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[Trends 2020] These Factors Will Shape the Biotechnology Industry Biotechnology has become the driving force of radical changes in innovation processes in various sectors

By Dr Puneet Gupta

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Biotechnology is the backbone of various industrial sectors and makes a significant contribution to the modernization of the country. Its broad range of high-tech applications is increasingly playing a role in enhancing market competitiveness, raising economic growth and improving the welfare of citizens. Biotechnology has become the driving force of radical changes in innovation processes in various sectors.

Healthcare productivity has reduced traveling and waiting time, and provided digital diagnostic tools that facilitate physical examinations from a distance. New funding models enable payers to give commissions for outcomes for a defined patient population, from vertically integrated accountable care organizations in every health economy. Digital parenting and other advancements of technology in biotech have also brought significant changes and innovations in the sector. Here are some of the top ten trends in biotechnology that the world should expect to see in 2020.

Intellectual Property and Legal Growth

Building on the regulatory frameworks from the 2000s, new regulations now encourage innovation through a convergence of science and technology. The pre-eminent regulatory agencies around the world have adapted to new realities as disruptive technologies challenge the traditional methods and processes used to assess the quality, safety and efficacy of prescribed medicines. Biotechnology is a field where technology advances rapidly but returns on investments may be slow. For this reason, public research organizations and enterprises need to protect the innovation that they generate with intellectual property rights, which provide a basis for return on investment in research and development, by granting monopoly rights for a certain period to their owners.

Also Read: #5 Ways Through Which Biotech Entrepreneurs are Going to Enhance Human Lives

Commercial Model for value-based pricing for biotech products

A successful value-based pricing arrangement is incumbent upon a clear definition of when the medication works, and when it does not work. There exists a consensus programme of data collection, typically initiated early in the commercial lifecycle. Value is relative to some alternative; incremental value over other treatment options is the basis for a higher price. The price must be linked explicitly by formula to the value metric of this programme of data collection. A clear payment or reimbursement mechanism is required. Under value-based pricing agreements, payers and pharmaceutical companies agree to link payment for medicine to value achieved, rather than volume. For pharmaceutical companies, these trends represent a paradigm shift in the structure of the market and call for innovative approaches to commercialization and pricing. In a new value-driven health care system, pharmaceutical companies will need to provide medicines that demonstrate real and measurable value to stakeholders. As a result, value-based pricing—the alignment of incentives between purchasers and manufacturers—is getting increased attention. Value-based pricing offers pharmaceutical companies the ability to substantiate product value propositions. Agreements could provide far greater transparency to the contribution of the pharmaceutical to the value-outcome of the consumer, and distribute risk differences between the payer and the pharmaceutical company.

Partnerships and collaborations among new scrutiny

Pharmaceutical companies collaborate with stakeholders earlier in the research and development (R&D) cycle and access the best research and development for their research. Pharmaceutical companies have prioritized the most valuable legacy and new R&D data sources, and have adopted the operating model to efficiently and routinely exploit these. In 2020, R&D will have new boundaries; the R&D model is networked, built around academic and other partnerships. R&D activities are widely distributed with companies coordinating and integrating at the center. The main focus in on understanding disease biology and genetics, current standards, cost of care and treatment pathways. Networked R&D combines pharmaceuticals and technology with increased patient engagement to treat and prevent diseases. Company R&D strategies compete on returns from high-value, low-volume Western markets, and high-value emerging markets.

Also Read: These Indian Start-ups are Disrupting the Biotechnology Sector

Clinical testing and drug regularisations

Investigator-less clinical trials in which clinical trial sites are replaced by local clinics, remote monitoring and virtual clinical visits have resulted in a significant reduction in the cost of clinical trials, and the generation of more meaningful data through continuous monitoring. DNA sequencing now costs less than $50 per genetic profile, allowing extensive screening and effective targeting of trial patients and personalization of drugs and interventions. Patients search out trials to participate in forcing pharmaceutical companies to compete for patients especially in well-characterized, small patient group trials. Regulators are now comfortable in step-wise launches and focus on safety, efficacy and quality of life. Massive data analysis is now fully integrated with the research process. Regulators have addressed the changing requirements for trials, establishing a new standard beyond Randomised Control Trials.

Flourished innovations in biotech

Bolstered by government support, a wealth of investment and an eager graduate workforce, the country's biotechnology industry is booming. More than half of the biotechnology start-ups are in the medical arena—diagnostics, drugs, and medical devices—but 14 per cent are in agricultural biotechnology, 3 per cent in bio-industry, 1 per cent in bioinformatics and 18 per cent in biotechnology services. Another major driver of the biotechnology boom in India is the accessibility of funding, from both government and private industry. The consumer demand goes hand-in-hand to innovations that bring ideas to generate and implement.

Investing opportunities

Due to biotechnology companies' broad reach, it comes as no surprise for investors to flock to the sector, eager to become associated with must be the next big thing. But it is like virtually any other sector: investing in it has both risks and benefits. One of the positives of investing in biotech is that the market worth is rising. According to a report published in 2018, the market will show a compounded annual growth rate of 9.9 per cent during the forecast period, reaching a total market worth of $775.20 billion by 2024. Biotech investors also get exceptional opportunities to directly support the advancement of medical progress that matters to them on a personal level. Biotech seeks to solve many of the world's medical problems and the prospect of that appeal to many investors.

The right set of opportunities for micro-fluidics in biotechnology

Interest in micro-fluidic technologies has been driven by concomitant developments in fields such as genomics, proteomics, drug discovery, high-throughput screening and diagnostics, as well as a recognized need to perform rapid and efficient experiments on small-sample volumes. Today, the relevance of micro-fluidics in these fields is significant and characterized by a range of features that accompany system miniaturization. Put simply, micro-fluidic activities have been stimulated by the fact that physical processes can be more easily controlled when instrumental dimensions are reduced to the micrometer scale.

New business models in emerging markets in 2020

While the traditional pharmaceutical markets in the US, Japan and western Europe remain as the main markets for drug companies, new markets requiring new business models are gaining pace. The focus on Brazil, Russia, India and China is now being challenged by new emerging markets. These are providing an even bigger surprise, incubating new business models and leading on the development of new drugs. The industry has responded to the various healthcare delivery models being adopted by different emerging countries and is tailoring their strategies accordingly. The focus is on access, affordability, and outcomes with an emphasis on local and being more than just a pill. The pharmaceutical companies have invested in local talent development initiatives which are paying them more dividends.

The upcoming innovations and improvements rightly depict that biotechnology remains as a critical part of the society as it works towards their wellbeing and giving a better life to the future generations.

Dr Puneet Gupta

Founder & CEO, Clensta International


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