Orthopedic Regenerative Medicine Market Analysis

Regenerative medicines are medical products or active pharmaceutical ingredients that have the ability to cure organs and tissues organs damaged by various factors such as aging, trauma, and can also be used to provide stability of health in congenital disorders such as cerebral palsy, Fragile X syndrome and Down syndrome. Regenerative medicines are useful in treating both chronic and acute disorders, in terms of various abnormalities such as cardiovascular diseases, dermal wounds, and in the treatment of certain types of cancer. Furthermore, the current therapy of organ and tissue transplantation for treating organ and tissue failures can result in patient death due to limited or no donor supply and often results in severe complications in immune system. Regenerative medicine helps to alleviate such issues to a major extent. Regenerative medicine include development of methods to regrow, repair or replace either the damaged or diseased cells, and organs or tissues. This medicinal branch includes generation and usage of stem cells and tissue engineering.

Figure 1. Global Regenerative Medicine (Bone and Joint) Market Value (US$ Mn), 2016-2027

Global regenerative medicine (Bone and Joint) market size is estimated to be valued at US$ 7,090.1million in 2020 and is expected to exhibit a CAGR of 10.3% over the forecast period (2020-2027).

Regulatory authorities and government organizations are engaged in launching various programs, in order to boost growth of the global regenerative medicine (bone and joint) market. For instance, in January 2017, the U.S. Food and Drug Administration (FDA) launched a new designation program for regenerative medicine therapies. This ‘Regenerative Medicine Therapy (RMAT) Designation’ program will foster the approval and development of regenerative medicine products.

Regenerative Medicine (Bone and Joint) Market Report Coverage

Report Coverage	Details
Base Year:	2019	Market Size in 2020:	US$ 7,090.1 Mn
Historical Data for:	2016 to 2019	Forecast Period:	2020 to 2027
Forecast Period 2020 to 2027 CAGR:	10.3%	2027 Value Projection:	US$ 14,074.3 Mn
Geographies covered:	North America: U.S. and Canada Latin America: Brazil, Argentina, Mexico, and Rest of Latin America Europe: Germany, U.K., Spain, France, Italy, Russia, and Rest of Europe Asia Pacific: China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific Middle East: GCC, Israel, and Rest of the Middle East Africa: South Africa, North Africa, and Central Africa
Segments covered:	By Technology: Stem Cell, Biomaterial, Tissue Engineering. By Application: Bone Graft Substitutes, Osteoarticular Diseases, Allogeneic Bones, Autogenic Bones, Others.
Companies covered:	Anika Therapeutics, Inc, Arthrex, Inc., Baxter International, Inc., CONMED Corporation, Johnson & Johnson, Medtronic, Plc, Smith & Nephew plc, Stryker Corporation, Zimmer Holdings, Inc., Aziyo Biologics, and Ortho Regenerative Technologies Inc.
Growth Drivers:	Increasing product approvals and launches by key companies Key companies focusing on research and development of stem and gene therapies Increasing Number of bone and joint disorders and orthopaedic surgeries globally
Restraints & Challenges:	Stringent government regulatory scenario in research and development of regenerative medicines Post implant failures and infections

Global Regenerative Medicine (Bone and Joint) Market- Impact of Coronavirus (Covid-19) Pandemic

The coronavirus (COVID-19) pandemic is the most recent outbreak, which was first reported on December 31, 2019 in Wuhan, China. The World Health Organization declared COVID-19 a pandemic on March 11, 2020.  According to the Coronavirus Disease (COVID-19) Weekly Epidemiological Update by the World Health Organization: January 10, 2021, globally over 109 Million cases were reported on 15^th February 2021.

Moreover, the COVID-19 pandemic has impacted negatively on the clinical trials of various new drug molecules, treatments, and therapies, which is expected to affect the global regenerative medicine (Bone and Joint) market. According to the Indian Journal of Medical Sciences, June 6, 2020, the COVID-19 pandemic has affected the commencement of clinical trials due to unavailability of trial site staff, restrictions for travelling, investigational product availability, and others.

According to National Center for Biotechnology Information (NCBI), April 29, 2020, across the cell and gene therapy sector, research programs and preclinical activities have been disrupted, as the companies have reduced the number of people working on the site to keep them safe. Around 85% of the cell and gene therapy companies’ employees are working from home for several weeks, which is one of the reasons for the delay in the commencement  of the trials. Moreover, lack of laboratory consumables, personal protective equipment (PPE), and reagents are some of the reasons for the delay in the commencement of clinical trials.

According to National Center for Biotechnology Information (NCBI), April 29, 2020, many clinical trials suspended the trial enrolment, in order to minimize the risk of contracting COVID-19 and this has led to the delay in the activation of new clinical trials. Moreover, many companies have already missed the follow-up for the patients already in trials. Furthermore, travel restrictions, patient concerns of contracting coronavirus infection, and others are some of the factors responsible for the withdrawal of patients from the clinical trial.

Figure 2. Global Regenerative Medicine (Bone and Joint) Market Share (%) by Region, 2020

In North America, increasing number of product approvals by regulatory authorities is expected to drive the regenerative medicine (Bone and Joint) market growth in the region, over the forecast period. For instance, in September 2019, Medtronic plc announced U.S. FDA approval of its prospective, randomized pivotal clinical trial for the use of Infuse Bone Graft in Transforaminal Lumbar Interbody Fusion (TLIF) spine procedures. A TLIF is a type of surgery that fuses or joins bones of the spine through a posterior approach.

Moreover, in Europe, market players are focused on opening new manufacturing facilities for research and development of regenerative medicines, in order to expand their geographical footprint, which is expected to create a lucrative environment for the market growth. For instance, on November 3, 2020, Minaris regenerative medicine (Bone and Joint), a contract development and manufacturing organization, announced to open a new facility in Ottobrunn, Germany, for the development and manufacturing services for cell and gene therapies. The new facility will be operational in 2023

Furthermore, regulatory constraints such as companies should follow  good manufacturing practice (GMP) guidelines and good tissue practice (GTP) guidelines while developing regenerative medicines are expected to hinder growth of the global regenerative medicine (bone and joint) market. Human cellular and tissue-based products are considered as biologics. All regenerative medicine products used in bone and joint reconstructive surgeries must meet criteria of good manufacturing practice (GMP) guidelines and good tissue practice (GTP) guidelines. The Office of Cellular, Tissue, and Gene Therapies (OCTGT) of the U.S. FDA regulates and monitors regenerative medicine products in the U.S. OCTGT has the responsibility of monitoring gene therapy, tissue engineering, tissue cellular therapy, and cellular gene therapy products.

Key Players

Major players operating in global regenerative medicine (Bone and Joint) market include Anika Therapeutics, Inc, Arthrex, Inc., Baxter International, Inc., CONMED Corporation, Johnson & Johnson, Medtronic, Plc, Smith & Nephew plc, Stryker Corporation, Zimmer Holdings, Inc., Aziyo Biologics, and Ortho Regenerative Technologies Inc.