蓬勃发展的全球仿制药市场：困难与复杂性(2013年)

蓬勃发展的全球仿制药市场

A robust generic market: difficulties and complexitiesAthens, 6th March 2013SARAH RICKWOOD, Director Thought Leadership, IMS HEALTH

蓬勃发展的全球仿制药市场

Agenda slide

The Global Generics Market No Longer Protected Brands Country Environment

Key Factors for a Robust Generic medicines market- Net Cost of Treatment - Rules and Incentives: INN Prescribing Case Studies

The Future of Generics

- Where growth will come from? - Biosimilars

蓬勃发展的全球仿制药市场

1 The Global Generics Market

Generics have seen superior growth performance for a number of years2008-2012: Global Generic Volume Sales 1,100 1,000 900 Volume in SU Billion 800 700 600 500 400 300 200 100 0 2008 2009 2010 2011 2012Generic Volume Generic Volume Growth Pharma growth

10 892 938 9 8 7 6 5 4 3 2 1 0 Volume Growth (%)

715

760

830

Growth is driven by government that under high debt and fiscal deficits are pushing for even greater generication In Pharmerging countries growth is underpinned by generic growth Fewer, smaller small molecules going forward

Pharma

Generics

5 yr CAGR

5.0%

7.2%

Source: IMS Health, MIDAS, MAT Sept 2012, Rx only. Market Segmentation+ LIC countries 3

蓬勃发展的全球仿制药市场

1 The Global Generics MarketTop 8 Mature

Accelerated shift in spending on generics is expected to continue to 2016 in the mature markets2007: 513 Bn13% 15% 11% 16%

2011: 587 Bn12% 14%

2016: 623– 643 Bn13% 20%

20%

61% Generics

58% Protected (Non-generic) Unprotected (Non-generic)

47% Other 5 Yr CAGR

Globally, growth between 2012-2016 is forecast to slow to 3-6% CAGR compared to 6% over the past five years. Largest growth seen in Generics as a result of increased LOE, payer reforms and growth

Region Top 8 Mature Protected (Non-Generic) Generics Unprotected (Non-Generic)

2007 -2011 4% 3% 9% 4%

2012-2016 0 - 3% (4)– (1)% 8– 11% 4– 7%

Source: IMS Health Market Prognosis, Sept 2012 (*) at ex-manufacturer price levels, not including rebates and discounts. Audit data only. Market size represented in constant US$. All CAGR calculations are 5 years 4

蓬勃发展的全球仿制药市场

1 Dynamics No Longer Protected Brands

Each country shows a unique pattern of products in the protected and un-protected sectorMarket share segmentation ranked by no longer protected brands100% 90% 80% 70% 60% 50% 40%

10%

11%

10% 0%

14%

16%

Others Branded

19%

20%

24%

25%

25%

INN Unbranded Protected

26%

27%

28%

29%

32%

Source: IMS Health, MIDAS, Market Segmentation, MAT Sep 2012, Rx only. 5

32%

20%

Company Branded No Longer Protected

33%

33%

34%

38%

46%

30%

蓬勃发展的全球仿制药市场

1 Country EnvironmentTop 8 Mature

Historically generic penetration moves slowly even in large markets: recently Spain has accelerated2003-2012: Generic volume penetration dynamics in the top 8 markets100 GENERIC VOLUME SHARE of UNPROTECTED MARKET% (SU) 90 80 70 60 50 40 30 20 2003 2004 2005 Canada France 2006 Italy 2007 2008 Japan Spain 2009 UK United States 2010 2011 2012 Germany

Source: IMS MIDAS Sep 2012 Ethical Total Market based on SU

. 6

蓬勃发展的全球仿制药市场

1 Models of Generics Systems

We have several different models of generic systemsPayer centric Low prices Patient get different mfg Logistic challenges Prescriber centric High prices No/low discounts Patient get same mfg

Payer centric

Prescriber centric

Pharmacist centric Pharmacist centric Varied prices High discounts Patient get same mfg7

蓬勃发展的全球仿制药市场

1 Challenges

Generic companies are in a period of significant opportunity, but there are challenges

Geography Which are the most promising countries to focus on? Country profitability and Geo-expansion Therapy area Which areas hold the greatest promise? Movement to specialty

Molecules Which are the molecules which will undergo least price erosion over time? Vertical integration and API control

Technologies What technologies will provide competitive edge and sustainable margins? Devices and delivery systems

And not forgetting

Evolving structures, changing regulations, role of stakeholders and scope of new players in generics

蓬勃发展的全球仿制药市场

Agenda slide

The Global Generics Market

No Longer Protected Brands Country Environment

Key Factors for a Robust Generic medicines market- Net Cost of Treatment - Rules and Incentives: INN Prescribing Case Studies

The Future of Generics

- Where growth will come from? - Biosimilars

蓬勃发展的全球仿制药市场

2 Net Cost of Treatment

Payers tend to focus on price, however, medicine mix is key to cost reductionIMS developed a methodology to assess drug mix and prices across countries... IMS Methodology Price per unit ...based on a basket of medicines including seven therapy areas

Mix of drugs

*

Cost per treatme nt day Pharmaceutical costs

*Treatment volume (treatment days)

Angiotensin II antagonists, antidepressants, anti-epileptics, antipsychotics, anti-ulcerants, cholesterol regulators and oral anti-diabetics. The cost is calculated as each countries mix of patented/ NLP, and generic products The TA weights are the same for all countries

蓬勃发展的全球仿制药市场

2 Net Cost of Treatment

Greece has historically higher cost/daily dose than the EU average but recent reforms change thisCost per treatment day, based on DDD, Q3 12 vs. Q3 11

Q3 2012

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