Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Brazil's biotech firms: From imitators to innovators in health-related products

09.06.2008
New Brazilian products emerge for local health needs; same trend seen also in emerging markets of India, China

Brazil is in the midst of a transition from imitator to innovator in health-related products, according to the most comprehensive analysis to date of barriers and opportunities facing that country's health biotech industry.

In the third study of its kind, the McLaughlin-Rotman Centre for Global Health (MRC), says South America's largest and most populous country has the scientific and market capacity to emerge as a major global player. It is held back, however, by a number of important challenges including regulatory barriers, limited access to private equity and a general lack of coordination and collaboration among stakeholders. MRC's previous studies focused on India and China.

Says study co-author Peter A. Singer, MD, Interim Director of the MRC, based at the University Health Network and the University of Toronto: "One thing is clear: when you think of biotechnology, its no longer just San Francisco, Boston, London and Tokyo. It's also Hyderabad, Shanghai, and Sao Paulo. While in the emerging economies it is still in it's adolescence, biotechnology is no longer the sole hegemony of the rich world. Biotechnology innovation is becoming globalized."

"Unlike most developing nations, what is holding back Brazil has little to do with the level of scientific expertise," adds Dr. Singer. "In fact, its science is world class. It is unfortunate that a set of relatively smaller challenges continues to slow down the country's transition to becoming a significant global innovator in health biotechnology."

The study says the fact that several of Brazil's small and medium-sized enterprises (SMEs) have succeeded in making innovative products is a testament to the country's strength in health sciences and to its entrepreneurs' creativity and astute management.

Published June 6 by Nature Biotechnology, the paper is based on case studies of 19 diverse Brazilian-owned private health biotech companies and four public institutes.

Having now analyzed biotech industry trends in Brazil, India and China, MRC says some common patterns and differences are evident. (A fourth study in the series, for release later this year, focuses on South Africa).

"Although each country faces a different set of challenges we are seeing a clear trend," says study co-author and MRC researcher Sarah E. Frew. "Countries such as China and India are emerging as major global players in health biotechnology, with the expertise and resources to produce new drugs and vaccines at a fraction of the costs of the big pharmaceutical companies. There is little reason to think that Brazil cannot do the same provided it deals with a few key remaining challenges."

While biotech entrepreneurs in China, India and Brazil employ some of the same core business models and strategies, there are also significant differences stimulated by firms' attempts to adapt to local conditions.

One common feature among health biotech enterprises in all three countries is a heavy reliance on a hybrid business model, where revenues from early activities – typically generics and modification of existing technologies as well as services – are reinvested in innovative products.

One difference is that, while Indian firms are among the world's leading vaccine manufacturers and supply the country's national immunization program, in Brazil this activity is primarily the domain of public institutes.

Also, in addition to their large domestic markets, Indian and Chinese companies also have a greater focus on exports than their Brazilian counterparts.

Rahim Rezaie, a co-author of the Brazilian study, states that: "Brazil faces a dilemma – how to reap the economic benefits of a robust private sector while finding affordable and sustainable solutions to local health needs. If the country can strike an effective balance between its public and private sectors, it could not only maximize health and economic benefits to Brazilians but also provide a compelling model for health biotech in other developing countries."

Neglected diseases and other business opportunities

Most companies interviewed report growing focus on innovative diagnostics or drug products. A number have a particular focus on developing and marketing affordable, easy to use products which address neglected diseases and other local health needs.

"What you call a neglected disease, I call a business opportunity," says Fernando Kreutz, president of Porto Alegre based FK Biotecnologia. The company produces monoclonal antibodies for various diagnostic tests while other firms such as Katal Biotecnológica, based in Belo Horizonte, and Labtest Diagnóstica, of Lagoa Santa, produce diagnostic kits suitable for small laboratories and rural settings in Brazil, a market usually neglected by large companies.

Katal is responding to Brazil's approximately 140.000 annual cases of tuberculosis by developing a $25 TB test to replace the current $150 version. It also supplies the public health system with an innovative test for screening the 25 million Brazilian men over 45 at risk of prostate cancer and has developed a test for Chagas disease that can be read by widely available equipment, removing the requirement for expensive laboratory machinery.

MRC investigators also found many private companies developing innovative therapeutics. Aché Laboratories is marketing the topical anti-inflammatory Acheflan, a natural product extracted from the Cordia curassavica plant, while Pele Nova Biotecnologia's BIOCURE is a natural latex membrane derived from the plant Havea brasiliensis for the treatment of skin lesions.

Silvestre Laboratories, of Rio de Janeiro, is marketing several drugs that have resulted from significant in-house R&D, including a treatment for burns and other skin lesions.

Notable products in the pipeline of various companies include:

several monoclonal antibodies for cancer treatment (Recepta Biopharma, of São Paulo);
a recombinant protein for treating melanoma as well as anti-hypertensive and an analgesic peptide – both isolated from snake venom (COINFAR, of São Paulo); and

fetal, neonatal and adult stem cell therapies for cardiac disease, type I diabetes and neonatal hypoxia (Cryopraxis, Rio de Janeiro).

Barriers to development

Major challenges include:

A patent regime in desperate need of reform

The Brazilian patent office can take over seven years to process patent applications for drug candidates. Brazilian law prohibits patenting some important biotechnologies, such as recombinant versions of proteins found in nature. Some companies are also concerned that once a pharmaceutical product has been approved by the patent office, ANVISA (the national regulatory agency that approves health products, among other activities) can withhold approval on grounds such as eventual public access issues.

Regulatory issues

The main regulatory roadblock highlighted by both public and private sector interviewees is the lack of practical experience in product development and manufacturing on the part of ANVISA regulators. Other commonly cited stumbling blocks include long delays in the ethics approval process for clinical trials as well as biosafety and biodiversity regulations.

Human resources

Although Brazil has been successful in raising the overall level of biotech expertise, there is evidence of a disconnect between the output of existing training programs and the actual needs of the health biotech sector. Lack of sufficiently specialized and targeted training programs and the "academic model" of university preparation are limiting the supply of appropriately-trained personnel. An additional challenge for private industry, especially SMEs, is their inability to match or exceed the incentive system in place for careers in the public sector.

Recommendations for Brazil

The government of Brazil has been proactive by making legislative changes and increasing public financing for innovative activities. However, these recent moves are unlikely to be sufficient on their own.

The MRC study says basic building blocks for an innovative health biotech sector are largely in place in Brazil. Recommendations to accelerate development and commercialization of innovative health products in the country include:

Improve the performance and transparency of government institutions involved in health product development, regulation, ethics review and intellectual property (IP) assessment and approval;

Promote and support the filing of patents outside Brazil and develop policies that encourage partnerships between Brazilian and off-shore collaborators based on the formation of international IP assets;

Administer biosafety and biodiversity laws in ways that encourage use of Brazilian resources for product discovery and creation while still preserving the knowledge rights of the indigenous population;

Identify crucial gaps in health product development infrastructure and stimulate the creation of facilities to provide required services;

Modify or remove policies that levy taxes or otherwise penalize companies that must out-source portions of their development programs to off-shore vendors;

Help build a culture of innovation by stimulating dialogue among regulators, policy makers, academics and the private sector to raise awareness and seek resolution of issues that hamper health product development;

Clarify the domain within which the public-sector will operate so as to allow the private sector to better target their investments;

Substantially increase R&D commitment to private firms to ensure they are viable employment destinations for academic researchers;

Build stronger linkages between firms to strengthen industry associations, identify challenges and pursue solutions;

Identify human resource requirements in specific disciplines and technical specialties and create and/or adapt training programs to meet the identified needs;

Stimulate the creation and expansion of academic and executive programs in entrepreneurial training specifically for the biotech sector;

Use public procurement mechanisms to support innovative startup firms.

Next steps in the MRC program

The MRC will continue to study health biotechnology companies in the developing world, and expand its focus to include Africa.

The next phase of MRC's Emerging Economies Program will involve continued research into commercialization of innovative health biotechnology products and services and its application in emerging markets.

Programme activities will follow two distinct tracks, each with its own research and commercialization phase:

1. Accelerate development of health products and services for improved global health by identifying better, cheaper and faster ways to produce health products including vaccines, drugs and diagnostics to improve global health. The research focus will examine how the innovative and productive capacity of emerging economy firms can be harnessed to strengthen health biotechnology development. Commercialization will involve linking innovative firms in emerging economies with the global health community, including other firms in developed and developing countries, investors, donors and product development partnerships.

2. Encouraging North-South entreprenurial collaboration in the health biotechnology sector to the benefit of all.

Terry Collins | EurekAlert!
Further information:
http://www.mrcglobal.org
http://www.facebook.com

More articles from Business and Finance:

nachricht Microtechnology industry is hiring – positive developments of past years continue
09.04.2018 | IVAM Fachverband für Mikrotechnik

nachricht RWI/ISL-Container Throughput Index with minor decline on a high overall level
20.03.2018 | RWI – Leibniz-Institut für Wirtschaftsforschung

All articles from Business and Finance >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: The taming of the light screw

DESY and MPSD scientists create high-order harmonics from solids with controlled polarization states, taking advantage of both crystal symmetry and attosecond electronic dynamics. The newly demonstrated technique might find intriguing applications in petahertz electronics and for spectroscopic studies of novel quantum materials.

The nonlinear process of high-order harmonic generation (HHG) in gases is one of the cornerstones of attosecond science (an attosecond is a billionth of a...

Im Focus: Magnetic micro-boats

Nano- and microtechnology are promising candidates not only for medical applications such as drug delivery but also for the creation of little robots or flexible integrated sensors. Scientists from the Max Planck Institute for Polymer Research (MPI-P) have created magnetic microparticles, with a newly developed method, that could pave the way for building micro-motors or guiding drugs in the human body to a target, like a tumor. The preparation of such structures as well as their remote-control can be regulated using magnetic fields and therefore can find application in an array of domains.

The magnetic properties of a material control how this material responds to the presence of a magnetic field. Iron oxide is the main component of rust but also...

Im Focus: Self-healing coating made of corn starch makes small scratches disappear through heat

Due to the special arrangement of its molecules, a new coating made of corn starch is able to repair small scratches by itself through heat: The cross-linking via ring-shaped molecules makes the material mobile, so that it compensates for the scratches and these disappear again.

Superficial micro-scratches on the car body or on other high-gloss surfaces are harmless, but annoying. Especially in the luxury segment such surfaces are...

Im Focus: Stellar cartography

The Potsdam Echelle Polarimetric and Spectroscopic Instrument (PEPSI) at the Large Binocular Telescope (LBT) in Arizona released its first image of the surface magnetic field of another star. In a paper in the European journal Astronomy & Astrophysics, the PEPSI team presents a Zeeman- Doppler-Image of the surface of the magnetically active star II Pegasi.

A special technique allows astronomers to resolve the surfaces of faraway stars. Those are otherwise only seen as point sources, even in the largest telescopes...

Im Focus: Heading towards a tsunami of light

Researchers at Chalmers University of Technology and the University of Gothenburg, Sweden, have proposed a way to create a completely new source of radiation. Ultra-intense light pulses consist of the motion of a single wave and can be described as a tsunami of light. The strong wave can be used to study interactions between matter and light in a unique way. Their research is now published in the scientific journal Physical Review Letters.

"This source of radiation lets us look at reality through a new angle - it is like twisting a mirror and discovering something completely different," says...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

VideoLinks
Industry & Economy
Event News

International Modelica Conference with 330 visitors from 21 countries at OTH Regensburg

11.03.2019 | Event News

Selection Completed: 580 Young Scientists from 88 Countries at the Lindau Nobel Laureate Meeting

01.03.2019 | Event News

LightMAT 2019 – 3rd International Conference on Light Materials – Science and Technology

28.02.2019 | Event News

 
Latest News

Solving the efficiency of Gram-negative bacteria

22.03.2019 | Life Sciences

Bacteria bide their time when antibiotics attack

22.03.2019 | Life Sciences

Open source software helps researchers extract key insights from huge sensor datasets

22.03.2019 | Information Technology

VideoLinks
Science & Research
Overview of more VideoLinks >>>