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Global Pharmaceutical Contract Manufacturing Market 

  • August 2013
  • -
  • Frost & Sullivan
  • -
  • 300 pages

Summary

Table of Contents

Injectable Dose Formulations will Likely Spur the Growth of CMOs

Big pharma companies increasingly consider outsourcing manufacturing to CMOs as a strategic move because of the uncomplicated, timely, and cost-effective services CMOs provide as well as the fact that companes can then focus on their core competencies. This study provides market overview, market engineering measurements, revenue forecasts, competitive analysis, and key trends for the pharmaceutical contract manufacturing market and its segments. Regional analysis includes The United States, European countries such as the United Kingdom, Germany, France, Italy, Spain, Benelux, Scandinavia, and Rest of World are covered. The period covered in the study is from 2009 to 2017, with the base year of 2012.

Methodology

-Primary interviews were conducted with industry stakeholders such as Tier I and Tier II contract manufacturing organisations (CMOs), pharmaceutical and biotech companies, industry experts, and regulatory authorities. Designation of interviewed participants include chief executive officers, marketing managers, directors, and vice presidents.
-Secondary research sources such as in-house Frost & Sullivan database, Frost & Sullivan’s Decision Support Database, company annual reports, scientific journals, and industry-related articles have been utilised.
-For the purpose of this research, pharmaceutical contract manufacturing refers to secondary manufacturing of finished dose formulations for small molecules. Manufacturing of active pharmaceutical ingredients (APIs) and intermediates are excluded.
-Revenues are from contract manufacturing and development services such as formulation, pre-formulation, packaging, testing, validation, regulatory, optimisation, and fill and finish services.
-Over-the-counter (OTC) products have not been included in the scope of this study.

Market Segmentation

The pharmaceutical contract manufacturing market can be broadly divided into 3 main segments: Solid dose formulations, liquid and semi-solid dose formulations, and injectable dose formulations.
-Solid dose formulations comprise basic (tablets and capsules) and advanced (controlled-release), fast-dissolving, and soft-gel, which are multi-active pharmaceutical ingredient (API) oral finished dose formulations.
-Liquid and semi-solid dose formulations include nasal, nebulized, ophthalmic, otic, and topical formulations, including sterile and non-sterile preparations.
-Injectable dose formulations are sterile preparations, including small- and large-volume parenterals. Small-volume parenterals are of 2 types: cytotoxic and non-cytotoxic.

CEO’s Perspective

- Lyophilisation and manufacturing of sterile products such as cytotoxics will likely be areas of growth potential, given the demand for oncology and high-potency drugs.
- The pharmaceutical contract manufacturing market is highly fragmented, and consolidation is required to improve profitability.
- Thirty percent of existing participants could exit the market due to pricing pressure and low profit margins, mainly in the liquid and semi-solid dose formulations segment.
- Capturing projects at the early life-cycle stage of products and a risk-sharing business model can help build long-term strategic relationships.

Key Findings
-In 2012, the global pharmaceutical contract manufacturing market generated $xx billion in revenue. The forecast shows a compound annual growth rate (CAGR) of xx% from 2012 to 2017.
oThe injectable dose formulations segment will likely be the primary growth driver for outsourcing throughout the forecast period.
-In 2012, solid dose formulations was the largest segment, constituting xx% of the total pharmaceutical contract manufacturing market, and is projected to grow at a CAGR of xx% from 2012 to 2017.
oGenerics will likely be a key growth driver for the solid dose formulations segment; however, this segment will likely lose shares to the injectable dose formulations segment because of big pharma’s shift in focus from small molecules to large molecules.
-Injectable dose formulations is the fastest growing segment and is projected to register a robust CAGR ofxx% from 2012 to 2017.
oKey growth drivers include increased pharmaceutical and biotechnological focus on complex disease areas, trends in disease control, growth in emerging markets, the pharmaceutical patent cliff (several blockbuster drugs losing patent protection), and reformulation of existing products.
oThe major growth contributor is expected to be cytotoxics as both cancer research and the development of new cancer therapies are driving growth in this area.
-The liquid and semi-solid dose formulations segment is quite mature and expected to experience a relatively lower CAGR of xx% from 2012 to 2017.
oDecreasing demand for liquid dose formulations is primarily attributed to transportation, storage, and packaging issues associated with these formulations as well as lower returns compared to injectable dose formulations manufacturing.
oThe sterile liquid and semi-solid dose preparations, particularly nasal ophthalmic dose formulations, are expected to experience strong growth; however, these preparations currently constitute a very small segment of the market.
-Because of big pharma’s increased outsourcing, the pharmaceutical contract manufacturing market is expected to show consistent growth. CMOs are striving to provide greater value proposition for clients by engaging in the early life-cycle stage projects and establishing long-term relationships.
oTo improve their value proposition to manufacturers, many CMOs are focusing on pre-clinical development services and can transition from offering clinical services to offering commercial manufacturing to integrate throughout the value chain of clients.
-Industry consolidation is on an increasing curve. The fragmented market nature will likely intensify pricing pressure and drive down CMO revenues.
-Catalent Inc., Patheon Inc., and Aenova (with the acquisition of the Temmler group) are the top xxmarket participants, constituting a combined share ofxx% in the global pharmaceutical contract manufacturing market.

Key Questions This Study Will Answer

- Is the pharmaceutical contract manufacturing market growing, how long will it continue to grow and at what rate?
- What are the fastest growing segments of the pharmaceutical contract manufacturing market?
- What opportunities exist in the pharmaceutical contract manufacturing industry?
- What are the key drivers and restraints affecting the growth of the CMOs?
- What are the key challenges the CMOs will likely face in the near and long-term future?
- In what ways is the pharmaceutical contract manufacturing industry likely to change to meet industry challenges?

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