Needs and market

Standard techniques for endoscopic sampling of submucosal (deep) tumors are currently carried out using biopsy forceps (with “alligator jaw”). The test material obtained from this methodology, however, is limited because the instrument only takes superficial samples. Poor quality or not representative tissue samples leads to uncertain diagnosis. If diagnosis is not obtained, sampling continues with more advanced methods; ultrasound-guided fine needle or x-ray-guided biopsy with coarser needles from the outside and through the body. The last resort is to operate the patient without established diagnosis. Fine needle aspiration provides limited information because they do not capture enough cohesive tissue. X-ray-guided biopsies, and not least surgery without diagnosis, are risky and resource-intensive alternatives. In the field of health care, it is generally known that there is no existing instrument or method that fully meets the requirements for diagnosis of deep growing tumors.[1]

In line with modern tailor-made treatment protocols for different tumor forms, there is an increasing demand for accurate diagnosis before treatment begins. Here, BiBBInstruments assesses that the EndoDrill® technology, through its in-depth function and precision, meets an important clinical need.

The global endoscope and associated equipment market has an annual turnover of SEK 225 billion, of which approximately 30% of the market (approximately SEK 70 billion), including BiBBInstrument’s products, consists of endoscopy accessories. The USA is by far the most important market and accounts for about 45% of global sales[2]. Global medical technology groups such as Olympus, Boston Scientific, Cook Medical and Medtronic dominate the market. There are more than 30 competitors in this market segment.

Globally, approximately 7 million patients suffer from cancer of the lung, stomach, intestine, breast and prostate, that is EndoDrill’s® target market[3] . The number of biopsies is considerably larger; for example, approximately 70 million biopsy forceps are sold globally every year.[4] In the USA alone, the Company estimates that more than 1 million GI biopsies (gastrointestinal), and approximately 3 million breast and prostate biopsies are performed each year. GI examinations grow the fastest and represent the largest area. The company’s first biopsy instrument EndoDrill® GI Upper is found in this segment.

The endoscope accessories market is expected to grow from approximately SEK 66 billion in 2013 to approximately SEK 92 billion in 2018 (CAGR approximately 7%).[5] Accessories are the largest segment and growing the fastest on the endoscopic market, and there is a huge number of different types of instruments on the market. The driving factors are primarily increased investments, rising numbers of hospitals and the growing incidence of diseases that require endoscopic examination together with an aging population. More specifically, the numbers of endoscopic examinations are increasing, as these constitute a non-invasive alternative to surgery and new technological innovations drive growth.

[1] European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline – Updated January 2017
[2] Frost & Sullivan 2014
[3] International Agency for Research on Cancer; 2014
[4] QYR Reseach Center 2015
[5] Frost & Sullivan 2014.