How Biotech Innovations Are Remodelling the Medical Field
Man’s evolution from a single-cell organism to his current form is neither a stroke of luck nor an act of divine benevolence. Cells have the power to repair and renew themselves because that is how life on earth is designed. Humans, with their superior intelligence, have understood the power of cell regeneration and are now taking concerted steps to exploit it. This has resulted in creating a market that not only ensures economic benefits, but can also become a harbinger of change in public health.
The Medical Research Council of the United Kingdom defines regenerative medicine as “a therapeutic intervention that replaces or regenerates human cells, tissues or organs to restore or establish normal function”. The Council published a report wherein it has been noted that regenerative medicine involves the use of biological products, cell-based therapies, small molecule drugs, and medical devices. Regenerative medicine is a revolutionary advancement in medicinal research and was first predicted by Leland Kaiser, a leading name in the field of health administration, in 1992. He believed that tissue rebuilding would become a landmark achievement in the treatment of chronic diseases such as diabetes and cardiovascular diseases. These diseases are known to cause disruption in normal functioning of organs, ultimately resulting in organ failure. For example, in case of diabetes, high blood sugar levels damage the tiny filters in kidneys, causing kidney failure over time. With increasing incidence of chronic diseases, as underscored by the Global Burden of Disease Report 2017, and with very few preventive measures in sight, regenerative medicine technology has emerged as the proverbial messiah for these ills.
Greater and deeper research into this burgeoning technology has given birth to some crucial sub-divisions within this field. These divisions include gene therapy that attempts to fight, or even cure, chronic conditions such as cancer through modification or introduction of new genes in the body; genome editing that involves alteration of DNA at specific locations of the human genome to treat inherited disorders, HIV, and cancer; cell therapy that refers to introduction of purified cells to replace or repair tissue damage caused by disease; and tissue engineering that is basically tissue reconstruction using cells or biologically active molecules.
A Plethora of Growth Opportunities Await Players
According to a renowned market research firm, Fortune Business Insights, the regenerative medicine market will reach USD 151,949.5 million by 2026. This is testament to the fact that this market is rapidly rising as a formidable economic entity, one that holds a wide spectrum of business opportunities for those interested in playing the field. Moreover, not just private companies, but public and academic organizations are also making great strides in taking this technology forward. Let us look at some of the recent innovations that are reshaping the contours of the field of medicine.
- In October 2019, researchers at the Medicine by Design at University of Toronto came out with their Microfluidic Cell Sorting (MICS) device that uses magnetic labelling to sort one billion cells per hour according to their molecular make up. This is achieved by pairing the magnetic cell sorting technique with CRISPR-based gene editing technology, wherein miniscule magnets are engineered to bind to the targeted proteins, with cells ending up in a collection channel. The researchers are aiming to further develop the technology to do multiple screenings and identify new areas for cancer therapeutic drugs and drug proteins involved in progression of tumors in the body.
- Kanazawa-based Shibuya Corporation is making outstanding headway into regenerative medicine technology. In 2015, the company collaborated with researchers at Saga University to develop a 3-dimensional bio-printer, which can replicate and produce 3D structures of cells without the use of a scaffold. This machine is capable of regenerating bone, nerve, cartilage, and other tissues. Seven years before this, Shibuya had created the world’s first robotic cell structure system, which can be programmed to perform functions of cells. This innovation is a landmark feat in the field of regenerative medicine.
- Kymriah, a CAR T-cell therapy, was developed by Novartis AG and became the first of its kind to receive US Food and Drug Administration (FDA) approval. Since its introduction, the therapy has made its mark in the market with its high effectivity and accuracy of treatment. In August 2017, it received clearance to treat acute lymphoblastic leukaemia in young adults. The following year, it got cleared to treat B-cell lymphoma in adults. The development of the therapy was a result of heavy investment made by the company in its R&D activities and launching innovative products in the market.
- French biotechnology firm, TxCell, specialises in T-cell therapy through manufacturing of T-cells using its ASTrIA and ENTrIA platforms for the purpose. The company designs its therapies specially for inflammatory diseases such as bullous pemphigoid and autoimmune diseases such as Lupus. Currently, the firm is partnering with Ospedale San Raffaele (Italy), University of British Columbia (Canada), and Lubeck Institute of Experimental Dermatology (Germany) to develop 10 new CAR T-cell programs.
From the above examples, it is clear that there is an abundance of lucrative opportunities that will spawn intense competition among players. Going by the current situation, companies seem to be lapping up these opportunities with growing appetency.
Regenerative Medicine in the Developing World
While regenerative medicine is a technological marvel forged in the crucible of western research, it is still virtually inaccessible to the poorest of poor nations and their people. However, bright spots in this dark scenario are China and India that are making staggering progress in innovating this technology further to make it more affordable.
China has been nothing less than a pioneer in advancing the cause of regenerative medicine through extensive research in stem cells, gene therapy, tissue engineering, and active molecules. In fact, the country has made astounding progress in stem cell therapy since the 1980s, catching the attention of world media. The Chinese Academy of Sciences established a specialized lab for stem cell research in 2001 and later, built a research network comprising members from different institutes such as the Guangzhou Institutes of Biomedicine and Health and the Kunming Zoology Institute. Since then, China has continued to astonish the world with its discoveries and innovations. For example, a study published in the peer-reviewed journal, Natural Cell Biology, by Chinese researchers revealed that they had successfully isolated and cultured reproductive stem cell strains that could self-renew over the long-term. Thus, regenerative medicine in China is a well-established field of study and business, with its core lying in intensive and extensive research.
In India, the scenario is different as the field is still in its nascent stages of development. But, a progressive outlook by the government has enhanced the potential of the market for regenerative medicine in the past couple of decades. Recognizing the need for scientific research in the then rising field of biotechnology, the Indian government set up the Department of Biotechnology (DBT) under the Ministry of Science and Technology in 1986. Since its inception, the DBT is spearheading biotech research in the country. In last few years, biotech research has grown by leaps and bounds in India. For instance, the DBT has recently launched a major study to analyse dominant blood and brain disorders among Indians using genetic and stem cell technology. The study is part of the Indo-Japan collaborative programme on stem cell and general biotechnology research. Furthermore, under this joint venture, Indian researchers and faculties will be given the opportunity to train and learn at the Centre or iPSc research and applications (CiRA) at Kyoto University in Japan. However, apart from a few private sector entities such as Serum Institute, the market for regenerative medicine is yet to gain traction in the private sector in India.
The regenerative medicine market is a dynamic one, witnessing fleeting advancements at breakneck speed. While developments in the West are being primarily led by private players, government-backed initiatives and funding are putting the research wheel in motion in South and East Asia. Thus, it may be right to say that the market is a promising one and leading companies in the medical and pharmaceutical industries are trying to make hay while the sun shines. Fortunately for them, the sun will be shining on this market for a very long time, with diseases and disorders becoming more and more commonplace around the globe.