Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:


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

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:

More articles from Business and Finance:

nachricht Blockchain Set to Transform the Financial Services Market
28.09.2016 | HHL Leipzig Graduate School of Management

nachricht Paper or plastic?
08.07.2016 | University of Toronto

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: New 3-D wiring technique brings scalable quantum computers closer to reality

Researchers from the Institute for Quantum Computing (IQC) at the University of Waterloo led the development of a new extensible wiring technique capable of controlling superconducting quantum bits, representing a significant step towards to the realization of a scalable quantum computer.

"The quantum socket is a wiring method that uses three-dimensional wires based on spring-loaded pins to address individual qubits," said Jeremy Béjanin, a PhD...

Im Focus: Scientists develop a semiconductor nanocomposite material that moves in response to light

In a paper in Scientific Reports, a research team at Worcester Polytechnic Institute describes a novel light-activated phenomenon that could become the basis for applications as diverse as microscopic robotic grippers and more efficient solar cells.

A research team at Worcester Polytechnic Institute (WPI) has developed a revolutionary, light-activated semiconductor nanocomposite material that can be used...

Im Focus: Diamonds aren't forever: Sandia, Harvard team create first quantum computer bridge

By forcefully embedding two silicon atoms in a diamond matrix, Sandia researchers have demonstrated for the first time on a single chip all the components needed to create a quantum bridge to link quantum computers together.

"People have already built small quantum computers," says Sandia researcher Ryan Camacho. "Maybe the first useful one won't be a single giant quantum computer...

Im Focus: New Products - Highlights of COMPAMED 2016

COMPAMED has become the leading international marketplace for suppliers of medical manufacturing. The trade fair, which takes place every November and is co-located to MEDICA in Dusseldorf, has been steadily growing over the past years and shows that medical technology remains a rapidly growing market.

In 2016, the joint pavilion by the IVAM Microtechnology Network, the Product Market “High-tech for Medical Devices”, will be located in Hall 8a again and will...

Im Focus: Ultra-thin ferroelectric material for next-generation electronics

'Ferroelectric' materials can switch between different states of electrical polarization in response to an external electric field. This flexibility means they show promise for many applications, for example in electronic devices and computer memory. Current ferroelectric materials are highly valued for their thermal and chemical stability and rapid electro-mechanical responses, but creating a material that is scalable down to the tiny sizes needed for technologies like silicon-based semiconductors (Si-based CMOS) has proven challenging.

Now, Hiroshi Funakubo and co-workers at the Tokyo Institute of Technology, in collaboration with researchers across Japan, have conducted experiments to...

All Focus news of the innovation-report >>>



Event News

#IC2S2: When Social Science meets Computer Science - GESIS will host the IC2S2 conference 2017

14.10.2016 | Event News

Agricultural Trade Developments and Potentials in Central Asia and the South Caucasus

14.10.2016 | Event News

World Health Summit – Day Three: A Call to Action

12.10.2016 | Event News

Latest News

Innovative technique for shaping light could solve bandwidth crunch

20.10.2016 | Physics and Astronomy

Finding the lightest superdeformed triaxial atomic nucleus

20.10.2016 | Physics and Astronomy

NASA's MAVEN mission observes ups and downs of water escape from Mars

20.10.2016 | Physics and Astronomy

More VideoLinks >>>