Pharmaceutical lifecycle Management (LCM) went through business transformation in 2017; it is the process of managing the entire lifecycle of a product from its design, research, and manufacturing to service and disposal. LCM manages product related intellectual capital from the beginning of an idea till its withdrawal. Knowledge, skill and strategic planning in the process are prerequisite for improving patient satisfaction, maximizing sale, revenue growth and Cost and clinical benefits. LCM is the driving force of pharmaceutical industry. The biggest challenge of the industry is increased drug patient cliffs, development cost, and pricing pressure, stringent regulatory and declining R&D productivity. The driving team must be thorough with different approaches to deal with different timescale, geographical location, probability of success and common issues attached to it. Major threat to pharmaceutical sector is generic and biosimilar competition.
According to “Pharmaceutical Lifecycle Management Strategies in 2017” Life cycle management strategies play an important role in supporting such extensive and complex activities whereas in terms of new drug products Contract development and manufacturing organizations (CDMOs) is professionally expert in both development and commercialization which thereby reduce the risk associated to it. Traditional lifecycle management primarily focused on drug product from launch to expiration assuming that revenues are minimal post exclusivity period. In improvised LCM it was held that post patent protection drug sale account to 30% of that of small molecule drugs. Therefore now pharmaceutical manufacturers have holistic approach towards product lifecycle management starting from its discovery to post market exclusively. Strategies of 2017 focus on generic competition planning on development stage rather than when product is launched. It leads to lower cost and higher yields n the market. Modern LCM strategies consist of combinations of method and formulation to drive multiple expiration date as per different geographical location. Diverse delivery methods, manufacturing processes and logistic and marketing activities are part of it. Pharmaceutical lifecycle management strategies 2017 is highly systematic and effective that design optimal synthetic sequence beginning from developing initial process. Moreover testing and evaluating results into better quality, yield and processability.
All the users whether government, physician or patent they all look for demonstrated value that is evidence based medicine and have high expectation towards its benefits and rely on it meeting their medical needs. Demonstrated value is extremely easy to use and has reduced side effects. Integrated approach leads to discovery of new market and technologies due to its cross functioning LCM team consisting of marketing, R&D manufacturing and engineering representatives.
In developed countries such as Europe and America generic holds majority share of small molecule drug. Increase in income is leading to rise in disposable income e of the user thus people seek medical treatment often resulting fierce competition in the market. Leading drug manufacturers such as Eisai, Merck & Co, Johnson & Johnson, Takeda and AbbVie must be profitable to continue investing towards discovery of potential, cost- effective new drugs. Market leaders are committed to integrated LCM strategies in order to provide real benefits to patient along with maximizing revenues. CDMOs are like fuel to the fire sponsoring companies to successfully implement these strategies.
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