Pharmaceutical industry is a global industry dealing with the varied and dynamic medical conditions of populations worldwide. This puts the industry at the heart of the healthcare system, compelling the industry professionals to look at it in a different way.

Change is one constant thing in every industry and the pharmaceutical industry is no exception. It’s a constant state of flux and to sustain and stay at the top you need to adapt to the cycle of changes. This cycle of changes provides growth opportunities to the organizations, helping them ride the wave.

Changing industry dynamics
In near future the world is likely to face Volatility, Uncertainty, Ambiguity and Complexity (UVAC) along with Black Swans (Unpredictability). UVAC’s world expresses the systemic failures and behavioral failures, imperative to organizational failure. The UVAC’s world is driven by digitization, sustenance and rise of developing world. This situation can be translated to various industries such as pharmaceuticals, automation, nutrition etc.

Whatever maybe the development, any forward thinking industry needs to stay abreast of the cycle of changes in order to be effectively engaged.

Changing environment
The threat to human health from environmental and climate change is so great that it weakens the last fifty years of gains in development in global health. There are complex interactions between both causes and direct and indirect effect of climate change on health and well-being. Ecological processes, such as impacts on biodiversity and changes in disease vectors, and social dynamics, can amplify health risks of the population. Social responses also enhance some risks through adaptive actions.

Changing trends of diseases
There have been shifts from infectious diseases to chronic diseases for past 200-300 years at different rates and dynamics across the globe, termed as the epidemiological transition. Globalization, urbanization, increased lifespan, exploding population, dietary changes, public health advances, environmental and climatic changes are the factors of this transition.

Diagnostics as the base
In pharmaceuticals, the overall performance is determined by diagnosis, since the best treatment can be chosen only after a proper diagnosis of the condition. Genetic disposition and damages along with health consciousness has given rise to genomics and genome based diagnostics. The arrival of genomics as a science of clinical significance was underscored by AstraZeneca’s announcement on April 21 that it would form a collaboration to sequence 500,000 samples taken during clinical trials it has conducted over the years. According to the British-Swedish firm, it plans to see 2m genomes so studied over the next decade. It all bodes well for the future of genome-based diagnosis. A report published in 2013 found that nearly a third of drugs in clinical development are associated either with a known DNA variant or with a variation in the structure of a specific protein, ultimately traceable to DNA. The presence in, or absence from, a patient of such variant allows drug makers to know whether their products are likely to work in that individual. This supports more precise genetic tests and molecular diagnostics for more targeted treatments.

Medical nutrition - A new base in the offing
Industries within the health & life science sector are moving towards one another leading to new avenues like the medical nutrition sector. Convergence of these industries plays an essential role of shaping new markets for pharmaceutical products. This birth of medical nutrition has shown the pharmaceutical industry a twin
path of relying on product and service.

Generic medicines revolution
The pharmaceutical industry in today’s world is at a crossroads between generic revolution and the needs of the ageing population. With rising drug prices, cost-effective generic drugs have a crucial role to play. As a result, many Governments are actively involved in promoting this generic revolution. This move will contribute for sustaining health care systems worldwide.

Innovative therapeutics, are more commercially successful than those that follow in their footsteps. The pharmaceutical industry is committed to the R&D of new treatments and cures for patients. With more than 7,000 drugs in development worldwide and over $500 billion invested in R&D, there is newer hope for the industry.

Life threatening medical conditions
Diseases like cancer, heart disease and diabetes are becoming the leading cause of death and disability globally. The change is driven by a adaptation to unhealthy lifestyles, with smoking and alcohol use springing child malnutrition over the last 20 years to become the second and third leading risk factors for disease.

India is witnessing a shift towards ‘lifestyle’ diseases that are more prevalent in Western markets, thus, changing its epidemiological profile. Such changes have increased the demand for better healthcare and for medications that address the chronic diseases.

Preventive therapies
Acharya Charaka seems to have been an early proponent of “Prevention is better than cure” doctrine. Increasing demographic and psychographic segmentation within the population has led to a desire to stay healthy and live a long life. A growing number of governments in both developed and developing countries are also trying to shift the focus from the treatment of disease to its prevention. Social and economic pressures are gradually causing a sea-change in attitudes towards healthcare.

The younger generation today has come to understand the criticality and constraints of modern medicines. The younger generation does not like to fall sick and would like to work on themselves to stay healthy by balancing nutrition, thus, bringing the pharmaceutical industry at a higher level of competition, limitation, collaboration and consolidation at solution level.

Integrated medicines
Integrated medicine is comparatively new approach to healthcare and medicine and is whole body healing oriented. It uses various biological therapies like nutraceuticals, alternative medicines as well as pharmacological agents for prevention, treatment or for maintaining optimum health. With increasing consciousness about health, fitness and overall well-being people have shifted towards wellness and prevention of diseases rather than treating them.

In this new age, preventive healthcare system is given more preference than curative healthcare system. Some other factors fuelling this shift are escalating healthcare costs, increasing awareness and education, rise in penetration of new medicinal treatment approaches etc.

Regulatory facilitation
The pharmaceutical industry is a highly regulated industry. The technological revolution can translate into innovative and affordable products only if the regulatory framework adapts to the changes. There is fragmentation of diseases. The challenge for the regulators lies in adapting to the state of the art facilities, ensuring availability of innovative treatments at a reasonable price while ensuring patient safety. The regulatory operating models, engaged by the pharmaceutical industry to maintain their compliance positions, have developed over time as regulation has undergone evolution. Regulatory compliance models would eventually be a fundamental keystone of future good pharmaceutical business practices.

Managing the complexities of a harmonized, increasingly complex, global regulatory landscape has become the prime concern for any pharmaceutical organization. Indeed, those organizations who successfully implement an effective regulatory compliance framework would be able to differentiate themselves from their competitors.

Innovation bringing disruption and future solutions
For any business to prosper and grow keeping up with the competition as well as getting ahead of them is very crucial. Getting ahead can be achieved by the means of innovation which is joined to research and development (R&D). Innovation in terms of business can be defined as the process of creating and delivering new value to the customer in the market.

Innovation in business can also be driven by the extent of innovation of different companies in the industry (among its competitors). Being the first to market with a new product can prove to be a significant advantage in terms of building a customer base.

Few innovations that are driving the pharmaceutical industry globally are bioelectronics like the electronic Aspirin, gene therapy, nano drugs for targeted drug delivery, digital drug like Thync, and 3D printed cast with embedded electronics.

Strategic elements and intent
In order for the pharmaceutical industry to have a clear strategy for the future, it needs to have certain strategic elements in place.

The industry needs to provide health solutions in terms of integrated medicines with respect to modern medicines, traditional medicines, alternative therapies, and nutraceuticals. There needs to be a shift of focus from cure to care of the patient, thus establishing the requirement of a total care model.

The intent of the industry should be to provide affordable and accessible medicines to the consumers without compromising on the quality of the products and keeping patient safety at the front.

Due to quality issues, dwindling safety profiles of drugs and ethical issues, the image of the industry is not very high. Thus, it is crucial to have methodologies in place to increase this image of the industry for consumers’ satisfaction.

The industry needs to take up projects that will cater to rural and poor populations to erase inequalities existing in the healthcare system and also concentrate on ‘care and cure’ formula with patient centricity.

The industry has to adopt a Mutually Exclusive, Collective Exhaustive (MECE) approach here to develop the strategy.

With these strategic elements and intent pharmaceutical industry can develop a clear strategy, yet it is a challenge.u