Bioavailability challenge 2013 - Outsourcing Dynamics for Bioavailability
March 20th 2013Outsourcing Dynamics for BioavailabilityDeepika Pramod ChopdaResearch Analyst - Life SciencesFrost & SullivanBioavailability Challenge 2013
2Focus PointsChallenges and Market Demands around BioavailabilityOverview—Current Scenario surrounding BioavailabilitySource: Frost & Sullivan analysis.Shifting Trends–Bioavailability Outsourcing- CRO’s and CMO’sFocus PointsKey Strategies and Conclusions
3Overview—Current Scenario surrounding BioavailabilitySource: Frost & Sullivan analysis.OverviewIntroductionDemandCompetitionOutsourcingBioavailability is the rate of an active pharmaceutical ingredientabsorbed from a drug product to an extent of it being available atthe site of action.Rise in disease incidence rate triggers the demand for newand improvised drug development, which directly accounts forthe development of first stage of laboratory trials starting frombioavailability.Despite the growth promising factors, this segment is effectedby pricing pressures due to high laboratory procedurecosts, in an economically constricted scenario.Outsourcing has increasingly become a strategic move for mostpharmaceutical and biotech companies intensifying the marketopportunities for companies offering contract services primarily for costeffective reasons
4Need for BioavailabilityBioavailability– Need ?To provide and estimate thefraction of orally administereddrug dose that is absorbed intothe systemic circulation whencompared to the bioavailability fora solution, suspension orintravenous dosage form that iscompletely available.Useful information toestablish drug dosageregimen and support druglabeling, such asdistribution and eliminationBioavailability studiesprovide information onperformance of drugformulationSource: Frost & Sullivan analysis.
6Bioavailability- Challenges• Controlling drug solubility and permeability is amajor challenge faced by the drug developmentindustry.• Weak stability of the dissolved drug at thephysiologic pH.• Intense presystemic metabolism• Lengthy drug development programs due to highinter-patient response variability increases costs,thus poses as a challengeChallengesSource: Frost & Sullivan analysis.BCSClass I~ 5%BCSClass IV~20%BCSClass II~70%BCSClass III~5%SolubilityPermeabilityHigh LowHighLowNote : BCS- Biopharmaceutics Classification SystemRef:L.Benet, Predicting drugdispositionbyApplicationofBDDCS, AAPS, 2008New Chemical EntitiesResponse of Poor Water Soluble Drugs
7Addressing the ChallengesBiologicalApproachPharmaceuticsApproachPharmacokineticApproachDissolutionEnhancementSource: Frost & Sullivan analysis.
8Bioavailability- Demands• Comprehensive availability of products andtechnologies supporting bioavailabilityenhancement.• Partnerships and collaboration between drugdiscovery research companies andmanufacturing companies for improved drugperformance.• Develop polymers to enhance drug solubility.DemandsSource: Frost & Sullivan analysis.Enhancing Bioavailability enhancingrepresented using a pro-drug designRev. Bras. Cienc.Farm. vol.40 no.3 SãoPaulo July/Sept. 2004
9Addressing DemandsUsing Hot MeltextrusionUse of Spray-driedDispersionsUsing Particlesize ReductionconceptCollaborationswith contractresearch/manufacturingorganizationsSource: Frost & Sullivan analysis.
11Market OverviewOutsourcingResearch /Manufacturing Outsourcing has increasinglybecome a strategic move for mostpharmaceutical and biotechcompanies. With manufacturing costscontributing to a major chunk ofexpenditure, pharmaceutical andbiotech companies are consideringcontract manufacturingThe European Pharmaceutical ContractManufacturing Market was estimated tobe $11.20 billion in 2012, growing at ratesof 10.4 per centThe European Contract Researchmarket generated $6.58 billion in2012, growing at rates of 8.5 per centrespectively.. More than 80 per cent of the CMOs inEurope are located in the West – whichincludes Germany, the United Kingdom,France, Spain, Italy, and theScandinavian and Benelux countries.▪ Rise in CROs in the EasternEuropean and the Asian regions hinderWestern European market growth dueto economic constraints. Contract Manufacturing Organizations(CMOs) and Contract ResearchOrganizations (CROs) are equippedwith the requiredexpertise, resources, technology, andtools as a viable option to save costand time. Independent services forpharmaceutical and biotechnologymarkets.Source: Frost & Sullivan analysis.
12Research andDevelopmentDiscoveryResearchPre-clinicalDevelopmentClinicalDevelopmentDrug SubstanceProductionPrimaryProcessDevelopmentDrugSubstanceProductionFormulated Drug ProductionDosageFormDevelop-MentDosageFormProductionPacking/Ass-emblyLog-isticsMore ImportantLess ImportantOutsourced Services• Discovery Research• Chemical Synthesis• Pharmacology & Toxicology• Clinical Trials• Analytics• Regulatory Support• Process Development• Formulation Development• Drug Substance Production• Dosage From Production• Packaging• LogisticsOutsourcing activities are well established along the whole pharmaceutical R&D and production value chain, from discovery research to packaging andlogistics. Most of the outsourced services are used in one or more process steps of the value chain. In contrast to the traditional companies or Fully IntegratedPharmaceutical Companies (FIPCO), emerging pharmaceutical companies are focused on selected stages of the pharmaceutical value chain.Shifting Trends of Pharmaceutical OutsourcingSource: Frost & Sullivan analysis.Pharmaceutical R&D and Production Value Chain —TheShifting Trends of Pharmaceutical Outsourcing
13FIPCO (Fully Integrated Pharma Co.)ResearchTechnologyManufacturingClinical andRegulatorySales andDistributionCSOCMOCROsPartnershipsAcademia,Scientific,InstitutionsR&DPreclinicalSupportClinicalDevelopmentManufacturingSales andDistributionPreclinical CROVIPCO (Virtually Integrated Pharma Co.)Source: Burrill & Co. and Frost & Sullivan analysisChanging Business ModelsPharma/Biotech Industry: Changing Business Models (Global), 2012
15• The cost of developing drug had increased to $1,318.0 million in 2006 from $802.0 million in 2001.• Increasing R&D expenditure, coupled with lower NCE approvals, resulted in continuous decline in R&D productivity.• R&D productivity declined from 51.0 percent in 2000 to a historic low of 17.0 percent in 2009.• R&D investment increased manifold during these years, but the number of NMEs launched every year remained almoststable.Pharmaceutical Market: Cost ofDeveloping Drugs, Global, 1975, 1987, 2001 and 2006Pharmaceutical Market: New FDA Approval and R&D Spending, Global, 2000-2011CostofDevelopment($Million)R&DSpending($Billion)YearNumberofNewFDAApprovalsYearNote: *Total NMEs + BiologicalsSource: Frost & Sullivan analysis.Rising Cost of Drug Development and Declining R&DProductivity1383188021,31802004006008001,0001,2001,4001975 1987 2001 2006
16Breakdown of Outsourced Drug Development Activities34.5%26.6%23.1%21.1%20.7%18.3%18.1%17.5%15.0%15.2%0 10 20 30 40Fill-finish operationsToxicity testingValidation servicesPlant maintainance servicesTesting for ProductcharacterisationContract Research (laboratory)Testing for other bio assaysTesting for lot releaseDownstream operationsUpstream operations30.1%27.8%24.5%24.8%18.3%0 5 10 15 20 25 30 35Upstream production operationsDownstream ProductionOperationsValidation servicesFill-finish operationsTesting for productcharacterisationBioavailability Outsourcing : Per cent Breakdown of activitiesbeing outsourced (Europe), 2011Bioavailability Outsourcing : Growth rates of segments likely towitness higher levels of outsourcing (Europe), 2012- 2018Note: All figures are rounded. The base year is 2011. Source: Frost & Sullivan analysisNote: All figures are rounded. The base year is 2011. Source: Frost & Sullivan analysis
18Bioavailability Outsourcing—Key Success FactorsSource: Frost & Sullivan analysis.CompetitiveKnowledgeCapitalInvestmentsVision&StrategyScale-upProductionCapabilitiesClinical &RegulatoryExpertiseMarketing& SalesSkills• Clearly defined long-term visioncommitment and strategic fit.• Goals for in-house developmentmarketing, and geographic focus.• Competitive intelligenceon bioavailabilityenhancement• Competitor pipelineanalysis competitor’sR&D investmentstrategy.• Competitive regionalbenchmarking.• Effective communicationto the scientific community• Effective market activities forcommercialization of biosimilars• Continuous promotional activitiesand marketing relationship withdoctors, pharmacists etc.• Technical know-how forclinical development• Regulatory expertise onguidelines such as EMEA,FDA andpharmacovigilanceExpertise• Stable multi-step reproduciblemanufacturing facilities• Proper supply chain management• Standard testing control facilitiesSuccess• Healthy finance infrastructurefor high upfront investments• Ability to cope with highmanufacturing, maintenance,and promotional costs
19ConclusionThe Last Word-Significance ofBioavailabilityDictating PK behaviour isessential for enhancingbioavailabilityPartnerships with CRO‘sto reduce costs andimprove processefficiencyDrug dissolution- ratedetermining step for oralabsorptionAlliances and jointlydeveloped programs forbioavailabilityenhancement- growingtrendTo build therapeuticefficacy in a drugBioavailability is the mostimportant factor to controldrug formulationA shift towards outsourcing for bioavailability is expected to build in the future to shortenthe duration of drug action for faster and effective results accomplished by marketexpertiseSource: Frost & Sullivan analysis.
20For Additional InformationDeepika Pramod ChopdaResearch AnalystFrost & Sullivan – Life SciencesDeepikaC@frost.comThank You!Please contact for additional information.Ranjith GopinathanProgram ManagerFrost & Sullivan – Life Sciencesranjith.email@example.com