New Delhi, July 09, 2016: The opportunity in biopharmaceuticals is rapidly growing. In today’s date, biopharmaceuticals generate global revenues of around $163 billion, almost about 20 percent of the pharmaceutical industry. Biopharmaceutical’s current annual growth rate of more than 8 percent is double that of conventional pharmaceuticals, and growth is expected to continue at that rate for the foreseeable future. The biopharmaceutical company’s best positioned to succeed in tomorrow’s market will be those that have a dab hand on a wide set of technical and operational capabilities. Decisions that are being made by the companies at present will have a critical influence on the success of the industry for two important reasons. First, operational excellence is not an easy skill to achieve. Capabilities of being lean, supple, and efficient manufacturing require sustained effort and commitment to develop and hardwire into the organization. Second, decisions made today will affect companies’ competitive positions years or even decades into the future. This is particularly true in areas such as footprint design and the choice of core manufacturing technologies.

Innovation resulting in improved productivity continues to be intensified and is a major and utmost driver for many of the current biopharmaceutical trends. Innovative ideas increase the speed of discovery, help maintain costs, and improve productivity. The existing game though in the biopharmaceutical industry is quite exciting, with bio-similars, new technologies, personalized medicines, and opportunities in emerging markets. The industry, however, believes more opportunities for advancement are coming in the near future. Innovations are driving a number of major industry trends; and many ongoing trends, themselves, are driving innovation.

The emerging long-term picture is even more exciting, with futuristic innovations such as immune therapies, antibody drug conjugates, and gene and cell therapies all making progress toward commercial launch in the next few years. Bio-pharmaceutical looks self-assured to transform the industry once more, as increasing understanding of the interaction between drugs and the genetic makeup of patients work sin improving the targeting of therapies. Combined with resilient, low-cost genetic profiling, this knowledge will improve treatment outcomes and serve to accelerate and improve the outcomes of clinical trials, helping to reduce the cost of drug development.

Some of such key micro-trends can be classified into different types. One of which are the Bio-similars. Bio-similars also known as generic medicines can be useful in the bio pharmaceutical industry. Bio-similars and bio-betters have played a major and an important role in the biopharmaceutical industry. With more than 700 bio-similars/bio-betters in the development channel, there will be ample biopharmaceutical manufacturers and products more than a dozen probably for each parallel reference product. This conduit will mean a lot to more new biopharmaceutical industry players, ranging from virtual and foreign to the largest and big Pharmaceutical companies, with many new manufacturers and facilities. These competitors usually compete on the basis of price; therefore, low manufacturing costs is required. This low-cost requirement is driving many companies to seek out and adopt bio-processing innovations that achieve the most cost-effective manufacturing. With more models and analytical methods for demonstrating bio-similarity and biochemical or biophysical characterization,more established regulations, definitions, and standards for bio-similars and bio-similarity and bio process tweaks allowing for fine-tuning of bio-similars to match innovator biologics and quality by design and design of experiments (DoE) for all products including bio-similars can be affective.

Another technology that could be affective,are the analytical methods like assays.Simpler assay processes that increase process knowledge and speed/simplify product release,more convenient, high-throughput assays that assess physicochemical properties of IgG /mAb clones for high level expression and therapeutic efficacyand assays to demonstrate bio-similarity and analytics to demonstrate equivalent product quality can turn the bio-pharmaceutical industry for good.

There are multiple challenges the biopharmaceutical industry faces. Knowledge about these can surely make a difference. The challenges faced are cost, complexity, and regulatory scrutiny. As bio-pharmaceurical industry moves from the scientific frontier to the business mainstream, the industry will increasingly be forced to confront the same challenges faced by other businesses like maintaining competitiveness by ensuring affordability, quality, and delivery performance. Another such challenged faced is the complexity of bio-pharma supply chain and operations. As the numbers of products rise and new process technologies such as continuous manufacturing are introduced, the complexity of bio-pharma operations and the bio-pharma supply chain will increase. Evidence indicates that current production programs are already sprawling the industry, with several active virtuoso’s efforts turning unsuccessful to deliver to the market. This challenge will only increase as sites move from the current “one line, one product” setup towards adroit and flexible multiple-product operations and are required to manage both present and future technologies under one roof. The high premium on biopharmaceutical products and the relatively smaller share of revenues they have historically accounted for in big pharmaceutical companies have led to industry-wide challenges in the supply chain. Complexity, cost, and service levels are far from small-molecule best practices, even considering the additional complexity of cold-chain requirements.

Quality functions are scuffling to keep up with the increasing demands of regulators, mainly the US Food and Drug Administration. The industry has received an unprecedented number of warning letters and remediation programs in the last five years, and scrutiny is unlikely to decrease. Furthermore, the increasing relevance of global markets (beyond the United States, European Union, and Japan) is adding the complexity of multiple quality standards and regulatory regimes. Compliance, robustness of processes, and efficiency will need to be squared in one equation.

Global pioneers will have to take forward the product innovation in order to continue to command surcharge prices, shifting the frontier of technology and exploring new operational setups such as the design and deployment of their future network. Bio-similarsvirtuous will have to focus on theexpenditure, quality, and scale. For them, speed, process innovation, and operational excellence are must-win battles. Players based in emerging-market nations will have to find their own niches with the right operational and quality performance to make the best use of privileged access to, and knowledge of, their local markets. Contract-manufacturing organizations will have to be at the leading edge of process innovation and operational efficiency while retaining or building a spotless reputation for service and performance. Beyond these generic player archetypes, each company will need a detailed view of its own strategic position, asking itself what it stands for in the market and what it needs to do in order to win.

The prize for organizations that rule the operational challenges is far more significant than just short-term competitive advantage. Many of the next major opportunities for biotech will require companies to develop innovative and new technologies and operating models. The actions taken today will shape companies’ keenness, to grasp the opportunities as they come to attainment.

At one end of the scale, for example, the industry must develop the capabilities to forthwith and infallibly produce the small batches of thoroughly personalized medicines required to deliver cell therapies. At the other end, it needs the high-volume; low-cost manufacturing capabilities necessary to deliver inexpensive insulin and vaccines against diseases such as malaria that cause permanent life damages today in low- and middle-income countries. Amidst these two extremes, companies will need to speed up their development and commercialization of new molecules to allow a broader and a wider range of illnesses to be sermonized, and they must deduct manufacturing costs, enhance quality, and build capacity to widen access to the industry’s life-changing products.

Whatever their competitive nook, companies must constantly evolve both their manufacturing technologies and their operational capabilities. Technologies are not yet adequately mature to rely only on operational improvement to take quality forward and productivity up and cost down. Nor will technological improvements alone be enough to do those things.

Corporate Comm India (CCI Newswire)


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