Generics lead the way
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This document discusses the global generic pharmaceutical market and product development. It begins with an introduction that outlines increasing demand for medicines globally and a shift toward generics. It then provides details on the size and growth of the global generics market. The document discusses key aspects of pharmaceutical research and development as well as quality by design (QbD) approaches. It outlines the common regulatory requirements for different markets like the US, Europe, and India. Finally, it concludes that regulations favoring generics and health insurance coverage will boost the generics market, while consolidation and complex therapies will present challenges.
Generics lead the way
- 1. Generics – Lead the way head Guru Balaji.S Product development scientist
- 2. Focus points Global pharmaceutical market Indianpharmaceuticalindustry PharmaceuticalR&D in a nutshell Introduction QbD Global Generic product development Quality TheCTD triangle, Regulatorydossier Conclusions and implications
- 3. Introduction Key global health care regulators has the common goals of improving health outcomes, while controlling costs and expanding access to more of their citizens There is a rapid expansion of demand for medicines in the world's fastest growing economies, fewer new medicines reaching patients. There is a rapid shifts in the mix of spending between branded products and generics
- 4. Global Pharmaceutical Domestic market (India) Bulk drugs (API, intermediates) Formulations ( Tablets, capsules, etc) International markets (US, EU, Japan and etc.) Generics Patented drugs Non- patented drugs NDDS NCE Global pharmaceutical market Mostly almost all NDDS,NCE formulation are patented
- 6. Global Generics: Facts and figures Global Generics The top 10 global generic pharmaceutical companies account for 47% market share The global generic pharmaceutical market is worth over $150 billion and is growing at CAGR (2013-2018) of 8.4% Blockbuster drugs has losed patents between 2010 and 2017 Over the next 5 years, emerging markets will grow at 15-20% and matured at 6-10%growth The top 8 global markets comprise 80% of the total generic sales
- 7. Pharmaceutical R&D in a nutshell Source: Frost and Sullivan analysis
- 8. Pharmaceutical drug development process-”The pipeline”
- 9. 200.2 380.6 2015 2016 2017 2018 2019 2020 2021 RevenueUSDBillion Global Generic drug market,2015-2021 (USD) Million) Revenue in $ billion
- 10. Key drivers for the change Overwhelmed health systems around the globe to control general spending on health care.
- 11. India’s pharmaceutical industry has filed the highest number of DMFS with USFDA and by the end of year 2015, number of filings stands at 3820. India’s ANDAS totalling 3470 by Feb 2016 covers all ATCs. Indian Pharmaceutical in 2015-16 – An overview Global Pharma market size in the calendar year 2015 is estimated at $1060 billion as per IMS with a very marginal growth rate of 1-2%. India’s total exports of Pharmaceuticals (APIs, Generics and Alternative system of medicine) during 2015-16 was $16.89 billion with a growth of 9.44%. India’s exports in INR terms has recorded a growth of 17% and was valued at 110,522 crore during Fy-15. Global generic market is estimated to be of size $ 294 billion. The market grew 2015approximately by 4% as Per IMS (World renowned market audit agency) data. India, a predominant player in Global Generic market has clocked $ 12.6 billion of Exports out of this $ 294 generic market with a growth of 12.8% during the year2015-16. Indian pharmaceutical industry
- 12. Future trends and directions Source: Frost and Sullivan analysis Key Trends Balance in terms of healthcare expenditure and sales revenue is likely to shift from developed m emerging markets owing to immense market opportunities and untapped market potentials. Partnerships, mergers, acquisitions and strategic alliances will help both branded and gen expand their global footprint and gain market shares. Large generic companies seek to establish their own R&D entity and hence are like investments in R&D activities for long-term growth. Generic manufacturers tend to increasingly focus on higher value biological therapies, biosimilar controlled release products, sterile formulations and niche therapeutic segments, which are less competitive yet commercially attractive. Generic consumption is likely to be favoured in a big way by the government, policy-makers and physicians owing to the huge cost-saving benefits to the patients and healthcare expenditure.
- 13. Difference in the cost
- 14. New Drug & Generics
- 15. Global product development flow chart
- 16. Aspects Traditional QbD Pharmaceutical development Empirical Systematic : Multivariate experiments Manufacturing process Fixed Adjustable with design space, opportunities for innovation Process control In process testing for go/on-go; offline analysis wide or slow response PAT utilized for feedback and feed forward at real time Product specification Primary means of quality control; based on batch data Part of the overall control strategy, based on the desired product performance Control strategy Mainly by intermediate product and end product testing Risk based; controlled shifted up stream, real time release Lifecycle management Reactive time problem and OOS; Post approval changes needed Continual improvement enabled within design space Pharmaceutical aspects: Traditional versus QbD
- 17. Roadmap for QbD Define Target product profile Product quality characteristics ensuring safety and efficacy Identification of critical quality attributes (CQA’s) Risk Assessment Material Attributes CQA’s Process parameters CQA’s Design space Control strategy quality risk management ( Life cycle management continuous )
- 18. Quality = Quality of Personnel (Qualification, Training…) + Quality of Materials (Specifications, Approved Suppliers...) + Quality of Means (Qualified equipment's, maintenance…) + Quality of Media (GMP premises, Controlled environment…) + Quality of Methods (Calibration, Validation…) QUALITY Raw Materials Personnel Procedures Validated processes Equipment Premises Environment Packing Materials The composition of quality
- 19. The CTD Triangle
- 20. Regulatory Dossier Regulatory approach: Parameters US Europe Other markets India API USP Ph.Eur. USP / Ph.Eur. IP USDMF COS (CEP) / EDMF DMF requirement depends on the target market Excipients USP Ph.Eur. USP / Ph.Eur. IP Reference product US Europe Depends on the target market Indian (if not available, then US or Europe) Packaging materials Complying to USP Ph.Eur. USP / Ph.Eur. IP Finished product USP As per Ph.Eur. General requirement USP / Ph.Eur. IP Submission batch 1 2 2 or 3 - Submission batch size 100,000 units or 1/10th of commercial batch 100,000 units or 1/10th of commercial batch Depends on the target market No such requirement
- 21. Regulatory Dossier Regulatory approach: Parameters US Europe Other markets India Stability data 1 batch 2 batches 2 or 3 batches 3 batches Stability condition Zone I & II condition Zone I & II condition Depends on the target market Zone IV condition Comparative dissolution study 3 media 3 media Depends on the target market 1 to 3 media Input materials TSE/BSE, OVI statements TSE/BSE Depends on the target market No such requirement Packaging materials Food grade certificate Food grade certificate Depends on the target market No such requirement Method validation data As per ICH ICH ICH No such guideline Process validation data Not required Not required Depends on the target market Not required for submission Bioequivalence study US reference product under fast and fed condition European reference product (generally under fasting condition) Generally fasting bio study Fasting bio study Bioequivalence study USFDA approved CRO anywhere in the world MHRA/EU approved CRO anywhere Depends on the target market Indian study required
- 22. Conclusions and implications Regulations favoring generics, wider health insurance coverage by Government and private bodies, and better co-operation from physicians and pharmacists are expected to boost generic consumption. The consolidation wave is likely to rise high in the global generic pharmaceuticals market CNS and Cardiovascular are expected to be the therapeutic areas of interest for generic drug manufacturers. However, market participants are likely to face challenges due to increasing pricing pressure, price-cuts and regulatory barriers. Source: Frost and Sullivan analysis