IDEAS home Printed from https://ideas.repec.org/a/inm/ormnsc/v69y2023i3p1449-1467.html
   My bibliography  Save this article

Manufacturing and Regulatory Barriers to Generic Drug Competition: A Structural Model Approach

Author

Listed:
  • Yixin (Iris) Wang

    (Gies College of Business, University of Illinois Urbana–Champaign, Champaign, Illinois 61820)

  • Jun Li

    (Ross School of Business, University of Michigan, Ann Arbor, Michigan 48109)

  • Ravi Anupindi

    (Ross School of Business, University of Michigan, Ann Arbor, Michigan 48109)

Abstract

Understanding the drivers of market concentration in the generic pharmaceutical industry is essential to guaranteeing the availability of low-cost generics. In this paper, we develop a structural model to capture the multiple determinants governing manufacturers’ entry decisions; in particular, we focus on how manufacturing complexity and the regulatory environment for generics approval affect concentration in drug markets. We estimate the model using data collated from six disparate sources. We find that manufacturing complexity, as reflected in the number of active ingredients, for example, significantly reduces the likelihood of generics entry. Moreover, the delay in the review process for the generics applications significantly affects the number of firms entering a market. Our policy simulations suggest that a shortened drug approval review time significantly increases the average number of entrants per market and reduces the fraction of markets with no generics entry; however, a notable portion of markets would still lack any generic competition.

Suggested Citation

  • Yixin (Iris) Wang & Jun Li & Ravi Anupindi, 2023. "Manufacturing and Regulatory Barriers to Generic Drug Competition: A Structural Model Approach," Management Science, INFORMS, vol. 69(3), pages 1449-1467, March.
    • Handle: RePEc:inm:ormnsc:v:69:y:2023:i:3:p:1449-1467
    DOI: 10.1287/mnsc.2022.4423
    as

    Download full text from publisher

    File URL: http://dx.doi.org/10.1287/mnsc.2022.4423
    Download Restriction: no
    File URL: https://libkey.io/10.1287/mnsc.2022.4423?utm_source=ideas
    LibKey link: if access is restricted and if your library uses this service, LibKey will redirect you to where you can use your library subscription to access this item
    ---><---

    References listed on IDEAS

    as
    1. I.P.L. Png & David Reitman, 1994. "Service Time Competition," RAND Journal of Economics, The RAND Corporation, vol. 25(4), pages 619-634, Winter.
    2. Hansen, Lars Peter, 1982. "Large Sample Properties of Generalized Method of Moments Estimators," Econometrica, Econometric Society, vol. 50(4), pages 1029-1054, July.
    3. Richard G. Frank & David S. Salkever, 1997. "Generic Entry and the Pricing of Pharmaceuticals," Journal of Economics & Management Strategy, Wiley Blackwell, vol. 6(1), pages 75-90, March.
    4. Federico Ciliberto & Elie Tamer, 2009. "Market Structure and Multiple Equilibria in Airline Markets," Econometrica, Econometric Society, vol. 77(6), pages 1791-1828, November.
    5. Zhaohui (Zoey) Jiang & Yan Huang & Damian R. Beil, 2022. "The Role of Feedback in Dynamic Crowdsourcing Contests: A Structural Empirical Analysis," Management Science, INFORMS, vol. 68(7), pages 4858-4877, July.
    6. McFadden, Daniel, 1989. "A Method of Simulated Moments for Estimation of Discrete Response Models without Numerical Integration," Econometrica, Econometric Society, vol. 57(5), pages 995-1026, September.
    7. Ken Moon & Kostas Bimpikis & Haim Mendelson, 2018. "Randomized Markdowns and Online Monitoring," Management Science, INFORMS, vol. 64(3), pages 1271-1290, March.
    8. Marcelo Olivares & Christian Terwiesch & Lydia Cassorla, 2008. "Structural Estimation of the Newsvendor Model: An Application to Reserving Operating Room Time," Management Science, INFORMS, vol. 54(1), pages 41-55, January.
    9. Berry, Steven T, 1992. "Estimation of a Model of Entry in the Airline Industry," Econometrica, Econometric Society, vol. 60(4), pages 889-917, July.
    10. Senthil Veeraraghavan & Laurens Debo, 2009. "Joining Longer Queues: Information Externalities in Queue Choice," Manufacturing & Service Operations Management, INFORMS, vol. 11(4), pages 543-562, April.
    11. Patrick Bajari & Han Hong & Stephen P. Ryan, 2010. "Identification and Estimation of a Discrete Game of Complete Information," Econometrica, Econometric Society, vol. 78(5), pages 1529-1568, September.
    12. Vidya Mani & Saravanan Kesavan & Jayashankar M. Swaminathan, 2015. "Estimating the Impact of Understaffing on Sales and Profitability in Retail Stores," Production and Operations Management, Production and Operations Management Society, vol. 24(2), pages 201-218, February.
    13. Robert L. Bray & Haim Mendelson, 2012. "Information Transmission and the Bullwhip Effect: An Empirical Investigation," Management Science, INFORMS, vol. 58(5), pages 860-875, May.
    14. George Ball & Enno Siemsen & Rachna Shah, 2017. "Do Plant Inspections Predict Future Quality? The Role of Investigator Experience," Manufacturing & Service Operations Management, INFORMS, vol. 19(4), pages 534-550, October.
    15. Aguirregabiria, Victor & Ho, Chun-Yu, 2012. "A dynamic oligopoly game of the US airline industry: Estimation and policy experiments," Journal of Econometrics, Elsevier, vol. 168(1), pages 156-173.
    16. Rena M. Conti & Ernst R. Berndt, 2020. "Four Facts Concerning Competition in US Generic Prescription Drug Markets," International Journal of the Economics of Business, Taylor & Francis Journals, vol. 27(1), pages 27-48, January.
    17. Marcelo Olivares & Gabriel Y. Weintraub & Rafael Epstein & Daniel Yung, 2012. "Combinatorial Auctions for Procurement: An Empirical Study of the Chilean School Meals Auction," Management Science, INFORMS, vol. 58(8), pages 1458-1481, August.
    18. Grabowski, Henry G & Vernon, John M, 1992. "Brand Loyalty, Entry, and Price Competition in Pharmaceuticals after the 1984 Drug Act," Journal of Law and Economics, University of Chicago Press, vol. 35(2), pages 331-350, October.
    19. Glenn Ellison & Sara Fisher Ellison, 2011. "Strategic Entry Deterrence and the Behavior of Pharmaceutical Incumbents Prior to Patent Expiration," American Economic Journal: Microeconomics, American Economic Association, vol. 3(1), pages 1-36, February.
    20. Deacon, Robert T & Sonstelie, Jon, 1985. "Rationing by Waiting and the Value of Time: Results from a Natural Experiment," Journal of Political Economy, University of Chicago Press, vol. 93(4), pages 627-647, August.
    21. Andrew T. Ching, 2010. "A Dynamic Oligopoly Structural Model For The Prescription Drug Market After Patent Expiration," International Economic Review, Department of Economics, University of Pennsylvania and Osaka University Institute of Social and Economic Research Association, vol. 51(4), pages 1175-1207, November.
    22. Zeynep Akşin & Barış Ata & Seyed Morteza Emadi & Che-Lin Su, 2013. "Structural Estimation of Callers' Delay Sensitivity in Call Centers," Management Science, INFORMS, vol. 59(12), pages 2727-2746, December.
    23. Amir Karimi & Anant Mishra & Karthik V. Natarajan & Kingshuk K. Sinha, 2021. "Managing Commodity Stock‐outs in Public Health Supply Chains in Developing Countries: An Empirical Analysis," Production and Operations Management, Production and Operations Management Society, vol. 30(9), pages 3116-3142, September.
    24. Gad Allon & Awi Federgruen & Margaret Pierson, 2011. "How Much Is a Reduction of Your Customers' Wait Worth? An Empirical Study of the Fast-Food Drive-Thru Industry Based on Structural Estimation Methods," Manufacturing & Service Operations Management, INFORMS, vol. 13(4), pages 489-507, October.
    25. Sang Won Kim & Marcelo Olivares & Gabriel Y. Weintraub, 2014. "Measuring the Performance of Large-Scale Combinatorial Auctions: A Structural Estimation Approach," Management Science, INFORMS, vol. 60(5), pages 1180-1201, May.
    26. Robert L. Bray & Haim Mendelson, 2015. "Production Smoothing and the Bullwhip Effect," Manufacturing & Service Operations Management, INFORMS, vol. 17(2), pages 208-220, May.
    27. Jun Li & Nelson Granados & Serguei Netessine, 2014. "Are Consumers Strategic? Structural Estimation from the Air-Travel Industry," Management Science, INFORMS, vol. 60(9), pages 2114-2137, September.
    28. Bresnahan, Timothy F. & Reiss, Peter C., 1991. "Empirical models of discrete games," Journal of Econometrics, Elsevier, vol. 48(1-2), pages 57-81.
    Full references (including those not matched with items on IDEAS)

    Most related items

    These are the items that most often cite the same works as this one and are cited by the same works as this one.
    1. Ken Moon & Kostas Bimpikis & Haim Mendelson, 2018. "Randomized Markdowns and Online Monitoring," Management Science, INFORMS, vol. 64(3), pages 1271-1290, March.
    2. Teck-Hua Ho & Noah Lim & Sadat Reza & Xiaoyu Xia, 2017. "OM Forum—Causal Inference Models in Operations Management," Manufacturing & Service Operations Management, INFORMS, vol. 19(4), pages 509-525, October.
    3. Christian Terwiesch & Marcelo Olivares & Bradley R. Staats & Vishal Gaur, 2020. "OM Forum—A Review of Empirical Operations Management over the Last Two Decades," Manufacturing & Service Operations Management, INFORMS, vol. 22(4), pages 656-668, July.
    4. Wang, Yafeng & Graham, Brett, 2010. "Simulation Based Estimation of Discrete Sequential Move Games of Perfect Information," MPRA Paper 23153, University Library of Munich, Germany.
    5. Sang Won Kim & Marcelo Olivares & Gabriel Y. Weintraub, 2014. "Measuring the Performance of Large-Scale Combinatorial Auctions: A Structural Estimation Approach," Management Science, INFORMS, vol. 60(5), pages 1180-1201, May.
    6. Jason R. Blevins, 2015. "Structural Estimation Of Sequential Games Of Complete Information," Economic Inquiry, Western Economic Association International, vol. 53(2), pages 791-811, April.
    7. Kostas Bimpikis & Wedad J. Elmaghraby & Ken Moon & Wenchang Zhang, 2020. "Managing Market Thickness in Online Business-to-Business Markets," Management Science, INFORMS, vol. 66(12), pages 5783-5822, December.
    8. Hector Perez-Saiz, 2015. "Building new plants or entering by acquisition? Firm heterogeneity and entry barriers in the U.S. cement industry," RAND Journal of Economics, RAND Corporation, vol. 46(3), pages 625-649, September.
    9. Michaela Draganska & Sanjog Misra & Victor Aguirregabiria & Pat Bajari & Liran Einav & Paul Ellickson & Dan Horsky & Sridhar Narayanan & Yesim Orhun & Peter Reiss & Katja Seim & Vishal Singh & Raphael, 2008. "Discrete choice models of firms’ strategic decisions," Marketing Letters, Springer, vol. 19(3), pages 399-416, December.
    10. Brett A. Hathaway & Seyed M. Emadi & Vinayak Deshpande, 2021. "Don’t Call Us, We’ll Call You: An Empirical Study of Caller Behavior Under a Callback Option," Management Science, INFORMS, vol. 67(3), pages 1508-1526, March.
    11. Ching, Andrew T., 2010. "Consumer learning and heterogeneity: Dynamics of demand for prescription drugs after patent expiration," International Journal of Industrial Organization, Elsevier, vol. 28(6), pages 619-638, November.
    12. Ken Moon & Patrick Bergemann & Daniel Brown & Andrew Chen & James Chu & Ellen A. Eisen & Gregory M. Fischer & Prashant Loyalka & Sungmin Rho & Joshua Cohen, 2023. "Manufacturing Productivity with Worker Turnover," Management Science, INFORMS, vol. 69(4), pages 1995-2015, April.
    13. Federico Ciliberto & Elie Tamer, 2009. "Market Structure and Multiple Equilibria in Airline Markets," Econometrica, Econometric Society, vol. 77(6), pages 1791-1828, November.
    14. Christian Bontemps & Raquel Menezes Bezerra Sampaio, 2020. "Entry games for the airline industry," Post-Print hal-02137358, HAL.
    15. Maruyama, Shiko, 2014. "Estimation of finite sequential games," Journal of Econometrics, Elsevier, vol. 178(2), pages 716-726.
    16. Yuko Onishi & Yasuhiro Omori, 2016. "Bayesian Estimation of Entry Games with Multiple Players and Multiple Equilibria," The Japanese Economic Review, Springer, vol. 67(4), pages 418-440, December.
    17. Larry G. Epstein & Hiroaki Kaido & Kyoungwon Seo, 2016. "Robust Confidence Regions for Incomplete Models," Econometrica, Econometric Society, vol. 84, pages 1799-1838, September.
    18. Wang, Yafeng & Graham, Brett, 2010. "Identification and Estimation of a Discrete Game by Observing its Correlated Equilibria," MPRA Paper 45656, University Library of Munich, Germany, revised 16 May 2011.
    19. Aradillas-Lopez, Andres, 2012. "Pairwise-difference estimation of incomplete information games," Journal of Econometrics, Elsevier, vol. 168(1), pages 120-140.
    20. A. Orhun, 2013. "Spatial differentiation in the supermarket industry: The role of common information," Quantitative Marketing and Economics (QME), Springer, vol. 11(1), pages 3-37, March.

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:inm:ormnsc:v:69:y:2023:i:3:p:1449-1467. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    If CitEc recognized a bibliographic reference but did not link an item in RePEc to it, you can help with this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: Chris Asher (email available below). General contact details of provider: https://edirc.repec.org/data/inforea.html .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.