Exploring India’s Expanding Regenerative Medicine Industry

About the Author: Niteen has successfully launched and driven operations of Orthobiologix Biotech, completing over 200 procedures in regenerative procedures. He also owns an NABL accredited diagnostic business. Previously, he has also worked as Senior Vice President with GE Equity Asia and GE Capital. Prior to that he spent over 10 years with the Corporate Finance practice of KPMG India where he advised companies on their M&A strategies and fund-raising initiatives.

Regenerative medicine therapies (RMT) aim to repair, replace, or regenerate human cells, tissues, and organs to restore their normal function. The term “regenerative medicine” was first introduced by Dr. Leland Kaiser way back in a 1992 article on hospital administration. Over the past decade or so, there has been a surge in research and renewed focus on regenerative medicine, not only internationally but also within India.

Key methodologies in RMT include cell therapy, tissue engineering, gene therapy, and biomaterials, each designed to target a broad spectrum of conditions, from degenerative diseases to traumatic injuries. These therapies are being adopted for applications in orthopedics, oncology, and cardiovascular diseases. Cell therapies are also showing immense potential for treating inflammatory and chronic conditions. Recent breakthrough in China where they reported first ever successful reversal of type 1 diabetes via stem cell transplantation, signal a new era of possibilities in the field.

Global Market Trends and Growth Drivers

The global market for regenerative medicine is projected to reach over USD 100 billion by 2030, up from USD 34.56 billion in 2023. This growth is primarily driven by technological advancements such as CRISPR and gene-editing tools which work at the root cause of the disease so as to bring the body back to its natural composition as much as possible.  Additionally, as more and more data and research become available, adoption rates of some of these procedures is going to be exponential.  It is strongly believed that these procedures because they are able to reverse the root cause of the disease, are going to bring down overall cost of healthcare.  India could play a very crucial role in this field. It has the necessary capital, the technological expertise, an ever-improving healthcare infrastructure and supportive government policies.

The Rise of Regenerative Medicine in India

Currently, primarily Orthopaedics, Aesthetics and Dermatology are widely using some form of RMTs in India. In Orthopaedics, treatments such as Platelet-Rich Plasma (PRP) therapy, Bone Marrow Aspirate Concentrate (BMAC) are being used regularly.  Adipose-derived stem cells is not being introduced to addressing conditions like osteoarthritis, and ligament injuries. Adipose derived stem cell therapy uses stem cells and growth factors from a patient’s fat to initiate regeneration of degraded or damaged tissue.  Till recently there is no real solution to OA knee issue other than total knee transplant even if it is detected early in the degenerative process.  Today Adipose derived RMTs hold huge promise in treating Osteoarthritis knee issues globally.

Stem cell therapies are also showing great promise in treatment of inflammatory diseases such as rheumatoid arthritis, for which there are few treatment options are currently available.  More research and data is required before the same can be rolled out to the public at large.  These therapies offer a great ray of hope for an improved quality of life, free of pain.

“The global market for regenerative medicine is projected to reach over USD 100 billion by 2030, up from USD 34.56 billion in 2023.”

It is the field of aesthetics where India is using the regenerative medicine routinely. In aesthetics, PRP is frequently used for skin rejuvenation, scar reduction, and hair restoration, capitalizing on its ability to enhance collagen production and improve skin texture. Cosmetic procedures are also beginning to incorporate advanced cell-based therapies, such as exosome therapy and adipose-derived stem cells, which aid in cell regeneration and provide minimally invasive solutions to age-related concerns. Many leading dermatologists and plastic surgeons are offering these therapies to their patients in India. These treatments reflect the versatility of regenerative medicine and its capacity to offer aesthetic improvements alongside therapeutic benefits​.

Expanding Applications in Other Medical Fields

Globally, a lot of research is being conducted in finding various application of RMTs across a wide array of health issues.  Not only are they being used of hematopoietic disorders, but also to treat autoimmune diseases such as rheumatoid arthritis, Inflammatory bowel syndrome , type 1 diabetes etc.  In Cardiology, stem cell therapy is being used to regenerate heart tissue following events such as heart attack. In neurology, research on regenerative therapies is advancing, with clinical studies exploring treatments for neurodegenerative diseases like multiple sclerosis and Parkinson’s disease.

How does India measure up in this evolving field

Government of India (GoI) seems to be keen on ensuring India holds a special place in adoption of this technology in India. A well thought out industry framework is the cornerstone of research and development. GoI has taken the first few steps in this direction by setting up regulatory framework to support the safe and ethical use of regenerative medicine. The Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology (DBT) have set guidelines to ensure patient safety while promoting research and innovation in the field. Notably, the DBT introduced comprehensive guidelines on stem cell research in 2013, highlighting the importance of ethical practices. The 2017 biopharma innovation program aims to make India a global hub for biopharma and regenerative medicine, supporting the growth of cutting-edge treatments​.

Whilst there is no dearth of scientist and infrastructure support, India still lacks proper framework for commercialization of newer technologies especially in healthcare. This will include streamlining requisite government approvals and the time lime for the same. Additionally, India will need to build a robust ecosystem that funds such initiatives.  Whilst currently these treatments are expensive, there needs to be a structured program to introduce the same under insurance coverage. This will ensure prices of approved RMT procedures will reduce drastically and many more people will benefit from the same.

Despite the increasing demand, India has relatively few medical professionals with expertise in regenerative medicine. Most practitioners are based in urban centers, creating disparities in access between urban and rural populations. Expanding training programs and integrating regenerative medicine into medical education could help increase the number of practitioners and make these therapies more accessible nationwide.

Shaping the future of healthcare

The future of regenerative medicine in India is promising, with transformative potential across a wide range of medical fields. With ongoing advancements, India has an opportunity to broaden the applications of regenerative medicine, bringing innovative therapies to more patients nationwide. By making these treatments accessible, affordable, and widely available, India can leverage regenerative medicine to not only transform individual lives but also contribute to a more innovative and resilient healthcare system. As India continues to invest in research, expand training, and enhance regulatory frameworks, regenerative medicine stands to offer patients hope and healing for a variety of conditions, ultimately shaping a healthier and more resilient future.

**This article was first published in the December 2024 issue of BioVoice eMagazine.