The global In Vitro Diagnostics Market is projected to reach USD 87.93 Billion by 2023 from USD 68.12 Billion in 2018, at a CAGR of 5.2%, as per a report by MarketsandMarkets.
How growing significance of companion diagnostics presents an opportunity?
Companion diagnostics include tests or assays intended to assist healthcare providers in making treatment decisions for patients, based on the best response to therapy. The co-development of companion diagnostics with therapeutic products has the potential to significantly alter the drug development process and commercialize drug candidates by yielding safer drugs with enhanced therapeutic efficacy quickly and cost-effectively. With an increase in the demand for high-priced specialist therapies and safer drugs, the market for companion diagnostics has high growth potential. The growing importance of companion diagnostics is also providing growth opportunities for the diagnostics segment and, in turn, the IVD market.
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Pharmaceutical companies are increasingly collaborating with diagnostic companies to make safer and more effective drugs. For instance, in October 2016, HTG Molecular Diagnostics Inc. (US) and Merck KGaA (Germany) entered into a comprehensive companion diagnostics master agreement. Similarly, in November 2015, Thermo Fisher Scientific Inc. (US) entered into an agreement with Novartis International AG (Switzerland) and Pfizer Inc. (US) to develop an NGS companion diagnostic oncology test.
Why operational barriers faced in conducting diagnostic tests is a challenge?
Clinical laboratories across major markets are still evolving; technicians face operational challenges in ensuring effective sample procurement, storage, and transportation, especially while adopting novel technologies such as NGS and lab-on-a-chip PCR devices. Laboratory space also needs to be reconfigured to meet the requirements of conducting specific molecular diagnostic tests used for pathogen detection, as a means of avoiding cross-contamination and ensuring efficient time management. This results in considerable cost escalation to maintain and operate advanced molecular diagnostic instruments, particularly those capable of handling a single sample type. Furthermore, due to the rapid mutation of microbes and the increasing outbreak of epidemics, clinical laboratories need to adopt innovative technologies capable of rapid sample diagnosis. However, the dearth of skilled and technically knowledgeable laboratory technicians to operate advanced molecular diagnostic products has hindered their overall adoption, particularly in emerging markets.
In addition, a reluctance to move from manual operations towards automation is another challenge for market growth. Many providers find it difficult to make the transition to IT-based approaches from manual or traditional approaches, or may not prefer to make the shift at all.
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