicly available, it can be difficult to extrapolate the data required to make informed decisions about outsourced manufacturing, or investments in this sector. To meet this need address we at Advitech have decided to conduct the first benchmarking study on API CDMOs, starting by a baseline analysis according to 2016 data. The work is structured in two parts: one with an evaluation of the reference market value of drug substances produced by CDMOs. In fact, while the market value of finished dosage forms (FDFs) manufactured by CDMOs can be relatively easily assessed, values for APIs are not as visible. Therefore, to obtain an estimated value of the market pertaining to the subsequent benchmarking study, we performed a series of extrapolations from a range of publicly available and published data. The analysis provides an insight, placing an actual figure on the global market for drug substance APIs. The second part is a benchmarking study where 27 companies were chosen due to their well-established role as contract manufacturers and small molecule API capabilities. The selected companies were mainly headquartered in Europe or in the US, although two best-in-class companies in Asia were also included to provide additional perspective.

  1. Introduction
  2. Executive summary
  3. Scope of work
    • Study rationale
    • Methodology
      • Qualitative determination of the market value of small molecule APIs produced by CDMOs
      • Benchmarking of CDMO companies active in small molecule APIs
  4. The pharmaceutical industry
  5. Global value of small molecue APIs for CDMO: a qualitative number
    • Financial market approach based on company performance
  6. Benchmarking of CDMO companies active in small molecule APIs 2016
    • The panel companies
    • The tools
    • Research and analysis 2016
      • Size and geography
      • Corporate structure and models of business
      • Service porfolio and scale capabilities
      • Technical capabilities: chemistry
      • Hazardous chemistry capabilities
      • Technical capabilities: drug products
      • Growth, investment and innovation
      • Competitive advantage and stress absorption
      • Quality and regulatory
    • Results: 10 key takeaways
  7. Conclusions
  8. Company snapshots
  9. References
  10. Bibliography
  11. Author biography

CDMO Benchmarking Report
A trend analysis 2016-2018

Author:

Advitech NEW report is focused on the latest trends in the global Contract Development and Manufacturing Organization (CDMO) market.

CDMO business models continue to evolve with CDMOs seeking to offer differentiated services or technologies, adding drug-product capabilities to existing small-molecule API expertise, or increasing investment in specialized technologies, such as high-potency manufacturing. The report details key differentiating technologies and services.

The report shows also several important trends in terms of pharmaceutical industry performance, drug development and recent new drug approvals, and the impact on the contract development and manufacturing (CDMO) market.

The focus of this analysis was to specifically examine the position of small-molecule drugs in the overall pharmaceutical market, drug development, and the impact on the strategy and business activity of CDMOs serving the small-molecule API space.

Last year Advitech selected a panel of 27 companies within the previous Baseline Analysis focused on 2016 data. These companies were chosen due to the following:

  • their well-established role as CMO/CDMO players;
  • headquarters in Europe or in US and the best-in-class companies in Asia;
  • and small-molecule API capabilities.

Now, with an unprecedented approach in our industry, Advitech has performed a three-year update of the same panel of companies that were considered in the Baseline Analysis as service providers in the CDMO sector for small-molecule APIs.
In a relatively short time frame, the panel has now evolved through mergers and acquisitions and rebranding activities into a new group of companies

All the companies in the panel offer specific expertise in the development and the production of small- molecule APIs.

  1. Executive summary
  2. Scope of work
    • The definition of VUCA today
    • VUCA and the pharmaceutical industry
    • Report methodology and data availability
    • The Pharmaceutical Industry and the latest trends in the API segment [Zoom OUT]
    • Benchmarking of CDMO companies active in small-molecule APIs [Zoom IN]
  3. The Pharmaceutical Industry in 2018
    1. The Pharmaceutical Global Outlook
    2. How many small-molecule APIs are in the world?
    3. Global performance of small-molecules vs biologics: the 30 top-selling drug products
      • INCREASE
      • DECREASE
  4. The pharmaceutical industry trends from the three-year update
    1. The 30 top-selling drug products: three-year trend performance of small-molecules vs biologics:
    2. The perceived growth rate in the 2016-2018 timeframe.
    3. Investments, Expansions and Acquisitions within the CDMO Panel: the Three-year TREND
      • Copycat investments or following the market need?
    4. The latest technologies in the pharmaceutical industry
      • Artificial Intelligence in Organic Chemistry
      • Robotic automation in pharma and chemistry industries
    5. New trends in the supply-chain network
      • Drug Shortages: the FDA and EMA Task Forces
      • Growth opportunities in the fine-chemicals sector: API starting materials, EMA publishes updated reflection paper
    6. New Trends in pharmaceutical service business models: full-service providers and the rise of Giga-CDMOs
      • Full-service providers
      • The rise of Giga-CDMOs
    7. The evolution of small-molecules:
      • Small-molecules vs biologics in New Drug Approvals: the 2011-2018 TREND
    8. New Trends in Orphan Drugs: smaller volumes of APIs needed for recently launched drugs / drugs to be launched in the future
      • The evolution of new Orphan Drugs since 2011:
    9. Summary of the pharmaceutical industry trends from the 3-year update
  5. Benchmarking of CDMO companies active in small-molecule APIs: the 3-year update
    • Benchmarking of CDMO companies: evolution of the 2016 data baseline
    • The new panel companies
    • The new tools
    • Size and Geography
    • Corporate structure and models of business: the 3-year trend
    • Finance and Business Model three-year trend analysis by segment (ZOOM OUT)
    • Finance and Business Model three-year trend analysis by company (ZOOM IN)
    • Global footprint, employees and API reactor capacity: the 3-year trend analysis
    • Service portfolio and scale capabilities
    • Technical capabilities: chemistry
    • Hazardous chemistry capabilities
    • Technical capabilities: drug products
    • Growth, investment and innovation: the 3-year update
    • Competitive advantage and stress absorption
    • Quality and Regulatory
  6. Company snapshots: the 3-year update
  7. Table of Figures
  8. Bibliography
    • Author biography
    • Appendix