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Agenda
API and Regulatory Intelligence at Thomson Reuters Why are regulated market players interested in Emerging markets? Opportunities and challenges of selling API to BRIC countries Q&A
Used by over 220 companies and 3000 users across the globe
Used by over 200 companies and 4000 users across the globe
Industry Backdrop
Growth Expectations for 2009
Will hold steady at 2008 levels*
US: 1-2%, EU5: 3-4%, Japan: 4-5% BRIC: 14-15%
Brand pharma
Innovation slump Blockbusters losing patent protection Outsourcing of manufacturing and R&D
Generics
Increasing competition, especially from India Low cost API coming from India, China Margin pressures in U.S., UK, Germany Drop in small molecule opportunities post-2011
Will growth in BRIC markets translate into opportunities for regulated market API manufacturers?
*2009 IMS Global Pharmaceutical and Therapy Forecast
INDIA
Increasing costs
Salaries, energy, raw materials from China
Gaps in technology
Fermentation, steroids, narcotics Filled by acquisitions (Strides-Diaspa, Sun-Chattem)
Increasing number of Big Pharma with manufacturing presence (ex: Glaxo, Pfizer)
Bureaucratic system
Amount of time required to get a product registered varies Paperwork can be held up on minor technicalities Open for potential abuse
Import Duties
In 2007, maximum customs duties on APIs and intermediates were reduced from 12.8% to 7.7%.
Import duties are waived if the finished dose product is ultimately exported
Almost 1200 unique Indian Import Registration (IIR) Certificates issued since introduction (Jan 2003) >1/3 from China 55% from regulated markets Filings for prestige? APIs in transit not registered
Rush by regulated market players to get their products registered in 2003 New filings primarily coming out of emerging markets
Cefotaxime sodium Clavulanate potassium Ofloxacin Amoxicillin Erythromycin Vancomycin hcl Thiamine mononitrate (Vit B1) Penicillin G Potassium Gatifloxacin Erythromycin thiocyanate Cefuroxime sodium Cefoperazone sodium
10 9 8 8 8 7 7 7 7 7 7 7
Clavulanate potassium Amoxicillin Amoxicillin sodium Beclomethasone dipropionate Cefuroxime Sodium Hydrocortisone sodium succinate Lactulose Pancreatin
CHINA
Increasing costs
Salaries, energy, workforce turnover, regulatory, environmental
Gaps in technology?
Registration certificate valid for 5 years A single agent per product required in China sFDA follows established timelines
Can track the process of dossier review on sFDA website About 18 months to register API
Duties are waived if the finished dose product is ultimately exported (lailiao jiagong)
Must import and export through the same port Quantity of incoming API must match quantity in outgoing finished dose
Unique IDLs
Over 400 unique Chinese Import Drug Licenses approved since January 2004
Considerably less than in India How many are for PR reasons?
Italy 5%
Rush by regulated market players to get their APIs registered (or re-registered) in 2004 New filings continuing to come out of regulated markets
Clavulanate potassium Ubidecarenone (coenzyme Q10) Clarithromycin Amoxicillin Ceftizoxime sodium Cephalexin Cefuroxime sodium Cefuroxime axetil Cefaclor Cefpodoxime proxetil Cefminox sodium Cefixime
5 5 4 4 5 4 4 4 4 4 4 4
Products with Most Unique Chinese Import Drug Licenses from Regulated Markets
Product Name IDLs from Regulated Markets 5 3 3 3 3 3 3 IDLs from Emerging Mkts (India) 0 (0) 1 (0) 0 (0) 1 (1) 2 (0) 0 (0) 0 (0) Confirmed Chinese Mfrs (US DMFs) 1 (0) 10 (2) 9 (0) 5 (2) 5 (0) 0 (0) 2 (0)
Ubidecarenone (CoQ10) Amoxicillin Cephradine Clarithromycin Clavulanate potassium Lactulose Minocycline hcl
USA Italy
9 9
Yes No
No No
Products with a marketing message Specialized anti-cancers Vaccines Diagnostics Very complex and hazardous chemistries Select small volume drugs Large volume products with economies of scale Products requiring dedicated facilities
RUSSIA
Gaps in technology
Everything except certain biologics
Medicines Import Licenses granted by Ministry for Economic Development Since January 2007, system of Declaration of Conformity
Replaced prior system of mandatory certification Applies to a particular consignment Valid until the expiration date of the pharmaceuticals in the consignment
Import license 0.05% of contract price Import Duties, VAT, and Custom Fees
Import duties: 5%, 10% or 15% depending on product VAT: 0% or 10% depending on product Custom fees: variable, including for custom legalization, custom escort, and storage
Source: Thomson Reuters IDRAC
BRAZIL
Focus continues to be on price Limited manufacturing of finished dose for export to regulated markets
Significant amounts exported to other Latin American countries
Import Duties
0% to 17% based on product Member countries of MERCOSUL (Argentina, Paraguay, Uruguay) exempted
CONCLUSIONS
China
New and better products
Must have relationships, marketing message, long-term strategy
Russia
Products not manufactured in India and China Products used only in Russia
Brazil
Products not manufactured in India and China Regulatory environment getting tougher
China
Capacity to manufacture most products locally Dose export into regulated markets just starting
Russia
Focus on price Complex and changing regulations
Brazil
Focus on price Rules and interpretation constantly changing
Analyze the market: Is there need for these products in individual BRIC countries?
Has the finished dose been launched? Can this be used in novel formulations? Is the API manufactured locally? If not, what are the barriers to manufacturing it locally? Are others from regulated market already selling this product into BRIC countries? Are you ready to commit for long term?
Thank you!
Consultants and industry friends Data and Research teams of Thomson Reuters API Intelligence Team IDRAC
Q&A
Kate Kuhrt Director, Generics and API Intelligence Thomson Reuters 215 Commercial Street Portland, Maine 04101 USA + 1 (207) 871-9700 x26 kate.kuhrt@thomsonreuters.com