12^th World Pharma Congress October 16-18, 2017 Budapest, Hungary

Producing safe and effective formulation is the main goal for Pharmaceutical industry. Hence pharmaceutical industry has great concern towards quality and quantity to develop pure and safe products. The trends in pharmaceutical analysis focuses on the modern methods, technology  and tools for control of  related impurities, and faster analysis time, better separation  time and faster method development.

To obtain a required  therapeutic effect, type of formulation, technology and system for transporting drug are the important variables. Drug delivery technologies alters the drug release profiles, absorption, distribution,  and elimination of product for the safety efficacy. Developing new avenues for drug delivery vehicles  reported promising results. The practice of drug delivery has changed dramatically in the past few decades and even greater changes are anticipated in the near future.

Clinical trials are the clinical investigation of a drug that administered or dispensed to, or used involving one or more human subjects. Clinical trials are the major parameter for the approval of drug, as they mainly deals with the effectiveness and safety.  Clinical trials plays a vital role in the development of new drug entity as it subjected to various phases for approval . Advancements in  clinical trials enhances the drug development process by means of reducing time duration, sometimes the cost.

The success rate of Phase II trials that proceed to Phase III, as of 2010, is 18%. The amount of money spent on Phase II/III trials in 2015 by Large Sponsors (R&D $500M+) was $465,725,000 on average, while Non-Large Sponsors (R&D <$500M) spent $13,352,000 on average. The entire process of a drug from lab to this point may take approximately 12 to 18 years (but not always), often costing over $1 billion.

Pharmaceutical formulations is extensive procedure involving  characterization of a drug's physical, chemical, and mechanical properties in order to choose what other ingredients (excipients) should be used in the preparation and resulting a safe and efficacy product. Modern pharmaceutical  formulation is expanding its sector with technology and innovation to formulate eminent result oriented formulations.

The global pharmaceutical excipients market is projected to reach USD 8.1 Billion in 2021 at a CAGR of 6.1% in the forecast period 2016 to 2021. The rising demand for new drug delivery systems, greater understanding of the functional benefits of excipients, growing pharmaceutical industry, and patent expiries of several blockbuster drugs are positively impacting the overall growth of the market.

Drug development involves  enormous  methods and development procedure to attain therapeutic effective level. Emerging new Formulation is a persistent process with utilisation of abundant knowledge of pharmaceutics. Considering all characteristics of substances used, and their behaviour towards formulations need more innovative approach of drug development.

The global market value for drug development technologies market share was about 30% in 2015 valued at $18 billion followed by Bioanalytical Assays or instruments by about $14 billion. Innovative formulations are estimated to have contributed to 73%. To develop a new pharmaceutical formulation and to conduct clinical trials it cost at € 1,926 million in 2016.

Regulatory Affairs has a very specific meaning within the healthcare industries . It's regulations are for systematic manufacturing and marketing of safe, efficacious and qualitative drugs. Improving  new regulations and adopting to the technology regulatory affairs set new goals and challenges to the pharmaceutical formulation .

The market is expected to expand at a substantial 11.5% CAGR from 2015 to 2023 and rise to a valuation of US$5.7 billion by 2023.

It deals with prevention of  adverse drug reaction by collection, detection, assessment, monitoring. It concerns with the identifying hazards associated with pharmaceutical formulation. The advancement associated with pharmacovigilance helps in producing the valid formulation by focussing on the collected data from patients and health care providers.

Patient awareness regarding adverse drug events is stimulating global pharmacovigilance market growth by increase in number of national pharmacovigilance centers. Spain pharmacovigilance market size was valued over USD 230 million in 2015 and witness 10.2% CAGR from 2016 to 2024, to surpass USD 550 million by 2024.

GMP is Set of guidelines to manufacturers must meet to assure that the products are high quality and safe. GMP covers all aspects of production from the starting to end of the manufacturing aspects. Introduced latest  trends in GMP are risk- based approaches which are to encourage adoption of new technology by pharmaceutical industry. Pharmaceutical industries are facing hurdles in adopting new technologies quickly.

Pharmacy is a healthcare profession assisting individual in making the best use of medicine. Ethics are intended to state publicly the principles that form the fundamental basis of the roles and responsibilities of pharmacists.

Spending on specialty drugs in 2012 in the United States was about $87 billion. Estimates suggest that it could quadruple by 2020, reaching about $400 billion.

Pharmacists are becoming a more integral part of the health care team. Pharmacists do indeed dispense medicines, but first they check for any possible interactions with other medicines or medical conditions. They also instruct patients on how to take the medicines and will inform them about what to do if certain side effects arise. Pharmacy is the healthcare service science and expertise of preparing and dispensing drugs. Pharmacy Modern service includes more traditional and advanced compounding and dispensing medication healthcare.The biggest challenge facing pharmacy is continuing to communicate its role, deliver its value, and be reasonably reimbursed.

the Bureau of Labor Statistics projects a slower-than-average 3 percent employment growth for pharmacists by 2024, with the field adding 9,100 new jobs. Employment of pharmacists is expected to decline slightly in traditional retail settings because more people are having their prescriptions filled online or through mail order.

Pharmacokinetic studies are more important for therapeutic biologics . Identifying the key factors that govern absorption, distribution, metabolism,  and excretion of biologics as therapeutic agents improved the opportunities for the scientists working in drug disposition research field.

A pharmaceutical company  is a commercial business licensed to research, develop, market and/or distribute drugs, most commonly in the context of healthcare. The winds of change are blowing through and, in fact, revolutionizing logistics in the global pharmaceutical industry. The prime contributing factors are rising costs, growing risks, changing consumer needs and tightening regulations ,globally.

Pharmaceuticals represented a US$300 bn-a-year market globally as of 2015, the World Health Organization states. The global pharmaceutical market is expected to surpass US $400 bn by 2018, with the ten largest pharmaceutical companies collectively commanding about a third of the market.

Bio availability is the rate and extent of active drug absorbed and available for action . Assessment of “interchangeability” between the generic and the innovator product is carried out by a study of bioequivalence (BE). During formulation of new entities bio availability and bio equivalents are also prime parameters. Through the conduct of bioavailability and bioequivalence studies, Generic drug products results on average bioequivalence in drug absorption. 

The top 15 biopharmaceutical products each profits annual revenue of more than $2 billion, with some drugs generating sales of more than $10 billion a year. In 2015 the top NMEs include Pfizer’s Ibrance, J&J’s Darzalex and Gilead’s Genvoya with a cumulative value of $32bn of sales expected in 2020.

The life sciences sector’s growth correlates highly with countries’ general economic strength and health care spending levels, and both of these vary widely around the globe.

The life sciences sector’s growth correlates highly with countries’ general economic strength and health care spending levels, and both of these vary widely around the globe. In 2015 North America accounted for 48.7% of world pharmaceutical sales compared with 22.2% for Europe. According to IMS Health data, 58% of sales of new drug discovery made during the period 2010–2015 were on the US market, compared with 23% on the European market. Europe is ensuring competitive growth along with other countries.  By 2022, products currently in drug development will account for 17% of sales in Europe. Europe is expected to show a 3% CAGR 2016-22, mainly driven by the launch of new products currently in development. The penetration of biotech products is set to increase from a 24% market share in 2015 to 29% in 2022.