Showing posts with label Active Pharmaceutical Ingredients. Show all posts
Showing posts with label Active Pharmaceutical Ingredients. Show all posts

MarketsandMarkets Published Global Active Pharmaceutical Ingredients (API) Market (2010 - 2015)


As defined by USFDA active Pharmaceutical Ingredients (API’s) are ‘’any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in the production of a drug becomes an active ingredient of the drug product’. These are also known as ‘bulk drug substances’. Basically drug manufacturers use API’s as a source material for manufacturing of drug products. As a part of Good Manufacturing Practice (GMP) pharmaceutical companies also use API’s at different stages of drug development such as stability sample testing, general analytical testing and method development and clinical trials.
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http://www.marketsandmarkets.com/Market-Reports/API-Market-263.html
Owing to patent expiry of many blockbuster drugs starting from 2011 to 2019 big pharma companies are eying for low cost suppliers for API’s. To achieve this objective many pharma companies are expected to outsource their in house API production to low cost manufacturing locations such as India and China. Emphasis on high potential API’s is increasing due to cost containment and this is likely to create opportunities for biosimilars and generic markets.
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ReportsandReports - The Global Active Pharmaceutical Ingredients (API) Market: Evaluating challenges, opportunities, innovations and the market environment



Active pharmaceutical ingredients (APIs), also known as ‘bulk drug substances’, are defined by the US Food and Drugs Administration (FDA) as ‘any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug becomes an active ingredient of the drug product’.

Companies use APIs at a number of stages of pharmaceutical development, including in stability sample testing, general analytical testing and method development, as GMP (Good Manufacturing Practice) APIs in clinical trials, and as source materials for manufacturing marketed drugs.

Sourcing APIs from low-cost suppliers is a key strategy for pharmaceutical companies pressured by the emerging ‘patent cliff’ . The model of vertical integration that dominated the pharmaceutical industry in the past century, characterized by tight control over all factions of the pharmaceutical manufacturing and development process is now being broken up. For example, UK-based AstraZeneca has stated that it is looking to outsource its entire API production between 2014 and 2019. There have been suggestions that this will be to China and India, although according to the company in November 2009, it has not yet made final decisions on outsourcing locations.

Key features of this report
  • Forecasts to 2014 for the global APIs market, including forecasts for biotechnology-based  APIs and third-party generic APIs (APIs sold to other companies as opposed to consumed in-house).
  • Evaluation and analysis of the key drivers and restraints impacting the global APIs market
  • Analysis of the competitive landscape including company profiles for  19 API companies
  • Analysis of the latest regulatory developments impacting the APIs market
Scope of this report
  • Understand the size the global APIs market and what the forecasted growth is between 2010-2014
  • Evaluate which market areas in the API industry have the most promise
  • Evaluate what new technology areas are driving the APIs market.
  • Understand the competitive landscape and the key strategies undertaken by the leading APIs companies
Key Market Issues
  • Outsourcing the production of APIs, or if already outsourced, finding a cheaper supplier, is a key way of saving money at the API manufacturing stage, whether it is for APIs for preclinical or clinical trials, or for the production of finished drugs.
  • Growth in the overall pharmaceutical market has slowed, as a result of patent expiries, generic encroachment, and price erosion, but growth is expected to revive from 2010, driven by increased demand for healthcare. Growth in the pharmaceutical market in-turn will drive expansion in the API market.
  • API producers in Europe and the US have the advantages of offering high levels of regulatory compliance, and having advanced technological capabilities. However, the major disadvantage of using these companies is higher costs. API producers from the Asia Pacific region are gaining similar advantages by acquiring facilities in Europe and the USA.
Key findings from this report
  • The overall growth rate for pharmaceuticals has slowed in the 2001-2008 period. Growth will accelerate from 2010 onwards, as the global economy begins to recover, although it will not hit pre-crisis levels.
  • Going forward an overall growth rate of around 7.3% is projected for the global APIs market, which is higher than the growth rate expected in the overall drug market.
  • The upcoming patent cliff is resulting in a surge in sales for generic APIs, which should comfortably outpace growth for innovator APIs over the next five years
  • In 2008, China was the largest API-producing country in the world. By 2010, India is predicted to be the second-largest market, growing from 6.5% of the global API market to around 10.5% by 2010.
Key questions answered
  • What is the size and growth rate of the global pharmaceutical market?
  • What are the main trends driving the growth of the APIs market?
  • How is the ‘patent cliff’ impacting API sales?
  • What impact is the growth in biotechnology and also the emerging biosimilars market having on the APIs sector?
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ReportsandReports comprises an online library of 10,000 reports, in-depth market research studies of over 5000 micro markets, and 25 industry specific websites. Our client list boasts almost all well-known publishers of such reports across the globe. We as a third-party reseller of market research reports employ a number of marketing tools, such as press releases, email-marketing and effective search-engine optimization techniques to drive revenues for our clients. We also provide 24/7 online and offline support service to our customers.

Contact:
Ms. Sunita
7557 Rambler road,
Suite 727, Dallas, TX 75231
Tel: +1-888-989-8004

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