12 Billion Dollar Market for In Vitro Diagnostic Test Contract Manufacturing

Press Release
Aug 15, 2018
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Rockville (MD), August 15, 2018 — The IVD industry is large and growing and so is the market for those who handle outsourcing tasks or secure materials for IVD companies. Valued at more than $12 billion in 2017, the global contract in vitro diagnostic (IVD) manufacturing segment is well positioned for long-term growth. Several trends and factors will boost the revenue potential of this business. Contract IVD companies will also derive significant demand from the production of private label and non-branded reagents, test kits, and instruments for medical supply wholesalers and retailers. This is according to healthcare market research firm Kalorama Information and their market study on the topic, Contract Manufacturing in IVD.

The range of contract IVD manufacturing activities available globally extends to most types of reagents, instruments, and related accessories. The large-scale production of antigens and monoclonal antibodies for immunoassays has emerged as a major application served by the business. Other IVD products widely supplied by contract manufacturers include blood glucose monitors and test strips, clinical chemistry reagents, chromogenic media, and amplified DNA probes. The business is also a major source of microwells, trays, and other custom packaging systems as well as OEM instrument components such as sensors and microfluidic devices.

“Most leading worldwide of producers of proprietary IVD systems will increase their reliance on outside contractors as a cost effective means to expand product lines, broaden manufacturing capacity and capabilities, and serve selected customers,” said Bruce Carlson, Publisher of Kalorama Information.

The report made the following observations:

  • Through 2022, the global contract IVD manufacturing market is projected to expand 6.0% per year to $16.2 billion. Gains will exceed the average pace of the overall IVD industry as participants in the business shift their strategic focus toward higher value-added products and procedures.

  • While point of care (POC) and core laboratory testing applications will continue to hold the largest shares of worldwide revenues posted by contract IVD companies, advanced molecular and histology/cytology offerings will account for much faster revenue growth.

  • The advanced, diversified IVD industries of the United States, Western Europe, and Japan, along with the emerging IVD industries of China and India, account for more than 90% of global contract IVD manufacturing revenues.

  • In developed markets, outside contractors are assuming an increasing role in the commercialization and production of both specialty and commodity products for major IVD producers such as Roche Diagnostics and Thermo.

  • Reflecting the concentrated nature of the industry, the developed countries will account for nearly 75% of the value of IVD products shipped globally in 2022. This share will partially reflect the impact of new product introductions and product line extensions.
  • In addition, small producers of IVD reagents and instruments in the developing countries will experience difficulty in expanding exports to the developed world due to regulatory obstacles and the strong competitive positions held by the top 15 industry leaders.

The extent of demand and growth opportunities for contract IVD manufacturing within a country or region is determined primarily by the level and mix of reagent, instrument, and related product production. Global IVD production is dominated by multinational concerns headquartered in the United States, Western Europe and Japan. These companies, which include Abbott Laboratories, Beckman Coulter (Danaher), Becton Dickinson, bioMerieux, Ortho-Clinical Diagnostics, Roche Diagnostics, Siemens Healthineers, Sysmex and Thermo Fisher Scientific, control more than three-fourths of the worldwide IVD market and are responsible for the vast majority of industry innovations and technological advances.

About Kalorama Information

Kalorama Information, a division of MarketResearch.com, supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services. Reports can be purchased through Kalorama’s website and are also available on www.marketresearch.com and www.profound.com.

We routinely assist the media with healthcare topics. Follow us on Twitter, LinkedIn and our blog at www.kaloramainformation.com.

Please link any media or news references to our reports or data to https://www.kaloramainformation.com/.

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