Hip Replacement Market Analysis

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2. HIP REPLACEMENT MARKET ANALYSIS Hip Replacement Market, By Product Type (Total Hip Replacement Implant, Partial Hip Replacement Implant, Hip Resurfacing, Revision Hip Implants), By Components (Hip Stem Systems, Acetabular Cup Systems, Revision Accessories and Components), By End User (Hospitals, Orthopedic Clinics, Ambulatory Surgical Centers), and By Region (North America, Latin America, Europe, Asia Pacific, Middle East & Africa) - Size, Share, Outlook, and Opportunity Analysis, 2019 - 2027

3. Statistics: • The global hip replacement market is estimated to account for US$ 10,311.3 Mn in terms of value by the end of 2027. • Global Hip Replacement Market: Drivers • Increasing prevalence of musculoskeletal disorders is expected to boost growth of the global hip replacement market over the forecast period. For instance, according to the study, ‘Osteoarthritis year in review 2019: epidemiology and therapy’, published in the journal Osteoarthritis and Cartilage in January 2020, the median proportion of years lived with disability due to musculoskeletal disorders increased from 11.8% in 2000 to 13.5% (9.6–16.6) in 2015. • North America region held dominant position in the global hip replacement market in 2014, accounting for 45.5% share in terms of value, followed by Europe.

4. Figure 1. Global Hip Replacement Market Share (%), by Region, 2019

5. . • Global Hip Replacement Market: Restraints • Stringent regulator scenario regarding marketing of hip replacement is expected to hinder growth of the market. For instance, from May 2016, the U.S. FDA mandated that all manufacturers of metal-on-metal total hip implants are required to stop marketing their devices and submit premarket approvals for approval before marketing the devices. • Moreover, high cost of hip implant products and surgeries is expected to hamper growth of the market. For instance, hip replacement surgery costs around US$ 20,000 to US$ 60,000 in the U.S.

6. Opportunities  Increasing geriatric population is expected to offer lucrative growth opportunities for players in the global hip replacement market. For instance, according to the World Health Organization, geriatric population is expected to reach 2 billion by 2050, up from 900 million in 2015 Total Hip Replacement Implant segment in the global hip replacement market was valued at US$ 4,179.1 Mn in 2019and is expected to reach US$ 6,112.4 Mn by 2027 at a CAGR of 4.9% during the forecast period.

7. Market Trends • The U.S. FDA has not approved any metal-on-metal total hip replacement devices for use in the US. There are two FDA-approved metal-on-metal hip resurfacing devices available, one of which was developed by Smith & Nephew. • Global Hip Replacement Market: Competitive Landscape  • Major players operating in the global hip replacement market include, Depuy Synthes (Johnson & Johnson), Microport Scientific Corporation, Zimmer Biomet, Exactech Inc., DJO Global Inc., Stryker Corporation, B. Braun Melsungen, and Smith & Nephew. • Global Hip Replacement Market: Key Developments • Major players in the market are focused on expanding their service portfolio. For instance, in February 2020, Smith & Nephew announced 'Positive Connections', a turnkey service to support healthcare providers that are focused on offering increased access for orthopedic cases to Ambulatory Surgery Centers (ASCs) and other outpatient settings.

8. Regulations • U.S. • Section 501(a)(2)(B) of the FD&C Act; 21 CFR parts 210 and 211; and 21 CFR part 600 • All manufacturing facilities to ensure compliance with cGMP regulations • cGMP includes the implementation of oversight and controls over the manufacture of drugs to ensure quality, including managing the risk of and establishing the safety of raw materials, materials used in the manufacturing of drugs, and finished drug products. • 21 CFR 211.22(d) • Requirement of the quality unit of a pharmaceutical company to monitor adherence to regulations by a CMO • When a pharmaceutical company uses a contract facility, their quality unit is legally responsible for approving or rejecting drug products manufactured by the contract facility, including for final release. The regulations require that the quality unit’s responsibilities and procedures be in writing and that they be followed. Quality agreements should clearly describe the materials or services to be provided, quality specifications, and communication mechanisms between the owner and contract facility.

9. Value Chain Analysis -

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