Commercialization of tissue engineering products – Market trend and a user’s clinical perspective

The landscape of global disease burden is transforming in recent decades rapidly. There has been a notable increase in non-communicable diseases, particularly, disability related diseases. Among disability related diseases, musculoskeletal diseases account for the second largest ratio with low back pain constantly holding top rank as a leading cause of disability-adjusted life year globally for almost three decades. As the life expectancy is rising globally, associated increase in years lived with disability can be anticipated (1-2).

A survey across 32 countries involving 178 teams in Europe and neighboring Eurasian countries reported 3686 patients treated with cellular or tissue-engineered therapies in 2015 with musculoskeletal/rheumatological disorders as major indications followed by cardiovascular disorders and hematologoy/oncology. Among the cell types autologous cells still hold the major share, nonetheless allogeneic cells have promising potential (3).

Official data say that the global tissue engineering market size was valued at around $5 billion in 2016. Tissue engineering can provide solutions that can replace the currently used tissue repair methods including transplants, surgical reconstruction, and mechanical devices. Growing potential of tissue engineering procedures in the treatment of tissue damages is supporting the market growth and by 2022 it is expected to reach $11.53 billion worth. According to Medicare more than 900,000 surgeries are performed annually in the US alone for bone reconstruction or replacement. The segments- Orthopedics, musculoskeletal and spine held majority of the market share in the year 2016 owing to rise in musculoskeletal disorders. However, the cardiology and vascular segment is expected to grow at the fastest rate with CAGR of 16.80% by 2025.

Advancements in stem cell biology, nanotechnology and material science has augmented the potential of tissue engineering technology including the development of 3D engineered organ tissue which has caught the attention of investors, government agencies and research institutions. NIH, USA has provided funding of $445 million and $180 million for human non-embryonic and human embryonic stem cell research respectively. The budget for EU funding program Horizon 2020 is around €77 billion for the period from 2014 to 2020. A chunk of budget around 3797 million is allotted for research in nanotechnology, advanced material and advanced manufacturing, processing. Furthermore, the European commission has proposed a €100 billion budget for Horizon Europe (2021-2027) in continuation of the Horizon 2020 program.

Presently, North America with US on the forefront is dominating the overall market in terms of revenue share in 2016. Among the industrial partners, Stryker, Organogenesis and Medtronic have had a stronghold on the international market in 2015. As tissue engineering market is gaining growth worldwide, by 2025 market growth is likely to be high in Asia pacific region followed by Europe and MEA (Middle East & Africa) region. In Europe, most of the start-up companies have failed to participate in this growth. The lack of venture capital and increase in the regulatory requirements have created a hostile climate for start-up companies in Europe over the last decade. New product development from pre-clinical research to market approval approximately takes 10 years. Needless to mention, gaining clinical evidence for the use of tissue engineered products is a daunting process, particularly in the field of musculoskeletal disorder/research. Companies are now entering into collaboration to gain advantages on research and technology competencies offered by other competitors. It is advisable for the start-ups to be open to market survival strategies- collaborations, mergers, acquisition and upgrading the technology.

From a clinical perspective, the medical unmet need and challenges have to be evaluated continuously. On one hand tissue engineering technology holds a great potential in multiple medical segments but on the other hand there is paucity of evidence on safety and efficacy. For instance, low strength of evidence precludes firm conclusions about efficacy and safety of cell therapy for lumbar IVD repair (4). Important issues such as cost efficiency, regional values and reimbursement of the therapy need to be considered, in addition. The research and development of tissue engineered products and clinical application is requiring an urgent harmonization for the needed translational process.

Written by Neha Agarwal, PhD with inputs from Hans Joerg Meisel, MD, PhD, Director Center of Neurosciences/Chair Dept. of Neurosurgery BG Klinikum Bergmannstrost, Halle, Germany/President Regenerate Europe e. V.

Note: Market trend data was taken from market research preview sample report provided by Grand View Research Inc., USA.

References:

1. Institute for Health Metrics and Evaluation. The Global Burden of Disease:Generating Evidence, Guiding Policy. Seattle, WA: IHME, 2013.

2. Institute for Health Metrics and Evaluation (IHME). Findings from the Global Burden of Disease Study 2017. Seattle, WA: IHME, 2018.

3. Martin I, et al. The Survey on Cellular and Engineered Tissue Therapies in Europe in 2013.Tissue Eng. 2016;22(1-2):5-16.

4. Meisel HJ, Agarwal N, et al. Cell Therapy for Treatment of Intervertebral Disc Degeneration: A Systematic Review. Global Spine J. 2019;9(1  Suppl):39S-52S.