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Beyond Borders: Global biotechnology report 2010

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China year in review<br />

Accelerating reforms<br />

It is evident that China will be an<br />

increasingly important market for<br />

<strong>biotechnology</strong> and pharmaceutical<br />

products and companies in the years<br />

to come. Indeed, it is now considered<br />

essential for companies with commercial<br />

operations or aspirations to formulate<br />

a strategy for the Chinese market — a<br />

market currently dominated by generics<br />

(including generic versions of Western<br />

biologic drugs) and traditional Chinese<br />

medicines (TCMs). Meanwhile, the<br />

Chinese Government is encouraging the<br />

development of a domestic innovative<br />

<strong>biotechnology</strong> sector through a combination<br />

of direct investment, intellectual property<br />

reforms and commercial incentives. Yet<br />

for all the promise, the sheer volume of<br />

change — driven both by market dynamics<br />

and Government reforms — is daunting,<br />

creating uncertainties for investors in<br />

China’s biotech sector.<br />

Growth and consolidation<br />

China’s pharmaceutical market continues<br />

to post impressive year-over-year<br />

growth driven by macro trends — an<br />

aging population, Government programs<br />

to significantly broaden access to<br />

medicines, increasing personal wealth<br />

and the increasing incidence of “middle<br />

class diseases,” such as diabetes and<br />

hypertension. A recent IMS Health <strong>report</strong><br />

pegged the market’s annual growth rate<br />

at 27% from 2006 to 2009 and projected<br />

that China would surpass Germany and<br />

France to become the third-largest drug<br />

market in the world by 2011 (behind only<br />

the US and Japan).<br />

At present, the industry is highly<br />

fragmented, with several thousand<br />

domestic manufacturers and distributors<br />

competing alongside most of the major<br />

multinational companies from the US,<br />

Europe and Japan. To boost efficiency and<br />

quality, the Government is encouraging<br />

consolidation of the domestic industry,<br />

partially through changes to the drug<br />

distribution system and price reforms.<br />

It is aiming to reshape the industry with<br />

fewer financially strong entities that have<br />

the scale necessary to undertake national<br />

distribution and investments in innovative<br />

R&D and, eventually, compete globally<br />

through exports.<br />

<strong>Beyond</strong> the market opportunity, China<br />

remains a highly attractive outsourcing<br />

destination in terms of cost efficiency and,<br />

increasingly, patient availability for clinical<br />

trials, expertise and infrastructure.<br />

Essential reform<br />

In March 2009, China adopted a massive<br />

reform of the health care system,<br />

committing RMB 850 billion (US$124<br />

billion) over the next three years to<br />

increase health insurance for the<br />

non-employed urban and rural<br />

populations. While health care reform<br />

was driven by the realization that a<br />

healthy population is necessary to<br />

sustain economic growth, the 2009<br />

policies were accelerated by the global<br />

recession. Chinese leaders concluded<br />

that the country needed to decrease its<br />

dependence on exports while maintaining<br />

employment levels through encouraging<br />

domestic consumption. The Chinese<br />

population has historically had a very<br />

high savings rate, in part to save for<br />

unexpected and uncovered medical<br />

expenditures; thus, providing greater<br />

30 <strong>Beyond</strong> borders <strong>Global</strong> <strong>biotechnology</strong> <strong>report</strong> <strong>2010</strong><br />

health coverage will presumably free up<br />

capacity for non-health related spending.<br />

The increased coverage will lead to higher<br />

pharmaceutical sales, but distribution<br />

to second- and third-tier cities and rural<br />

populations will remain a challenge for<br />

many manufacturers.<br />

<strong>Beyond</strong> health insurance coverage, the<br />

Government is also addressing the drug<br />

distribution process itself as part of the<br />

reform efforts. A significant majority<br />

of drug sales are now made through<br />

state-owned hospitals. Hospitals depend on<br />

the margin from these sales (generally 15%)<br />

to fund their operations and are therefore<br />

motivated to prescribe higher-priced<br />

medicines to maximize the margin earned.<br />

This drives up overall system costs and<br />

creates an environment that encourages<br />

improper sales practices.<br />

Finally, in August 2009, China updated<br />

its Essential Drugs List (EDL), which<br />

includes 307 medicines that will be given<br />

priority from a usage and reimbursement<br />

standpoint. Approximately two-thirds of the<br />

EDL is composed of products discovered and<br />

developed outside China (most of which are<br />

available in generic form in China already)<br />

and one-third is composed of TCMs. The<br />

Government will set the prices for drugs on<br />

the EDL, which will put a premium on costeffective<br />

manufacturing and distribution and<br />

generally benefit larger players. Innovative<br />

and patented drugs sold by multinational<br />

companies will continue to be funded largely<br />

by patients.<br />

Despite their higher cost, brand-name<br />

drugs that no longer have patent protection<br />

are often favored by populations in more<br />

affluent urban settings as they are<br />

perceived to be of higher quality than<br />

generic competitors.

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