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The document provides a comprehensive overview of the pharmaceutical industry, covering its evolution, key characteristics, and regulatory frameworks in both global and Indian contexts. It highlights the growth of the industry, the challenges of rising R&D costs, and the transition towards generic drugs and biosimilars. Additionally, it discusses market dynamics, including the size and segmentation of the global market, trends in major therapeutic areas, and the impact of regulations on drug manufacturing and pricing.

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Pharmaceutical Industry
Index 1. Introduction 2. Evolution 3. Characteristics 4. Classification Generics Bio Phrama Formulations CRAMS 5. Regulations Global Indian 6. Global Pharmaceutical Industry • Indian Pharmaceutical Industry
7. Patents 8. Future …………………………………………………..
Introduction • The industry is one of the basic industries in any country. • has facilities to manufacture various types of medicine. • The Size of Indian Pharma is $ 25 billion as of April 2010
Global Overview • Highly research based • Revenues and profits are being squeezed, • The costs and risks of developing new drugs are climbing, and • The industry is rapidly transforming from a U.S./E.U.-focused business to a global market for both developing and selling drugs.
Indian Overview • Self-reliance displayed by the production of 70% of bulk drugs • · Low cost of production; • · Low R&D costs; • · development of cost effective technologies; • · Increasing balance of trade in pharmacy sector; • · An efficient and cost effective source for procuring generic drugs • especially the drugs going off patent in the next few years; • · An excellent centre for clinical trials in view of the diversity in population.
Evolution • Global Industry • Indian Industry
Global • In the 1940s and 1950s – Penicillin was a major discovery for the emergent industry, and during R&D became firmly established within the sector. • in the 1960s – The industry expanded rapidly, benefiting from significant new discoveries with permanent patent protection. – Regulatory controls on clinical development and marketing were light and healthcare spending boomed as economies prospered. – Decision-making was in the hands of medical practitioners who were insensitive to price but susceptible too drug men enabling me too drugs, which had the same therapeutic outcome.
• In the 1970’s – There was tighter regulation control on clinical trials, greatly increasing development costs – Enactment of legislation to set a fixed period on patent protection (typically 20 years from initial filing as a research discovery) led to the appearance of “generic” medicines which led to substantial increases in R&D spending. • In the 1980’s – Many countries introduced some form of price or reimbursement control and price increases began to be outlawed. The industry lacked the public or political support to resist these changes. – Emergence of small biotechnology start-ups
• In the 1990s, – Worldwide economic recession reduced cash for provision of healthcare through government and employer funded systems. – In 1993, Overall pharmaceutical sales fell by 11 per cent while the four leading generics manufacturers increased their sales between 10 and 63 per cent. – Putting Pressure on the industry to deliver genuine products. • Year 2000 to date – Even after substantially increasing the R&D expense number of new drug approvals has declined steadily. As a result, many drug firms are focusing on ways to improve the efficiency and productivity of their R&D programs.
Characteristics Of Industry • New products drive revenue growth. • Patent protection encourages new product development. • Selling effort is direct to doctors. • Price increases are restricted by government and institutional buyers. • Distribution network for mass market drugs is crucial in most countries.
Classification Of Industry Formulations – Types of drugs • Branded formulations • Generics • Orphan • Active Pharmaceutical Ingredient (API) • Contract Research And Manufacturing Services (CRAMS). • Bio Pharma
Regulations For Pharmaceutical Industry • Global • Indian
Global Despite this controversy, a series of regulatory and legislative changes have been implemented that are helping launch this segment of the pharmaceutical industry. – EMEA’s (the European Medicines Agency) establishment of a legal framework for biosimilars in 2004, followed in 2007 by guidelines for their final approval. – EMEA and FDA gave approval to Novartis for Omnitrope, a biosimilar version of a growth hormone designed to compete with Genotropin, a biologic manufactured by Pfizer.
Indian • The Drugs and Cosmetics Act, 1940: This Act regulates the import, manufacture, distribution and sale of drugs in India. · Schedule M of the Drugs and Cosmetics Act specifies the general and specific requirements for factory premises and materials, plant and equipment and minimum recommended areas for basic installation for certain categories of drugs. · Schedule T of the Drugs and Cosmetics Act prescribes Good Manufacturing Practices (GMP) specifications for manufacture of Ayurvedic, Siddha and Unani medicines. · Schedule Y of the Drugs and Cosmetics Act governs the clinical trials legislative requirements of the Drugs and Cosmetics Act. • The Pharmacy Act, 1948: This legislation regulates the profession of Pharmacyin India. Under the provisions of this act the Central Government constitutes a Central Pharmacy Council of India and the State Governments constitute State Pharmacy Councils.
• The Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954: This Act provides to control the advertisements regarding drugs and prohibits the advertising of remedies alleged to possess magic qualities. • The Narcotic Drugs and Psychotropic Substances Act, 1985: This is an act concerned with control and regulation of operations relating to Narcotic Drugs and Psychotropic Substances. • The Medicinal and Toilet Preparations (Excise Duties) Act, 1956: An Act to provide for the levy and collection of duties of excise on medicinal and toilet preparations • The Drugs Price Control Order (DPCO), 1995: This is an order issued by the • Government of India under the Essential Commodities Act,1955 To regulate the prices of drugs. The Order provides the list of price controlled drugs, procedure for fixation of prices of drugs, method of implementation of prices fixed by Government and penalties for contravention of provisions among other things. For the purpose of implementing provisions of DPCO, powers of the Government have been vested in the National Pharmaceutical Pricing Authority (NPPA).
• Good Clinical Practice (GCP) Guidelines: The Ministry of Health, along with Drugs Controller General of India (DCGI) and Indian Council for Medical Research (ICMR) has come out with draft guidelines for research in human subjects. These GCP guidelines are essentially based on Declaration of Helsinki, World Health Organization (WHO) guidelines and International Conference on Harmonization (ICH) requirements for good clinical practice. • The following are laws which have a bearing on pharmaceutical manufacture, distribution and sale in India: · The Industries (Development and Regulation) Act, 1951 · The Trade and Merchandise Marks Act, 1958 · The Indian Patent and Design Act, 1970 · Factories Act
Regulatory Bodies: • Ministry of Chemicals and Fertilisers (MoC&F): • The following departments are entrusted with the responsibility of policy making, planning, development and regulations relating to Chemicals, Petrochemicals and Pharmaceuticals. • Department of Chemicals & Petro-Chemicals:achieving growth and development of pharmaceuticals in the country and to attract investment. • The first comprehensive pharmaceutical policy in India was formulated in 1978. new policy guidelines issued in 1986, 1994 and recently in 2002.
• Pharmaceutical Policy 2002 • To ensure availability of good quality essential pharmaceuticals at reasonable prices for mass consumption. • To strengthen the indigenous capability for cost effective quality production and export of pharmaceuticals by reducing trade barriers in the • pharmaceutical sector. • · Quality control system for pharmaceutical production and distribution to • make quality an essential attribute of the domestic industry. • · Encouraging pharmaceutical R&D that is compatible with the country's • needs. • · To encourage new investment in the pharmaceutical industry and the • introduction of new technologies and new drugs.
• · To ensure availability of good quality essential pharmaceuticals at reasonable prices for mass consumption. • · To strengthen the indigenous capability for cost effective quality • production and export of pharmaceuticals by reducing trade barriers in the • pharmaceutical sector. • · Quality control system for pharmaceutical production and distribution to • make quality an essential attribute of the domestic industry. • · Encouraging pharmaceutical R&D that is compatible with the country's • needs. • · To encourage new investment in the pharmaceutical industry and the • introduction of new technologies and new drugs.
Global Pharmaceutical Industry • Size • Region Wise Break up • Top 12 players • Top therapies • Top drugs by sale
Size • The global pharmaceutical market is roughly $750 billion as of April 2010. • The global pharmaceutical market is forecasted to grow to $1 trillion in 2013, an equivalent compound annual growth rate (CAGR) of 5.5-8% over the next three years. • Even as growth slowed somewhat in Europe and North America, the United States accounts for almost half of the global pharmaceutical market, with followed by the EU and Japan. • Emerging markets such as China, Russia, South Korea and Mexico outpaced that market, growing a huge 81 percent.
Region Wise Break Up • Thirty-four major pharmaceutical markets from North America, Latin America, Europe, Asia-Pacific and Africa have been selected as the most important regions to be presented in this report.
• Latin America – The Latin American pharmaceutical market generated $28.8bn sales in 2008, an increase of 15.3%from previous year. Therapeutic indications that fuelled growth include included antihypertensives, dermatologicals and sex hormone preparations. • Brazil was the largest market with $11.4bn sales amounting to 39.6% share of the Latin American market. • Peru was the smallest accounting for only 1.9% share. • Venezuela at 32.2% increase was the fastest growing regional market in 2008. • Recession hit Mexico reported flat y-o-y growth of 0.1%. • Argentinean pharmacy market is US$3.0 billion
• drug sales in Germany reached US$53.73bn in 2009. • Eastern Europe. – The Eastern European pharma market is forecast to grow at a CAGR of 10.2% to reach a value of $41.4bn in 2014. The cardiovascular market is expected to register the highest sales ($7.8bn) in 2014, followed by alimentary canal & metabolic disorders ($6bn). – Romania recorded the highest growth in pharma sales over the 2006–07 period (44.6%), followed by Slovakia (37.1%). Growth in these markets has been driven by increasing access to modern medicines, as regional branded generic manufacturers enter the market and take share from domestic suppliers. – Novartis led the Eastern European pharma market with $1.5bn sales in 2007, a 27.3% increase over 2006. The company has the unique advantage of marketing both generic and branded pharma products across a wide range of therapy areas. – Lovenox (enoxaparin) from Sanofi-Aventis was the leading treatment in the Eastern European pharma market in 2007, with sales of $152m. Other leading brands were dominated by low molecular weight fractionated heparin and ACE inhibitor drugs.
• Russian – In 2005 the Russian pharmaceuticals market was worth approx. $9bn in consumer prices and $7.2bn in wholesaler prices • UK – In the UK the retail pharmacy market was worth £12.8bn in 2006 – little is written about this sector as a whole.
Company Country Total Revenue Total Income/loss R&D costs Fortune 500 rank Johnson & Johnson United States 61897 12266 6986 103 Pfizer United States 50009 8635 7845 152 Roche Switzerland 45304 7,678.00 8909 171 GlaxoSmithKline United Kingdom 44421 8,405 6088 168 Novartis Switzerland 44267 8454 7469 183 Sanofi-Aventis France 40870 8471 4583 181 AstraZeneca United Kingdom 32804 7544 4409 268 Abbott Laboratories United States 30765 5746 2744 294 Merck & Co. United States 27428 13024 5800 378 BayerHealthCare Germany 22297 1696 1845 154 Eli Lilly United States 21836 4328 N/A 455 Bristol-Myers Squibb United States 18808 4420 3647 435 Top Players
In 25 years, the market capitalization of the top 6 companies has grown from less than $25 billion in 1982 to nearly $525 billion by 2006. Industry Consolidation has Turned 51 Companies Into 10. Pfizer Warner Lambert Pharmacia AB Agouron The Upjohn Company Monsanto (Searle) Esperion Therapeutics Inc. Vicuron Pharmaceuticals Inc. Abbott Knoll AG Thera Sense Inc. Kos Pharmaceuticals Inc. SmithKline Beckman Beecham Group Glaxo Wellcome Diversified Pharmaceutical Services Inc. Sterling Health Block Drug Co. ID Biomedical Corp. Merck Sirna Serono Medco Pfizer Merck GlaxoSmithKline Abbot
American Cyanamid (Lederle) American Home Products A.H. Robins Co. Genetics Institute Inc. Rhone-Poulenc Rorer Marion Laboratories Merrel Dow Pharmaceuticals Hoechst Roussel Uclaf Synthelabo Sanofi Fisons Bristol-Myers Squibb DuPont Pharmaceuticals Astra AB Zeneca Group PLC MedImmune Cambridge Antibody Technology Ciba-Geigy Sandoz Eon Labs Hexal AG Chiron Eli Lilly ICOS Corp. AstraZenca Sanofi-Aventis Novartis Bristol-Myers Squibb Eli Lilly Wyeth
Top Therapautic Areas
Cardiovascular In cholesterol management, Lipitor will almost certainly remain the top statin in 2010, but the availability of generic simvastatin has resulted in increased therapeutic substitution and declining franchise share • Potential new product is GlaxoSmithKline's darapladib • In hypertension, Merck's Cozaar, goes off patent in April. • Novartis's Tekturna, • In the antiplatelets arena Bayer and Johnson & Johnson's rivaroxaban will go before the FDA once again in early 2010, seeking approval for the treatment of venous thromboembolism post-surgery. If approved, the drug will be the first new oral anticoagulant to reach the market in 40 years. • Effient may be more effective than Plavix in preventing death, myocardial infarction and stroke, but it may also cause more serious bleeding. • The Plavix patent expiry in 2011 will present a further opportunity for Effient, should additional bleeding data become available in 2010. • AstraZeneca's Brilinta, is the first reversible oral ADP receptor antagonist, and is also expected to go before the FDA in August 2010.
Oncology • Despite varied therapeutic development, it is still cancer which grabs the lion's share of the industry's attention. • Two major anticancer categories are expected to post further significant increases in 2011. • In particular, monoclonal antibodies are gaining market share, with six antibodies now appearing in the top 15 drugs of 2011 by sales. • Targeted therapies are changing the cancer market and are expected to be used in most cancer patients within five years. Indeed, cancer monoclonal antibody sales could reach over $20 billion in 2011. • Rituxan, is likely to remain the world's best selling cancer drug with forecast sales reaching $7 billion. • Roche's Avastin, has validated anti-angiogenesis as a therapeutic strategy, and follows closely behind with expected sales of $6.9 billion. • Sales of supportive care drugs for anemia (Amgen's Aranesp and J&J's Procrit) are being decimated by safety issues, but the market for white blood cell support (Amgen's Neupogen/Neulasta) is expected to remain strong, approaching $5 billion in 2011.
Central nervous system • Selective serotonin reuptake inhibitors should continue to be the mainstay treatment for depression and anxiety, despite concerns over suicide, but sales of the class are declining due to generics, as well as issues of efficacy. • Patent expiry for Effexor XR in 2010 will bring further generic erosion to the sector. • Dual-acting agents impacting both serotonin and norepinephrine (stress hormone) systems should continue to gain prescription market share from the SSRIs in 2010, driven primarily by Lilly's Cymbalta. • Melatonin (biological clock) receptor agonists are also in development for depression, with one of the lead compounds, agomelatine (from Novartis), now entering the market in Europe and expected to gain ground in 2010. Compared with existing antidepressants, agomelatine is the first melatonergic agent to demonstrate favorable data in its effect on sleep, weight and sexual function. • The migraine market is unlikely to grow significantly in 2010, given the little differentiation between Imitrex generics. • The antipsychotics (disordered thought) market may begin to change in 2010 as a third generation of antipsychotics reach the market, which may provide broader efficacy, reduced side effects and improved tolerability. Among them is sertindole (from Lundbeck), associated with less sedation when used to treat schizophrenia, and asenapine (from Schering-Plough).
Diabetes • Insulin will remain the cornerstone of treatment in 2011, for which sales will be driven by increased penetration of insulin analogs. • Lantus appears poised to retain its position as the leading insulin. • Lilly's Humalog and Novo Nordisk's Novolog share the market and new competitors are expected to have little impact. • Oral DPP-IV inhibitors are shaping up to be the next oral diabetes blockbusters. • The launch of Merck's Januvia has been positive, but the drug faces new competition from BMS/AstraZeneca's Onglyza. • Novartis's Galvus has been delayed indefinitely in the US on safety concerns. • In the GLP (glucagon-like peptide) analog sector, Lilly/Amylin's Byetta forecasts have slowed since the launch of Januvia, although Byetta LAR, a long-acting formulation, is expected to hit the US market in 2010. • Other GLP-1 analogs which look promising include Novo Nordisk's liraglutide, which has demonstrated a lower risk of hypoglycemia than existing drugs. • Liraglutide is expected to be launched in the US in 2010 • MannKind could gain approval for a delivery system that administers an inhaled dry-powder insulin formulation.
Infectious disease • GlaxoSmithKline will almost certainly maintain its pole position in the antibiotic/antiviral drug category in 2011, although Merck's share should increase, driven by its vaccine franchise (Gardasil, Zostavax). • Quinolones and macrolides have been impacted by generics, and sales forecasts are declining, but a number of new anti-MRSA antibiotics are in late-stage development and could make significant advances in 2011. These include telavancin, dalbavancin and iclaprim. • HIV, hepatitis and influenza also offer large market opportunities for new drugs in the sector. Merck's Isentress had a strong launch in 2008, and its sales are expected to top $1 billion in 2011. • H1N1 will be a particularly significant boost in 2010/2011 for vaccine manufacturers GlaxoSmithKline, sanofi-aventis, Novartis, AstraZeneca and CSL. • Roche/Gilead and GSK will also benefit from significant Tamiflu and Relenza demand respectively, both of which are expected to double sales from 2008 levels.
Top Drugs As Of 2008 Rank Drug Name Of Company Total Retail Dollars ($000) % change from 2007 1 Lipitor Phyzer 5,880,128 -4.60% 2 Nexium AstraZenca 4,794,450 10.10% 3 Plavix Bristol 3,796,221 23.10% 4 Advair Diskus GSK 3,572,473 5.40% 5 Prevacid Takeda Pharmaceuticals 3,295,465 -0.60% 6 Seroquel AstraZenca 2,908,971 15.50% 7 Singulair Merck 2,898,060 1.20% 8 Effexor XR Eli lilly 2,657,729 7.80% 9 OxyContin Purdue Pharma 2,502,982 139.80% 10 Actos Takeda Pharmaceuticals 2,447,602 9.80% 11 Lexapro Takeda Pharmaceuticals 2,412,048 4.70% 12 Abilify Ostuka 2,371,795 33.10%
13 Topamax AstraZenca 2,177,348 18.50% 14 Cymbalta Elililly 2,170,162 25.20% 15 Zyprexa Eli lilly 1,748,259 10.70% 16 Valtrex Pfizer 1,684,192 20.70% 17 Crestor AstraZenca 1,676,553 22.60% 18 Vytorin Merck 1,545,643 -20.30% 19 Lamictal GSK 1,539,101 -10.40% 20 Celebrex pfizer 1,526,818 7.80% 21 Lantus Aventis 1,475,110 13.20% 22 Levaquin GSk 1,461,080 2.00% 23 Adderall XR Shire pharmaceuticals 1,446,629 12.20% 24 Lyrica GSK 1,389,205 38.90% 25 Diovan Novartis 1,283,141 14.80% 26 Tricor Abbott 1,249,299 12.90% 27 Flomax Pfizer 1,236,963 23.40% 28 Risperdal J&J 1,221,505 -31.80%
29 Diovan HCT Novartis 1,212,308 15.30% 30 Zetia Merck 1,183,627 -15.80% 31 Aricept pfizer 1,149,221 16.90% 32 Spiriva Pfizer 1,142,746 31.60% 33 Concerta Novartis 1,103,973 7.10% 34 Aciphex Eisai Co. 1,052,133 -4.30% 35 Imitrex Oral GSK 972,778 2.30% 36 Lidoderm Endo pharma 970,208 20.10% 37 Keppra UCB 940,941 32.80% Drugs.com
Drugs Going Off Patent
Future Of The Global Pharmacy Industry • Prepare for accelerating importance of open innovation – External partners to improve the performance of R&D departments. – reasons why pharmaceutical companies increasingly engage in R&D activities with external partners. • Intensive competition • access to markets • scarce own resources • lack of know-how • cost cutting or re-structuring • growth aspirations • synergies and efficiencies • and last but not least risk reduction represent the foremost
• Commercialize internal research results more strategically – Pharmaceutical companies should not only actively look for potential in-licensing candidates but also for out-licensing candidates coming from their own inventory of intellectual property. • Balance quality and volatility of the development – Better quality and less volatility • Re-define the traditional pharmaceutical business model. – fewer companies with more blockbusters. – diseases will also become increasingly more complex to treat. – tailor-made drugs – New business models are required. • Eg. Even a single compound can create its own market.
• Reduce serendipity in discovery – eliminating the reliance on serendipity alone for future successes by involving: • Advanced database technologies • faster algorithms • improving statistical analyses • Establish strategy how to benefit from scientific breakthroughs. – number of targets will increase to over 10,000 targets in the near future. – With – access to technologies is estimated to require a minimum US$100 million annual commitment. • Complement R&D with marketing capabilities. – Which will result in in a shift from a product- to a patient-driven strategy.
• Merge functional and therapeutic knowledge – The formation of multidisciplinary teams is necessary – Marketing experts should be included as early in the R&D process as possible. – Confronting the tension between an organization by function and an organization by product group. • Challenge R&D employees – Thus eliminate the linear structured process and move towards more group- and team-oriented R&D. • Enhance people development. – Better run companies by • people development • Training • Thus enabling a more flexible career
• Balance scale and creativity – R&D is most likely to occur in smaller teams. – Hence, with any acquisition of outside knowledge, which is expected to be a major driver for improvement in R&D, there is a possible loss of creativity. – Embedded small functional units within the larger unit is a successful approach.
Future Of Indian Pharmaceutical Industry • The capability of Indian laboratories is growing by leaps and bounds each year, largely because they are stocked with people who have trained at universities and worked for companies in the U.S. and E.U. However creative work – such as the design of a molecule for a certain target – is still produced in the U.S. • The R&D costs in laboratories in India are a fraction of that in the U.S. or E.U. – There is a more favorable regulatory environment for developing new drugs in India as It is a national priority for India to develop its own pharmaceutical industry. – Consequently, India often pursues a more cooperative rather than adversarial relationship with pharmaceutical companies.
• Finally, because India wants to build its own pharmaceutical industry and export their drugs to other markets, we have begun the first stages of abiding by and respecting the intellectual property rights of foreign drug manufacturers. – For example, to comply with the Trade Related Aspects of Intellectual Property Rights (TRIPs) Agreement of the World Trade Organization (WTO), India introduced product patent protection for pharmaceuticals in January 2005. China also has begun to make progress by implementing new drug administration laws designed to streamline product registration and protect intellectual property rights.

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pharmaceuticalindustry-140625025002-phpapp02.ppt

  • 1.
  • 2.
    Index 1. Introduction 2. Evolution 3.Characteristics 4. Classification Generics Bio Phrama Formulations CRAMS 5. Regulations Global Indian 6. Global Pharmaceutical Industry • Indian Pharmaceutical Industry
  • 3.
  • 4.
    Introduction • The industryis one of the basic industries in any country. • has facilities to manufacture various types of medicine. • The Size of Indian Pharma is $ 25 billion as of April 2010
  • 5.
    Global Overview • Highlyresearch based • Revenues and profits are being squeezed, • The costs and risks of developing new drugs are climbing, and • The industry is rapidly transforming from a U.S./E.U.-focused business to a global market for both developing and selling drugs.
  • 6.
    Indian Overview • Self-reliancedisplayed by the production of 70% of bulk drugs • · Low cost of production; • · Low R&D costs; • · development of cost effective technologies; • · Increasing balance of trade in pharmacy sector; • · An efficient and cost effective source for procuring generic drugs • especially the drugs going off patent in the next few years; • · An excellent centre for clinical trials in view of the diversity in population.
  • 7.
  • 8.
    Global • In the1940s and 1950s – Penicillin was a major discovery for the emergent industry, and during R&D became firmly established within the sector. • in the 1960s – The industry expanded rapidly, benefiting from significant new discoveries with permanent patent protection. – Regulatory controls on clinical development and marketing were light and healthcare spending boomed as economies prospered. – Decision-making was in the hands of medical practitioners who were insensitive to price but susceptible too drug men enabling me too drugs, which had the same therapeutic outcome.
  • 9.
    • In the1970’s – There was tighter regulation control on clinical trials, greatly increasing development costs – Enactment of legislation to set a fixed period on patent protection (typically 20 years from initial filing as a research discovery) led to the appearance of “generic” medicines which led to substantial increases in R&D spending. • In the 1980’s – Many countries introduced some form of price or reimbursement control and price increases began to be outlawed. The industry lacked the public or political support to resist these changes. – Emergence of small biotechnology start-ups
  • 10.
    • In the1990s, – Worldwide economic recession reduced cash for provision of healthcare through government and employer funded systems. – In 1993, Overall pharmaceutical sales fell by 11 per cent while the four leading generics manufacturers increased their sales between 10 and 63 per cent. – Putting Pressure on the industry to deliver genuine products. • Year 2000 to date – Even after substantially increasing the R&D expense number of new drug approvals has declined steadily. As a result, many drug firms are focusing on ways to improve the efficiency and productivity of their R&D programs.
  • 11.
    Characteristics Of Industry •New products drive revenue growth. • Patent protection encourages new product development. • Selling effort is direct to doctors. • Price increases are restricted by government and institutional buyers. • Distribution network for mass market drugs is crucial in most countries.
  • 12.
    Classification Of Industry Formulations –Types of drugs • Branded formulations • Generics • Orphan • Active Pharmaceutical Ingredient (API) • Contract Research And Manufacturing Services (CRAMS). • Bio Pharma
  • 13.
  • 14.
    Global Despite this controversy,a series of regulatory and legislative changes have been implemented that are helping launch this segment of the pharmaceutical industry. – EMEA’s (the European Medicines Agency) establishment of a legal framework for biosimilars in 2004, followed in 2007 by guidelines for their final approval. – EMEA and FDA gave approval to Novartis for Omnitrope, a biosimilar version of a growth hormone designed to compete with Genotropin, a biologic manufactured by Pfizer.
  • 15.
    Indian • The Drugsand Cosmetics Act, 1940: This Act regulates the import, manufacture, distribution and sale of drugs in India. · Schedule M of the Drugs and Cosmetics Act specifies the general and specific requirements for factory premises and materials, plant and equipment and minimum recommended areas for basic installation for certain categories of drugs. · Schedule T of the Drugs and Cosmetics Act prescribes Good Manufacturing Practices (GMP) specifications for manufacture of Ayurvedic, Siddha and Unani medicines. · Schedule Y of the Drugs and Cosmetics Act governs the clinical trials legislative requirements of the Drugs and Cosmetics Act. • The Pharmacy Act, 1948: This legislation regulates the profession of Pharmacyin India. Under the provisions of this act the Central Government constitutes a Central Pharmacy Council of India and the State Governments constitute State Pharmacy Councils.
  • 16.
    • The Drugsand Magic Remedies (Objectionable Advertisement) Act, 1954: This Act provides to control the advertisements regarding drugs and prohibits the advertising of remedies alleged to possess magic qualities. • The Narcotic Drugs and Psychotropic Substances Act, 1985: This is an act concerned with control and regulation of operations relating to Narcotic Drugs and Psychotropic Substances. • The Medicinal and Toilet Preparations (Excise Duties) Act, 1956: An Act to provide for the levy and collection of duties of excise on medicinal and toilet preparations • The Drugs Price Control Order (DPCO), 1995: This is an order issued by the • Government of India under the Essential Commodities Act,1955 To regulate the prices of drugs. The Order provides the list of price controlled drugs, procedure for fixation of prices of drugs, method of implementation of prices fixed by Government and penalties for contravention of provisions among other things. For the purpose of implementing provisions of DPCO, powers of the Government have been vested in the National Pharmaceutical Pricing Authority (NPPA).
  • 17.
    • Good ClinicalPractice (GCP) Guidelines: The Ministry of Health, along with Drugs Controller General of India (DCGI) and Indian Council for Medical Research (ICMR) has come out with draft guidelines for research in human subjects. These GCP guidelines are essentially based on Declaration of Helsinki, World Health Organization (WHO) guidelines and International Conference on Harmonization (ICH) requirements for good clinical practice. • The following are laws which have a bearing on pharmaceutical manufacture, distribution and sale in India: · The Industries (Development and Regulation) Act, 1951 · The Trade and Merchandise Marks Act, 1958 · The Indian Patent and Design Act, 1970 · Factories Act
  • 18.
    Regulatory Bodies: • Ministryof Chemicals and Fertilisers (MoC&F): • The following departments are entrusted with the responsibility of policy making, planning, development and regulations relating to Chemicals, Petrochemicals and Pharmaceuticals. • Department of Chemicals & Petro-Chemicals:achieving growth and development of pharmaceuticals in the country and to attract investment. • The first comprehensive pharmaceutical policy in India was formulated in 1978. new policy guidelines issued in 1986, 1994 and recently in 2002.
  • 19.
    • Pharmaceutical Policy2002 • To ensure availability of good quality essential pharmaceuticals at reasonable prices for mass consumption. • To strengthen the indigenous capability for cost effective quality production and export of pharmaceuticals by reducing trade barriers in the • pharmaceutical sector. • · Quality control system for pharmaceutical production and distribution to • make quality an essential attribute of the domestic industry. • · Encouraging pharmaceutical R&D that is compatible with the country's • needs. • · To encourage new investment in the pharmaceutical industry and the • introduction of new technologies and new drugs.
  • 20.
    • · Toensure availability of good quality essential pharmaceuticals at reasonable prices for mass consumption. • · To strengthen the indigenous capability for cost effective quality • production and export of pharmaceuticals by reducing trade barriers in the • pharmaceutical sector. • · Quality control system for pharmaceutical production and distribution to • make quality an essential attribute of the domestic industry. • · Encouraging pharmaceutical R&D that is compatible with the country's • needs. • · To encourage new investment in the pharmaceutical industry and the • introduction of new technologies and new drugs.
  • 21.
    Global Pharmaceutical Industry •Size • Region Wise Break up • Top 12 players • Top therapies • Top drugs by sale
  • 22.
    Size • The globalpharmaceutical market is roughly $750 billion as of April 2010. • The global pharmaceutical market is forecasted to grow to $1 trillion in 2013, an equivalent compound annual growth rate (CAGR) of 5.5-8% over the next three years. • Even as growth slowed somewhat in Europe and North America, the United States accounts for almost half of the global pharmaceutical market, with followed by the EU and Japan. • Emerging markets such as China, Russia, South Korea and Mexico outpaced that market, growing a huge 81 percent.
  • 23.
    Region Wise BreakUp • Thirty-four major pharmaceutical markets from North America, Latin America, Europe, Asia-Pacific and Africa have been selected as the most important regions to be presented in this report.
  • 24.
    • Latin America –The Latin American pharmaceutical market generated $28.8bn sales in 2008, an increase of 15.3%from previous year. Therapeutic indications that fuelled growth include included antihypertensives, dermatologicals and sex hormone preparations. • Brazil was the largest market with $11.4bn sales amounting to 39.6% share of the Latin American market. • Peru was the smallest accounting for only 1.9% share. • Venezuela at 32.2% increase was the fastest growing regional market in 2008. • Recession hit Mexico reported flat y-o-y growth of 0.1%. • Argentinean pharmacy market is US$3.0 billion
  • 25.
    • drug salesin Germany reached US$53.73bn in 2009. • Eastern Europe. – The Eastern European pharma market is forecast to grow at a CAGR of 10.2% to reach a value of $41.4bn in 2014. The cardiovascular market is expected to register the highest sales ($7.8bn) in 2014, followed by alimentary canal & metabolic disorders ($6bn). – Romania recorded the highest growth in pharma sales over the 2006–07 period (44.6%), followed by Slovakia (37.1%). Growth in these markets has been driven by increasing access to modern medicines, as regional branded generic manufacturers enter the market and take share from domestic suppliers. – Novartis led the Eastern European pharma market with $1.5bn sales in 2007, a 27.3% increase over 2006. The company has the unique advantage of marketing both generic and branded pharma products across a wide range of therapy areas. – Lovenox (enoxaparin) from Sanofi-Aventis was the leading treatment in the Eastern European pharma market in 2007, with sales of $152m. Other leading brands were dominated by low molecular weight fractionated heparin and ACE inhibitor drugs.
  • 26.
    • Russian – In2005 the Russian pharmaceuticals market was worth approx. $9bn in consumer prices and $7.2bn in wholesaler prices • UK – In the UK the retail pharmacy market was worth £12.8bn in 2006 – little is written about this sector as a whole.
  • 27.
    Company Country TotalRevenue Total Income/loss R&D costs Fortune 500 rank Johnson & Johnson United States 61897 12266 6986 103 Pfizer United States 50009 8635 7845 152 Roche Switzerland 45304 7,678.00 8909 171 GlaxoSmithKline United Kingdom 44421 8,405 6088 168 Novartis Switzerland 44267 8454 7469 183 Sanofi-Aventis France 40870 8471 4583 181 AstraZeneca United Kingdom 32804 7544 4409 268 Abbott Laboratories United States 30765 5746 2744 294 Merck & Co. United States 27428 13024 5800 378 BayerHealthCare Germany 22297 1696 1845 154 Eli Lilly United States 21836 4328 N/A 455 Bristol-Myers Squibb United States 18808 4420 3647 435 Top Players
  • 28.
    In 25 years,the market capitalization of the top 6 companies has grown from less than $25 billion in 1982 to nearly $525 billion by 2006. Industry Consolidation has Turned 51 Companies Into 10. Pfizer Warner Lambert Pharmacia AB Agouron The Upjohn Company Monsanto (Searle) Esperion Therapeutics Inc. Vicuron Pharmaceuticals Inc. Abbott Knoll AG Thera Sense Inc. Kos Pharmaceuticals Inc. SmithKline Beckman Beecham Group Glaxo Wellcome Diversified Pharmaceutical Services Inc. Sterling Health Block Drug Co. ID Biomedical Corp. Merck Sirna Serono Medco Pfizer Merck GlaxoSmithKline Abbot
  • 29.
    American Cyanamid (Lederle) American Home Products A.H.Robins Co. Genetics Institute Inc. Rhone-Poulenc Rorer Marion Laboratories Merrel Dow Pharmaceuticals Hoechst Roussel Uclaf Synthelabo Sanofi Fisons Bristol-Myers Squibb DuPont Pharmaceuticals Astra AB Zeneca Group PLC MedImmune Cambridge Antibody Technology Ciba-Geigy Sandoz Eon Labs Hexal AG Chiron Eli Lilly ICOS Corp. AstraZenca Sanofi-Aventis Novartis Bristol-Myers Squibb Eli Lilly Wyeth
  • 30.
  • 31.
    Cardiovascular In cholesterol management,Lipitor will almost certainly remain the top statin in 2010, but the availability of generic simvastatin has resulted in increased therapeutic substitution and declining franchise share • Potential new product is GlaxoSmithKline's darapladib • In hypertension, Merck's Cozaar, goes off patent in April. • Novartis's Tekturna, • In the antiplatelets arena Bayer and Johnson & Johnson's rivaroxaban will go before the FDA once again in early 2010, seeking approval for the treatment of venous thromboembolism post-surgery. If approved, the drug will be the first new oral anticoagulant to reach the market in 40 years. • Effient may be more effective than Plavix in preventing death, myocardial infarction and stroke, but it may also cause more serious bleeding. • The Plavix patent expiry in 2011 will present a further opportunity for Effient, should additional bleeding data become available in 2010. • AstraZeneca's Brilinta, is the first reversible oral ADP receptor antagonist, and is also expected to go before the FDA in August 2010.
  • 32.
    Oncology • Despite variedtherapeutic development, it is still cancer which grabs the lion's share of the industry's attention. • Two major anticancer categories are expected to post further significant increases in 2011. • In particular, monoclonal antibodies are gaining market share, with six antibodies now appearing in the top 15 drugs of 2011 by sales. • Targeted therapies are changing the cancer market and are expected to be used in most cancer patients within five years. Indeed, cancer monoclonal antibody sales could reach over $20 billion in 2011. • Rituxan, is likely to remain the world's best selling cancer drug with forecast sales reaching $7 billion. • Roche's Avastin, has validated anti-angiogenesis as a therapeutic strategy, and follows closely behind with expected sales of $6.9 billion. • Sales of supportive care drugs for anemia (Amgen's Aranesp and J&J's Procrit) are being decimated by safety issues, but the market for white blood cell support (Amgen's Neupogen/Neulasta) is expected to remain strong, approaching $5 billion in 2011.
  • 33.
    Central nervous system •Selective serotonin reuptake inhibitors should continue to be the mainstay treatment for depression and anxiety, despite concerns over suicide, but sales of the class are declining due to generics, as well as issues of efficacy. • Patent expiry for Effexor XR in 2010 will bring further generic erosion to the sector. • Dual-acting agents impacting both serotonin and norepinephrine (stress hormone) systems should continue to gain prescription market share from the SSRIs in 2010, driven primarily by Lilly's Cymbalta. • Melatonin (biological clock) receptor agonists are also in development for depression, with one of the lead compounds, agomelatine (from Novartis), now entering the market in Europe and expected to gain ground in 2010. Compared with existing antidepressants, agomelatine is the first melatonergic agent to demonstrate favorable data in its effect on sleep, weight and sexual function. • The migraine market is unlikely to grow significantly in 2010, given the little differentiation between Imitrex generics. • The antipsychotics (disordered thought) market may begin to change in 2010 as a third generation of antipsychotics reach the market, which may provide broader efficacy, reduced side effects and improved tolerability. Among them is sertindole (from Lundbeck), associated with less sedation when used to treat schizophrenia, and asenapine (from Schering-Plough).
  • 34.
    Diabetes • Insulin willremain the cornerstone of treatment in 2011, for which sales will be driven by increased penetration of insulin analogs. • Lantus appears poised to retain its position as the leading insulin. • Lilly's Humalog and Novo Nordisk's Novolog share the market and new competitors are expected to have little impact. • Oral DPP-IV inhibitors are shaping up to be the next oral diabetes blockbusters. • The launch of Merck's Januvia has been positive, but the drug faces new competition from BMS/AstraZeneca's Onglyza. • Novartis's Galvus has been delayed indefinitely in the US on safety concerns. • In the GLP (glucagon-like peptide) analog sector, Lilly/Amylin's Byetta forecasts have slowed since the launch of Januvia, although Byetta LAR, a long-acting formulation, is expected to hit the US market in 2010. • Other GLP-1 analogs which look promising include Novo Nordisk's liraglutide, which has demonstrated a lower risk of hypoglycemia than existing drugs. • Liraglutide is expected to be launched in the US in 2010 • MannKind could gain approval for a delivery system that administers an inhaled dry-powder insulin formulation.
  • 35.
    Infectious disease • GlaxoSmithKlinewill almost certainly maintain its pole position in the antibiotic/antiviral drug category in 2011, although Merck's share should increase, driven by its vaccine franchise (Gardasil, Zostavax). • Quinolones and macrolides have been impacted by generics, and sales forecasts are declining, but a number of new anti-MRSA antibiotics are in late-stage development and could make significant advances in 2011. These include telavancin, dalbavancin and iclaprim. • HIV, hepatitis and influenza also offer large market opportunities for new drugs in the sector. Merck's Isentress had a strong launch in 2008, and its sales are expected to top $1 billion in 2011. • H1N1 will be a particularly significant boost in 2010/2011 for vaccine manufacturers GlaxoSmithKline, sanofi-aventis, Novartis, AstraZeneca and CSL. • Roche/Gilead and GSK will also benefit from significant Tamiflu and Relenza demand respectively, both of which are expected to double sales from 2008 levels.
  • 36.
    Top Drugs AsOf 2008 Rank Drug Name Of Company Total Retail Dollars ($000) % change from 2007 1 Lipitor Phyzer 5,880,128 -4.60% 2 Nexium AstraZenca 4,794,450 10.10% 3 Plavix Bristol 3,796,221 23.10% 4 Advair Diskus GSK 3,572,473 5.40% 5 Prevacid Takeda Pharmaceuticals 3,295,465 -0.60% 6 Seroquel AstraZenca 2,908,971 15.50% 7 Singulair Merck 2,898,060 1.20% 8 Effexor XR Eli lilly 2,657,729 7.80% 9 OxyContin Purdue Pharma 2,502,982 139.80% 10 Actos Takeda Pharmaceuticals 2,447,602 9.80% 11 Lexapro Takeda Pharmaceuticals 2,412,048 4.70% 12 Abilify Ostuka 2,371,795 33.10%
  • 37.
    13 Topamax AstraZenca2,177,348 18.50% 14 Cymbalta Elililly 2,170,162 25.20% 15 Zyprexa Eli lilly 1,748,259 10.70% 16 Valtrex Pfizer 1,684,192 20.70% 17 Crestor AstraZenca 1,676,553 22.60% 18 Vytorin Merck 1,545,643 -20.30% 19 Lamictal GSK 1,539,101 -10.40% 20 Celebrex pfizer 1,526,818 7.80% 21 Lantus Aventis 1,475,110 13.20% 22 Levaquin GSk 1,461,080 2.00% 23 Adderall XR Shire pharmaceuticals 1,446,629 12.20% 24 Lyrica GSK 1,389,205 38.90% 25 Diovan Novartis 1,283,141 14.80% 26 Tricor Abbott 1,249,299 12.90% 27 Flomax Pfizer 1,236,963 23.40% 28 Risperdal J&J 1,221,505 -31.80%
  • 38.
    29 Diovan HCTNovartis 1,212,308 15.30% 30 Zetia Merck 1,183,627 -15.80% 31 Aricept pfizer 1,149,221 16.90% 32 Spiriva Pfizer 1,142,746 31.60% 33 Concerta Novartis 1,103,973 7.10% 34 Aciphex Eisai Co. 1,052,133 -4.30% 35 Imitrex Oral GSK 972,778 2.30% 36 Lidoderm Endo pharma 970,208 20.10% 37 Keppra UCB 940,941 32.80% Drugs.com
  • 39.
  • 47.
    Future Of TheGlobal Pharmacy Industry • Prepare for accelerating importance of open innovation – External partners to improve the performance of R&D departments. – reasons why pharmaceutical companies increasingly engage in R&D activities with external partners. • Intensive competition • access to markets • scarce own resources • lack of know-how • cost cutting or re-structuring • growth aspirations • synergies and efficiencies • and last but not least risk reduction represent the foremost
  • 48.
    • Commercialize internalresearch results more strategically – Pharmaceutical companies should not only actively look for potential in-licensing candidates but also for out-licensing candidates coming from their own inventory of intellectual property. • Balance quality and volatility of the development – Better quality and less volatility • Re-define the traditional pharmaceutical business model. – fewer companies with more blockbusters. – diseases will also become increasingly more complex to treat. – tailor-made drugs – New business models are required. • Eg. Even a single compound can create its own market.
  • 49.
    • Reduce serendipityin discovery – eliminating the reliance on serendipity alone for future successes by involving: • Advanced database technologies • faster algorithms • improving statistical analyses • Establish strategy how to benefit from scientific breakthroughs. – number of targets will increase to over 10,000 targets in the near future. – With – access to technologies is estimated to require a minimum US$100 million annual commitment. • Complement R&D with marketing capabilities. – Which will result in in a shift from a product- to a patient-driven strategy.
  • 50.
    • Merge functionaland therapeutic knowledge – The formation of multidisciplinary teams is necessary – Marketing experts should be included as early in the R&D process as possible. – Confronting the tension between an organization by function and an organization by product group. • Challenge R&D employees – Thus eliminate the linear structured process and move towards more group- and team-oriented R&D. • Enhance people development. – Better run companies by • people development • Training • Thus enabling a more flexible career
  • 51.
    • Balance scaleand creativity – R&D is most likely to occur in smaller teams. – Hence, with any acquisition of outside knowledge, which is expected to be a major driver for improvement in R&D, there is a possible loss of creativity. – Embedded small functional units within the larger unit is a successful approach.
  • 52.
    Future Of IndianPharmaceutical Industry • The capability of Indian laboratories is growing by leaps and bounds each year, largely because they are stocked with people who have trained at universities and worked for companies in the U.S. and E.U. However creative work – such as the design of a molecule for a certain target – is still produced in the U.S. • The R&D costs in laboratories in India are a fraction of that in the U.S. or E.U. – There is a more favorable regulatory environment for developing new drugs in India as It is a national priority for India to develop its own pharmaceutical industry. – Consequently, India often pursues a more cooperative rather than adversarial relationship with pharmaceutical companies.
  • 53.
    • Finally, becauseIndia wants to build its own pharmaceutical industry and export their drugs to other markets, we have begun the first stages of abiding by and respecting the intellectual property rights of foreign drug manufacturers. – For example, to comply with the Trade Related Aspects of Intellectual Property Rights (TRIPs) Agreement of the World Trade Organization (WTO), India introduced product patent protection for pharmaceuticals in January 2005. China also has begun to make progress by implementing new drug administration laws designed to streamline product registration and protect intellectual property rights.