Bringing Biologics to Market in the BRIC Countries

Pharmaceutical companies are realizing the lucrative opportunities for growth offered by biologics because these high-priced drugs can target growing niche markets, compensate for dwindling pipelines, and even offset revenue loss as a result of patent expirations. In particular, pharmaceutical companies are slowly realizing the effectiveness of this strategy in Brazil, Russia, India, and China (collectively referred to as "BRIC")-emerging markets with thriving economies, unmet medical needs, growing patient populations, and increased investment in healthcare. With regulators, payers, physicians, and patients showing increasing interest in biologics, pharmaceutical companies may be pleasantly rewarded for emphasizing biologics development-if they can successfully navigate the diverse country-specific healthcare trends in the emerging markets.

Questions Answered in This Report:

• Whether it is a country's health infrastructure, growing affluent population, better life expectancy rates, incentive programs, or government policies, several key emerging markets are primed for biologics. What is the appeal of the pharmaceutical markets in the BRIC countries to manufacturers of biologics? What challenges do these markets present?
• Intellectual property laws for pharmaceuticals in BRIC markets vary widely, creating a key challenge for multinational corporations (MNCs) interested in launching biologics launches in these markets. Which of the BRIC countries has the least-developed intellectual property protection? How do the patent laws influence the marketing of biologics in these countries?
• Formal regulatory pathways for approval of biologics are nascent, incomplete, or nonexistent in many of the BRIC countries. However, in some markets, such as China and India, numerous domestic versions of easy-to-produce biological products are commonly available. What actions are foreign and domestic companies as well as the government taking to create a competitive biologics environment in the BRIC markets?
• The uptake of biologics in Brazil is strongly influenced by cost and reimbursement considerations. As few as 25% of eligible patients are able to secure coverage from private insurers. What factors are used to determine cost and reimbursement values for monoclonal antibodies (MAbs), for instance? How do public-sector patients ensure reimbursement for their biologics?
• Hospitals in China are the dominant distribution channels for prescription drugs, accounting for approximately 80% of prescription volume. However, only 6% of all hospitals are considered to be "tier 3" (municipal/university urban), which is the setting in which high-priced biologics are most likely to be administered. How can access to these agents improve in rural regions and in other areas lacking tier 3 facilities, thereby increasing the sales potential for biologics? How will financial incentives impact sales of biologics?
• The lack of adequate funding and facilities for proper distribution and storage of biologics in rural India exacerbates the challenge of making biological treatment available locally, creating an untreated population of disproportionate size. What roles do the government, nongovernment organizations, MNCs, and domestic manufacturers play in promoting wider use of biologics in India? How do public funding, biologics regulation, and the existing reimbursement infrastructure factor into the situation?
• Russia is a cost-conscious market and thus presents a limited scope for the uptake of high-priced biologics. However, an increase in government spending on healthcare is expected in Russia, as is an increase in the use of expensive and more-efficacious treatment regimens including high-priced biologics. What hurdles must MNCs overcome to capitalize on the anticipated opportunities in the Russian pharmaceutical market?

Scope:

Markets covered: Brazil, Russia, India, and China.

Indications: Market potential of biologics uptake in hepatitis C virus, rheumatoid arthritis, colorectal cancer, non-small-cell lung cancer (NSCLC), and breast cancer populations in the BRIC countries.

Populations and segments of interest: Urban/rural, public/private sector, and domestic/foreign biologics manufacturing.

Primary research: Insight from surveys and interviews administered by Decision Resources analysts on brand perception, reimbursement, and use of biosimilars.

Market forecast features: Comparing sales and patient population forecasts for trastuzumab, interferon therapies, etanercept, and other biologics in BRIC countries with those of major markets.

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